Making Medicines Affordable


Book Description

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.







Rare Diseases and Orphan Products


Book Description

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.




Closing the Medicare Part D Coverage Gap


Book Description

The standard Medicare Part D benefit structure contains a gap in coverage (or so-called "doughnut hole") which requires beneficiaries to pay 100% of the cost for prescription drugs until they reach the catastrophic coverage phase. This coverage gap has been linked to a financial burden for beneficiaries resulting in poor medication adherence and other cost-related access problems. Under the 2010 Affordable Care Act (ACA) reform, the coverage gap has been gradually phasing out since 2011 such that beneficiaries will only pay 25% of drug costs by 2020. This study evaluated the impact of closing the coverage gap under the ACA by conducting three separate studies using data from the 2008-2015 Medicare Current Beneficiary Survey. Outcomes assessed included the utilization of and expenditures for prescription drugs, as well as cost-related access problems. Chapter 3 (Manuscript #1) analyzes trends in the distribution of beneficiaries in each benefit phase, prescription drug utilization, and expenditures among Part D beneficiaries not receiving the Low-Income Subsidy (LIS). After the ACA, the proportion of beneficiaries reaching the catastrophic coverage threshold increased (from 4% in 2010 to 6% in 2015), and they reached the threshold earlier in the year. The overall number of 30-day drug fills also increased after the ACA, although no significant changes in the number of 30-day drug fills were seen among those reaching the catastrophic coverage threshold. Total drug spending steadily increased after the ACA, with the largest increase seen in those reaching the catastrophic threshold; however, out-of-pocket spending significantly decreased among all beneficiaries (17% decrease in 2015 compared to 2009). Chapter 4 (Manuscript #2) evaluates the effects of the ACA coverage gap reform on drug utilization and expenditures using a difference-in-differences study design. Over the first five years after implementation of the ACA, out-of-pocket drug spending significantly decreased among non-LIS beneficiaries (treatment) relative to LIS beneficiaries (control), with growing decreases over time (average decreases of $41 in 2011 versus $135 in 2015). This was particularly noticeable among those who reached the coverage gap but not the catastrophic threshold. Despite seemingly large reductions in cost-sharing in the coverage gap, there were no significant changes in the number of 30-day drug fills and total drug spending after the ACA reform between non-LIS and LIS beneficiaries. Chapter 5 (Manuscript #3) evaluates the effects of the ACA coverage gap reform on cost-related access problems among beneficiaries using a difference-in-differences study design. Cost-related access problems were estimated by the likelihood of having cost-related nonadherence (CRN) or the adoption of drug cost-reduction strategies (CRS) by beneficiaries. Compared to LIS beneficiaries, no significant changes in CRN were seen among non-LIS beneficiaries after the ACA; furthermore, the likelihood of adopting CRS increased by 4 percentage points for non-LIS beneficiaries relative to LIS beneficiaries. Although the ACA reform has helped reduce out-of-pocket drug costs for beneficiaries by gradually reducing the beneficiary cost-sharing rate in the Part D coverage gap, the significant reduction in cost-sharing rate did not translate into an increased use of prescription drugs or resolved cost-related access problems for beneficiaries. Additionally, this study provides evidence of increased Part D spending, which has been a growing concern for the Medicare program. The findings of this study provide empirical evidence on the effects of closing the Part D coverage gap and address gaps in the limited existing literature. Overall, although the ACA decreased out-of-pocket drug costs, this study suggests additional initiatives will be needed to provide better protection against the cost of prescription drugs for Part D beneficiaries.







The Role of NIH in Drug Development Innovation and Its Impact on Patient Access


Book Description

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.




Competition and the Cost of Medicare's Prescription Drug Program


Book Description

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the Medicare Modernization Act, or MMA) substantially expanded the federal Medicare program by creating the prescription drug benefit known as Part D. In FY 2013, Medicare Part D covered 39 million people. The federal government spent $59 billion net of premiums on Part D in that year; after accounting for certain payments from states under the program, the net federal cost was $50 billion, which represented 10% of net federal spending for Medicare. A combination of broader trends in the prescription drug market and lower-than-expected enrollment in Part D has contributed to much lower spending for the program than projected when the MMA became law in 2003. This report examines the federal budgetary cost and competitive design of Medicare Part D and compares Medicare Part D and Medicaid Fee for Service. Figures and tables. This is a print on demand report.