Amgen's Parsabiv Doubles in Most Recent Quarter But Strict Usage Guidelines from Large Dialysis Organizations, DaVita and Fresenius Medical Care, Stifle Potential

EXTON, Pa., July 24, 2018 /PRNewswire/ -- Nephrologists largely believe that an IV calcimimetic (e.g. Parsabiv) will improve outcomes in secondary hyperparathyroidism. So, why the muted uptake?  According to a survey of over 200 US nephrologists in June 2018, one of the leading barriers is restrictive protocols put in place by large dialysis organizations (LDOs) such as DaVita and Fresenius Medical Care (FMC).  Apparently where you dialyze matters, as nephrologists report that access to Parsabiv is highly varied depending on chain affiliation. Indeed, with most current LDO protocols requiring "failure" on Sensipar (Amgen's own oral calcimimetic), the target population is being largely controlled given that LDOs manage the majority of dialysis patients' lives. This is reflected in calcimimetic share estimates where nephrologists primarily affiliated with LDOs report single-digit Parsabiv share compared to those in small-to-mid sized chains and independent units where Parsabiv share is four to five times higher.

Upside for Parsabiv does exist and the trajectory appears to be aggressive. The user base increased from just 9% in Q4 2017 to 31% the following quarter and most recently reached 53%.  Importantly, in six months time, 80% of nephrologists anticipate prescribing the product, estimating that current share will more than double as it did between Q1 and Q2 this year. Furthermore, the calcimimetic class also appears to be expanding as a healthy mix of Parsabiv new starts are not being switched from Sensipar. Discontinuations are low and seemingly manageable while Amgen's promotional support is strong. Indeed, among six relatively recent renal product approvals, 31% of the surveyed nephrologists say Parsabiv is the product they are most excited about.

The survey also explored nephrologists use of Opko's Rayaldee. After a nice uptick in the user base between Q4 2017 and Q1 2018, Rayaldee hit another plateau, with only a slight increase in the user base which remains well below the midpoint. Opko has not successfully differentiated from inexpensive generic nutritional vitamin D agents, and (coming into the second year of launch) many physicians admit to not knowing where it fits, hence, not being inclined to use it. Those who have prescribed Rayaldee can clearly differentiate the product; unfortunately, there are not that many of them. With only 22% of the surveyed nephrologists agreeing Opko is doing a good job promoting Rayaldee, physicians offer Opko plenty of advice: calling for increased promotion, the need to differentiate the product, and the need for more clinical data to support use of Rayaldee. 

In the hyperphosphatemia market, Keryx's Auryxia appears to be riding a momentum that began about six months ago. Self-reported usage metrics show an 18% increase in hemodialysis prescriptions over Q1 2018, increasing the spread between Auryxia and FMC's Velphoro. Auryxia may be capitalizing on the vacancy left by Sanofi-Genzyme when Renvela generics entered the market as well as the newly secured supplemental indication for iron deficiency anemia, which takes the product into the pre-dialysis realm. Promotion is reportedly up for both Auryxia (53%) and Velphoro (42%) and the brands face similar market access barriers. Future share projections show both brands significantly increasing share in the hemodialysis setting. In the peritoneal dialysis setting, Auryxia is slated to capture nearly one in five binder-treated patients. 

RealTime Dynamix™: Bone and Mineral Metabolism is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development. The next quarterly update of this report will be released in September.

About Spherix Global Insights
Spherix Global Insights is an independent market intelligence agency, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

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

For more information contact:
Nikki Curtis, Associate Insights Director, Cardio-Renal
Email: [email protected]
www.spherixglobalinsights.com

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