News from Tuesday, November 12, 2024
Articles
Lowering RA Disease Activity With Biologics Enhances Protective Cardiovascular PON1 Activity
(11/11, Victoria Johnson, HCPLive) reports “...[Amir A. Razmjou, MD, MS] and colleagues analyzed data from 1213 adult participants with moderate-to-high disease activity RA in the Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory CoNditions cohort study. Participants had initiated either tocilizumab (TCZ; n = 296), abatacept (n = 374), tumor necrosis factor inhibitors (n = 427), or rituximab (n = 116) and were followed prospectively with serum specimens analyzed for PON1 activity by arylesterase (ARYL), lactonase (LAC) and PON assays at baseline and after 6 months of biologic therapy.” Full
Video: Naim Alkhouri, MD: First Real-World Data for Resmetirom Use in Clinical Practice
(11/12, Abigail Brooks, MA, HCPLive) “...‘What we are showing here is that in the real world, we are able to identify appropriate patients to be prescribed resmetirom based on noninvasive testing without the need for liver biopsy, and that the patient characteristics and the NIT data are very consistent with MAESTRO-NASH, implicating that we can really replicate the results from the phase 3 program, hopefully, in the real world,’ Alkhouri said.” View Video
Former HHS Secretary Again Suggests Trump May Keep Rx Price Negotiation
(11/12, Gabrielle Wanneh, InsideHealthPolicy) reports “...During a conference held by America’s Physician Groups (APG) Monday, [Alex] Azar and Donna Shalala, who served as HHS secretary in the Clinton administration, predicted Trump would also back allowing the United States to import more affordable drugs from select foreign countries as he did in his previous term. Azar had suggested before that Trump might not try to discontinue Medicare drug price negotiation, predicting he may try to out-do the Biden administration by seeking to achieve even greater discounts.” Subscription Required
The Trump Sequel: What to Expect on PBMs, 340B, Drug Pricing, and RFK Jr
(11/12, The American Journal of Managed Care) reports “...[Lindsay Bealor Greenleaf, JD, MBA, who is vice president and head of Federal and State Policy for ADVI Health:] So, if we have a Republican sweep of Congress and with Trump in the White House, I think it makes it even more likely that we could get some significant 340B reforms enacted into legislation...When we're talking about IRA government negotiation changes, things like that, we're picturing what we refer to as a reconciliation package; when it comes to 340B legislative reforms, it would probably have to be through a different vehicle, where you would have to deal with the filibuster, unlike the reconciliation packages where there is a specific tie to federal funds.” Full
Press Releases
Lessons from a Quantitative Analysis of the First Round of CMS Patient Listening Sessions for IRA’s Medicare DPNP
(11/12, National Pharmaceutical Council Press Release) “Medicare administrators held a series of patient-focused listening sessions in Fall 2023 for each of the first 10 drugs selected for the Inflation Reduction Act’s Medicare Drug Price Negotiation Program...A new analysis from the National Pharmaceutical Council published in PharmacoEconomics – Open, ‘CMS’s Drug Price Negotiation Program 2023 Patient-Focused Listening Sessions: A Descriptive Analysis of Speaker Remarks,’ quantifies important details about the number and makeup of speakers and reports how long they talked about key areas of interest related to the DPNP process. The study suggests gaps in the initial process of obtaining stakeholder input and highlights suggested improvements for future iterations.” Full
Journals
CMS’s Drug Price Negotiation Program 2023 Patient-Focused Listening Sessions: A Descriptive Analysis of Speaker Remarks
Julie A. Patterson, Tyler D. Wagner, Rayan K. Salih, Gabri’el D. Shabazz & Jonathan D. Campbell
November 11, 2024, PharmacoEconomics - Open
Real-World Data: Bridging the Gap Between Clinical Trials and Practice
Brooke E. Wilson, Christopher M. Booth
December 2024, eClinicalMedicine