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
  • 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
  • for continuation of therapy, 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
  • inadequate response, adverse reaction, or contraindication to high-dose methylprednisolone; and
  • if request is for continuation of therapy 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 a diagnosis of 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.

Radicava

• Documentation of all of the following is required:
  • medical records supporting the diagnosis of amyotrophic lateral sclerosis; and
  • prescriber is a neurologist; and
  • prescriber submits 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.

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.

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.†

Xyrem

• Documentation of all of the following is required for a diagnosis of narcolepsy with cataplexy:
  • appropriate diagnosis; and
  • medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
  • prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
  • inadequate response or adverse reaction to one, or contraindication to all of the following: tricyclic antidepressant, SSRI, venlafaxine.
• Documentation of all of the following is required for a diagnosis of excessive daytime sleepiness due to narcolepsy (without cataplexy):
  • appropriate diagnosis; and
  • medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
  • prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to one cerebral stimulant agent from each class (methylphenidate and amphetamine); and

  • inadequate response, adverse reaction, or contraindication to armodafinil or modafinil.

Soliris

• Documentation of all of the following is required for a diagnosis of atypical hemolytic-uremic syndrome:
  • 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 paroxysmal nocturnal hemoglobinuria:
  • 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:
  • diagnosis of paroxysmal nocturnal hemoglobinuria; 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.

Korlym

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • member has failed surgical intervention (reoccurrence after surgery or failed tumor removal); or
    • surgical interventions are not an option; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: ketoconazole tablet, Lysodren; and
  • quantity requested is ≤ 120 units/30 days.

Signifor

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • member has failed surgical intervention (reoccurrence after surgery or failed tumor removal); or
    • surgical interventions are not an option; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: ketoconazole tablet, Lysodren; and

  • quantity requested is ≤ 60 units/30 days.

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.

pseudoephedrine > 240 mg/day

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

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.

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.

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.

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).

Hetlioz

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is totally blind; and
  • prescriber is a sleep specialist, or a sleep specialist consult is provided; and
  • inadequate response (defined as at least four weeks of therapy), adverse reaction, or contraindication to melatonin; and
  • quantity requested is ≤ 30 units/30 days.

melatonin powder

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

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.

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.

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.

Oralair (grass pollen allergen extract)

• 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 ≥ 10 years of age; and
  • skin test confirmation of pollen-specific immunoglobulin E (IgE) antibodies for the specific antigen is provided; 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.

Cuvposa

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member’s current weight; and
  • clinical rationale why generic 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 generic glycopyrrolate tablets may not be appropriate.

glycopyrrolate 1.5 mg tablet

• Documentation of the following is required:
  • medical records documenting clinical rationale why generic glycopyrrolate 1 mg and/or 2 mg tablets may not be appropriate.

Lokelma and Veltassa > 30 units/month

• Documentation of the following is required:
  • medical necessity for exceeding the quantity limit.

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
  • one of the following:
    • the requested medication will be used in combination with pyridostigmine; or
    • clinical rationale why use of pyridostigmine is not appropriate; and
  • appropriate dosing.

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.

Nuedexta

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

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.†

Asclera, Sotradecol

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

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.

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.†

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.

dimethyl sulfoxide liquid

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

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.