ACHP Media Report: Pharmacy News – October 13, 2017



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October 13, 2017

 Administration actions on ACA
The Administration will end CSR subsidies, citing a lack of Congressional approval for the payments. Experts believe the decision could prompt insurers to raise premiums or withdraw from the individual market. Lawmakers from both parties had hoped the Administration would continue the payments. Senate HELP Chairman Lamar Alexander (R-TN) and Sen. Patty Murray (D-WA) are attempting to negotiate a bipartisan market stabilization package that would include CSR funding. ACHP’s statement can be found here.

President Trump has also signed an executive order to relax regulations on association health plans, make it easier to use pretax dollars to purchase insurance and expand the use of short-term coverage. Analysts believe association health plans and short-term coverage plans would be exempt from certain ACA protections. However, details about implementation are unclear. ACHP President and CEO Ceci Connolly warned the executive order could draw younger and healthier people away from the exchanges and drive additional plans out of the market. ACHP’s statement can be found here.

Both actions are being interpreted by many experts as just two of many ways the Administration is attempting to undo major aspects of the ACA. The New York Times has compiled a list of 12 ways the President has scaled back the ACA.

Drug Pricing Discussion Continues
Gov. Jerry Brown signs drug transparency law
On Monday, California Governor Jerry Brown signed into law legislation that requires drug manufacturers to give a 60-day notice if prices are raised more than 16 percent over a two-year period, and insurers to file reports documenting how drug costs impact premium rates. The legislation aims to increase transparency in drug pricing and could serve as a model for other states. The Governor also signed an additional measure that limits the use of rebates and coupons for brand-name medications when a cheaper generic form of the drug is available.

Trade groups call into question Allergan Plc’s patent deal
ACHP joined a coalition of 10 groups including hospitals, health plans and generic drugmakers in sending a letter to Congressional leaders asking them to examine Allergan’s controversial patent deal with a Native American tribe. The letter came after at least nine Members of Congress raised objections to the deal, in which Allergan transferred patents from its $1.4 billion eye drug Restasis to the Saint Regis Mohawk Tribe, whose sovereign immunity could shield it from certain patent challenges from generic drugmakers.

FDA Happenings
FDA approves record number of generics
The FDA approved a record number of generic drugs in fiscal year 2017. The agency approved 763 applications, well above its previous high of 651 in 2016. Generic drugmakers filed more than double the amount of applications in fiscal year 2017 then they did just two years ago. The rise in activity is also in response to the expiration of patents on brand-name drugs and greater interest in the U.S. market among foreign companies. FDA hopes bringing more generics into the market will create competition and bring down costs.

FDA advisers review gene therapy treatment
Health advisers are reviewing a new treatment for a type of inherited blindness that could lead to the launch of a new genetic medicine. An FDA panel will vote on a recommendation for approval of the treatment that improves vision by replacing a defective gene. If approved, the treatment would be the first gene therapy in the U.S. for an inherited disease.

An FDA program to approve old drugs causes higher prices and shortages
The FDA launched the Unapproved Drug Initiative in 2006 requiring drug manufactures who had not complied with a 1962 law requiring they prove their medicines were effective to seek approval for drugs on the market or remove them from sale. However, the FDA program had some unintended consequences. According to a recent study, the program did lead to more approved drugs, but shortages and price increases – by a median of 37 percent – followed. The researchers concluded that when the FDA acts against an unapproved drug, fewer manufacturers remain in the market potentially enabling price increases and greater susceptibility to drug shortages. Many believe the program can be improved.

NIH and pharma partner on Cancer Moonshot
The National Institutes of Health is teaming up with 11 pharmaceutical companies to collaborate on cancer immunotherapy research as part of the Cancer Moonshot. The partners will contribute a total of $215 million to the five-year project called the Partnership for Accelerating Cancer Therapies. The partnership seeks to find out why immunotherapy works differently on different patients and will test biomarkers in clinical trials to understand how cancers respond to or resist immunotherapy.

The Opioid Epidemic
Many Medicare plans lack limits on opioids
A study from Yale found many Medicare plans do not restrict coverage for opioids in a way that conforms with CDC guidelines. In 2015, one third of opioid prescriptions covered by Medicare were not subject to any restrictions, such as prior authorization or step therapy. Medicare often serves as a standard for other insurers, and the study’s authors believe enacting tighter controls on opioids for Medicare plans could lead to broader and more effective industry standards.

To curb opioid prescriptions, Colorado turns to alternative treatments
Hospitals and emergency rooms in Colorado are testing non-opioid pain treatments to help cut down the number of opioids prescribed. A coalition of health care providers have begun prescribing non-opioid pain relievers, topical therapies and muscle relaxants, and are tracking data to see if opioid prescription rates decrease. Swedish Medical Center Medical Director Dr. Donald Stader, one of the doctors leading the effort, believes the final results will be released next year, but notes preliminary data suggests the effort is proving successful.

Cities and states continue to pursue legal action against drugmakers
Almost a dozen cities and 46 states have taken legal action against drugmakers for deceptive practices that downplayed the risks of opioids. Drugmakers continue to dispute the allegations and claim they are committed to fighting the epidemic. One state—Washington—has already extracted settlements from Cardinal Health and AmericasoureBergen, worth more than $35 million dollars. One of the chief litigators for many of the states suing drugmakers is Paul Hanly, who managed one of the few lawsuits to successfully extract a settlement from drugmakers for opioid advertising practices in the mid 2000s. Hanly believes he was successful due to his efforts to humanize those addicted to opioids and his willingness to commit most of his resources to the case.

Federal lawmakers propose solutions to opioid crisis at hearing
More than 50 lawmakers testified Wednesday at a House of Representatives committee hearing on the nation’s opioid epidemic. The lawmakers discussed how the crisis has impacted their communities along with possible solutions. Many applauded the bipartisan legislation passed last year allotting hundreds of millions of dollars to combat opioid abuse, but said that more remains to be done. Solutions proposed by lawmakers included providing doctors with patient histories of opioid use and a repayment program for students who focus on addiction treatment.

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