efgartigimod alf-hyalur-qvfc — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following: (A) Diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following: (1) positive serological test for anti-AChR antibodies (medical records required) AND (2) MGFA clinical classification class II–IVb AND (3) MG-Activities of Daily Living (MG-ADL) total score ≥ 5 AND (4) ONE of the following: (A) medications known to exacerbate myasthenia gravis discontinued OR (B) discontinuation not clinically appropriate AND (5) ONE of the following: (A) BOTH: (1) stage IV metastatic cancer and requested agent used to treat cancer or associated condition; (2) use consistent with best practices and FDA approved OR (B) tried and inadequate response to ≥ 1 conventional agent for myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR (C) intolerance or hypersensitivity to ≥ 1 conventional agent OR (D) FDA labeled contraindication to ALL conventional agents OR (E) required chronic IVIG OR (F) required chronic plasmapheresis/plasma exchange AND (6) NOT used in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy. OR (B) Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) AND ALL of the following: (1) progressive or relapsing/remitting disease ≥ 2 months AND (2) progressive or relapsing motor sensory impairment of > 1 limb AND (3) electrodiagnostic findings indicating demyelination with ≥ 1 of the following: prolonged distal motor latency in ≥ 2 nerves; reduced motor conduction velocity in ≥ 2 nerves; prolonged or absent F-wave, partial motor conduction block, abnormal temporal dispersion, or distal CMAP duration increase as specified AND (4) ONE of the following: (A) tried and inadequate response to ≥ 3-month trial of ONE standard therapy (corticosteroids, immunoglobulins, plasma exchange) OR (B) intolerance or hypersensitivity to ONE standard therapy OR (C) FDA labeled contraindication to ALL standard therapies. OR (C) Patient has another FDA labeled indication for the requested agent and route of administration AND (2) patient’s age within FDA labeling OR supported for that age AND (3) prescriber is a specialist (e.g., neurologist) or has consulted one AND (4) no FDA labeled contraindications to requested agent.
• BCBSMT specific pediatric allowance: request for fully insured or HIM member < age 18 years AND no FDA labeled contraindications AND indication supported in TWO major peer-reviewed journal articles as generally safe and effective and age bracket supported in TWO such articles (randomized, double blind, placebo controlled clinical trials; case studies not acceptable).
• Ohio specific allowance: member resides in Ohio; plan Fully Insured or HIM SHOP (SG); no FDA labeled contraindications; ONE of the following: another FDA labeled indication OR another compendia-supported indication OR TWO major peer-reviewed journal articles supporting use as safe and effective (accepted study designs randomized, double blind, placebo controlled; case studies not acceptable); compendia allowed: non-oncology: DrugDex 1, 2A, 2B or AHFS-DI supportive; oncology: NCCN 1 or 2A; AHFS-DI supportive; DrugDex 1, 2A, 2B; Clinical Pharmacology supportive; LexiDrugs evidence level A; or peer-reviewed medical literature.

Reauthorization criteria

• Patient previously approved through plan’s Prior Authorization process AND experienced clinical benefit with requested agent AND prescriber is a specialist (e.g., neurologist) or has consulted one AND NOT used in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy AND no FDA labeled contraindications.

Approval duration

12 months