Authors' objectives:

Erythropoietin is a natural hormone, mostly produced in the kidney. In advanced renal disease its production becomes deficient, and to prevent anemia it is necessary to replace it with administered recombinant human erythropoietin. Over the past 4 years reports have accumulated of the development of Pure Red Cell Aplasia (PRCA), a form of refractory anemia caused by the development of anti-erythropoietin antibodies in chronic renal failure patients receiving recombinant erythropoietin products. The preparation principally concerned is epoetin alfa (Eprex(R)).

The present document will address the following question: What should be the policy of the MUHC for hemodialysis patients in view of the newly reported risk of anemia associated with the use of Eprex(R).

Authors' recommendations: 1) Both Aranesp sc, and Eprex iv should be available options for MUHC patients. The cost to the MUHC of either drug is comparable. When either drug is purchased through the Rgime gnrale dassurance mdicament (RGAM) there is no additional cost to the MUHC. Both have acceptable profiles of efficacy and safety. However, at the present time the evidence of safety of Eprex iv is based on a longer and more extensive experience. Other than in Qubec this has led to a widespread, but not universal, adoption of Eprex iv as the option of choice. In Qubec the intravenous administration of these medications constitutes a problem. This is because of a directive from the Ministry of Health to the effect that hospitals must pay for any medications they administer, even to outpatients. If this directive were to be strictly observed, the in-hospital administration of iv Eprex would add approximately $2 million to the annual costs of the MUHC. In order to remain budget neutral this would necessitate an equivalent reduction in hospital services. However, since patients up to this time have been purchasing their Eprex themselves through the RGAM, it may be possible to convince the Ministry to agree that the applicability of this directive to this particular case should be modified. 2) Until this matter is clarified, all patients should continue to purchase their own medication, whether Eprex or Aranesp. As a short-term policy, patients should bring their medication to hospital for administration during dialysis. As a corollary, these patients must be regularly instructed in the care of the medication. 3) In order to regularize recommendation 2, the Ministry should urgently be requested to exclude the use of recombinant erythropoietin products used in the treatment of hemodialysis patients from their directive on the in-hospital administration of drugs. 4) In addition, the Ministry should be requested to revise the policy by which these medications are paid for through the RGAM, and to reinstitute a policy of their direct acquisition by, and reimbursement of their costs to, the hospitals. To require patients to purchase their own medication and transport it to hospital for iv administration is not only inconvenient for patients, but runs the risk of medications being subjected to undue physical stress, thus increasing the risk of immunogenicity and adverse health outcomes. 5) These policies should be kept under continual review by the physicians concerned and the Pharmacy and Therapeutics committee. It must be remembered that the information available on this subject derives almost entirely from post marketing reports collected by the manufacturers. In spite of their best efforts the data must be considered fragile, and subject to change with the passage of time. Thus, policy revision will be necessary both in the light of new evidence and as a consequence of Ministerial policy decisions.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.mcgill.ca/tau/publications/2003

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Technology Assessment Unit of the McGill University Health Centre (MUHC)

Contact Address: Technology Assessment Unit of the MUHC, Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, 5252 boul. de Maisonneuve, Bureau 3F.50, Montreal, Quebec H4A 3S5

Contact Name: nandini.dendukuri@mcgill.ca

Contact Email: nandini.dendukuri@mcgill.ca

Copyright: Technology Assessment Unit of the McGill University Health Centre (MUHC)