NICE and biosimilars 4 March 2015 Paul Chrisp Programme Director, NICE Medicines and Prescribing Centre

Outline NICE position on biosimilars Why we revised our position What it means

Old NICE position on biosimilars ‘The National Institute for Health Research Horizon Scanning Centre will notify NICE of all new biosimilar indications as per standard topic selection procedures. Biosimilars are different to generic drugs. Any guidance on biosimilars will use brand names as substitutability and interchangeability cannot be assumed, and ultimate decision making on biosimilars versus originator biologic must rest with the responsible clinician.’ 7 | 27 Mar 14

Old NICE position on biosimilars Biosimilars included in NICE technology appraisals on somatropin and erythropoiesis stimulating agents Biosimilars have been considered by NICE only in the context of reviews of existing guidance and in both cases multiple versions of the products were already available The relevant NICE guidance does not indicate which specific brand of biologic to provide or prescribe 7 | 27 Mar 14

The issue for NICE Driver: prioritising our resources, adding value Need to provide clear advice and guidance Potentially large volume of biosimilars coming to market 18 approved in EU, 45 products in phase III development

Scottish Medicines Consortium SMC currently requires a full submission for all new biosimilar medicines SMC accepts extrapolation of clinical data for a single indication for the biosimilar medicine 8 | 27 Mar 14

All Wales Medicines Strategy Group Full appraisal for biosimilars that meet criteria (i.e. new medicine, new indication, extension to product licence with potential significant impact) Limited submission may be appropriate for a follow on biologic medicine (i.e. a biologic product which is identical to an existing product but with a different product licence) Cost-minimisation analysis is used if the reference product has been recommended by NICE or AWMSG for the intended indication; cost-utility analysis is used if the reference product has not been recommended Page No. | Date

Current picture Taken from a BGMA report

Biologics patent expiry Bernstein Research , www.gabionline.com, accessed 21 Mar 2014 12 | 27 Mar 14

Biologics patent expiry Nov 2013-Aug 2014 key window for significant patent expiry – rituximab, trastuzumab, infliximab Bernstein Research , www.gabionline.com, accessed 21 Mar 2014 12 | 27 Mar 14

Revised NICE approach Aim: to provide guidance and advice for the managed introduction of biosimilars Help local decision making and planning for the introduction of key new medicines recently introduced or due to be introduced in the UK

Revised NICE approach: TAs NICE will consider biosimilars notified to it by the National Institute for Health Research Horizon Scanning Centre for referral to the Technology Appraisal topic selection process These products will usually be considered in the context of a Multiple Technology Appraisal in parallel with their reference products in the indication under consideration TAs will use the name of the active drug substance including reference products and brand named biosimilars

Revised NICE approach: TAs The Department of Health has confirmed that a technology appraisal remit referred to NICE enables NICE to decide to apply the same remit, and the resulting guidance, to relevant licensed biosimilar products which subsequently appear on the market

Revised NICE approach: Evidence summaries In other circumstances where it is considered a review of the evidence for a biosimilar is necessary, NICE will consider producing an Evidence summary new medicine Evidence summaries will use the brand names of the medicines because substitutability and interchangeability cannot be assumed Evidence summaries do not make recommendations; the choice of biosimilar or originator biologic for an individual patient rests with the responsible clinician in consultation with the patient

Making it work Revised statement published on NICE website (topic selection and TA useful documents pages) https://www.nice.org.uk/news/article/evaluating-biosimilar-medicines https://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection A lay summary has been published Include the DH wording on applicability of TAs guidance to biosimilars in biologic TAs Decide in what circumstances we would produce an evidence summary

Making it work A biosimilar in a TA may preclude us from producing an Evidence summary We’re exploring the development of a resource to support the introduction of biosimilar infliximab following publication of ‘Infliximab, adalimumab and golimumab for the second line treatment of moderately to severely active ulcerative colitis’ Will considerations for biosimilars in general, the evidence on infliximab, and case studies/shared learning from sites experienced in introducing biosimilars and/or planning for biosimilar infliximab

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