CER Daily Newsfeed

FDA’s Califf: Expect to See More RWE-Based Regulatory Decisions

(9/22, Ferdous Al-Faruque, Regulatory Focus) reports “...[FDA commissioner Robert Califf] said that using RWE to expand product indications has been a sound theory, but it has taken a long time to make it a reality. ‘I'm optimistic we're going to make a real run at it in this upcoming year, across the whole federal government, not just within the FDA,’ said Califf. ‘I believe that we're moving very rapidly now to a place where more and more of the data we use for evidence is going to come from the so-called real-world clinical environment. After all, the reason we do a randomized trial is to take a sample of people and reach a causal inference that allows us to extrapolate to the population,’ he added.” Full

Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment

(9/24, Bridget Silverman, Pink Sheet) reports “...Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.” Subscription Required

Editorial: Here's How Medicare Should Negotiate Drug Prices

(9/22, Bloomberg) comments “...[Other countries including Australia and the UK] regularly use cost-effectiveness assessments and, unsurprisingly, their prescription-drug spending is a fraction the US’s. Unfortunately, the process for Medicare won’t be so straightforward. With QALYs banned, it will need to use other (less tested) methodologies. Even so, effective alternatives exist, including some that have been developed to minimize the disparities that disability advocates cite. Medicare should embrace these metrics and be transparent with the public about its pricing methods.” Subscription Required

Congressman Yakym Introduces Legislation to Bring Greater Awareness to Lifesaving Medical Devices

(9/22, Kathy Bottorff, WTCA 106.1) reports “This week, Congressman Yakym (IN-02) introduced H.R. 5458, the ‘Baby Observation Act’ or ‘BO’s Act.’...‘BO’s Act’ requires the Patient-Centered Outcomes Research Institute to study the use of home cardiorespiratory monitors (medical devices that track the respiratory effort and heart rate of a sleeping infant) to reduce and prevent sleep-related sudden infant death syndrome or sudden unexpected infant death.” Full

How Can Predictive Analytics Help ACOs Boost Value-Based Care Delivery?

(9/25, Shania Kennedy, Health IT Analytics) reports “...In the past, ACOs have relied on Medicare data and risk adjustment factor scores to gain insights into their patient populations, but these are limited in that they cannot capture all the complexities associated with a patient and her health. Digital twins—digital or virtual representations of people, objects, processes, or systems designed to help simulate a potential outcome—represent a ‘third wave’ of analysis, [David Clain, chief product officer at the Health Data Analytics Institute,] posited, tying de-identified data from these and other sources to an ACO population.” Full

Gene Therapy HTA: How Do The European, Australian And Canadian Systems Shape Up?

(9/25, Eliza Slawther, Pink Sheet) reports “...A report comparing the health technology assessment methods used in nine European countries, Australia and Canada found that England has the most favorable reimbursement landscape for gene therapies – but outlined several areas for improvement across the board.” Subscription Required