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 Tuesday, October 19, 2021

Articles

The Future Of Value Assessment In A Post-Pandemic United States

(10/19, Donna Cryer, Health Affairs Blog) comments “..If we learn the right lessons from the COVID pandemic, the future of value assessment will be one that highly values people with—and without—serious, chronic conditions or disabilities as essential members of society. Value assessment will operate with the speed, flexibility and wisdom necessary to maximize that value. Achieving this future will require innovation, compromise, courage—and inclusion. To move forward, the people most affected by health care decisions—namely, patients of all colors and backgrounds—must be at the center of the process.” Full

 

The Key to Addressing Rising Health Care Costs Is Patient-Centered Evidence

(10/19, Nakela Cook, Morning Consult) comments “...What makes PCORI unique is its focus on the patient at the individual level. There is no one answer for everyone confronting a particular condition. What works for one person may not be the appropriate option for another. We must see patients as individuals with particular circumstances, needs and preferences — not as conditions to be treated. PCORI works closely with patients to understand their needs so that the work we fund is truly relevant to those it is intended to benefit.” Full

 

Failed Cancer Immunotherapies Cost Medicare Hundreds of Millions. How Should FDA Revamp Accelerated Approvals?

(10/19, Angus Liu, Fierce Pharma) reports “...Across six cancer indications for four medicines through the FDA’s accelerated approval program which have since been pulled, Medicare had spent $224 million between 2017 and 2019, a new study published in JAMA Internal Medicine shows. Describing the expenditure as ‘waste,’ the team of researchers from Harvard University and London School of Economics and Political Science suggests the FDA should ‘enforce timely completion of confirmatory trials and accelerated withdrawal’ if a drug fails to confirm its benefit.” Full

 

MedPAC's Part B Options Include ‘Value-Based' Payment During Accelerated Approval

(10/18, Michael McCaughan, Pink Sheet) reports “...The US Medicare Payment Advisory Commission's initial list of ideas to overhaul payment for drugs in the physician-administered Part B setting includes applying cost-effectiveness benchmarks for new drugs and biologics approved via the Accelerated Approval pathway... Among the menu of items brought forward by MedPAC staff, the proposal to use ‘value-based pricing’ for Accelerated Approval drugs has perhaps the most limited overall scope – but still bears watching as an idea that could move quickly through Congress in the context of potential efforts to reform the FDA pathway.” Paid Subscription Required

 

UK: A Test of NICE’s Resolve: Clinical Guidelines for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

(10/19, Leela Barham, PharmaPhorum) comments “...The incentives to follow NICE clinical guidelines are a little unclear. Unlike Technology Appraisals there’s no funding directive but this is a case where the recommendations are to do less, not more. Yet at the same time, the argument goes that the new guideline will be followed and that’s the issue for some clinicians: that GET and CBT when it does add clinical value won’t be offered to patients. The issue is therefore circular: NICE won’t publish because they don’t believe it will be implemented, some clinicians don’t want it to be published because they believe it will be implemented. But perhaps it also signals a degree of panic within NICE. The decision to pause is perhaps understandable, but to do so the day before the final guidance was due to come out suggests leaving that tricky decision too late.” Full

Press Releases

Analysis Group's Real-World Data Study Supports FDA's Recent Exkivity™ (Mobocertinib) Approval

(10/19, Analysis Group Press Release) “...‘The FDA's acceptance of RWD and real-world evidence (RWE) in approvals is changing how pharma thinks about R&D,’ said Analysis Group Managing Principal Mei Sheng Duh, M.P.H., Sc.D. ‘Takeda is at the fore of this understanding, and retained us to collaborate on the plan of the RWD study after its end of Phase 1 Type B meeting with the FDA to ensure the RWD study would align with the single-arm trial in the regulatory submission. The RWD provides contemporaneous natural history information and a benchmark of current treatment. The totality of evidence supports the clinical trial outcome for regulatory consideration.’” Full

Journals

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval

Mahnum Shahzad, BA, et al.

October 18, 2021, JAMA Internal Medicine

JAMA Internal Medicine

Events

PCORI Board of Governors Meeting

October 26, 2021

1:00 - 3:30PM ET

PCORI