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Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Rethinking Clinical Trials

point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. The initiative would bring to the U.S.

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Novo Nordisk’s Ozempic Shortage Spurs Demand for Eli Lilly’s Diabetes Injection Mounjaro

XTalks

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication.

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Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. We have products that are living therapies. How do you characterise and think about the potency of a living drug when that final product is still changing and dividing? One challenge is in potency.

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No sign of stopping: The rise of cell and gene therapy

Drug Discovery World

But are these price tags a barrier to access? From private plans to government programmes, there are workable systems that support CGTs, proven by MediCare’s support of CAR-T and the UK’s National Health Service coverage. CGTs are classified as ‘living drugs’ and are much more complex entities than other biologics.

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Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” He explained that based on communications with payers so far, the company expects coverage to be similar to that of existing CAR-T therapies, with a prior authorization requirement.

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Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

Aducanumab Controversy and Price Tag. Industry experts say that while 85 percent to 90 percent of patients in the US are eligible to be covered for the drug by Medicare, it is likely that other insurers, and even Medicare, will limit their coverage to the type of patients who participated in the trial. Clinical Evidence.

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AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

XTalks

Payer coverage decisions could have a greater impact on this if large health insurers decide to add aducanumab to their formulary. With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market. This is another case in which careful clinical trial design is of the utmost importance.