Biosimilars and HTA: Results of a Roundtable Discussion

OHE convened a roundtable to discuss using HTA to assess biosimilars, including which methods are most appropriate in specific situations. Just published is an OHE Briefing that summarises that discussion[1].

Biosimilars[2] present a range of challenges to both regulators and HTA entities. The number that are available on markets worldwide still is low, which means that experience with their assessment is limited.

OHE convened a one-day roundtable specifically to discuss whether and how biosimilars should be evaluated from a health economics perspective. Participating were ten experts, including leading academics and representatives from the UK regulatory agency, the MHRA; the three UK HTA entities, NICE and its Welsh (AWMSG) and Scottish (SMC) counterparts; and the UK industry trade association, the ABPI. Background for discussion at the meeting included an OHE literature review and ABPI’s position paper on biosimilar medicines. The published Briefing focuses primarily on discussion about recommendation five from the ABPI position paper: ‘Biosimilar medicines should be subject to health technology assessment processes in the UK’.

Current HTA policies for biosimilars in the UK

Currently in the UK, the Scottish Medicines Consortium (SMC) requires a full submission for all biosimilars that details its comparison with the originator, or reference, product. It does not require a particular type of economic analysis, but cost-minimisation analysis has been used for all seven approved submissions to date.

The All Wales Medicines Strategy Group (AWMSG) is more explicit, stating that cost-minimisation analysis is appropriate only when NICE or AWMSG has recommended the reference product for the intended indication or it is in widespread use for the indication. In all other cases, a cost utility analysis is required. In practice, of the seven decisions made, the analyses were cost minimisation, cost savings or budget impact.

NICE does not have a separate policy for biosimilars, although a consultation for one is now in progress.

Roundtable discussion

The sense of the discussion was that the need for HTA for a biosimilar is reduced when the reference product has been recommended by the HTA agency, or is the standard of care, and is expected to exhibit no clinical differences with the reference product.  In such cases, cost minimisation analysis should be sufficient, if HTA is necessary at all. Cost utility analysis would be more appropriate when the originator was rejected for reimbursement or its use restricted. In such cases, moreover, the comparator for the biosimilar HTA assessment should be the standard of care, not the reference product. The majority of the roundtable participants urged that the process be flexible—both for selecting which biosimilars to subject to HTA and which HTA approach to use.

The roundtable also agreed that it is important to prescribe biosimilars by brand name, rather than INN name, to allow tracking of possible adverse events. Because of the nature of biotherapeutics, moreover, physicians and patients should agree explicitly when a biosimilar is substituted for the originator product or for another biosimilar.

Download Mestre-Ferrandiz, J. & Towse, A., 2014. What is the role of HTA for biosimilars? Briefing, 54, London: Office of Health Economics.

For other OHE publications on biosimilars, click here.

For additional information, please contact Jorge Mestre-Ferrandiz.

[1] All participants of the roundtable had an opportunity to suggest revisions to the draft summary, but the content of the final version is entirely the responsibility of its authors.
[2] A ‘biosimilar’ is a biologic medicine that is similar to an existing off-patent version.


Posted in Biosimilars, Health Technology Assessment | Tagged Briefing