20151002 - Oct 2, 2015
ISSUE 36 – OCT. 2, 2015PDF

CMS to Trim Spending on Diagnostic Lab Tests

The Centers for Medicare and Medicaid Services appear to be executing a two-step strategy to shrink the $8 billion annual price tag of clinical diagnostic laboratory tests.

On Sept. 25, CMS released a final payment determination for the Clinical Laboratory Fee Schedule that cuts payment by over 90 percent for some tests.

One of the industry leaders, Genomic Health, saw payments for Oncotype DX breast cancer tests drop by 15 percent, and a 79 percent drop for its colon cancer test. The determination involves a set of nine codes for advanced diagnostic laboratory tests.

Guest Editorial

Local Medicare Contractors Bring Chaos to CMS Coverage of Next Generation Tests

By Dane Dickson

Yesterday, two Medicare administrative contractors—National Government Services and Cahaba Government Benefit Administrators—released draft local coverage determinations for next generation sequencing in advanced lung cancer.

The NGS LCD covers the initial diagnosis of lung cancer and Cahaba’s LCD covers patients who have been re-biopsied to test for additional mutations that may have been missed on testing of the initial biopsy by older technology.

    BMS Combination Approved in Melanoma;

    Dana-Farber Challenges BMS Patent Rights

    A combination of two Bristol-Myers Squibb immuno-oncology agents—Opdivo (nivolumab) and Yervoy (ipilimumab)—received an accelerated approval for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

    The Oct. 1 announcement marks the first time FDA has approved a combination regimen of two immuno-oncology agents in cancer—both drugs had previously been approved as monotherapies for the same indication.

      Capitol Hill

      Congress Averts Shutdown, Funds NIH Through December

      Congress passed a continuing resolution Sept. 30—averting a shutdown—that will fund the federal government at current levels through Dec. 11.

      Funding for both NIH and NCI dipped slightly as part of a 0.21 percent cut to all non-defense discretionary agencies.

        USPSTF Speaks on its Role In the Affordable Care Act

        The U.S. Preventive Services Task Force published a viewpoint in the Journal of the American Medical Association to clarify how their recommendations are linked to the Affordable Care Act coverage mandate—and how they believe clinicians, payers, and the public should interpret their recommendations.

        The viewpoint, titled “Evidence-Based Clinical Prevention in the Era of the Patient Protection and Affordable Care Act: The Role of the US Preventive Services Task Force,” describes how some have misinterpreted task force grades of C or I as recommendations against screening or even against coverage.

          Funding Opportunity

          Pershing Square Sohn Cancer Research Alliance Prize For Young Investigators

          The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research.

            In Brief

            • Richard O’Reilly to step down as chair of pediatrics at MSKCC

            • James Wade named deputy director at Inova cancer institute

            • MSKCC’s Lorenz Studer named MacArthur Fellow

            • Three investigators named winners of the Paul Marks Prize

            • Kesari joins Providence Saint John’s Health Center

            • Turaga named endowed professor in sarcoma research at Medical College of Wisconsin

            • Jan Schluchter named CCO at Myriad Genetics GmbH

            • Stand Up to Cancer Canada Dream Team members announced

            • Center to Advance Palliative Care publishes state-by-state report card
            Drugs and Targets

            • FDA grants accelerated approval to Keytruda in NSCLC

            • EMA CHMP grants two positive opinions to Kyprolis and Blincyto

            • FDA grants priority review to defibrotide for hepatic VOD

            • Aspen Park acquires Ohio State’s APP-111

            • UbiVac and Janssen form collaboration

            • City of Hope and Sorrento Therapeutics form LA Cell Inc.

            20150925 - Sep 25, 2015
            ISSUE 35 – SEPT. 25, 2015PDF

            Information Blocking by E-Health Record Firms Threatens CancerLinQ, ASCO Says 

            Congress must put an end to the emerging practice of “information blocking” by demanding that electronic health records are able to exchange data in an “interoperable” fashion, the American Society of Clinical Oncology urged at a congressional briefing.

            At the briefing Sept. 15, ASCO said that some EHR companies are erecting obstacles that preclude the sharing of data contained in patient health records.

            Baselga: Why I Believe NIH is On Threshold of the Largest Budget Increase in 12 Years

            As congressional leaders discuss potential ways to avert a government shutdown, which could happen in less than a week if policymakers are unable to agree to a short-term continuing resolution to keep the government running beyond Sept. 30, I remain optimistic that NIH will receive its largest annual budget increase in 12 years.

            After 12 years of flat funding, a significant number of members of Congress on both sides of the aisle are enthusiastically backing the NIH, which is the largest supporter of medical research in the world. Many in Congress, Republicans and Democrats alike, appear to be singing from the same song sheet about the importance of prioritizing the NIH budget.

              In Brief

              • UNC, Vanderbilt get “exceptional” scores for Cancer Center Support Grant renewal applications

              • Peter Schultz named CEO, Steve Kay named president of The Scripps Research Institute

              • Jeffrey Medin named MACC Fund Endowed Professor at the Medical College of Wisconsin 

              • Evelyn Whitlock named chief science officer at Patient-Centered Outcomes Research Institute

              • Joaquin Espinoza named associate director of science at the Linda Crnic Institute for Down Syndrome
              • Robert Schreiber, Philip Greenberg named editors-in-chief of Cancer Immunology Research
              • Christoph Zielinski named editor-in-chief of ESMO Open
              • Huntsman Cancer Institute becomes first Mediso Preclinical Imaging Center of Excellence in North America
              • SCIEX announces collaboration with Fred Hutchinson on targeted proteomics
              • Experimental Therapeutics at Mount Sinai team up with Regeneron on antibody research
              • Thomas Jefferson and GenomOncology co-developing cancer profiling system
              • Gilda’s Club Chicago, cancer organizations launch metastatic breast cancer awareness campaign
              • The Ride to Conquer Cancer raises $2.1 million for cancer research
              Drugs and Targets

              • FDA approves Varubi for chemotherapy-induced nausea

              • Roche NimbleGen introduces enhanced whole exome sequencing solution for medical and translational research

              • CTI BioPharma Corp. plans to submit NDA for pacritinib

              • Amgen Inc. and Xencor Inc. enters immunotherapy research agreement

              20150918 - Sep 18, 2015
              ISSUE 34 – SEPT. 18, 2015PDF

              A New Doubling: Advocates, NCI Seek 7% Boost for Medical Research Funding

              NIH, NCI and FDA should receive budget increases of at least 7 percent a year, the 2015 Cancer Progress Report by the American Association for Cancer Research recommends.

              The NCI Bypass Budget for 2017, published almost simultaneously with the AACR report, requests a series of annual 7-percent increases for NCI, which over a decade would double the institute’s budget. 

              NCI Bypass Budget Calls for 7% More in 2017—and Doubling by 2026

              The NCI Bypass Budget for 2017 asks for a 7-percent increase over fiscal 2016, followed by a series of annual 7-percent increases that would continue through 2026, when the institute’s budget would double.

              The Bypass Budget is submitted by the NCI director to the U.S. President under a unique authority given to NCI under the National Cancer Act of 1971. Over the years, the budgets have had different functions, which reflected the priorities—and styles—of the institute directors who submitted them.

                Lowy: Increase for Cancer Center Grants Is Contingent on FY2016 Appropriations

                NCI is planning to increase funding for the Cancer Center Core Grants, Acting Director Douglas Lowy said to the National Cancer Advisory Board at a meeting Sept. 16.

                “Whatever we do, I’m not going to talk about the FY16 budget, but I just want to point out that it has not been passed, and until it is passed and until we get an increase in our appropriation, we would need to hold in abeyance the commitment for full funding for the increases in order to be fiscally responsible,” said Lowy during his second director’s report since he became acting director.

                Robert Califf Tapped for FDA Commissioner Position

                President Barack Obama nominated Robert Califf to the post of Commissioner of Food and Drugs.

                Earlier this year, Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency. Califf, 63, is an expert in cardiology, clinical research, and medical economics.

                NCI Funds Five Teams to Work with Animal Models for Children’s Cancer

                NCI has funded five research teams to participate in its Pediatric Preclinical Testing Consortium.

                The consortium is designed to focus on preclinical models in order to help prioritize agents for entry into clinical trials.

                In Brief

                • Jones, Parwani recruited to key roles in Ohio State Wexner pathology programs

                • Broad Institute, MD Anderson Cancer Center designated as Genome Characterization Centers

                • Robin Davisson named president and CEO-elect of Melanoma Research Alliance

                • MD Anderson and Esperance Pharmaceuticals enter strategic alliance

                Drugs and Targets

                • AbbVie submits sNDA for Imbruvica in CLL Patients

                • FDA grants fast track designation to Can-Fite BioPharma Ltd.’s liver cancer drug 
                • FDA accepts Wellstat Therapeutics’ NDA for treatment of chemotherapy overdose

                • FDA and the European Medicines Agency accepts regulatory applications for Gilotrif
                • AstraZeneca and Peregrine Pharmaceuticals enter into immunotherapy clinical trial collaboration

                • ICON teams up with IBM to reduce time and costs of drug development