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Drug Category: Immunological Agents

Medication Class/Individual Agents: Anti-TNF-Alpha, Corticosteroid, Immunosuppressant, Interleukin Antagonist, Miscellaneous, Topical

I. Prior-Authorization Requirements

 Immunological Agents – Anti-TNF-Alpha

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

adalimumab Humira PD PA  
certolizumab Cimzia PA  
etanercept Enbrel PD PA  
golimumab Simponi PA  
golimumab for infusion Simponi Aria PA  
infliximab Remicade PA  
infliximab-abda Renflexis PA  
infliximab-dyyb Inflectra PA  

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.

For PA drugs, one of the following FDA-approved indications must be met. For unlabeled uses, approval is considered based on current medical evidence.

Immunological agents warnings and precautions:

  • Chronic obstructive pulmonary disease, concomitant use of biologic therapy, use of live vaccines in previous three months, viral hepatitis, hypersensitivity reactions, tuberculosis, injection site reactions, infusion reactions, infections, demyelinating disease, heart failure, malignancy, induction of autoimmunity. See manufacturers’ information for full details on each agent.

Monoclonal antibodies warning and precautions:

  • History of malignancy, patients with human immunodeficiency virus (HIV) infection, lymphopenia, malignancy, serious infections, immunosuppression, allergic reactions, hepatic injury, immune-mediated thrombocytopenia or hemolytic anemia, psoriasis worsening and variants; see manufacturers’ information for full details.

Oral Corticosteroids:

  • Due to their anti-inflammatory and immunosuppressive effects, glucocorticosteroids are widely used in the treatment of various inflammatory conditions including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.1,2
  1. Rayos [package insert on the internet]. Deerfield (IL): Horizon Pharma USA, Inc.; 2012 July [cited 2012 Sept 14]. Available from: https://hznp.azureedge.net/public/rayos-prescribing-information.pdf.
  2. Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, et al. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomized controlled trial. Lancet. 2008 Jan 19;371(9608):205-14.
 

 Immunological Agents – Corticosteroids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

betamethasone injection Celestone # test  
cortisone test  
deflazacort Emflaza PA  
dexamethasone injection test  
dexamethasone solution, tablet Decadron # test  
dexamethasone tablet pack PA  
hydrocortisone injection A-Hydrocort # test  
hydrocortisone injection-Solu-Cortef Solu-Cortef # test  
hydrocortisone tablet Cortef # test  
methylprednisolone Medrol # test  
methylprednisolone acetate Depo-Medrol # test  
methylprednisolone sodium succinate Solu-Medrol # test  
prednisolone 10 mg/5 mL oral solution PA  
prednisolone 15 mg/5 mL, 25 mg/5 mL oral solution test  
prednisolone 20 mg/5 mL oral solution PA  
prednisolone 5 mg/5 mL oral solution Pediapred # test  
prednisolone orally disintegrating tablet Orapred ODT PA  
prednisolone tablet test  
prednisone test  
prednisone delayed-release Rayos PA  
triamcinolone extended-release injectable suspension Zilretta PA  
triamcinolone injection Aristospan test  
triamcinolone injection Kenalog # test  

 Immunological Agents – Immunosuppressants

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

azathioprine 50 mg tablet Imuran # test  
azathioprine 75 mg, 100 mg tablet PA  
azathioprine injection test  
belatacept Nulojix PA  
cyclosporine Sandimmune # test  
cyclosporine modified Neoral # test  
everolimus-Zortress Zortress test  
mycophenolate mofetil Cellcept # test  
mycophenolic acid Myfortic PA  
sirolimus solution Rapamune BP test  
sirolimus tablet Rapamune # test  
tacrolimus extended-release capsule Astagraf XL test  
tacrolimus extended-release tablet Envarsus XR test  
tacrolimus injection Prograf ^ test  
tacrolimus oral Prograf # test  

 Immunological Agents – Interleukin Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

anakinra Kineret PA  
basiliximab Simulect test  
brodalumab Siliq PA  
canakinumab Ilaris PA  
guselkumab Tremfya PA  
ixekizumab Taltz PA  
rilonacept Arcalyst PA  
risankizumab-rzaa Skyrizi PA  
sarilumab Kevzara PA  
secukinumab Cosentyx PA  
siltuximab Sylvant PA  
tildrakizumab-asmn Ilumya PA  
tocilizumab Actemra PA  
ustekinumab Stelara PA  

 Immunological Agents – Janus Kinase (JAK) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

baricitinib Olumiant PA  
tofacitinib Xeljanz PA  
tofacitinib extended-release Xeljanz XR PA  

 Immunological Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

apremilast Otezla PA  
methotrexate oral solution Xatmep PA  
methotrexate subcutaneous injection-Otrexup Otrexup PA  
methotrexate subcutaneous injection-Rasuvo Rasuvo PA  
methotrexate tablet test  
vedolizumab Entyvio PA  

 Immunological Agents – Selective T-Cell Costimulation Blocker

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

abatacept Orencia PA  

 Immunological Agents – Topical Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

calcipotriene cream Dovonex # PA   - > 60 grams/month
calcipotriene foam Sorilux PA  
calcipotriene ointment PA   - > 60 grams/month
calcipotriene scalp solution test  
calcitriol ointment Vectical PA  
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.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 
^ 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:

  • Acute lymphoblastic leukemia – Xatmep
  • Ankylosing spondylitis – Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria 
  • Crohn’s disease – Cimzia, Entyvio, Humira, Stelara
  • Crohn’s disease (including fistulizing disease) – Inflectra, Remicade, Renflexis
  • Cytokine release syndrome – Actemra
  • Duchenne muscular dystrophy (DMD) – Emflaza
  • Familial cold autoinflammatory syndrome – Arcalyst, Ilaris
  • Familial Mediterranean fever – Ilaris
  • Giant cell arteritis – Actemra
  • Hidradenitis Suppurativa – Humira
  • Hyperimmunoglobulin D syndrome/Mevalonate kinase deficiency – Ilaris
  • Inflammatory, allergic, or immunological disorders – dexamethasone tablet pack, prednisolone ODT, prednisolone oral solution, Rayos
  • Muckle-Wells syndrome – Arcalyst, Ilaris
  • Multicentric Castleman's Disease – Sylvant
  • Neonatal-onset multisystem inflammatory disease – Kineret
  • Non-infectious uveitis – Humira
  • Osteoarthritis pain of the knee – Zilretta
  • Plaque psoriasis – calcipotriene cream, ointment, calcitriol ointment, Sorilux
  • Plaque psoriasis, moderate-to-severe – Cosentyx, Enbrel, Humira, Ilumya, Inflectra, Otezla, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, Tremfya 
  • Polyarticular juvenile idiopathic arthritis – Xatmep
  • Polyarticular juvenile idiopathic arthritis, moderate-to-severe – Actemra, Enbrel, Humira, Orencia, Otrexup, Rasuvo 
  • Prevention of rejection of kidney allografts – Nulojix
  • Prevention of rejection of kidney, heart, or liver allografts – azathioprine, mycophenolic acid
  • Psoriasis, severe, recalcitrant, disabling – Otrexup, Rasuvo
  • Psoriatic arthritis – Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Stelara, Taltz, Xeljanz, Xeljanz XR 
  • Rheumatoid arthritis – Actemra, Cimzia, Enbrel, Humira, Inflectra, Kevzara, Kineret, Olumiant, Orencia, Otrexup, Rasuvo, Remicade, Renflexis, Simponi, Simponi Aria, Xeljanz, Xeljanz XR 
  • Systemic juvenile idiopathic arthritis – Actemra, Ilaris
  • Tumor necrosis factor receptor associated periodic syndrome – Ilaris
  • Ulcerative colitis – Entyvio, Humira, Inflectra, Remicade, Renflexis, Simponi, Xeljanz

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 (see below).

   

Actemra for cytokine release syndrome

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • concurrent therapy with CAR T-cell therapies (request must include anticipated date of administration); and
    • appropriate dosing.

   

Actemra for giant cell arteritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • an inadequate response, or adverse reaction to one systemic glucocorticoid or contraindication to all systemic glucocorticoids; and
    • an inadequate response, or adverse reaction to one systemic immunosuppressive therapy or contraindication to all systemic immunosuppressive therapy.

   

Actemra for juvenile idiopathic arthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ two years of age; and
    • appropriate dosing; and
    • an inadequate response, adverse reaction, or contraindication to methotrexate.

   

Actemra, Cimzia, Enbrel, Humira, Inflectra, Kevzara, Orencia, Remicade, Renflexis, Simponi, and Simponi Aria for rheumatoid arthritis (RA)

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • appropriate dosing; and
    • for Actemra, and Kevzara, member is ≥ 18 years of age; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for RA.

 

Arcalyst and Ilaris for familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate age (for Arcalyst member is ≥ 12 years of age, for Ilaris member is ≥ four years of age); and
    • appropriate treatment dose and frequency; and
    • one of the following:
      • evidence of symptoms indicative of the disease; or
      • confirmation of diagnosis through genetic testing; and
    • for Arcalyst, an inadequate response, adverse reaction or contraindication to Ilaris.

 

azathioprine 75 mg, 100 mg tablet

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical necessity for the use of the 75 mg or 100 mg tablets over the generically available 50 mg tablets.

SmartPA: Claims for azathioprine 75 mg and 100 mg tablets will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent and the member has a history of MassHealth medical claims for organ transplant, complications of transplanted organs, or paid MassHealth pharmacy claims for sirolimus in the past 365 days.

 

calcipotriene cream, ointment > 60 grams/month

  • Documentation of the following is required:
    • diagnosis of plaque psoriasis; and 
    • member is ≥ 18 years of age; and
    • clinical rationale for the use of > 60 grams/month.

 

calcitriol ointment, and Sorilux

  • Documentation of the following is required: 
    • diagnosis of plaque psoriasis; and
    • member is ≥ 18 years of age; and
    • an inadequate response, adverse reaction, or contraindication to a topical corticosteroid; and
    • an inadequate response, adverse reaction, or contraindication to calcipotriene cream, ointment or solution; and
    • for Sorilux, one of the following:
      • request is for the 60 gram tube; or
      • clinical rationale for the use of > 60 grams/month.

  

Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Remicade, Renflexis, Simponi, and Simponi Aria for ankylosing spondylitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • appropriate dosing; and
    • for Cosentyx, member is ≥ 18 years of age; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for ankylosing spondylitis.

 

Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Stelara, and Taltz for psoriatic arthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • appropriate dosing; and
    • for Cosentyx, Otezla, Stelara, and Taltz, member is ≥ 18 years of age; and
    • for Otezla, quantity requested is ≤ 60 tablets/30 days; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for psoriatic arthritis.

 

Cimzia, Entyvio, Humira, Inflectra, Remicade, and Renflexis for Crohn’s disease

  • Documentation of the following is required for moderate-to-severe Crohn's disease (see below for fistulizing Crohn's disease):
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease; or
      • an inadequate response, adverse reaction, or contraindication to all of the following:
        • an aminosalicylate; and 
        • an antibiotic; and
        • a corticosteroid; and 
        • an immunomodulator (e.g., azathioprine, 6-mercaptopurine, or methotrexate).

 

  • For Inflectra, Remicade, and Renflexis for fistulizing Crohn's disease, documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease; or
      • an inadequate response, adverse reaction, or contraindication to one immunomodulator (e.g., azathioprine or 6-mercaptopurine); or
      • clinical rationale for use over oral immunomodulator.

 

Cosentyx, Enbrel, Humira, Ilumya, Inflectra, Otezla, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, and Tremfya for moderate-to-severe plaque psoriasis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • for Cosentyx, Ilumya, Otezla, Siliq, Skyrizi, Taltz, and Tremfya, member is ≥ 18 years of age; and
    • for Stelara, member is ≥ 12 years of age; and
    • for Otezla, quantity requested is ≤ 60 tablets/30 days; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for plaque psoriasis; or 
      • an inadequate response, or adverse reaction to two conventional therapies (as defined in appendix below) in any one of the following combinations:  
        • one topical agent plus one systemic agent; or 
        • one topical agent plus one phototherapy; or 
        • one systemic agent plus one phototherapy; or 
        • two systemic agents; or
      • a contraindication to all conventional therapies (topical agents, phototherapy, and systemic agents).

 

dexamethasone tablet pack

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • clinical rationale for requested medication; or
      • requested medication provides a significant or unique therapeutic advantage over the conventionally packaged formulation.

 

Emflaza

  • Documentation of the following is required:
    • genetically confirmed mutation in the dystrophin gene representative of DMD; and
    • member is ≥ two years of age; and
    • one of the following:
      • prescriber is a neuromuscular neurologist; or
      • consult notes from a neuromuscular neurology office are provided; and
    • trial of prednisone and experienced significant weight gain [e.g., crossing two major percentiles and/or reaching the 98th percentile for body mass index (BMI) for age and gender] that was not alleviated with at least a 25% dose reduction (~0.56 mg/kg/day); and
    • dose is appropriate for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
    • for suspension formulation, medical necessity for use of the suspension formulation instead of the tablet formulation.

 

  • For recertification, documentation of the following is required:
    • genetically confirmed mutation in the dystrophin gene representative of DMD; and
    • member is ≥ two years of age; and
    • one of the following:
      • prescriber is a neuromuscular neurologist; or
      • consult notes from a neuromuscular neurology office are provided; and
    • dose is appropriate for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
    • medical records to support improvement from baseline in steroid-specific side-effects after treatment with the requested agent.

  

Enbrel, Humira, and Orencia for polyarticular juvenile idiopathic arthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • appropriate dosing; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for polyarticular juvenile idiopathic arthritis.

 

Entyvio, Humira, Inflectra, Remicade, Renflexis, Simponi, and Xeljanz for ulcerative colitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • for Xeljanz, member is ≥ 18 years of age and quantity requested is ≤ 60 tablets/30 days; and
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for ulcerative colitis; or
    • an inadequate response, adverse reaction, or contraindication to all of the following:
      • an aminosalicylate; and
      • a corticosteroid; and 
      • an immunomodulator (e.g., azathioprine, 6-mercaptopurine or methotrexate).

 

Humira for hidradenitis suppurativa

  • Documentation of the following is required:
    • diagnosis of moderate-to-severe hidradenitis suppurativa (Hurley Stage II or Hurley Stage III disease); and
    • appropriate dosing.

 

Humira for non-infectious uveitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and 
    • an inadequate response, or adverse reaction to one topical or systemic glucocorticoid, or a contraindication to all topical and systemic glucocorticoids; and
    • an inadequate response, or adverse reaction to one systemic immunosuppressive therapy, or a contraindication to all systemic immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine, tacrolimus, cyclophosphamide).

  

Ilaris for familial Mediterranean fever (FMF), Hyperimmunoglobulin D syndrome (HIDS)/Mevalonate kinase deficiency (MKD), or Tumor necrosis factor receptor associated periodic syndrome (TRAPS)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate treatment dose and frequency; and
    • one of the following:
      • evidence of symptoms indicative of the disease; or
      • confirmation of diagnosis through genetic testing; and
    • for diagnosis of FMF, an inadequate response, adverse reaction or contraindication to colchicine.

  

Ilaris for sJIA

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ two years of age; and
    • an inadequate response, adverse reaction, or contraindication to one NSAID; and
    • an inadequate response, adverse reaction, or contraindication to one corticosteroid; and
    • an inadequate response, adverse reaction, or contraindication to Kineret; and
    • appropriate treatment dose and frequency.

 

Kineret for neonatal-onset multisystem inflammatory disease (NOMID)

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

 

Kineret for RA

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for RA, or a contraindication to all biologic DMARDs that are FDA-approved for RA.

 

mycophenolic acid

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to mycophenolate mofetil.

SmartPA: Claims for mycophenolic acid will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent and the member has a history of MassHealth medical claims for organ transplant, complications of transplanted organs, or paid MassHealth pharmacy claims for sirolimus in the past 365 days.

  

Nulojix

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age.

     

Olumiant for RA

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • member is ≥ 18 years of age; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for RA, or a contraindication to all biologic DMARDs that are FDA-approved for RA; and
    • an inadequate response, adverse reaction, or contraindication to Xeljanz or Xeljanz XR; and
    • quantity requested is ≤ 30 tablets/30 days.

   

Otrexup

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to oral methotrexate; and
    • an inadequate response, or adverse reaction to Rasuvo; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to intramuscular methotrexate; or
      • medical necessity for prefilled methotrexate injector as noted by one of the following:
        • physical disability; or
        • visual impairment; or
        • cognitive impairment.

 

prednisolone 10 mg/5 mL oral solution, prednisolone 20 mg/5 mL oral solution, and prednisolone orally disintegrating tablet

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • compelling clinical rationale why the requested prednisolone product would offer a therapeutic advantage over generically available, less-costly alternatives.

 

Rasuvo

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to oral methotrexate; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to intramuscular methotrexate; or
      • medical necessity for prefilled methotrexate injector as noted by one of the following:
        • physical disability; or
        • visual impairment; or
        • cognitive impairment.

 

Rayos

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical records documenting inadequate response or adverse reaction to generic prednisone immediate-release tablets.

 

Stelara for Crohn’s disease

  • Documentation of the following is required for moderate-to-severe Crohn's disease:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • an inadequate response, or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease, or a contraindication to all biologic DMARDs that are FDA-approved for Crohn's disease; and
    • an inadequate response, adverse reaction, or contraindication to all of the following:
      • an aminosalicylate; and 
      • an antibiotic; and
      • a corticosteroid; and 
      • an immunomodulator (e.g., azathioprine, 6-mercaptopurine or methotrexate).

 

Sylvant

  • Documentation of the following is required:
    • diagnosis of multicentric Castleman's disease (MCD); and
    • member is ≥ 18 years of age; and
    • member is HIV negative and HHV-8 negative; and
    • member's current weight; and
    • results from hematological laboratory tests at baseline showing all of the following:
      • absolute neutrophil count ≥ 1.0x109/L; and
      • platelet count ≥75x109/L; and
      • hemoglobin <17 g/dL.

 

Xatmep

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • member is < 13 years of age; and
    • member's current body surface area; and
    • clinical rationale why generic injectable methotrexate may not be appropriate; and
    • clinical rationale why generic methotrexate tablets may not be appropriate.

 

Xeljanz and Xeljanz XR for psoriatic arthritis and RA

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • member is ≥ 18 years of age; and
    • an inadequate response, or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
    • quantity requested is within quantity limits (for Xeljanz ≤ 60 tablets/30 days, for Xeljanz XR ≤ 30 tablets/30 days).

 

Zilretta

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • an inadequate response or adverse reaction to two intra-articular corticosteroid injections; or
      • a contraindication to all other intra-articular corticosteroid injections; and
    • appropriate dosing.

  

Appendix:

Conventional Therapies for Plaque Psoriasis

Phototherapy

Topical Agents

Systemic Agents

ultraviolet A and topical psoralens (topical PUVA)

  emollients

Traditional DMARDs:

ultraviolet A and oral psoralens (systemic PUVA)

  keratolytics

    methotrexate

 narrow band UV-B (NUVB)

  corticosteroids

    sulfasalazine

 

  calcipotriene

    cyclosporine

 

  tazarotene

    tacrolimus

 

 

    acitretin

 

 

    mycophenolate mofetil

 

 

    azathioprine

 

 

    hydroxyurea

 

 

    leflunomide

 

 

    6-thioguanine

 

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: 09/2003

Last Revised Date: 10/2019


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Last updated 11/08/19