Since their development in the late 1980s, Statins have remained the gold standard in treating and regulating cholesterol production. Blockbuster drugs such as Lipitor (atorvastatin) and Crestor (rosuvastatin) produced annual revenues of over $12B globally in the mid-2000s. However, this blog post will discuss the emergence of a unique alternative treatment in lowering LDL cholesterol (LDL-C) levels and how payers have reacted in response to the new agents.
On July 24, 2015 the FDA granted approval of Regeron-Sanofi’s Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) inhibitor, Praluent (alirocumab). Just one month later, Amgen also gained FDA-approval of its PCSK9 inhibitor, Repatha (evolocumab). Both Praluent and Repatha are injectables indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. PCSK9 inhibitors work by blocking the PCSK9 protein, allowing the body to clear LDL-C from the bloodstream. In a study published by the American College of Cardiology (ACC), the LDL-C level of patients receiving evolocumab treatment over the course of 56-58 weeks was lowered 61% from a baseline of 120mg/dL. Also, Regeneron-Sanofi provided additional trial data regarding a 24-week study of alirocumab. The agent lowered LDL-C levels by 61% for patients with LDL-C levels above 70mg/dL and currently taking high-dose statins or maximum tolerated dosages. While clinical trials show that patients respond favorably over time to both agents, physicians are unwilling to pass judgment on the newly-approved drug class. Many are awaiting extended trials data before prescribing to patients. Payer response mirrors that of physicians. This is due to high price of the PCSK9 treatments, compared to generic alternatives, coupled with the lack of clinical data. Bi-weekly doses of Praluent costs over $14,000, annually, compared to $3,000 a year for branded statin Crestor (unbranded statin treatments are available for even less).
An analysis, conducted by the Policy and Access Tracking Tool team at Zitter Health Insights, has shown that over one-half of Commercial payers, accounting for 36% of lives, have yet to review the new agents. Payer management has been highly restrictive for Commercial payers that have made decisions for Praluent and Repatha. ZHI Healthplan Management criteria segments each plan according to specific prior authorization information.
Payers that account for over one-third of Commercial lives highly manage Praluent by requiring failure at least two high intensity statins prior to approval. Payers further restrict access by requiring failure of non-statins, specific LDL-C levels above 130 mg/dL and specialist approval by a cardiologist prior to approval of PCSK9 agents. While no plans currently fall into the Step Edit category by requiring trial and failure of one PCSK9 prior to approval of the other, it is possible that this could change in the future. Pfizer is in the midst of Phase III trials for its drug, bococizumab, which will further saturate the market. As new PCSK9 inhibitors gain FDA-approval will the trend of payer restriction continue? Or will additional clinical trials data outweigh the overwhelming cost burden and lead to less restrictive access across the drug class? Be sure to monitor Zitter Health Insights’ Policy & Access Tracking Tool to find out.
Clary, MD, Julie Marie. “PCSK9 Inhibition and CVD Events.” American College of Cardiology. American College of Cardiology Foundation, 01 June 2015. Web. 29 Oct. 2015.
Garde, Damian. “Amgen Scores a Victory for PCSK9, Halving Cardio Risks after One Year.” FierceBiotech. N.p., 15 Mar. 2015. Web. 29 Oct. 2015.
Shrank, William, Alan Lotvin, Surya Singh, and Troyen Brennan. “In The Debate About Cost And Efficacy, PCSK9 Inhibitors May Be The Biggest Challenge Yet.” Health Affairs Blog. Health Affairs, 17 Feb. 2015. Web. 04 Nov. 2015.