FROM JAMA

Enforcing more stringent requirements for exclusivity rights, ensuring timely generic drug availability, and providing greater opportunities for meaningful price negotiation by government payers could help combat high medication costs in the United States, according to an analysis published Aug. 23 in JAMA.

Per capita prescription drug spending in the United States exceeds that in all other countries, largely fueled by brand-name drug prices rising at rates far beyond the consumer price index. For example, in 2013, per capita spending on prescription drugs was $858, compared with an average of $400 for 19 other industrialized nations, according to the analysis conducted by Aaron S. Kesselheim , MD, of Brigham & Women’s Hospital, Boston, and colleagues. In addition, between 2008 and 2015, prices for the most commonly used brand-name drugs in the United States rose by 164%, far more than the consumer price index increased (12%), authors reported (JAMA 2016. doi: 10.1001/jama.2016.11237 ).

“We found that indeed, drug prices in the United States are much high than anywhere else in the world and the main contributors to that are the U.S. drug marketplace which allows drug companies to charge whatever the market will bear and then in many respects, places limitations on the ability of payers to try to negotiate lower drug prices,” Dr. Kesselheim said in a video interview for JAMA.

To reduce high drug prices, authors propose better federal oversight of drug makers who attempt to extend market exclusivity. For example, changing how the U.S. Patent and Trademark Office interprets novelty and non-obviousness when issuing drug patents could help avoid new secondary patents based on clinically irrelevant changes to active drug products. Other strategies outlined include:

• Decrease industry expenses. Reviews have pointed to the increasing expenditures for drug research and development, with the suggestion that steps be taken to make companies’ investments more efficient.

• Pass state laws permitting substitution of clinically similar drugs within the same class in carefully selected circumstances.

• Increase attention to the generic drug marketplace. Proposed federal legislation would forbid brand-name manufacturers from refusing to share samples of products with generic drug manufacturers for necessary bioequivalence studies.

• Authorize Medicare to negotiate prices of drugs paid for by Medicare Part D plans.

Physicians can also play a role in decreasing drug prices by discussing drug prices and choices with patients and limiting practices such as writing “dispense as written” prescriptions to avoid generic medications, Dr. Kesselheim noted. More education about drug costs and value-based prescribing integrated into physicians’ initial and continuing education could also be beneficial.

“There needs to be more education of patients and physicians about the implications of high drug prices and ways they can ensure that the prescribing they are doing is of highest value,” Dr. Kesselheim said in the video interview.

agallegos@frontlinemedcom.com

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