Letter from the Director

Happy Holidays! This newsletter highlights new research examining how expedited FDA drug approvals are shaping cancer treatment and the role of clinical guidelines. We're also excited to share our involvement in CMS coverage evaluations and dissemination activities. 

We appreciate your interest in our work over the past year!

Best, 

Kathryn

News

Advising CMS on Medicare Coverage: Center Director Phillips joins MEDCAC 

Center Director Kathryn Phillips has been appointed to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), based on her expertise in evidence review and technology assessment. The MEDCAC advises the Centers for Medicare & Medicaid Services whether adequate evidence exists to determine whether specific medical items and services are reasonable and necessary under Medicare law. 

Emily Mrig Named UCSF Emerging Scholar 

Emily was named as one of only two 2026 UCSF Emerging Scholars. This program is designed to provide career development opportunities for UCSF early-career faculty via invited presentations at prestigious peer universities.

Publications

New Study Reveals How "Fast-Track" Drug Approvals Are Reshaping Colorectal Cancer Treatment 

TRANSPERS researchers Danea Horn, Mireille Jacobson, and Kathryn Phillips had a study published in the Journal of Managed Care & Specialty Pharmacy showing that 75% of colorectal cancer drugs were approved through expedited FDA pathways that prioritize speed over extensive testing.  One-third of current CRC drugs still lack confirmed long-term benefits from required follow-up studies, with some waiting up to seven years for confirmation. The study also highlights the growing complexity of precision medicine, with 100% of drugs approved since 2018 requiring diagnostic biomarker testing, which complicates both clinical decisions and managed care coverage policies. This study serves as a foundation for Danea’s broader research program, considering how limited evidence from expedited approvals shapes decision-making in healthcare. 

TRANSPERS Research Shows Clinical Guidelines May Not Reflect FDA Drug Approval Status 

In a paper published in Cancer Letters, Danea Horn, Kathryn Phillips, and Kevin Schulman examined how FDA expedited drug approvals are reflected in clinical practice guidelines by studying immune checkpoint inhibitors for the treatment of colon cancer. They found that the National Comprehensive Cancer Network (NCCN) guidelines sometimes recommend drugs before FDA approval and don't always distinguish between drugs with full FDA approval versus those still requiring confirmatory studies. This means clinicians may receive different information about treatments depending on whether they consult FDA labeling or clinical guidelines, which could affect treatment decisions and patient counseling.

Additional publications include the following:

• Use Of Independent Medical Review: Almost One-Half Of Coverage Denials Overturned

  • Lin GA, Coffman JM, Douglas MP, Phillips KA. Use Of Independent Medical Review: Almost One-Half Of Coverage Denials Overturned. Health Aff (Millwood). 2025 Dec 10:101377hlthaff202500716. doi: 10.1377/hlthaff.2025.00716. Epub ahead of print. PMID: 41370722.

• When Covering and Discovering Are at Odds: How the Logic of US Health Insurance Undercuts the Promise and Equity of Precision Medicine for People with Hereditary Cancer Risks

  • Mrig EH, Schlesinger M, Weiss JM, Pandhi N, Smith KC, Jacobson N, Grob R. When Covering and Discovering Are at Odds: How the Logic of US Health Insurance Undercuts the Promise and Equity of Precision Medicine for People with Hereditary Cancer Risks. J Health Polit Policy Law. 2025 Nov 19:12317993. doi: 10.1215/03616878-12317993. Epub ahead of print. PMID: 41254836.

Dissemination

TRANSPERS Director Phillips Contributes to Debate over Value, Coverage, and Access

Kathryn had two recent opportunities to join lively discussions on policy debates. On Nov. 14, she was a panelist at the Personalized Medicine Conference, joining experts from professional societies, payers, and industry to discuss evidentiary standards and ensuring fair access. On Oct. 1, she addressed questions on drug policy in a local news interview (KTVU Fox). 

TRANSPERS Researchers Emily Mrig and Grace Lin Present at Fall Conference

Emily and Grace both presented their work on blood-based biomarker tests for Alzheimer’s Disease at the UCSF Dementia Day conference.