CER Daily Newsfeed

Unadjusted Price Increase Report? ICER’s UPI Reports Continue to Do More Harm than Good

(12/12, National Pharmaceutical Council: E.V.I.dently Today) comments “...ICER’s UPI reports are subject to substantial methodological limitations that undermine the reliability and applicability of their findings, particularly for informing patient access and policy decisions. NPC continues to view ICER’s UPI reports as doing more harm than good. One of the many limitations of ICER’s UPI methodology is its failure to adjust for inflation when estimating net price year-over-year changes for prescription drugs. This omission violates best practices for conducting economic analyses and leads to findings that overstate the magnitude – and sometimes even the direction – of annual drug price increases.” Full

Prices for 5 Drugs Were Hiked Without Proof of New Benefits, Costing the U.S. $815M in 2023, Report Finds

(12/12, Ed Silverman, STAT+) reports “...The [ICER] report does ‘more harm than good,’ [NPC chief strategy officer Kimberly Westrich] said in a statement. ‘They have serious methodological limitations, contradict ICER's core value assessment framework, and ignore a tremendous amount of evidence submitted by manufacturers...One critical limitation is ICER's failure to adjust for inflation when calculating the headline number in the report. If ICER simply followed this best practice for economic analysis and inflation-adjusted their findings using the CPI-U (for all urban consumers), the estimated $815 million “increase” in this year's report disappears, becoming instead a $10 million decrease, causing the premise of the entire report to collapse.’” Subscription Required

Handful of 'Unsupported' Drug Price Increases Added $800M to US Costs, ICER Claims

(12/12, Zachary Brennan, Endpoints News) reports “...The National Pharmaceutical Council, a drug industry trade group, argued that the reports ‘do more harm than good: They have serious methodological limitations, contradict ICER's core value assessment framework, and ignore a tremendous amount of evidence submitted by manufacturers.’ Kimberly Westrich, NPC chief strategy officer, told Endpoints News by email, ‘We continue to call on ICER to stop producing this consistently flawed report that misleads stakeholders and risks driving harmful policy decisions.’” Subscription Required

Comparing CAR T-Cell Therapies for LBCL: Insights From CART-SIE Study

(12/12, Kimberly Rath, PharmD, The American Journal of Managed Care) reports “...Axi-cel demonstrated superior progression-free survival compared to tisa-cel, despite a higher toxicity profile, including increased neurotoxicity and cytokine release syndrome.” Full

AstraZeneca Sees Bright Future For Registry-Based Randomized Clinical Trials

(12/11, Bridget Silverman, Pink Sheet) reports “...Registry-based randomized clinical trial designs ‘may become one of the widely used RWE designs in the coming years,’ AstraZeneca regulatory science executive Jingyu (Julia) Luan predicted during a presentation on the company’s experience with a pioneering R-RCT, the Phase III DAPA-MI cardiovascular outcomes trial of Farxiga (dapagliflozin).” Subscription Required

The IRA And Post-Approval Clinical Research For Cancer Medicines

(12/12, Kirsten Axelsen, Henry Grabowski, Genia Long, Health Affairs Forefront) comments “...The Inflation Reduction Act’s DPNP, which is expected to encompass more oncology medicines in the coming years, could have significant impacts on investment in post-approval studies for cancer treatment including for new disease indications, small patient populations with high unmet needs, pediatric populations, new combination treatments, or special patient populations. Likewise, it could affect the relative attractiveness of certain drug candidates relative to others (such as small molecule drugs relative to biologics, drugs with higher rather than lower Medicare population shares, and those whose development profile would otherwise reflect a series of post-approval indications).” Full

These Pharma Lawsuits Could Transform 340B

(12/12, Bridget Early, Modern Healthcare) reports “...In part, pharmaceutical companies are responding to the Inflation Reduction Act of 2022, which established a rebate model for Medicare drug price negotiations, Williams said. Now that Medicare Part D has one, the argument that drugmakers can't, too, is weaker, [Barbara Straub Williams, a principal at the law firm Powers Pyles Sutter & Verville,] said.” Subscription Required