Patient Characteristics and Treatment Patterns among Medicare Beneficiaries Initiating PCSK9 Inhibitor Therapy

Abstract

Purpose

There is limited real-world evidence around use of proprotein convertase subtilisin-kexin type 9 inhibitors (PCSK9i) among US older adults. This study examined baseline characteristics of fee-for-service (FFS) Medicare beneficiaries newly initiating PCSK9i therapy during the period immediately following market availability.

Methods

This cross-sectional study used Medicare claims (2013–2016) to identify 5051 FFS Medicare beneficiaries who filled ≥ 1 PCSK9i prescription between August 2015 and December 2016. We analyzed patient demographics, clinical characteristics, and baseline healthcare expenditures in the 12-month period prior to PCSK9i initiation, for these beneficiaries.

Results

Most beneficiaries initiating PCSK9i were female (57%), < 75 years of age (61%), white (89%), and lived in metropolitan areas (83%). At baseline, these PCSK9i initiators had 6 chronic conditions on average, with conditions such as hyperlipidemia, hypertension, and ischemic heart disease being most prevalent. Approximately 88% had a diagnosis of atherosclerotic cardiovascular disease (ASCVD), and 14% experienced acute cardiovascular events during the 12-month baseline period. Use of any statin and/or ezetimibe ranged from 54 to 76% in the 6-month and 24-month baseline period. Their total annual Medicare expenditures averaged US$17,552, of which most were attributable to ambulatory care and prescription use, in the 12-month baseline period.

Conclusion

High burden of cardiovascular conditions and prescription expenditures at baseline were common among FFS beneficiaries initiating PCSK9i therapy. These findings suggest that physicians prescribe PCSK9i to elderly patients at high risk for adverse cardiovascular events. Considering the evolving treatment landscape, PCSK9i utilization might increase in Medicare.

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Data Availability

Not available.

References

  1. 1.

    U.S. Food and Drug Administration (FDA). Repatha (evolocumab) injection. 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000TOC.cfm. Accessed 15 Jun 2019.

  2. 2.

    FDA. Praluent Alirocumab. 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125559Orig1s000TOC.cfm. Accessed 15 Jun 2019.

  3. 3.

    FDA. Highlights of prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s014lbl.pdf. Accessed 15 Jun 2019.

  4. 4.

    FDA. Highlights of prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf. Accessed 15 Jun 2019.

  5. 5.

    Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73:e285–350.

    Article  PubMed  Google Scholar 

  6. 6.

    Rane PB, Patel J, Harrison DJ, Shepherd J, Leith A, Bailey H, et al. Patient characteristics and real-world treatment patterns among early users of PCSK9 inhibitors. Am J Cardiovasc Drugs. 2018;18:103–8.

    Article  PubMed  Google Scholar 

  7. 7.

    Fairman KA, Davis LE, Sclar DA. Real-world use of PCSK-9 inhibitors by early adopters: cardiovascular risk factors, statin co-treatment, and short-term adherence in routine clinical practice. Ther Clin Risk Manag. 2017;13:957–65.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  8. 8.

    Hines DM, Rane P, Patel J, Harrison DJ, Wade RL. Treatment patterns and patient characteristics among early initiators of PCSK9 inhibitors. Vasc Health Risk Manag. 2018;14:409–18.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  9. 9.

    Karalis DG, Mallya UG, Ghannam AF, Elassal J, Gupta R, Boklage SH. Prescribing patterns of proprotein convertase subtilisin-kexin type 9 inhibitors in eligible patients with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia. Am J Cardiol. 2018;121:1155–61.

    CAS  Article  PubMed  Google Scholar 

  10. 10.

    Centers for Medicare & Medicaid Services. CCW chronic Conditions. 2019. https://www2.ccwdata.org/web/guest/condition-categories. Accessed 17 Oct 2019.

  11. 11.

    Lassman D, Sisko AM, Catlin A, Barron MC, Benson J, Cuckler GA, et al. Health spending by state 1991–2014: measuring per capita spending by payers and programs. Health Aff. 2017;36:1318–27.

    Article  Google Scholar 

  12. 12.

    Thorpe CT, Thorpe JM, Jiang T, Atkinson D, Kang Y, Schleiden LJ, et al. Healthcare utilization and expenditures for United States Medicare beneficiaries with systemic vasculitis. Semin Arthritis Rheum. 2018;47:507–19.

    Article  PubMed  Google Scholar 

  13. 13.

    Feng X, Higa GM, Safarudin F, Sambamoorthi U, Tan X. Potentially inappropriate medication use and associated healthcare utilization and costs among older adults with colorectal, breast, and prostate cancers. J Geriatr Oncol. 2019;10:698–704.

    Article  PubMed  Google Scholar 

  14. 14.

    Nasir K, Angraal S, Virani SS. PCSK9 inhibitors prior authorization: redundant process due for a redesign. Circ Cardiovasc Qual Outcomes. 2019;12:e005910.

    Article  PubMed  Google Scholar 

  15. 15.

    Myers KD, Farboodi N, Mwamburi M, Howard W, Staszak D, Gidding S, et al. Effect of access to prescribed PCSK9 inhibitors on cardiovascular outcomes. Circ Cardiovasc Qual Outcomes. 2019;12:e005404.

    Article  PubMed  Google Scholar 

  16. 16.

    Hess GP, Natarajan P, Faridi KF, Fievitz A, Valsdottir L, Yeh RW. PCSK9 inhibitor therapy: payer approvals and rejections, and patient characteristics for successful prescribing. Circulation. 2017;136:2210–9.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  17. 17.

    Kazi DS, Penko J, Ollendorf DA, Coxson PG, Bibbins-Domingo K. Effect of money-back guarantees on the cost-effectiveness of proprotein convertase subtilisin/kexin type 9 inhibitors. Ann Intern Med. 2018;168:896–8.

    Article  PubMed  Google Scholar 

  18. 18.

    Kazi DS, Moran AE, Coxson PG, Penko J, Ollendorf DA, Pearson SD, et al. Cost-effectiveness of PCSK9 inhibitor therapy in patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease. JAMA. 2016;316:743–53.

    CAS  Article  PubMed  Google Scholar 

  19. 19.

    Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, et al. Cost-effectiveness of evolocumab therapy for reducing cardiovascular events in patients with atherosclerotic cardiovascular disease. JAMA Cardiol. 2017;2:1069–78.

    Article  PubMed  PubMed Central  Google Scholar 

  20. 20.

    Arrieta A, Hong JC, Khera R, Virani SS, Krumholz HM, Nasir K. Updated cost-effectiveness assessments of PCSK9 inhibitors from the perspectives of the health system and private payers: insights derived from the FOURIER trial. JAMA Cardiol. 2017;2:1369–74.

    Article  PubMed  PubMed Central  Google Scholar 

  21. 21.

    Kazi DS, Penko J, Coxson PG, Moran AE, Ollendorf DA, Tice JA, et al. Updated cost-effectiveness analysis of PCSK9 inhibitors based on the results of the FOURIER trial. JAMA. 2017;318:748–50.

    Article  PubMed  PubMed Central  Google Scholar 

  22. 22.

    Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated cost-effectiveness analysis of evolocumab in patients with very high-risk atherosclerotic cardiovascular disease. JAMA Cardiol. 2019;4:691–5.

    Article  PubMed  PubMed Central  Google Scholar 

  23. 23.

    Kazi DS, Penko J, Coxson PG, Guzman D, Wei PC, Bibbins-Domingo K. Cost-effectiveness of alirocumab: a just-in-time analysis based on the Odyssey outcomes trial. Ann Intern Med. 2019;170:221–19.

    Article  PubMed  Google Scholar 

  24. 24.

    Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;378:1713–22.

    Article  Google Scholar 

  25. 25.

    Koren MJ, Sabatine MS, Giugliano RP, Langslet G, Wiviott SD, Ruzza A, et al. Final report of the OSLER-1 study: long-term evolocumab for the treatment of hypercholesterolemia. Circulation. 2018;138:A14154.

    Google Scholar 

  26. 26.

    Harvey PD, Sabbagh MN, Harrison JE, Ginsberg HN, Chapman MJ, Manvelian G, et al. No evidence of neurocognitive adverse events associated with alirocumab treatment in 3340 patients from 14 randomized phase 2 and 3 controlled trials: a meta-analysis of individual patient data. Eur Heart J. 2017;39:374–81.

    Article  PubMed Central  Google Scholar 

  27. 27.

    Amgen. Amgen Makes Repatha® (Evolocumab) Available in the US at a 60 Percent Reduced List Price. 2018. https://www.amgen.com/media/news-releases/2018/10/amgen-makes-repatha-evolocumab-available-in-the-us-at-a-60-percent-reduced-list-price/. Accessed 29 Aug 2019.

  28. 28.

    Regeneron. Regeneron and Sanofi Offer Praluent® (Alirocumab) at a New Reduced U.S. List Price. 2019. https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-offer-praluentr-alirocumab-new-reduced-us. Accessed 29 Aug 2019.

  29. 29.

    National Lipid Association. National Lipid Association Statement Paper Provides Clinicians with Updated Guidance for Enhanced Value of PCSK9 Use in Select Patient Population. 2019. https://www.lipid.org/sites/default/files/files/pcsk9press.pdf. Accessed 29 Aug 2019.

  30. 30.

    Robinson JG, Jayanna MB, Brown AS, Aspry K, Orringer C, Gill EA, et al. Enhancing the value of PCSK9 monoclonal antibodies by identifying patients most likely to benefit. J Clin Lipidol. 2019;13:525–37.

    Article  PubMed  Google Scholar 

  31. 31.

    Choudhry NK, Shrank WH. Four dollar generics – increased accessibility, impaired quality assurance. N Engl J Med. 2010;363:1885–7.

    CAS  Article  PubMed  Google Scholar 

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Funding

Funding for this research was provided by Amgen Inc. to Tufts Medical Center.

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Correspondence to Xue Feng.

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Authors XF, FB, and PJL report no conflict of interest. Authors PBR and MH are employees of Amgen Inc. and own Amgen stock options.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Appendix

Appendix

Table 4 Statin intensity

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Feng, X., Berklein, F., Rane, P.B. et al. Patient Characteristics and Treatment Patterns among Medicare Beneficiaries Initiating PCSK9 Inhibitor Therapy. Cardiovasc Drugs Ther (2020). https://doi.org/10.1007/s10557-020-07028-3

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Keywords

  • PCSK9i
  • LDL-C
  • Medicare beneficiaries
  • Lipid-lowering therapy
  • ASCVD