Nivolumab

IRVING, Texas--(BUSINESS WIRE)--Vizient released its summer 2026 Spend Management Outlook, projecting 3.54% pharmacy inflation and 4.73% indirect spend and purchased services inflation for 2027. Growth in technology, facilities, construction, and other non-clinical services reflects the expanding role these investments play in healthcare organizations' overall spending. Together, these trends are projected to drive overall supply chain, capital, and purchased services inflation to 3.39% in 2027, underscoring the need for healthcare organizations to manage costs across both clinical and operational categories. "The drivers of healthcare spending continue to evolve," said Carina Dolan, associate vice president, clinical oncology, pharmacoeconomics and market insights, Vizient. "As care expands beyond the hospital and organizations invest in technology and infrastructure, spending decisions are becoming increasingly interconnected. Understanding these trends is essential to making informed investment decisions while maintaining financial sustainability." Pharmacy spending continues to follow patients beyond the hospital Care will continue to move beyond the traditional hospital setting, reshaping where healthcare organizations invest and how they plan for future demand. Overall ambulatory pharmacy inflation is projected at 3.64%, driven by projected inflation of 4.04% for specialty and complex medications. GLP-1 therapies continue to reshape self-administered pharmacy spending. Tirzepatide rose to the No. 2 self-administered medication by spend, accounting for 3.47% of pharmacy spend, while semaglutide remained in the top five at 2.33%. Together, these two therapies now represent 5.80% of self-administered pharmacy spend, up from 4.74% in the winter 2026 Outlook. Annual utilization for tirzepatide increased 101.2% from 2024 to 2025 among Vizient Pharmacy Program participants, reflecting continued strong demand. Additionally, almost half of pharmaceutical spending will come from two categories that will also have two of the highest rates of price inflation: Oncology drugs, including Keytruda, Darzalex Faspro, Opdivo, and Imfinzi, account for 25.59% of pharmacy spending, with costs projected to increase 4.14%. Autoimmune and anti-inflammatory therapeutics, such as Skyrizi, Dupixent, Humira, and Enbrel, account for 23.39% of spending with costs projected to increase by 4.10%. Investment in technology infrastructure and operational services continues to fuel indirect spend growth As healthcare organizations continue investing in clinical informatics, AI-enabled diagnostics, and digital transformation, there will be growing costs associated with both the acquisition and utilization of these capabilities. Projections show the inflation increase of these indirect spend categories will be driven by continued increases in IT security (8.50%), IT hardware and accessories (8.00%), and IT software and licensing (7.50%) as organizations strengthen operations. Beyond technology spending, organizations continue to face growing pressure from wider macroeconomic trends driving up the cost of food (4.16% projected increase), construction (4.70%), and capital equipment (4.15%). These investments increasingly influence organizational resilience, services continuity and long-term performance, requiring greater coordination across finance, supply chain, operations, and clinical leadership. "Indirect spend has evolved from support categories into a strategic capability,” said Dolan. “Investments in technology and infrastructure increasingly influence how organizations deliver care, strengthen resiliency, and position themselves for future growth." Pharmacy projections for the summer 2026 Spend Management Outlook are based on Vizient client purchases April 2025–March 2026. Non-pharmacy supply chain projections are based on a Vizient analysis of various public sources including the U.S. Bureau of Labor Statistics, U.S. Department of Agriculture and Energy Information Administration. Read more in the Vizient Spend Management Outlook. About Vizient Vizient® enables healthcare providers to deliver better, more affordable care by improving financial sustainability, enhancing system performance, and accelerating strategic growth. More than two-thirds of the nation's acute care providers and more than one-third of ambulatory providers rely on Vizient solutions and services. By combining the nation’s most influential healthcare leader networks with industry-leading data and analytics, comprehensive solutions, and advisory services through Kaufman Hall, Vizient helps providers achieve financial, clinical, and operational excellence. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at vizient.com.

iStock , useng The FDA’s rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy. The FDA has deemed the single-arm mid-stage study submitted by Replimune to support the approval of an oncolytic immunotherapy “not interpretable,” setting up what should be a challenging advisory committee meeting for the biotech this week. The drug, vusolimogene oderparepvec, or RP1, has been rejected by the FDA twice . The agency accepted another resubmission in June and committed to rendering a third verdict by August 2—but also announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss the therapy. Two days ahead of that Thursday meeting , FDA briefing documents show that the agency still has significant concerns about the data package that Replimune has offered to support RP1’s accelerated approval in combination with Bristol Myers Squibb’s PD-1 inhibitor Opdivo for adults with unresectable advanced cutaneous melanoma who experience disease progression after a PD-1-blocking antibody-based therapy. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); The response assessment used in the Phase 1/2 IGNYTE study “confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results,” the FDA reviewers said. Moreover, the agency determined that the objective response data from the single-arm trial “are not of sufficient magnitude to overcome concerns” about the drug’s efficacy. Without a reliable historical control, the FDA stated “it cannot be determined whether RP1 contributes to any observed effect” when combined with Opdivo. “The overall survival analysis from the single-arm IGNYTE study is not interpretable,” the FDA wrote. Replimune was down as much as 20% to $6.98 in premarket trading Tuesday. Replimune argued that experts have determined a randomized trial to be unethical in this population. “It is not feasible or ethical to randomize this patient population to a comparator arm of anti-PD-1 monotherapy that offered no hope for response, therefore a study comparing RP1 in combination with nivolumab, to nivolumab monotherapy in patients whose disease progressed while on nivolumab or other anti-PD-1 was not conducted,” the company wrote in its own briefing document . Replimune also addressed the FDA’s questions regarding historical data. When IGNYTE was performed, there were no treatments available for patients who had progressed after anti-PD-1 treatment, the company explained. And there is no evidence that continuing on an anti-PD-1 therapy poses any benefit to patients. “Consequently, there is very little literature evaluating this specific scenario, as continuing a therapy that has definitively failed would generally not be considered appropriate clinical practice,” Replimune wrote, adding that the IGNYTE study had strict criteria to ensure patients were “truly anti-PD-1 resistant.” Replimune also pointed out that the FDA has previously granted approval based on a single-arm study for melanoma patients. Iovance Biotherapeutics most recently received approval in 2024 for Amtagvi in this scenario. Merck’s Keytruda and Opdivo also got FDA nods for unresectable or metastatic melanoma following that of BMS’s Yervoy with single arm trials. With Replimune, however, the FDA has been consistent in its disagreement with this study design. In its first complete response letter in July 2025, the FDA said it “did not consider IGNYTE an “adequate and well-controlled clinical investigation,” a ccording to Replimune at the time. In a second CRL in April, trial design remained the sticking point for the regulator, which wrote that it “would not recommend” seeking approval based on results from a single-arm study. Complete response letters Replimune’s advanced melanoma drug rebuffed by FDA for second time The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1. April 10, 2026 · 2 min read · Heather McKenzie Read more On Thursday, the CTGTAC will vote on just one question: Are the efficacy results from IGNYTE evaluable and clinically meaningful? Replimune’s turn before the CTGTAC will be the committee’s second event this week. On Monday, the FDA similarly released adcomm documents for Capricor’s Duchenne muscular dystrophy cell therapy deramiocel. The agency disagrees with the company’s claim that a Phase 3 trial submitted to support approval was successful. That hearing will take place Wednesday. The meetings follow a nine-month drought of adcomms at the FDA under the Trump administration. After a leadership shakeup, the agency appears to be recommitting to these public meetings. FDA FDA has recommitted to adcomms—but to what end? The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings were called at all, while many have questioned the rationale behind them and other adcomms on deck. July 27, 2026 · 5 min read · Michael Gibney Read more