Chronic kidney disease (CKD) is a general term for a set of heterogeneous disorders that negatively affect the function and structure of the kidney. Because the kidney plays a unique role in many of the body’s regulatory functions, CKD is accompanied by a wide range of comorbidities and complications. Renal anemia, a common complication of CKD, is managed through the use of oral/intravenous iron supplements and premium priced erythropoietin stimulating agents (ESAs). ESAs stimulate the formation of red blood cells (erythropoiesis) and are commonly used in the treatment of anemia that occurs secondary to CKD. Several ESAs are used in clinical practice and can be divided into two categories: short-acting ESAs such as Epogen and Procrit (epoetin alfa), typically requiring multiple injections per week, and long-acting ESAs such as Aranesp (darbepoetin alfa) and Mircera (methoxy polyethylene glycol-epoetin beta) which are administered at one to four-week intervals. Other than convenience, majority of the physicians do not make a distinction between short-acting and long-acting ESAs on efficacy or safety grounds. As short-acting ESAs typically require thrice-weekly injections, these agents are most commonly used in patients undergoing dialysis. The inconvenience of more frequent administrations to these patients is relatively insignificant because they can be treated with ESAs while undergoing dialysis. Historically, long-acting ESAs are more commonly used in the nondialysis setting because these patients can benefit from less frequent injections.

Long-acting ESA Mircera received US FDA approval in November 2007 and is marketed by Roche in Europe and is well established both in Europe and Japan. Despite approval, it had never launched in the US due to a settlement agreement under which Roche agreed to delay the launch until mid-2014. However, on May 28, 2015 Roche entered into an exclusive license agreement for the commercialization of Mircera in the US with Galenica, the parent company of Vifor Pharma.1 In addition, Galenica entered into a supply agreement with Fresenius Medical Care North America (FMCNA), a health care company that provides products and services for dialysis, hospitals as well as inpatient and outpatient medical care. Under this agreement, Galenica would supply Mircera for FMCNA’s use solely within its dialysis facilities. On February 29, 2016 FMCNA announced that they aim to have 71% or 110,000 of their dialysis patients using Roche’s drug Mircera instead of Amgen’s Epogen by the end of Q1 2016. According to FMCNA, about 155,000 of its 180,000 patients need drug therapy to treat their anemia2 and during an investor call on May 3, 2016, FMCNA reported that it had 120,000 dialysis patients on Mircera, exceeding the originally targeted 110,000 patients they had planned to have on the drug by the end of Q1 2016.3

For over two decades, Epogen or epoetin alfa, the first to market ESA, has been the most commonly prescribed ESA among US dialysis patients. Our quarterly tracking study4 fielded in April/May 2015 indicated that almost 80% of dialysis patients were on epoetin alfa. However, Mircera use has rapidly risen to 15% of ESA-treated dialysis patients while epoetin alfa use has fallen from 80% in April/May 2015 to 64% in April/May 2016, clearly showing Mircera use at the expense of epoetin alfa, according to our biannual tracking study5. Not surprisingly, surveyed nephrologists primarily affiliated with FMCNA reported using significantly more Mircera than did physicians primarily affiliated with all other dialysis segments, including DaVita. Our market access study6 on renal anemia fielded in February/March 2016 suggested that 90% of FMCNA affiliated nephrologists have high accessibility to Mircera. But, surveyed payers quoted prior authorization (PA) as the control they most frequently used for Mircera. However, PA can be overcome as most payers want to ensure Mircera is being used according to the FDA label and is prescribed by specialists. In addition to cost controls such as PA and quantity limits, 67% of the payers reported that Mircera is not a preferred brand on their formulary and will likely stay non-preferred over the next 12 months because, 1) Mircera is too expensive compared with other renal anemia agents, 2) there is insufficient clinical advantage of Mircera over other renal anemia agents, and 3) payers are able to negotiate a more favorable contract for a comparable agent.

Given FMCNA’s successful push for Mircera over Epogen, Mircera’s expedited growth among dialysis patients within FMCNA and the fact that the more conveniently delivered long acting ESA Mircera is already well established in Europe and Japan, Mircera use in the US is expected to continue to grow within FMCNA. However, Mircera may face some reimbursement related roadblocks along the way.

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1Roche enters into exclusive license agreement with Galenica for the commercialization of Mircera in the United States http://www.roche.com/investors/updates/inv-update-2015-05-28.htm

2 Fresenius Medical Care North America aims to move more dialysis patients to Mircera http://www.nephrologynews.com/fresenius-medical-care-north-america-aims-to-move-more-dialysis-patients-to-mircera/

3 Fresenius Medical Care North America surpasses Mircera target for Q1 2016 http://www.nephrologynews.com/fresenius-medical-care-surpasses-mircera-target-for-q1-2016/

4 Decision Resources Group’s TreatmentTrends® Nephrology Q2 2015 (US), a quarterly report series, examines the management of dialysis and mid-to late-stage CKD patients from the perspective of 200 nephrologists. Emphasis is on renal anemia management, calcium-phosphorus metabolism, SHPT, and hyperkalemia. The content provides insight into practice patterns, attitudes and perceptions, and current and projected use of various products. It evaluates perceived product advantages and disadvantages, as well as sales and messaging efforts, of key market players.

5 Decision Resources Group’s CurrentTreatment® Renal Anemia Q2 2016 (US) provides a deep dive and longitudinal information on the renal anemia market dynamics. It examines the management of dialysis and mid-to late-stage chronic kidney disease patients from the perspective of 100 nephrologists. How is renal anemia being treated in the US today, and what are the factors behind those treatment decisions? Also included in this content are sales and messaging efforts of key market players and coverage of late-stage products for the treatment of renal anemia.

6 Decision Resources Group’s Access & Reimbursement® Renal Anemia 2016 (US) examines the market access factors that influence success of therapies for the treatment of renal anemia. This content is based on primary research data with 100 US nephrologists and 30 MCO pharmacy and medical directors. This research explores how payers and physicians interact and how reimbursement decisions impact the prescribing and uptake of specific therapies at the brand level.

 

Related DRG reports:

Chronic Kidney Disease | Landscape & Forecast | Disease Landscape & Forecast

Chronic Kidney Disease | Epidemiology | Mature Markets Data

Chronic Kidney Disease | Current Treatment | Detailed, Expanded Analysis CKD Referrals (US)

 

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