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This Week in Managed Care: September 5, 2015


The top managed care news this week included draft guidance to reign in the controversial 340B drug program and the top pharmacy benefit managers made it clear they are looking for price discounts for the PCSK9 inhibitors.


Hello, I’m Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, from the Managed Markets News Network.

PCSK9 Drugs

This week, the nation’s top pharmacy benefit managers, ExpressScripts and CVS Health, made it clear they expect price discounts when they talk with makers of newly approved PCSK9 inhibitors, which lower cholesterol up to 60%.

After the FDA approved Amgen’s Repatha late last week, the PBMs said they are no rush to put this drug class on formulary, and both will wait until their pharmacy and therapeutics committees meet while negotiating with the drug makers. ExpressScripts’ Chief Medical Officer Steve Miller, MD, said exclusions are not desired, but they are possible.

Amgen set Repatha’s price at $14,100 a year, just $500 below Sanofi-Regeneron’s Praluent. But prices in Europe, where regulators made the drug available to a broader group of patients, are about half that amount.

340B Draft Guidance

A draft guidance issued this week seeks to rein in a drug program designed to help safety-net hospitals. Many say the program has been abused at the expense of small providers, especially in oncology. The Health Resources and Services Administration this week unveiled a “mega guidance” that clarifies which types of services and settings trigger eligibility for the program, known as 340B.

The guidance doubles the number of conditions a covered entity must meet to gain the discounts. For example, prescriptions that are based on referrals from an organization affiliated with a 340B provider will not meet the test. Some experts wonder if the task of running a 340B program will become so bureaucratic that it won’t be worth it.

Said Beth Feldpush of America’s Essential Hospitals, “A hospital could say that the costs to run this program may outweigh the benefit of participation in it.”


The recent news that former President Carter will be treated with Keytruda introduced the term “immunotherapy” to many Americans for the first time. For oncologists, there’s amazing progress with immunotherapy in lung cancer, which claims more lives than any form of cancer in the United States.

Andrew Pecora, MD, recently discussed how immunotherapy works with chemotherapy for our AJMC Insights Series. Watch the interview with Dr Pecora on ajmc.com.

Veterans Affairs

Is all well with the VA? More than a year after the scandals over long waits for care—and altered records—comes a report from the Government Accountability Office (GAO) that asks a new question: Why are VA medical centers doing fewer studies of their mistakes?

It turns out that the “root cause analysis,” a key tool to improve quality, is less common than it used to be. The GAO found the number of these case studies dropped from 1862 to 1523 over a 5-year period, and no one seems to know why. This happened even though reports of adverse events, which trigger the reports, are up 7%. Quality care initiatives that the VA has pursued in recent years may account for the drop-off in root cause analyses, but the GAO said this should be tracked and recorded.

The VA didn’t argue with GAO’s findings and said it would follow up.

Accountable Care

Finally, there’s still time to register for the fall live meeting of the ACO and Emerging Healthcare Delivery Coalition, which takes place October 15th and 16th in Palm Harbor, Florida.

The keynote speaker will be Leah Binder of the Leapfrog Group, who is consistently named one of the most influential leaders in healthcare. A recent report from CMS found that ACOs with more experience perform better on financial and quality ratings, Coalition meetings are a great way to learn from those who have that experience. For information and to register visit our meeting page.

For everyone at the Managed Markets News Network, I’m Justin Gallagher. Thanks for joining us.

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