inv-06: CIDP (Chronic Inflammatory Demyelinating Polyneuropathy)
CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) — Approve when ONE of the following is met:
ALL of the following
Electrodiagnostic studies support the diagnosis of CIDP (as documented by nerve conduction studies or other appropriate testing).
ANY of the following
A) Initial Therapy
Initial therapy: Approve for 3 months if both of the following are met:
Electrodiagnostic studies support the diagnosis of CIDP; AND
The medication is prescribed by or in consultation with a neurologist.
B) Currently Receiving Immune Globulin
Patient is currently receiving immune globulin with significant improvement in neurologic symptoms as determined by the prescriber (examples: improved disability, improved/stabilized nerve conduction study results, improved grip strength or other strength measures, improved sensation or physical examination).
Approve for duration noted if responding to therapy according to the prescriber.
Dosing: Approve one of the following regimens: (A) Initial loading dose: 2 g/kg given intravenously in divided doses over 2 to 5 consecutive days; OR (B) Maintenance dose: 1 g/kg given intravenously in divided doses over 1 to 4 consecutive days every 3 weeks; OR (C) Dose and interval adjusted according to clinical response with maximum dose per treatment course of 2 g/kg.
inv-07: Dermatomyositis/Polymyositis
Dermatomyositis/Polymyositis — Approve when ALL of the following are met:
ALL of the following
Prior to starting therapy, patient has tried a systemic corticosteroid OR corticosteroid is contraindicated according to the prescriber; AND
Patient has tried an immunosuppressive agent OR an immunosuppressive agent is contraindicated according to the prescriber (examples: methotrexate, cyclosporine, cyclophosphamide, mycophenolate mofetil).
Patient has or had an elevated creatine kinase (CK) level OR other diagnostic evidence supportive of inflammatory myopathy (e.g., limited skin manifestations, autoantibody testing, muscle biopsy results, electromyography).
The medication is prescribed by or in consultation with a neurologist or a rheumatologist.
inv-09: Autoimmune Mucocutaneous Blistering Diseases
Autoimmune Mucocutaneous Blistering Diseases (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita) — Approve when ONE of the following is met:
ANY of the following
A) Initial Therapy
Approve for 6 months if both of the following are met:
Patient has tried systemic corticosteroid OR corticosteroid is contraindicated; AND
Patient has tried an immunosuppressive agent OR immunosuppressive agent is contraindicated (examples: azathioprine, cyclophosphamide, dapsone, methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus).
OR the disease is so severe/rapid that there is inadequate time for steroid plus immunosuppressive therapy to take effect; AND patient has debilitating, progressive disease not controlled by standard therapy.
inv-10: NMOSD (AQP4-IgG-Positive)
NMOSD (AQP4-IgG-Positive) — Approve when ONE of the following is met:
ALL of the following
Patient has presence of at least one core clinical feature of NMOSD (examples: optic neuritis, acute myelitis, acute brainstem syndrome) as documented by the prescriber; AND
Diagnosis was confirmed by a positive blood serum test for AQP4-IgG (detection in cerebrospinal fluid also acceptable).
ANY of the following
A) Initial Therapy
Approve for 6 months if all of the following are met:
Patient is 18 years of age; OR according to the prescriber the patient has tried or has contraindication to one other therapy for this condition (examples: azathioprine, mycophenolate mofetil, rituximab, satralizumab, eculizumab, ravulizumab, inebilizumab).
inv-11: Transplant and Desensitization Indications
Transplant and Desensitization Indications — Approve when prescribed by or in consultation with a physician affiliated with a transplant center:
ANY of the following
Antibody-Mediated Rejection in Transplantation
Approve for 1 year if prescribed by or in consultation with a transplant-affiliated physician.
Dosing: Up to 2 g/kg as an intravenous infusion (single dose or divided doses, e.g., 400 mg/kg daily for 5 days); OR dosing per transplant center protocol.
Desensitization Therapy Prior to and Immediately after Transplantation
Approve for 1 year if prescribed by or in consultation with a transplant-affiliated physician.
inv-12: Guillain-Barré Syndrome (GBS)
Guillain-Barré Syndrome (GBS) — Approve when ONE of the following is met:
ANY of the following
A) Initial Therapy
Initial therapy: Approve for 1 month (one course of therapy) if both are met:
Medication is initiated within 2 weeks and no longer than 4 weeks after onset of neuropathic symptoms; OR patient had a treatment-related fluctuation but had an initial response to IVIG; AND
Medication is prescribed by or in consultation with a neurologist or specialist experienced in GBS.
B) Currently Receiving Immune Globulin
Patient is currently receiving immune globulin: Approve for 1 month.
inv-13: Secondary Immunodeficiency due to B-cell targeted therapies / Hematologic Neoplasm-associated Hypogammaglobulinemia
Secondary Immunodeficiency due to B-cell targeted therapies / Hematologic Neoplasm‑associated Hypogammaglobulinemia — Approve when ONE of the following is met:
ANY of the following
A) Initial Therapy
Patient has an IgG level < 600 mg/dL (6.0 g/L) [excluding paraprotein]; AND
Patient has recurrent or severe infections or is at high risk of infection according to the prescriber; AND
Medication is prescribed by or in consultation with an oncologist, hematologist, infectious disease physician, or immunologist.
B) Currently Receiving Immune Globulin
inv-15: HIV-related recurrent infections
HIV-related recurrent infections — Approve when ONE of the following is met:
ALL of the following
Patient is receiving combination antiretroviral therapy; AND
Patient has hypogammaglobulinemia (IgG ≤ 400 mg/dL [4.0 g/L]) OR functional antibody deficiency demonstrated by poor specific antibody titers (failure to develop responses to protein and polysaccharide antigens); AND
Patient has recurrent serious infections (e.g., two or more per year such as bacteremia, meningitis, pneumonia) despite appropriate therapy and prophylaxis; AND
Medication is prescribed by or in consultation with an infectious diseases specialist or immunologist.
Initial therapy: Approve for 6 months if above are met. Continuation: If patient is currently receiving immune globulin and frequency/severity of infections have decreased per prescriber, approve for 1 year.
inv-16: Immune-mediated Necrotizing Myopathy and Myopathies
Immune‑Mediated Necrotizing Myopathy and Myopathies — Approve when ONE of the following is met:
ANY of the following
A) Initial Therapy
Approve for 6 months if all of the following are met:
Patient has muscle weakness; AND
Patient has or had an elevated CK level above 1,000 IU/L (per prescriber); AND
Patient meets one of: has myositis-associated autoantibodies (e.g., anti-SRP, anti-HMGCR) OR supportive testing (EMG, muscle MRI, or muscle biopsy) per prescriber; AND
inv-17: Immunotherapy-Related Toxicities from Checkpoint Inhibitors
Immunotherapy‑Related Toxicities from Checkpoint Inhibitors — Approve when ONE of the following is met:
ANY of the following
A) Initial Therapy
Initial therapy: Approve for 1 month if one of the following is met:
Patient has tried a systemic corticosteroid and has not adequately responded; OR
Medication is started concurrently with a systemic corticosteroid (per prescriber); OR
A corticosteroid is contraindicated per the prescriber.
B) Currently Receiving Immune Globulin
inv-18: Lambert-Eaton, Multiple Myeloma, and MS acute relapses
Lambert‑Eaton, Multiple Myeloma, and MS acute relapses — Indication‑specific criteria:
For MS acute relapses, a trial of repository corticotropin (ACTH) counts toward meeting steroid trial requirement.
inv-19: Myasthenia Gravis — Acute and Maintenance
Myasthenia Gravis — Acute and Maintenance criteria:
ANY of the following
Short-term (Acute) Use
Initial therapy for short‑term/acute use: Approve for 5 days (one course) if both are met: patient has an exacerbation of myasthenia gravis OR requires stabilization before surgery; AND (patient has been started on a corticosteroid to prevent/minimize exacerbations or has been started on an immunosuppressive drug and IVIG is used while waiting for effect).
Dosing: Short‑term use: 2 g/kg IV in divided doses over 2 to 5 consecutive days.
Initial Therapy for Maintenance
Approve for 1 year if all of the following are met: patient has refractory myasthenia gravis; patient has tried pyridostigmine; patient has tried immunosuppressive therapy with at least one agent (azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, methotrexate, tacrolimus) and had inadequate response; medication prescribed by or in consultation with a neurologist; and patient is responding to therapy per prescriber.
inv-20: MOGAD — Initial and Ongoing Therapy
MOGAD — Initial and Ongoing Therapy — Approve when ONE of the following is met:
ANY of the following
A) Initial Therapy
Approve for 6 months if all of the following are met:
Patient has a clinical demyelinating event (examples: optic neuritis, acute disseminated encephalomyelitis, transverse myelitis) as documented by the prescriber; AND
Diagnosis confirmed by positive serum test for MOG‑IgG (detection in CSF also acceptable); AND
Patient has tried a systemic corticosteroid OR corticosteroids are contraindicated per prescriber; OR patient is the requested medication for acute attacks and meets urgency criteria; AND
inv-21: MS — Acute Severe Exacerbation
MS — Acute Severe Exacerbation criteria:
ALL of the following
Approve for 1 month (one course of therapy) if the patient meets ALL of the following:
Patient has either not responded to OR has had a significant adverse reaction with systemic corticosteroids (e.g., methylprednisolone) OR plasma exchange; OR a systemic corticosteroid is contraindicated per prescriber; AND
Patient is already on maintenance therapy for MS or will be starting maintenance therapy for MS; AND
Medication is prescribed by or in consultation with a neurologist.
Dosing: Approve 0.4 g/kg IV per infusion for 5 consecutive days; alternative dosing such as single 1 g/kg also noted per clinical scenario.
inv-22: Post‑Exposure Prophylaxis (Measles, Varicella, Tetanus)
Post‑Exposure Prophylaxis (Measles, Varicella, Tetanus) — Single‑dose approvals:
ANY of the following
Passive Immunization for Measles (Post-Exposure)
Approve for 1 day (single dose) if one of the following is met:
Patient is pregnant and has been exposed to measles; AND cannot readily show evidence of immunity (no history of disease or age‑appropriate vaccination); OR
Patient is immunocompromised and has been exposed to measles.
Dosing: 0.4 g/kg IV administered one time.
Post‑Exposure Prophylaxis for Varicella or Tetanus
inv-23: Parvovirus B19 and PRCA
Parvovirus B19 Infection and Pure Red Cell Aplasia (PRCA) — Approve when ONE of the following is met:
Parvovirus B19 regimens added as alternative dosing; consult specialist for immunocompromised hosts.
inv-24: Notable coverage criteria revisions
Notable coverage criteria revisions — summary of key changes and additions:
Added approvals: Aquaporin-4 (AQP4‑IgG) NMOSD; Immune‑Mediated Necrotizing Myopathy; Myelin Oligodendrocyte Glycoprotein Antibody‑Associated Disease (MOGAD).
CIDP dosing clarified: initial loading dose 2 g/kg divided over 2–5 days; maintenance 1 g/kg in divided doses over up to 4 days every ~3 weeks; added grip strength as an example of improvement on exam.
Guillain‑Barré Syndrome continuation language updated: removed wording referencing a second course ~3 weeks after first course; current wording provides for additional therapy when clinically indicated per prescriber.
Passive immunization for measles language updated: 'cannot readily show evidence of immunity' replaces previous phrasing regarding lack of evidence of immunity; varicella post‑exposure timing language simplified; chronic fatigue syndrome removed from 'Not Recommended' list.
Policy statement updated to note that requests for doses outside established dosing will be considered case‑by‑case by a clinician (Medical Director or Pharmacist); approvals for specialty‑managed preferred products may be entered without another clinical review per program rules.