20160311 - Mar 11, 2016
ISSUE 10 – MARCH 11, 2016PDF



CMS Experiment Targets Incentive To Use the Most Expensive Drug

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive for doctors to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services announced a proposed rule to test new models to improve Part B payment for prescription drugs.

 

Slamming the Door

Part VII: DePinho’s Stock Tip Revisited

On May 25, 2012, I received an email from Len Zwelling:

Paul: It can’t get worse than having our President pushing his own stock on TV. Len.

I clicked on the provided link to CNBC. What I saw was indeed difficult to process: a video of Ron DePinho, extolling the virtues of the stock of AVEO Pharmaceuticals Inc., a company he co-founded.

National Academy of Medicine Calls for Integrated FDA-CMS Pathway for Biomarker Tests

The National Academy of Medicine listed 10 goals for advancing the appropriate use of biomarker tests in precision medicine.

“How do we ensure patients have timely access to appropriate tests that may accurately direct targeted therapies, while at the same time protecting them from potential harm due to the adoption of poorly validated tests or inappropriately used tests?” the report asked, saying that broader implementation was being held back by a lack of consensus over evidentiary standards, inefficient and inconsistent regulatory and reimbursement approaches, the need for a framework for collecting patient data, and translating that data into improved patient outcomes.

Companies, Health Systems Commit to Data Interoperability

Companies that provide 90 percent of electronic health records used by U.S. health care organizations have agreed to improve the flow of health information for consumers and health care providers, HHS officials said.

 

Study: California Hospitals with Low Volumes of Surgeries Associated with Higher Risks

In California, nearly 75 percent of the state’s hospitals performed only one or two surgeries when treating one of 11 selected cancer types in 2014, according to a report from the California Health Care Foundation.

The report linked the low hospital surgery volumes with higher rates of mortality and complications, while evaluating cancers of the bladder, brain, breast, colon, esophagus, liver, lung, pancreas, prostate, rectum and stomach.

Obituary

UNMC Scientist Michael Brattain Dies Unexpectedly at Age 68

Michael Brattain, University of Nebraska Medical Center Eppley Institute professor and associate director for basic research in the Fred & Pamela Buffett Cancer Center, died unexpectedly in his sleep March 5. He was 68.

“Mike was a brilliant scientist who had a prolific scientific career,” said Kenneth Cowan, director of the Eppley Institute and the Buffett Cancer Center. “Mike’s experience and input was extremely valuable to me in many areas within the Buffett Cancer Center.

In Brief
  • Sadik Esener to lead OHSU Center for Early Detection Research

  • Jorge Lopez Jr. Named MSKCC General Counsel

  • Aron Parekh receives research grant from American Cancer Society
  • Robin Mjelle receives grant from Addario Foundation and International Association for the Study of Lung Cancer

  • William Grady receives grant from DeGregario Family Foundation and the Price Family Foundation

  • Baylor College of Medicine and Baylor Scott & White Health enter collaboration

  • Tufts Medical Center and New England Cancer Specialists form affiliation

  • UC San Francisco and Berkeley Lights Inc. form collaboration

Drugs and Targets
  • FDA Approves Xalkori in NSCLC with ROS-1 mutations

  • FDA Approves American College of Radiology Digital Mammography QC Manual

  • Regulatory Authorities in Six Countries approve Yondelis

  • China Food and Drug Administration Approves CINtec PLUS Cytology Test

  • Veritas Genetics introduces whole genome platform for under $1,000

 

20160308 - Mar 8, 2016
BREAKING NEWS – MARCH 8, 2016 

In an Experiment, CMS Will Vary Part B Drug Payments by Providers’ ZIP Codes

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services is on the verge of announcing a Part B Drug Payment Demo, a project where ASP add-ons would vary based on zip codes.

    20160304 - Mar 4, 2016
    ISSUE 9 – MARCH 4, 2016PDF



    NCI Developing Mouse Models To Succeed NCI-60 Cell Lines

    The NCI-60, a panel of 60 cancer cell lines that have become the Rosetta Stone for the development of anticancer drugs, may be entering its twilight years as NCI develops new, and more expansive, patient-derived xenografts, or PDX models.

    For over 25 years, the NCI-60, a set of about a dozen tissue types—leukemia, non-small cell lung, small cell lung, colon, CNS, melanoma, ovarian, renal, and breast—have been used to perform initial screens on over 100,000 compounds.

     

    Conversation with The Cancer Letter

    Doroshow: Evidence Suggests PDX Models Come Closer to Simulating Human Cancer

    NCI is developing patient-derived xenograft mouse models as a potential substitute for the NCI-60 cell lines, a standard screen which experts say can no longer keep up with advances in cancer research and targeted molecular therapy.

    “The goal is to try to understand whether these new models will be more successful in providing a better reflection of the underlying biology in the context of the clinical history and treatment history of patients from whence the tissues came,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis and deputy director for clinical and translational research.

    Slamming the Door

    Part VI: The Provost’s Choice

    After my conversation with Gilman, I called MD Anderson and asked to talk with somebody about the $18 million grant for a biotech incubator.

    First, folks at the press shop told me that they view the controversy arising from the application as CPRIT’s problem.

    Let’s see: the wife of president of MD Anderson gets a grant seemingly out of turn, causing a political disaster, and this is not an MD Anderson problem?

    National Academy of Medicine Publishes Report on Categorizing Different Ovarian Cancers

    Ovarian cancer should not be categorized as a single disease, but as many different cancers involving the ovary, according to a report published by the National Academy of Medicine.

    Questions remain on how and where various ovarian cancers arise, said the report that also presents research opportunities for reducing the number of women who are diagnosed with or die from ovarian cancers. Roughly two-thirds of women are diagnosed at an advanced stage when the cancer has already spread beyond the ovary, of which less than 30 percent survive past five years. The report was also sponsored by the Centers for Disease Control and Prevention.

    Funding Opportunity

    FDA Providing $2 Million for Natural History Studies in Rare Diseases

    FDA will provide $2 million in two to five research grants for the study of the natural history of rare diseases. The objective of the grants is to expedite the development of products for these conditions.

    The Feb. 29 announcement marks the first time FDA will provide funding through its Orphan Products Grants to collect data on the progression of specific rare diseases in individuals over time.

    In Brief

    • Joan Massagué wins Pezcoller-AACR International Cancer Research Award

    • David Weiner named executive vice president at The Wistar Institute

    • Douglas Levine named director of gynecologic oncology at NYU Perlmutter Cancer Center
    • Lauren Streicher joins Northwestern Medical Group as medical director

    • Michael Bukosky appointed chief operating officer of USMD Holdings Inc.

    • International Cancer Genome Consortium authorizes 1,000th user

    • IBM and New York Genome Center to collaborate using Watson technology

    • Vantage Oncology LLC acquired by McKesson Specialty Health

     Drugs and Targets

    • Imbruvica granted approval for first-line CLL patients

    • Health Canada approves Opdivo for metastatic NSCLC

    • FDA grants orphan drug designation to SELLAS’s WT1 cancer vaccine

    • EMA grants orphan drug designation to venetoclax

    • FDA and EMA grant orphan designations to FLAG-003 for glioma

    • Merck KGaA, Pfizer and Verastem enter into avelumab research agreement

    • NanoString Technologies and Merck to collaborate on Keytruda assay