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

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.

KEYWORDS:

• NICE
• has
• health technology assessment
• france
• england
• ocrelizumab
• primary progressive multiple sclerosis

Article highlights

• Ocrelizumab is the first approved drug to treat patients with primary progressive multiple sclerosis (PPMS). In Europe, this medicine has not been widely covered across countries.

• We have compared the HTA process in England and France which has resulted in different outcomes in these two countries.

• Our comparison identified differences in the paradigm of assessment, as well as on the evidence submitted by the Company.

• Differences in the HTA process may result in appreciable differences in timing and outcome from marketing authorization to health service adoption of newly licensed drugs.

This box summarizes the key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper is not funded.