OBR Daily Commentary

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Judge's Ruling Challenges US Transplant System

(New York Times/Associated Press) June 7, 2013 - It's a life or death matter: Who gets the next scarce donated organ? In an unprecedented challenge to the nation's transplant system, a federal judge has allowed one dying child — and a day later another — to essentially jump the line in rulings that could have ramifications for thousands of people awaiting new organs.

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William McGivney, PhD (Posted: June 10, 2013)

quotesEasy to Set Policies: Can be Gut-Wrenching to Make Decisions Based on Policies The recent cases and arguments regarding the eligibility of 10 year old Sarah Murnaghan and 11 year old Javier Acosta to be placed on the national waiting list for adult lungs illustrate the distinction between sitting around a table and having a serious debate to set national policy about the allocation of vital organs and actually making the individual decision about whether or not a living human being becomes eligible to receive a life-saving organ or might die. I was privileged to be a member of the Board of Directors of the United Network for Organ Sharing (UNOS), the organization that sets the rules and standards for the allocation of organs in the United States from 1990 to 1992. The earnest debates about how to best allocate the scarce supply of vital organs indeed could be sobering given the ultimate stakes for seriously ill populations of patients. The debate has always centered around how best to use the precious supply of organs that are donated every year. Indeed, that is what it was; it was an earnest, informed debate with policies established that would apply to seriously-ill and dying people. In June of 1991, I joined Aetna Health Plans where prominent among my first responsibilities was to establish the general coverage policies as to how Aetna would cover devices, procedures and techniques, including organ transplantation. What I was not expecting was to then see individual cases that were outliers where regional medical directors had made decisions to deny the specific intervention prescribed. I was asked to make the final decision. I was then in the position of setting coverage policy but also deciding on its application for individual people out there. These were people who were like me, my wife, my brother, my mother, my children etc. One Friday afternoon, I received a call from a transplant nurse asking if I would cover a heart transplant proposed for a fetus who had been diagnosed in utero. There were many questions that might be addressed: 1. Could a fetus be put on a national transplant waiting list? 2. Was a fetus legally a beneficiary of an Aetna Health Plan? 3. Would I cover the heart transplant for this fetus if a heart became available and was allocated to the child after her/his birth? I jumped the first two questions. I called the transplant nurse back and told her that Aetna would cover the transplant should the child receive a heart after birth. This decision is not entirely analogous to the current cases. However, the case illustrates a key point. Learned and caring women and men can develop standards, rules and guidelines. Notwithstanding this, there will always be outlier cases, patients at the margins. There are thousands and thousands of such patients. These patients will need a learned and compassionate fellow human being to make a decision about what care might be made available. There are always tradeoffs; many with serious consequences. I was not prepared to make such decisions, but I made them at least weekly and really more often. For, I looked around the room and there was no one else there to decide. The present cases will cause a reconsideration of national policy. Such reevaluation is warranted. In the meantime, two children, like yours and mine, have a chance to receive the lifesaving gift of lungs for transplant from a donation pool that falls far short of meeting the urgent and dire needs of many people. quotes

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China Drugmaker Access May Require Profit Cut, Chen Says

(Bloomberg) Apr 8, 2013 - Western drugmakers may have to give hefty subsidies and forgo some profit on expensive cancer drugs if they want access to China’s “huge market,” the country’s former health minister said.

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William McGivney, PhD (Posted: April 10, 2013)

quotes Access to and Availability of Oncologic Agents in China The Marketplace in China for oncologic drugs and biologics is a complex and critical one for the expansion of pharma/biotech companies, large and small. The complexity of the system relates to a rapidly developing and expanding health care infrastructure as mandated by the government and an equally rapidly developing scientific and clinical sophistication as evidenced by the increasing contributions by thought leading oncologists at Universities such as the Chinese Academy of Medical Sciences (Beijing), the Fudan University Cancer Center (Shanghai) and the Sun Yat-Sen University Cancer Hospital (Guangzhou). The Chinese system of the delivery of cancer care looks somewhat like that in the United States with an overarching layer of academic, university-based centers. The next layer down constitutes the very large provincial cancer centers most often found in the province capitals. Some of these provincial cancer centers treat almost staggering numbers of cancer patients annually. For example, one center may treat more Non-Small Cell Lung Cancer patients than the total volume of such patients treated at a number of large academic centers in the United States. The third tier, so to speak, are the hospitals that serve the rural populations in China cutting across the great expanse of the country. The Thought Leaders in China have been interested for about 10 to 12 years in the development of guidelines for cancer care. Indeed, for years, these leaders collaborated with NCCN Guideline Panel Members to develop Chinese versions for use mainly in the academic cancer centers in China. This collaboration eventually expanded to include thought leaders from across Asia. The Chinese Guideline versions are very similar in their recommendations to the NCCN Guidelines. The Chinese Government has expressed interest in seeing Guidelines being used in the provincial cancer centers. The increasing use of Guidelines in China establishes an interesting dichotomy with respect to the use of expensive drugs and biologics. The guidelines can be characterized as being very open with respect to evidence-based inclusion of drugs and biologics and also open with respect to the recognition of off-label uses, be they off-label to the US FDA or to the sFDA in China. In China, in general, expensive cancer agents placed upon the National Reimbursement Drug List are limited to sFDA approved indications. The National Reimbursement Drug List dictates which drugs are to be reimbursed and for what indications. Access to expensive agents may be limited to those with private out-of-pocket payment ability, private insurance, certain political affiliations, etc. The same is true when expensive agents are considered for off-label use, as we call it here in the United States. Clearly, China represents a market where there is tight government control over the utilization of and payment for drugs and biologics. Given the huge population, such control can fully be expected to be maintained. The National Institute for Clinical Excellence and Health (NICE from the UK) has been working with the Chinese government. Clearly, application and implementation of a NICE like organization and process would erect a hurdle and barrier to the access to and the availability of innovative drugs and biologics. The economics and reimbursement rules and processes will no doubt present challenges to the marketing and sales of expensive oncologic agents in China. A possible and complementary option would be the implementation of extensive electronic decision-assist and data collection tools that would be embedded in electronic health record systems (EHRs) to track utilization and outcomes. In the early stages of the build out of the Chinese cancer care delivery system, such forward thinking would serve policy-makers, clinicians and patients well. Hopefully, optimal utilization of innovative drugs and biologics would enhance the efficiency, acceptance and integration of such therapeutics into the daily practice of Oncology in China. quotes

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Little Support for Idea of Medicare Payments That Vary

(New York Times) Mar 22, 2013 - Medicare should not adjust payments on a broad regional basis to reward hospitals and doctors that spend less to achieve high-quality care, an interim report issued Friday by the Institute of Medicine concluded.

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William McGivney, PhD (Posted: March 27, 2013)

quotesThe focus of the IOM report and associated article is on the variation in level of reimbursement for services across the United States. There is another issue related to variation in the Medicare program and that is the variation in access to treatments for Medicare beneficiaries across Medicare regions. Variation in access can be caused by differences in local coverage determinations by regional Medicare Administrative Contractors (MACs). Issues in drug/biologic coverage have arisen from an interpretation that Medicare Contractors need not be bound by the indications listed in the 4 drug compendia recognized by CMS. The most influential of these compendia is the NCCN Drugs/Biologics Compendium. Indeed, it was the intent of Congress in the OBRA 1993 legislation that the recommendations of recognized Compendia be followed to assure that Medicare beneficiaries have equal access to appropriate drugs and biologics in cancer care. The use of drug/biologic compendia uniformly across Medicare regions would help to maintain equal access to treatments for beneficiaries of this one national government insurance plan for the elderly, Medicare. Specifically, the NCCN Drugs/Biologics Compendium with its wide and deep expertise, its explicit evaluation of evidence, and its transparency in communication of decisions should be determinative across MACs with regard to coverage policies for oncologic agents. quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

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H. Jack West, MD

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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
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Jeff Patton, M.D.

CEO Tennessee Oncology...

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Chief Medical Officer and Founder, N-of-One...

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Michael G. King Jr.

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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

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Winston Wong, PharmD

President, W-Squared Group...