PCSK9 inhibitors are a class of injectable drugs used to significantly lower low-density lipoprotein (LDL) cholesterol. These agents are typically reserved for patients who cannot achieve their cholesterol goals with statins or other standard therapies. They are among the most expensive chronic medications available, making their cost a primary concern for patients and the healthcare system.
Understanding the Wholesale Acquisition Cost
The financial discussion of PCSK9 inhibitors begins with the Wholesale Acquisition Cost (WAC), which is the manufacturer’s list price for the drug before any discounts, rebates, or negotiations. At their launch, the annual WAC for the two primary PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha), was over $14,000 per year. This high initial price created significant access barriers for patients.
The manufacturers later responded by introducing a new, lower WAC. Both Praluent and Repatha are now available at a reduced list price of $5,850 per year. This list price is the basis for all financial transactions, though very few patients, even those with insurance, pay the full WAC amount.
The Role of Insurance and Prior Authorization
The final cost a patient pays is determined almost entirely by their health insurance plan. These drugs are almost always placed on the highest formulary tiers, typically Tier 4 or Tier 5. Placement on a specialty tier means the patient’s cost is often calculated as a percentage of the drug’s price, known as coinsurance, rather than a fixed copayment. A coinsurance rate of 20% to 30% on a drug with a $5,850 annual WAC can result in thousands of dollars of out-of-pocket costs for a single year, especially before the patient meets their annual deductible.
Nearly all insurance plans require a process called prior authorization (PA). This demands extensive documentation from the prescriber to prove the drug is medically necessary and appropriate. The PA process for PCSK9 inhibitors is complex, often requiring proof of a confirmed diagnosis like familial hypercholesterolemia (FH) or established atherosclerotic cardiovascular disease (ASCVD).
Insurers also frequently impose a step therapy requirement, meaning the patient must first try and fail less-expensive, established lipid-lowering therapies like statins and ezetimibe. The administrative burden of this process has historically led to high rates of prescription abandonment. Even with the reduced WAC, the patient’s final cost is a product of their specific plan’s deductible, coinsurance rate, and whether the PA process is successful.
Strategies for Reducing Out-of-Pocket Costs
For commercially insured patients, the most direct strategy to mitigate high costs is through manufacturer-sponsored copay assistance programs. These programs allow eligible patients with commercial insurance to pay a reduced amount, often $5 to $15 per month, for their prescription. The copay card covers the patient’s deductible, copayment, and coinsurance amounts up to a certain annual limit, which for Repatha can be up to $5,500 per year.
These copay cards are not valid for patients enrolled in government healthcare programs like Medicare or Medicaid. For uninsured patients or those with Medicare/Medicaid who face high costs, non-profit foundations or manufacturer-sponsored Patient Assistance Programs (PAPs) are available. These PAPs typically provide the medication at no cost to patients who meet specific income criteria, often set at or below a percentage of the Federal Poverty Level. Patients must provide proof of income and coverage status to qualify for this assistance.