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Anupam B. Jena, MD, PhD; Daniel M. Blumenthal, MD, MBA; Warren Stevens, PhD; Jacquelyn W. Chou, MPP, MPL; Thanh G.N. Ton, PhD; and Dana P. Goldman, PhD
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Value of Improved Lipid Control in Patients at High Risk for Adverse Cardiac Events

Anupam B. Jena, MD, PhD; Daniel M. Blumenthal, MD, MBA; Warren Stevens, PhD; Jacquelyn W. Chou, MPP, MPL; Thanh G.N. Ton, PhD; and Dana P. Goldman, PhD
Reducing lipid levels in high-risk patients can significantly reduce disease burden and, depending on final negotiated prices, PCSK9 inhibitors can make an economic contribution to this goal.
Fourth, we did not account for growing efforts to prescribe high-intensity statins, which may increase the proportion of high-risk patients who achieve target LDL-C goals, potentially reducing demand for PCSK9 inhibitors. Indeed, as of 2009, more than 70% of patients with indications for high-intensity statins—including patients hospitalized for acute coronary syndrome—did not receive statin prescriptions.10,38

Finally, while we defined an LDL-C goal of ≤70 mg/dL, current cholesterol treatment guidelines do not recommend treating to a specific LDL-C goal because some have argued that the data to support this practice is not sufficiently robust.3 However, existing evidence indicates that statins reduce MACEs when the baseline LDL-C level is >70 mg/dL.3 Moreover, in many countries, ≤70 mg/dL remains an important LDL-C treatment goal for high-risk patients.39 Nonetheless, our definition of the PCSK9 inhibitor–eligible population as all high-risk patients with LDL-C >70 mg/dL could have led us to overestimate the size of the patient population that stands to benefit from these drugs.

CONCLUSIONS
The population burden of CVD continues to grow despite improvements in CVD treatment. Among those at high risk for CVD who do not achieve sufficient LDL-C reduction despite LLT, we estimated substantial economic value associated with reducing the burden of hyperlipidemia by the ACC/AHA goal of 50%. Moreover, although at an early stage, early clinical studies suggest that PCSK9 inhibitors may substantially reduce MACEs and CVD-related deaths. Although our estimates suggest that these drugs may generate significant value for society, PCSK9 inhibitors’ net impact will depend on the final costs of these therapies and on pending results of trials evaluating their clinical outcomes. The number of individuals initially prescribed PCSK9 inhibitors is likely to be significantly lower than that suggested by previous estimates.

Acknowledgments

Support for this research was provided by Amgen. Administrative and editorial support was provided by Alison Silverstein, MPH. 

Author Affiliations: Harvard Medical School (ABJ and DMB), Boston, MA; Massachusetts General Hospital (ABJ and DMB), Boston, MA; Precision Health Economics (WS, TGNT, JWC), Oakland, CA; University of Southern California (DPG), Los Angeles, CA.

Source of Funding: Funding for this research was provided by Amgen, Thousand Oaks, CA.

Author Disclosures: Dr Goldman is founder and Ms Chou, Drs Stevens, and Ton are employees at Precision Health Economics (PHE), a company providing consulting services to the life-sciences industry. Drs Jena, and Blumenthal have received consulting fees from PHE, which received funding from Amgen for this work.

Authorship Information: Concept and design (ABJ, WS, DPG); acquisition of data (ABJ, WS, TGNT, JWC, DPG); analysis and interpretation of data (ABJ, DMB, WS, TGNT, JWC); drafting of the manuscript (ABJ, DMB, WS, TGNT, JWC); critical revision of the manuscript for important intellectual content (ABJ, DMB, TGNT, JWC); statistical analysis (ABJ, TGNT); obtaining funding (DPG); administrative, technical, or logistic support (JWC); and supervision (ABJ, WS, DPG).

Address correspondence to: Anupam B. Jena, MD, PhD, Harvard Medical School, Department of Health Care Policy, 180 Longwood Ave, Boston, MA 02115-5899. E-mail: Jena@hcp.med.harvard.edu.
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