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, January 13, 2022

Articles

Value Assessment’s “Leaky Bucket” Problem Needs To Be Addressed

(1/13, Kimberly Westrich and Robert W. Dubois, Health Affairs Blog) comments “...Our first recommendation is that current gaps in value measurement should be addressed through adoption of a societal perspective on value, and new and improved methods...Our second recommendation is that the potential for and implications of ‘leakage’ in value measurement should be called out explicitly in value assessments.” Full

 

AHRQ Funds Clinical Decision Support Innovation Collaborative

(1/12, David Raths, Healthcare Innovation) reports “...AHRQ has created the Clinical Decision Support Innovation Collaborative (CDSiC) to explore CDS domains, including trust, interoperability, measurement/value, and partnership with patients...The specific aims of the research are...Work with stakeholders to identify PCOR-based evidence amenable to implementation through CDS; Test and evaluate patient-centered CDS in real-world applications; Disseminate and make findings from the stakeholder work groups and Innovation Center available.” Full

 

Senate Panel Advances Biden's FDA Pick in 13-8 Vote

(1/13, Lauren Gardner, Politico) reports “The Senate HELP Committee voted 13-8 on Thursday to advance Robert Califf's nomination to head the Food and Drug Administration, putting the Biden administration one step closer to installing a permanent leader at an agency critical to the pandemic response.” Full

 

Use Of Real-World Data Hindered By Different Regulator Requirements

(1/13, Ian Schofield, Pink Sheet) reports “...Challenges to the use of real-world data and the importance of wider international regulatory collaborations were among topics addressed by the European industry body EFPIA in a survey of its member companies.” Paid Subscription Required

 

New Lung Cancer Treatment Combo Approved on NHS in England

(1/12, Harry Jenkins, Cancer Research UK) reports “...The decision means the immunotherapy drug pembrolizumab (Keytruda), in combination with the chemotherapy drugs carboplatin and paclitaxel, will continue to be an option for adults with untreated, squamous non small cell lung cancer that’s spread to other parts of the body. The combination was previously available to people in England through the Cancer Drugs Fund, which gives people access to innovative treatment while more data is collected on their long-term benefits.” Full

Press Releases

Orphan Drugs: Privilege of "Fictitious" Added Benefit Not Justified

(1/12, IQWiG Press Release) “...For all orphan drugs that have undergone a regular benefit assessment procedure since 2011 due to the exceedance of the above threshold, IQWiG has now analysed whether the fictitious added benefit initially specified was still valid, and thus whether the previous preferential handling of these drugs in the benefit assessment was justified. Result: The specification of a fictitious added benefit upon market access of orphan drugs was not confirmed in more than half of the cases.” Full

Journals

Accounting for Missing Data Caused by Drug Cessation in Observational Comparative Effectiveness Research: A Simulation Study

Denis Mongin, et al.

January 13, 2022, Annals of the Rheumatic Diseases

Annals of the Rheumatic Diseases

 

Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans

Barbra A. Dickerman, Ph.D., et al.

January 13, 2022, The New England Journal of Medicine

NEJM

Events

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February 10, 2022

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