Under a standard 2016 Medicare Part D drug benefit, Medicare beneficiaries start each year with a $360 deductible. This is followed by the initial coverage phase, with out-of-pocket costs determined by a plan’s cost-sharing requirements for covered drugs. Once total drug costs reach $3310, beneficiaries enter the coverage gap or “donut hole,” in which they are responsible for greater cost-sharing (45% for brand-name drugs [PCSK9 inhibitors] and 58% for generic drugs [atorvastatin]). If out-of-pocket costs reach $4850, catastrophic coverage takes effect, reducing cost-sharing to 5% for the remainder of the year. We accounted for each of these coverage phases in our projections of PCSK9i cost-sharing. Standard deviations on the estimated mean monthly out-of-pocket costs range from $1 to $8.
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Kazi DS, Lu CY, Lin GA, et al. Nationwide Coverage and Cost-Sharing for PCSK9 Inhibitors Among Medicare Part D Plans. JAMA Cardiol. 2017;2(10):1164–1166. doi:10.1001/jamacardio.2017.3051
Approximately 9 million US adults with atherosclerotic cardiovascular disease or familial hypercholesterolemia do not achieve optimal levels of low-density lipoprotein cholesterol despite maximally tolerated statin therapy.1 Adding a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) may significantly lower low-density lipoprotein cholesterol levels and reduce the risk of myocardial infarction and stroke.2 However, PCSK9is are expensive, with annual costs exceeding $14 500.1 Understanding patients’ share of drug costs is important because high out-of-pocket costs can adversely affect affordability and adherence to lifelong treatment.3 Because 1 in 4 Medicare beneficiaries has ischemic heart disease and nearly 1 in 2 has hyperlipidemia,4 we examined PCSK9i cost-sharing requirements for Medicare Part D plans nationwide, which insure 41 million beneficiaries.5
We analyzed the June 2016 Centers for Medicare and Medicaid Services Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files for all Part D plans except special-needs plans that may have specialized formularies. Files contained drug benefit design data (formularies and copayment requirements) and not patient claims. We examined out-of-pocket cost requirements for PCSK9is (alirocumab and evolocumab) averaged across all plans by counties and states.
We projected annual out-of-pocket costs under a standard 2016 Medicare Part D benefit for beneficiaries receiving a PCSK9i and generic atorvastatin 80 mg but no other drugs. We sequentially included (1) an initial $360 deductible; (2) a coverage phase in which out-of-pocket costs were estimated from mean cost-sharing requirements nationwide for PCSK9is and atorvastatin; (3) a coverage gap (donut hole) once total drug costs reached $3310, with cost-sharing increasing to 45% for brand-name drugs and 58% for generic drugs; and (4) catastrophic coverage when out-of-pocket costs exceeded $4850, reducing cost-sharing to 5% for the remainder of the year.5
The University of Hawaii Office of Research Compliance provided the institutional review board waiver, and patient consent was waived.
We analyzed 2575 Part D plans across 50 states and the District of Columbia. In mid-2016, 88% of plans covered PCSK9is (87% covered alirocumab and 42% covered evolocumab) (Table). Mean (SD) required cost-sharing for a 30-day supply was $336 ($3) for alirocumab, $321 ($8) for evolocumab, and $4 ($1) for atorvastatin. Under a standard 2016 Part D plan, beneficiaries receiving a PCSK9i and atorvastatin would have reached the coverage gap by March (Figure), with projected annual out-of-pocket costs of $4997 for alirocumab/atorvastatin and $4968 for evolucumab/atorvastatin (Table). This represented approximately one-third the annual total costs ($14 330 for alirocumab/atorvastatin and $13 760 for evolocumab/atorvastatin).
Nearly 9 in 10 Medicare Part D plans nationwide cover PCSK9is. However, affordability is of substantial concern: mean cost-sharing requirements exceeded $300 per month, and projected annual out-of-pocket costs approached $5000 under a standard 2016 Part D benefit. Because cost-sharing can reduce adherence even for less expensive statins,3 the effect of these high out-of-pocket costs on adherence and real-world effectiveness warrants examination.
We estimate that beneficiaries would pay one-third of PCSK9i costs under a standard 2016 Part D plan if they filled prescriptions for PCSK9i and atorvastatin and no other medications. Prior efforts to improve drug affordability have been aimed at decreasing the percentage of cost-sharing by beneficiaries.5,6 The Affordable Care Act will reduce cost-sharing for brand-name drugs during the coverage gap to 25% by 2020.5 While this might work for cheaper drugs, the high price of PCSK9i indicates that lower coinsurance rates could still result in thousands of dollars in out-of-pocket costs annually.
We projected annual cost-sharing based only on PCSK9i and atorvastatin use. Actual out-of-pocket costs would reflect a beneficiary’s coverage phase when filling each prescription, which in turn is affected by their non-PCSK9i medication use.
Our findings suggest a need to lower out-of-pocket costs to ensure affordability of PCSK9is for Medicare beneficiaries covered by Part D.
Corresponding Author: Dhruv S. Kazi, MD, MSc, MS, Division of Cardiology at Zuckerberg San Francisco General Hospital, University of California, San Francisco, 1001 Potrero Ave, Room 5G1, San Francisco, CA 94110 (email@example.com).
Accepted for Publication: July 19, 2017.
Published Online: September 13, 2017. doi:10.1001/jamacardio.2017.3051
Author Contributions: Drs Kazi and Tseng had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Kazi, Lu, Dudley, Tseng.
Acquisition, analysis, or interpretation of data: Kazi, Lin, DeJong, Tseng.
Drafting of the manuscript: Kazi, Dudley, Tseng.
Critical revision of the manuscript for important intellectual content: Kazi, Lu, Lin, DeJong, Dudley, Tseng.
Statistical analysis: Tseng.
Obtained funding: Tseng.
Administrative, technical, or material support: Tseng.
Supervision: Kazi, Dudley, Tseng.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This study was funded by grant R03HS016772 from the Agency for Healthcare Research and Quality and the Hawaii Medical Services Association Endowed Chair in Health Services and Quality Research.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: Dr Chien-Wen Tseng is a member of the US Preventive Services Task Force. This article is the original work of its authors and does not represent the position or recommendation of the US Preventive Services Task Force.
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