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

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

3. 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

4. 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
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5. 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

6. 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

7. 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

8. Current picture
Taken from a BGMA report

9. Biologics patent expiry
Bernstein Research , accessed 21 Mar 2014
12 | 27 Mar 14

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

11. 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

12. 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

13. 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

14. 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

15. Making it work
Revised statement published on NICE website (topic selection and TA useful documents pages)
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

16. 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

17. Thank you