TY - JOUR
T1 - Ocrelizumab not recommended in France for patients with primary progressive multiple sclerosis while recommended in England
T2 - a review comparing the assessment by HAS and NICE
AU - Armoiry, Xavier
AU - Späth, Hans-Martin
AU - Henaine , Anna-Maria
AU - Dussart, Claude
AU - Counsell, Carl
AU - Connock, Martin
PY - 2021/6/3
Y1 - 2021/6/3
N2 - 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.
AB - 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.
KW - primary progressive multiple sclerosis
KW - Ocrelizumab
KW - NICE
KW - HAS
KW - Health technology assessment
KW - England
KW - France
KW - health technology assessment
KW - england
KW - ocrelizumab
KW - france
KW - has
UR - http://www.scopus.com/inward/record.url?scp=85098540547&partnerID=8YFLogxK
U2 - 10.1080/14712598.2021.1865305
DO - 10.1080/14712598.2021.1865305
M3 - Review article
SN - 1744-7682
VL - 21
SP - 741
EP - 747
JO - Expert opinion on biological therapy
JF - Expert opinion on biological therapy
IS - 6
ER -