fitusiran sodium — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following: (A) Eligible for continuation of therapy: patient has been treated with Qfitlia within the past 90 days (not samples) and is at risk if therapy is changed OR (B) Meets all of the following clinical criteria:
• For Hemophilia A: diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND Qfitlia used for routine prophylaxis to prevent or reduce bleeding episodes AND ONE of: primary prophylaxis in severe factor VIII deficiency (factor VIII <1%) OR secondary prophylaxis in patients with ≥2 spontaneous joint bleeds AND ONE of the following based on inhibitor status: (1) With factor VIII inhibitors: prior prophylaxis therapy AND one of: inadequate response to Immune Tolerance Induction (ITI) OR inhibitor level ≥200 BU (records required) OR support for not being a candidate for ITI; OR (2) Without inhibitors: one of the following: inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII agent) OR inadequate response to ONE prerequisite agent plus intolerance/hypersensitivity to ONE prerequisite agent (Hemlibra and an antihemophilic factor VIII agent) OR intolerance/hypersensitivity to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII agent) OR FDA-labeled contraindication to BOTH Hemlibra AND all antihemophilic factor VIII agents.
• For Hemophilia B: diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing AND Qfitlia used for routine prophylaxis to prevent or reduce bleeding episodes AND ONE of: primary prophylaxis in severe factor IX deficiency (factor IX ≤2%) OR secondary prophylaxis in patients with ≥2 spontaneous joint bleeds AND ONE of the following based on inhibitor status: (1) With factor IX inhibitors: prior prophylaxis therapy AND one of: inadequate response to ITI OR inhibitor level ≥200 BU OR support for not being a candidate for ITI; OR (2) Without inhibitors: one of the following: inadequate response to an antihemophilic factor IX agent OR intolerance/hypersensitivity to an antihemophilic factor IX agent OR FDA-labeled contraindication to all antihemophilic factor IX agents.
• For all patients: (1) Age within FDA labeling for requested indication OR support for off-label age use, (2) No co-existing thrombophilic disorder or history/risk factors for thrombosis, (3) Qfitlia not used for treatment of breakthrough bleeding, (4) Prescriber is a specialist in hemophilia or has consulted one, (5) Qfitlia not used in combination with immune tolerance induction with factor products, hemophilia bypassing agent prophylaxis, or emicizumab, (6) Factor VIII or IX products allowed for breakthrough bleeds >7 days after Qfitlia initiation, (7) Baseline antithrombin activity ≥60% and monitored regularly, (8) Patient does not have hepatic impairment (Child-Pugh class A, B, or C).
• If request is for NM Fully Insured/HIM or OH Fully Insured/HIM Shop: patient has no FDA-labeled contraindications AND indication is a rare disease AND (a) has another FDA-labeled indication for requested agent/route OR (b) another compendia-supported indication OR (c) two peer-reviewed journal articles supporting use (randomized, double blind, placebo controlled). Compendia allowed: DrugDex level 1,2A,2B; AHFS-DI supportive narrative; NCCN 1 or 2A, Clinical Pharmacology supportive narrative; LexiDrugs evidence level A.

Approval duration

6 months (all other plans); 12 months (BCBSIL, BCBSMT, BCBSTX, and special NM/OH scenarios)