Prescription Drug Costs: Trends and Tradeoffs in the Pipeline from Lab to Market

Innovative drugs have brought about significant progress in treating costly and complex conditions. While there is agreement among many stakeholders that some of these breakthrough drugs have had a positive impact on Americans’ health and life expectancy, increasing prices have also caused some confusion about the methods by which drug prices are determined. The goal of this briefing was to discuss recent prescription drug price trends, as well as demystify the pricing process. It identified contributors to the rising prices of many drugs, including shareholder interests and R&D costs, in addition to explaining possible future pricing-related challenges for manufacturers, providers, and consumers.

Biosimilars Toolkit: Unpacking Complex Issues

The Alliance for Health Reform has released a new toolkit, “Biosimilars: Unpacking Complex Issues.” The Affordable Care Act created an expedited licensure pathway for biosimilars, and, in March 2015, the U.S. approved the first biosimilar, leaving policy makers, regulators, providers and stakeholders to grapple with regulatory and financial questions.

Biosimilars in the U.S.: Current & Emerging Issues

With Congress focused intently on the discovery, development, and delivery pipeline for innovative drugs and devices – and in the wake of the first-ever U.S. approval of a biosimilar medication– key policy and regulatory questions are being actively debated, with important implications for industry, patients, and the health care system

21st Century Cures: Can Congress Come Together?

Join us for a special breakfast for reporters, where former FDA Commissioner Andrew von Eschenbach will give you the latest on the fast-moving 21st Century Cures legislation. Karen Riley, deputy director of strategy at the FDA’s Office of External Affairs, will also be available to answer questions. The briefing comes just a week after the House Energy and Commerce Committee unveiled bipartisan draft legislation. The committee may begin voting on the measure as early as next week.

21st Century Cancer Care: Will New Models Lead to Better Care at Lower Cost?

The United States spends more than $125 billion annually on cancer care. By 2022, there will be 18 million people with cancer and by 2030 cancer incidence is expected to rise by 2.3 million new cases per year. The high cost of cancer drugs and the “buy and bill” model of paying for them under Medicare have received significant attention. But other factors, such as highly-variable practice patterns and a lack of meaningful engagement of patients in care decisions, have also been called into question.

Prescription Opioid Abuse: Fighting Back on Many Fronts

According to the Centers for Disease Control and Prevention (CDC), drug overdose is the leading cause of injury death in the United States. In 2010, opioid pain relievers accounted for approximately 17,000 of overdose deaths— more than twice the number of deaths from cocaine and heroin combined. Despite the tremendous importance of prescription drugs in treating pain, some medications have a high risk of being misused or abused. Some researchers have voiced concerns that prescription painkillers could even be a gateway drug for heroin users. With the steady rise in prescription rates and drug overdose deaths, policymakers are coming to a consensus that this national problem must be addressed.

Pharmaceutical Policy and Pricing: Are Other Countries Getting Greater Value?

Spending on prescription drugs in the U.S. rose at a faster clip in 2009 than spending for hospital and physician care, a trend that is expected to continue through 2020. By some estimates, prescription drugs account for 15 cents of every health care dollar spent. Thus, federal and state budget cutters – as well as private health plans and hospitals – have a keen interest in restraining drug costs.

Comparative Effectiveness: Can We Get Better Health Value for the Dollars We Spend?

Comparative effectiveness research holds out the tantalizing prospect of making it easier for patients and their doctors to choose the best treatment, thus improving quality. At the same time, it could also justify denying or reducing payment for a host of treatments or procedures that may be clinically ineffective or unworthy of their high price.

Medicare Part D: What Now, What Next?

Close to 24 million Medicare beneficiaries enrolled in Part D coverage for prescription drugs in the first two enrollment cycles. According to the Centers for Medicare and Medicaid Services (CMS), more than 75 percent of beneficiaries are satisfied with the program. However, evidence suggests that seniors who were uncovered in 2005 benefited more than other enrollees in 2006. HHS has announced that more than 90 percent of Medicare beneficiaries in a stand-alone prescription drug plan will have access to at least one plan with a lower premium in 2008[1]; and the third open enrollment period is now upon us – November 15 through December 31, 2007.

Medicare 101: What You Really Need to Know

Medicare covers nearly 44 million beneficiaries who are elderly, including 37 million seniors and 7 million younger adults with permanent disabilities, and end stage renal disease. The program cost the federal government approximately $375 billion in 2006, accounting for 13 percent of federal spending. Why is Medicare important for congressional staffers to know about?

Health Legislation 2007-2008: What’s Possible?

Suddenly, Capitol Hill is talking about health issues again. Incoming House Speaker Nancy Pelosi promises that Democrats will roll back the prohibition against the federal government negotiating drug prices on behalf of Medicare beneficiaries. (A Kaiser Family Foundation poll released today found broad bipartisan support for this idea.) Incoming Senate Majority Leader Harry Reid says one of his three top priorities will be more funding for stem cell research. Others want to revisit the importation of prescription drugs from Canada. Additionally, the 110th Congress will consider whether to continue the State Children’s Health Insurance Program in its present form.

Prospects for Health Care: Where Will New Congressional Leadership Take Us?

Come January, we can expect to see some new approaches to health legislation. Sen. Harry Reid, incoming Senate majority leader, says one of his top three priorities will be more funding for stem cell research. House Speaker-to-be Nancy Pelosi wants a vote early on to roll back the prohibition against the federal government negotiating prescription drug prices for Medicare beneficiaries. And these are just two of the health issues likely to be debated in the new Congress. The White House too will have a definite voice in the debates to come.

Balancing the Promise and Cost of Biotechnology

Biotechnology accounts for only one percent of insurers’ costs, but those costs are growing at a double digit rate. As science produces increasingly sophisticated and expensive medical products and procedures based on the manipulation of living organisms, payers will increasingly struggle with managing their use.

Reviewing Prescription Drug Coverage: Policies and Practices Across Several Health Systems

The Medicare prescription drug program offers coverage for prescription drugs through competing private plans, within a framework established by law and through rules established by the Centers for Medicare and Medicaid Services. In contrast, other countries, including Australia, the UK, and Canada, provide similar prescription drug programs, but within different regulatory structures.

Helping the Medicare Savings Programs Get Savings to Seniors

The Medicare Savings Programs provide assistance with premiums — and in some instances, cost sharing requirements — to Medicare beneficiaries of limited income and resources who do not qualify for full Medicaid benefits. Medicare Part B premiums currently amount to over $1,000 annually — which can be a large sum for some beneficiaries.

Making Sense of Medicare’s Drug Benefit: Information and Resources to Help Beneficiaries

Medicare now covers nearly 42 million beneficiaries who are elderly, or who have a severe disability or end stage renal disease. The Medicare Modernization Act of 2003 made many changes to the program – including the addition of an outpatient prescription drug benefit (“Part D”), which will become effective in January 2006. Understanding this new benefit is of paramount importance to the many people who advise senior citizens, and to millions of Medicare beneficaries who will be scrutinizing different prescription drug plans available in their area.

Implementing the Medicare Drug Benefit: The Stories Ahead

Medicare now covers nearly 42 million beneficiaries who are elderly, or who have a severe disability or end stage renal disease. The Medicare Modernization Act of 2003 made many changes to the program – including the addition of an outpatient prescription drug benefit (“Part D”), which will become effective in January 2006. Understanding this new benefit is of paramount importance to the many people who advise senior citizens, and to millions of Medicare beneficaries who will be scrutinizing different prescription drug plans available in their area.

Weighing the Evidence: Conducting Reviews of Pharmaceuticals in Four Countries

A worldwide discussion is under way on the role of evidence-based medicine in evaluating the relative effectiveness of prescription drugs. Publicly funded health programs, large employers and managed care plans all are working to learn more about how the costs and benefits of one drug compare with those of another. At the same time, these payers of health care want to make sure that their beneficiaries have access to new pharmaceuticals that offer measurable improvements over older products.