Value-based pricing and reimbursement models are not common in the United States, but this may change after recent programs by Pfizer and Takeda. These pricing strategies are based upon the value provided to the patient and have long been held back due to insufficient outcome data infrastructures. […]
Possible Impact of the Build Back Better Plan on Chronic Illness – Patients Rising Podcast
With the Build Back Better Act having passed the House, some question how changes to the bill in the Senate will affect care for those with chronic diseases. In the latest Patients Rising Podcast episode, hosts Terry Wilcox, Kate Pecora, and Dr. Bob Goldberg discuss what happens next in the process. […]
Will Rob Califf’s industry ties sink his FDA commissioner nomination?
Dr. Rob Califf’s extensive industry ties cast uncertainty on his nomination for FDA commissioner. The nominee’s financial disclosures, released this week reveal that his industry ties grew since leaving the position in 2016. In a report by Zachary Brennan, senior editor of Endpoints News, Califf […]
Navigating the FDA Real-Time Oncology Review Process for Sponsors
Started in 2018, the FDA’s “Real-Time Oncology Review (ROTR)” project gives sponsors a head start on the application review process and poses additional challenges. The ROTR helps sponsors plan around anticipated FDA results immediately to begin preparing their full submission package […]
“Specialty Pharmacy’s Post-Pandemic Outlook” Asembia 2021 Keynote Recap
The future of specialty pharmacy in the post-pandemic world was the topic of the October 27th keynote sessions at Asembia 2021 in Las Vegas. Speakers covered how pharmacy benefit managers (PBMs) are grappling with the question of how to generate profits in the specialty pharmacy market while still […]
Changing Dynamics Between NICE and Pharmaceutical Industry
Recent shifts in the UK’s National Institute for Health and Care Excellence’s (NICE) approach to health technology assessment (HTA) are encouraging a more collaborative relationship with the agency and the pharmaceutical industry. Earlier this year, NICE published their 5-year strategy entitled, […]
Panalgo and HealthEconomics.Com Host Webinar on Successful ICER Strategies
Panalgo and HealthEconomics.Com hosted a webinar detailing strategies that lead to successful evaluation by the Institute for Clinical and Economic Review (ICER). President of HealthEconomics.Com Patti Peeples moderated the session, which included important insights from Center for the Evaluation of […]
Xcenda HEOR Experts Discuss ICER’s UPI Assessments
Xcenda’s Tasmina Hydery and Anne Loos shared their thoughts on the methodologies used by the Institute for Clinical and Economic Review (ICER) in its Unsupported Price Increase (UPI) assessments. Payers are increasingly incorporating these ICER reviews in their coverage decision-making […]
ICER Releases Final Evidence Report for Hypertrophic Cardiomyopathy Drug
The Institute for Clinical and Economic Review (ICER) has published its Final Evidence Report for mavacamten, produced by MyoKardia and Bristol-Myers Squibb. The drug is used in patients diagnosed with hypertrophic cardiomyopathy (HCM). Panelists voted on the drug’s clinical effectiveness compared […]
Flatiron ResearchX On-Demand Webinar on RWE in Regulatory Submissions
Flatiron ResearchX invited real world evidence (RWE) and pharma leaders to discuss how RWE impacts submissions to regulatory bodies. Available on-demand, the webinar covers RWE applications throughout the research and development pipeline. “This ResearchX session included presentations from Eli […]
