Switching to Generics as a Cost Saving Measure - Safe or Unsafe? - A Single Centre UK Experience With Mycophenolate Mofetil in Adult Kidney Transplantation.

Background There is pressure to look at cost savings in transplantation. With cheaper generic drugs there is a dilemma whether cost savings will be associated with a loss of therapeutic efficacy. In 2010 we changed our immunosuppression protocol to switch kidney transplant recipients established on Myfortic (Novartis) or Cellcept (Roche) to Myfenax (Teva). We present the results of this process. Method Recipients at 6 months post-transplant receive immunosuppression via home delivery and our objective was to convert eligible recipients at their next delivery date. A letter detailing the process was sent. Doses for 2 months were supplied with further information reiterating the change in brand. Each patient was asked to inform the transplant team when they started Myfenax and renal functions were tested 2 weeks later. A second lot of Myfenax for 4 months was dispatched where the graft function remained stable. At a year, an audit was undertaken to determine how successful and smooth the transition to a generic medication had been. The successfully switched patients were sent a symptom quality of life questionnaire focussing on Gastro-intestinal issues. Objective ( and subjective analysis was performed. Results 248 potential suitable kidney recipients were identified, 177 (71.3%) were successfully switched to Myfenax. Of the 71 who did not 2 had not yet started due to existing stock of current Mycophenolate. 4 refused. 10 could not be converted because of clinical reasons. 39 experienced adverse events with Myfenax and had to be taken off. 16 lost to follow up. Questionnaires were circulated to the 177 who were switched with a response rate of 113(63.8%). 45(39.8%) experienced nil, 39(34.5%) mild and 29 (25.6%) moderate to severe symptoms. Less than 50% recipients let the Transplant team know when they had started Myfenax and hence didn't receive serum tests at the optimal time. The switch resulted in a cost saving of £415,000.00 ($681091.00) Conclusion In appropriately selected adult kidney transplant recipients switching to generic Mycophenolate mofetil was not associated with adverse outcomes. The process of switching requires considerable investment in time and patient education by transplant professionals.Longer term outcomes of the switch are not yet known. It is possible to make significant cost savings by switching to generic drugs. DISCLOSURES:Stacey, J.: Grant/Research Support, Novartis.