PCSK9 inhibitors — Blue Cross Blue Shield of Illinois

off-label rare disease use for BCBS NM Fully Insured or NM HIM members

Initial criteria

For BCBS MT Fully Insured or MT HIM member: (A) Patient age < 18 years; AND (B) No FDA labeled contraindications; AND (C) Indication supported in TWO articles from major peer-reviewed medical journals (JAMA, NEJM, Lancet) as generally safe and effective; AND (D) Age group supported in TWO similar articles with accepted study designs (e.g., randomized, double-blind, placebo-controlled trials)
For BCBS NM Fully Insured or NM HIM member: (A) No FDA labeled contraindications; AND (B) Indication is a rare disease; AND ONE of: another FDA labeled indication; OR compendia-supported indication for route of administration
For Ohio member (Fully Insured or HIM Shop): (A) Member resides in Ohio; AND (B) Plan is Fully Insured or HIM Shop; AND (C) No FDA labeled contraindications; AND ONE of: another FDA labeled indication; OR compendia-supported indication; OR prescriber submitted TWO peer-reviewed journal articles showing safe and effective use
Non-oncology compendia allowed: DrugDex level 1, 2A or 2B, AHFS-DI (supportive narrative)
Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI (supportive narrative), DrugDex level 1, 2A, or 2B, Clinical Pharmacology (supportive narrative), Lexi-Drugs evidence level A, or peer-reviewed medical literature

12 months