According to Spherix Global Insights, the potential approval of the hypoxia-inducible factors prolyl-hydroxylase inhibitors could alter referral and treatment patterns for patients with anemia of chronic kidney disease being managed by hematologists/oncologists.
EXTON, Pa., July 14, 2020 / PRNewswire / – Spherix recently fielded a survey of 152 hematologists/oncologists in the US in order to assess the current and future treatment paradigms of anemia patients treated by this specialist population. According to the Market Dynamix™ survey, anemia is a highly prevalent co-morbidity for many of the patients under their management. Hematologists/oncologists frequently receive referrals for anemia work-ups from primary care physicians as well as certain specialists, including gastroenterologists, nephrologists, and OB-GYNs.
While hematologists/oncologists report that anemia is often linked to multiple factors, they estimate that chronic kidney disease (CKD) is a cause in about one-in-four of the anemia cases they see. Frequently, these patients also either have a history of cancer or current malignancy. Many of the patients with anemia being seen by hematologists/oncologists are also iron deficient, and the survey respondents estimate treating about 30 patients per month with intravenous (IV) iron. Most hematologists/oncologists do have a preferred IV iron brand, usually American Regent’s Venofer or Daiichi Sankyo’s Injectafer1. More than half indicate high interest in Pharmacosmos’ Monoferric, a recently FDA-approved agent offering the advantage of single dose delivery of 1,000mg of iron.
Hematologists/oncologists are also highly interested in a new class of oral anemia treatments known as hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PH inhibitors), of which three are in late stage development (FibroGen/AstraZeneca/Astellas’ roxadustat, Akebia Therapeutics’ vadadustat2, and GSK’s daprodustat). While hematologist/oncologists report being largely comfortable with erythropoietin stimulating agents (ESAs), such as Amgen’s Epogen and Aranesp, nearly three-quarters agree that there is a high unmet need for new, non-ESA anemia treatments. Two-thirds of respondents agree that patients would prefer an oral anemia treatment over agents that are administered subcutaneously like the ESAs.
More than half of the respondents rated a HIF-PH inhibitor profile as very favorable, with a similar percentage noting that the class offers a substantial advance over ESAs. In fact, over half agree that if these agents are approved, they would treat patients with CKD anemia sooner than they currently do with ESAs – citing initiation at higher hemoglobin levels (assuming this is permissible in the product label). It is worth noting, however, that the referral and treatment patterns between nephrologists and hematologists/oncologists could change if an oral agent becomes available. More than half agree that if these new agents are FDA approved, nephrology referrals for patients with CKD anemia will likely decrease, and a similar percent say that the loss of nephrology CKD patients who are currently being treated with ESAs could have a moderate to significant impact on practice revenues.
Hematologists/oncologists also weighed in about their familiarity with and use of Celgene/BMS’ Reblozyl (luspatercept-aamt), which was originally FDA approved in November 2019 to treat anemia in patients with beta thalassemia. In April 2020, the drug was approved to treat anemia in very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Notably, hematologists/oncologists rate anemia of MDS as the area of anemia with the greatest unmet need, but despite this, less than half of the survey respondents have prescribed Reblozyl for MDS anemia (even lower for beta thalassemia) – citing the narrow indication and difficult payer approval process.
About Market Dynamix™
Market Dynamix™ is an independent, subscription-based service that explores future dynamics of evolving healthcare markets within specific indications to help your company make well-informed, strategic decisions. The Spherix research method pairs together both qualitative analyses, fueled by interviews with leading international opinion leaders, and quantitative analysis (n=~100), leveraging a proprietary network of specialists “in the trenches.”
About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.
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1 Venofer® and Injectafer® are manufactured under license from, and are registered trademarks of, Vifor (International) Inc., Switzerland. American Regent, Inc. is a member of the Daiichi Sankyo Group. Source: www.venofer.com
2 In 2015, Akebia entered into a collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC), providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries. In 2016, Akebia entered into a collaboration and license agreement with Otsuka Pharmaceutical Company (Otsuka) for development and commercialization of vadadustat in the U.S. In 2017, Akebia and Vifor Pharma (Vifor) entered into an agreement granting Vifor an exclusive license to sell vadadustat, if approved by the FDA and included in the Centers for Medicare & Medicaid (CMS) End Stage Renal Disease Prospective Payment System (ESRD PPS) bundle, to Fresenius Kidney Care Group, an affiliate of Fresenius Medical Care North America, for use solely within its dialysis facilities in the U.S. In 2019, we expanded this agreement so that the license would also be effective during the Transitional Drug Add-on Payment Adjustment (TDAPA) two-year period that is expected to precede the ESRD bundle period, and to provide Vifor with a license to sell vadadustat to certain third-party dialysis organizations in the U.S. as well. Source: https://akebia.com/partnering/