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Spotlight on Market Access Actionable Understandings from AIS Health’S In-Depth Coverage

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Spotlight on Market Access Actionable Understandings from AIS Health’S In-Depth Coverage Spotlight on Market Access Actionable understandings from AIS Health’s in-depth coverage May 17, 2021 Research Shows COVID’s Impact on Health Care Has Lessened but Not Disappeared Chart: Anticipated Prescribing When the COVID-19 pandemic struck and the U.S. essentially shut down, 2 Actions for Tivozanib Assuming FDA Approval many people put off medical procedures as facilities didn’t have the capaci- ty to see them and patients didn’t want to potentially expose themselves to Reality Check: Hereditary 9 Angioedema COVID. A report from the IQVIA Institute for Human Data Science released in May 2020 examined the pandemic’s impact on the U.S. health care sys- tem, including huge drops in diagnostic screenings for cancer (SMA 6/1/20, p. 1). Now, more than a year later, data from the institute are showing that while numbers have improved, they have not returned to normal. “Disruptions from the pandemic that we’ve been experiencing, both the initial shock disruptions last spring and the sustained impact over the entire year, affecting both logistical visits, procedures, diagnostics, but also engagement with preventive screenings and the concern just generally about engagement in health care with potential long-term risks,” still continue, according to Michael Kleinrock, senior director of research development at the IQVIA Institute for Human Data Science. continued on p. 4 Fotivda Approval Provides New Option for Certain People With Renal Cell Carcinoma The renal cell carcinoma (RCC) therapeutic class boasts multiple agents, but a recent entrant is offering a new tool for certain patients. A Zitter In- sights survey shows that the majority of oncologist respondents are likely to prescribe Aveo Oncology’s Fotivda (tivozanib) for advanced RCC. On March 10, the FDA approved Fotivda for the treatment of adults with relapsed or refractory advanced RCC who have received at least two prior systemic therapies. It is the first FDA-approved therapy for this use. The recommended dose of the oral, next-generation vascular endothe- lial growth factor (VEGF) tyrosine kinase inhibitor (TKI) is 1.34 mg once daily for 21 days every 28 days on treatment, followed by seven days off. The capsule’s monthly list price is $24,150. According to an Aveo slide deck, that price compares to those of other relapsing or refractory RCC options: Pfizer Inc.’s Inlyta (axitinib) is $16,628 per treatment cycle, Bayer’s Nexavar (sorafenib) is $20,760, Exelixis, Inc.’s Cabometyx (cabozantinib) is $21,663, © Managed Markets Insight & Technology, LLC | 1 MMIT’s Spotlight on Market Access May 17, 2021 and the combination of Eisai Inc.’s Lenvima (lenva- in advanced RCC and do not anticipate incentivizing tinib) plus Novartis Pharmaceuticals Corp.’s Afinitor oncologists to prescribe Fotivda over Nexavar. (everolimus) is $37,505. Zitter Insights also surveyed 100 oncologists during For the Managed Care Oncology Index: Q4 2020, the same time frame. Almost 70% said they were likely from Dec. 2, 2020, to Jan. 5, 2021, Zitter Insights to prescribe Fotivda for advanced RCC, as well as polled 40 commercial payers with 132.0 million prescribe it over Nexavar (see chart below). Respon- covered lives. Payers with 84% of lives expected they dents were fairly evenly divided on whether they would would manage the drug to label, while those with 10% refrain from prescribing Nexavar. of lives anticipated covering it more restrictively than “With advances in RCC treatment, patients are its label. Respondents with 6% of lives expected that living longer, increasing the need for proven, well-tol- they would not require prior authorization for Fotivda. erated treatment options in the relapsed or refractory None of the payers anticipated not covering the drug. setting,” said Brian Rini, M.D., chief of clinical trials Zitter Insights and AIS Health are both MMIT com- at Vanderbilt Ingram Cancer Center and principal in- panies. vestigator of the TIVO-3 trial, in an Aveo press release. The drug’s approval was based on a handful of clin- “The TIVO-3 study is the first positive Phase 3 study in ical trials, including TIVO-3, a Phase III study pitting it RCC patients who received two or more prior system- against Nexavar. Payers covering 40% of lives said they ic therapies, and also the first Phase 3 RCC study to are likely to use Fotivda to negotiate greater discounts include a predefined population of patients who have for Nexavar, but those with 42% of lives said they received prior immunotherapy, the current standard are unlikely to take that action. Those covering 78% of care in earlier-line treatment. With this approval, I of lives do not expect to prefer Fotivda over Nexavar believe Fotivda represents an attractive intervention, SOURCE: Zitter Insights, Managed Care Oncology Index: Q4 2020. © Managed Markets Insight & Technology, LLC. Contact [email protected]. | 2 MMIT’s Spotlight on Market Access May 17, 2021 and expect it to play a meaningful role in the evolving Asked if payers are likely to cover Fotivda, Wong RCC treatment landscape.” notes that the agent “is a potent, selective inhibitor of When it comes to the RCC class in general, any VEGFRs [i.e., VEGF receptors] 1, 2 and 3 with a long management of it “will be limited to approved indica- half-life designed to improve efficacy and tolerabili- tions for the medications being utilized or consistency ty. It would be my expectation that payers will cover with the accepted treatment guidelines,” such as those Fotivda as a third-line treatment option for advanced from the National Comprehensive Cancer Network RCC since it is consistent with the approved FDA indi- (NCCN) or the American Society of Clinical Oncology cation, and there is nothing really indicated for this far (ASCO), says Winston Wong, Pharm.D., president of an advanced disease. Further strength for coverage of W-Squared Group. “It was not that long ago that will occur if/when the third-line treatment option is RCC was one of the most difficult cancers to treat. The included in the NCCN and ASCO guidelines.” (NCCN effectiveness of immunotherapy as a treatment option added Fotivda to its guidelines on March 29, after this has changed the landscape significantly. True man- interview took place.) agement of this cancer type would only be present in plans with pathway programs in place, and, even then, management would most likely be found for early and “It was not that long ago that RCC was first- or second-line advanced disease. Fotivda is the one of the most difficult cancers to treat. first option for third-line or later RCC disease, based The effectiveness of immunotherapy upon the TIVO-3 trial.” as a treatment option has changed the In that trial, points out Mesfin Tegenu, CEO of landscape significantly.” RxParadigm, “Fotivda was able to show improved progression-free survival compared to sorafenib. “Sutent (sunitinib malate) has been the long- However, Fotivda fell short in showing overall survival standing standard of care for renal cell carcinoma relative to sorafenib. The key takeaway for Fotivda will treatment,” says Tegenu. “Despite NCCN recently rec- be its safety profile relative to current therapies for ognizing Fotivda by making updates to the guidelines RCC. Therefore, Fotivda may be an option for a subset following the recent FDA approval, plans will continue of patients who have failed previous therapies and to monitor its place in therapy similar to the PD-1 [i.e., require a more tolerable and safe option.” programmed cell death-1] inhibitors drug class. For ex- ample, while PD-1 inhibitors have recently been mak- ing moves to being first-line therapy treatments, there “The key takeaway for Fotivda will be continue to be inconsistencies in commercial payer its safety profile relative to current coverage for this class of drugs compared to the TKI, therapies for RCC.” VEGF and mTOR [i.e., mechanistic target of rapamy- cin] inhibitor classes.” In addition, Wong points out that “patients who “The choice of treatment for an advanced RCC received prior therapy with a checkpoint inhibitor in patient is mostly determined by their prognostic risk combination with a VEGF inhibitor or two prior VEGF stratification,” Wong explains. “The risk stratification inhibitors saw the greatest reduction in the risk of is based upon the International Metastatic Renal Cell progression. Thus, there is now an option for third-line Carcinoma Database Consortium (IMDC) prognostic treatment, which would otherwise be a referral to a model, based upon Karnofsky performance status, time clinical trial. Response rates were also higher with Fo- from first diagnosis to treatment, hemoglobin level, tivda compared to sorafenib. The real question at this serum calcium, neutrophil count and platelet count.” point, however, is whether to proceed with a third-line treatment or move on to a clinical trial. Luckily, this RCC has comorbidities that may complicate man- would be a determination by the treating oncologist aging the condition, including obesity, diabetes and and their patient and not a payer.” cardiovascular-related conditions, points out Tegenu. © Managed Markets Insight & Technology, LLC. Contact [email protected]. | 3 MMIT’s Spotlight on Market Access May 17, 2021 “Taking into account an individual’s overall health COVID Impact Wanes but Persists status and other variables (e.g., age and gender) are continued from p. 1 standard in predicting their outcome; however, there is still work to be done as it relates to individually “There were about 1 billion fewer diagnosis visits in managing these patients to improve overall survival. the country in 2020 compared to what we would have With this said, currently there are no standard meth- expected without COVID,” as well as a drop of around ods in capturing comorbidities in cancer registries to 21% in expected diagnosis visits in 2020, he explained aid in tracking and monitoring the patients following during a recent webinar.
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