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Table 72: Agents not Otherwise Classified


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Drug Category: Various

Medication Class/Individual Agents: Various

I. Prior-Authorization Requirements

 Agents not Otherwise Classified – Acetylcholinesterase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

pyridostigmine bromide 30 mg tablet PA   A90

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.
 
pyridostigmine bromide 60 mg tablet, 180 mg extended-release tablet Mestinon test   # , A90
pyridostigmine bromide solution Mestinon test   BP, A90

 Agents not Otherwise Classified – Adrenocorticotropic Hormone

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

corticotropin Acthar PA  

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.
 
corticotropin Cortrophin PA  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

edaravone injection Radicava PA  

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.
 
edaravone suspension Radicava ORS PA  
riluzole film Exservan PA  
riluzole suspension Tiglutik PA  
riluzole tablet Rilutek test   # , A90
sodium phenylbutyrate / sodium taurursodiol Relyvrio PA  
tofersen Qalsody PA   MB

 Agents not Otherwise Classified – Antioxidant

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

coenzyme Q10 PA   - ≥ 21 years

coenzyme Q10 for members ≥ 21 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 ≥ 21 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.
 
sodium thiosulfate Pedmark PA   MB

 Agents not Otherwise Classified – C-Type Natriuretic Peptide

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

vosoritide Voxzogo PA  

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.
 

 Agents not Otherwise Classified – COVID-19 Related Medications

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

baricitinib COVID EUA - November 19, 2020 for members 2 to 17 years of age Olumiant test   MB
baricitinib for members ≥ 18 years of age COVID Olumiant test   MB
molnupiravir COVID EUA – December 23, 2021 Lagevrio test  
nirmatrelvir / ritonavir for members ≥ 12 years of age Paxlovid test  
remdesivir Veklury test   MB
tocilizumab vial COVID Actemra test   MB
vilobelimab COVID EUA - April 4, 2023 Gohibic test   MB

 Agents not Otherwise Classified – COVID-19 Test Kit Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

COVID-19 antigen self-test Binaxnow PA   - > 2 tests/28 days

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.
 
COVID-19 antigen self-test Carestart PA   - > 2 tests/28 days
COVID-19 antigen self-test CVS COVID-19 At-Home Test PA   - > 2 tests/28 days
COVID-19 antigen self-test Flowflex PA   - > 2 tests/28 days
COVID-19 antigen self-test Genabio PA   - > 2 tests/28 days
COVID-19 antigen self-test Ihealth PA   - > 2 tests/28 days
COVID-19 antigen self-test Inteliswab PA   - > 2 tests/28 days
COVID-19 antigen self-test On-Go PA   - > 2 tests/28 days
COVID-19 antigen self-test Quickvue PA   - > 2 tests/28 days

 Agents not Otherwise Classified – Cerebral Adrenoleukodystrophy [CALD] Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

elivaldogene autotemcel Skysona PA   CO, MB

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.
 

 Agents not Otherwise Classified – Complement Inhibitors and Miscellaneous Immunosuppressive Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

avacincaptad pegol Izervay PA   MB

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.

 

Izervay and 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 ≥ 50 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
    • one of the following:
      • for Izervay, requested dosing is 2 mg (0.1 mL) every 28 days; or
      • for Syfovre, 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 GA secondary to AMD:
    • positive response to therapy; and
    • member has not developed nAMD (wet AMD); and
    • for Izervay, total treatment duration ≤ 1 year; and
    • for Syfovre, if requested dosing is ≥ every 60 days, prescriber has assessed using less frequent 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 CD55-deficient protein-losing enteropathy (PLE), or complement hyperactivation, angiopathic thrombosis, and protein-losing enteropathy (CHAPLE) disease:
    • appropriate diagnosis; and
    • member is ≥ two months of age; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • prescriber is a specialist in rare genetic or hematologic diseases or consult notes from specialist are provided; and
    • results from genetic testing confirming a CD55 loss-of-function mutation; and
    • appropriate dosing.
  • For recertification, medical records documenting all of the following is required for a diagnosis of CD55-deficient PLE, or CHAPLE disease:
    • one of the following:
      • increase in current serum albumin concentration from baseline serum albumin concentration; or
      • serum albumin concentration stabilized above lower threshold for normal range (≥3.5 g/dL); and
    • one of the following:
      • increase in current serum IgG concentration from baseline serum IgG concentration; or
      • serum IgG concentration stabilized above lower threshold for age-adjusted normal range; and
    • improvement or no worsening of clinical symptoms (e.g., abdominal pain, bowel movements, facial and peripheral edema).
  • 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.

 

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.

 

Veopoz

  • Documentation of all of the following is required for a diagnosis of CD55-deficient PLE, or CHAPLE disease:
    • appropriate diagnosis; and
    • member is ≥ one year of age; and
    • member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
    • prescriber is a specialist in rare genetic or hematologic diseases or consult notes from specialist are provided; and
    • results from genetic testing confirming a CD55 loss-of-function mutation; and
    • inadequate response, adverse reaction, or contraindication to Soliris (eculizumab); and
    • appropriate dosing.
  • For recertification, medical records documenting all of the following is required for a diagnosis of CD55-deficient PLE, or CHAPLE disease:
    • one of the following:
      • increase in current serum albumin concentration from baseline serum albumin concentration; or
      • serum albumin concentration stabilized above lower threshold for normal range (≥3.5 g/dL); and
    • one of the following:
      • increase in current serum IgG concentration from baseline serum IgG concentration; or
      • serum IgG concentration stabilized above lower threshold for age-adjusted normal range; and
    • improvement or no worsening of clinical symptoms (e.g., abdominal pain, bowel movements, facial and peripheral edema).

 

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.
 
avacopan Tavneos PA  
eculizumab Soliris PA   MB
efgartigimod alfa-fcab Vyvgart PA   MB
efgartigimod alfa-fcab and hyaluronidase-qvfc Vyvgart Hytrulo PA   MB
inebilizumab-cdon Uplizna PA   MB
pegcetacoplan 1,080 mg/20 mL vial Empaveli PA  
pegcetacoplan 150 mg/mL vial Syfovre PA   MB
pozelimab-bbfg Veopoz PA   MB
ravulizumab-cwvz Ultomiris PA   MB
rozanolixizumab-noli Rystiggo PA   MB
satralizumab-mwge Enspryng PA  
sutimlimab-jome Enjaymo PA   MB

 Agents not Otherwise Classified – Cystinosis Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

cysteamine 0.37% ophthalmic solution Cystadrops PA  

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.
 
cysteamine 0.44% ophthalmic solution Cystaran PA  
cysteamine delayed-release capsule Procysbi PA  
cysteamine delayed-release granule Procysbi PA  
cysteamine immediate-release capsule Cystagon test  

 Agents not Otherwise Classified – Decongestant

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

pseudoephedrine PA   - > 240 mg/day *

pseudoephedrine > 240 mg/day

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

 Agents not Otherwise Classified – Epinephrine Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

epinephrine 0.15 mg auto-injection-Epipen Jr Epipen Jr test   #

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.

 

 
epinephrine 0.3 mg auto-injection-Epipen Epipen test   #
epinephrine auto-injection test  
epinephrine auto-injection-Auvi-Q Auvi-Q PA  
epinephrine injection Adrenalin test  
epinephrine injection Symjepi test  

 Agents not Otherwise Classified – Farnesyltransferase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

lonafarnib Zokinvy PA  

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.
 

 Agents not Otherwise Classified – Friedreich's Ataxia Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

omaveloxolone Skyclarys PA  

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.

 


 

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

gabapentin enacarbil Horizant PA  

gabapentin 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.
 
gabapentin extended-release Gralise PA  
pregabalin extended-release Lyrica CR PA   BP

 Agents not Otherwise Classified – Gene Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

voretigene neparvovec Luxturna PA   CO, MB

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.
 

 Agents not Otherwise Classified – Glycine-Proline-Glutamate Analog

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

trofinetide Daybue PA  

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.
 

 Agents not Otherwise Classified – Hormone Replacement Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

estradiol / progesterone Bijuva PA  

Bijuva

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the combination product instead of the commercially available separate agents.

 

 

 Agents not Otherwise Classified – Human Nerve Growth Factor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

cenegermin-bkbj Oxervate PA  

Oxervate

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

 Agents not Otherwise Classified – Interferon Gamma Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

emapalumab-lzsg Gamifant PA  

Gamifant

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., hematologist or oncologist) or 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.
 

 Agents not Otherwise Classified – Leptin Analog

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

metreleptin Myalept PA  

Myalept

  • Documentation of all of the following is required:
    • diagnosis of one of the following:
      • Congenital Generalized Lipodystrophy (CGL) or Berardinelli-Seip syndrome; or
      • Acquired Generalized Lipodystrophy (AGL) or Lawrence syndrome; and
    • member has at least one of the following metabolic abnormalities:
      • diabetes mellitus; or
      • fasting 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).
 

 Agents not Otherwise Classified – Melanocortin Receptor Agonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

afamelanotide Scenesse PA   MB

 

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.
 
setmelanotide Imcivree PA  

 Agents not Otherwise Classified – Melatonin Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

melatonin / pyridoxine tablet test   A90
 
melatonin gummy, solution, tablet test   *, A90

 Agents not Otherwise Classified – Monoclonal Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

anifrolumab-fnia Saphnelo PA   MB

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.
 
belimumab auto-injection, prefilled syringe Benlysta PA  
belimumab vial Benlysta PA   MB

 Agents not Otherwise Classified – Neuromuscular Potassium Channel Blockers

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

amifampridine Firdapse PA  

Firdapse

  • Documentation of all of the following is required:
    • diagnosis of symptomatic Lambert-Eaton myasthenic syndrome (LEMS); and
    • member is ≥ six 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.
 

 Agents not Otherwise Classified – Nonhormonal Agents for Menopausal Symptoms

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

fezolinetant Veozah PA  

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.

 

 
paroxetine mesylate capsule PA   A90

 Agents not Otherwise Classified – Oral Carbonic Anhydrase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

acetazolamide test   A90

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.
 
dichlorphenamide Keveyis PA  

 Agents not Otherwise Classified – Oral Immunotherapy Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

grass pollen allergen extract Oralair PA  

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.
 
house dust mite allergen extract Odactra PA  
peanut allergen powder-dnfp Palforzia PA  
short ragweed pollen allergen extract Ragwitek PA  
timothy grass pollen allergen extract Grastek PA  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

glycopyrrolate 1 mg, 2 mg tablet test   A90

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; and
    • 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.
 
glycopyrrolate 1.5 mg tablet PA   A90
glycopyrrolate injection PA  
glycopyrrolate oral solution Cuvposa PA   A90
glycopyrrolate orally disintegrating tablet Dartisla ODT PA  

 Agents not Otherwise Classified – Potassium Binding Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

patiromer Veltassa PA   - > 1 unit/day

Lokelma and Veltassa > 1 unit/day

  • Documentation of the following is required:
    • medical necessity for exceeding the quantity limit.
 
sodium polystyrene sulfonate test  
sodium zirconium cyclosilicate Lokelma PA   - > 1 unit/day

 Agents not Otherwise Classified – Presbyopia Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

pilocarpine 1.2% ophthalmic solution Vuity PA  

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.
 

 Agents not Otherwise Classified – Progestin Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

mifepristone 200 mg Mifeprex test   #

 Agents not Otherwise Classified – Protein C Deficiency Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

protein C concentrate Ceprotin PA   MB

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.
 

 Agents not Otherwise Classified – Pseudobulbar Affect Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

dextromethorphan / quinidine Nuedexta PA  

Nuedexta

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

 Agents not Otherwise Classified – Purified Collagenase

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

collagenase clostridium histolyticum Xiaflex PA  

Xiaflex

  • Documentation of all of the following is required for a diagnosis of Dupuytren’s contracture:
    • appropriate diagnosis; and
    • number of cords being treated.
  • Documentation of all of the following is required for a diagnosis of Peyronie’s disease:
    • appropriate diagnosis; and
    • prescriber is a urologist or 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.†

 

 Agents not Otherwise Classified – Retinoic Acid Derivative

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

alitretinoin Panretin PA  

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.

 

 

 Agents not Otherwise Classified – Retinoic Acid Receptor Agonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

palovarotene Sohonos PA  

Sohonos

  • Documentation of all of the following is required:
    • diagnosis of Fibrodysplasia Ossificans Progressiva (FOP) with ACVR1 R206H mutation; and
    • results from genetic testing to confirm diagnosis; and
    • one of the following: 
      • for members assigned female at birth/biologic female, member is ≥ eight years of age; or
      • for members assigned male at birth/biologic male, member is ≥ ten years of age; and
    • prescriber is a specialist in rare connective tissue disorders or consult notes from a specialist are provided; and
    • for members < 14 years of age, current weight; and
    • appropriate dosing; and
    • for members of reproductive potential, both of the following:
      • attestation that the member is not pregnant; and
      • appropriate contraception methods will be used at least one month before treatment, during treatment, and one month after the last dose.

 

 

 Agents not Otherwise Classified – SSKI

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

potassium iodide SSKI PA   - > 1 mL/day

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.

 

 Agents not Otherwise Classified – Sclerosing Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

polidocanol Asclera PA   MB

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.
 
tetradecyl sulfate injection Sotradecol PA   MB

 Agents not Otherwise Classified – Small Interfering RNA Therapies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

givosiran Givlaari PD PA   MB

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.
 
lumasiran Oxlumo PD PA   MB

 Agents not Otherwise Classified – Stem Cell Therapies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

omidubicel-onlv Omisirge PA   CO, MB

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.
 

 Agents not Otherwise Classified – Thyroid Eye Disease Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

teprotumumab-trbw Tepezza PA   MB

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
    • inadequate response, adverse reaction, or contraindication to glucocorticoids; and
    • appropriate dosing. 

 

 

 Agents not Otherwise Classified – Transthyretin Amyloidosis Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

inotersen Tegsedi PA  

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. 

 
patisiran Onpattro PD PA   MB
vutrisiran Amvuttra PD PA   MB

 Agents not Otherwise Classified – Transthyretin Stabilizer

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

tafamidis Vyndamax PA  

Vyndamax, Vyndaqel

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a 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.
 
tafamidis Vyndaqel PA  

 Agents not Otherwise Classified – Urinary Tract Anti-Inflammatory Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

dimethyl sulfoxide solution Rimso-50 test  
 

 Agents not Otherwise Classified – Vasopressin Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

tolvaptan-Jynarque Jynarque PA  

Jynarque

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 and < 56 years of age; and
    • prescriber is a nephrologist or 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.
 

 Agents not Otherwise Classified – Wound Care

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

anacaulase-bcdb Nexobrid PA   MB

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.

 

 

 
becaplermin Regranex PA  
beremagene geperpavec-svdt Vyjuvek PA  
collagenase Santyl PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
CO Carve-Out. This agent is listed on the Acute Hospital Carve-Out Drugs List and is subject to additional monitoring and billing requirements.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Various

Non-FDA-approved, for example:

  • Various

Note: The above lists may not include all FDA-approved and non-FDA approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

Please see clinical criteria for agents requiring PA in the table above under the Clinical Notes section.

† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 11/2014

Last Revised Date: 03/2024


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Last updated 06/24/24

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