pyridostigmine bromide 30 mg tablet

• Documentation of the following is required.  
  • appropriate diagnosis; and
  • medical necessity for the 30 mg tablet instead of the 60 mg tablet.
• For recertification, documentation of continued medical necessity for the requested dosage formulation is required.

Acthar and Cortrophin

• 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 neurologist are provided; and
  • for Cortrophin, medical necessity for use instead of Acthar; 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 [body surface area (BSA) must be documented] followed by a gradual taper over a two-week period (specific and appropriate taper must be documented); or
  • 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 neurologist are provided; and
  • for Cortrophin, medical necessity for use instead of Acthar; 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 or contraindication to both of the following: high-dose intravenous methylprednisolone, high-dose oral corticosteroids; and
  • for recertification for the same exacerbation, medical necessity for use beyond initial therapy, and requested dose and duration is ≤ 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 nephrologist are provided; and
  • for Cortrophin, medical necessity for use instead of Acthar; 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 all of the following: corticosteroids, calcineurin inhibitors (e.g., cyclosporine, tacrolimus), cyclophosphamide, mycophenolate, rituximab; and
  • requested dose is 40 or 80 units twice weekly for 12 to 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 nephrologist are provided; and
  • for Cortrophin, medical necessity for use instead of Acthar; 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
  • total treatment duration is ≤ 24 weeks.

Exservan, Tiglutik

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • one of the following:
    • member has severe dysphagia and is currently utilizing only dosage formulations that can easily be swallowed; or
    • member utilizes tube feeding (J-tube, G-tube) and is unable to use crushed tablets; or
    • medical necessity for use instead of riluzole tablets; and
  • appropriate dosing.

• For recertification, documentation of all of the following is required:
  • one of the following:
    • member has severe dysphagia and is currently utilizing only dosage formulations that can easily be swallowed; or
    • member utilizes tube feeding (J-tube, G-tube) and is unable to use crushed tablets; or
    • continued medical necessity for use instead of riluzole tablets; and
  • appropriate dosing.

Radicava, Radicava ORS

• Documentation of all of the following is required:
  • medical records supporting the diagnosis of definite, probable, or probable-laboratory supported ALS per El Escorial criteria; and
  • prescriber is a neurologist, neuromuscular specialist, or other specialist in the treatment of ALS, or consult notes from a specialist are provided; and
  • pre-treatment ALSFRS-R questionnaire score (within the past 12 weeks); and
  • pre-treatment ALSFRS-R questionnaire score of ≥ two on each individual item; and
  • pre-treatment FVC ≥ 80%; and
  • member is not dependent on invasive mechanical ventilation by intubation or tracheostomy; and
  • appropriate dosing; and
  • one of the following:
    • requested agent will be used in combination with riluzole; or
    • adverse reaction or contraindication to riluzole.

• For recertification, documentation of all of the following is required:
  • a current (within the last 12 weeks) copy of the ALSFRS-R questionnaire including scores on each individual domain; and
  • member is not dependent on invasive mechanical ventilation by intubation or tracheostomy.

Relyvrio

• Documentation of all of the following is required:
  • prescriber is a neurologist, neuromuscular specialist, or other specialist in the treatment of ALS, or consult notes from a specialist are provided; and
  • medical records supporting the diagnosis of definite, probable, or probable-laboratory supported ALS per El Escorial criteria; and
  • pre-treatment ALSFRS-R questionnaire score (within the past 12 weeks); and
  • pre-treatment forced viral capacity (FVC) of slow vial capacity (SVC) ≥ 60 %; and
  • member is not depended on invasive mechanical ventilation by intubation or tracheostomy; and 
  • requested quantity is ≤ two units/day; and
  • one of the following:
    • requested agent will be used in combination with riluzole; or
    • adverse reaction or contraindication to riluzole. 

• For recertification, documentation of all of the following is required:
  • a current (within the last 12 weeks) copy of the ALSFRS-R questionnaire including scores on each individual domain; and
  • member is not dependent on invasive mechanical ventilation by intubation or tracheostomy.

Qalsody

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • member is ≥ 18 years of age; and
  • prescriber is a neurologist, neuromuscular specialist, or other specialist in the treatment of ALS, or consult notes from a specialist are provided; and
  • genetic test confirming SOD1 mutation; and
  • pre-treatment ALSFRS-R questionnaire score (within the past 12 weeks); and
  • appropriate dosing; and
  • member is not depended on invasive mechanical ventilation by intubation or tracheostomy; and 
  • one of the following:
    • requested agent will be used in combination with riluzole; or
    • adverse reaction or contraindication to riluzole. 

• For recertification, documentation of all of the following is required:
  • a current (within the last 12 weeks) copy of the ALSFRS-R questionnaire including scores on each individual domain; and
  • member is not dependent on invasive mechanical ventilation by intubation or tracheostomy.

coenzyme Q10 for members ≥ 22 years of age

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

SmartPA: Claims for coenzyme Q10 and coenzyme Q10 with vitamin E combination products will usually process at the pharmacy without a PA request if the member is ≥ 22 years of age and has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days of the requested agent.†

Pedmark

• Documentation of all of the following is required:
  • diagnosis of localized, non-metastatic solid tumor; and
  • prescriber is an oncologist; and 
  • member is ≥ one month and < 18 years of age; and 
  • member is receiving cisplatin with an infusion duration ≤ six hours; and 
  • appropriate dosing.

Voxzogo

• Documentation of the following is required:
  • medical records documenting diagnosis of achondroplasia based on symptoms and radiographic findings or generic testing; and
  • member is ≥ five years of age; and
  • prescriber is an endocrinologist or geneticist or consult notes from an endocrinologist or geneticist are provided; and
  • requested dose is 15 mcg/kg once daily; and
  • requested quantity is ≤ one unit/day; and 
  • member has open epiphyses.

• For recertification, documentation of the following is required:
  • member continues to have open epiphyses; and
  • growth velocity is at least 2.5 cm/year.

All requests for COVID-19 antigen self-test kits at quantities above established quantity limits

• Documentation of the following is required:
  • Medical necessity for increased testing.

Skysona

• Documentation of all of the following is required:
  • diagnosis of cerebral adrenoleukodystrophy (CALD); and
  • member is ≥ four years and < 18 years of age at the time of treatment; and
  • elevated very long chain fatty acids (VLCFAs); and
  • genetic testing showing mutation in the ABCD1; and
  • prescriber is a neurologist; and
  • member has all of the following:
    • neurologic Function Score (NFS) score ≤1; and
    • loes score between 0.5 and 9 (inclusive); and
    • gadolinium enhancement on brain magnetic resonance imaging (MRI); and
  • member has not had previous allogeneic transplant or gene therapy.

• MassHealth Drug Utilization Review will be reaching out to prescribers after PA approval to verify administration date and at ongoing intervals for long-term monitoring of response.

Empaveli

• 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.

Enjaymo

• Documentation of all of the following is required for the diagnosis of cold agglutinin disease (CAD):
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • Hemoglobin (Hb) ≤ 10 g/dL (dated within the last 60 days); and 
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to a rituximab-containing regimen; or
    • requested agent is being used as a bridge therapy to initiate a rituximab-containing regimen; and
  • member has received a vaccine against encapsulated bacteria (Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae) at least two weeks prior to treatment initiation; and 
  • appropriate dosing.

Enspryng

• Documentation of all of the following is required for the diagnosis of neuromyelitis optica spectrum disorder (NMOSD):
  • appropriate diagnosis; and
  • a positive serologic test for anti-aquaporin 4 (AQP4); and
  • member is ≥ 18 years of age; and
  • appropriate dosing.

Rystiggo

• 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 or MuSK antibody positive; and
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • inadequate response, adverse reaction or contraindication to pyridostigmine; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and 
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to Vyvgart or Vyvgart Hytrulo; or
    • member is MuSK antibody positive; and
  • appropriate dosing.

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; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris.
• 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, adverse reaction or contraindication to pyridostigmine; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: 
    • Rystiggo; or 
    • Vyvgart or Vyvgart Hytrulo; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and 
  • appropriate dosing.
• Documentation of all of the following is required for a diagnosis of NMOSD:
  • appropriate diagnosis; and
  • a positive serologic test for anti-aquaporin-4 (AQP4); 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 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
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • appropriate dosing.

Syfovre

• Documentation of all of the following is required for a diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD):
  • appropriate diagnosis; and
  • prescriber is an ophthalmologist; and
  • member is ≥ 60 years of age; and
  • all of the following:
    • absence of choroidal neovascularization (CNV or wet AMD) in the treatment eye; and
    • normal luminance best corrected visual acuity (BCVA) ≥ 24 letters (20/230 Snellen equivalence); and
    • total GA lesion area ≥ 2.5 and ≤ 17.5 mm2, with at least 1 lesion ≥ 1.25 mm2 if GA is multifocal; and 
    • presence of any pattern of hyperautoflorescence in the junctional zone of GA; and
  • requested dosing is 15 mg (0.1 mL) once every 25 days to 60 days.

• For recertification, documentation of all of the following is required for a diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD):
  • positive response to therapy; and
  • member has not developed nAMD (wet AMD); and
  • if requested dosing is ≥ every 60 days, prescriber has assessed using less frequent dosing.

Tavneos

• Documentation of all of the following is required for a diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a rheumatologist or nephrologist or consult notes from a rheumatologist or nephrologist are provided; and
  • requested quantity is ≤ six capsules/day; and
  • appropriate dosing; and
  • requested agent will be used as adjunctive therapy with both of the following:
    • a systemic glucocorticoid; and
    • one of the following: azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, or rituximab.

Uplizna

• Documentation of all of the following is required for the diagnosis of NMOSD:
  • appropriate diagnosis; and
  • a positive serologic test for anti-aquaporin 4 (AQP4); and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to Enspryng; 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 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, adverse reaction or contraindication to pyridostigmine; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: 
    • Rystiggo; or
    • Vyvgart or Vyvgart Hytrulo; and
  • appropriate dosing.

Vyvgart and Vyvgart Hytrulo

• 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
  • prescriber is a neurologist or consult notes from a neurology office are provided; and
  • inadequate response, adverse reaction or contraindication to pyridostigmine; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and 
  • appropriate dosing.

Cystaran, Cystadrops

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

Procysbi

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • appropriate dosing; and
  • prescriber is a nephrologist; and
  • medical records documenting an inadequate response or adverse reaction to cysteamine immediate-release capsule; and
  • for Procysbi granules, medical necessity for the requested formulation.
• For recertification of Procysbi granules, documentation of continued medical necessity for the requested formulation.

pseudoephedrine > 240 mg/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • medical necessity for exceeding the dose limit.

Auvi-Q

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • for Auvi-Q 0.15 mg and 0.3 mg auto-injector, medical necessity for the use of the requested agent instead of alternatives available without prior authorization; and
  • for Auvi-Q 0.1 mg dose auto-injector, one of the following:
    • member’s current weight is <13 kg; or
    • both of the following:
      • member’s current weight is 13 kg to <15 kg; and
      • medical necessity for use of Auvi-Q 0.1 mg auto-injector.

Zokinvy

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • results from genetic testing or molecular analysis to confirm diagnosis; and
  • prescriber is a specialist in genetic diseases or consult notes from a specialist are provided; and
  • member is ≥ one year of age; and
  • member's BSA is ≥ 0.39 m²; and
  • appropriate dosing; and
  • requested dose requested cannot be consolidated; and
  • requested quantity is ≤ four units/day.

Skyclarys

• Documentation of all of the following is required:
  • diagnosis of Friedreich's Ataxia (FA); and
  • member is ≥ 16 years of age; and
  • prescriber is a neurologist or consult notes from a neurologist are provided; and
  • genetic testing confirming the diagnosis of FA; and
  • requested quantity is ≤ three units/day.

gabapentin extended-release

• Documentation of all of the following is required for a diagnosis of postherpetic neuralgia:
  • 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 ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to gabapentin immediate-release.

• Documentation of all of the following is required for a diagnosis of fibromyalgia:
  • appropriate diagnosis; and
  • inadequate response (defined by ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to gabapentin immediate-release; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: cyclobenzaprine, SSRI/SNRI, tricyclic antidepressant.

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

Horizant

• Documentation of all of the following is required for a diagnosis of restless leg syndrome:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one, or contraindication to both of the following: pramipexole, ropinirole; and
  • inadequate response (defined by ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to gabapentin immediate-release; and
  • requested quantity 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 ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to  gabapentin immediate-release; and
  • requested quantity is ≤ two units/day.

• Documentation of all of the following is required for a diagnosis of fibromyalgia:
  • appropriate diagnosis; and
  • inadequate response (defined by ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to gabapentin immediate-release; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: cyclobenzaprine, SSRI/SNRI, tricyclic antidepressant; and
  • requested quantity is ≤ two tablets/day.

• Documentation of all of the following is required for a diagnosis of diabetic peripheral neuropathy:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response (defined by ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to gabapentin immediate-release; and
  • inadequate response, adverse reaction, or contraindication to all of the following: cyclobenzaprine, SSRI/SNRI, tricyclic antidepressant; and
  • requested quantity is ≤ two tablets/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: duloxetine, lidocaine patch, a tricyclic antidepressant, venlafaxine; and
  • inadequate response (defined as ≥ 14 days of therapy at a dose of ≥ 1,200 mg/day), adverse reaction or contraindication to gabapentin; and
  • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to pregabalin immediate-release ; and
  • one of the following:
    • for diabetic peripheral neuropathy, requested quantity is ≤ one unit/day; or
    • for postherpetic neuralgia, requested quantity 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 (ophthalmologist or retinal specialist) or consult notes from a specialist are provided; and
  • the treatment procedure will be performed at a specialized treatment center; and
  • medical records documenting the results from genetic testing showing mutations in the RPE65 gene; and
  • viable retinal cells (e.g., retinal thickness > 100 microns); and
  • 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 last six months; and
  • member has discontinued retinoid compounds for at least 18 months; and
  • appropriate dosing and treatment schedule.

• MassHealth Drug Utilization Review will be reaching out to prescribers after PA approval to verify administration date and at ongoing intervals for long-term monitoring of response.

Daybue

• Documentation of all of the following is required for a diagnosis of classic or typical Rett syndrome:
  • appropriate diagnosis; and
  • member is ≥ two years of age; and
  • prescriber is a neurologist or consult notes from a neurologist are provided; and
  • results from genetic testing confirming a mutation in the MECP2 gene; and
  • RTT Clinical Severity Scale (RTT-CSS) rating of 10 to 36; and
  • Clinical Global Impression-Severity (CGI-S) score of ≥ four; and
  • appropriate dosing.

Bijuva

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for the combination product instead of 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 consult notes from a specialist are provided.

Gamifant

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., hematologist or oncologist) or consult notes from a specialist are 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 in combination 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 in combination 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 insulin levels > 30 microU/mL; or
    • fasting serum triglycerides > 200 mg/dL; and
  • member will be using 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 at least 90 days of therapy, adverse reaction or contraindication to both of the following: a fibrate, a high-potency statin (rosuvastatin 20 mg or 40 mg or atorvastatin 40 mg or 80 mg).

Imcivree

• Documentation of the following is required for a diagnosis of obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency:
  • diagnosis of obesity is due to to a homozygous or presumed homozygous variant in at least one of the following genes (genetic test must be provided): POMC, PCSK1, LEPR; and
  • one of the following: 
    • for adult members, baseline height and weight supporting body mass index (BMI) ≥ 30 kg/m²; or
    • for pediatric members, baseline BMI supporting ≥ 95th percentile using growth chart assessment; and
  • genetic testing demonstrating that the variants in POMC, PCSK1, or LEPR genes are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS); and
  • prescriber is an endocrinologist; and
  • appropriate dosing; and
  • member is ≥ six years of age.

• Documentation of all of the following is required for a diagnosis of obesity due to Bardet-Biedl syndrome (BBS):
  • appropriate diagnosis; and
  • member is ≥ six years of age; and
  • one of the following:
    • for adult members, baseline height and weight supporting BMI of ≥ 30 kg/m2; or
    • for pediatric members, baseline BMI supporting ≥ 95th percentile using growth chart assessment; and
  • prescriber is an endocrinologist; and
  • requested dose is ≤ three mg/day.

• For recertification, documentation of the following is required:
  • one of the following: 
    • for adult members, at least a 5% reduction in baseline body weight or maintenance in reduction of at least 5% in baseline body weight; or
    • for pediatric members, at least a 5% reduction in baseline BMI or maintenance in reduction of at least 5% in baseline BMI in members with continued growth potential; and
  • requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to the requested agent.

Scenesse

• Documentation of the following is required for a diagnosis of erythropoietic protoporphyria: 
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a dermatologist or consultation notes from a dermatologist are provided; and
  • implant procedure will be performed at a specialized treatment center; and
  • appropriate dosing.

Benlysta

• Documentation of all of the following is required for a diagnosis of lupus nephritis:
  • appropriate diagnosis; and
  • member is ≥ five years of age; and
  • member is receiving concurrent immunosuppressive therapy, excluding cyclophosphamide and biologics; and 
  • appropriate dosing.

• Documentation of all of the following is required for a diagnosis of systemic lupus erythematosus:
  • appropriate diagnosis; and
  • member is ≥ five years of age; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate; and
  • appropriate dosing.

Saphnelo

• Documentation of all of the following is required for a diagnosis of systemic lupus erythematosus:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate; and
  • inadequate response, adverse reaction, or contraindication to Benlysta; and
  • appropriate dosing.

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 consultation notes from a neurologist are provided; 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.
• Requests for members ≥ six years of age may be considered if all criteria above are met. 

paroxetine mesylate 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: clonidine, desvenlafaxine or venlafaxine, gabapentin, menopausal hormone therapy, oxybutynin, an SSRI other than paroxetine.

Veozah

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to all menopausal hormonal agents; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: clonidine, gabapentin, oxybutynin, SNRI, SSRI; and
  • requested quantity is ≤ one unit/day.

dichlorphenamide

• Documentation of all of the following is required for a diagnosis of primary hyperkalemic periodic paralysis:
  • appropriate diagnosis; and
  • prescriber is a specialist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to both of the following: acetazolamide, 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 consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to both of the following: acetazolamide, spironolactone.

Grastek

• Documentation of all of the following is required:
  • diagnosis of allergic rhinoconjunctivitis; and
  • prescriber is an allergist or immunologist, or consult notes from an allergist or immunologist 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: intranasal antihistamine, intranasal corticosteroid, second generation antihistamine; and
  • inadequate response, adverse reaction, or contraindication to Oralair; and
  • requested quantity is ≤ one unit/day.

Odactra

• Documentation of all of the following is required:
  • diagnosis of allergic rhinoconjunctivitis; and
  • prescriber is an allergist or immunologist, or consult notes from an allergist or immunologist are provided; and
  • member is ≥ 12 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: intranasal antihistamine, intranasal corticosteroid, second generation antihistamine; and
  • requested quantity is ≤ one unit/day.

Oralair

• Documentation of all of the following is required:
  • diagnosis of allergic rhinoconjunctivitis; and
  • prescriber is an allergist or immunologist, or consult notes from an allergist or immunologist 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: intranasal antihistamine, intranasal corticosteroid, second generation antihistamine; and
  • for Oralair 300 mg immediate-release tablet, requested quantity is ≤ one unit/day.

Palforzia

• Documentation of all of the following is required:
  • diagnosis of peanut allergy; and
  • prescriber is an allergist or immunologist, or consult notes from an allergist or immunologist are provided; and
  • one of the following:
    • member is ≥ four to 18 years of age; or
    • documentation that member started Palforzia at four to 18 years of age; 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.

Ragwitek

• Documentation of all of the following is required:
  • diagnosis of allergic rhinoconjunctivitis; and
  • prescriber is an allergist or immunologist, or consult notes from an allergist or immunologist 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: intranasal antihistamine, intranasal corticosteroid, second generation antihistamine; and
  • requested quantity is ≤ one unit/day.

Dartisla ODT

• Documentation of all of the following is required for a diagnosis of adjunctive therapy in treatment of peptic ulcer:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to glycopyrrolate tablets; and
  • medical necessity for use of orally disintegrating formulation as noted by one of the following: 
    • member utilizes tube feeding (J-tube, G-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age.
  • requested quantity is ≤ three units/day.

• Documentation of all of the following is required for a diagnosis of neurologic condition associated with drooling:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to glycopyrrolate tablets; and
  • appropriate dosing; and
  • medical necessity for use of orally disintegrating formulation as noted by one of the following: 
    • member utilizes tube feeding (J-tube, G-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age; and
  • inadequate response, adverse reaction, or contraindication to both of the following: glycopyrrolate tablets, scopolamine patches.

glycopyrrolate injection

• Documentation of all of the following is required for a diagnosis of adjunctive therapy in treatment of peptic ulcer:
  • appropriate diagnosis; and
  • medical necessity for use of an injection formulation as noted by one of the following: 
    • member utilizes tube feeding (J-tube, G-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age.

• Documentation of all of the following is required for a diagnosis of neurologic condition associated with drooling:
  • appropriate diagnosis; and
  • member’s current weight; and
  • medical necessity for use of an injection formulation as noted by one of the following: 
    • member utilizes tube feeding (J-tube, G-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age; and 
  • inadequate response, adverse reaction, or contraindication to both of the following: glycopyrrolate tablets, scopolamine patches.

glycopyrrolate oral solution

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member’s current weight; and
  • medical necessity for use of a solution formulation as noted by one of the following: 
    • member utilizes tube feeding (J-tube, G-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age; and
  • for members ≥ 17 years of age, both of the following:
    • inadequate response, adverse reaction, or contraindication to Dartisla ODT; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: scopolamine patches, trihexyphenidyl solution.

glycopyrrolate 1.5 mg tablet

• Documentation of the following is required:
  • medical records documenting medical necessity for the 1.5 mg tablet instead of 1 mg or 2 mg tablet.

Lokelma and Veltassa > 1 unit/day

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

Vuity

• Documentation of all of the following is required:
  • diagnosis of presbyopia; and
  • prescriber is an optometrist or ophthalmologist or consult notes from an optometrist or ophthalmologist are provided; and
  • member is ≥ 40 years of age; and
  • member has a contraindication to the use of corrective lenses; and
  • appropriate dosing.

Ceprotin

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a hematologist are provided; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: Eliquis, dabigatran etexilate mesylate, Savaysa, warfarin, Xarelto; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: enoxaparin, fondaparinux, Fragmin.

Nuedexta

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • requested quantity is ≤ two units/day.

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 consult notes from a urologist are 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: interferon, pentoxifylline, verapamil.

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.†

Panretin

• Documentation of all of the following is required for the diagnosis of AIDS-related Kaposi's sarcoma:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to all of the following: chemotherapy, local radiation therapy, systemic antiretoviral therapy. 

• Documentation of all of the following is required for the diagnosis of Non-AIDS-related Kaposi's sarcoma:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to all of the following: two first line systemic therapies (e.g., pegylated liposomal doxorubicin, vinblastine or vincristine with or without bleomycin, paclitaxel, oral etoposide, vinorelbine, gemcitabine), intralesional therapy, radiation.

SSKI

• Documentation of the following is required:
  • indication for the use of thyroid protection prior to MIBG scan or prior to thyroidectomy surgery; and
  • requested dose and frequency; and
  • requested duration of therapy.

Please note, requests for all other indications, drug may be subject to additional non-rebate restrictions. Please see MassHealth Pharmacy Operational document for additional information.

Asclera, Sotradecol

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • symptoms due to varicose veins are non-cosmetic.
• For recertification, documentation that significant symptoms persist following previously approved invasive treatment is required.

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.

Oxlumo

• Documentation of all of the following is required for primary hyperoxaluria type 1: 
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., nephrologist) or consult notes from a specialist are provided; and
  • results from genetic testing showing mutations in the AGXT gene; and
  • member’s current weight; and
  • appropriate dosing.
• For recertification, documentation of all of the following is required:
  • positive response to therapy; and
  • updated member weight; and
  • appropriate dosing.

Omisirge

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • prescriber is a hematologist or oncologist; and
  • member is ≥ 12 years of age on treatment date; and
  • member is planned for umbilical cord blood transplantation following myeloablative conditioning; and
  • appropriate dosing of one-time treatment.

• MassHealth Drug Utilization Review will be reaching out to prescribers after PA approval to verify administration date and at ongoing intervals for long-term monitoring of response.

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 consult notes from an endocrinologist or ophthalmologist are provided; and
  • clinical activity score ≥ four in at least one eye; and
  • inadequate response, adverse reaction, or contraindication to glucocorticoids; and
  • appropriate dosing. 

Amvuttra and 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
  • for Onpattro, member’s current weight; and
  • baseline polyneuropathy disability (PND) score of I, II, IIIa, or IIIb; 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 rheumatologist or neurologist or consult notes from a rheumatologist or neurologist are provided; and
  • results from genetic testing showing mutations in the TTR gene; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: Amvuttra, Onpattro; and
  • baseline PND score of I, II, IIIa, or IIIb; and
  • appropriate dosing.

MassHealth Drug Utilization Review will be reaching out to prescribers after Amvuttra or Onpattro PA approval to verify clinical effectiveness and for long-term monitoring of sustained response. 

Vyndamax, Vyndaqel

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a cardiologist or consult notes from a cardiologist are 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.

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 consultation notes from a nephrologist are provided; and
  • estimated glomerular filtration rate (eGFR) ≥ 25 mL/min (e.g., within the last 6 months).
• For recertification, documentation of positive response to therapy and that eGFR continues to be ≥ 25 mL/min (e.g., within the last 6 months) is required.

Nexobrid

• Documentation of all of the following is required:
  • diagnosis of deep partial thickness and/or full thickness thermal burns; and
  • prescriber is a specialist (e.g., dermatologist, burn specialist) or consult notes from a specialist are provided; and
  • one of the following:
    • requested quantity is one unit; or
    • both of the following:
      • requested quantity is two units; and 
      • BSA of wound area is > 15 % and ≤ 20 %.

Regranex

• Documentation of all of the following is required:
  • appropriate diagnosis of diabetic neuropathic ulcers in the lower extremities; and
  • number and size of the ulcers intended for treatment; and
  • requested duration of treatment; and
  • ulcer extends to subcutaneous tissue or beyond; and
  • lower extremities have adequate blood supply; and
  • ulcer is clear of infection; and
  • member has had a minimum of two months of good wound care (sharp debridement, saline dressing, and pressure relief) without adequate ulcer healing. 

Santyl

• Documentation of all of the following is required:
  • diagnosis of chronic dermal ulcers or severely burned areas; and
  • number and size of the ulcers and/or size of lesion intended for treatment; and
  • requested duration of treatment; and
  • one of the following:
    • member is not a candidate for surgical intervention alone; or
    • member is not a candidate for autolytic debridement; or
    • the requested agent is being used in combination with surgery.

Vyjuvek

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • copy of a genetic test confirming diagnosis of dystrophic epidermolysis bullosa (e.g., mutation of COL7A1 gene); and
  • member is ≥ 6 months of age; and
  • prescriber is a specialist (i.e., dermatologist, geneticist, histopathologist, etc.) or consult notes from a specialist are provided; and
  • member has ≥ one cutaneous wound that is clean in appearance with adequate granulation tissue, has excellent vascularization, and dose not appear infected; and
  • appropriate dosing.

• For recertification, documentation of all of the following is required:
  • one of the following:
    • complete wound healing of ≥ one wound after six months of treatment; or
    • clinical rationale for continued treatment despite lack of efficacy; and
  • member has ≥ one cutaneous wound that is clean in appearance with adequate granulation tissue, has excellent vascularization, and dose not appear infected.