Some of the most rewarding work we are involved in at Axtria right now is in the Health Economics and Outcomes Research (HEOR) space, where we are partnering with our clients to help demonstrate the value of their medications and get them to the patients who need them. Challenges in the healthcare space—including rising costs, an aging population, advanced technology, and increased patient awareness of medical options—have resulted in an increase in evaluating medications from an HEOR perspective. Through our modelling and analytical work, we work with clients and key opinion leaders (KOLs) to identify which patients would benefit from various treatment options and the impact those treatments could have on patient health.
One recent example of this was looking at the impact of a new class of drugs for the lowering of cholesterol and the impact they could have for high-risk patients with atherosclerotic cardiovascular disease (ASCVD). This new class of drugs, proprotein convertase subtilisin/kexintype 9 (PCSK9) inhibitors, is the center of a lot of debate in the cardiovascular world. As there are numerous drugs on the market which lower cholesterol—including oral therapies such as statins (e.g., Lipitor® and Zocor®) and Zetia®—patients, physicians, insurance companies, and pharmaceutical companies are actively discussing which patients could best benefit from PCSK9 inhibitors and the corresponding impact of treatment.
To help aid in these important discussions, Axtria recently collaborated on a study, Simulation of Lipid-Lowering Therapy Intensification in a Population With Atherosclerotic Cardiovascular Disease.
We are very proud to announce that the manuscript of this study has been published in the Journal of the American Medical Association (JAMA) Cardiology. The manuscript can be accessed online here:
http://jamanetwork.com/journals/jamacardiology/fullarticle/2646531?resultClick=1
This manuscript expands upon the analysis presented in the European Society of Cardiology® (ESC) poster, Modeling lipid-lowering therapy intensification in the real world: how many patients with the atherosclerotic cardiovascular disease would need a PCSK9 inhibitor? (http://insights.axtria.com/blog/crucial-analysis-and-insights-for-the-cardiovascular-community).1
As described in the manuscript, the simulation model takes anonymized patient data from the US MarketScan database, randomly samples individual patients, and incrementally treats patients with a combination of cholesterol-lowering therapies based on current guidelines to reduce cholesterol levels below acceptable thresholds. Using this real-world evidence, the simulation model estimates which patients would need different combinations of cholesterol-lowering therapy and what impact this has on their cholesterol.
The manuscript highlights a few key insights to aid in the ongoing discussions regarding which patients would require PCSK9 inhibitor therapy:
In this simulation model study based on a large, representative cohort of 105 269 patients with the atherosclerotic cardiovascular disease, only 53.2% were receiving statins at baseline, and only 25.2% achieved low-density lipoprotein cholesterol levels of less than 70mg/dL. Simulation of maximal lipid-lowering treatment intensification indicated that 99.3% could achieve low-density lipoprotein cholesterol levels of less than 70mg/dL, including 86% receiving statins and ezetimibe and 14% with add-on proprotein convertase subtilisin/kexin type 9 inhibitors. An opportunity exists to improve the achievement of low-density lipoprotein cholesterol goals in the population with the atherosclerotic cardiovascular disease by giving oral-only lipid-lowering treatment, with a modest percentage requiring a proprotein convertase subtilisin/kexin type 9 inhibitor.2
Through this analysis, we can see how most ASCVD patients are not achieving current cholesterol goals and the low proportion of patients on therapy, despite current guidelines. Ultimately, this HEOR analysis can aid in these important conversations around which patients would benefit from various treatment combinations and the impact it should have on patient health.
References:
1. Khan, I et al. Modelling lipid-lowering therapy intensification in the real world: How many patients with atherosclerotic cardiovascular disease would need a PCSK9 inhibitor? Poster presented at: The European Society of Cardiology Congress 2016; August 27-31; Rome, Italy.
2. Cannon CP, Khan I, Klimchak AC, Reynolds MR, Sanchez RJ, Sasiela WJ. Simulation of Lipid-Lowering Therapy Intensification in a Population With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. Published online August 02, 2017. doi:10.1001/jamacardio.2017.2289