Cathy has covered US regulation and reimbursement policy for the biopharma industry since 2004, starting with the establishment of the Medicare Part D program. Since then, she has written extensively about developments in all major sectors of the US insurance market (Medicare, Medicaid and commercial plans). She has covered key legislation affecting biopharma, including the Medicare Prescription Drug, Improvement, and Modernization Act which created Part D, health care reform under President Obama, and the Inflation Reduction Act which establishes a government price negotiation program in Medicare for the first time and redesigns of the Part D benefit.
She has closely followed the increasing influence of pharmacy benefit managers and their use of formulary negotiations and rebates to control pricing. Cathy also has covered developments in health technology assessments, including the growing influence of the Institute for Clinical and Economic Review, and has monitored industry progress on novel drug contracting that reflects value-based pricing.
She has worked as a health care reporter and editor while raising three daughters. Cathy lives outside DC in Bethesda, MD, with her husband Sean.
Latest From Cathy Kelly
The early February date for publishing the list of products eligible for price negotiations could dictate approval strategies for drugs with potential for big sales in Medicare going forward.
Increased application of utilization management controls expected as plans face higher costs under the redesign. However, the formulary advantages available to drugs in the protected classes may lead developers to sharpen their focus on those categories.
FDA-approved language recommending ongoing patient monitoring through a registry is unusual but not unprecedented to address potential safety concerns.
After getting a formal request for Medicare to reconsider coverage for Eisai’s new drug and other mAbs, CMS must decide by mid February whether to undertake the process. The formal timeline for reconsideration runs six to 12 months; past reviews have taken around nine months.
Unusual national coverage determination for a prevention-only drug was opened in response to a formal request from ViiV for its long-acting injectable.
As milestone approaches in FDA effort to pull the pre-term birth drug, the findings suggest that by leaving Makena on the market, the agency may be ‘furthering plan inaction,’ Tufts Medical Center researchers conclude.