Amgen's Parsabiv Starts to Gain Ground in US Dialysis Market with the Nephrology User Base Expected to Climb from 20% to Over 80% Within the Next Six Months

EXTON, Pa., Feb. 1, 2018 /PRNewswire/ -- It has been nearly a year since Amgen received FDA approval for Parsabiv (etelcalcetide), an IV calcimimetic agent to treat secondary hyperparathyroidism (SHPT) in hemodialysis patients. Despite having obtained regulatory approval, nephrologists had to wait out 2017 while reimbursement issues were addressed, delaying the launch of the product. As of January 2018, Parsabiv has a J-code and the scramble to develop protocols for use has begun.

According to RealTime Dynamix: Bone and Mineral Metabolism, a quarterly survey of about 200 US nephrologists, familiarity with Parsabiv increased significantly in December, but frame of reference for many nephrologists is "the IV form of Sensipar." More than one-third of nephrologists indicate that Parsabiv is a significant advance over active vitamin D, but a similar percent view it as highly interchangeable with Sensipar. Current perceptions show Parsabiv holding a significant advantage over Sensipar when it comes to convenience and adherence, improvements in FGF-23, inhibition of calcification, and GI tolerability.

Despite this excitement, conversion may not come quickly. Indeed, according to a survey fielded only last week (n=99), only one in five nephrologists has clinical experience with the drug, resulting in a 2% calcimimetic share overall. However, more than 80% of the recent survey respondents expect to be using Parsabiv within the next six months, capturing over 20% of the calcimimetic market in addition to expanding the class. Presently, about 30% of the nephrologists surveyed report that their primary dialysis center either has an established protocol for Parsabiv or is in the process of developing one, and until these are in place, lack of access within the dialysis center will remain the greatest barrier.

Also in the CKD-MBD market, iron-based phosphate binders, in the form of Keryx Biopharmaceuticals' Auryxia and Vifor Fresenius Medical Care Renal Pharma's Velphoro, are now reportedly used in about 15% of the hemodialysis population. Auryxia appears to be enjoying recent momentum, increasing share significantly over the past year and surpassing that of Velphoro mid-year. Indeed, promotion for both of these brands has increased over the past three months according to the nephrologists surveyed in Q4 (47% report increased promotion of Velphoro and 63% report increased promotion of Auryxia), a trend that is fueling favorable future projections for both brands. Auryxia has an added opportunity with the new indication for iron deficiency anemia in the non-dialysis setting, as more than two-thirds of the respondents report the new indication will lead to an increase in their use of the brand overall.

Opko Pharmaceuticals' Rayaldee (calcitriol) continues to struggle, facing market access issues, as well as the challenge of creating meaningful differentiation from less expensive, generic vitamin D products. Although the user base remains low, it did significantly increase from Q3 2016 to Q4 2017, and nephrologists that are using the product do view it as unique and are generally satisfied. Over 80% of the current users anticipate new prescriptions in the next month, which could indicate a turning point for the brand, though it remains to be seen if this is the start of a trend.

The next wave of RealTime Dynamix: Bone and Mineral Metabolism (Q1 2018) will field in mid-February.

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