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Cathy Kelly

Senior Writer

Washington, DC
Cathy Kelly has been covering reimbursement and market access news for more than a decade for "The Pink Sheet" and other publications that are now part of Informa's pharmaceutical intelligence resources. Her expertise spans legislative, regulatory and public policy topics as well as coverage trends in public and private insurance markets. Cathy is especially interested in following the ongoing transformation of the US health care system and its effect upon major stakeholders in the biopharma industry. She is based in Washington D.C.

Latest From Cathy Kelly

FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE

Results from the US Food and Drug Administration’s RCT DUPLICATE demonstration are in. The findings both legitimize certain real-world evidence studies and also highlight the challenges involved in using RWE to replicate randomized clinical trials.

Real-World Evidence Drug Approval Standards

Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill

By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.

Advertising, Marketing & Sales Reimbursement

A Case For Transparency: J&J Suit Targets Opaque PBM Affiliate’s Efforts To Exploit Copay Programs

Lawsuit highlights the lack of transparency into pharmacy benefit manager activities and how their programs can influence drug pricing. A Senate hearing on PBMs held shows increasing momentum behind a Federal Trade Commission study on potential anti-competitive activity in the market sector.

Reimbursement Policy

Medicare Part D Cost Sharing Rule Will Save Manufacturers Nearly $17bn

Despite objections from pharmacy benefit managers and insurers, the Centers for Medicare and Medicaid Services moves ahead with rule to transfer concessions directly to beneficiaries.

Medicare Reimbursement

Lilly’s Tirzepatide For Obesity Faces Uphill Road To Medicare Part D Acceptance

Eli Lilly’s drug could join Novo Nordisk’s Wegovy on the market in the next year or so as treatments offering significantly more weight loss than previous drugs have been able to. Could that open the door to greater access?

Reimbursement Market Access

Lilly Phase III Alzheimer’s Data Will Set Stage For Unrestricted Medicare Coverage Request

Donanemab results due next year have a good chance of persuading CMS to offer unrestricted coverage, Lilly argues, even though the drug might just have accelerated approval at that point. ‘We believe that having two positive pivotal trials should meet that high level of evidence.’

Medicare Reimbursement
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