Tuesday, November 29, 2016

Drug Channels News Roundup, November 2016: CVS Caremark, Generic Drugs, Health-System Pharmacies, and the FDA

Hope everyone enjoyed the Thanksgiving holiday! Now that you’ve stretched your stomach, stretch your mind with some food for thought. In this issue:
  • Dispensing oncology practices win their battle with PBM CVS Caremark
  • 2016 was a record year for generic drug approvals (data below)
  • The ASHP’s latest forecast for health system pharmacy
Plus: The FDA approves a new product—with a twist!

P.S. ON SALE! Our 2016 Economic Report on Retail, Mail, and Specialty Pharmacies is now 40% off. The 2017 edition will be released in early February. (FYI: I announced the sale yesterday on @DrugChannels.)

CVS Indicates Reversal of Decision to Block Oncology Clinics Dispensing Patients’ Drugs, Community Oncology Alliance

Here’s a follow-up to a story that I highlighted in our September news roundup.  As you may recall, CVS Caremark notified dispensing physicians that under its interpretation of Part D regulations, practices without a pharmacy license would be excluded beginning January 1, 2017. Prescriptions filled at these practices would therefore become ineligible for third-party reimbursement by the Medicare Part D program.

The biggest impact would have been felt at oncology practices, which now account for 7% of the dispensing of patient-administered oral oncology products and 11% of patient self-injectable drugs. (See Section 3.2.3. of our 2016-17 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.)

The Community Oncology Alliance (COA) reports that CVS has reversed course and will not proceed with its plan. Physicians won this battle, but expect the war between payer-owned specialty pharmacies and physician dispensing practices to continue.

Office of Generic Drugs (OGD) Director’s Update (October 24, 2016), CDER/FDA

Kathleen Uhl, MD, director of the FDA’s Office of Generic Drugs, delivered this presentation at the GPhA Fall Technical Meeting. It provides a valuable data-filled look at the generic drug application process. As you can see in Dr. Uhl’s slide below, the government’s 2016 fiscal year (ending on September 30, 2016) was a record for approvals.

[Click to Enlarge]

Generic inflation began easing in 2015. This was due partly to the FDA’s having cleared much of the backlog for new generic drug applications. The FDA’s actions show why generic inflation is unlikely to return soon.

ASHP Foundation Pharmacy Forecast 2017: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems, American Journal of Health-System Pharmacy

Check out the latest trend report from the ASHP Research and Education Foundation's Center for Health-System Pharmacy Leadership. The report relies on responses from a panel of 148 pharmacists nominated by the leaders of the five ASHP sections.

Lots of intriguing insights here. For example, there is overwhelming agreement that health systems will have a formal payer agreement designed to enhance cost-effective use of specialty medications. (See page e630.) However, a majority of pharmacists are skeptical about “risk sharing agreements with biopharmaceutical manufacturers that call for price discounts if a product’s performance fails to meet specified targets.” (See page e633.)

In my experience, the forecasting track record of this survey is very mixed. However, the report offers valuable insights about how leading health-system pharmacists see the world.


FDA Approves New Pasta Shape, The Onion

America’s finest news source does it again with this important scoop. How long before the ANDA backlog starts boiling over? Dr.Uhl will hopefully address this topic in a future presentation.



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