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Canadian Drug Review Reimbursement Decision


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  Revolade
Generic eltrombopag olamine
Company GlaxoSmithKline Inc.
Indication chronic ITP
Condition Immune System
Submission Type Initial
Patient Population Eltrombopag olamine has a Health Canada indication for adult chronic ITP to increase platelet counts in splenectomized patients who are refractory to first-line treatments (e.g., corticosteroids, immunoglobulins). Health Canada further indicates that eltrombopag olamine may be considered as second-line treatment for adult non-splenectomized patients where surgery is contraindicated. Eltrombopag olamine is a thrombopoietin receptor agonist. It is available in 25 mg and 50 mg tablets of eltrombopag (as eltrombopag olamine). The Health Canada-recommended starting dose is 50 mg once daily; if after two to three weeks of initial therapy, the platelet counts are below the clinically indicated levels (e.g., 50 x 10^9/L), the dose may be increased to a maximum of 75 mg once daily. The product monograph indicates that therapy with eltrombopag olamine should not exceed one year of continuous treatment and, that after one year of continuous treatment, therapeutic options should be reassessed.
Status Complete
Date of Recommendation 2011-10-24
Recommendation Summary Do not list
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that eltrombopag olamine not be listed.
Reason for Recommendation 1. In the three double-blind, randomized placebo-controlled trials of patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), the primary outcome was platelet response, which the Committee considered less clinically relevant than bleeding events. 2. There are no head-to-head randomized controlled trials (RCTs) comparing eltrombopag with individual comparator treatments for ITP. 3. The manufacturer reported an incremental cost per quality-adjusted life-year (QALY) in excess of [confidential information removed at manufacturer’s request] for eltrombopag compared with standard of care, for both splenectomized and non-splenectomized patients, which greatly exceeds conventional standards for cost-effectiveness.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


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