Changes Afoot in the Management of CKD Mineral Bone Disorder Reinforced by a Clinical Practice Guideline Update from KDIGO

EXTON, Pa., Aug. 10, 2017 /PRNewswire/ -- Since the introduction of Renagel by Genzyme Corporation nearly 20 years ago, the use of non-calcium binders has been steadily gaining ground, buoyed by clinical data as well as heavy promotion by companies with non-calcium based phosphate binders.  Recently, KDIGO published updates to the Clinical Practice Guidelines for CKD-MBD with two standout recommendations that may shift practice patterns.  These include:

• In adult patients with CKD G3a-G5D receiving phosphate-lowering treatment, we suggest restricting the dose of calcium-based phosphate binders
           
• In adult patients with CKD G3a-G5 not on dialysis, we suggest calcitriol and vitamin D analogs not be routinely used. It is reasonable to reserve the use of calcitriol and vitamin D analogs for patients with CKD G4-G5 with severe and progressive hyperparathyroidism

Regarding the recommendation for avoidance of calcium based binders, more than 94% of surveyed nephrologists (n=192) use calcium based binders in hemodialysis patients, and more than one-third report a preference for calcium binders as first-line binders for dialysis patients.  An even higher percentage prefer calcium binders as first line options for the     pre-dialysis population.  Over time, share has gradually shifted to non-calcium agents, dominated by Sanofi-Genzyme's Renvela.  However, nephrologists estimate that more than one-third of their hemodialysis patients are still treated with calcium agents and overall, at any given time, close to 40% are above target for phosphorus.  Future projections for non-calcium binders show significant share gains for Auryxia and Velphoro at the expense of calcium-based binders and Renvela in the next six months - a trend which could be further fueled by the KDIGO update.

According to Dr. Geoffrey Block, a recognized expert in CKD-MBD and a member of the KDIGO workgroup for the updated Clinical Practice Guidelines, "With regard to P lowering therapy the new CPG update now recommends that the use of calcium containing phosphate binders (CCPB) be restricted- with no caveats or limitations.  This recommendation is the result of new data published since the 2009 Guidelines which demonstrate several important findings:  1) patients with CKD are in positive calcium balance (over the short term) with even modest doses of CCPB 2) RCT's evaluating patient level outcomes which compare CCPB to non-CCPB demonstrate that use of the non-CCPB sevelamer resulted in reduced progression of CKD to RRT, reduced CV events and reduced mortality, while CCPB accelerated arterial calcification in a study in patients in CKD stages 3b-4, and 3) several recent meta-analyses demonstrate an increased risk of mortality with CCPB as compared to non-CCPB in patients with dialysis-dependent and non-dialysis dependent CKD.  There is no data from RCT's to assess whether or not there is a 'safe' dose of calcium and how CCPB could be useful in moderate doses in combination therapies with non-CCPB, and thus no guidance can be provided as to specific limitations on total daily dose of elemental calcium.  As a result, the workgroup chose a more general recommendation to restrict the use of calcium based P binders, but still did not suggest to completely avoid them. This represents an important change in paradigm for providers who manage patients with CKD who are in need of phosphate lowering therapy."

The guidance around avoidance of calcitriol and vitamin D analogs in pre-dialysis may be more controversial and is yet one more challenge faced by OPKO in their launch of Rayaldee.  Although the guideline does reference Rayaldee as a novel vitamin D prohormone that both increases 25D and 1,25D levels and lowers iPTH, the majority of nephrologists fail to see a distinction between Rayaldee and other, mostly generic, options.  Indeed, only 10% view Rayaldee as a significant advance over other options for secondary hyperparathyroidism and at seven months post launch, close to 90% of the surveyed nephrologists have yet to prescribe the drug. 

Another potential market change is coming with Amgen's Parsabiv, an IV calcimimetic approved earlier this year. Although nephrologists are bullish about using Parsabiv in place of oral Sensipar, due to perceptions of better adherence and improved tolerability, dialysis center formulary approval and protocols for use are largely on hold until clear guidance around the reimbursement mechanism for Parsabiv is issued by CMS.  Originally, surveyed Medical Directors expected this to occur in the June/July timeframe, but expectations as well as communications from Amgen sales representatives are now pointing to a 2018 resolution.  In a "follow the money" environment that surrounds the US dialysis market, exactly how Parsabiv and Sensipar are reimbursed will strongly influence adoption patterns.

The next wave of this on-going study will be released in September.  Parallel reports cover trends in the renal anemia and hyperkalemia markets.

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