Spotlight on Market Access

With a new executive order on prescription drug prices, President Donald Trump directed HHS to extend the period in which new-to-market small molecule drugs are exempt from Medicare price negotiation, a policy change that pharmaceutical companies have long supported.

The Medicare Drug Price Negotiation Program, which is part of the Inflation Reduction Act, allows the federal government to negotiate the prices of select drugs if they are brand-name medications or biological products without generic or biosimilar equivalents. Drugs subject to negotiation also must have been on the market seven years (for small molecule drugs) or 11 years (for biologics) after FDA approval.

New entities within the biggest vertically integrated PBMs have allowed the parent companies to restructure their profit sources. And the old approach of dispensing generic drugs by mail has largely been abandoned in favor of new ways to grow profit, such as becoming integral parts of the specialty market. Longtime industry expert Adam J. Fein, Ph.D., president of Drug Channels Institute, an HMP Global Company, explored these and other trends and challenges within the PBM industry during an April 4 webinar.

Vertical integration, he explained, can be beneficial to these companies because “they can do more things; they can take more risk.” He pointed to UnitedHealth Group, which has more than 5 million lives for whom it is fully at risk because the company “can control all aspects of care except for hospitalization” via its infusion clinics, physicians, pharmacies, PBM management and insurance. It can “go completely at risk.”

Several oncology drugs that initially came to market as intravenous infusions are now available as subcutaneous injections. Both payers and oncologists expect the agents will have a positive impact in several aspects, according to a Zitter Insights survey.

Roche Group member Genentech USA, Inc. has a handful of these agents: Rituxan Hycela (rituximab and hyaluronidase), which was approved June 22, 2017; Herceptin Hylecta (trastuzumab and hyaluronidase-oysk), which was approved Feb. 28, 2019; and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), which was approved Sept. 12, 2024.

Finding a vendor that shares an insurer’s organizational values while enhancing member experience is crucial to getting good return on investment (ROI) from digital health solutions, according to panelists on a recent webinar sponsored by Medicaid Health Plans of America.  

“One of the things that I would say we value is partners who are equally value-based,” said Rebecca Geist, national director of government programs business development for Kaiser Permanente. 

It’s also a matter of ensuring a vendor is “a reflection of our mission and values” and ensuring members retain care and coverage, Geist added. 

President Donald Trump’s administration on April 4 abandoned a proposal from Joe Biden’s administration that would have expanded Medicare and Medicaid beneficiaries’ access to obesity drugs, including the popular but costly GLP-1 medications.

Data from MMIT Analytics shows that fewer than 4% of Medicare enrollees have plans that put  Wegovy (semaglutide) and Zepbound (tirzepatide) — GLP-1s that were approved for weight loss — under the preferred/preferred (prior authorization and/or step therapy) tier and covered/covered (PA/ST) tiers, as of April 2025 (AIS Health is a division of MMIT.) While Medicare Part D plans are barred by statute from covering weight-loss medications, they can cover them when they are approved for other indications, like reducing the risk of stroke or heart attack in patients with obesity.