News & Views: 6/1 - 6/7

June 8, 2021

The FDA approved of Biogen’s controversial Alzheimer’s disease drug, Aduhelm (aducanumab).

The drug is the first new therapy approved for Alzheimer’s disease since 2003 and the first to address the pathophysiology of the disease. The FDA went against the advisory panel’s vote, which opined that there is minimal if any beneficial clinical results so far and granted Aduhelm broad label, which has few restrictions on usage. Part of the accelerate approval pathway requires the manufacturer, Biogen, to conduct post-approval studies to verify the drugs clinical benefits. The drug’s wholesale price is set to be $56,000 which was greater than both Wall Street expectations and cost-effective estimates. To read the FDA’s press release and more about the approval and pricing, click here and here, respectively.

The White House’s response to PhRMA’s lawsuit on allowing the importation of Canadian drug implies the FDA will not be allowing states to import drugs anytime soon.

The White House’s court filing requesting the lawsuit be thrown out noted that while two states have submitted proposals to the FDA, there is currently no timeline for a decision to be made. To read the full article, click here.

FTC released a report on their intentions to investigate and how it could potentially prosecute rebate walls.

Rebate walls or the rebate paid by manufacturers to PBMS for superior formulary placement impede effective competition, according to the FTC. These rebate walls incentivize PBMs to block access to less expensive drugs that would be just as effective, because the more expensive drug manufacturer is offering a larger rebate. The report was notably absent of any potential consumer benefits but did include three previous health care lawsuits that could be applied to rebate walls in the future. To read the full report, click here.

Tennessee Governor Lee (R) signed a new PBM reform legislation into law.

The new law (SB167/HB1398) will allow for more oversight of PBMs. The law will primarily prohibit PBMs from reimbursing pharmacies below their acquisition costs, steering patients through coercive copays, spread pricing, and discriminatory payments for 340B prescriptions. To read the TN bill, click here.

The AARP Public Policy Institute analyzed the significant increase in Medicare Part D spending over the past decade.

The report concludes that one of the largest drivers of this increase is the increase in brand-name drug price growth faster than the rate of inflation. In 2019,Medicare Part D spent $77 billion on the 50 drugs with top Part D spending, however if price increases on those drugs were limited to the rate of inflation since 2015, Medicare could have saved $16 billion. Between 2015-2019, Medicare Part D has spent an extra $38 billion on the top 50 drugs alone, due to price increases that have exceeded the rate of inflation. To read the full report, click here.

A recent KFF tracking poll found that prescription drug prices are still the public’s top health care priority.

The poll found that 88% of voters favor allowing the federal government to negotiation for lower drug prices, including 77% of Republicans, even after hearing the pharmaceutical industry’s innovation arguments.  To review all of the finding, click here.

CIDSA Experts in the News

Sean Dickson and Richard Frank, along with colleagues, authored a Health Affairs blog post on the FDA’s recent approval of the new Alzheimer’s disease drug, Aduhelm. The authors call on CMS to preemptively request a National Coverage Determination (NCD) to best protect vulnerable Medicare beneficiaries from a drug that has significant risks and minimal potential benefits. To read the full article, click here.  

Stacie Dusetzina spoke on KHN’s ‘What the Health?’ podcast on how high drug prices are difficult to address in Congress.  Dusetzina addressed why drug prices seem to be of a particular focus lately, even though hospital care makes up the most of healthcare spending, the role of PBMS, and price controls used in other countries. To listen to the full podcast episode, click here.

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