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.

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.

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.

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.†

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.

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.

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 ≤ one unit/day.
• 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 ≤ two units/day.

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 immediate release pregabalin; and
  • one of the following:
    • request is for diabetic peripheral neuropathy and quantity requested is ≤ one unit/day; or
    • request is for postherpetic neuralgia and quantity requested is ≤ two units/day.

Luxturna

• Documentation of all of the following is required:
  • diagnosis of biallelic RPE65 mutation-associated retinal dystrophy; and
  • prescriber is a specialist (opthalmologist or retinal specialist) or consult is provided; and
  • documentation that the treatment procedure will be performed at a specialized treatment center; and
  • medical records documenting the results from generic testing showing mutations in the RPE65 gene; and
  • documentation of viable retinal cells (e.g., retinal thickness > 100 microns); and
  • documentation of baseline full-field light sensitivity threshold (FST) scores; and
  • member is ≥ 1 year of age on treatment date; and
  • member has not undergone recent ocular surgery in the past six months; and
  • member has discontinued retinoid compounds for at least 18 months; and
  • appropriate dosing and treatment schedule.

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.

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.

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.

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).

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.

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.

Tegsedi

• Documentation of all of the following is required for hereditary transthyretin-mediated (hATTR) amyloidosis:
  • 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
  • inadequate response, adverse reaction, or contraindication to Onpattro; 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

• 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. 

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.

Lokelma and Veltassa > 30 units/month

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

Ceprotin

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • prescriber is a hematologist; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: warfarin, direct oral anticoagulants (direct thombin inhibitors or factor Xa inhibitors); 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.†

Givlaari

• Documentation of all of the following is required for acute hepatic porphyria (AHP):
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • member’s current weight; and
  • appropriate dosing.

Onpattro

• Documentation of all of the following is required for hereditary transthyretin-mediated (hATTR) amyloidosis:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • member’s current weight; and
  • baseline PND score of I, II, IIIa, or IIIb; and
  • appropriate dosing.

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. 

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.

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.