There are numerous drugs on the market to lower cholesterol and ultimately reduce cardiovascular risk. Drugs in the statin class, like Lipitor® and Zocor®, are generally effective and economical since many of them are generic. While statins help many patients reduce their cholesterol, there are individuals who experience side effects that prevent them from taking statins altogether or at a high-enough dose1.
Proprotein convertase subtilisin/kexintype 9 inhibitors (PCSK9is) are a new class of cholesterol-lowering drugs that are causing a lot of debate in the cardiovascular world. PCSK9is are effective and suitable for patients who cannot tolerate statins or need additional cholesterol-reduction beyond statins2. PCSK9is are very expensive for many reasons, such as they are intended for a small target group of patients, they are an injectable form of medicine, and there was a great deal of R&D needed to bring them to market. Since they are costly, insurance companies are imposing numerous restrictions on which patients can receive PCSK9is. As a result, many patients, cardiologists, insurance companies, and pharmaceutical companies are wondering which patients actually require PCSK9is for additional cholesterol reduction.
A poster presented at the European Society of Cardiology® (ESC) used a simulation model to estimate how many patients with a history of cardiovascular disease may require PCSK9is3. (The poster can be accessed at the MyESC website.) The simulation model randomly samples individual patients with cardiovascular disease from the US MarketScan database. It then incrementally treats patients with a combination of statins and PCSK9is, mimicking how a cardiologist may treat the patient to get them to an acceptable cholesterol level. Using this real-world evidence, the simulation model predicts which patients would need different combinations of statins and PCSK9is and what impact this has on their cholesterol.
As shown in the poster, the simulation model estimated that only 14% of patients would require PCSK9is in addition to statins. The majority of the patients (the remaining 86%) would not require PCSK9is in order to achieve an acceptable cholesterol level. Even with a small proportion of patients requiring PCSK9is, the vast majority of the patients with cardiovascular disease should be able to achieve an acceptable level of cholesterol. This demonstrates the benefits of leveraging a strategic combination of cholesterol-lowering drugs to help patients achieve their health goals.
Lowering cholesterol has been shown to reduce cardiovascular events like heart attacks and strokes4. While the poster focused only on reducing cholesterol to physician-recommended levels, additional analysis is being performed to determine what impact this has on the risk for these patients with cardiovascular disease. By giving PCSK9is to patients who truly need them, those patients should be able to achieve a greater reduction in risk than would have been possible without PCSK9is.
While reducing cholesterol (and presumably reducing cardiovascular risk) has an obvious benefit for patients, it also has a benefit for insurance companies. When patients avoid cardiovascular events, they are also able to avoid the costs associated with those events. Thus, even though PCSK9is are very expensive, they may be valuable and economical for the select group of patients who actually require them (although additional analysis would need to be performed to determine this).
The analysis in the poster suggests that if insurance companies can better identify the 14% of patients who should get PCSK9is, they can control the costs associated with the expensive medication while ensuring the appropriate patients can get access to PCSK9is to further reduce their cholesterol5. While the cardiovascular community is actively discussing which patients could benefit from PCSK9is and what impact it will have on the market, this poster helps provide some crucial analysis. The poster by Khan, Canon et al won a Moderated Poster Award in its topic at this year’s ESC conference. The poster received this recognition because it is helping to identify the patients who truly need PCSK9is and therefore improve patient health.
Click here to access the poster.
1.Statin side effects: Weight the beenefits and risks. Mayo Clinic.http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statin-side-effects/art-20046013. Accessed September 8, 2016.
2.FDA approves Praluent to treat certain patients with high cholesterol. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm. Accessed September 8, 2016.
3.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.
4.Cholesterol Treatment Trialists. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. The Lancet. 2012 Aug 17;380(9841):581-90.
5.Susman, E. ESC: Study touts PCSK9 tx add-on to reach lower LDL target. http://www.medpagetoday.com/MeetingCoverage/ESC/59971. Accessed September 8, 2016.