CER Daily Newsfeed

The Comparative Effectiveness Research Daily Newsfeed®, known for short as the CER Daily Newsfeed®, offers the latest news, research and related information on comparative effectiveness research, real-world data and evidence, value assessment and other important health care topics. 

News from Thursday, October 21, 2021


AMCP Partnership Forum: Exploring Paths to Equitable Benefit Design

(10/21, National Pharmaceutical Council: E.V.I.dently Today) comments “...NPC sponsored the forum, ‘Racial Health Disparities: A Closer Look at Benefit Design,’ and presented relevant work, including its commentary Ignoring Inequitable Benefit Design Is Not an Option, which encourages employers to expand diversity, equity and inclusion (DEI) practices to ensure that all low-wage workers have affordable access to health care, as well as NPC's Myth of Average booklet on the importance of considering individual treatment effects to provide optimal care. Forum participants made recommendations to reduce structural and organizational issues in formulary and benefit design that may impact racial health disparities in the use of medications and related therapies...” Full


FDA Contracts Aetion’s Real-World Evidence Platform to Assess COVID-19 Treatments

(10/21, Rebecca Torrence, Fierce Healthcare) reports “...The Aetion Evidence Platform, which analyzes real-world data (RWD) pulled from electronic health records and medical claims, will enable the FDA to assess inpatient COVID-19 treatments in real-time. ‘As part of this agreement, they’ll be able to apply the best practice science to different real-world data sources that are fit for the purpose of understanding inpatient treatments, learn to do this themselves and be able to apply it now or to other questions that emerge in the future,’ said Jeremy Rassen, Sc.D., co-founder of Aetion, in an interview with Fierce Healthcare.” Full


How to Collect and Submit RWD to Win Approval for a New Drug Indication: FDA Spells it out in a Long-Awaited Guidance

(10/21, Zachary Brennan, Endpoints News) reports “...Aetion CEO Carolyn Magill told Endpoints News in an interview that the draft guidance is helpful, as it spells out how RWD must be in an electronic format that the agency can process, review and archive, unless there’s an exemption. She said she expects FDA to update the current data standards catalog and provide further guidance on that topic ‘because real world data isn’t standardized,’ and there are varying global standards that lead to the acceptance today around varied curation methods and algorithms influenced by care delivery.” Full


How COVID Can Help Us Refocus On The How And Why Of Value Assessment

(10/21, Darius N. Lakdawalla, Mark Linthicum and Charles Phelps, Health Affairs Blog) comments “...First, we must improve methods to incorporate a wider array of patient preferences than current methods allow...On another front, two of us have developed the Generalized Risk Adjusted Cost Effectiveness (GRACE) model that formally incorporates patients’ attitudes towards uncertain treatment outcomes and provides a formal method for incorporating disease severity in the measure of patient value. In GRACE, treatments for more severe illness have greater value than in standard CEA methods, providing an alternative to the usual CEA mantra that ‘…a QALY is a QALY.’” Full


Take Doctors Off the 'Fee-for-Service Treadmill,' Senator Says

(10/20, by Joyce Frieden, Medpage Today) reports “...‘Once you free up the doctors from having to march to the fee-for-service treadmill, we give them the ability to adapt the way they treat patients to a “patient-first” way of dealing with the patients, and you then open up this arena in which three things happen at once: patients are happier and healthier, costs go down, and everybody wins,’ [Sen. Sheldon Whitehouse (D-R.I.)] said. He was referring to the idea of having doctors join accountable care organizations, in which clinicians are financially rewarded based on the quality of care they deliver.” Full


UK: Alnylam's Givlaari Wins NICE Reversal after Offering Discount for Rare Genetic Liver Condition Therapy

(10/21, Kevin Dunleavy, Fierce Pharma) reports “Since Alnylam’s Givlaari was approved in Europe in March 2020, those in the U.K. with the rare disorder called acute hepatic porphyria have been waiting to be able to use it. Nineteen months later, the wait is almost over. With Thursday’s nod from England’s drug-price watchdog, Givlaari will soon be provided through the National Health Service. The recommendation reverses the National Institute for Health and Care Excellence's previous decision to reject the treatment...” Full


Can Cost–Effectiveness Principles Be Ignored in Urgent Times?

Zoltán Kaló, et al.

October 20, 2021, Journal of Comparative Effectiveness Research

Journal of Comparative Effectiveness Research


Real-World Evidence: A Practical Toolbox for Collecting Health State Utilities

Veronique Lambert-Obry, et al.

October 20, 2021, Journal of Comparative Effectiveness Research

Journal of Comparative Effectiveness Research


Budesonide/Formoterol Versus Salmeterol/Fluticasone for Asthma in Children: An Effectiveness and Safety Analysis

Ping Jiang, et al.

October 20, 2021, Journal of Comparative Effectiveness Research

Journal of Comparative Effectiveness Research


Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry: DRAFT GUIDANCE

October 2021