The Institute for Clinical and Economic Review (ICER) issued updated analyses to inform public debate of pricing for Gilead Sciences Inc.’s remdesivir and other future COVID-19 treatments. According to ICER’s adapted methodology, its COVID models comprise two alternative pricing paradigms: cost recovery for the manufacturer, in which the price is adequate to return the costs of production of the drug and may also recoup drug-specific development costs, and traditional cost-effectiveness analyses, which looks at the incremental health benefits and costs within the health system. The updated cost-recovery benchmark price is now framed as a range, with a maximum of $1,600 per 10-day regimen when incorporating assumptions regarding the manufacturer’s 2020 development expenses, uptake of remdesivir and consideration of early examples of real-world generic pricing. The cost-effectiveness benchmark price has shifted slightly higher to a range of $4,580 to $5,080, based on new peer-reviewed data on remdesivir; however, a new scenario analysis assuming the likely incorporation of dexamethasone as standard of care produces a lower benchmark price range for remdesivir of $2,520 to $2,800.
The FDA reported it has launched Project Patient Voice (PPV), created by the agency's Oncology Center of Excellence (OCE). The PPV website provides publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While those data have historically been analyzed by the FDA during the drug approval process, they are rarely included in product labeling and, therefore, are largely inaccessible to the public. The data can provide additional, complementary information for health care professionals, specifically when discussing the potential side effects of a particular cancer treatment. In contrast to the clinician-reported safety data in product labeling, the data in PPV are obtained directly from patients and can show symptoms before treatment starts and at multiple time points while receiving cancer treatment. In the first phase of the pilot website, only one trial will be included while the FDA seeks public feedback on how the information is presented. It will use that feedback to consider improvements to the website in order to make the information as user-friendly as possible. The FDA will seek public feedback regarding the pilot effort at a virtual public workshop co-sponsored with the American Society of Clinical Oncology on July 17.
Cambridge, U.K.-based Kymab Ltd. said the Supreme Court of the U.K. has held that all of the claims of two patents (European Patents EP(UK) 1 360 287 and EP(UK) 2 264 163, the Murphy patents) owned by Regeneron Pharmaceuticals Inc. that were asserted against Kymab are invalid. The decision upholds the February 2016 decision of the High Court trial judge, Justice Henry Carr, to revoke the claims and reverses the Appeal Court’s determination that they were valid. The Supreme Court noted that Kymab’s ability to create transgenic mice with the entire human antibody variable region depended upon Kymab’s own inventions made separately after the priority date of the Murphy patents.