NPC Submits Comments to FDA on Exchange of Clinical and Economic Information
(4/19, National Pharmaceutical Council: E.V.I.dently Today) comments “...In comments submitted today to the [FDA], the National Pharmaceutical Council (NPC) outlined ways to improve how the exchange of clinical and economic information between biopharmaceutical manufacturers, payers, and population-health decision makers is regulated...As NPC noted in its comments, ‘The communication of health care information is now more important than ever. The products available to treat conditions, the ways health care is organized, delivered and reimbursed, and the information sources and analytic processes available have become more sophisticated. Now is the time for regulations and guidance for communication to evolve in parallel.’” Full | Read Comments
PCORI-Funded Study Advises Patient Preference When Treating Prostate Cancer
(4/18, Surabhi Dangi-Garimella, PhD, The American Journal of Managed Care) reports “Comparing the immediate and long-term impact of radical prostatectomy, external beam radiotherapy, brachytherapy, and active surveillance, a study published in JAMA recommends consulting patients on their individual preferences prior to making a treatment decision...The comparative effectiveness method used in this study shows that contemporary treatment options were associated with distinct patterns of QOL changes, the authors write.” Full
UC Riverside Awarded $250,000 to Study HIV and Aging
(4/19, Edge Media Network) reports “...The project, titled ‘The Coachella Valley Community Research Initiative for Healthy Aging with HIV,’ is part of a portfolio of projects that PCORI has funded to help develop a community of patients and other healthcare stakeholders who have the knowledge, skills and partnerships to participate in and advance patient-centered outcomes research and patient-centered comparative effectiveness research.” Full
Payers' Perspective: Incorporating Real-World Evidence in Patient Care
(4/2017, American Health & Drug Benefits) reports “...The survey results show that although payers are mainly unaware of the CPIC guidelines, they do believe that preemptive pharmacogenetic testing can be informative. However, some payers are concerned that this testing can lead to more expensive first-line treatments versus a one-size-fits-all treatment approach. In addition, many payers indicate that this testing currently lacked utility, because coverage decisions have not been established, and some payers would prefer real-world evidence over randomized controlled clinical trials for demonstrating the usefulness of preemptive pharmacogenetic testing.” Full
Lawmaker Wants to Make it Easier for Pharma to Talk Off-Label Drug Use
(4/18, Ed Silverman, STAT Plus: Pharmalot) reports “In a bid to loosen off-label communications, a congressman quietly introduced a bill late last month that would expand the ability of drug makers to discuss unapproved uses of their medicines with doctors. The legislation, which was proposed by Representative Morgan Griffith (R-Va.), addresses a controversial, if technical term called ‘intended use.’” Paid Subscription Required
How Will Real World Evidence Affect Off-Label Communications and FDA?
(4/18, Paul Gadiock and James Ravitz, BNA) comments “...Although it is not completely clear whether real world evidence will prove to a be a tool at FDA's disposal for monitoring medical product performance or instead a lightning rod that, coupled with fewer restrictions on unapproved claim communications, erodes the agency's oversight of drugs and devices, it is apparent real world evidence will significantly influence the role of FDA.” Paid Subscription Required
Can Big Data Match Up To The Big Promise?
(4/19, Ian Schofield, The Pink Sheet) reports “...The benefits of large amounts of data will only become apparent if the data are meaningful and if we trust the evidence generated from it, [EMA’s Alison Cave] said. ‘We talk a lot about real world evidence but the evidence is derived from the data and we are still working on it’ and trying to understand issues like biases and confounding factors.” Paid Subscription Required
UK: NICE Nod for Novartis' Cosentyx in PsA
(4/19, Selina McKee, PharmaTimes) reports “The National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Determination (FAD) which backs NHS use of Novartis' Cosentyx (secukinumab) in adults with active and progressive psoriatic arthritis (PsA).” Full
EBSCO Health, Dartmouth and Option Grid™ Collaborative Founders Join Forces to Improve Patient Engagement and Evidence-Based Shared Decision Making
(4/19, EBSCO Health Press Release) “...With this new collaboration, EBSCO Health will combine methodologies utilized at The Dartmouth Institute for Health Policy and Clinical Practice (TDI) at the Geisel School of Medicine with EBSCO Health's expertise in evidence-based medicine to develop a multitude of new patient decision aids to be distributed under the Option Grid trademark.” Full
Healthcare Costs and Medication Adherence Among Patients with Fibromyalgia: Combination Medication vs. Duloxetine, Milnacipran, Venlafaxine, and Pregabalin Initiators
Marlow NM, et al.
April 18, 2017, Pain Practice
Issues at the Heart of Advancing the De-Adoption of Low-Value Care
Leonard Davis Institute of Health Economics Link