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New Health Policy Brief: Drug Shortages


September 11th, 2014

A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at the ongoing problem of drug shortages in the United States. From 2005 to 2010, the number of reported drug shortages almost tripled.

Today, newly reported drug shortages overall are decreasing, but the total amount of drug shortages continues to increase, reflecting just how long it can take to rectify a shortage. Generic sterile injectable drugs, a vital component for patients fighting cancer, combatting an infection, or about to undergo surgery, are in especially short supply.

One of the most cited reasons for generic sterile injectable drug shortages is low reimbursement rates from Medicare Part B that came about after a change in law in 2003. These changes incentivized both physicians and manufacturers to switch to higher-cost drugs, reducing investment in cheaper generic drugs and causing “growing market concentration,” and eventual drug shortages.

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Birth Control Pills Should Be Available Over The Counter, But That’s No Substitute For Contraceptive Coverage


September 10th, 2014

In recent weeks, some opponents of the Affordable Care Act’s (ACA) contraceptive coverage guarantee have promoted the idea that oral contraceptive pills should be available to adult women without a prescription. Sens. Kelly Ayotte (R-NH) and Mitch McConnell (R-KY), for example, recently introduced the so-called Preserving Religious Freedom and a Woman’s Access to Contraception Act, a bill that would urge the Food and Drug Administration (FDA) to study whether to make contraceptives over the counter (OTC) — though for adults only.

Making birth control pills available over the counter, if done right, would meaningfully improve access for some groups of women. However, such a change is no substitute for public and private insurance coverage of contraceptives — let alone justification for rolling back coverage of all contraceptive methods and related services for the millions of women who currently have it.

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Projected Slow Growth In 2013 Health Spending Ahead Of Future Increases


September 3rd, 2014

Insurance Coverage, Population Aging, and Economic Growth Are Main Drivers of Projected Future Health Spending Increases

New estimates released today from the Office of the Actuary at the Centers for Medicare and Medicaid Services project a slow 3.6 percent rate of health spending growth for 2013 but also project a 5.6 percent increase in health spending for 2014 and an average 6.0 percent increase for 2015–23. The average rate of projected growth for 2013–23 is 5.7 percent, exceeding the expected average growth in gross domestic product (GDP) by 1.1 percentage points.

Increased insurance coverage via the Affordable Care Act (ACA), projected economic growth, and population aging will be the main contributors of this growth, ultimately leading to an expected 19.3 percent health share of nominal GDP in 2023, up from 17.2 percent in 2012.  This compares to the Office of the Actuary’s 2013  report, published in Health Affairs, predicting an average growth rate of 5.8 percent for 2012–22.

Every year, the Office of the Actuary releases an analysis of how Americans are likely to spend their health care dollars in the coming decade. The new findings appear as a Health Affairs Web First article and will also appear in the journal’s October issue.

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Integrity In Retail Health Care: Rethinking The Sale Of Tobacco Products


September 3rd, 2014

Retail health care is a relatively new development in American health care.  It is true that much of the dispensing of medications has historically occurred through retail pharmacies, which sold a variety of other goods and services, but somehow that was not seen as the provision of health care.   Health care institutions, including doctors’ offices, hospitals and clinics, were the places that people went to be diagnosed and treated.  And those institutions did little other than health care; they did not, and still do not today, offer any products other than provision of care, including testing and treatment.  As such, these institutions demonstrated high integrity, defined as a state of being whole, and synonymous with cohesion and unity of purpose.

Now retail pharmacies, mass merchandisers and grocery stores are adding “health care” as another consumer good to be purchased on a mass scale.  Retail health care is in some cases, extending what the pharmacist does in the retail pharmacy: providing more advice about a variety of health care issues, giving vaccines, and working more closely with doctors’ offices.  In other cases, it is the opening of small clinic practices, often staffed by nurse practitioners, caring for minor ailments.  These kinds of clinics make great sense from the point of view of convenience and cost and have proven to be very popular, particularly given the shortage of convenient primary care that exists in many communities.

There are signs that the scope of retail health is deepening.  Pharmacies are planning to do more laboratory testing, in part to support a broader array of health advice from pharmacists, and in part to allow a wider set of complaints to be addressed in the retail pharmacies.  Walgreens has developed accountable care organizations with hospital partners.  At CVS Health, we have been very public about our effort to align with integrated delivery systems to help them manage population health by emphasizing joint efforts to improve medication adherence, support the management of complex patients, and create direct electronic medical record connectivity between our 900 retail clinics and the doctors’ offices.  Just last month, Walmart announced that their new clinics would be primary care offices, capable of caring for a range of chronic disease.

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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era


August 27th, 2014

The Development of Brincidofovir and its Possible Use to Treat Josh Hardy

Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.

His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. They were aware of another anti-viral in Phase 3 clinical development, brincidofovir, an oral compound chemically related to Vistide. In earlier clinical testing brincidofovir had shown the potential for enhanced antiviral potency and a more favorable safety profile.

Chimerix (where one of us, Moch, was CEO), a 55 person North Carolina-based biopharmaceutical company, had previously made brincidofovir available to more than 430 critically ill patients in an expanded access program for the treatment of serious or life-threatening DNA viral infections, including adenovirus as well as herpes viruses (such as cytomegalovirus) and polyomaviruses.  This program started in 2009 as a series of individual physician-sponsored emergency INDs — investigational new drug exemptions issued in physician-certified compassionate use situations.

The program evolved via word of mouth to the extent that brincidofovir was made available under emergency INDs for more than 215 patients. During 2011, Chimerix received funding from Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to provide brincidofovir to an additional 215 critically ill patients for the purpose of gaining insights into the potential use of brincidofovir as a medical countermeasure against smallpox. (Department of Health and Human Services Contract No. HHSO100201100013C.  For further information on brincidofovir Study CMX001-350, see ClinicalTrials.gov Identifier NCT01143181.)

When BARDA funding ended in 2012, Chimerix stopped accepting new requests for compassionate use under its expanded access program. Although requests continued from physicians around the world, the company decided that it was in the best interests of the greatest number of patients to devote its limited human and financial resources to the clinical development pathway necessary for FDA approval of brincidofovir.

This post examines the implications of the ultimately successful campaign waged by Josh Hardy’s family to obtain access to brincidofovir for their son. We discuss several issues raised by the Hardy case, including the overarching question of whether it is fair for social media or influence of any form to play a role in determining which patients get access to experimental treatments; whether rescuing individual patients in need can be reconciled with an evidence-based regulatory approval process for new therapies; and whether there is a duty to “rescue” terminally ill patients by paying for access to experimental therapies.

Finally, we propose a new framework for regulating access to experimental treatments.

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Health Affairs Briefing: Advancing Global Health Policy


August 22nd, 2014

Please join us on Monday, September 8, when Health Affairs Editor-in-Chief Alan Weil will host a briefing to discuss our September 2014 thematic issue, “Advancing Global Health Policy.”  In an expansion of last year’s theme, “The ‘Triple Aim’ Goes Global,” we explore how developing and industrialized countries around the world are confronting challenges and learning from each other on three aims: cost, quality, and population health.

A highlight of the event will be a discussion of international health policy—led by Weil—featuring former CMS and FDA administrator and current Brookings Institution Senior Fellow Mark McClellan and Lord Ara Darzi, surgeon, scholar, and former UK Health Minister. Additional panels will look at how countries are transforming chronic care, lowering costs, and redesigning delivery systems.

WHEN: 
Monday, September 8, 2014
9:00 a.m. – 12:30 p.m.

WHERE: 
National Press Club
529 14th Street NW
Washington, DC, 13th Floor

REGISTER NOW!

Follow Live Tweets from the briefing @HA_Events, and join in the conversation with #HA_GlobalHealth.

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The Role Of Black Box Warnings In Safe Prescribing Practices


August 20th, 2014

In the Health Affairs article, “Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received black-box warnings or were withdrawn from the market for safety-related reasons prior to the 1992 Prescription Drug User Fee Act (PDUFA) with black-box warnings and safety-related withdrawals in the post-PDUFA era.

PDUFA for the first time authorized FDA to collect user fees from brand-name manufacturers that submitted New Drug Applications, with the funds being earmarked for more review staff (not until 2007 were funds also permitted to be used to expand post-approval safety surveillance capacity).

As a quid pro quo, the FDA was required to act on all new drugs within a fixed deadline: drugs given priority review designations because they were particularly promising therapies offering substantial improvements in treating serious conditions were to be reviewed within 6 months and standard review drugs were to be reviewed within 12 months (later shortened to 10 months in 2002). By all accounts, PDUFA substantially expedited the review process. The review times for new molecular entities decreased from an average of 33.6 months between 1978 and 1986 to about 10 months for drugs approved between 2001-2010.

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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework


July 31st, 2014

Editor’s note: In addition to Meaghan George, Sara Bencic and Darshak Sanghavi also coauthored this post. 

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer.

Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

A Call to Action: The Importance of Expanded Access Programs

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage.

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The Double-Faced Pain Problem: Reflections On July’s Narrative Matters Essay


July 28th, 2014

Reading Janice Lynch Schuster’s tormented account of her persistent pain and her journey through the medical maze of care in the July issue of Health Affairs, I’m reminded of how millions of Americans are living with not one, but two, pain challenges. The first is the epidemic of over-prescription; the second is the condition of endemic under-medication.

In her essay “Down The Rabbit Hole: A Chronic Pain Sufferer Navigates The Maze Of Opioid Use,” Schuster herself hints at the dual issues when she writes: “pain patients like me often feel trapped between the clinical need to treat and manage pain and the social imperative to restrict access to such drugs and promote public safety.”

People coping with chronic pain confront a double-faced problem: a society simultaneously providing too much relief and too little. Which face of the American pain dilemma any patient will experience depends on where they live, who they are, and what kind of practitioner they encounter in their pursuit of relief. As Schuster writes, the situation is perplexing, maddening, and sometimes arbitrary.

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Narrative Matters: A Chronic Pain Sufferer Navigates The Maze Of Opioid Use


July 17th, 2014

In the July Health Affairs Narrative Matters essay, a woman living with chronic pain tries to manage her condition while maneuvering through the maze of opioid medications. Janice Lynch Schuster’s article is freely available to all readers, or you can listen to the podcast.

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Positive Results For 2012 Physician Quality Reporting System And eRx Program


July 17th, 2014

In April, the Centers for Medicare & Medicaid Services (CMS) released the 2012 Physician Quality Reporting System and Electronic Prescribing (eRx) Experience Report, showing a significant increase in participation in two programs that allow eligible professionals to earn incentive payments through voluntary participation.

Record Participation in 2012

With over 430,000 professionals participating in the Physician Quality Reporting System (PQRS) and more than 340,000 e-prescribing, the 2012 report marks encouraging progress in efforts to improve quality measurement and reporting through the PQRS and eRx programs. Thanks to increased participation, more clinicians are actively measuring and reporting on quality and focusing on improvement.

CMS is beginning to add this information to Physician Compare, a website that can be viewed by patients. Measuring, transparently sharing, and improving quality performance provide the keys to a better health system.

At CMS, we are pleased by the success of these programs and other CMS quality measurement programs. We are also encouraged by the potential of these initiatives to empower patients and providers with information that can support care coordination and improved delivery of care.

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The Era Of Big Data And Its Implications For Big Pharma


July 10th, 2014

Editor’s note: For more on the topic of big data, check out the July issue of Health Affairs In addition to Marc Berger, Kirsten Axelsen and Prasun Subedi also coauthored this post. 

Health care research is on the cusp of an era of “Big Data” — one that promises to transform the way in which we understand and practice medicine.

The Big Data paradigm has developed from two different points of origin. First, significant efforts to digitize and synthesize existing data sources (e.g., electronic health records) have been driven by policy and practice economics. Second, a wide range of novel ways to capture both clinical and biological data points (e.g., wearable health devices, genomics) have emerged.

The era of Big Data holds great possibility to improve our ability to predict which health care interventions are most effective, for which patients, and at what cost.

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New Drug And Device Approval: What Is Sufficient Evidence?


July 1st, 2014

Editor’s note: In addition to Jonathan Darrow, this post is also coauthored by Aaron Kesselheim. 

The federal Food, Drug, and Cosmetic Act gives the Food and Drug Administration (FDA) the authority to evaluate all prescription drugs and high-risk medical devices before they can be marketed to physicians and patients to ensure that they are safe and effective.

However, there is growing pressure to lessen the traditional standards for defining “safe and effective” for particularly promising therapies and accelerate patient access to these products.

A recent national health policy conference in Washington, D.C., explored the nature of the evidence needed for the regulatory approval of new therapeutics and the implications for patient care. The conference was organized by the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital/Harvard Medical School, the National Center for Health Research, and the American Academy for the Advancement of Science (AAAS).

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Correcting The Blind Spot In Accountability: The Role Of Pharmacy Care


June 25th, 2014

Editor’s note: In addition to William Shrank, this post is also coauthored by Andrew Sussman, Patrick Gilligan, and Troyen Brennan.

The Centers for Medicare and Medicaid Services (CMS) recently issued a Request for Information (RFI) to solicit suggestions about how to improve the Accountable Care Organization (ACO) programs. CMS stated that they seek recommendations about how the ACO program might evolve to “encourage greater care integration and financial accountability.”

The RFI explicitly stated that they seek information about how to better integrate Part D expenditures into ACO cost calculations to make pharmaceuticals part of the approach to care delivery and health care transformation.

The deadline for comments about encouraging Part D integration in ACOs has now passed. But the issue extends beyond ACOs. In addition, bundled payments and patient-centered medical home programs target hospitals and primary care providers to promote higher quality and lower cost care. All these programs have largely excluded prescription drug costs in their calculus, and offer no direct incentives for Part D plans to participate in and improve care.

Nonetheless, retail pharmacies and Part D plans have developed a number of strategies to participate. As CMS and policymakers reconsider ACO regulations to stimulate greater integration of prescription drug use in delivery system reform, we thought it important to offer a description of the marketplace response to payment reform activities at large.

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Behind The Numbers: Slight Rise In Health Care Spending Growth Projected


June 24th, 2014

PwC’s Health Research Institute (HRI) released its ninth annual Medical Cost Trend: Behind the Numbers report today. This forward-looking report is based on interviews with industry executives, health policy experts, and health plan actuaries whose companies cover a combined 93 million members. Findings from PwC’s Health and Well-being Touchstone Survey of 1,200 employers from 35 industries are also included.

HRI projects that after a five-year contraction in spending growth in the employer-sponsored market, the growth rate will rise to 6.8 percent in 2015, up from the 6.5 percent projected last year.

What are the biggest drivers of the growth in health care costs? We identify four cost inflators in this report, and I would like to highlight two. First, the economy. More than five years after the end of the Great Recession, the improved economy is finally translating into greater medical spending. Consumers are now addressing health issues they ignored or postponed previously.

Secondly, the high cost of specialty drugs. While only four percent of patients use specialty drugs, those medications account for 25 percent of total U.S. drug spending. And estimates are that U.S. specialty drug spending will quadruple by 2020

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The Role Of Sales Representatives In Driving Physicians’ Off-Label Prescription Habits


June 19th, 2014

Off-label prescribing is widespread in Canada and the United States (U.S.). One in nine prescriptions for Canadian adults are for off-label uses with the highest percentages coming from anticonvulsants (66.6 percent), antipsychotics (43.8 percent), and antidepressants (33.4 percent). Overall, 79 percent of the off-label prescriptions lacked strong scientific evidence for their use.

For 160 drugs commonly prescribed to U.S. adults and children, 21 percent were for off-label indications totaling 150 million prescriptions. In this case, 73 percent had little to no scientific backing and once again psychoactive drugs such as gabapentin had the highest level of off-label use.

Moreover, doctors do not seem to know what are and are not approved FDA use for many of the drugs that they prescribe. Now an article published in the June issue of Health Affairs by Ian Larkin and colleagues points to active promotion by sales representatives as one reason for the widespread off-label use of antipsychotics and antidepressants in children.

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The End Of The Blockbuster? Implications For Pricing Of New Drugs


June 16th, 2014

Editor’s note: In addition to Elias Dayoub, Anupam Jena and Darius Lakdawalla also coauthored this post. 

The productivity slowdown in drug innovation has been identified and widely discussed in recent years. In addition, the stagnation in the number of novel drugs (new molecular entities and new biologics) approved by the U.S. Food and Drug Administration (FDA) has also been well-documented.  Less well-appreciated, however, is the decline in the “applicability” of new drug approvals.  Each new drug treats fewer disease indications than drugs approved in earlier years.

Measuring the applicability of new drugs serves a dual purpose in helping better understand drug innovation. For one, assessing the number of indications for new drugs adds more nuance to assessments of growth or slowdown in the development pipeline. The relevant question is not necessarily how many new drugs are launched, but how many patients and diseases can be newly treated.  By accounting for the number of indications a new drug treats, one can better assess the number of patients the new therapy may benefit as well as the potential impact the drug approval will have on pharmaceutical spending.

The second important reason to measure pharmaceutical applicability is that it sheds light on how the costs of drug development translate into drug prices. If a drug has broad applicability to a larger number of indications, a drug developer can reasonably anticipate a greater number of patients will take the new medication. Conversely, if the drug treats only one indication, a developer expects fewer patients will use their drug.

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Roll-Out Of New TB Drug Must Be Handled With Care


June 13th, 2014

Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, has announced that it will make its breakthrough new tuberculosis (TB) drug, Sirturo, available at a discount in 130 developing countries. As the first new antibiotic to be approved to treat TB in over 40 years, Sirturo will be an important new weapon in the aging arsenal of medicines used to treat this deadly disease.

Sirturo’s approval was a breakthrough for global health and TB treatment. In 2012, the airborne disease killed about 1.3 million people, making it second only to HIV/AIDS in the ranks of infectious killers. While the number of people dying from TB each year is slowly falling, drug-resistant strains are proliferating. According to the World Health Organization, ninety two countries have reported cases of extensively drug resistant TB since it was first reported in 2006.

Tuberculosis Treatment Programs

Now that Sirturo is ready for prime time – and poised for international distribution – it’s critical that the roll-out is meticulously managed by health care systems in each and every country that plans to administer it. TB drug resistance usually arises from poorly managed tuberculosis treatment programs. Treatment is long – about six months for basic treatment, and up to two years for drug-resistant strains – and only adds to the challenge of successful treatment completion. With improper or inadequate treatment, virulent new forms can evolve.

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Wynne, Jost Posts Lead Health Affairs Blog Most-Read List For May


June 10th, 2014

Billy Wynne’s post on the 340B Rx Drug Discount program was the most-read Health Affairs Blog post in May. The top-15 list also featured several contributions from Tim Jost; his posts on the final 2015 Exchange and Insurance Market Standards rule (part 1 and part 2) and COBRA/ACA interaction made the top five. Also in the top five was James Rickert’s look at patient satisfaction and perceptions of care.

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When ICD-10 Implementation Becomes A Game


June 9th, 2014

Editor’s note: For more on this topic, stay tuned for the upcoming Health Policy Brief update on transitioning to ICD-10. 

The on again, off again plans for ICD-10 code set implementation leaves many organizations at a crossroads. In a previous blog post, we discussed the details of ICD-10 and assessed the industry’s readiness for implementation.  This assessment assumed the improbability of a further delay.  In February, CMS Administrator Marilyn Tavenner had seemingly given the green light, declaring, “There are no more delays and the system will go live on October 1.”

However, at the end of March 2014 Congress passed another temporary delay of Medicare physician reimbursement rate cuts that also included language unexpected to many — including CMS — that ICD-10 would be delayed until October of 2015.  Given this latest development, ICD-10 implementation has begun to feel like a high stakes game of the childhood pastime, “Red Light, Green Light,”  in which players must run forward at full speed, until the words ‘red light’ are called out with no warning, forcing them to stop on a dime.  In this case, countless organizations and institutions may be feeling a little disoriented by the latest change.

Some entities are grateful. Congress’s “red light” gives them extra time to prepare.  A February 2014 survey of over 570 physician group practices conducted by the Medical Group Management Association revealed that a large number of providers aren’t ready for the transition to ICD-10.  The survey showed that:

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