This article from our April issue addresses another example where CMS’ good intentions fall short: in this care, a rule change to rein in abuses of prior authorization (PA) by Medicare Advantage (MA) plans. Bipartisan agreement that MA plans were using the PA process to block patients from getting care to which they were entitled did not prevent the rule from leaving out a huge area of contention—use of PA to limit access to life-saving cancer drugs. That same month, Debra Patt, MD, PhD, MBA, FASCO, now president of the Community Oncology Alliance, offered a recap of her testimony in the Senate in which she shared an account of being told she might have to wait up to 6 weeks for a peer-to-peer review involving one of her patients with breast cancer.
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3. NCCN Guidelines Update Adds Mirvetuximab Soravtansine Plus Bevacizumab for FRα-Expressing, Platinum-Sensitive Ovarian Cancer
Also from our February issue, this article reported on the National Comprehensive Cancer Network (NCCN) update to its clinical guidelines for the treatment of ovarian cancer. Mirvetuximab soravtansine (Elahere; Immunogen) plus bevacizumab was added to the NCCN Clinical Practice Guidelines in Oncology as a 2B recommendation for patients with platinum-sensitive ovarian cancer and folate receptor alpha (FRα)-expressing tumors. The update also changed mirvetuximab soravtansine plus bevacizumab from a category 2B to a category 2A recommendation for platinum-resistant ovarian cancer with FRα-expressing tumors. FDA granted accelerated approval to mirvetuximab soravtansine for women with platinum-resistant, FRα-positive advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers in November 2022. Positive results from the confirmatory MIRASOL trial confirmed the antibody drug conjugate confers progression-free survival and overall survival benefits compared with previous standards of care.
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2. Cancer Drugs Speed to Accelerated Approvals, Then Hit the Brakes in Timely, Clinically Beneficial Confirmatory Trials
This commentary by Evolent’s Terra Wontsettler, PharmD, MBA, explores the 30-year history of FDA’s accelerated approval pathway, which have allowed patients to gain early access to 278 drugs that fulfilled unmet needs. About a third of all oncology drugs now receive initial approval this way, and the pathway has come under scrutiny following some high-profile withdrawals of some indications after results did not hold up in confirmatory trials. As Wontsettler explains, the accelerated approval is the beginning, not the end of the journey, and health plans have a critical role to play.
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In Wake of Express Scripts Suit, FTC Takes On 3 Largest PBMs.
This article, which appeared online first and then in our October issue, remains as timely as 2024 concludes as it was when it appeared. The Biden administration Federal Trade Commission, on the heels of its interim report on PBM practices, answered a strike by ExpressScripts with a lawsuit accusing the largest PBMs of forcing patients to pay higher costs on insulin products to increase their profits. EBO featured reactions from COA, which has helmed the debate over PBM practices since its inception, due to the effects on oncology practices and patients.
As 2024 drew to a close, bipartisan frustration with PBM practices fueled a health care transparency package, with President-elect Donald Trump making several statements about reforming “middlemen” practices. However, the PBM reform measures died when the original continuing resolution to keep the government open was replaced with a stripped-down version, which President Joe Biden signed Saturday. Some observers believe PBM legislation seems likely to come in early 2025, but others see these entities as "cats with 9 lives" that continue to elude reform efforts.
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