News from Friday, October 22, 2021
Articles
Drugmakers Get FDA Guidance for Submitting Real-World Data
(10/21, Celine Castronuovo, Bloomberg Law) reports “...The [FDA’s] draft guidance includes recommendations on how to include these data sources in regulatory submissions in compliance with the Food, Drug and Cosmetic Act. Real-world data include indicators of a patient’s health status or the delivery of health care, gathered from electronic health records and billing activities, according to the FDA...Thursday’s draft document states that electronic submissions of clinical and nonclinical study data can be processed, reviewed, and stored by the FDA using standards in the agency’s Data Standards Catalog.” Paid Subscription Required
Takeda Inks Risk-Sharing Deal With Health Plan Over Lung Cancer Drug Effectiveness
(10/22, FDA News) reports “Takeda Pharmaceutical has signed a risk-sharing agreement with Point32Health, the second-largest health plan in New England, that has Takeda returning a portion of the cost of its lung cancer drug Alunbrig in circumstances when it doesn’t work...The agreement will make Alunbrig available to Point32Health’s more than 2 million members ‘with Takeda standing behind the medicine with a unique outcomes-based structure,’ the companies said.” Full
Novartis Has Negotiated Zolgensma Access for Half of the European SMA Population, Exec Says. How'd It Get There?
(10/22, Eric Sagonowsky, Fierce Pharma) reports “...To hit the ground running, the company implemented a “day one" access program. In government access negotiations, Novartis offered outcomes-based contracting, annuity payments or deferred payments, in which the company would cover the cost of treatment upfront and collect payments after access talks play out.” Full
CMS, CMMI Officials Seek More Data From Medicare Advantage Plans on Impact of Health Equity
(10/21, Robert King, Fierce Healthcare) reports “Biden administration officials want more information from Medicare Advantage (MA) plans on how key benefits are helping underserved patient populations. Officials with the Centers for Medicare & Medicaid Services (CMS) discussed the need for greater collaboration during a conference this week sponsored by the Better Medicare Alliance. Officials said they want to better understand the impact of incentives in the MA program to address health equity and to spur more participation in the value-based insurance design (VBID) model.” Full
Video: Christina Barrington on the Benefit of RWE for Subpopulations and Diverse Populations
(10/21, AJMC) reports “The benefit of real-world evidence is that it provides more data on subpopulations and diverse populations, said Christina Barrington, vice president of pharmacy programs at Priority Health.” Full
Euro Roundup: EMA Seeks Feedback on Framework for Incorporating Patient Views Into Regulatory Decisions
(10/21, Nick Paul Taylor, Regulatory Focus) reports “...CHMP officials adopted the opinion on IMI PREFER, an Innovative Medicines Initiative-funded ‘framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making.’ The developers submitted the framework to EMA and EUnetHTA for review.” Full
How FL's Centralized EHR Data Repository Supports Clinical Research
(10/21, Hannah Nelson, EHR Intelligence) reports “A centralized, statewide patient data repository has boosted the use of EHR data for clinical research in Florida, according to a new article published in JAMIA. The OneFlorida Clinical Research Consortium is one of nine clinical research networks (CRNs) in the Patient-Centered Outcomes Research Institute’s (PCORI) National Patient-Centered Clinical Research Network (PCORnet) 2.0.” Full
Journals
Comparative Efficacy and Safety of Biologic Therapies for Moderate-to-Severe Crohn's Disease: A Systematic Review and Network Meta-Analysis
Siddharth Singh, MD, et al.
October 21, 2021, The Lancet