Spherix Global Insights

August 01, 2019

US Nephrologists Are Optimistic About the Potential for Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHIs) for the Treatment of Renal Anemia

According to Spherix Global Insights, nephrologists have high expectations that this novel class of oral agents may offer a safer way to treat renal anemia compared to erythropoietin stimulating agents (ESAs) such as Amgen’s Epogen and Aranesp

 EXTON, Pa., August 1, 2019 / PRNewswire/ – In the latest report included in the RealTime Dynamix: Renal Anemia service, which represents the 16th consecutive wave, Spherix Global Insights surveyed 200 US nephrologists about the latest trends and perceptions related to renal anemia in the dialysis and non-dialysis settings. In addition to tracking the evolution of the ESA market and the rising familiarity with HIF-PHIs, the survey also covers market receptivity to Akebia’s Auryxia in iron-deficiency anemia, familiarity and perceptions of Rockwell Medical’s Triferic, and uptake of Daiichi Sankyo/Vifor’s Injectafer.

Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHIs)

In the US, three HIF-PHIs are in late stage development – AstraZeneca/Astellas/FibroGen’s roxadustat, Akebia Therapeutics/Mitsubishi Tanabe Pharma Corporation/Otsuka’s vadadustat, and GSK’s daprodustat. Indeed, roxadustat has recently been approved in China, and just last week, Akebia announced the first worldwide filing in Japan for vadadustat. Although only 29% of surveyed nephrologists report high familiarity with HIF-PHIs, among those that are familiar, the class is perceived as a potential game-changer. According to the findings, 60% of these nephrologists believe that HIF-PHIs have the potential to significantly improve outcomes in both the CKD-ND (chronic kidney disease – non-dialysis) and CKD-DD (chronic kidney disease – dialysis dependent) settings. Indeed, over half of surveyed nephrologists (and 69% of those highly familiar) expect the HIF-PHIs to be “safer” than ESAs, describing anticipated advantages specifically related to lower risk of cardiovascular events.  Whether this can be delivered in the final labels remains to be seen.

With two of the HIF-PHI developers already having an active commercial presence in the renal space, AstraZeneca is promoting Lokelma (sodium zirconium cyclosilicate) for hyperkalemia, and Akebia is promoting Auryxia for hyperphosphatemia and iron-deficiency anemia; both companies are well-positioned to launch their respective HIF-PHIs. While roxadustat is likely to win the coveted first-to-market position, Akebia has an edge in the dialysis setting, having forged a partnership with Vifor that may afford preferential access for vadadustat in the majority of dialysis units in the US. At present, most nephrologists see very little differentiation between HIF-PHIs, making market access and promotional muscle paramount to success.

Auryxia (ferric citrate)

Auryxia (ferric citrate) was first approved in the US market at the end of 2014 with an initial indication for hyperphosphatemia in CKD. Three years later, Auryxia scored an additional indication for the treatment of iron deficiency anemia (IDA) in adult patients with CKD-ND. Although approved over a year and a half ago for IDA, most nephrologists (84%) still view Auryxia as a moderate-to-substantial advance over other available therapies in the IDA CKD-ND space.

Survey results suggest that nephrologists have a positive view of Auryxia as a treatment for patients with IDA in CKD-ND; however, self-reported share of Auryxia for the IDA indication has appeared to plateau, and despite continual favorable projections, the user base has also been flat and is significantly lower than the user base for hyperphosphatemia. Coverage restrictions may be limiting use of Auryxia, as CMS began mandating a prior authorization for the drug earlier this year. Accordingly, nephrologists report that market access issues are the greatest barrier to their increased use of the brand.

Among drugs in the renal anemia space, Auryxia is the most actively promoted by far. In a market where sales representative reach and frequency are strongly correlated to future share gains, this is Akebia’s best bet to turn prescribing intentions into reality.

Retacrit (epoetin alfa-epbx)

Pfizer and Vifor’s Retacrit, an epoetin alfa biosimilar, was approved in the US in May 2018 and launched 6 months later. Although 8 months have passed since the initial launch of Retacrit, only 23% of US nephrologists reported being highly familiar with the biosimilar. Not surprisingly, only 12% of nephrologists reported use of Retacrit, and only 11% reported that they will begin using the biosimilar in the next three months. When asked about specific barriers to Retacrit use in the CKD-DD setting, 64% noted lack of formulary placement. In the CKD-ND setting, nephrologists noted lack of familiarity as the greatest barrier (43%) to Retacrit use.

From a clinical perspective, nephrologists do not appear to be concerned with using ESA biosimilars, as close to half of those surveyed report very low concern with the introduction of Retacrit into the US market. Close to one-third of nephrologists indicate they would be willing to undergo a full unit conversion to Retacrit if the price is right, though there may be some reluctance to switch patients who are stable on other ESAs. With Roche-Genentech/Vifor’s long-acting Mircera now the dominant ESA in the dialysis setting, switching may be a bit more complicated than a simple reference brand to biosimilar conversion.

The nephrologists participating in this survey represented 37 states and have been in practice for an average of 17 years. Most (78%) are in office-based practices; 71% are primarily affiliated with a large dialysis organization (such as DaVita or Fresenius Medical Care); and 67% are Medical Directors at their primary dialysis unit.

About RealTime Dynamix™

RealTime Dynamix™ is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. Subscriptions to the service are available for the following markets: Bone and Mineral Metabolism, Renal Anemia, Hyperkalemia, and Polycystic Kidney Disease. The next wave of the CKD-Renal Anemia study will field in late August.

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 immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

 For more information contact:
Jake B. Guinto, PhD, Cardio-Renal Insights Director

Phone: (484) 879-4284
Email: [email protected]

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