SP681NICE GUIDELINES FOR THE PRESCRIPTION OF CINACALCET IN HAEMODIALYSIS PATIENTS; A DISTRICT GENERAL HOSPITAL’S EXPERIENCE

Abstract

Introduction and Aims: Secondary hyperparathyroidism is a source of significant morbidity for haemodialysis patients. NICE guidelines recommend cinacalcet for those who have high levels of parathyroid despite standard treatments and are not suitable for a parathyroidectomy. While effective at reducing parathyroid hormone levels, cinacalcet treatment is expensive and a recent multi-centre trial has not shown a mortality benefit with its use. In light of the results from the EVOLVE study we set out to analyse the adherence to NICE guidelines and their suitability and relevance to haemodialysis patients in a U.K. setting. Methods: This was a retrospective data analysis of all haemodialysis patients at Basildon Hospital who were on cinacalcet therapy at any time from 01/11/2012 to 31/ 10/2013.We analysed all PTH, calcium, and phophate levels that were taken from the initiation of their cinacalcet therapy until their cessation, parathyroidectomy, or the chronological end point of our dataset. Our data was analysed in the context of NICE's stipulations for initiation and continuation of therapy [PTH levels should be > 85pmol/ L and show a 30% reduction at 4 months]. Expenditure on cinacalcet was calculated, and compared to expenditure if NICE guidance was rigidly followed. Results: BTUH has 177 patients on haemodialysis, 176 of whom have secondary hyperparathyroidism. 17 of these received cinacalcet therapy (9 male, 8 female, age range 25 to 79 years, mean 59.8 years). At 4 months the mean reduction in PTH was 29.8% (range -5.8% to 69.4%). At 8 months the mean reduction in PTH was 51.8% (range 6.5% to 84.6%). Mean time to become therapeutic [>30% reduction] was 25.2 weeks (range 4 to 53 weeks). Only 1 patient managed to stay consistently therapeutic on cinacalcet therapy. All others rose above the 70% cut off at least once, with all except 4 patients climbing above their PTH baseline whilst on cinacalcet therapy. 10 patients failed to reach therapeutic targets by 4 months however were continued on treatment. Of these 10, 9 of them reached therapeutic range at 12 months of. One patient failed to ever become therapeutic. 13 out of 17 patients had a therapeutic PTH level at 12 months. Three patients went on to have a surgical parathyroidectomy. 1 patient was hypocalcaemic at initiation; at 18 months 5 were hypocalcaemic. By initiating cinacalcet in those with a PTH of less than 85pmol/L and continuing it in those who failed to meet therapeutic targets at 4 months BTUH spent over 30,000 in one year. Conclusions: The results show that in a our setting cinacalcet was effective at reducing parathyroid levels, however the time taken to achieve this occurred outside of NICE guidance for the majority (10 out of 17 failed to have a 30% reduction at 4 months). Furthermore many patients saw their PTH levels climb above baseline at some point during cinacalcet therapy. Undoubtedly with more rigorous follow up and aggressive dose escalation of cinacalcet more effective suppression of PTH levels could be seen. However this work gives insight into the realities of cinacalcet in a "real world" setting (which we believe is not dissimilar to the practice of many renal units in the U.K.). Even with appropriate dose escalation of cinacalcet a large randomized controlled trial has failed to prove it has a mortality benefit over placebo (EVOLVE). In light of the findings of EVOLVE and our data showing the realities of cinacalcet prescribing one would have to question the value of cinacalcet in a setting such as ours. The other consideration is that, given the relative young age of the patients in this study (mean 60), weather we our overlooking surgery in many patients on cinacalcet.