Radar on Drug Benefits

CivicaRx, the nonprofit drug manufacturer owned by a consortium of health systems and health plans, aims to release a line of three insulins — glargine (Lantus), lispro (Humalog) and aspart (Novolog) — as soon as 2024. Those insulins will be available in vials or prefilled pens and will be priced at “no more than $30 per vial and no more than $55 for a box of five pen cartridges” for all consumers, regardless of whether they have insurance; the products will soon be submitted for review for interchangeable biosimilar approval by the FDA.

The CivicaRx initiative could do something that existing proposals to cap the price of insulin would not: It may actually lower the list price of insulin products. Ge Bai, Ph.D., tells AIS Health, a division of MMIT, that she expects the insulins will set the standard price in their category when they become available. (Bai, a professor at Johns Hopkins University’s schools of business and public health, has authored several publications with Dan Liljenquist, an executive at the Intermountain Healthcare hospital system and the chair of CivicaRx’s board.)

The main health insurer and PBM trade groups are not fans of CMS’s proposal to reform the direct and indirect remuneration (DIR) system in Medicare Part D, judging by their recently submitted comment letters and interpretation of a recently published actuarial analysis.

The policy in question is part of the 2023 Medicare Advantage and Part D proposed rule, which CMS issued in January. Among a slew of other provisions, the agency is seeking to require part D plan sponsors to apply all price concessions that they receive from network pharmacies at the point of sale. Smaller pharmacies have long complained that the current system — in which Part D plan sponsors can recoup price concessions (i.e., DIR) from pharmacies for dispensed drugs if the pharmacies do not meet certain metrics — makes it difficult if not impossible to do business.

After disruptions during the height of the COVID-19 pandemic, the National Academies of Science, Engineering and Medicine (NASEM) convened a committee to ensure that supplies of medical technology and pharmaceuticals wouldn’t be interrupted during future crises. Experts tell AIS Health, a division of MMIT, that while the report’s recommendations will help prevent disaster pricing if implemented, it won’t have a significant effect on the pricing behaviors or day-to-day operations of PBMs.

The panel, a multidisciplinary group of business leaders, medical practitioners and academics — which included recently approved FDA head Robert Califf, M.D. — had seven notable recommendations, according to an official summary:

With drug price reforms on the agenda, pharmaceutical companies last year rallied their significant lobbying resources to block or water down transformational policies. Partly as a result of those lobbying efforts, drug price reform is on the ropes, though sources say there is a meaningful chance that a standalone drug price reform bill could pass Congress this year before the midterm elections.

Drug price reform efforts have most recently been part of the proposed Build Back Better Act (BBBA), a bill that contains much of President Joe Biden’s proposed policy agenda. That bill stalled out in December, when centrist Sen. Joe Manchin (D-W.Va.) said he could not back the measure as proposed. When Congress disbanded for the holiday recess, the BBBA had several notable drug-pricing provisions. The federal government would have been able to negotiate the prices of certain high-cost medications with pharmaceutical manufacturers. Also, drug prices would be barred from rising at a higher rate than inflation, the Medicare Part D benefit design would be revamped to lower beneficiaries’ out-of-pocket costs and the price of insulin would be capped. Moreover, the never-implemented Trump-era rule that would have overhauled the prescription drug rebate structure in Medicare Part D would have been repealed.