OBR Daily Commentary

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Value-Based Oncology Care an Imperfect Proposition Still

(Medscape Medical News) Apr 7, 2017 - ASCO said its value framework is still not ready for use, while a cancer center shared how it has implemented the Oncology Care Model, but has no data yet.

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William McGivney, PhD (Posted: April 12, 2017)

quotesThe developers of Value Metric Frameworks continue to struggle to make them relevant and also to make them usable and utilized by a meaningful number of policy-makers and clinicians. In the MedScape article, the key point was made with surprising honesty by ASCO’s Dr. Grubbs who was quoted regarding the ASCO Value Score Framework: “The organization is working to include cross-trial comparisons”, said Dr Grubbs. "Until we have that, there's going to be limited benefit to this.” This was an obvious observation made by many when the ASCO Value Score Model was first introduced. Mandating the use of head to head comparator trials as the source of data and other limiting characteristics created a model that once again ended up as confirmation of the saying, “The Perfect is the Enemy of the Good”. In what I called “The Rush to Value” in my analysis for a journal in July of 2015, organizations and individuals raced to the spotlight for presumptive crowning as “Value Czars” with incompletely thought-out products. Here we are two years later and these products languish. Actually, the one product that still has “legs” is the ICER analytical model. However, any momentum that ICER had was substantially diminished by the results of the 2016 Presidential election. The pronouncement that many oncologists do not know the price of the drugs that they prescribe continues to amaze me. I submit that this population of docs will not be interested in understanding and reviewing results of the many “Value” Models out there. For the others, a simple statement of Price will probably facilitate the prescriber’s understanding of the Value of what she/he is prescribing. quotes

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This Federal Agency That Aims To Make Health Care More Effective Is On The Chopping Block, Again

(STAT) Mar 30, 2017 - A little-known federal agency responsible for making health care safer and more efficient has survived 20 years in Washington with a target on its back, but its time may be running out.

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William McGivney, PhD (Posted: April 02, 2017)

quotesAs we now rest “comfortably” in the “Valley of Value-Based Policy-Setting and Decision-Making”, it is quite reasonable to evaluate the benefits of providing organizations like AHRQ with half-a-billion dollars a year and compare how such health care dollars might be better (or not) spent. While one is at it, one might as well throw in PCORI to this evaluative and valuation effort. My experiences with AHRQ are based upon my serving as a reviewer for a grant about 12 years ago, a meeting I had with AHRQ folks when I was CEO of a national organization, my experience with the work product of a large contract let by AHRQ, and general tracking of the agency as it changed names through the years. I started to describe those experiences but thought better of heading down that path. In the briefest of my comments (ever), I believe it is a good time to evaluate the products of these agencies and the Value that they might provide. quotes

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Are Right-To-Try Laws A Last Hope For Dying Patients — Or A False Hope?

(Washington Post) Mar 26, 2017 - The battle over access to unapproved treatments moves from the states to Congress.

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William McGivney, PhD (Posted: March 30, 2017)

quotesThe issue of offering access to “investigational” treatments for serious and life-threatening illnesses is a very difficult issue from a clinical perspective, especially with respect to the provision of a treatment with an ill-defined adverse event profile. However we must remind ourselves that we are talking about people with serious and life-threatening illnesses such as ALS, lung cancer etc. There are ways to and examples of how the issue has been addressed. Clearly, the FDA has compassionate use guidelines. Further and even better, during the rise of the AIDS epidemic in the 1980s, the FDA produced and finalized the Treatment-IND regulation that made drugs that had shown some early efficacy and had been granted the Treatment-IND designation available to patients with AIDS before FDA approval. The road to finalization of the Treatment-IND was a controversial and a rocky path; but it happened. In my view the Treatment-IND, pushed by then Commissioner Frank Young, MD, was successful in terms of offering hope to patients, establishing a bridge to possible better drugs, and spurring on innovative research, especially the involvement of smaller biotech companies. The support of the American Medical Association was key and I was fortunate to be the FDA liaison for the AMA at the time and work with Stuart Nightingale, MD Associate Commissioner for Health Affairs at the FDA. I took the lessons from that experience with me to Aetna in 1991. Six days after joining Aetna as VP Clinical and Coverage Policy, Aetna was on “60 Minutes” for the second time for having denied coverage for high dose chemotherapy/bone marrow transplant. I was charged with addressing the issue of the use of investigational treatments in patients with less than a year to live. The bottom line was the establishment in 1991 of the Aetna “Terminal Illness Policy” whereby investigational treatments, especially HDCT/BMT, were evaluated on an individual patient/beneficiary basis for patients with limited life expectancies. The limit of life expectancy was treated with great flexibility. This program was highly successful and well-respected by patient groups, providers, other payers, employer customers, state legislators, etc. A modified version of this policy still exists at Aetna. Through it all, I learned one of the commandments for my decision-making in setting coverage policy and making individual patient medical necessity determinations at Aetna: “The more serious and life-threatening the illness, the lesser degree of certitude about efficacy and the greater risk of harm about treatments that patient, provider and payer should accept.” This real-world commandment came into decision-making play every day and still does. quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

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

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Associate Cancer Center Director, Yale Cancer Center P...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

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

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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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...

Payer
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Winston Wong, PharmD

President, W-Squared Group...