News & Views: 2/8 -2/14

February 15, 2022

President Biden remains confident that the Build Back Better drug pricing policy proposals will remain the centerpiece of the package, even if the package is scaled-back.

Biden detailed the anticipated impact of each of the prescription drug related proposals, including Medicare negotiation, the insulin cap, and the Part D benefit design in a recent speech. The Build Back Better package remains at a standstill as Senator Ben Ray Lujan (D-NM) recovers from a stroke he suffered last month. To watch the full speech, click here.

Senators Sanders (D-VT) and Klobuchar (D-MN) introduced a new drug pricing bill, the Cutting Medicare Prescription Drug Prices in Half Act.

The bill would allow Medicare to pay the same prices that the VA currently pays for prescription drugs. The bill is similar to Senate Finance Committee Chair Wyden’s initial Medicare negotiation proposal, which has since been cut down to the current proposal in the House’s Build Back Better bill. The Senators tried to bring the bill up before the Senate but were blocked by Senator Crapo (R-IN). To read the full bill, click here.

The Senate confirmed Biden’s pick for FDA Chief, Robert Califf.

Califf had previously told Senate Finance Committee Chair Wyden that he will ensure the FDA use “every authority at its disposal” to ensure manufacturers of drugs approved under the accelerated approval pathway are held accountable in collecting postmarket data. While he has offered little detail on his plan, Califf has also stated he intends to work with Congress to give FDA more authority to regulate manufacturers who are granted accelerated approvals. Some Democrats remained opposed to Califf’s nomination, claiming his ties to the pharmaceutical industry are cause for concern. To read more about Calif’s position, click here.

CMS’ proposed NCD to cover approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through a coverage with evidence development (CED) received 9958 comments during the 30-day comment period.

The commenters included pharmaceutical manufacturers, drug price advocacy groups, academics, and patient groups. Notably, MedPAC submitted comments in support of CMS’ proposal. The group does not often comment on coverage decisions, but stated that they felt obligated to, as this decision has significant future implications, “including the potential fiscal implications, and because the decision invokes coverage with evidence development (CED), which we have discussed in the context of our prescription drug work.” To review the comments, click here.

  • To review CIDSA’s comment letter, click here.  

IQVIA released a new report on global pharmaceutical research and development trends up through 2021.

The report details the US launches, noting that it remains the country with earliest and highest number of new drug launches; the US launched 72 novel active substances in 2021, 44 of which were first-in-class and 40 of which had an orphan drug designation. The report also found that the 15 largest manufacturers invested $133 in R&D expenditures in 2021. The R&D pipeline, clinical trial activity, and clinical development productivity are also examined throughout the report. To read the full report, click here.

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