Agents Not Otherwise Classified – Acetylcholinesterase Inhibitors |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
pyridostigmine bromide
|
Mestinon
|
test
|
#
|
pyridostigmine bromide 30 mg tablet
- Documentation of the following is required.
- appropriate diagnosis; and
- clinical rationale why pyridostigmine bromide 60 mg tablets may not be appropriate.
|
pyridostigmine bromide 30 mg tablet
|
|
PA
|
|
|
Agents Not Otherwise Classified – Adrenocorticotropic Hormone |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
corticotropin
|
Acthar
|
PA
|
|
Acthar
- Documentation of the following is required for a diagnosis of infantile spasms:
- appropriate diagnosis; and
- member is < two years of age; and
- prescriber is a neurologist or consult notes from a neurology office are provided; and
- if the request is for initial therapy, one of the following:
- requested dose and duration is 20 units daily for two weeks followed by a taper over one week (specific taper must be documented); or
- requested dose and duration is 75 units/m2 twice daily for two weeks (BSA must be documented) followed by a gradual taper over a two-week period (specific and appropriate taper must be documented), and medical necessity for use of high-dose corticotropin instead of low-dose corticotropin; or
- if the request is for recertification, one of the following:
- inadequate response to 20 units daily for the initial two weeks, and request is for continuation of therapy at 40 units daily for four weeks followed by a taper over one week (specific taper must be documented); or
- history of relapse after previous treatment with corticotropin and medical necessity for retreatment.
- Documentation of all of the following is required for a diagnosis of an acute exacerbation of multiple sclerosis:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- prescriber is a neurologist or consult notes from a neurology office are provided; and
- requested dose and duration is 80 to 120 units daily for two to three weeks; and
- medical records documenting inadequate response or adverse reaction to one of the following, or contraindication to both of the following: high-dose intravenous methylprednisolone, high-dose oral corticosteroids; and
- if the request is for recertification for the same exacerbation, medical necessity for use beyond initial therapy, and requested dose and duration does not exceed 120 units daily for three weeks.
- Documentation of all of the following is required for use to induce remission of proteinuria associated with idiopathic nephrotic syndrome:
- appropriate diagnosis; and
- etiology of proteinuria in nephrotic syndrome has been confirmed with renal biopsy; and
- prescriber is a nephrologist or consult notes from a nephrology office are provided; and
- pretreatment proteinuria > 50 mg/kg per day or a spot urine sample with a total protein/creatinine ratio > 3 mg; and
- pretreatment serum albumin < 3 g/dL (30 g/L); and
- inadequate response, adverse reaction, or contraindication to corticosteroids; and
- inadequate response, adverse reaction, or contraindication to all appropriate second-line treatment options (ACE inhibitor or ARB, azathioprine, calcineurin inhibitors, cyclophosphamide, diuretics, mycophenolate, rituximab); and
- one of the following:
- requested dose is 40 or 80 units twice weekly for 12 to 24 weeks; or
- clinical rationale for a dose greater than 80 units, more frequent dosing than twice weekly, and/or duration longer than 24 weeks.
- For recertification for use to induce remission of proteinuria associated with idiopathic nephrotic syndrome, documentation of all of the following is required:
- prescriber is a nephrologist or consult notes from a nephrology office are provided; and
- current proteinuria or spot urine total protein/creatinine ratio; and
- positive response to therapy as shown by improvements in proteinuria or spot urine total protein/creatinine ratio; and
- for extension of treatment duration beyond 24 weeks, duration of therapy does not exceed one year and one of the following:
- member has achieved and maintained partial or complete response on current dose of corticotropin; or
- clinical rationale for use beyond 24 weeks when partial or complete remission has not been achieved or maintained.
|
|
Agents Not Otherwise Classified – Amyotrophic Lateral Sclerosis (ALS) Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
edaravone
|
Radicava
|
PA
|
|
Radicava
- Documentation of all of the following is required:
- medical records supporting the diagnosis of amyotrophic lateral sclerosis; and
- prescriber is a neurologist; and
- a copy of the pre-treatment ALSFRS-R questionnaire including scores on each individual domain and duration of disease (within the past 12 weeks); and
- appropriate dosing; and
- one of the following:
- medical records documenting the requested medication will be used in combination with riluzole; or
- clinical rationale for not using the requested agent in combination with riluzole.
- For recertification, documentation of all of the following is required:
- a current (within the past 12 weeks) copy of the ALSFRS-R questionnaire including scores on each individual domain; and
- one of the following:
- total decrease in ALSFRS-R score from pre-treatment baseline is five points or less; or
- medical necessity for continuing treatment.
Tiglutik
- Documentation of all of the following is required:
- diagnosis of amyotrophic lateral sclerosis; and
- member is ≥ 18 years of age; and
- clinical rationale why generic riluzole tablets may not be appropriate; and
- appropriate dosing.
|
riluzole suspension
|
Tiglutik
|
PA
|
|
riluzole tablet
|
Rilutek
|
test
|
#
|
|
Agents Not Otherwise Classified – Antioxidant |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
coenzyme Q10
|
|
PA
- ≥ 19 years
|
|
coenzyme Q10 for members ≥ 19 years of age
- Documentation of all of the following is required:
- appropriate diagnosis; and
- muscle biopsy positive for mitochondrial disease; or
- pathogenic mtDNA abnormality.
SmartPA: Claims for coenzyme Q10 will usually process at the pharmacy without a PA request if the member is ≥ 19 years of age and has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent.† |
|
Agents Not Otherwise Classified – Complement Inhibitors |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
eculizumab
|
Soliris
|
PA
|
|
Soliris
- Documentation of all of the following is required for a diagnosis of atypical hemolytic-uremic syndrome (aHUS):
- appropriate diagnosis; and
- member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
- appropriate dosing.
- Documentation of all of the following is required for a diagnosis of generalized myasthenia gravis:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member is AchR antibody positive; and
- inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, intravenous immunoglobulin, mycophenolate, plasma exchange or plasmapheresis, tacrolimus; and
- member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
- appropriate dosing.
- Documentation of all of the following is required for a diagnosis of neuromyelitis optica spectrum disorder:
- appropriate diagnosis; and
- laboratory tests showing positive AQP4 antibody; and
- member is ≥ 18 years of age; and
- member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
- appropriate dosing.
- Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
- appropriate dosing.
Ultomiris
- Documentation of all of the following is required for a diagnosis of aHUS:
- appropriate diagnosis; and
- member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
- appropriate dosing.
- Documentation of all of the following is required for a diagnosis of PNH:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member has received a meningococcal vaccine at least two weeks prior to treatment initiation; and
- appropriate dosing.
|
ravulizumab-cwvz
|
Ultomiris
|
PA
|
|
|
Agents Not Otherwise Classified – Cystinosis Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
cysteamine delayed-release capsule
|
Procysbi
|
PA
|
|
Cystaran
- Documentation of all of the following is required:
- appropriate diagnosis; and
- prescriber is a nephrologist or ophthalmologist.
Procysbi
- Documentation of all of the following is required:
- appropriate diagnosis; and
- appropriate dose; and
- prescriber is a nephrologist; and
- medical records documenting an inadequate response or adverse reaction to cysteamine immediate-release capsule; and
- if the request is for Procysbi granules, compelling clinical rationale for use of the requested formulation.
- For recertification of Procysbi granules, documentation of continued necessity of dosage form.
|
cysteamine delayed-release granule
|
Procysbi
|
PA
|
|
cysteamine immediate-release capsule
|
Cystagon
|
test
|
|
cysteamine ophthalmic
|
Cystaran
|
PA
|
|
|
Agents Not Otherwise Classified – Decongestant |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
pseudoephedrine
|
|
PA
- > 240 mg/day
|
*
|
pseudoephedrine > 240 mg/day
- Documentation of all of the following is required:
- appropriate diagnosis; and
- medical necessity for exceeding the dose limit.
|
|
Agents Not Otherwise Classified – Epinephrine Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
epinephrine 0.15 mg auto-injection-Epipen Jr
|
Epipen Jr
|
PA
|
|
Epipen, Epipen Jr
- Documentation of all of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response or adverse reaction to the therapeutically equivalent generic formulation.
|
epinephrine 0.3 mg auto-injection-Epipen
|
Epipen
|
PA
|
|
epinephrine auto-injection
|
|
test
|
|
epinephrine injection
|
Adrenalin
|
test
|
|
epinephrine injection
|
Symjepi
|
test
|
|
|
Agents Not Otherwise Classified – Gamma-Aminobutyric Acid (GABA) Analogs |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
gabapentin enacarbil
|
Horizant
|
PA
|
|
gabapentin powder
- Documentation of the following is required for the diagnosis of epilepsy or a seizure disorder:
- appropriate diagnosis; and
- prescriber is a neurologist or consult notes from a neurology office are provided; and
- member will be using the requested agent as adjunctive therapy; and
- clinical rationale why other commercially available alternatives cannot be used.
- Documentation of the following is required for the diagnosis of postherpetic neuralgia:
- appropriate diagnosis; and
- clinical rationale why other commercially available alternatives cannot be used.
Gralise
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- inadequate response, adverse reaction, or contraindication to a tricyclic antidepressant; and
- inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to immediate release gabapentin.
Horizant
- Documentation of all of the following is required for a diagnosis of restless leg syndrome:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to pramipexole or ropinirole; and
- inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to immediate release gabapentin; and
- quantity requested is ≤ one unit/day.
- Documentation of the following is required for a diagnosis of postherpetic neuralgia:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to a tricyclic antidepressant; and
- inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), or adverse reaction to immediate release gabapentin; and
- quantity requested is ≤ two units/day.
Lyrica CR
- Documentation of all of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all of the following: a tricyclic antidepressant, duloxetine, lidocaine patch, venlafaxine; and
- inadequate response (defined as at least 14 days of therapy at a dose of ≥ 1,200 mg/day), adverse reaction or contraindication to gabapentin; and
- inadequate response (defined as at least 14 days of therapy) or adverse reaction to immediate release pregabalin; and
- one of the following:
- request is for diabetic peripheral neuropathy and quantity requested is ≤ one unit/day; or
- request is for postherpetic neuralgia and quantity requested is ≤ two units/day.
|
gabapentin extended-release
|
Gralise
|
PA
|
|
gabapentin powder
|
|
PA
|
|
pregabalin extended-release
|
Lyrica CR
|
PA
|
|
|
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 ^
|
Luxturna
- Documentation of all of the following is required:
- diagnosis of biallelic RPE65 mutation-associated retinal dystrophy; and
- prescriber is a specialist (opthalmologist or retinal specialist) or consult is provided; and
- documentation that the treatment procedure will be performed at a specialized treatment center; and
- medical records documenting the results from generic testing showing mutations in the RPE65 gene; and
- documentation of viable retinal cells (e.g., retinal thickness > 100 microns); and
- documentation of baseline full-field light sensitivity threshold (FST) scores; and
- member is ≥ 1 year of age on treatment date; and
- member has not undergone recent ocular surgery in the past six months; and
- member has discontinued retinoid compounds for at least 18 months; and
- appropriate dosing and treatment schedule.
|
|
Agents Not Otherwise Classified – Hormone Replacement Therapy |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
estradiol / progesterone
|
Bijuva
|
PA
|
|
Bijuva
- Documentation of all of the following is required:
- appropriate diagnosis; and
- compelling clinical rationale that the combination product would offer a therapeutic advantage over the commercially available separate agents.
|
|
Agents Not Otherwise Classified – Human Nerve Growth Factor |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
cenegermin-bkbj
|
Oxervate
|
PA
|
|
Oxervate
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ two years of age; and
- prescriber is a specialist (e.g., ophthalmologist) or provides consult notes from a specialist.
|
|
Agents Not Otherwise Classified – Interferon Gamma Inhibitor |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
emapalumab-lzsg
|
Gamifant
|
PA
|
|
Gamifant
- Documentation of all of the following is required:
- appropriate diagnosis; and
- prescriber is a specialist (e.g., hematologist or oncologist) or or a specialist consult is provided; and
- one of the following:
- molecular tests confirming diagnosis of primary hemophagocytic lymphohistiocytosis (HLH); or
- at least five of the following tests suggesting primary HLH: fever, splenomegaly, cytopenia (defined by two of the following: hemoglobin < 9 g/dL, platelets < 100 x 109/L, neutrophils < 1 x 109/L), hypertriglyceridemia (defined by fasting triglycerides > 3 mmol/L or ≥ 265 mg/dL) and/or hypofibrinogenemia (≤ 1.5 g/L), hemophagocytosis in bone marrow, spleen, or lymph nodes, low or absent NK-cell activity based on laboratory reference, ferritin ≥ 500 mcg/L, soluble CD25 ≥ 2400 U/mL; and
- member has active disease; and
- member does not have active infections caused by specific pathogens favored by interferon gamma neutralization (e.g., mycobacteria, Histoplasma Capsulatum, Shigella, salmonella, campylobacter, leishmanial infections); and
- inadequate response, adverse reaction, or contraindication to conventional HLH therapy (chemotherapy, systemic corticosteroids, immunosuppressive therapy); and
- requested agent will be administered concurrently with dexamethasone, or clinical rationale for not using dexamethasone; and
- anticipated hematopoietic stem cell transplantation (HSCT) date is provided, or member is not a candidate for HSCT; and
- baseline clinical parameters and laboratory values including presence of fever, presence of splenomegaly, presence of CNS symptoms, hemoglobin, platelets, neutrophils, fasting triglycerides, fibrinogen, D-dimer, presence of hemophagocytosis, NK-cell activity, ferritin, and soluble CD25; and
- appropriate dosing.
- For recertification, documentation of the following is required:
- positive response to therapy as evidenced by one of the following:
- complete response (normalization of all HLH abnormalities); or
- partial response (normalization of ≥ 3 HLH abnormalities); or
- HLH improvement (≥ 3 HLH abnormalities improved by at least 50% from baseline); and
- requested agent will be administered concurrently with dexamethasone, or clinical rationale for not using dexamethasone; and
- anticipated HSCT date is provided, or member is not a candidate for HSCT.
|
|
Agents Not Otherwise Classified – Leptin Analog |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
metreleptin
|
Myalept
|
PA
|
|
Myalept
- Documentation of all of the following is required:
- diagnosis of one of the following:
- Congenital Generalized Lipodystrophy (CGL) or Berardinelli-Seip syndrome; or
- Acquired Generalized Lipodystrophy (AGL) or Lawrence syndrome; and
- member has at least one of the following metabolic abnormalities:
- diabetes mellitus; or
- fasting serum triglycerides > 200 mg/dL; or
- fasting insulin levels > 30 microU/mL; and
- requested medication is being used as an adjunct to dietary restrictions; and
- one of the following:
- if the member has diabetes mellitus or fasting insulin levels > 30 microU/mL, medical records documenting an inadequate response to 90 days of therapy or adverse reaction to three different classes of antidiabetic therapies; or
- if the member has fasting serum triglycerides > 200 mg/dL, medical records documenting an inadequate response to 90 days of therapy or adverse reaction to a fibrate and a high-potency statin (rosuvastatin 20 mg or 40 mg or atorvastatin 40 mg or 80 mg).
|
|
Agents Not Otherwise Classified – Melatonin Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
melatonin / pyridoxine tablet
|
|
test
|
*
|
melatonin powder
- Documentation of all of the following is required:
- appropriate diagnosis; and
- clinical rationale why other commercially available alternatives cannot be used.
|
melatonin powder
|
|
PA
|
|
melatonin tablet, solution
|
|
test
|
*
|
|
Agents Not Otherwise Classified – Monoclonal Antibodies |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
belimumab
|
Benlysta
|
PA
|
|
Benlysta
- Documentation of all of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate; and
- appropriate dose.
|
|
Agents Not Otherwise Classified – Neuromuscular Potassium Channel Blockers |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
amifampridine
|
Firdapse
|
PA
|
|
Firdapse
- Documentation of all of the following is required:
- diagnosis of symptomatic Lambert-Eaton myasthenic syndrome (LEMS); and
- member is ≥ 18 years of age; and
- prescriber is a neurologist or provides consultation notes from a neurologist; and
- one of the following laboratory results confirming the diagnosis:
- neurophysiology study tests; or
- positive anti-P/Q type voltage-gated calcium channel antibody test; and
- appropriate dosing; and
- medical records documenting inadequate response, adverse reaction, or contraindication to Ruzurgi.
Ruzurgi
- Documentation of all of the following is required:
- diagnosis of symptomatic LEMS; and
- member is ≥ six years of age; and
- prescriber is a neurologist or provides consultation notes from a neurologist; and
- one of the following laboratory results confirming the diagnosis:
- neurophysiology study tests; or
- positive anti-P/Q type voltage-gated calcium channel antibody test; and
- appropriate dosing.
|
amifampridine
|
Ruzurgi
|
PA
|
|
|
Agents Not Otherwise Classified – Oligonucleotide Therapies |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
inotersen
|
Tegsedi
|
PA
|
|
Tegsedi
- Documentation of all of the following is required for hereditary transthyretin-mediated (hATTR) amyloidosis:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- prescriber is a specialist (e.g., rheumatologist or neurologist) or a specialist consult is provided; and
- results from genetic testing showing mutations in the TTR gene; and
- inadequate response, adverse reaction, or contraindication to Onpattro; and
- baseline polyneuropathy disability (PND) score of I, II, IIIa, or IIIb; and
- appropriate dosing.
|
|
Agents Not Otherwise Classified – Oral Carbonic Anhydrase Inhibitors |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
acetazolamide
|
Diamox
|
test
|
#
|
Keveyis
- Documentation of all of the following is required for a diagnosis of primary hyperkalemic periodic paralysis:
- appropriate diagnosis; and
- prescriber is a specialist or a specialist consult is provided; and
- inadequate response, adverse reaction, or contraindication to acetazolamide and hydrochlorothiazide.
- Documentation of all of the following is required for a diagnosis of primary hypokalemic periodic paralysis:
- appropriate diagnosis; and
- prescriber is a specialist or a specialist consult is provided; and
- inadequate response, adverse reaction, or contraindication to acetazolamide and spironolactone.
|
dichlorphenamide
|
Keveyis
|
PA
|
|
|
Agents Not Otherwise Classified – Oral Immunotherapy Agent |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
grass pollen allergen extract
|
Oralair
|
PA
|
|
Oralair
- Documentation of all of the following is required:
- diagnosis of allergic rhinoconjunctivitis; and
- prescriber is an allergist or immunologist, or specialist consult notes are provided; and
- member is ≥ five years of age; and
- medical records of the skin test confirming pollen-specific immunoglobulin E (IgE) antibodies for the specific antigen; and
- member is not currently a candidate for subcutaneous immunotherapy; and
- inadequate response (defined as at least two weeks of therapy), adverse reaction, or contraindication to one agent from all of the following classes of symptomatic therapy: second generation antihistamine, intranasal corticosteroid, intranasal antihistamine, leukotriene modifier; and
- quantity requested is ≤ 30 units/30 days.
Palforzia
- Documentation of all of the following is required:
- diagnosis of peanut allergy; and
- prescriber is an allergist or immunologist, or specialist consult notes are provided; and
- one of the following:
- member is ≥ four to 17 years of age; or
- documentation that member started Palforzia at four to 17 years old; and
- confirmation of diagnosis with one of the following:
- serum peanut-specific immunoglobulin (IgE); or
- skin test confirmation of immunoglobulin (IgE) antibodies for the specific antigen; and
- appropriate dosing.
- For recertification of Palforzia, documentation of tolerance to therapy during the initial dose escalation and up-dosing phases.
|
peanut allergen powder-dnfp
|
Palforzia
|
PA
|
|
|
Agents Not Otherwise Classified – Oral, Injectable, and Miscellaneous Glycopyrrolate Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
glycopyrrolate 1 mg, 2 mg tablet
|
|
test
|
|
Cuvposa
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member’s current weight; and
- clinical rationale why glycopyrrolate tablets may not be appropriate; and
- for members > 16 years of age, inadequate response, adverse reaction or contraindication to scopolamine patches.
glycopyrrolate injection
- Documentation of all of the following is required:
- appropriate diagnosis; and
- clinical rationale why glycopyrrolate tablets may not be appropriate.
glycopyrrolate powder
- Documentation of all of the following is required:
- appropriate diagnosis; and
- clinical rationale why other commercially available alternatives cannot be used.
glycopyrrolate 1.5 mg tablet
- Documentation of the following is required:
- medical records documenting clinical rationale why glycopyrrolate 1 mg and/or 2 mg tablets may not be appropriate.
|
glycopyrrolate 1.5 mg tablet
|
|
PA
|
|
glycopyrrolate injection
|
|
PA
|
|
glycopyrrolate oral solution
|
Cuvposa
|
PA
|
|
glycopyrrolate powder
|
|
PA
|
|
|
Agents Not Otherwise Classified – Potassium Binding Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
patiromer
|
Veltassa
|
PA
- > 30 units/month
|
|
Lokelma and Veltassa > 30 units/month
- Documentation of the following is required:
- medical necessity for exceeding the quantity limit.
|
sodium polystyrene sulfonate
|
|
test
|
|
sodium zirconium cyclosilicate
|
Lokelma
|
PA
- > 30 units/month
|
|
|
Agents Not Otherwise Classified – Protein C Deficiency Agent |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
protein C concentrate
|
Ceprotin
|
PA
|
|
Ceprotin
- Documentation of all of the following is required:
- appropriate diagnosis; and
- prescriber is a hematologist; and
- inadequate response or adverse reaction to one or contraindication to all of the following: warfarin, direct oral anticoagulants (direct thombin inhibitors or factor Xa inhibitors); and
- inadequate response or adverse reaction to one or contraindication to all of the following: enoxaparin, Fragmin.
|
|
Agents Not Otherwise Classified – Pseudobulbar Affect Agent |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
dextromethorphan / quinidine
|
Nuedexta
|
PA
|
|
Nuedexta
- Documentation of all of the following is required:
- appropriate diagnosis; and
- quantity requested is ≤ 60 units/30 days.
|
|
Agents Not Otherwise Classified – Purified Collagenase |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
collagenase clostridium histolyticum
|
Xiaflex
|
PA
|
|
Xiaflex
- Documentation of all of the following is required for a diagnosis of Dupuytren’s contracture:
- appropriate diagnosis; and
- number of cords being treated.
- Documentation of all of the following is required for a diagnosis of Peyronie’s disease:
- appropriate diagnosis; and
- prescriber is a urologist or a urology consult is provided; and
- member is ≥ 18 years of age; and
- appropriate dosing; and
- member is not a candidate for surgery; and
- inadequate response or adverse reaction to one of the following: carnitine, colchicine, interferon, pentoxifylline, tamoxifen, verapamil, vitamin E.
SmartPA: Claims for Xiaflex will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for Dupuytren’s contracture and the current claim plus all history is ≤ one vial.† |
|
Agents Not Otherwise Classified – Sclerosing Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
polidocanol
|
Asclera
|
PA
|
^
|
Asclera, Sotradecol
- Documentation of all of the following is required:
- appropriate diagnosis; and
- symptoms due to varicose veins are non-cosmetic.
|
tetradecyl sulfate injection
|
Sotradecol
|
PA
|
|
|
Agents Not Otherwise Classified – Selective Serotonin Reuptake Inhibitor |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
paroxetine 7.5 mg capsule
|
Brisdelle
|
PA
|
|
paroxetine 7.5 mg capsule
- Documentation of all of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response or adverse reaction to paroxetine hydrochloride; and
- medical records documenting an inadequate response or adverse reaction to three or contraindication to all of the following:
- hormone replacement therapy; or
- venlafaxine or desvenlafaxine; or
- an SSRI other than paroxetine; or
- gabapentin; or
- clonidine.
|
|
Agents Not Otherwise Classified – Serotonin/Norepinephrine Reuptake Inhibitor |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
milnacipran
|
Savella
|
PA
|
|
Savella
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- requested dose does not exceed two tablets daily; or
- compelling clinical rationale for exceeding the quantity limit; and
- inadequate response (defined as at least two weeks of therapy with a minimum dose of 1,200 mg/day), adverse reaction, or contraindication to gabapentin; and
- inadequate response (defined as at least four weeks of therapy) or adverse reaction to one or contraindication to all of the following: tricyclic antidepressant, cyclobenzaprine, SSRI, SNRI.
SmartPA: Claims for Savella for quantities ≤ 60 units/30 days will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 out of the last 120 days of the requested agent.† |
|
Agents Not Otherwise Classified – Small Interfering RNA Therapies |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
givosiran
|
Givlaari
PD
|
PA
- (effective 01/01/2021)
|
|
Givlaari
- Documentation of all of the following is required for acute hepatic porphyria (AHP):
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member’s current weight; and
- appropriate dosing.
Onpattro
- Documentation of all of the following is required for hereditary transthyretin-mediated (hATTR) amyloidosis:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member’s current weight; and
- baseline PND score of I, II, IIIa, or IIIb; and
- appropriate dosing.
|
patisiran
|
Onpattro
PD
|
PA
|
|
|
Agents Not Otherwise Classified – Thyroid Eye Disease Agent |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
teprotumumab-trbw
|
Tepezza
|
PA
|
|
Tepezza
- Documentation of all of the following is required:
- diagnosis of thyroid eye disease; and
- member is ≥ 18 years of age; and
- prescriber is an endocrinologist or ophthalmologist or provides consultation notes from an endocrinologist or ophthalmologist; and
- clinical activity score ≥ four in at least one eye; and
- inadequate response, adverse reaction, or contraindication to glucocorticoids; and
- appropriate dosing.
|
|
Agents Not Otherwise Classified – Transthyretin Stabilizer |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
tafamidis
|
Vyndamax
|
PA
|
|
Vyndamax, Vyndaqel
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- prescriber is a specialist (e.g., cardiologist) or a specialist consult is provided; and
- one of the following:
- results from genetic testing showing mutations in the TTR gene; or
- presence of amyloid deposits in biopsy tissue with confirmed TTR; or
- TTR precursor protein identification by immunohistochemistry, scintigraphy, or mass spectrometry; and
- appropriate dosing.
|
tafamidis
|
Vyndaqel
|
PA
|
|
|
Agents Not Otherwise Classified – Urinary Tract Anti-Inflammatory Agents |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
dimethyl sulfoxide liquid
|
|
PA
|
|
dimethyl sulfoxide liquid
- Documentation of the following is required.
- appropriate diagnosis; and
- clinical rationale why other commercially available alternatives cannot be used.
|
dimethyl sulfoxide solution
|
Rimso-50
|
test
|
|
|
Agents Not Otherwise Classified – Vasopressin Antagonist |
Drug Details
Drug Generic Name |
Drug Brand Name |
PA Status
|
Drug Notes
|
Clinical Notes
|
tolvaptan-Jynarque
|
Jynarque
|
PA
|
|
Jynarque
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 and < 56 years of age; and
- prescriber is a nephrologist or provides consultation notes from a nephrologist regarding the diagnosis and treatment recommendations; and
- estimated glomerular filtration rate (eGFR) ≥ 25 mL/min.
|
|