Journal of Bioequivalence & Bioavailability

Economic implications of adopting high cost breakthrough technologies- PCSK9 inhibitors as a case study

2^nd International Conference & Expo on Biopharmaceutics and Biologic Drugs

September 14-16, 2016 San Antonio, USA

Ronen Arbel

Sapir College and Ben-Gurion University of the Negev, Israel

Posters & Accepted Abstracts: J Bioequiv Availab

Abstract:

The proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have shown a significant benefit in reducing the levels of low-density lipoprotein cholesterol and early evidence of improving patient outcomes by reducing the rate of major adverse cardiovascular events (MACE) compared to standard statin therapy. Based on these trials, the FDA approved two PCSK9i drugs for the treatment of hyperlipidemia. PCSK9i present an extraordinary challenge for healthcare payers. This is the first major case in which a specialty biologic drug is approved for a relatively common condition. The entire intended population for use according to the approved FDA indications is estimated at more than 9.3 million patients in the US. The annual budget needed to treat this population would be more than $130 billion. Performing a traditional cost-effectiveness analysis (CEA) using the current limited data is challenging and requires modeling and many assumptions. We therefore built a unique model with straightforward economic implications, based on the limited available data at present. The cost of preventing any one MACE would be $2,004,918 and the cost of preventing one death would be $8,777,518. These figures are one hundred fold higher than the cost of curing one Hepatitis C (HPC) patient with novel HPC drugs (~$84,000). If upcoming outcome trials will demonstrate similar rates of MACE prevention, it seems that at current prices, using these drugs to improve cardiovascular outcomes would not be affordable for many healthcare systems. The model developed could be relevant to any high cost breakthrough Technologies.

Biography :

Email: ronen.arbel@gmail.com