The FDA granted Breakthrough Therapy designation to olezarsen for the treatment of severe hypertriglyceridemia (triglycerides ≥500 mg/dL) on December 1, 2025. This designation is intended to expedite the development and review of therapies that demonstrate substantial improvement over available options for serious conditions.
Olezarsen, marketed as Tryngolza, was approved by the FDA on December 19, 2024, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). As of January 9, 2026, the drug has been approved for approximately three weeks.
Given the recent approval, reimbursement and tier status on pharmacy benefit managers (PBMs) are in the early stages of establishment. Several PBMs and health plans have initiated prior authorization requirements and medical necessity policies, but full tier integration is not yet widespread. For example:
• UnitedHealthcare (UHC) requires prior authorization/medical necessity review, with coverage guidelines emphasizing trial of lower-cost alternatives.
• Highmark and Molina Marketplace have issued pharmacy policy bulletins mandating prior authorization, often positioning it as non-preferred until step therapy (e.g., trial of fibrates or omega-3s) is met.
• Health Net and Mass General Brigham Health Plan have similar PA policies, with effective dates ranging from August 2025 onward for some updates.
• VA Formulary lists it as “Non-Formulary” (Tier 3 equivalent), indicating restricted access pending further review.
• Optum and other major PBMs mention emerging criteria, but no standardized tier (e.g., Tier 3–4 non-preferred) is confirmed across all plans.
Reimbursement is expected to evolve as payers assess cost-effectiveness (list price not yet public, but anticipated high due to orphan status) and integrate Breakthrough Therapy benefits. Ionis Pharmaceuticals anticipates broad coverage discussions, with initial PA-heavy access similar to other rare disease therapies.
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