Home » Blog » Flatiron and NCCN Announce Cancer Quality and Outcomes Partnership and FDA Panel Recommends Approval of First Generic Biologic Drug

Flatiron and NCCN Announce Cancer Quality and Outcomes Partnership and FDA Panel Recommends Approval of First Generic Biologic Drug


IP Blog | Dave Melin | January 11, 2015

BioBlog Weekly oncologyThis week in healthcare, the FDA may soon approve the first-ever generic biologic drug in the U.S. and a study finds that if ACA subsidies were rescinded millions of Americans would be unable to afford their insurance coverage.

NCCN and Flatiron Health Announce Collaboration to Launch Novel Oncology Outcomes Database

Big data startup Flatiron Health and NCCN recently announced that they would collaborate to “create a cloud-based data repository of NCCN Member Institution data – the NCCN Outcomes Database.” According to a press release, this database would aggregate and sort EHR data with a focus on “cancer quality and outcomes assessment, as well as identification of key trends and patterns in the care of patients with cancer.”

For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug

On Wednesday, for the first time an expert panel unanimously recommended a lower-cost generic biologic drug, called a “biosimilar”, for approval by the FDA. “Express Scripts, the nation’s largest manager of prescription drug benefits, estimates that the introduction of EP2006 — to be called Zarxio in the United States — could save $5.7 billion in drug costs over the next 10 years.” For the full press release about Sandoz’s drug filgrastim, see this Nasdaq report.

ACA subsidies ‘essential’ to individual market, studies show

Two studies of federal ACA subsidies (which are currently being challenged in the Supreme Court case King v. Burwell) show that if the Court rules against allowing the subsidies to continue, “more than 9.6 million people would lose coverage they purchased through the health insurance exchanges, dropping the enrollment down to 4.1 million from 13.7 million people. That’s because they wouldn’t be able to afford the annual premiums, which would rise from $3,450 to more than $5,000.”

Multiple Pay Cuts Hit Doctors in 2015

As we move into 2015, doctors will be dealing with a “flurry” of new pay cuts, including reimbursement reductions, pay reductions, and reductions to Medicaid. “The biggest pay decrease will be a return to the old rates paid by the Medicaid program for poor Americans when a two-year pay bump under the Affordable Care Act that increased reimbursement 40 percent or more expires.”

Pharma and docs up in arms over Cancer Drug Fund cuts

PharmaTimes reports that while “the list of drugs to be cut from the Cancer Drugs Fund has yet to be confirmed… drugmakers and doctors have already gone public with their criticisms.” Particularly outspoken about their outrage are Eisai, makers of Halaven (eribulin), which is reported to be among the drugs pulled from coverage.

Harvard faculty who advised on healthcare reform upset with coverage

Faculty at Harvard University who advised the White House on health care reform aired their displeasure with their university health care plans in a recent New York Times article. One professor called the changes “deplorable, deeply regressive, a sign of corporatization of the university”; another said, “The changes in Harvard faculty benefits are parallel to changes that all Americans are seeing. Indeed, they have come to our front door much later than to others.”

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