News & Views: 7/6 - 7/12

July 13, 2021

The Biden administration issued an executive order on ‘promoting competition in the American economy.’

The executive order addresses the trend of corporate consolidation and the subsequent reduction in competition that has led to lower wages and higher prices across most industries, in particular healthcare and prescription drugs. Among the 72 initiatives outlined in the order, President Biden took particular notice to rising prescription drug costs. The order includes directions for the FDA, CMS, and FTC to boost biosimilar markets, urges HHS to create a comprehensive plan to address high prices and price gauging by allowing states to import drugs from Canada, and reverses Trump’s proposed rule that weakened march-in rights. To read the full order, click here.

Senate Finance Committee Chair Wyden (D-OR) is exploring a domestic reference pricing mechanism for his upcoming drug pricing legislation.

The use of international reference pricing in the House’s HR 3 has been a particular point of contention by patient advocacy groups. Most of the comparable countries in the House bill base their drug prices off of QALYs, which patient groups advocate against as they assign lower value to medications for people with disabilities and seniors. By creating a domestic reference pricing mechanism that appraises a drug’s clinical worth, prices will not be based off of QALYs and therefore deflect some of the lobbyists’ concerns. To read the full article, click here.

The House Committee on Oversight and Reform released a new staff report into pharmaceutical pricing and business practices.

The report is the seventh staff report from the pharmaceutical industry investigation that began back in January 2019.  This report analyzes the financial data of the 14 largest leading pharmaceutical manufacturers in the world to “evaluate the amount they spend to enrich investors and executives, the amount the invest to research and develop new treatments, and the potential impact of direct Medicare price negotiations.” In addition to discovering that twelve of the fourteen leading companies spend more on buybacks and dividends than R&D, it also analyzes trends in executive compensation and what kind of expenses get classified as R&D expenditures. To read the full report, click here.

The FTC announced drug makers, pharmacy benefit managers (PBMs), and hospitals will be among their law enforcement priority industries for the next ten years.

The priority target areas were chosen based off of which industries are common offenders. The resolutions passed by the FTC authorize the agency staff to use compulsory process (i.e., subpoenas) to investigate the specified industries. The resolutions also permit staff to use the compulsory process to investigate anticompetitive mergers. To read the complete press release, click here.

AARP released a new survey on seniors’ views on prescription drug costs.

The survey asked Americans (50 and older) about their prescription drug use, spending, and feelings towards the industry.  While seniors 50-64 years old were found to be more concerned with costs than Americans 65 and older, 87% of all surveyed seniors believe Congress should take action to address this problem. When asked about specific policies, 87% of respondents supported allowing Medicare to negotiate with manufacturers for lower prices. To review all of the findings, click here.

CIDSA Experts in the News

Sean Dickson spoke with Inside Health Policy reporters on AHIP’s request for a national coverage determination (NCD) for Aduhelm. The petition for an NCD now aligns with the new narrow label that Biogen issued, which indicates that the drug is only meant for patients with mild Alzheimer’s. Dickson discussed how this petition is additional evidence that plans are worried about the significant impact that the cost of Aduhelm will have on their finances. To read the full article, click here.

Stacie Dusetzina and colleagues discussed drug pricing reforms of 2021 in a JAMA Forum post. The authors compare the success of the COVID-19 vaccine and the government’s success in purchasing at a reasonable cost to allow US residents to receive it free of charge to the controversial approval of aducanumab priced at $56,000. They opined that the US could continue the success of the COVID vaccine by engaging in price negotiations and value-based pricing. To read the full post, click here.

Stacie Dusetzina also spoke with reporters at Bloomberg Law on President Biden’s recent executive order. Dusetzina specifically spoke to how importing drugs from Canada is not a practical policy solution to lower drug costs for patients. When the Trump administration released a similar drug importation policy in 2019, the Canadian government objected, as they do not have the infrastructure to support America’s needs. Instead, Dusetzina suggested Congress work to pass direct negotiation. To read the full article, click here.

Rachel Sachs spoke with Washington Post reporters on the rushed approval process of Aduhelm. Sachs, along with other experts, insisted that the approval was atypical for the FDA and that an investigation into the process would alleviate some of the public’s concerns. This article was written in the wake of FDA acting commissioner, Janet Woodcock, requesting the acting inspector general of HHS to investigate if Biogen and the FDA’s relationship was “inconsistent with the FDA policies and procedures.” To read the full article, click here.

Rachel Sachs spoke with reporter with Reuters and CNN on the impact of Aduhelm’s high price. Sachs emphasized that the high costs associated with aducanumab will increase Medicare out-of-pocket costs for all seniors, not just those on the drug. While the specific impact is still unknown, experts are estimating a significant increase to premiums. To read the articles, click here and here.

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