HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Cathy Kelly

Senior Writer

Washington, DC

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

IRA Innovation Debate Showcased At House Hearing On Rare Disease Legislation

Bills to narrow the Medicare price negotiation program’s reach generated extensive discussion at the hearing.

Pricing Debate Rare Diseases

Medicaid Payment Model For Sickle Cell Gene Therapy May Have Limited Impact Until 2026

As further details emerge, questions continue about whether the CMMI model could delay access to Lyfgenia and Casgevy; states will be added on ‘rolling basis.’ A new administration could change or cancel the model, but a CMS official predicts that is unlikely.

Reimbursement Policy

Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says

As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.

Reimbursement Policy

340B Audit ‘Protections’ Needed Prior To Dispute Resolution Final Rule, Lilly Tells OMB

Lilly wants White House Office of Management and Budget to delay final rule until there are regulatory controls against duplicate and diverted discounts. OMB has also held three meetings over past few months with organizations representing 340B providers.

Reimbursement Pricing Strategies

PhRMA’s Lawsuit Against Medicare Trips Over ‘Administrative Remedy’ Standard; Will Others?

West Texas District Court dismisses lawsuit against Medicare price negotiation program on jurisdictional grounds without considering the merits of the case. PhRMA is weighing next steps.

Reimbursement Policy

Letting Paxlovid Go: HHS Seeking To Buffer Drug’s Sticker Shock In ‘Cold’ Commercial World

HHS Secretary Becerra challenges the commercial price Pfizer chose for its COVID-19 therapeutic as the government transitions from being the primary US customer for the drug.

Reimbursement Policy
See All
UsernamePublicRestriction

Register