Understanding the List Price and Annual Cost
Merck announced the FDA approval of Winrevair (sotatercept) in March 2024, alongside its list price of $14,000 per vial. For most patients receiving one injection every three weeks, this results in an estimated annual cost of around $240,000 before discounts or rebates. The list price is a baseline, and the actual cost to patients and insurers will vary.
Patient costs depend significantly on insurance coverage, as specialty drugs like Winrevair have different co-pay, co-insurance, and deductible requirements. Manufacturer assistance programs can help uninsured or underinsured patients.
Factors that influence patient out-of-pocket costs
Insurance Coverage
- Commercial Insurance: Out-of-pocket costs are determined by the specific policy's deductibles, co-insurance, and co-pays for specialty drugs. Patients need to use a specialty pharmacy for the medication.
- Medicare and Medicaid: A large number of Winrevair patients are expected to be covered by these programs. Coverage and costs follow federal and state guidelines, and the Merck Access Program can assist with understanding benefits.
- Prior Authorization: Most insurers require prior authorization, a process where a healthcare provider justifies the medical necessity of the drug.
Financial Assistance Programs
Merck offers the Merck Access Program to support patients with financial navigation.
- Co-pay Coupon Program: Eligible commercially insured patients can receive a co-pay coupon to lower out-of-pocket costs.
- Patient Assistance Program (PAP): Uninsured or underinsured patients meeting specific criteria may receive Winrevair for free through this program.
Comparing the cost of PAH therapies
Winrevair's cost can be compared to other PAH treatments, which range from a few thousand to over $50,000 annually. Winrevair is a new class of therapy with a higher price point reflective of its novel mechanism.
| Feature | Winrevair (sotatercept) | Opsynvi (macitentan/tadalafil) | Opsumit (macitentan) | Treprostinil (generic prostacyclin) |
|---|---|---|---|---|
| Manufacturer | Merck | Johnson & Johnson | Johnson & Johnson | Multiple |
| Drug Class | Activin Signaling Inhibitor | Endothelin/PDE5 Inhibitor | Endothelin Receptor Antagonist | Prostacyclin Analogue |
| Delivery Method | Subcutaneous injection | Oral tablet | Oral tablet | Inhalation/IV/Subcutaneous |
| List Price (Est.) | ~$240,000/year | Parity to Opsumit price | ~$160,000+/year* | ~$50,000+/year* |
| ICER Benchmark | $17,900-$35,400/year | N/A | N/A | N/A |
| Key Cost Factor | High drug acquisition cost | Combination drug cost | High drug acquisition cost | High drug acquisition cost |
*Estimates based on search results for related drugs, not specific to this table.
The healthcare system perspective and economic value
The price of new drugs like Winrevair impacts the healthcare system. Organizations like the Institute for Clinical and Economic Review (ICER) assess cost-effectiveness. ICER's analysis suggested a health-benefit price benchmark for sotatercept between $17,900 and $35,400 per year, significantly lower than Merck's list price.
This price disparity sparks debate about access and affordability. While Merck justifies the price based on innovation, insurers and policymakers consider the budget impact. Patients and providers must navigate potential coverage issues, making patient support programs crucial for access to this therapy.
Conclusion: Navigating the cost of sotatercept
The cost of sotatercept is multifaceted, starting with a $14,000 list price per vial. The potential annual cost is high, but patient costs depend on insurance, assistance programs, and individual circumstances. Patients with PAH should discuss costs with healthcare providers and explore manufacturer resources for accessing this treatment.
For more information on patient support, visit the Merck Access Program website or contact the Pulmonary Hypertension Association.
