PCSK9 inhibitors have struggled to gain momentum since their US launch in 2015. As a result, PCSK9 inhibitor developers slashed prices in 2018 in order to boost uptake, according to GlobalData, a leading data and analytics company.

The major barrier to the adoption of these PCSK9 inhibitors has been their high price tag, which led to Sanofi and Regeneron halving the US net price of Praluent (alirocumab) from $14,000 to $7,000 in 2018. Amgen followed suit by lowering the price of biweekly Repatha (evolocumab) down to $5,850 per year from $14,000.

Dr. Jesus Cuaron, Managing Pharma Analyst at GlobalData, comments: “When regulatory bodies approved PCSK9 inhibitors for a relatively broad proportion of dyslipidemia patients, payers reacted by placing strict requirements on who is eligible to receive these expensive therapies. As such, PCSK9 inhibitors have largely been limited to patients who are unable to lower low-density lipoprotein cholesterol levels with conventional lipid-lowering statins.”

There is also another PCSK9 targeting therapy in the pipeline, the Medicines Company’s inclisiran, a small interfering ribonucleic acid in Phase III clinical trials. The company has considered undercutting competitor prices, but only a minimal price cut is expected as inclisiran might have an administration advantage against its competitors since it could be administered only once or twice per year.

Dr. Cuaron concludes: “Throughout 2017 and 2018, PCSK9 inhibitor developers continued to improve drug administration and file for new indications to promote use in high-risk patients, such as once-monthly dosing for Praluent, as well as new cardiovascular indications for Praluent and Repatha.

“However, one of the most anticipated developments in 2019 will be monitoring the uptake and sales of Praluent and Repatha following the price cuts made in 2018. Questions remain about whether the improvement in patient outcomes justifies the high price point of PCSK9 inhibitors, but GlobalData expects that these price reductions will undoubtedly fuel their uptake moving forward.”