OBJECTIVES: Cardiovascular disease (CVD) accounted for 42% of deaths in the Kingdom of Saudi Arabia (KSA) in 2011. Patients with CVD, especially coronary heart disease (CHD), are at high risk of CV events; low-density lipoprotein-cholesterol (LDL-C) levels being the major risk factor. Few patients remain uncontrolled with statins monotherapy to achieve desired LDL-C levels. Recently, proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) such as alirocumab and evolocumab, were approved as adjunct to statin therapy for the management of patients with CHD having uncontrolled LDL-C levels. This study estimated the budgetary impact of adopting PCSK9i as an add-on treatment to statin therapy for the management of uncontrolled LDL-C patients with CHD in the Ministry of Health (MoH) of KSA.

METHODS: A budget impact (BI) model was developed to assess two scenarios - “with PCSK9i” and “without PCSK9i” as add-on therapy to statins over a five-year time horizon. The key model inputs included CVD patients eligible for PCSK9i treated at MoH facilities, statin market shares, CV event rates and costs, and drug costs. The CV event rate reduction was based on the rate ratio obtained from the ODEYSSEY outcomes study. Model inputs were retrieved from literature and validated by key-experts through face-to-face interviews.

RESULTS: The BI analysis demonstrated that the “with PCSK9i” scenario resulted in an increase of 6.1% (SAR 91.16 million) in the budget of Hypercholesterolemia management compared to the “without PCSK9i” scenario. The overall increase was partially offset by SAR 13.5 million reduction in CV events from 0.3% (year 1) to 1.5% (year 5).

CONCLUSIONS: Introducing PCSK9i as an add-on therapy for the management of CHD patients with uncontrolled LDL-C would reduce CV events and could likely be associated with a steady increase in the MoH budget in KSA triggering restriction to certain patient pool and innovative entry agreement.