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Drug Category: Oncology Agents

Medication Class/Individual Agents: Antineoplastics

I. Prior-Authorization Requirements

 Alkylating Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

bendamustine Belrapzo test   IV  

    

 
bendamustine Bendeka test   IV  
bendamustine Treanda test   IV  
bendamustine test   IV  
busulfan injection Busulfex # test   IV  
busulfan tablet Myleran test   PO  
carboplatin test   IV  
carmustine Bicnu # test   IV/ Implantation  
chlorambucil Leukeran test   PO  
cisplatin test   IV  
cyclophosphamide test   IV  
dacarbazine test   IV  
estramustine Emcyt test   PO  
ifosfamide Ifex # test   IV  
mechlorethamine gel Valchlor test   Topical  
mechlorethamine injection Mustargen test   IV  
melphalan hydrochloride injection Alkeran # test   IV  
melphalan injection Evomela test   IV  
melphalan tablet Alkeran # test   PO  
oxaliplatin test   IV  
procarbazine Matulane test   PO  
temozolomide Temodar # test   IV / PO  

 Anthracenediones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

mitoxantrone Novantrone # test   IV  

   

 

 Anthracyclines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

arsenic trioxide Trisenox test   IV  

      

 
daunorubicin, conventional test   IV  
doxorubicin Adriamycin # test   IV  
doxorubicin liposomal injection Doxil # test   IV  
epirubicin Ellence # test   IV  
idarubicin test   IV  
streptozocin Zanosar test   IV  
teniposide Vumon test   IV  
valrubicin Valstar test   Intravesically  

 Anti-VEGF

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

bevacizumab Avastin PA   IV  

Avastin for cervical cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be given concurrently with one of the following:
      • paclitaxel and cisplatin; or
      • paclitaxel and topotecan.

Avastin for glioblastoma and ovarian cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Avastin for metastatic colorectal cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a regimen containing 5-fluorouracil; or
    • all of the following:
      • requested agent will be given concurrently with either fluoropyrimidine-irinotecan-containing or fluoropyrimidine-oxaliplatin-containing chemotherapy; and
      • member progressed on a treatment containing bevacizumab.

Avastin for metastatic renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • if predominant clear cell histology, requested agent will be given concurrently with interferon alfa.

Avastin for non-squamous non-small cell lung cancer (NSCLC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be given concurrently with carboplatin and paclitaxel.

Zaltrap

  • Documentation of the following is required:
    • diagnosis of metastatic colorectal cancer; and
    • prescriber is a specialist; and
    • appropriate dosing; and
    • requested agent will be given concurrently with either irinotecan or FOLFIRI; and
    • a previous trial with one of the following regimens or a contraindication to all of the following regimens: a fluoropyrimidine (capecitabine or fluorouracil), CAPEOX, FOLFOX; and
    • clinical rationale for use of requested agent instead of Avastin (bevacizumab).
 
ziv-aflibercept Zaltrap PA   IV  

 Antiandrogens

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

abiraterone 125 mg Yonsa PA   PO  

abiraterone 250 mg, 500 mg

  • Documentation of the following is required:
    • diagnosis of metastatic prostate cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • if member has metastatic high-risk castration-sensitive prostate cancer, then medication will be used in combination with prednisone and one of the following:
      • medication will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Erleada

  • Documentation of the following is required:
    • diagnosis of non-metastatic castration-resistant prostate cancer (NM-CRPC); and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with a gonadotropin-releasing hormone (GnRH) analog; or
      • member had a bilateral orchiectomy.

Xtandi for metastatic prostate cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Xtandi for NM-CRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with a gonadotropin-releasing hormone (GnRH) analog; or
      • member had a bilateral orchiectomy.

Yonsa

  • Documentation of the following is required:
    • diagnosis of metastatic prostate cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with methylprednisolone; and
    • one of the following:
      • medication will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.
 
abiraterone 250 mg, 500 mg Zytiga BP PA   PO  
apalutamide Erleada PA   PO  
bicalutamide Casodex # test   PO  
enzalutamide Xtandi PA   PO  
flutamide test   PO  
nilutamide Nilandron # test   PO  

 Antibiotics

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

bleomycin test   IV / IM / SC  

    

 
dactinomycin Cosmegen # test   IV  
mitomycin injection test   IV  

 Antiestrogen

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

tamoxifen solution Soltamox PA   PO  

Soltamox for metastatic breast cancer in women and men, node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, or breast irradiation, invasive breast cancer in women with ductal carcinoma in situ (DCIS), and women at high risk for breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • medical necessity for oral tamoxifen solution formulation (i.e., dysphagia).
 
tamoxifen tablet test   PO  

 Antimetabolites

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

capecitabine Xeloda BP test   PO  

Arranon

  • Documentation of the following is required:
    • diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL); and
    • prescriber is an oncologist; and
    • appropriate dosing.

Purixan

  • Documentation of the following is required:
    • diagnosis of acute lymphoblastic leukemia (ALL); and
    • one of the following:
      • member is < 13 years of age; or
      • medical necessity for the use of an oral suspension formulation (e.g. swallowing disorder).

SmartPA: Claims for Purixan (mercaptopurine oral suspension) will usually process at the pharmacy without a PA request if the member has a MassHealth history of medical claims for acute lymphoblastic leukemia and the member is < 13 years of age.

 
cladribine test   IV  
clofarabine Clolar # test   IV  
cytarabine test   IV  
floxuridine test   Intra-arterial  
fludarabine test   IV  
fluorouracil injection Adrucil # test   IV  
gemcitabine Gemzar # test   IV  
hydroxyurea Hydrea # test   PO  
mercaptopurine oral suspension Purixan PA   PO  
mercaptopurine tablet test   PO  
methotrexate injection test   IM / IV / Intra-arterial  
methotrexate tablet test   PO  
nelarabine Arranon PA   IV  
pemetrexed Alimta test   IV  
pentostatin test   IV  
pralatrexate Folotyn test   IV  
thioguanine Tabloid test   PO  

 Antimicrotubulars

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

cabazitaxel Jevtana PA   IV  

Jevtana

  • Documentation of the following is required:
    • diagnosis of metastatic prostate cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one docetaxel-containing regimen.
 
ixabepilone Ixempra test   IV  
paclitaxel injectable suspension Abraxane test   IV  
paclitaxel injection test   IV  

 Aromatase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

anastrozole Arimidex # test   PO  

   

 
exemestane Aromasin # test   PO  
letrozole Femara # test   PO  

 Asparaginase

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

asparaginase erwinia chrysanthemi Erwinaze ^ PA   IM  

 Erwinaze

  • Documentation of the following is required:
    • diagnosis of acute lymphoblastic leukemia; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of hypersensitivity to E. coli-derived asparaginase (i.e., Oncaspar).
 
pegaspargase Oncaspar ^ test   IM or IV  

 CD123-Directed Cytotoxins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

tagraxofusp-erzs Elzonris PA   IV  

Elzonris

  • Documentation of the following is required:
    • diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • first infusion will take place in an inpatient setting, and subsequent infusions may take place in an outpatient setting with appropriate monitoring.
 

 DNA Methylation Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

azacitidine Vidaza # test   IV / SC  

   

 
decitabine Dacogen # test   IV  

 Estrogen Receptor Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

fulvestrant Faslodex PA   IM  

fulvestrant in postmenopausal women

  • Documentation of the following is required:
    • diagnosis of hormone receptor-positive metastatic breast cancer with disease progression following antiestrogen therapy; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to one aromatase inhibitor; or
      • inadequate response, adverse reaction, or contraindication to tamoxifen or toremifene; or
      • member is unable to take oral medications.

fulvestrant in premenopausal women

  • Documentation of the following is required:
    • diagnosis of hormone receptor-positive metastatic breast cancer with disease progression following antiestrogen therapy; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with ovarian ablation/suppression; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to one aromatase inhibitor; or
      • inadequate response, adverse reaction, or contraindication to tamoxifen or toremifene; or
      • member is unable to take oral medications.
 

 Hedgehog Pathway Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

glasdegib Daurismo PA   PO  

Daurismo

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with low dose cytarabine; and
    • request is within quantity limit of 30 units/30 days; and
    • one of the following:
      • member is ≥ 75 years of age; or
      • member is ≥ 60 years of age and one of the following:
        • member is not a candidate for intensive induction chemotherapy; or
        • member has significant comorbidities that preclude the use of intensive induction chemotherapy.

Erivedge and Odomzo

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dose; and
    • member is ≥ 18 years of age; and
    • member has persistent or recurring basal cell carcinoma following surgery and/or radiation therapy; or
    • member is not a candidate for surgery and/or radiation therapy.
 
sonidegib Odomzo PA   PO  
vismodegib Erivedge PA   PO  

 Histone Deacetylase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

belinostat Beleodaq PA   IV  

Beleodaq and romidepsin for peripheral T-cell lymphoma (PTCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one second-line treatment option; or
      • contraindication to all second-line treatment options.

Farydak

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response to bortezomib; and
    • quantity limit of six capsules for a 21 day supply; and
    • concomitant therapy with bortezomib and dexamethasone; and
    • inadequate response or adverse reaction to one of the following immunomodulatory agents or contraindication to all of the following immunomodulatory agents:
      • Revlimid (lenalidomide); or
      • Thalomid (thalidomide); or
      • Pomalyst (pomalidomide).

romidepsin for cutaneous T-cell lymphoma (CTCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist, hematologist or dermatologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to Zolinza (vorinostat); and
    • inadequate response, adverse reaction, or contraindication to one of the following agents:
      • Interferon (Actimmune or Intron A); or
      • bexarotene capsules.
 
panobinostat Farydak PA   PO  
romidepsin Istodax PA   IV  
vorinostat Zolinza test   PO  

 Immunomodulator/Immunosuppressant

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

lenalidomide Revlimid PA   PO  

Pomalyst

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • quantity limit of 21 capsules for a 28 day supply; and
    • inadequate response, adverse reaction or contraindication to Revlimid (lenalidomide); and
    • inadequate response or adverse reaction to one of the following proteasome inhibitors or contraindication to both proteasome inhibitors:
      • bortezomib; or
      • Kyprolis (carfilzomib); or
      • Ninlaro (ixazomib).

 

Revlimid

  • Documentation of the following is required:
    • diagnosis of multiple myeloma, myelodysplastic syndrome, or mantle cell lymphoma (MCL); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • if the request is for the 2.5 mg, 5 mg, or 10 mg strength, quantity limit of 28 capsules for a 28 day supply; or
    • if the request is for the 15 mg, 20 mg, or 25 mg strength, quantity limit of 21 capsules for a 28 day supply.

SmartPA: Claims within quantity limits for Revlimid (lenalidomide) will usually process at the pharmacy without a PA request if the member has a MassHealth history of medical claims for multiple myeloma.

 
pomalidomide Pomalyst PA   PO  
thalidomide Thalomid test   PO  

 Interferon

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

interferon gamma-1b Actimmune test   SC  

     

 

 Interleukin

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

aldesleukin Proleukin test   IV  

                                                                                 

 

 Kinase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

abemaciclib Verzenio PA   PO  

 Alecensa

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer that is anaplastic lymphoma kinase (ALK)-positive; and
    • request is within quantity limit of 240 units/30 days.

Aliqopa

  • Documentation of the following is required:
    • diagnosis of follicular lymphoma (FL); and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of FL with at least two systemic therapies.

Alunbrig

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is anaplastic lymphoma kinase (ALK)-positive; and
    • one of the following:
      • if the request is for the 30 mg tablet, quantity limit of 60 units for a 30 day supply; or
      • if the request is for the 90 mg or 180 mg tablet, or the 90 mg-180 mg tablet pack, quantity limit of 30 units for a 30 day supply.

Balversa

  • Documentation of the following is required:
    • diagnosis of FGFR3- or FGFR2-mutated locally advanced or metastatic urothelial carcinoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has received prior treatment with platinum-containing chemotherapy or is not a candidate for platinum-containing chemotherapy.

Braftovi

  • Documentation of the following is required:  
    • diagnosis of unresectable or metastatic melanoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation; and
    • documentation that the agent will be used in combination with Mektovi (binimetinib).

Calquence

  • Documentation of the following is required:  
    • diagnosis of MCL; and
    • member ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of MCL.

Copiktra for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of CLL/SLL with at least two prior therapies.

Copiktra for FL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of FL with at least two systemic therapies.

Cotellic

  • Documentation of the following is required:  
    • diagnosis of unresectable or metastatic melanoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation; and
    • documentation that the agent will be used in combination with Zelboraf (vemurafenib).

Ibrance for HER2-negative, ER-positive breast cancer in women

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • concurrent therapy with letrozole and member is postmenopausal; or
      • concurrent therapy with fulvestrant and one of the following:
        • inadequate response, adverse reaction, or contraindication to at least one aromatase inhibitor and member is postmenopausal; or
        • inadequate response, adverse reaction, or contraindication to tamoxifen or toremifene and member is premenopausal or perimenopausal.

Ibrance for HER2-negative, ER-positive breast cancer in men

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • concurrent therapy with an aromatase inhibitor.

Kisqali

  • Documentation of the following is required:
    • diagnosis of HER2-negative ER-positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member is postmenopausal and the requested agent will be used in combination with anastrozole, exemestane, fulvestrant, or letrozole; or
      • member is pre/perimenopausal, received ovarian ablation or suppression, and the requested agent will be used in combination with anastrozole, exemestane, or letrozole.

Kisqali-Femara Co-Pack

  • Documentation of the following is required:
    • diagnosis of HER2-negative ER-positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is postmenopausal.

Lenvima for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested regimen includes everolimus; and
    • request is within quantity limit of 90 units/30 days; and
    • one of the following:
      • tumor is non-clear cell histology and inadequate response or adverse reaction to one or contraindication to all systemic therapies; or
      • all of the following:
        • tumor is clear cell histology; and
        • inadequate response or adverse reaction to one or contraindication to all first-line therapies; and
        • inadequate response or adverse reaction to one or contraindication to both of the following: cabozantinib, nivolumab.

Lenvima for differentiated thyroid cancer (DTC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 90 units/30 days.

Lenvima for unresectable hepatocellular carcinoma (HCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • clinical rationale for use of the requested agent instead of Nexavar (sorafenib); and
    • request is within quantity limit of 90 units/30 days.

Lorbrena

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ALK-positive; and
    • one of the following:
      • inadequate response or adverse reaction to Xalkori (crizotinib) and at least one other ALK inhibitor; or
      • inadequate response or adverse reaction to Alecensa (alectinib) or Zykadia (ceritinib); and
    • request is within quantity limit of 30 units/30 days.

Mekinist for locally advanced or metastatic anaplastic thyroid cancer

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E mutation; and
    • documentation that the agent will be used in combination with Tafinlar (dabrafenib); and
    • member has no satisfactory locoregional treatment options.

Mekinist for adjuvant treatment of melanoma 

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation; and
    • documentation that the agent will be used in combination with Tafinlar (dabrafenib); and
    • member has lymph node involvement and complete resection.

Mekinist for unresectable or metastatic melanoma 

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation; and
    • one of the following:
      • documentation that the agent will be used in combination with Tafinlar (dabrafenib); or
      • all of the following:
        • documentation that the agent will be used as a single agent; and
        • no history of prior therapy with a BRAF inhibitor (i.e., Tafinlar [dabrafenib] or Zelboraf [vemurafenib]); and
        • clinical rationale for bypassing use of a BRAF inhibitor (i.e., Tafinlar [dabrafenib] or Zelboraf [vemurafenib]).

Mekinist for NSCLC

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E mutation; and
    • documentation that the agent will be used in combination with Tafinlar (dabrafenib).

Mektovi

  • Documentation of the following is required:  
    • diagnosis of unresectable or metastatic melanoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation; and
    • documentation that the agent will be used in combination with Braftovi (encorafenib).

Nerlynx

  • Documentation of the following is required:
    • diagnosis of extended adjuvant treatment of early stage HER2-postive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member received trastuzumab therapy within the past two years; and
    • request is within quantity limit of 180 units/30 days.

Rydapt for FLT3-mutated acute myeloid leukemia (AML)

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • for induction therapy, requested agent will be used in combination with cytarabine and daunorubicin; or
      • for consolidation therapy, requested agent will be used in combination with cytarabine; and
    • request is within quantity limit of 56 units/28 days.

Rydapt for aggressive systemic mastocytosis (SM), SM with associated hematological neoplasm, and mast cell leukemia

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • member has aggressive SM without the D816V c-Kit mutation (as determined by an FDA-approved test) or with c-Kit mutation status unknown; and
        • inadequate response, adverse reaction, or contraindication to imatinib; or
      • D816V c-Kit mutation positive (as determined by an FDA-approved test); and
    • request is within quantity limit of 112 units/28 days.

Stivarga for gastrointestinal stromal tumor (GIST)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist; and
    • appropriate dose; and
    • documentation of a previous trial with or a contraindication to both of the following: imatinib and Sutent (sunitinib).

Stivarga for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist; and
    • appropriate dose; and
    • member has Child-Pugh Class A; and
    • inadequate response, adverse reaction, or contraindication to Nexavar (sorafenib).

Stivarga for metastatic colorectal cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist; and
    • appropriate dose; and
    • a previous trial with one of the following regimens or a contraindication to all of the following regimens: CAPEOX, FOLFIRI, FOLFOX, FOLFOXIRI; and
    • if KRAS/NRAS wild-type cancer is present, a previous trial with one or a contraindication to both of the following: Erbitux (cetuximab), Vectibix (panitumumab).

Tafinlar for locally advanced or metastatic anaplastic thyroid cancer

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E mutation; and
    • documentation that the agent will be used in combination with Mekinist (trametinib); and
    • member has no satisfactory locoregional treatment options.

Tafinlar for adjuvant treatment of melanoma 

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation; and
    • documentation that the agent will be used in combination with Mekinist (trametinib); and
    • member has lymph node involvement and complete resection.

Tafinlar for unresectable or metastatic melanoma

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E or V600K mutation.

Tafinlar for NSCLC

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF-V600E mutation; and
    • documentation that the agent will be used in combination with Mekinist (trametinib).

Tagrisso

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 30 units/30 days; and
    • one of the following:
      • cancer displays the EGFR exon 19 deletion or exon 21 L858R mutation; or
      • both of the following:
        • cancer displays the EGFR mutation and the T790M resistance mutation; and
        • inadequate response or adverse reaction to one or contraindication to all of the following: erlotinib, Gilotrif (afatinib), Iressa (gefitinib).

Verzenio

  • Documentation of the following is required:
    • diagnosis of HR-positive, HER2-negative advanced or metastatic breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is postmenopausal; and
    • one of the following:
      • concurrent therapy with an aromatase inhibitor; or
      • concurrent therapy with fulvestrant when disease has progressed after hormonal therapy; or
      • monotherapy when disease has progressed after both hormonal therapy and chemotherapy; and
    • request is within quantity limit of 60 tablets/30 days.

Vitrakvi

  • Documentation of the following is required:
    • diagnosis of solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is metastatic; or
      • member is not a candidate for surgical resection; and
    • one of the following:
      • requested agent is first-line for the requested indication; or
      • member has no satisfactory alternative treatment options; or
      • disease has progressed following at least one first-line treatment for the requested indication (e.g., chemotherapy, radiation, surgical intervention); and
    • if the request is for oral solution formulation, medical necessity for the use of an oral solution formulation (e.g., swallowing disorder) must be provided.

Vizimpro

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has epidermal growth factor receptor (EGFR) mutations; and
    • request is within quantity limit of 30 units/30 days.

Xospata

  • Documentation of the following is required:  
    • diagnosis of FLT3-mutated AML; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member has received at least one line of treatment; or
      • member has relapsed or refractory disease; and
    • request is within quantity limit of 84 units/28 days.

Zydelig for CLL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • documentation of relapsed or refractory CLL; or
      • documentation of prior therapy for the treatment of CLL with at least one systemic therapy; and
    • inadequate response, adverse reaction, or contraindication to Imbruvica (ibrutinib).

Zydelig for FL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of FL with at least two systemic therapies.

Zydelig for SLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of SLL with at least two systemic therapies.

Zykadia

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is anaplastic lymphoma kinase (ALK)-positive; and
    • request is within quantity limit of 90 units/30 days.
 
acalabrutinib Calquence PA   PO  
alectinib Alecensa PA   PO  
binimetinib Mektovi PA   PO  
brigatinib Alunbrig PA   PO  
ceritinib Zykadia PA   PO  
cobimetinib Cotellic PA   PO  
copanlisib Aliqopa PA   IV  
dabrafenib Tafinlar PA   PO  
dacomitinib Vizimpro PA   PO  
duvelisib Copiktra PA   PO  
encorafenib Braftovi PA   PO  
erdafitinib Balversa PA   PO  
gilteritinib Xospata PA   PO  
idelalisib Zydelig PA   PO  
larotrectinib Vitrakvi PA   PO  
lenvatinib Lenvima PA   PO  
lorlatinib Lorbrena PA   PO  
midostaurin Rydapt PA   PO  
neratinib Nerlynx PA   PO  
osimertinib Tagrisso PA   PO  
palbociclib Ibrance PA   PO  
regorafenib Stivarga PA   PO  
ribociclib Kisqali PA   PO  
ribociclib / letrozole Kisqali-Femara Co-Pack PA   PO  
trametinib Mekinist PA   PO  

 Miscellaneous

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

amifostine test   IV  

Fusilev and levoleucovorin injection

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ six years of age; and
    • medical records documenting member is not a candidate for leucovorin therapy due to hypersensitivity to a component of leucovorin.

Idhifa

  • Documentation of the following is required:  
    • diagnosis of IDH2-mutated AML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • documentation of relapsed or refractory IDH2-mutated AML; or
      • documentation of prior therapy for the treatment of IDH2-mutated AML with at least one systemic therapy; and
    • request is within quantity limit of 30 units/30 days.

Imlygic

  • Documentation of the following is required:
    • diagnosis of melanoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • unresectable cutaneous, subcutaneous, or nodal lesions; and
    • melanoma is recurrent after initial surgery.

Lonsurf

  • Documentation of the following is required:
    • diagnosis of metastatic colorectal cancer; and
    • prescriber is a specialist; and
    • appropriate dosing; and
    • a previous trial with one or more of the following regimens or a contraindication to all of the following regimens: CAPEOX, FOLFOX, FOLFIRI, FOLFOXIRI; and
    • if KRAS/NRAS wild-type cancer is present, a previous trial with one or a contraindication to both of the following: Erbitux (cetuximab), Vectibix (panitumumab).

Lumoxiti

  • Documentation of the following is required:
    • diagnosis of relapsed or refractory hairy cell leukemia (HCL); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of HCL with at least two systemic therapies, including at least one purine nucleoside analog (PNA).

Provenge

  • Documentation of the following is required:
    • diagnosis of metastatic prostate cancer; and 
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • ECOG score 0-1 (good performance status); and
    • estimated life expectancy > six months; and
    • no hepatic metastases; and
    • no/minimal symptoms; and
    • requested quantity does not exceed three doses (one complete cycle).

Synribo

  • Documentation of the following is required:
    • diagnosis of chronic myelogenous leukemia (CML); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to two or contraindication to all of the following: Bosulif (bosutinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib); or
      • documentation of confirmed T315I mutation.

Tibsovo

  • Documentation of the following is required:  
    • diagnosis of IDH1-mutated AML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • documentation of relapsed or refractory IDH1-mutated AML; or
      • documentation of prior therapy for the treatment of IDH1-mutated AML with at least one systemic therapy; and
    • request is within quantity limit of 60 units/30 days.

Venclexta

  • Documentation of the following is required:  
    • diagnosis of CLL or SLL; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of CLL or SLL with at least one systemic therapy; and
    • requested agent will be used in combination with Rituxan (rituximab).

Vyxeos

  • Documentation of the following is required:  
    • diagnosis of newly diagnosed therapy-related AML or AML with myelodysplasia-related changes (AML-MRC); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • clinical rationale for use over separate daunorubicin and cytarabine chemotherapy agents.

Xofigo

  • Documentation of the following is required:
    • diagnosis of metastatic prostate cancer with metastasis to the bone; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • documentation that member does not have visceral metastatic disease.

Zelboraf for Erdheim-Chester Disease

  • Documentation of the following is required:
    • appropriate diagnosis; and 
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • documentation of positive BRAF-V600 mutation.

Zelboraf for unresectable or metastatic melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and 
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • documentation of positive BRAF-V600E mutation.
 
daunorubicin / cytarabine Vyxeos PA   IV  
enasidenib Idhifa PA   PO  
iobenguane I 131 Azedra ^ test   IV  
ivosidenib Tibsovo PA   PO  
leucovorin test   IV / PO  
levoleucovorin injection PA   IV  
levoleucovorin powder for injection Fusilev PA   IV  
mitotane Lysodren test   PO  
moxetumomab pasudotox-tdfk Lumoxiti PA   IV  
omacetaxine mepesuccinate Synribo PA   SC  
radium Ra 223 dichloride Xofigo ^ PA   IV  
sipuleucel-T Provenge ^ PA   IV  
talimogene laherparepvec Imlygic ^ PA   intralesional  
trifluridine / tipiracil Lonsurf PA   PO  
vemurafenib Zelboraf PA   PO  
venetoclax Venclexta PA   PO  

 Mitotic Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

brentuximab Adcetris PA   IV  

Adcetris for relapsed or refractory Hodgkin Lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member is at high risk of relapse as post autologous hematopoietic stem cell transplantation (auto-HSCT); or
      • inadequate response to auto-HSCT; or
      • member is not a candidate for auto-HSCT and inadequate response or adverse reaction to two prior multi-agent chemotherapy regimens; or
      • clinical rationale as to why the other available treatment regimens cannot be used.

Adcetris for treatment-naïve Hodgkin Lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with chemotherapy.

Adcetris for primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one systemic therapy; or
      • contraindication to the use of systemic therapy.

Adcetris for previously untreated CD-30 expressing PTCL, including systemic anaplastic large cell lymphoma (sALCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested agent will be used with chemotherapy.

Adcetris for sALCL after failure of at least one prior multiagent chemotherapy regimen

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one prior chemotherapy regimen or agent; or
      • clinical rationale as to why the other available treatment regimens cannot be used.

Halaven for metastatic or recurrent breast cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • two prior chemotherapy regimens that included an anthracycline and a taxane; and
    • inadequate response, adverse reaction or contraindication to vinorelbine (may have been part of prior chemotherapy regimens).

Halaven for unresectable or metastatic liposarcoma 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to an anthracycline-containing regimen.
 
docetaxel-Docefrez Docefrez test   IV  
docetaxel-Taxotere Taxotere # test   IV  
eribulin Halaven PA   IV  

 Monoclonal Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

ado-trastuzumab Kadcyla PA   IV  

Arzerra for relapsed or refractory CLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to fludarabine; and
    • inadequate response, adverse reaction, or contraindication to alemtuzumab.

Arzerra for untreated CLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • contraindication to fludarabine; and
    • one of the following:
      • requested agent will be used in combination with chlorambucil; or
      • clinical rationale as to why the agent will not be used with chlorambucil.

Besponsa and Blincyto

  • Documentation of the following is required:
    • diagnosis of ALL; and
    • if the request is for Besponsa, member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • Philadelphia chromosome-positive; and
        • inadequate response or adverse reaction to one tyrosine kinase inhibitor for the treatment of ALL; or
      • all of the following:
        • Philadelphia chromosome-negative; and
        • B-cell precursor ALL; and
        • documentation of prior therapy for the treatment of ALL with one systemic therapy.

Cyramza for gastric or gastro-esophageal junction (GEJ) adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a fluoropyrimidine- or platinum-containing chemotherapy regimen.

Cyramza for metastatic colorectal cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be given concurrently with FOLFIRI or irinotecan; and
    • previous trial with or a contraindication to a 5-fluorouracil/leucovorin or capecitabine-based regimen.

Cyramza for NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be given concurrently with docetaxel; and
    • inadequate response, adverse reaction, or contraindication to a platinum-containing chemotherapy regimen.

Darzalex

  • Documentation of the following is required for monotherapy:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all of the following proteasome inhibitors: bortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib); and
    • inadequate response or adverse reaction to one or contraindication to all of the following immunomodulatory agents: Revlimid (lenalidomide), Thalomid (thalidomide), Pomalyst (pomalidomide); and
    • one of the following:
      • inadequate response or adverse reaction to one proteasome inhibitor and one immunomodulatory agent noted above; or
      • history of a total of three trials with chemotherapy regimens for the requested indication.

 

  • Documentation of the following is required for combination therapy:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication and one of the following:
        • requested agent will be used in combination with Revlimid (lenalidomide) and dexamethasone; or
        • requested agent will be used in combination with bortezomib and dexamethasone; or
      • inadequate response or adverse reaction to two prior chemotherapy regimens for the requested indication and requested medication will be used in combination with Pomalyst (pomalidomide) and dexamethasone; or
      • member is newly diagnosed and ineligible for autologous stem cell transplant (ASCT), and requested medication will be used in combination with bortezomib, melphalan, and prednisone.

Empliciti

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication; and
    • requested agent will be used in combination with Revlimid (lenalidomide) and dexamethasone.

Gazyva for CLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Gazyva for FL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • relapsed or refractory FL after treatment with a rituximab-containing regimen; or
      • concurrent therapy with first-line chemotherapy agent.

Kadcyla

  • Documentation of the following is required:
    • diagnosis of HER-2 positive recurrent or metastatic breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has recurrent or metastatic breast cancer and an inadequate response or adverse reaction to trastuzumab and a taxane, separately or in combination; or
      • member has early breast cancer (EBC) and residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Lartruvo

  • Documentation of the following is required:
    • diagnosis of soft tissue sarcoma; and
    • appropriate dosing and frequency; and
    • member is ≥ 18 years of age; and
    • member is not a candidate for surgery and/or radiation therapy; and
    • requested agent will be used in combination with doxorubicin for the first eight cycles of treatment.

Mylotarg for newly-diagnosed CD33-positive AML in adults

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • documentation that requested agent will be used in combination with daunorubicin and cytarabine; or
      • clinical rationale why combination therapy with daunorubicin and cytarabine is not appropriate.

Mylotarg for relapsed or refractory CD33-positive AML 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • documentation of relapsed or refractory AML; or
      • documentation of prior therapy for the treatment of AML with one systemic therapy.

Perjeta 

  • Documentation of the following is required:
    • diagnosis of HER-2 positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • for recurrent or stage IV disease, requested agent will be used in combination with Herceptin (trastuzumab) and docetaxel or paclitaxel; or
      • for adjuvant or neoadjuvant chemotherapy, requested agent will be used in combination with trastuzumab and chemotherapy.

Portrazza 

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer of squamous cell histology; and
    • requested agent will be used in combination with gemcitabine and cisplatin.

Poteligeo for mycosis fungoides

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • Stage IA to IIA disease and member is refractory to skin-directed therapy; or
      • Stage IIB disease; or
      • Stage III disease with blood involvement; or
      • diagnosis of large-cell transformed or follicular mycosis fungoides.

Poteligeo for Sézary syndrome

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Rituxan and Rituxan Hycela for CLL 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • concurrent therapy with at least one other chemotherapy agent; or
      • clinical rationale as to why the agent is being used as monotherapy.

Rituxan for Non-Hodgkin’s Lymphoma (NHL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing.

Rituxan for Pemphigus Vulgaris (PV)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • inadequate response or adverse reaction to one systemic immunosuppressive therapy (azathioprine, mycophenolate, cyclophosphamide) or contraindication to all systemic immunosuppressive therapy.

Rituxan for Rheumatoid Arthritis (RA) 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response, adverse reaction or contraindication to one TNF antagonist; and
    • one of the following:
      • concurrent therapy with methotrexate; or
      • contraindication or adverse reaction to methotrexate.

Rituxan for Wegener's Granulomatosis and Microscopic Polyangiitis (MPA)

  • For induction (initial) therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to cyclophosphamide; and
    • one of the following:
      • concurrent use with a glucocorticoid; or
      • adverse reaction or contraindication to glucocorticoids.
  • For maintenance (subsequent) therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, methotrexate, mycophenolate.

Rituxan Hycela for diffuse large B-cell lymphoma 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • concurrent therapy with at least one other chemotherapy agent; or
      • clinical rationale as to why the agent is being used as monotherapy.

Rituxan Hycela for FL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing.
 
alemtuzumab 30 mg Campath test   IV  
blinatumomab Blincyto PA   IV  
cetuximab Erbitux test   IV  
daratumumab Darzalex PA   IV  
elotuzumab Empliciti PA   IV  
gemtuzumab ozogamicin Mylotarg PA   IV  
inotuzumab ozogamicin Besponsa PA   IV  
ipilimumab Yervoy test   IV  
mogamulizumab-kpkc Poteligeo PA   IV  
necitumumab Portrazza PA   IV  
obinutuzumab Gazyva PA   IV  
ofatumumab Arzerra PA   IV  
olaratumab Lartruvo PA   IV  
panitumumab Vectibix test   IV  
pertuzumab Perjeta PA   IV  
ramucirumab Cyramza PA   IV  
rituximab Rituxan PA   IV  
rituximab / hyaluronidase human Rituxan Hycela PA   SC  
trastuzumab Herceptin test   IV  

 PD-1/PD-L1 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

atezolizumab Tecentriq PA   IV  

Bavencio and Keytruda for metastatic Merkel cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Bavencio, Imfinzi, and Opdivo for urothelial carcinoma (UC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a platinum-containing regimen.

Imfinzi for Stage III NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Keytruda for cervical cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • documentation of PD-L1 expression [combined positive score (CPS) ≥1]; and
    • an inadequate response or adverse reaction to one systemic chemotherapy regimen, or contraindication to the use of systemic chemotherapy.

Keytruda for recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • if microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), at least one prior treatment regimen with systemic therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; or
      • if PD-L1-positive, at least two prior treatment regimens with systemic therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

Keytruda for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has Child-Pugh Class A; and
    • inadequate response, adverse reaction, or contraindication to Nexavar (sorafenib).

Keytruda for Hodgkin Lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has relapsed or has received three or more lines of prior therapy, one of which was brentuximab.

Keytruda for microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) solid tumors or metastatic colorectal cancer (mCRC) 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • disease progression following at least one prior regimen FDA-approved to treat the indication.

Keytruda and Opdivo for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a platinum-containing regimen.

Keytruda and Opdivo for melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Keytruda for Stage III NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • documentation of PD-L1 expression [tumor proportion score (TPS) ≥1%]; and
    • requested agent will be used in combination with carboplatin and either pemetrexed or paclitaxel.

Keytruda for unresectable or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with pemetrexed and either carboplatin or cisplatin for nonsquamous NSCLC in the first-line setting; or
      • requested agent will be used in combination with carboplatin and either paclitaxel or albumin-bound paclitaxel for squamous NSCLC in the first-line setting; or
      • documentation of PD-L1 expression and an inadequate response, adverse reaction or contraindication to a platinum-containing regimen; or
      • all of the following:
        • documentation of PD-L1 expression ≥ 50% of tumor cells; and
        • member does not have EGFR or ALK genomic tumor aberrations; and
        • member has not had prior systemic chemotherapy for this indication.

Keytruda for primary mediastinal B-cell lymphoma (PMBCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • an inadequate response or adverse reaction to two systemic chemotherapy regimens, or contraindication to the use of systemic chemotherapy.

Keytruda for first-line treatment of RCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor is clear cell histology; and
    • requested agent will be used in combination with Inlyta (axitinib).

Keytruda for UC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • if treatment-naïve, documentation of PD-L1 expression with CPS ≥10, or member is not a candidate for any platinum-containing chemotherapy due to poor performance status; and
    • one of the following:
      • inadequate response or adverse reaction to a regimen containing cisplatin; or
      • contraindication to cisplatin and inadequate response or adverse reaction to a regimen containing gemcitabine and carboplatin; or
      • contraindication to cisplatin and contraindication to gemcitabine or carboplatin.

Libtayo for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is not a candidate for surgery and/or radiation therapy; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Opdivo for advanced renal cell carcinoma 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is non-clear cell histology and the requested agent will be used as monotherapy; or
      • tumor is clear cell histology and inadequate response or adverse reaction to one or contraindication to all first-line therapies; or
      • tumor is clear cell histology and requested agent will be used in combination with ipilimumab.

Opdivo for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has Child-Pugh Class A or B7; and
    • inadequate response, adverse reaction, or contraindication to Nexavar (sorafenib).

Opdivo for Hodgkin Lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • disease progression after ASCT; and
    • member received post-transplant brentuximab.

Opdivo for MSI-H/dMMR mCRC 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to a fluoropyrimidine, oxaliplatin, and irinotecan; or
      • contraindication to a fluoropyrimidine, oxaliplatin, and irinotecan.

Opdivo for unresectable or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a platinum-containing regimen.

Opdivo for metastatic small cell lung cancer (SCLC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to one line of platinum-based chemotherapy.

Tecentriq for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • PD-L1-stained tumor-infiltrating immune cells covering ≥1% of tumor area; and
    • requested agent will be used in combination with albumin-bound paclitaxel.

Tecentriq for unresectable or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to a platinum-containing regimen; or
      • requested agent will be used in combination with Avastin (bevacizumab), paclitaxel, and carboplatin in the first-line setting for nonsquamous NSCLC.

Tecentriq for extensive-stage (ES) SCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has extensive stage disease; and
    • requested agent will be used in combination with carboplatin and etoposide.

Tecentriq for UC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • if treatment-naïve, PD-L1-stained tumor-infiltrating immune cells covering ≥5% of tumor area, or member is not a candidate for any platinum-containing chemotherapy due to poor performance status; and
    • one of the following:
      • inadequate response or adverse reaction to a regimen containing cisplatin; or
      • contraindication to cisplatin and inadequate response or adverse reaction to a regimen containing gemcitabine and carboplatin; or
      • contraindication to cisplatin and contraindication to gemcitabine or carboplatin.
 
avelumab Bavencio PA   IV  
cemiplimab-rwlc Libtayo PA   IV  
durvalumab Imfinzi PA   IV  
nivolumab Opdivo PA   IV  
pembrolizumab Keytruda PA   IV  

 Poly-Adenosine Diphosphate Ribose Polymerase (PARP) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

niraparib Zejula PA   PO  

Lynparza for germline BRCA-mutated breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is HER-2 negative; and
    • one of the following:
      • request is within quantity limit of 480 capsules/30 days; or
      • request is within quantity limit of 120 tablets/30 days.

Lynparza for ovarian cancer

  • For progressive disease, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has confirmed or suspected deleterious BRCA germline mutation; and
    • one of the following:
      • inadequate response or adverse reaction to at least three prior chemotherapy regimens; or
      • contraindication to the use of recommended chemotherapy regimens; and
    • one of the following:
      • request is within quantity limit of 480 capsules/30 days; or
      • request is within quantity limit of 120 tablets/30 days.

 

  • For maintenance therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) and has completed one line of platinum-based chemotherapy; or
      • member has completed two or more lines of platinum-based chemotherapy; or
      • contraindication to the use of recommended chemotherapy regimens; and
    • member has achieved a partial or complete response requiring maintenance therapy; and
    • one of the following:
      • request is within quantity limit of 480 capsules/30 days; or
      • request is within quantity limit of 120 tablets/30 days.

Rubraca for ovarian cancer

  • For progressive disease, documentation of the following is required:
    • appropriate diagnosis; and 
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has confirmed deleterious BRCA germline mutation; and
    • one of the following:
      • inadequate response or adverse reaction to at least two prior chemotherapy regimens; or
      • contraindication to the use of recommended chemotherapy regimens; and
    • request is within quantity limit of 120 units/30 day.
  • For maintenance therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has completed two or more lines of platinum-based chemotherapy; or
      • contraindication to the use of recommended chemotherapy regimens; and
    • member has achieved a partial or complete response requiring maintenance therapy; and
    • request is within quantity limit of 120 tablets/30 days.

Talzenna

  • Documentation of the following is required:
    • diagnosis of germline BRCA-mutated breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is HER-2 negative; and
    • request is within quantity limit of 30 capsules/30 days.

Zejula

  • Documentation of the following is required:
    • diagnosis of ovarian cancer; and 
    • appropriate dosing; and
    • prescriber is an oncologist; and
    • one of the following:
      • member has completed two or more lines of platinum-based chemotherapy; or
      • contraindication to the use of recommended chemotherapy; and
    • member has achieved a partial or complete response requiring maintenance therapy; and
    • request is within quantity limit of 90 units/30 days.
 
olaparib Lynparza PA   PO  
rucaparib Rubraca PA   PO  
talazoparib Talzenna PA   PO  

 Proteasome Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

bortezomib Velcade test   IV / SC  

Kyprolis

  • Documentation of the following is required for monotherapy:
    • diagnosis of multiple myeloma; and
    • appropriate dosing; and
    • prescriber is an oncologist or hematologist; and
    • inadequate response, adverse reaction or contraindication to bortezomib; and
    • inadequate response or adverse reaction to one of the following immunomodulatory agents or contraindication to all of the following immunomodulatory agents:
      • Revlimid (lenalidomide); or
      • Thalomid (thalidomide); or
      • Pomalyst (pomalidomide).

  

  • Documentation of the following is required for combination therapy:
    • diagnosis of multiple myeloma; and
    • appropriate dosing; and
    • prescriber is an oncologist or hematologist; and
    • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication; and
    • one of the following:
      • documentation that the agent will be used in combination with Revlimid (lenalidomide) and dexamethasone; or
      • documentation that the agent will be used in combination with dexamethasone.

Ninlaro

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • appropriate dosing; and
    • prescriber is an oncologist or hematologist; and
    • documentation that the agent will be used in combination with Revlimid (lenalidomide) and dexamethasone; and
    • request is within quantity limit of 3 capsules/28 days.
 
bortezomib test   IV  
carfilzomib Kyprolis PA   IV  
ixazomib Ninlaro PA   PO  

 Retinoids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

bexarotene Targretin # test   PO / Topical  

    

 
tretinoin capsule test   PO  

 Selective Estrogen Receptor Modulator (SERM)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

toremifene Fareston # test   PO  

       

 

 Topoisomerase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

etoposide test   IV / PO  

Onivyde

  • Documentation of the following is required:
    • diagnosis of metastatic adenocarcinoma of the pancreas; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • requested agent will be used in combination with fluorouracil and leucovorin; and
    • inadequate response, adverse reaction, or contraindication to the use of a gemcitabine- or fluoropyrimidine-based chemotherapy regimen.
 
irinotecan Camptosar # test   IV  
irinotecan liposome Onivyde PA   IV  
topotecan Hycamtin # test   IV / PO  

 Tyrosine Kinase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

afatinib Gilotrif PA   PO  

Bosulif

  • Documentation of the following is required:
    • diagnosis of CML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one of the following or a contraindication to both of the following: Sprycel (dasatinib), Tasigna (nilotinib).

Cabometyx

  • Documentation of the following is required:
    • diagnosis of advanced renal cell carcinoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: Votrient (pazopanib), Sutent (sunitinib); and
    • request is within quantity limit of 30 units/30 days.

Caprelsa

  • Documentation of the following is required:
    • diagnosis of symptomatic or progressive medullary thyroid cancer; and
    • one of the following:
      • request is within quantity limit of 30 units/30 days for 300 mg tablets or 60 units/30 days for 100 mg tablets; or
      • medical necessity for exceeding quantity limit of 30 units/30 days for 300 mg tablets or 60 units/30 days for 100 mg tablets.

Cometriq

  • Documentation of the following is required:
    • diagnosis of symptomatic or progressive medullary thyroid cancer; and
    • one of the following
      • requested dose does not exceed 140 mg/day; or
      • medical necessity for exceeding the 140 mg/day dose.

erlotinib for advanced or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has epidermal growth factor receptor (EGFR) mutations; and
    • request is within quantity limit of 30 units/30 days.

erlotinib for advanced or metastatic pancreatic cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member will be using the requested agent in combination with gemcitabine; and
    • request is within quantity limit of 30 units/30 days.

Gilotrif

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has epidermal growth factor receptor (EGFR) mutations; or
      • inadequate response or adverse reaction to at least one platinum-based chemotherapy regimen; or
      • contraindication to the use of platinum-based chemotherapy; and
    • request is within quantity limit of 30 units/30 days.

Iclusig for ALL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one of the following or contraindication to all of the following: imatinib, Sprycel (dasatinib), Tasigna (nilotinib).

Iclusig for CML

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to two of the following or a contraindication to all of the following: Bosulif (bosutinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib); or
      • confirmed T315I mutation.

Imbruvica for chronic graft versus host disease (cGVHD)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of cGVHD with at least one systemic therapy.

Imbruvica for CLL, SLL, CLL/SLL with 17p deletion, and Waldenstrom's macroglobulinemia (WM)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Imbruvica for MCL and marginal zone lymphoma (MZL)

  • Documentation of the following is required:
    • appropriate diagnosis;  and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • documentation of prior therapy for the treatment of MCL or MZL with at least one systemic therapy.

Inlyta

  • Documentation of the following is required:
    • diagnosis of advanced renal cell carcinoma; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Iressa

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has epidermal growth factor receptor (EGFR) mutations; and
    • request is within quantity limit of 30 units/30 days.

Jakafi

  • Documentation of the following is required:
    • diagnosis of polycythemia vera (PV), intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis; and
    • inadequate response, adverse reaction or contraindication to hydroxyurea; and
    • request is within quantity limit of 60 units/30 days.

Nexavar

  • Documentation of the following is required:
    • diagnosis of advanced renal cell carcinoma, DTC, or unresectable HCC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 120 units/30 days.

Sutent for advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors (PNET)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 30 units/30 days.
    •  

Sutent for GIST

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to imatinib; and
    • request is within quantity limit of 30 units/30 days.

Sutent for renal cell carcinoma (adjuvant setting)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor is clear cell histology; and
    • request is within quantity limit of 30 units/30 days.

Votrient for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 120 units/30 days.

Votrient for soft tissue sarcoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to prior chemotherapy; and
    • request is within quantity limit of 120 units/30 days.

Xalkori

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is anaplastic lymphoma kinase (ALK)-positive; and
    • request is within quantity limit of 60 units/30 days.
 
axitinib Inlyta PA   PO  
bosutinib Bosulif PA   PO  
cabozantinib capsule Cometriq PA   PO  
cabozantinib tablet Cabometyx PA   PO  
crizotinib Xalkori PA   PO  
dasatinib Sprycel test   PO  
erlotinib Tarceva BP PA   PO  
gefitinib Iressa PA   PO  
ibrutinib Imbruvica PA   PO  
imatinib Gleevec # test   PO  
lapatinib Tykerb test   PO  
nilotinib Tasigna test   PO  
pazopanib Votrient PA   PO  
ponatinib Iclusig PA   PO  
ruxolitinib Jakafi PA   PO  
sorafenib Nexavar PA   PO  
sunitinib Sutent PA   PO  
vandetanib Caprelsa PA   PO  

 Vinca Alkaloid

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

vinblastine test   IV  

Marqibo

  • Documentation of the following is required:
    • diagnosis of Philadelphia chromosome negative ALL; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • medical records documenting trials with two previous chemotherapy regimens.      
 
vincristine test   IV  
vincristine liposome Marqibo PA   IV  
vinorelbine Navelbine # test   IV  

 mTOR Kinase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Route of Administration

Clinical Notes

everolimus tablets for oral suspension Afinitor Disperz PA   PO  

Afinitor for advanced hormone receptor-positive, HER2-negative breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested regimen includes exemestane; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: anastrozole, letrozole; and
    • request is within quantity limit of 30 units/30 days.

Afinitor for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is non-clear cell histology; or
      • tumor is clear cell histology and inadequate response or adverse reaction to one or contraindication to all first-line therapies; and
    • request is within quantity limit of 30 units/30 days.

Afinitor and Afinitor Disperz for treatment-resistant epilepsy associated with tuberous sclerosis complex (TSC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurologist are provided; and
    • inadequate response to combination therapy with at least two anticonvulsants or contraindication to all other anticonvulsants; and
    • requested agent will be used as adjunctive therapy with at least one anticonvulsant agent; and
    • request is within quantity limit of 30 units/30 days.

Afinitor for renal angiomyolipoma with TSC, advanced PNET, advanced neuroendocrine tumors (NET) of gastrointestinal or lung origin, and subependymal giant cell astrocytoma (SEGA) with TSC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 30 units/30 days.

Afinitor Disperz for SEGA with TSC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • request is within quantity limit of 30 units/30 days.
 
everolimus-Afinitor Afinitor PA   PO  
temsirolimus Torisel # test   IV  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

 FDA-approved, for example:

  • Cancer

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication.

 

Please see clinical criteria for agents requiring PA in the table above under the Clinical Notes section. 

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 07/2011

Last Revised Date: 08/2019


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Last updated 08/29/19