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Exhibit of the Month: Improving Pharmaceutical Innovation


February 27th, 2015

Editor’s note: This post is part of an ongoing “Exhibit of the Monthseries. Readers who’d like to highlight other noteworthy exhibits from the same issue are encouraged to make their pitch in the comments section below.

This month’s exhibits, published in the February issue of Health Affairs, illustrate annual new drug approvals by the Food and Drug Administration (FDA), industry spending on research and development, and more specifically, the number of drugs approved per $1 billion spent on research and development.

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In Regulating E-Cigarettes, No Easy Fix For The FDA


February 20th, 2015

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

It is a victory that was made possible, in large measure, by a constellation of state and federal regulatory interventions: laws regulating the marketing and sale of cigarettes, barring sales to youth, banning indoor smoking, and taxing cigarette sales have all played a role in reducing rates of smoking.

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The Need For Publicly Funded Trials To Get Unbiased Comparative Effectiveness Data


February 20th, 2015

Comparative effectiveness research was one of the hotly debated components of the Affordable Care Act. The pharmaceutical industry is marketing driven, with pharmaceutical companies spending more on marketing than they do on research and development. The need for a marketing edge can also drive drug development.

As illustrated by the discussion below of Gazyva and Nexium, drugs can be developed at higher doses than the drugs they are intended to replace. When the newer, higher-dose drugs are tested against the older, lower-dose drugs, the trials are intended to show that the newer, higher dose drugs are superior to the older drugs that will soon be available as a biosimilar or generic.

It can be very difficult to tell whether the results of such trials reflect the differences between the active ingredients or simply the difference in doses, but such trials are almost certain to lead to increased use of the newer, higher-priced drugs. Because the money at stake creates such an incentive for companies to stack the deck, publicly funded trials are the only way to make sure that evidence-based medicine is based on the best possible evidence.

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An Era Of Precision Medicine And Rapid Learning


February 20th, 2015

At a recent White House event, President Obama presented his proposals for a Precision Medicine Initiative. The key elements include a national research system where 1 million or more volunteers can share their (privacy protected) electronic health records, genetics, and other data, and a national cancer initiative. The proposals will be developed in more detail based on meetings led by the National Institutes of Health (NIH) Director Francis Collins.

If national health policy adopts these proposals, much about today’s medical care system—including biomedical science, medical education, diagnostics, treatment options, comparative effectiveness research, quality metrics, payment systems, the role of patients, the personalization of medical care and prevention, and an understanding of the roles of environment, nutrition, culture, and many other factors—may greatly change.

The Obama administration proposes a highly collaborative, non-partisan public-private process. These proposals bring the era of “big data” to the center of the heath policy arena (see the July 2014 Health Affairs theme issue, “Using Big Data To Transform Care”). Many in the health system may want to take part in developing the proposals and being part of the implementation.

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How Open Data Can Reveal—And Correct—The Faults In Our Health System


February 18th, 2015

In April 2014, the Centers for Medicare and Medicaid (CMS) released millions of lines of Medicare Part B physician payment data, that led many researchers, analysts, journalists, and the general public to use the data to answer a number of pressing health care questions. And while the dataset does not include patient-level information, it does offer provider identifiers, which can facilitate data aggregation, highlight practice patterns, and cost trends (i.e. specialties with disproportionately higher payments and individual providers as “outliers”).

Our goal here, like many before us, is to highlight striking disparities in this dataset (despite its limitations); attempt to understand why they occur; and provide opportunities to address them.We examine three major issues: geographic variation; individual provider variation; and variation across care settings. Finally, we outline recommendations for future data releases to encourage more practical analyses.

Geographic Variation in Practice Patterns

A popular example highlighted by the CMS data was the rate of use of Lucentis — a drug prescribed for patients with age-related macular degeneration (AMD). Although a clinical study demonstrated similar outcomes for Lucentis ($2,000 per dose) versus Avastin ($50 per dose), the CMS data revealed total Lucentis spending of $1 billion.

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Health Affairs Web First: Recent US Hospital Productivity Growth


February 11th, 2015

Between 2002 and 2011, US hospitals increased their productivity in treating Medicare patients for several serious illnesses, refuting fears about a “cost disease” in health care and potentially mitigating concerns about provider payment under the Affordable Care Act.

The study, released today by Health Affairs as a Web First, addresses the quality of care and the severity of patient illness (considerations not fully taken into account by previous studies on this topic) found that during those years, the annual rates of productivity growth were 0.78 percent for heart attacks, 0.62 percent for heart failure, and 1.90 percent for pneumonia.

When the authors John Romley, Dana Goldman, and Neeraj Sood calculated productivity growth rates without factoring in trends in the severity of patient conditions or outcomes achieved after hospitalization, the annual productivity rates were different: -0.64 percent for heart attacks, -0.91 percent for heart failure, and -0.39 percent for pneumonia.

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How To Restore The Innovation Ecosystem For Medical Technology


February 10th, 2015

The recent February issue of Health Affairswhich features a series of articles on innovation, provides us with an opportunity to examine the state of America’s innovation ecosystem for medical technology. This ecosystem has produced a myriad of medical advances, ranging from advanced imaging to molecular diagnostics, minimally invasive surgical tools, and incredibly sophisticated implants. These technologies have shortened hospital stays, reduced the economic burden of disease, and saved and improved millions of lives.

But the system is severely stressed. Policy improvements are essential if America is to remain a world leader in medical devices and diagnostics and fulfill its potential for medical progress in this century of the life sciences. In the following blog post, we will look at the current state of the medical technology industry and make some policy recommendations covering regulatory approval processes, payment and coverage policies, and tax policy.

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Request For Abstracts: Health Affairs Food And Health Theme Issue


February 4th, 2015

Health Affairs is planning a theme issue on food and health in November 2015. The issue will present work that explores the relationship between the food we consume and our wellbeing on the individual, societal, and global levels. Articles will address causes and consequences of dietary excess and insufficiency, analyze policies and programs aimed at influencing these, and explore the roles of public policy, industry, and stakeholder groups in the context of dietary behavior.

We invite all interested authors to submit abstracts for consideration for this issue.

The issue will consider the implications of global food production and distribution for the health of consumers and food workers, environmental quality, and food prices, among other things. It will also examine actions taken from the community level upward to address increasingly universal concerns about food-related illness. Several papers will provide broad overviews of key issues, but we are particularly interested in empirical analyses of specific policies, programs, and practices aimed at influencing dietary behavior and clarifying our thinking about food’s role in health.

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The Puzzle Of Antibiotic Innovation


February 3rd, 2015

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

Dame Sally Davies, the Chief Medical Officer of England, warns that we are approaching an antibiotic apocalypse. A former chief economist at Goldman Sachs estimates that unless dramatic action is taken now, antimicrobial resistance could kill 50 million people a year and cause $100 trillion in cumulative economic damages.

In the US, dire warnings have issued from the Centers for Disease Control and Prevention (CDC), the President’s Council of Advisors on Science and Technology, and the President himself through an Executive Order on Combating Antibiotic-Resistant Bacteria in September 2014 (summary here). The President’s new budget asks for $1.2 billion to be spent on antibiotic resistance.

But last week, the science press breathlessly celebrated the discovery of a new antibiotic, teixobactin, cultured from soil samples collected in a grassy field in Maine (the study was published in Nature). Crisis over?

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Health Affairs Event Reminder: Biomedical Innovation


February 3rd, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC. Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

REGISTER NOW!

Follow live Tweets from the briefing @Health_Affairs, and join in the conversation with #HA_BiomedInnovation.

See the full agenda. Among the confirmed speakers are:

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Health Affairs’ February Issue: Biomedical Innovation


February 2nd, 2015

The February issue of Health Affairs includes a number of studies examining issues pertaining to biomedical innovation. Some of the subjects covered: how declining economic returns for new drugs may affect future investments, the changing landscape of Medicare coverage determinations for medical interventions, the slowly emerging US biosimilar market, and more.

With declining economic returns, can manufacturers afford to continue investing?

Ernst Berndt of Massachusetts Institute of Technology’s Alfred P. Sloan School of Management and coauthors compared present values of average lifetime pharmaceutical revenues to present values of average drug research and development, and lifetime operating costs. Upon examining new prescription drugs launched over four distinct time periods between 1991 and 2009, the authors found that net economic returns reached a peak in the late 1990s and early 2000s.

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Beyond Wellness ROI Part II: The Case Study Of A Major Self-Funded Employer


January 30th, 2015

In a recent post, we agreed with Goetzel et al. about the advisability of moving away from a preoccupation with the return-on-investment (ROI) of wellness programs and toward the more systemic, iterative view required to make progress toward workplace “cultures of health.”

At the same time, we acknowledged Lewis et al. and others for helping to usher in a new and needed scrutiny of the fairness and effectiveness of employment-based wellness programs. But, we also cited peer-reviewed evidence that counters Lewis et al.’s conclusion that there are no conditions under which employer wellness programs, and by extension employer efforts to manage their core health-related value/sustainability challenge, can achieve a return-on-investment (ROI) ratio of better than 1-to-1 savings to cost.

Lewis et al. have added their voice to the scrutiny increasingly applied to employer use of outcome-triggered incentives or penalties to promote employee behavior change in the context of health-contingent programs under financial provisions in the Affordable Care Act. The momentum fueling these developments could soon extend far beyond wellness programs.

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Moving Beyond Wellness ROI Toward Employment-Based Cultures Of Health: Part I


January 26th, 2015

With their recent post declaring that employment-based wellness initiatives “increase rather than decrease employer spending on health care with no net health benefit,” Al Lewis and coauthors are continuing to exert a clarifying presence in a field with a history of unsubstantiated claims and suspect methods. This conclusion is not supported by the work with which we and others have been associated and is thus not one with which we agree.

Nevertheless, Lewis et al. are to be acknowledged for fueling the need for a sharper focus on the core challenge at hand for employers: how best to improve the value of their health care investment—that is, how to manage health care costs while improving employee health and productivity—in ways that are sustainable. Incremental, inconsistent and, at times, maddeningly slow progress has been made. Employment-based wellness has been at the forefront, even as the need for quality improvement continues.

Moreover leading employers with well-developed management and measurement approaches have moved well beyond calculating the return on investment of individual wellness efforts and are demonstrating the more comprehensive value of building “cultures of health.”

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Health Affairs Briefing: Biomedical Innovation


January 20th, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The upcoming February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC.  Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

Register Now!

Follow live Tweets from the briefing @Health_Affairsand join in the conversation with #HA_BiomedInnovation.

Read the rest of this entry »

Health Affairs Web First: New Medicare Per Capita Spending Shows A Rise With Age, Then A Decline After 96


January 14th, 2015

New analysis of Medicare spending from 2000–11 found that in 2011 per capita spending increased with age, from $7,566 for beneficiaries age seventy to $16,145 at age ninety-six, and then declining for even older beneficiaries. The study authors Patricia Neuman, Juliette Cubanski, and Anthony Damico also found that since 2000, the age that Medicare per capita spending peaks has increased each year: In 2000, the highest spending was found to be among those age ninety-two.

They also found that Medicare beneficiaries ages eighty and older, who comprised 24 percent of the beneficiaries, accounted for a disproportionate share (33 percent) of traditional Medicare spending in 2011. This study, being released by Health Affairs as a Web First, is part of its re-established DataWatch series, which features timely health-related data and surveys.

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Reconsidering Pauly And Coauthors’ ‘Economic Framework For Preventive Care Advice’


January 12th, 2015

In the November issue of Health Affairs, Mark Pauly and coauthors criticize the lack of cost-effectiveness considerations in the Affordable Care Act (ACA), which mandates that health plans include preventive care free at the point of use. The bodies critiqued, the Advisory Committee on Immunization Practices (ACIP) and the U.S. Preventive Services Task Force, convene health experts to develop recommendations for immunizations and other preventive services.

According to the authors, the task entrusted to these bodies by the ACA, of offering sound advice on preventive care without considering its cost-effectiveness, is “impossible to do well.” They propose instead an “economic framework” under which only services with “substantial external benefits” (e.g. a vaccination for contagious disease) would be mandated for coverage. We believe this position is misguided.

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The Challenge Of Financing Sustainable Community-Based Palliative Care Programs


December 29th, 2014

Since its publication in September 2014, there has been widespread praise for the Institute of Medicine (IOM) report, Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. It is a masterful piece of scholarship that summarizes the spectrum of issues facing palliative care.

We hope the report will influence key decision-makers in medicine and various legislatures to promote the many changes outlined in the document, enabling palliative care to further improve the quality of life for those with advanced illness.

Yet, despite the encyclopedic scope of Dying in America, the report did not make suggestions about how to achieve sustainable funding for community-based palliative care. Freestanding programs provide special value to some of the sickest members of the population who struggle with their serious illness while living in the community, outside any facility or hospice program.

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The Value of Workplace Health Promotion (Wellness) Programs


December 22nd, 2014

The recent Health Affairs Blog post by Al Lewis, Vik Khanna, and Shana Montrose titled, “Workplace Wellness Produces No Savings” has triggered much interest and media attention. It highlights the controversy surrounding the value of workplace health promotion programs that 22 authors addressed in an article published in the September 2014 issue of the Journal of Occupational and Environmental Medicine titled, “Do Workplace Health Promotion (Wellness) Programs Work?”  That article also inspired several follow-up discussions and media reports, including one published by New York Times columnists Frakt and Carroll who answered the above question with: “usually not.”

There are certainly many points of contention and areas for continued discussion on this topic. It turns out that Lewis et al. and I agree on many things, and there are other areas where we see things differently.

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Request For Abstracts: Health Affairs Non-Communicable Disease Theme Issue


December 19th, 2014

Health Affairs is planning a theme issue on non-communicable diseases (NCDs) in September 2015. The issue will present work that describes the burden of NCDs, approaches to prevention and treatment of NCDs, and analysis of policies and initiatives aimed at prevention and treatment. The issue will have a global perspective.

We invite interested authors to submit abstracts for consideration for this issue.

We are using a broad definition of NCDs to include cancer, cardiovascular disease, respiratory illness, diabetes, mental illness, and the like. The issue will not focus on injuries, per se, but will address disability as an element of the disease burden of NCDs.

We plan to publish 15-20 peer-reviewed articles including research, analyses, and commentaries from leading researchers and scholars, analysts, industry experts, and health and health care stakeholders. Some papers will provide an overview of an issue relevant to NCDs, but we are particularly interested in empirical analyses of specific policies, care models, and other approaches to addressing NCDs. All papers must focus on issues of interest to public policy makers and private leaders in health care and related sectors.

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Investing In The Health And Well-Being Of Young Adults


December 15th, 2014

Young adulthood — ages approximately 18 to 26 — is a critical time in life. What happens during these years has profound and long-lasting implications for young adults, and — because many are parents — for the next generation.  Healthy, productive, and skilled young adults are critical for the nation’s workforce, global competitiveness, public safety, and national security.

Although young adults are resilient and adaptable, they are surprisingly unhealthy, showing a worse health profile than both adolescents and adults in their late 20s and 30s. Recent national attention on young adults has focused primarily on enrolling them in health care insurance to offset the higher costs associated with care for older adults under the Affordable Care Act 2010 provisions — mistakenly implying that it is not in their own interest to have health insurance. Unfortunately, too little attention has been paid to young adults’ specific health needs and the transitions they face once they are in the health care delivery system.

The Institute of Medicine and National Research Council recently released a new report titled Investing in the Health and Well-Being of Young Adults, which reviews what is known about the health, safety, and well-being of young adults and offers recommendations for policy and research. It was prepared by a committee with expertise in multiple disciplines, including public health, health care, behavioral health, sociology, social services, human development, neuroscience, economics, business, occupational health, media, and communications. We served as chair and a member of the committee, respectively.

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