fitusiran sodium — Blue Cross Blue Shield of New Mexico

Preferred products

• Hemlibra
• antihemophilic factor VIII agent
• antihemophilic Factor IX agent

Initial criteria

• Continuation of therapy eligible if the prescriber states the patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) and is at risk if therapy is changed
• For Hemophilia A (factor VIII deficiency): ALL of the following:
• • Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing
• • Requested agent used for routine prophylaxis to prevent or reduce frequency of bleeding episodes
• • Used as primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level <1%) OR secondary prophylaxis in patients with ≥2 episodes of spontaneous joint bleeding
• • ONE of the following:
• – Patient has factor VIII inhibitors AND BOTH of:
• • Previous prophylaxis therapy
• • ONE of: inadequate response to Immune Tolerance Induction (ITI) OR inhibitor level ≥200 BU (medical records required) OR support for not a candidate for ITI
• – Patient does NOT have factor VIII inhibitors AND ONE of:
• • Tried and had inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII agent)
• • Tried and had inadequate response to ONE prerequisite agent AND intolerance or hypersensitivity to ONE prerequisite agent (Hemlibra AND an antihemophilic factor VIII agent)
• • Intolerance or hypersensitivity to BOTH Hemlibra AND an antihemophilic factor VIII agent
• • FDA labeled contraindication to BOTH Hemlibra AND ALL antihemophilic Factor VIII agents
• For Hemophilia B (factor IX deficiency): ALL of the following:
• • Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing
• • Requested agent used for routine prophylaxis to prevent or reduce frequency of bleeding episodes
• • Used as primary prophylaxis in patients with severe factor IX deficiency (factor IX level ≤2%) OR secondary prophylaxis in patients with ≥2 episodes of spontaneous joint bleeding
• • ONE of the following:
• – Patient has factor IX inhibitors AND BOTH of:
• • Previous prophylaxis therapy
• • ONE of: inadequate response to ITI OR inhibitor level ≥200 BU (medical records required) OR support for not a candidate for ITI
• – Patient does NOT have factor IX inhibitors AND ONE of:
• • Tried and had inadequate response to antihemophilic Factor IX agent
• • Intolerance or hypersensitivity to antihemophilic Factor IX agent
• • FDA labeled contraindication to ALL antihemophilic Factor IX agents
• If the patient has an FDA labeled indication, ONE of:
• • Patient’s age is within FDA labeling for the indication OR
• • Support provided for use at patient’s age
• Patient does NOT have a co-existing thrombophilic disorder or a history/risk factors predisposing to thrombosis
• Requested agent NOT used for treatment of breakthrough bleeding
• Prescriber is a specialist in hemophilia (e.g., hemophilia treatment center, hematologist with experience) or has consulted with such a specialist
• Requested agent NOT used in combination with immune tolerance induction with clotting factor products, hemophilia bypassing agent prophylaxis, or emicizumab for hemophilia A with inhibitors (factor VIII or IX products can be used for breakthrough bleeds >7 days after starting Qfitlia)
• Patient has antithrombin (AT) activity ≥60% at baseline and will have AT activity monitored regularly
• Patient does NOT have hepatic impairment (Child-Pugh Class A, B, or C)
• For NM Fully Insured or NM HIM members: ALL of:
• • No FDA labeled contraindications to requested agent
• • Requested indication is a rare disease
• • ONE of: another FDA indication for the agent/route OR supported in compendia (DrugDex level 1,2A,2B or AHFS-DI narrative supportive)
• For Ohio Fully Insured or HIM Shop (SG) members: ALL of:
• • Member resides in Ohio and plan is Fully Insured or HIM Shop
• • No FDA labeled contraindications to agent
• • ONE of:
• – Another FDA labeled indication for agent and route OR
• – Another compendia supported indication (non-oncology: DrugDex 1,2A,2B, AHFS-DI supportive; oncology: NCCN 1 or 2A, AHFS-DI supportive, DrugDex 1,2A,2B, Clinical Pharmacology supportive, LexiDrugs level A, peer-reviewed literature) OR
• – Two articles from major peer-reviewed medical journals supporting use (randomized, double-blind, placebo-controlled; case studies not acceptable)

Approval duration

6-12 months