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Table 72: Agents Not Otherwise Classified


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Drug Category: Various

Medication Class/Individual Agents: Various

I. Prior-Authorization Requirements

 Agents Not Otherwise Classified – Acetylcholinesterase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

pyridostigmine bromide Mestinon test   #

pyridostigmine bromide 30 mg tablet

  • Documentation of the following is required.  
    • appropriate diagnosis; and
    • clinical rationale why pyridostigmine bromide 60 mg tablets may not be appropriate.
 
pyridostigmine bromide 30 mg tablet PA  

 Agents Not Otherwise Classified – Adrenocorticotropic Hormone

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

corticotropin Acthar PA  

Acthar

  • Documentation of the following is required for a diagnosis of infantile spasms:
    • appropriate diagnosis; and
    • member is < two years of age; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • if the request is for initial therapy, one of the following:
      • requested dose and duration is 20 units daily for two weeks followed by a taper over one week (specific taper must be documented); or
      • requested dose and duration is 75 units/m2 twice daily for two weeks (BSA must be documented) followed by a gradual taper over a two-week period (specific and appropriate taper must be documented), and medical necessity for use of high-dose corticotropin instead of low-dose corticotropin; or
    • if the request is for recertification, one of the following:
      • inadequate response to 20 units daily for the initial two weeks, and request is for continuation of therapy at 40 units daily for four weeks followed by a taper over one week (specific taper must be documented); or
      • history of relapse after previous treatment with corticotropin and medical necessity for retreatment. 

 

  • Documentation of all of the following is required for a diagnosis of an acute exacerbation of multiple sclerosis: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • requested dose and duration is 80 to 120 units daily for two to three weeks; and
    • medical records documenting inadequate response or adverse reaction to one of the following, or contraindication to both of the following: high-dose intravenous methylprednisolone, high-dose oral corticosteroids; and
    • if the request is for recertification for the same exacerbation, medical necessity for use beyond initial therapy, and requested dose and duration does not exceed 120 units daily for three weeks.

 

  • Documentation of all of the following is required for use to induce remission of proteinuria associated with idiopathic nephrotic syndrome: 
    • appropriate diagnosis; and
    • etiology of proteinuria in nephrotic syndrome has been confirmed with renal biopsy; and
    • prescriber is a nephrologist or consult notes from a nephrology office are provided; and
    • pretreatment proteinuria > 50 mg/kg per day or a spot urine sample with a total protein/creatinine ratio > 3 mg; and
    • pretreatment serum albumin < 3 g/dL (30 g/L); and
    • inadequate response, adverse reaction, or contraindication to corticosteroids; and
    • inadequate response, adverse reaction, or contraindication to all appropriate second-line treatment options (ACE inhibitor or ARB, azathioprine, calcineurin inhibitors, cyclophosphamide, diuretics, mycophenolate, rituximab); and
    • one of the following:
      • requested dose is 40 or 80 units twice weekly for 12 to 24 weeks; or
      • clinical rationale for a dose greater than 80 units, more frequent dosing than twice weekly, and/or duration longer than 24 weeks.

 

  • For recertification for use to induce remission of proteinuria associated with idiopathic nephrotic syndrome, documentation of all of the following is required: 
    • prescriber is a nephrologist or consult notes from a nephrology office are provided; and
    • current proteinuria or spot urine total protein/creatinine ratio; and
    • positive response to therapy as shown by improvements in proteinuria or spot urine total protein/creatinine ratio; and
    • for extension of treatment duration beyond 24 weeks, duration of therapy does not exceed one year and one of the following:
      • member has achieved and maintained partial or complete response on current dose of corticotropin; or
      • clinical rationale for use beyond 24 weeks when partial or complete remission has not been achieved or maintained.
 

 Agents Not Otherwise Classified – Amyotrophic Lateral Sclerosis (ALS) Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

edaravone Radicava PA  

Radicava

  • Documentation of all of the following is required:
    • medical records supporting the diagnosis of amyotrophic lateral sclerosis; and
    • prescriber is a neurologist; and
    • a copy of the pre-treatment ALSFRS-R questionnaire including scores on each individual domain and duration of disease (within the past 12 weeks); and
    • appropriate dosing; and
    • one of the following:
      • medical records documenting the requested medication will be used in combination with riluzole; or
    • clinical rationale for not using the requested agent in combination with riluzole.

    

  • For recertification, documentation of all of the following is required:
    • a current (within the past 12 weeks) copy of the ALSFRS-R questionnaire including scores on each individual domain; and
    • one of the following:
      • total decrease in ALSFRS-R score from pre-treatment baseline is five points or less; or
      • medical necessity for continuing treatment.

 

Tiglutik

  • Documentation of all of the following is required:
    • diagnosis of amyotrophic lateral sclerosis; and
    • member is ≥ 18 years of age; and
    • clinical rationale why generic riluzole tablets may not be appropriate; and
    • appropriate dosing.
 
riluzole suspension Tiglutik PA  
riluzole tablet Rilutek test   #

 Agents Not Otherwise Classified – Antioxidant

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

coenzyme Q10 PA   - ≥ 19 years

coenzyme Q10 for members ≥ 19 years of age

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • muscle biopsy positive for mitochondrial disease; or
    • pathogenic mtDNA abnormality.

SmartPA: Claims for coenzyme Q10 will usually process at the pharmacy without a PA request if the member is ≥ 19 years of age and has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent.†

 

 Agents Not Otherwise Classified – Complement Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

eculizumab Soliris PA  

Soliris

  • Documentation of all of the following is required for a diagnosis of atypical hemolytic-uremic syndrome (aHUS):
    • appropriate diagnosis; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • appropriate dosing.
  • Documentation of all of the following is required for a diagnosis of generalized myasthenia gravis:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member is AchR antibody positive; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, intravenous immunoglobulin, mycophenolate, plasma exchange or plasmapheresis, tacrolimus; and 
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • appropriate dosing.
  • Documentation of all of the following is required for a diagnosis of neuromyelitis optica spectrum disorder:
    • appropriate diagnosis; and
    • laboratory tests showing positive AQP4 antibody; and
    • member is ≥ 18 years of age; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • appropriate dosing.
  • Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • appropriate dosing.

   

Ultomiris

  • Documentation of all of the following is required for a diagnosis of aHUS:
    • appropriate diagnosis; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • appropriate dosing.
  • Documentation of all of the following is required for a diagnosis of PNH:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • appropriate dosing.
 
ravulizumab-cwvz Ultomiris PA  

 Agents Not Otherwise Classified – Cystinosis Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

cysteamine delayed-release capsule Procysbi PA  

Cystaran

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a nephrologist or ophthalmologist.

 

Procysbi

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • appropriate dose; and
    • prescriber is a nephrologist; and
    • medical records documenting an inadequate response or adverse reaction to cysteamine immediate-release capsule; and
    • if the request is for Procysbi granules, compelling clinical rationale for use of the requested formulation.
  • For recertification of Procysbi granules, documentation of continued necessity of dosage form.
 
cysteamine delayed-release granule Procysbi PA  
cysteamine immediate-release capsule Cystagon test  
cysteamine ophthalmic Cystaran PA  

 Agents Not Otherwise Classified – Decongestant

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

pseudoephedrine PA   - > 240 mg/day *

pseudoephedrine > 240 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for exceeding the dose limit.
 

 Agents Not Otherwise Classified – Diabetes Emergency Treatments

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

glucagon auto-injection, prefilled syringe Gvoke PA  

Gvoke

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • member is ≥ two years and < four years of age; or
      • inadequate response, adverse reaction or contraindication to Baqsimi.

 

 
glucagon nasal powder Baqsimi PD test  
glucagon vial Glucagen test  
glucagon vial test  

 Agents Not Otherwise Classified – Epinephrine Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

epinephrine 0.15 mg auto-injection-Epipen Jr Epipen Jr PA  

Epipen, Epipen Jr

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction to the therapeutically equivalent generic formulation.
 
epinephrine 0.3 mg auto-injection-Epipen Epipen PA  
epinephrine auto-injection test  
epinephrine injection Adrenalin test  
epinephrine injection Symjepi test  

 Agents Not Otherwise Classified – Gamma-Aminobutyric Acid (GABA) Analogs

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

gabapentin enacarbil Horizant PA  

gabapentin powder

  • Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • member will be using the requested agent as adjunctive therapy; and
    • clinical rationale why other commercially available alternatives cannot be used.
  • Documentation of the following is required for the diagnosis of postherpetic neuralgia:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

 

Gralise

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to a tricyclic antidepressant; and
    • inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to immediate release gabapentin.

 

Horizant

  • Documentation of all of the following is required for a diagnosis of restless leg syndrome:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to pramipexole or ropinirole; and
    • inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to immediate release gabapentin; and
    • quantity requested is ≤ 30 units/month.
  • Documentation of the following is required for a diagnosis of postherpetic neuralgia:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to a tricyclic antidepressant; and
    • inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to immediate release gabapentin; and
    • quantity requested is ≤ 60 units/month.

 

Lyrica CR

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: a tricyclic antidepressant, duloxetine, lidocaine patch, venlafaxine; and
    • inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), adverse reaction or contraindication to gabapentin; and
    • inadequate response (defined as at least 14 days of therapy) or adverse reaction to Lyrica; and
    • one of the following:
      • request is for diabetic peripheral neuropathy and quantity requested is ≤ 30 units/month; or
      • request is for postherpetic neuralgia and quantity requested is ≤ 60 units/month.
 
gabapentin extended-release Gralise PA  
gabapentin powder PA  
pregabalin extended-release Lyrica CR PA  

 Agents Not Otherwise Classified – Hormone Replacement Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

estradiol / progesterone Bijuva PA  

Bijuva

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • compelling clinical rationale that the combination product would offer a therapeutic advantage over the commercially available separate agents.

 

 

 Agents Not Otherwise Classified – Human Nerve Growth Factor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

cenegermin-bkbj Oxervate PA  

Oxervate

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • prescriber is a specialist (e.g., ophthalmologist) or provides consult notes from a specialist.
 

 Agents Not Otherwise Classified – Interferon Gamma Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

emapalumab-lzsg Gamifant PA  

Gamifant

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., hematologist or oncologist) or or a specialist consult is provided; and
    • one of the following:
      • molecular tests confirming diagnosis of primary hemophagocytic lymphohistiocytosis (HLH); or
      • at least five of the following tests suggesting primary HLH: fever, splenomegaly, cytopenia (defined by two of the following: hemoglobin < 9 g/dL, platelets < 100 x 109/L, neutrophils < 1 x 109/L), hypertriglyceridemia (defined by fasting triglycerides > 3 mmol/L or ≥ 265 mg/dL) and/or hypofibrinogenemia (≤ 1.5 g/L), hemophagocytosis in bone marrow, spleen, or lymph nodes, low or absent NK-cell activity based on laboratory reference, ferritin ≥ 500 mcg/L, soluble CD25 ≥ 2400 U/mL; and
    • member has active disease; and
    • member does not have active infections caused by specific pathogens favored by interferon gamma neutralization (e.g., mycobacteria, Histoplasma Capsulatum, Shigella, salmonella, campylobacter, leishmanial infections); and
    • inadequate response, adverse reaction, or contraindication to conventional HLH therapy (chemotherapy, systemic corticosteroids, immunosuppressive therapy); and
    • requested agent will be administered concurrently with dexamethasone, or clinical rationale for not using dexamethasone; and
    • anticipated hematopoietic stem cell transplantation (HSCT) date is provided, or member is not a candidate for HSCT; and
    • baseline clinical parameters and laboratory values including presence of fever, presence of splenomegaly, presence of CNS symptoms, hemoglobin, platelets, neutrophils, fasting triglycerides, fibrinogen, D-dimer, presence of hemophagocytosis, NK-cell activity, ferritin, and soluble CD25; and
    • appropriate dosing.
  • For recertification, documentation of the following is required:
    • positive response to therapy as evidenced by one of the following:
      • complete response (normalization of all HLH abnormalities); or
      • partial response (normalization of ≥ 3 HLH abnormalities); or
      • HLH improvement (≥ 3 HLH abnormalities improved by at least 50% from baseline); and
    • requested agent will be administered concurrently with dexamethasone, or clinical rationale for not using dexamethasone; and
    • anticipated HSCT date is provided, or member is not a candidate for HSCT.
 

 Agents Not Otherwise Classified – Leptin Analog

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

metreleptin Myalept PA  

Myalept

  • Documentation of all of the following is required:
    • diagnosis of one of the following:
      • Congenital Generalized Lipodystrophy (CGL) or Berardinelli-Seip syndrome; or
      • Acquired Generalized Lipodystrophy (AGL) or Lawrence syndrome; and
    • member has at least one of the following metabolic abnormalities:
      • diabetes mellitus; or
      • fasting serum triglycerides > 200 mg/dL; or
      • fasting insulin levels > 30 microU/mL; and
    • requested medication is being used as an adjunct to dietary restrictions; and
    • one of the following:
      • if the member has diabetes mellitus or fasting insulin levels > 30 microU/mL, medical records documenting an inadequate response to 90 days of therapy or adverse reaction to three different classes of antidiabetic therapies; or
      • if the member has fasting serum triglycerides > 200 mg/dL, medical records documenting an inadequate response to 90 days of therapy or adverse reaction to a fibrate and a high-potency statin (rosuvastatin 20 mg or 40 mg or atorvastatin 40 mg or 80 mg).
 

 Agents Not Otherwise Classified – Melatonin Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

melatonin / pyridoxine tablet test   *

melatonin powder

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.
 
melatonin powder PA  
melatonin tablet, solution test   *

 Agents Not Otherwise Classified – Monoclonal Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

belimumab Benlysta PA  

Benlysta

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate; and
    • appropriate dose.
 

 Agents Not Otherwise Classified – Neuromuscular Potassium Channel Blockers

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

amifampridine Firdapse PA  

Firdapse

  • Documentation of all of the following is required:
    • diagnosis of symptomatic Lambert-Eaton myasthenic syndrome (LEMS); and
    • member is ≥ 18 years of age; and
    • prescriber is a neurologist or provides consultation notes from a neurologist; and
    • one of the following laboratory results confirming the diagnosis:
      • neurophysiology study tests; or
      • positive anti-P/Q type voltage-gated calcium channel antibody test; and
    • appropriate dosing; and
    • medical records documenting inadequate response, adverse reaction, or contraindication to Ruzurgi.

 

Ruzurgi

  • Documentation of all of the following is required:
    • diagnosis of symptomatic LEMS; and
    • member is ≥ six years of age; and
    • prescriber is a neurologist or provides consultation notes from a neurologist; and
    • one of the following laboratory results confirming the diagnosis:
      • neurophysiology study tests; or
      • positive anti-P/Q type voltage-gated calcium channel antibody test; and
    • appropriate dosing.
 
amifampridine Ruzurgi PA  

 Agents Not Otherwise Classified – Oligonucleotide Therapies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

inotersen Tegsedi PA  

Tegsedi

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., rheumatologist or neurologist) or a specialist consult is provided; and
    • results from genetic testing showing mutations in the TTR gene; and
    • baseline polyneuropathy disability (PND) score of I, II, IIIa, or IIIb; and
    • appropriate dosing.
 

 Agents Not Otherwise Classified – Oral Carbonic Anhydrase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

acetazolamide Diamox test   #

Keveyis

  • Documentation of all of the following is required for a diagnosis of primary hyperkalemic periodic paralysis:
    • appropriate diagnosis; and
    • prescriber is a specialist or a specialist consult is provided; and
    • inadequate response, adverse reaction, or contraindication to acetazolamide and hydrochlorothiazide.
  • Documentation of all of the following is required for a diagnosis of primary hypokalemic periodic paralysis:
    • appropriate diagnosis; and
    • prescriber is a specialist or a specialist consult is provided; and
    • inadequate response, adverse reaction, or contraindication to acetazolamide and spironolactone.
 
dichlorphenamide Keveyis PA  

 Agents Not Otherwise Classified – Oral Immunotherapy Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

grass pollen allergen extract Oralair PA  

Oralair

  • Documentation of all of the following is required:
    • diagnosis of allergic rhinoconjunctivitis; and
    • prescriber is an allergist or immunologist, or specialist consult notes are provided; and
    • member is ≥ five years of age; and
    • medical records of the skin test confirming pollen-specific immunoglobulin E (IgE) antibodies for the specific antigen; and
    • member is not currently a candidate for subcutaneous immunotherapy; and
    • inadequate response (defined as at least two weeks of therapy), adverse reaction, or contraindication to one agent from all of the following classes of symptomatic therapy: second generation antihistamine, intranasal corticosteroid, intranasal antihistamine, leukotriene modifier; and
    • quantity requested is ≤ 30 units/30 days.

 

Palforzia

  • Documentation of all of the following is required:
    • diagnosis of peanut allergy; and
    • prescriber is an allergist or immunologist, or specialist consult notes are provided; and
    • one of the following:
      • member is ≥ four to 17 years of age; or
      • documentation that member started Palforzia at four to 17 years old; and
    • confirmation of diagnosis with one of the following:
      • serum peanut-specific immunoglobulin (IgE); or
      • skin test confirmation of immunoglobulin (IgE) antibodies for the specific antigen; and
    • appropriate dosing.
  • For recertification of Palforzia, documentation of tolerance to therapy during the initial dose escalation and up-dosing phases. 
 
peanut allergen powder-dnfp Palforzia PA  

 Agents Not Otherwise Classified – Oral, Injectable, and Miscellaneous Glycopyrrolate Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

glycopyrrolate 1 mg, 2 mg tablet test  

Cuvposa

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member’s current weight; and
    • clinical rationale why glycopyrrolate tablets may not be appropriate; and
    • for members > 16 years of age, inadequate response, adverse reaction or contraindication to scopolamine patches.

 

glycopyrrolate injection

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why glycopyrrolate tablets may not be appropriate.

 

glycopyrrolate powder

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

 

glycopyrrolate 1.5 mg tablet

  • Documentation of the following is required:
    • medical records documenting clinical rationale why glycopyrrolate 1 mg and/or 2 mg tablets may not be appropriate.
 
glycopyrrolate 1.5 mg tablet PA  
glycopyrrolate injection PA  
glycopyrrolate oral solution Cuvposa PA  
glycopyrrolate powder PA  

 Agents Not Otherwise Classified – Potassium Binding Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

patiromer Veltassa PA   - > 30 units/month

Lokelma and Veltassa > 30 units/month

  • Documentation of the following is required:
    • medical necessity for exceeding the quantity limit.
 
sodium polystyrene sulfonate test  
sodium zirconium cyclosilicate Lokelma PA   - > 30 units/month

 Agents Not Otherwise Classified – Protein C Deficiency Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

protein C concentrate Ceprotin PA  

Ceprotin

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a hematologist; and
    • inadequate response, adverse reaction, or contraindication to warfarin; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: enoxaparin, Fragmin.
 

 Agents Not Otherwise Classified – Pseudobulbar Affect Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

dextromethorphan / quinidine Nuedexta PA  

Nuedexta

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • quantity requested is ≤ 60 units/30 days.
 

 Agents Not Otherwise Classified – Purified Collagenase

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

collagenase clostridium histolyticum Xiaflex PA  

Xiaflex

  • Documentation of all of the following is required for a diagnosis of Dupuytren’s contracture:
    • appropriate diagnosis; and
    • number of cords being treated.
  • Documentation of all of the following is required for a diagnosis of Peyronie’s disease:
    • appropriate diagnosis; and
    • prescriber is a urologist or a urology consult is provided; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • member is not a candidate for surgery; and
    • inadequate response or adverse reaction to one of the following: carnitine, colchicine, interferon, pentoxifylline, tamoxifen, verapamil, vitamin E.

SmartPA: Claims for Xiaflex will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for Dupuytren’s contracture and the current claim plus all history is ≤ one vial.†

 

 Agents Not Otherwise Classified – Sclerosing Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

polidocanol Asclera PA   ^

Asclera, Sotradecol

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • symptoms due to varicose veins are non-cosmetic.
 
tetradecyl sulfate injection Sotradecol PA  

 Agents Not Otherwise Classified – Selective Serotonin Reuptake Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

paroxetine 7.5 mg capsule Brisdelle PA  

paroxetine 7.5 mg capsule

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction to paroxetine hydrochloride; and
    • medical records documenting an inadequate response or adverse reaction to three or contraindication to all of the following:
      • hormone replacement therapy; or
      • venlafaxine or desvenlafaxine; or
      • an SSRI other than paroxetine; or
      • gabapentin; or
      • clonidine.
 

 Agents Not Otherwise Classified – Serotonin/Norepinephrine Reuptake Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

milnacipran Savella PA  

Savella

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • requested dose does not exceed two tablets daily; or
      • compelling clinical rationale for exceeding the quantity limit; and
    • inadequate response (defined as at least two weeks of therapy with a minimum dose of 1,200 mg/day), adverse reaction, or contraindication to gabapentin; and
    • inadequate response (defined as at least four weeks of therapy) or adverse reaction to one or contraindication to all of the following: tricyclic antidepressant, cyclobenzaprine, SSRI, SNRI.

SmartPA: Claims for Savella for quantities ≤ 60 units/30 days will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent.†

 

 Agents Not Otherwise Classified – Small Interfering RNA Therapies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

patisiran Onpattro PA  

Onpattro

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., rheumatologist or neurologist) or a specialist consult is provided; and
    • results from genetic testing showing mutations in the TTR gene; and
    • member’s current weight; and
    • baseline PND score of I, II, IIIa, or IIIb; and
    • appropriate dosing.
 

 Agents Not Otherwise Classified – Thyroid Eye Disease Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

teprotumumab-trbw Tepezza PA  

Tepezza

  • Documentation of all of the following is required:
    • diagnosis of thyroid eye disease; and
    • member is ≥ 18 years of age; and
    • prescriber is an endocrinologist or ophthalmologist or provides consultation notes from an endocrinologist or ophthalmologist; and
    • clinical activity score ≥ four in at least one eye; and
    • inadequate response, adverse reaction, or contraindication to glucocorticoids; and
    • appropriate dosing. 

 

 

 Agents Not Otherwise Classified – Transthyretin Stabilizer

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

tafamidis Vyndamax PA  

Vyndamax, Vyndaqel

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., cardiologist) or a specialist consult is provided; and
    • one of the following:
      • results from genetic testing showing mutations in the TTR gene; or
      • presence of amyloid deposits in biopsy tissue with confirmed TTR; or
      • TTR precursor protein identification by immunohistochemistry, scintigraphy, or mass spectrometry; and
    • appropriate dosing.
 
tafamidis Vyndaqel PA  

 Agents Not Otherwise Classified – Urinary Tract Anti-Inflammatory Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

dimethyl sulfoxide liquid PA  

dimethyl sulfoxide liquid

  • Documentation of the following is required.  
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.
 
dimethyl sulfoxide solution Rimso-50 test  

 Agents Not Otherwise Classified – Vasopressin Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

tolvaptan-Jynarque Jynarque PA  

Jynarque

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 and < 56 years of age; and
    • prescriber is a nephrologist or provides consultation notes from a nephrologist regarding the diagnosis and treatment recommendations; and
    • estimated glomerular filtration rate (eGFR) ≥ 25 mL/min.
 
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.
 
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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
^ 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:

  • Various

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 prior-authorization 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).

  

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: 11/2014

Last Revised Date: 08/2019


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Last updated 10/26/20

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