OBJECTIVES : Cardiovascular disease (CVD) affects approximately 6 million people in England and costs the NHS an estimated £7 billion a year. A key risk factor for CVD is hypercholesterolaemia. PCSK9 inhibitors, such as alirocumab and evolocumab, are a treatment option for patients who, despite taking the maximum tolerated dose of statins, still have cholesterol higher than recommended levels. This study compares actual prescription of PCSK9 inhibitors with expected use and considers opportunities for improved access to these drugs.

METHODS : An analysis of the initial uptake estimates from the NICE resource impact report for alirocumab and evolocumab and actual daily dose (ADD) prescribing data from the NICE innovation scorecard for the same drugs in 2018. The study included a review of the NICE technology appraisal guidance (TAG) for alirocumab (TA393) and evolocumab (TA394), and publications from 2016–2019 relating to uptake of, and guidance and initiatives associated with, PCSK9 inhibitors in England.

RESULTS : On publication of the TAG for alirocumab and evolocumab in 2016, NICE estimated that there would be 11,542 people receiving PCSK9 inhibitors by 2018. However, analysis of data from the NICE innovation scorecard for 2018 shows that 755,806 ADDs of alirocumab and evolocumab were actually prescribed. This is equivalent to approximately 2,069 people receiving treatment and indicates that uptake of PCSK9 inhibitors was 82% lower than expected in 2018.

CONCLUSIONS : While there is considerable potential for PCSK9 inhibitors to alleviate some of the burden of CVD, prescription of these drugs is considerably lower than expected. Despite price reduction, the cost of PCSK9 inhibitors may remain the main barrier to access to these drugs. Further barriers could include a lack of clear guidance for clinicians, patient identification and, until recently, limited clinical trial data regarding CVD outcomes. New initiatives, such as the Accelerated Access Collaborative, may ultimately lead to improved access to PCSK9 inhibitors.