ICER Says AbbVie's Rinvoq for RA May Be Cost-Effective but Still Questions the Value of JAK Class
(10/11, Arlene Weintraub, Fierce Pharma) reports “...Instead of analyzing the costs of the medicines over a lifetime, ICER changed the time horizon of treatment to one year. And the new assessment calculated long-term cost-effectiveness of Rinvoq based on an assumed net price that matches the current net price of Humira and that reflects the average discount of the other two JAK inhibitors. Those changes were enough to bring the cost burden of Rinvoq below ICER's threshold for cost-effectiveness...” Full
Who is Driving the HTA Bus? And Where is it Headed?
(10/10, Jeffrey J. Lemay, et al., PharmExec) comments “...By their actions, federal agencies are focused on conducting CER within subpopulations and generating RWE through observational trials and pragmatic randomized clinical trials. Regulatory changes may facilitate an increase in value-based contracting, which would increase demand for outcomes benchmarks to enable such contracts. Finally, an increase in data availability and future standards for RWE, could mean that payers will expect [pharmaceutical value assessment] organizations to update their findings with RWE at some point after a drug is launched. For-profit companies and not-for-profit organizations that have access to real world data or the technology for sophisticated analysis will evolve stronger capabilities to play a key role in PVA.” Full
Real-World Evidence Can Better Inform Diabetes, Cardiometabolic Care
(10/10, Regina Schaffer, Healio Endocrine Today) reports “...Randomized controlled trials remain the gold standard for the initial assessment of efficacy and safety for any therapy, but real-world evidence can answer some questions that are difficult or impossible to answer with a randomized controlled study design, Lawrence Blonde, MD, FACP, MACE...said during a presentation. Real-world data — information on patient characteristics, care and outcomes derived from electronic health records, claims databases and patient registries — can inform patient care and outcomes research, safety surveillance, research on health care systems and well-controlled effectiveness studies, Blonde said.” Full
Study Finds Real-World Evidence Replicates less than One-Fifth of Clinical Trials
(10/11, Alaric Dearment, MedCity News) reports “...‘I think there are lots of ways that RWE will be used for medical product evaluation, but for these data to be a suitable replacement, work is still needed to enhance the data that are available,’ one of the researchers, Yale professor of medicine Dr. Joseph Ross, wrote in an email. ‘Working with current real-world data sources, I believe large, safety-oriented evaluations are useful and feasible. But I think more needs to be done to better discern product effectiveness using real-world data.’” Full
Replicating RCTs With Real-World Data Is Unlikely for Most Trials
(10/11, Laura Joszt, The American Journal of Managed Care) reports “...While RWE better reflects patient demographics, comorbidities, adherence, and use of concurrent treatment in actual clinical environments, ‘enthusiasm for using retrospective RWE to complement the evidence generated by RCTs may still need to be tempered by feasibility concerns because it is unclear whether it is reasonable to expect that observational data can be used to address the same clinical questions being answered by traditional clinical trials,’ the authors explained.” Full
Are Value-Based Models Helping or Hindering Care Delivery for Primary Care Providers?
(10/10, Jaime Rosenberg, The American Journal of Managed Care) reports “...No matter what value-based models providers are participating in, whether it be the 2 under the Primary Cares Initiative or under ACOs, physicians are at risk; however, the financial implications differ based on the model, said [Roji Health Intelligence CEO Theresa Hush]. While Direct Contracting, ACOs, and Medicare Advantage models all leave providers responsible for their costs of care, the extent to which they are responsible may differ. For example, Direct Contracting offers partial and global capitation. Meanwhile, under Primary Care First, there are rewards and penalties for hospital utilization.” Full
3 Reforms Aim to Reduce Administrative Burden of Value-Based Care
(10/11, Laura Dorr, Managed Healthcare Executive) reports “...[The American Medical Group Association] suggested CMS scale down the amount of quality measures for value-based care providers. ‘Using a standard set of value measures will help reduce the variation in the measures that are reported and help eliminate unnecessary confusion and administrative burdens,’ AMGA wrote in their comment letter to CMS. AMGA suggested that CMS use a set of 14 process and outcomes quality measures approved in 2018 by the association's Board of Directors.” Full
ICER Releases Updated Draft Evidence Report on Rheumatoid Arthritis Therapies
(10/11, ICER Press Release) “...After initially publishing an earlier version of this Draft Evidence Report on September 26, 2019, ICER's internal reviewers identified the need to reevaluate some of the assumptions and calculations in the report to better align our economic modeling with how patients transition between these therapies in the real world. In our updated model, patients that are failed by first-line treatment now transition to a market basket of targeted immune modulators, instead of palliative care. Also, because clinical differentiation between these therapies is uncertain over time, we will now analyze their cost-effectiveness in the first year of use, instead of over a patient's lifetime.” Full
Another Treatment Option for Ovarian Cancer Approved for the Cancer Drugs Fund
(10/11, NICE Press Release) “...Rucaparib can now be offered to women with relapsed ovarian, fallopian tube or peritoneal cancer, that has responded to platinum-based chemotherapy. Taken as a tablet, twice daily, it slows the progression of cancer by preventing cancer cells repairing so slowing down the tumour's growth. Around 1,350 people in England could benefit from this new treatment which will be available immediately through the CDF.” Full
Trends in High- and Low-Value Cardiovascular Diagnostic Testing in Fee-for-Service Medicare, 2000-2016
Vinay Kini, MD, MSHP, et al.
October 11, 2019, JAMA Network Open
JAMA Network Open
RA Update: Draft Evidence Report
October 11, 2019