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Published on: November 17, 2018
Outcomes, Access, and Cost Issues Involving PCSK9 Inhibitors to Lower LDL-Cholesterol
1Gill Heart and Vascular Institute, University of Kentucky, 326 Wethington Building, 900 South Limestone Street, Lexington, KY, 40536-0200, USA. twhayn0@uky.edu.
Insights
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors offer significant cardiovascular benefits for high-risk patients. Cost remains the primary barrier to their widespread clinical use, not efficacy.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
Background:
- Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are crucial for high-risk cardiovascular patients.
- They are particularly beneficial for statin-intolerant individuals or those not reaching low-density lipoprotein cholesterol (LDL-C) goals.
Purpose of the Study:
- To evaluate the established clinical importance and benefits of PCSK9 inhibitors in high-risk cardiovascular patients.
- To identify the primary barriers to the appropriate clinical utilization of PCSK9 inhibitors.
Main Methods:
- Review of clinical evidence supporting PCSK9 inhibitor efficacy.
- Analysis of factors hindering patient access and approval processes.
Main Results:
- The clinical benefit and LDL-C lowering effects of PCSK9 inhibitors are well-documented.
- Cost is identified as the principal obstacle to appropriate clinical use, overshadowing efficacy concerns.
Conclusions:
- The efficacy of PCSK9 inhibitors for high-risk cardiovascular patients is established.
- Addressing cost and regulatory roadblocks is essential to improve patient access to these vital therapies.
Abstract:
The clinical importance and benefit of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors appears well established for the high-risk cardiovascular (CV) patient. This applies especially to the statin-intolerant patient or the patient who does not attain an appropriate low-density lipoprotein cholesterol (LDL-C) target. Therefore, the barriers to appropriate clinical use of the PCSK9 inhibitors involve cost and not the documented CV benefit or LDL-C lowering. Multiple roadblocks affect many high-risk CV patients in arranging approval of a PCSK9 inhibitor. Overcoming these roadblocks may require legal pressures, some increased regulation, and facilitation by competitive forces.
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