OBR Daily Commentary

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COA Strongly Supports “Strengthening Innovation in Medicare and Medicaid Act”

(COA) Feb 3, 2020 - CMMI models are important to reform, but impact on patients should be carefully tested prior to widescale implementation.

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William McGivney, PhD (Posted: February 04, 2020)

quotesThe work of COA has been critically important in the support of patients, practicing oncologists, and the enhancement of innovation. One opportunity that lays wide open out there is the recognition in the OCM model that the NCCN recommendations lead the way in providing innovative off-label uses for drugs and biologics. As a matter of fact, of the first 88 indications for the checkpoint inhibitors, 58% of such indications were based upon NCCN recommendations for off-label uses. The NCCN Guidelines/Drugs-Biologics Compendium clearly represent the standard of care in Oncology in the US. NCCN recommendations are primary drivers of coverage policies of payers/MCOs. As such, under the OCM, new NCCN recommendations for the use of drugs/biologics should qualify for "novel therapies payments" within the OCM program. Limiting such "novel therapies payments" to only FDA approved indications clearly shows either a lack of understanding of the impact of NCCN on coverage policy and prescribing or a resistance to truly accelerate innovation through a payment system that seeks to best satisfy the needs of patients with Cancer. quotes

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Many Patient Groups Have Deep Ties To Pharma But Fail To Disclose Backing

(STAT Plus) Jan 23, 2020 - Amid ongoing debate over the role the pharmaceutical industry plays in shaping health policy, a new analysis finds that patient groups funded by drug makers generally support corporate interests, few groups have policies governing industry backing, and transparency is often lacking.

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William McGivney, PhD (Posted: January 27, 2020)

quotesThe article (with totally ex-US authors) referred to was published in the British Medical Journal in 2020. It comes to two main conclusions: 1. Industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship. 2. Industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of the sponsor over those of the public. For patient advocacy groups and for provider organizations, educational efforts and programs in need of funding can look to two sources for funding, biopharma companies and payers/MCOs. Clearly both of these industries achieve substantial revenue each year. The biopharma industry is quite interested in and generous in funding such programs that are tightly bound by rules about industry involvement (basically none) that biopharma companies can have in determining content, speakers, etc. The other source of funding is the managed care/health insurance industry. This latter industry is characterized by stinginess and a miserly nature. When I was CEO of an influential provider organization, I listened to the ongoing mantra about the same issue. So, one year, I decided that every time that my organization would ask for money from biopharma, we would submit the same educational or informational funding request to insurance companies. That year, we had a perfect record in that all 35 of our requests to insurance companies were turned down, or in some cases, were not responded to at all! C’est Ca for issue #1! Or C’est la guerre! In terms of issue number two, it occurs to me that patients, providers, and biopharma companies are aligned in seeking to achieve the availability of and access to novel drugs and biologics that address the many unmet needs of the many cancers for the many, many patients in need. As such, would anyone be surprised to see that patient groups, funded and unfunded, actually generally have the same policy positions as biopharma companies do. These are important issues to raise but it would be good if a small dose of reality, and yes, common sense, could permeate the grey matter of those involved in study design and analysis, as it is likely that this issue will be raised continuously over the course of our careers! quotes

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FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find

(NPR/Shots blog) Jan 14, 2020 - The Food and Drug Administration has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker, according to new research published Tuesday.

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William McGivney, PhD (Posted: January 17, 2020)

quotesThe header for this subject states that while drug/biologic approvals have arrived faster at the FDA over the past four decades, “the evidence it relies on in making those decisions is getting weaker”. Further in clicking the link to the article one finds the quote “As a result, patients and physicians should not expect that new drugs will be dramatically better than older ones." Only a few headlines up in the list of news in Today’s OBR Daily is the headline “Cancer Research Booms, Cancer Mortality Falls”. So, we have the sound bites: 1. Drug approvals by FDA are faster 2. Cancer Research Booms 3. Cancer Mortality Falls 4. The evidence is getting weaker 5. Should not expect new drugs to be better than old ones. Thus, we have the construct (Merriam definition: “as a contrast between lived reality and the construct held in the mind”) that the evidence for such decisions is getting weaker. Okay, I will accept so-called “weaker” evidence if I can get quicker access to drugs/biologics that, from 1991 thru 2017, helped to drop the cancer death rate by 29%. For those about to pounce and say “Yah-But, how much of that is attributable to new drugs/biologics?”, please look no further than to 2016-2017 wherein there was a 2.2% drop in the death rate, the largest annual death-rate drop ever recorded. For my meager money, I’ll take that last statistic no matter the strength of the evidence. As per the Chief Medical Officer of the American Cancer Society: "The accelerated drops in lung cancer mortality as well as in melanoma that we're seeing are likely due at least in part to advances in cancer treatment over the past decade, such as immunotherapy," I will extend my analytic diatribe by asking: who would look 40 years in the rear-view mirror to look at the strength of evidence used in approvals by the FDA now vs then. Are we not today in a totally different world, a world of genomes, exosomes, proteomes, etc., with significant advances coming almost monthly, at a rapid pace? Are not the populations of patients in need becoming smaller and smaller as they are exquisitely defined by molecular biomarker disease classifications? As such, how large an “n” of subjects can be generated in a reasonable amount of time to evaluate outcomes for patients in need? Do we need Double-Blinded RCTs for every evaluation? The FDA rightly is saying “no” and its track record, since the arrival of Dr. Pazdur, is exemplary. One final comment: “you know what they say ‘Publish or Perish’”. Wow, 40 years ago; even I was still in the Lab at Harvard (not in the Law School), no less! 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...

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

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

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...