OBR Daily Commentary

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Medicare Advantage Plan Proposed Use Of Step Therapy For Part B Drugs

(Forbes) Sept 17, 2018 - Payers must balance patient access to biopharmaceuticals and cost containment. A public payer such as Medicare and its contractors is no different in this regard.

William McGivney, PhD (Posted: September 17, 2018)

quotes “Your First Chance is Your Best Chance” The title used to be the tagline for some of the advertisements of Memorial Sloan Kettering. CMS has either not heard or dismisses such considerations given the recent announcement to allow Medicare Advantage Plans to enact Step Therapy programs for Part B agents. As quoted in the Forbes article, “Step therapy is controversial. It is the most onerous condition of reimbursement in that it defers certain treatments until a later point in time”. It all just seems to get worse and worse for physician autonomy and patient well-being. Does CMS not see the distinct possibility in this program of actually increasing the variability of Medicare beneficiaries’ access to therapies given that it is quite likely that MA Plans will have Step Therapy Programs that will differ, one from the other? Will MA Plans deftly handle Part B to Part D stepping processes with a lack of understanding of patient likelihood of non-adherence under Part D. What will implementation of such a Program do to personalized medicine with biomarker-directed care? How long will such step therapy policies delay drugs/biologics for patients in need? The list of concerns goes on and on! An NCCN Panel Chair recently told me the story of that person’s latest “peer to peer” discussion with a payer. When the Payer’s cardiology nurse finished misquoting the relevant NCCN Guideline, the Panel Chair told her that she/he was actually the Chair for that Panel and cited the page and line that justified the use of the drug in question. How will a patient’s first chance be guided with this “most onerous condition of reimbursement” being applied by well-meaning cardiology nurses? quotes

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Progenics Pharmaceuticals Reports Top Line Phase 3 Data for Prostate Cancer Imaging Agent 1404

(NASDAQ) Sept 12, 2018 - Meets co-primary endpoint of specificity; 1404 successfully identifies patients without clinically significant prostate cancer; co-primary endpoint of sensitivity to identify patients with clinically significant disease not met.

Tomasz M. Beer, MD, FACP (Posted: September 13, 2018)

quotesLow sensitivity seen in this trial is a bit of a disappointment. We will need to learn more about this result as the data are fully analyzed, presented, and published. Low sensitivity means that a negative result is not as reassuring for patients as one would have hoped.quotes

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FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS ≥1%)

(Merck) Sept 12, 2018 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. The application is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 clinical trials with KEYTRUDA in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Jan. 11, 2019.

H. Jack West, MD (Posted: September 12, 2018)

quotesThe results of KEYNOTE-042 were positive for an OS benefit of pembro over platinum doublet chemo as first line treatment for patients with tumor PD-L1 expression 1% or higher (about 2/3 of patients), a broadening compared to the established place for pembro as first line treatment for patients with tumor PD-L1 expression 50% or higher (about 30% of patients). However, reviewing how different subgroups did actually demonstrates that the patients in whom pembro was superior was limited to the 50% and higher group that we already treat with first line pembro. The entire trial, including patients with a lower PD-L1 threshold of 20% or 1%, was positive only because the good results were driven by the high PD-L1 group and were favorable enough to still be positive for the trial even after being DILUTED by the lack of benefit for pembro in the lower PD-L1 patient subgroup. One could argue that the results with pembro in the 1-49% group are comparable for OS as that seen for patients who started with chemo, and pembro is better tolerated, so why not favor it? The answer is because the trial prohibited crossover to pembro upon progression, and only 20% of the patients assigned to first line chemo ever got an immune checkpoint inhibitor off protocol subsequently. This represents an unfair comparison in which pembro only looks comparable to a chemo arm that was severely handicapped by being denied a treatment that is extremely well established as a standard of care as second line treatment with a consistently proven strong survival benefit. In the US, three checkpoint inhibitors are approved and widely used as second line treatment after initial chemotherapy, so the first line pembro arm only comes out looking as good as a first line chemo arm that received what we can only consider overall sub-standard care on the control arm. This isn't just a revisionist view based on current standards, but represents what was a standard of care in the US while this trial was being conducted. I review the trial results and discuss these issues further in my video here: http://bit.ly/BMIC38quotes

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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

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

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...