OBJECTIVES

Alirocumab and evolocumab were introduced in generics-dominated therapy area, such as statins, prompting European payers to limit them to the most difficult-to-treat patients. This research aimed to analyze the pricing and market access impact of European payer experience with PCSK9is on new cardiovascular entrants.

METHODS

We used a non-systematic review of public data sources to identify PCSK9i annual prescription volume in selected EU countries compared to the eligible populations per the EMA label. We assessed the discrepancy between eligibility criteria and actual volume prescribed yearly. We then identified rationale from European payers in eligibility criteria for PCSK9is.

RESULTS

In studied countries (DE, ES, FR, IT), payers required patients to maximize first-line lipid-lowering therapy (statins/eztimibe) before becoming eligible for PCSK9i, while also demonstrating adherence. In Germany, only 2-8% of patients were on maximized lipid-lowering therapy. Payers also set bundled payment amounts at level with the standard of care, without updating them to account for the cost of new molecules. This led hospitals to invest in statin adherence programs rather than in new drugs. In Spain, 0.1-1.7% of patients who had received at least one LDL-C measurement were eligible for PCSK9is. PCSK9i list prices were therefore significantly discounted of the current US list prices for Repatha and Praluent (≈$487.5 per month) without increasing access. For example, in France, current price is $247.66 per month for Repatha and $333.85 for Praluent.

CONCLUSIONS

European payers are not allowed to restrict eligible patient populations based on drug price, but on evaluated added clinical benefit to patients; however, they may consider additional clinical benefit from these newer drugs for broader access or will increase investments in prevention programs and ensuring maximal patient adherence to first-line therapies.