News & Views: 10/5 - 10/11

October 12, 2021

Senate and House Democrats continue to face uncertainty for the fate of their drug pricing legislation.

In the Senate, senators are waiting on Sen. Sinema (D- AZ) who has yet to state which policy proposal she will be supporting or what negotiations she will participate in. In the past, she has opposed all of the drug pricing proposals including Medicare negotiation in H.R. 3, but her spokesperson has said she is “reviewing various proposals around the issue” and is dedicated to lowering costs for patients. In the House, to garner support from the centrist members, some progressive members are willing to allow negotiation on a narrower set of drugs than outlined in H.R. 3. To read the full article, click here.

A US federal court judge dismissed Pfizer’s lawsuit that claimed their drug copay assistance programs help lower Medicare beneficiaries’ out-of-pocket costs.

Pfizer’s lawsuit was an attempt to seek approval for two copay assistance programs, one was direct assistance to patients and the other was providing funding to a charity that would assist patients directly. The judge ruled that copay assistance programs are clearly not permitted in the Medicare program so that manufacturers cannot encourage someone to purchase and take a certain drug over another. Pfizer settled a similar case for $23.9 million in 2018. To read the full article, click here.  

Researchers from Harvard Medical School examined the impact that the court decision on “skinny labeling” has on less expensive drugs in a JAMA viewpoint.

Skinny labeling is a way in which generic manufacturers can seek approval for their bioequivalent drugs even when the brand drug has patents covering the method-of-use. Generic manufacturers list the unpatented uses for their drug and exclude any methods that may still be patented. This allows generic alternatives to enter the market even when a brand manufacturer has a large patent thicket protecting their exclusivity. The researchers discuss the implications that the recent court decision in GlaxoSmithKline v Teva, where the judge ruled in favor of GlaxoSmithKline, will have on patients to access affordable prescription medications. Researchers called on Congress to propose legislation that will add a safe harbor for skinny labels. To read the full viewpoint, click here.

CIDSA Experts in the News

Richard Frank and his colleague from the Perelman School of Medicine at UPenn analyzed the price of cancer drugs approved through the accelerated approval process in a JAMA viewpoint. The accelerated approval pathway grants approval to drugs that have significant evidence of a benefit over existing treatments for serious and life-threatening conditions. All drugs approved through this pathway must complete confirmatory trials that confirm long-term patient benefit. Frank and his colleague proposed a CMMI demonstration, “pay for drugs that work,” that would ensure patients are not paying astronomical prices for drugs with no real evidence that they are better than the standard of care for that disease. To read the full proposal, click here.

Rachel Sachs, Stacie Dusetzina, and colleagues analyzed Medicaid spending and usage trends of drugs that used the accelerated approval pathway in a JAMA article. The researchers analyzed 216 drugs that have been approved through the accelerated pathway between 1992 to 2020. Of all drugs paid for by Medicaid, these drugs made up less than 1% of usage, but between 6.4% to 9.1% of net Medicaid spending on drugs (in 2015 and 2018, respectively). To read the full study, click here.

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