FDA-approved, for example:

• Active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis – Tavneos
• Atypical hemolytic-uremia syndrome (aHUS) – Bhemv, Epysqli, Soliris, Ultomiris
• Chronic inflammatory demyelinating polyneuropathy (CIDP) – Vygart Hytrulo
• Complement 3 glomerulopathy (C3G) – Empaveli, Fabhalta
• Cold agglutinin disease (CAD) – Enjaymo
• Generalized  myasthenia gravis (MG) – Bkemv, Epysqli, Imaavy, Rystiggo,Soliris, Ultomiris, Vygart, Vygart Hytrulo, Zilbrysq
• Geographic atrophy secondary to age-related macular degeneration (AMD) – Izervay, Syfovre
• Immunoglobulin A nephropathy (IgAN) – Fabhalta
• Immunoglobulin G4-related disease (IgG4-RD) – Uplizna
• Microscopic polyangiitis (MPA) – Tavneos
• Neuromyelitis optica spectrum disorder (NMOSD) – Enspryng, Soliris, Ultomiris, Uplinza
• Paroxysmal nocturnal hemoglobinuria (PNH) - Bkemv, Empaveli, Epysqli, Fabhalta, Piasky, Soliris, Ultomiris, Voydeya
• Primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) – Empaveli
• Protein-losing enteropathy (PLE) or complement hyperactivation, angiopathic thrombosis, and protein-losing enteropathy (CHAPLE) disease – Veopoz

Non-FDA-approved, for example:

• Neuromyelitis optica spectrum disorder (NMOSD) – Bkemv, Epysqli
• PLE/CHAPLE –  Bkemv, Epysqli, Soliris

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

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 PA 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.

Bkemv

• Documentation of all of the following is required for a diagnosis of atypical hemolytic-uremic syndrome (aHUS):
  • appropriate diagnosis; and
  • prescriber is a hematologist or nephrologist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • clinical rationale for use of the requested agent instead of Epysqli; and 
  • appropriate dosing.

• Documentation of all of the following is required for a diagnosis of generalized myasthenia gravis (MG):
  • appropriate diagnosis; and
  • member is ≥ six years of age; and
  • member is AchR antibody positive; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to pyridostigmine; and
  • one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • inadequate response, adverse reaction, or contraindication to both of the following: Ultomiris, Zilbrysq; and
  • clinical rationale for use of the requested agent instead of Epysqli; and
  • appropriate dosing.

• Documentation of all of the following is required for a diagnosis of neuromyelitis optica spectrum disorder (NMOSD):
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • a positive serologic test for anti-aquaporin 4 (AQP4); and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • clinical rationale for use of the requested agent instead of Epysqli.

• Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • inadequate, adverse reaction, or contraindication to Ultomiris; and
  • clinical rationale for use of the requested agent instead of Epysqli; and
  • appropriate dosing.

• 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
  • prescriber is a specialist in rare generic or hematologic diseases or consult notes from a specialist are provided; and
  • results from genetic testing confirming a CD55 loss-of-function mutation; and
  • clinical rationale for use of the requested agent instead of Epysqli; and
  • appropriate dosing.

• For recertification, medical records documenting all of the following are 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).

Empaveli

• Documentation of all of the following is required for a diagnosis of complement 3 glomerulopathy (C3G):
  • appropriate diagnosis; and
  • prescriber is a nephrologist or consult notes from a specialist are provided; and
  • member is ≥ 12 years of age; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to both of the following: glucocorticoids, mycophenolate; and
  • one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days: urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g or proteinuria > 1.0 g/day; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; or
    • both of the following:
      • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
      • intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated dose.

• For recertification for a diagnosis of C3G, documentation of positive response to therapy is required.

• Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: Piasky, Soliris, Ultomiris; and
  • requested quantity is ≤ 8 injections/28 days.

• Documentation of all the following is required for a diagnosis of primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN):
  • appropriate diagnosis; and
  • prescriber is a nephrologist or consult notes from a specialist are provided; and
  • member is ≥ 12 years of age; and
  • appropriate dosing; and
  • attestation member does not have IC-MPGN secondary to another condition; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: cyclophosphamide, mycophenolate plus glucocorticoids, rituximab; and
  • one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days: urine protein-to-creatine ratio (UPCR) ≥ 1.5 g/g or proteinuria > 1.0 g/day; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; or
    • both of the following:
      • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
      • intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated dose.

Enjaymo

• Documentation of all of the following is required for the diagnosis of cold agglutinin disease (CAD):
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; 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
  • appropriate dosing.

Enspryng

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

Epysqli

• Documentation of all of the following is required for a diagnosis of atypical hemolytic-uremic syndrome (aHUS):
  • appropriate diagnosis; and
  • prescriber is a hematologist or nephrologist or consult notes from a specialist are provided; and
  • appropriate dosing.

• Documentation of all of the following is required for a diagnosis of generalized myasthenia gravis (MG):
  • appropriate diagnosis; and
  • member is ≥ six years of age; and
  • member is AchR antibody positive; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to pyridostigmine; and
  • one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • appropriate dosing.

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

• Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • appropriate dosing.

• 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
  • prescriber is a specialist in rare generic or hematologic diseases or consult notes from a 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 are 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).

Fabhalta

• Documentation of all of the following is required for a diagnosis of complement 3 glomerulopathy (C3G):
  • appropriate diagnosis; and
  • prescriber is a nephrologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • requested quantity is  ≤ two units/day; and
  • inadequate response, adverse reaction, or contraindication to both of the following: glucocorticoids, mycophenolate; and
  • one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days: urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g, proteinuria > 1.0 g/day; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; or
    • both of the following:
      • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
      • intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated.

• For recertification of a diagnosis of C3G, documentation of positive response to therapy is required.

• Documentation of all of the following is required for a diagnosis of immunoglobulin A nephropathy (IgAN):
  • appropriate diagnosis; and
  • prescriber is a nephrologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • one of the following: 
    • both of the following:
      • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
      • medical records documenting intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated dose; or
    • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; and
  • one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days: urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g, proteinuria >1.0 g/day; and
  • inadequate response or adverse reaction to two, or contraindication to all of the following: Filspari, Tarpeyo, Vanrafia; and
  • requested quantity is ≤ two units/day.

• Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: Empaveli, Piasky, Soliris, Ultomiris; and
  • requested quantity is ≤ two units/day.

Imaavy

• Documentation of all of the following is required for a diagnosis of generalized myasthenia gravis (MG):
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • member is AchR or MuSK antibody positive; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to pyridostigmine; and
  • for AChR antibody positive members, need one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • for MuSK antibody positive members, need one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, rituximab, tacrolimus; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to one of the following: Vyvgart, Vyvgart Hytrulo; or
    • member is MuSK antibody positive; 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
  • 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.

Piasky

• Documentation of all of the following is required for a diagnosis of PNH:
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 13 years of age; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • appropriate dosing.

Rystiggo

• Documentation of all of the following is required for a diagnosis of generalized myasthenia gravis:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • member is AchR or MuSK antibody positive; and
  • prescriber is a neurologist or consult notes from specialist are provided; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to pyridostigmine; and
  • for AChR antibody postitive members, one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • for MuSK antibody positive members, one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, rituximab, tacrolimus; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to Vyvgart or Vyvgart Hytrulo; or
      • member is MuSK antibody positive.

Soliris

• Documentation of all of the following is required for a diagnosis of atypical hemolytic-uremic syndrome (aHUS):
  • appropriate diagnosis; and
  • prescriber is a hematologist or nephrologist or consult notes from specialist are provided; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • clinical rationale for use of the requested agent instead of both of the following: Bkemv, Epysqli.

• 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
  • 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
  • clinical rationale for use of the requested agent instead of both of the following: Bkemv and Epysqli; and
  • appropriate dosing.

• For recertification, medical records documenting all of the following are 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 ≥ 6 years of age; and
  • member is AchR antibody positive; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction or contraindication to pyridostigmine; and
  • one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: 
    • Imaavy; or
    • Rystiggo; or 
    • Vyvgart or Vyvgart Hytrulo; and
  • inadequate response, adverse reaction, or contraindication to both of the following: Ultomiris and Zilbrysq; and 
  • clinical rationale for use of the requested agent instead of both of the following: Bkemv and Epysqli; and
  • appropriate dosing.

• For recertification for a diagnosis of generalized myasthenia gravis, documentation of positive response to therapy is required. 

• Documentation of all of the following is required for a diagnosis of NMOSD:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • a positive serologic test for anti-aquaporin-4 (AQP4); and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and 
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • clinical rationale for use of requested agent instead of both of the following: Bkemv and Epysqli.

• Documentation of all of the following is required for a diagnosis of PNH:
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to Ultomiris; and
  • clinical rationale for use of the requested agent instead of both the following: Bkemv and Epysqli; 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 specialist 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.

• For recertification, documentation of all of the following is required:
  • approprate dosing; and
  • requested quantity is ≤ six units/day; and
  • one of the following:
    • all of the following: 
      • request is continued induction of remission; and
      • requested agent is being used as adjunctive therapy; and
      • total treatment duration is ≤ one year; or
    • all of the following:
      • request is for maintenance of remission; and
      • inadequate response or adverse reaction of two or contraindication to all of the following: azathioprine, low-dose glucocorticoids, rituximab.

Ultomiris

• Documentation of all of the following is required for a diagnosis of aHUS:
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., hematologist or nephrologist) or consult notes are provided; 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
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • inadequate response, adverse reaction or contraindication to pyridostigmine; and
  • one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: 
    • Imaavy; or
    • Rystiggo; or
    • Vyvgart or Vyvgart Hytrulo; and
  • appropriate dosing.

• For recertification for a diagnosis of generalized myasthenia gravis, documentation of positive response to therapy is required.
• Documentation of all of the following is required for a diagnosis of NMOSD:
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a specialist are provided; and
  • a positive serologic test for anti-aquaporin-4 (AQP4); and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and

• Documentation of all of the following is required for a diagnosis of PNH:
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • appropriate dosing.

Uplizna

• Documentation of all of the following is required for the diagnosis of immunoglobulin G4 related disease (IgG4-RD):
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., nephrologist, endocrinologist, hepatologist) or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • IgG4-RD affecting ≥ two organs or sites at any time in disease history; and
  • inadequate response or adverse reaction to one or contraindication to all glucocorticoids; and
  • inadequate response, adverse reaction, or contraindication to rituximab; and
  • appropriate dosing.

• Documentation of all of all of the following is required for the diagnosis of neuromyelitis optica spectrum disorder (NMOSD):
  • appropriate diagnosis; and
  • prescriber is a neurologist or consult notes from a specialist are provided; 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.

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
  • 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; and
  • appropriate dosing.

• For recertification, medical records documenting all of the following are 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).

Voydeya

• Documentation of all of the following is required for a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH):
  • appropriate diagnosis; and
  • prescriber is a hematologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • member has clinically significant extravascular hemolysis; and
  • inadequate response (defined as ≥ 6 months of therapy) to one of the following: Soliris, Ultomiris; and 
  • requested medication will be used in combination with one of the following: Soliris, Ultomiris.

Vyvgart and Zilbrysq

• 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 specialist are provided; and
  • inadequate response, adverse reaction or contraindication to pyridostigmine; and
  • one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and 
  • appropriate dosing.

• For recertification of Zilbrysq for a diagnosis of generalized myasthenia gravis, documentation of positive response to therapy is required.

Vyvgart Hytrulo

• Documentation of all of the following is required for a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP):
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a neurologist or consult notes from a neurologist are provided; and
  • appropriate dosing; and
  • two of the following: 
    • inadequate response, adverse reaction, or contraindication to immune globulin; or
    • inadequate response, adverse reaction, or contraindication to plasma exchange; or
    • one of the following:
      • inadequate response or adverse reaction to glucocorticoids (e.g., budesonide, methylprednisolone, prednisone); or 
      • both of the following:
        • inadequate response or adverse reaction to immunosuppressants (e.g., azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, rituximab); and
        • contraindication to glucocorticoids.

• 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 specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to pyridostigmine; and
  • one of the following:
    • both of the following:
      • member has severe disease requiring faster onset medication; and
      • inadequate response, adverse reaction, or contraindication to IVIG or plasmapheresis with glucocorticoids; or
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus; and
  • appropriate dosing.