Hympavzi — Blue Cross Blue Shield of New Mexico

Initial criteria

• ONE of the following: (A) The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR (B) ALL of the following subcriteria apply
• For Hemophilia A: BOTH of the following: (1) ONE of the following: (A) Requested agent used for primary prophylaxis in severe factor VIII deficiency (factor VIII <1%) OR (B) Requested agent used for secondary prophylaxis with ≥2 spontaneous joint bleeds; AND (2) ONE of the following: (A) Patient currently stable on requested agent OR (B) Has tried and had inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII) OR (C) Has tried one prerequisite agent and has intolerance/hypersensitivity to another (Hemlibra and an antihemophilic factor VIII) OR (D) Has intolerance/hypersensitivity to TWO prerequisite agents OR (E) TWO prerequisite agents discontinued for lack of efficacy/adverse event OR (F) Has FDA-labeled contraindication to BOTH Hemlibra AND all antihemophilic factor VIII agents OR (G) TWO prerequisite agents expected to be ineffective or cause adherence, comorbid, functional, or safety issues OR (H) TWO prerequisite agents not in patient’s best interest based on medical necessity OR (I) Has tried another drug in same pharmacologic class as TWO prerequisite agents that was discontinued due to lack of efficacy or adverse event
• For Hemophilia B: BOTH of the following: (1) ONE of the following: (A) Requested agent used for primary prophylaxis in severe factor IX deficiency (factor IX <1%) OR (B) Requested agent used for secondary prophylaxis with ≥2 spontaneous joint bleeds; AND (2) ONE of the following: (A) Patient currently stable on requested agent OR (B) Has tried and had inadequate response to an antihemophilic factor IX agent OR (C) Has intolerance/hypersensitivity to antihemophilic factor IX agent OR (D) Has FDA-labeled contraindication to all antihemophilic factor IX agents OR (E) Antihemophilic factor IX products discontinued for lack of efficacy/adverse event OR (F) Antihemophilic factor IX agents expected ineffective, unsafe, or obstructive to adherence, comorbidities, function OR (G) Antihemophilic factor IX agents not in best medical interest OR (H) Has tried another drug in same pharmacologic class as antihemophilic factor IX agent that was discontinued due to lack of efficacy/adverse event
• For all patients: (1) Patient’s age is within FDA labeling for requested indication OR there is support for age/indication per medical literature; AND (2) Requested agent used as prophylaxis to prevent/reduce frequency of bleeding episodes; AND (3) Requested agent NOT used for treatment of breakthrough bleeding; AND (4) Patient is NOT pregnant; AND (5) Prescriber is a specialist in hemophilia or has consulted a specialist; AND (6) Requested agent NOT used in combination with prophylactic factor VIII or IX products (use permissible for breakthrough bleeds only); AND (7) Patient has no FDA-labeled contraindications to requested agent
• Alternative approval logic by plan exceptions:
• For BCBS MT Fully Insured or MT HIM members: Patient age <18 years old AND no FDA contraindications AND requested indication supported by TWO peer-reviewed medical journal articles demonstrating safety/effectiveness AND proposed age bracket supported by TWO such articles (infancy 0–<2 years; childhood 2–11 years; adolescence 12–17 years)
• For BCBS NM Fully Insured or NM HIM members: No FDA contraindications AND indication is a rare disease AND ONE of the following: (1) Patient has another FDA-labeled indication for agent/route OR (2) Indication supported in compendia for agent/route
• For Ohio residents with Fully Insured or HIM Shop plan: No FDA contraindications AND ONE of the following: (1) Other FDA-labeled indication for same agent/route OR (2) Indication supported in compendia for same agent/route OR (3) TWO peer-reviewed medical journal articles show proposed use as safe/effective

Approval duration

6–36 months (plan dependent; BCBSOK:36mo, BCBSIL/MT/TX:12mo, others:6mo; plan exceptions up to 12mo)