Life expectancy in the United States has improved substantially over the past 30 years. A recent study found that this improvement has arisen nearly equally from public health measures and advances in medical care, including pharmaceutical and other treatments.1 In this study, reductions in mortality associated with ischemic heart disease and stroke accounted for two-thirds of the overall 3.3-year gain in life expectancy in the US from 1990 through 2015. More than half of these changes in cardiovascular mortality were attributed to pharmaceutical treatments, particularly increased use of effective cholesterol-lowering statins and antihypertensive drugs over this 25-year period.
A new study2 in JAMA Cardiology provides a focused assessment of more recent changes in the use and costs of cholesterol-lowering drugs among Medicare beneficiaries enrolled in Part D prescription drug coverage. Sumarsono and colleagues2 analyzed Medicare Part D claims for generic and brand-name statins, ezetimibe, and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors from 2014 through 2018. As Medicare Part D enrollment grew from 37.7 million to 44.3 million beneficiaries during these years, the number of beneficiaries using cholesterol-lowering drugs rose from 20.5 million (54.3%) to 25.2 million (56.9%), which was largely associated with beneficiaries using statins rising from 19.6 million (52.0%) in 2014 to 24.2 million (54.7%) in 2018.
Over these years, annual Part D spending on statins decreased from $4.8 billion to $2.3 billion, and the annual spending per beneficiary decreased by 61%, from $243 to $95. Most of this reduction in spending resulted from rosuvastatin becoming available in generic form in 2016, with a rapid 97% decrease by 2018 in the use of and spending for the brand-name version and a corresponding increase in use of the generic form. The authors2 estimated that switching all users of brand-name statins to available generic versions could have further reduced Medicare Part D spending by $2.1 billion over the study period.
Since the US Food and Drug Administration (FDA) approved lovastatin in 1987 as the first statin for lowering cholesterol, the use of statins to reduce cardiovascular mortality has steadily grown as many subsequent randomized clinical trials have demonstrated their effectiveness for primary and secondary prevention of adverse cardiovascular outcomes in middle-aged and older adults. More potent cholesterol-lowering statins, including atorvastatin and rosuvastatin, became widely used after FDA approval in 2001 and 2003, respectively.
Four decades after Medicare was created in 1965, the Medicare Part D prescription drug benefit was enacted in 2003 and fully implemented in 2006.3 Prior to this milestone, Medicare beneficiaries with ischemic heart disease who lacked prescription drug coverage were much less likely to be taking cholesterol-lowering drugs than those who had drug coverage through private supplemental insurance or Medicaid.4,5
With the launch of Medicare Part D, the proportion of Medicare beneficiaries with no prescription drug coverage declined from 24% in 2004 to only 7% in 2006, and most who remained without coverage had very low drug spending.6 By 2018, Medicare Part D had grown to cover 72% of all Medicare beneficiaries, with 58% of these enrolled in stand-alone Part D plans and 42% enrolled in Medicare Advantage Part D plans.7 As demonstrated by the findings of Sumarsono et al,2 Medicare Part D has enhanced financial access to highly effective generic statins for millions of Medicare beneficiaries at a relatively modest cost to society.
This study also sheds light on Medicare beneficiaries’ use of PCSK9 inhibitors, the newest class of cholesterol-lowering drugs, which received initial FDA approval in 2015.2 These drugs have been prescribed much less commonly than statins, with only about 62 000 beneficiaries using them in 2018. At an annual cost of $491 million, however, Medicare spending on this new class of drugs was $6283 per beneficiary, profoundly dwarfing the concurrent spending on statins of less than $100 per beneficiary in 2018.
The complex economic issues related to pricing and spending for PCSK9 inhibitors have been discussed in a recent JAMA Health Forum commentary.8 In response to the slow uptake of these drugs and cost-effectiveness studies challenging their high prices, pharmaceutical manufacturers reduced the prices of these agents by up to 60% in 2019. Future studies of Part D data can assess the outcomes of these pricing changes on the use of PCSK9 inhibitors by Medicare beneficiaries and the spending for them by the Medicare program and its beneficiaries.
The ultimate value of spending on cholesterol-lowering drugs hinges on their being prescribed to individuals appropriately assessed as being at increased risk for cardiovascular morbidity and mortality and those individuals being able to afford them.9 The Medicare Part D benefit has clearly helped many beneficiaries gain these benefits from statins. It remains to be determined whether similar value will be achieved for the more select group of Medicare Part D beneficiaries who could benefit from PCSK9 inhibitors.
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Ayanian JZ. The Value of Medicare Part D Drug Coverage to Curb Cardiovascular Disease. JAMA Health Forum. 2020;1(9):e201195. doi:10.1001/jamahealthforum.2020.1195