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MFN Goes to Court

 A U.S. District Court in Maryland heard arguments this morning on PhRMA’s attempt to delay implementation of the Trump administration’s Most Favored Nation drug pricing rule. Lawyers from PhRMA and the National Infusion Center Association, in asking for a temporary restraining order and injunction, argued that the rule should be delayed past Jan. 1 to avoid disruption and negative impacts to Medicare patients. A decision about issuing a restraining order is expected by Christmas.

Also, Coherus and Regeneron filed their own MFN suits. Coherus said its sole product, Udenyca, would see its price drop immediately by more than 20%, and by 95% within four years. Udenyca is the only biosimilar included in the MFN project and is not sold outside the U.S., so the MFN program is using Udenyca’s branded counterpart, Amgen’s Neulasta, as its benchmark.

Drug Prices Are Falling

Reports of drug prices going up is always news: last January, we counted 40-plus pieces on beginning-of-year price list-price hikes. The opposite trend – evidence that drug prices are dropping – doesn’t seem to generate the same excitement.

As a result, the blockbuster finding from the Centers for Medicare & Medicaid Services that the cost paid for medicines via retail pharmacies dropped in 2019 for a second straight year went almost unnoticed. But make no mistake: CMS’ National Health Expenditures data reported a 0.4% drop in prices following a 1.0% drop in 2018. Overall, drug spending was up 5.7%, driven by more use of medicines.

Higher spending of specialty medicines did play into one other finding: the larger-than-usual jump in Medicare spending, which was driven by more seniors ending up in the “catastrophic” phase of Part D.

The NHE report – which also found that overall spending in the United States was up 4.6%, to $3.8 trillion – breaks out only spending at retail pharmacies, which means that other drug spending, such as hospital use of medicines, isn’t captured.

Vaccine Prices in Europe Get Leaked

On Thursday, Belgium’s Budget State Secretary Eva De Bleeker accidentally leaked the EU’s COVID-19 vaccine prices…in a since-deleted tweet. The tweet contained a chart of each vaccine and the respective price per dose. European prices range between €1-€15, roughly equivalent to $2-$18, and The Washington Post reports that the Pfizer/BioNTech, Oxford/AstraZeneca and Sanofi/GlaxoSmithKline vaccines are priced lower in the E.U. than in the U.S.

A European Commission spokesperson refused to comment on the leak, except to reiterate that prices are confidential and that vaccine developers contractually require secrecy over prices in their purchasing agreements. De Bleeker said the incident was “a mistake” made by the Belgian communications team.

The tweet:

340B in NYT and Objections from the AGs

 The two things notable on the 340B front this week: the ongoing dispute moved into the mainstream, with a story in The New York Times that focused on the hospitals and clinics objecting to drug company actions to keep contract pharmacies – which manufacturers say aren’t eligible – out of the program. Also, in another show of how politically influential hospitals are at the state level, a bipartisan group of 28 state attorneys general – led by Health and Human Services Secretary-designate Xavier Becerra, the California AG – filed a lawsuit against HHS in an attempt to get the agency to impose fines on the drug makers if they continue the restrictions.

 ACCESS: Pharma CEOs Should Step Up Globally

  • Jayasree Iyer, executive director of the Access to Medicine Foundation, urged pharma CEOs to leverage their power to help solve global health challenges and expand access to medicines around the world, especially in low-income countries. In a Fortune op-ed, Iyer said that a fundamental shift is needed across the industry to challenge the “ingrained expectations of sky-high profit margins.”
  • Rural Americans will likely have a harder time getting vaccinated against the novel coronavirus than their urban counterparts due to a weak health care infrastructure, vaccine hesitancy and a complex vaccine distribution process, Axios reported.