Spotlight on Market Access

Fourth-quarter 2024 “capped a dynamic year” for merger and acquisition (M&A) activity within health care services, including among large wholesalers purchasing physician groups, as well as interest in infusion providers. That’s according to health care investment banking firm Provident Healthcare Partners in introducing the most recent quarter’s market update report. In addition, private-equity groups continued to be active within health care services, both with platform companies and add-ons to those entities. And with a new administration perceived by many to be pro-business, expectations are high that deal activity across several sectors will be strong, say many industry experts.

In fact, this already has been seen in the pharma industry, which started the new year with multiple deals unveiled at the J.P. Morgan Healthcare Conference in mid-January, led by Johnson & Johnson’s $14.6 billion deal for Intra-Cellular Therapies.

The FDA recently approved a new antibody-drug conjugate (ADC) for the treatment of the most common form of breast cancer. While payers expect it to have some impact in their management of the condition, oncologists said they anticipate it having more of an impact on their prescribing, according to a Zitter Insights survey.

On Jan. 17, the FDA approved Daiichi Sankyo, Inc. and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk or Dato DXd) for the treatment of adults with unresectable or metastatic hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have received endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The agency used the Assessment Aid in its review of the Trop-2-directed antibody and topoisomerase inhibitor conjugate. The recommended dose is 6 mg/kg via intravenous infusion every three weeks, and the price of one 100 mg single-dose vial is $4,891.07.

When it comes to how the country’s three dominant PBMs cover the blockbuster drug Humira (adalimumab) and its many biosimilars, one year has made a major difference.  

As of 2025, AbbVie’s Humira either “has or will vanish from PBMs’ standard formularies,” Drug Channels CEO Adam Fein, Ph.D., wrote in his annual post analyzing which drugs were excluded on the standard commercial formularies offered by The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx, as of January 2025. 

One of the most notable drugs missing from the three largest PBMs’ standard commercial formularies this year is Humira (adalimumab), AbbVie’s blockbuster drug for treating autoimmune conditions that has seen significant biosimilar competition in the U.S. since 2023.

Overall, The Cigna Group's Express Scripts removed 21 medications from its 2025 National Preferred Formulary, while CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx cut 16 and 12 drugs from their Standard Control Formulary and Premium Standard Formulary, respectively, according to Pharmaceutical Strategies Group’s analysis.

From more merger and acquisition (M&A) activity due to the incoming administration’s pro-business stance to continued impacts from the Inflation Reduction Act (IRA), 2025 is likely to be a busy year for pharma. Will there be a potential increase in flexibility around planned deals by the Federal Trade Commission (FTC), or will challenges to deals persist? AIS Health spoke with Yana Faykina, director of advisory services at MMIT, and Kristin Pothier, U.S sector leader for life sciences at KPMG, about what the pharma industry may see in 2025. (Editor’s note: These comments have been edited for length and clarity. AIS Health and MMIT are both Norstella companies.)