FDA Approval for Ibrance in Men with Breast Cancer Sets Precedent for Use of Real-World Evidence
(5/14, Pharmaceutical Technology) comments “...Due to the small target patient population, leading to the difficulty in conducting a large-scale clinical trial, and the established efficacy of Ibrance in women, the extension of Ibrance into the treatment of men provided a perfect opportunity for the applicability of RWE. Using data from clinical registries, Pfizer was able to demonstrate that the efficacy and safety profile in men was consistent with women treated with Ibrance.” Full
4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development
(5/14, Jamie Cartland and Philip Winkworth, Clinical Leader) comments “...Real-world evidence from routine clinical care is increasingly being used in regulatory settings. Regulatory bodies are becoming more comfortable with innovative applications such as external and synthetic control arms to supplement placebo or current standard of care arms in randomized clinical trials.” Full
Utilizing an Integrated, MultiChannel Approach Can Improve Access for Oncology Products
(5/13, PharmExec) comments “...Payers are paying increasing attention to that kind of real-world evidence of both safety and effectiveness, she continued. When biopharma companies are building their value story, real world evidence plays an important role. Real-world evidence can also inform commercialization strategies. The distributor has a direct view on treatment and utilization patterns nationwide, where a new product is taking off, where it is lagging behind existing treatments.” Full
AJMC® Study Finds Removing Cost Sharing in Primary Care Reduces Cost, Emergency Visits
(5/14, The American Journal of Managed Care Press Release) “When a large national employer removed cost sharing for primary care visits, medical utilization fell, as did monthly costs, driven mostly by reduced emergency department visits. The findings on this value-based insurance design model, coming as the nation grapples with rising healthcare spending, putting pressure on payers, employers, and consumers, are reported in the May issue of The American Journal of Managed Care.
Health Informatics Program Director Selected as Patient Centered Outcomes Research Partnership Scholar
(5/13, Idaho State University Press Release) “Idaho State University's Velma L. Payne has recently been accepted to participate in the Patient Centered Outcomes Research Partnership, a highly sought after opportunity offered by the University of Washington. According to their website, the PCORP is a training program designed to prepare scientists, clinicians, and health care managers for conducting research on patient-centered outcomes.” Full
Canada To Open Up Priority Review To More New Drugs
(5/14, Vibha Sharma, Pink Sheet) reports “...Using more information about drugs in real-world settings to build up Health Canada's understanding of their benefit-risk profile and to facilitate the approval of drugs for rare diseases...Working with provinces and territories through the Canadian Agency for Drugs and Technologies in Health and the Institut national d'excellence en santé et en services sociaux to align reviews and share information to streamline processes.” Paid Subscription Required
Cost-Effectiveness of DPP-4 Inhibitor and SGLT2 Inhibitor Combination Therapy for Type 2 Diabetes
Manjiri Pawaskar, PhD, et al.
May 14, 2019, The American Journal of Managed Care
Potentially Inappropriate Prescribing Among Older Persons: A Meta-Analysis of Observational Studies
Tau Ming Liew, MRCPsych, et al.
May/June 2019, Annals of Family Medicine
Annals of Family Medicine