FDA and ASPR issue policy recommendations to reform US pharmaceutical supply chains; insurer coverage implications of the newly approved therapy in Alzheimer disease; Apple announces new health data sharing features.
Today, HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and the FDA issued a series of policy recommendations accepted by President Joe Biden to address vulnerabilities within US pharmaceutical supply chains. Describing the pharmaceutical supply chain as complex, global, and variable to market factors, FDA and ASPR focused recommendations on 4 key aspects, including boosting local production and fostering international cooperation, and promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience.
As the first new therapy in nearly 20 years to receive FDA approval for Alzheimer disease (AD), health care experts expect Biogen’s aducanumab (Aduhelm) to be broadly covered by insurers, but they say that patients’ cost will vary depending on their insurance plan. According to the Associated Press, Biogen said that the drug would cost $56,000 for a yearly supply, with Medicare and insurers that offer private or commercial insurance expected to cover the treatment if use is deemed medically necessary. In some cases, such as when patients have advanced AD where research shows the drug is not as effective, the insurer may not pay for it—leading to several thousand dollars in costs for patients.
Yesterday, Apple announced new features at the Worldwide Developers Conference that will allow users to opt into sharing their medical records on their devices, letting them choose to share privacy-protected and secured information, such as elevated cholesterol level or physical activity history, with family members or clinicians. As reported by STAT, doctors will be able to access their patients’ information from Apple devices within the electronic health record without the need to download or open another app. Patients will also be able to view how lab testing results and other data, such as blood glucose levels and sleep, change over time with a new feature called “Trends.”