Ocrelizumab not recommended in France for patients with primary progressive multiple sclerosis while recommended in England: a review comparing the assessment by HAS and NICE. (3rd June 2021)

• Record Type: Journal Article
• Authors: Armoiry, Xavier; Späth, Hans-Martin; Henaine, Anna-Maria; Dussart, Claude; Counsell, Carl; Connock, Martin
• Is Part Of: Expert opinion on biological therapy. Volume 21:Number 6(2021)
• Page Start: 741
• Page End: 747
• Publication Date: 2021-06-03
• Subjects: NICE -- has -- health technology assessment -- france -- england -- ocrelizumab -- primary progressive multiple sclerosis; Gene therapy -- Periodicals; Protein drugs -- Periodicals; Peptide drugs -- Periodicals; Immunotherapy -- Periodicals; Drug delivery systems -- Periodicals; 615.5
• DOI: 10.1080/14712598.2021.1865305
• Languages: English
• ISSNs: 1471-2598

Abstract

ABSTRACT: Introduction: Ocrelizumab is the first approved drug for primary progressive multiple sclerosis. Following appraisal by health technology assessment (HTA) bodies, this medicine has not been widely covered across European countries. We have compared the HTA process in England and France. Area covered: We undertook an analysis of relevant documents that were published by the two HTA bodies. We analyzed patients' availability of Ocrelizumab at the different stages of the process. Expert opinion: We identified differences in the assessment, one being the use of a different population of the pivotal trial, which has resulted in the consideration of distinct clinical effectiveness estimates. Ocrelizumab became available earlier in France as part of an early access program. However, rapid access was discontinued for newly eligible patients following an opinion concluding that Ocrelizumab yielded no additional benefit over placebo. This opinion was not compatible with the criteria allowing reimbursement in France. In England, there was no early access program and following an appraisal that included cost-effectiveness evaluation combined with pricing agreements, medicine was finally recommended. In conclusion, differences in the HTA process may result in appreciable differences in timing and outcome from marketing authorization to the adoption of newly licensed drugs.