NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
RPP decision paper
Review of TA107; Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer, TA108; Paclitaxel for the
adjuvant treatment of early node-positive breast cancer, and TA109; Docetaxel for the adjuvant treatment of early node-positive
breast cancer
Final recommendation post consultation
The guidance should be updated in an on-going clinical guideline.
1. Background
TA107 was issued in August 2006.
TA108 and TA109 were issued in September 2006.
At the GE meeting of 4 October 2016 it was agreed that we would consult on the recommendations made in the GE proposal paper. A
four week consultation has been conducted with consultees and commentators and the responses are presented below.
2. Proposal put to consultees and commentators
The guidance should be updated in an on-going clinical guideline.
3. Rationale for selecting this proposal
In 2007, it was decided that TA107, TA108 and TA109 should be updated in a forthcoming clinical guideline. This guideline (CG80 Early
and locally advanced breast cancer: diagnosis and treatment) was published in February 2009 and the recommendations from TA107,
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TA108 and TA109 remained unchanged. Since the publication of these three appraisals, generic formulations of two of the treatments
(paclitaxel and docetaxel) are now available.
In November 2015 it was decided that CG80 should be updated, and a new clinical guideline is now in development (anticipated
publication date is July 2018). The clinical guideline is the appropriate setting to consider the use of these treatments within their clinical
context and as such we propose that TA107, TA108 and TA109 be updated in the forthcoming clinical guideline. Upon publication of the
new guideline, all three appraisals will be withdrawn.
4. Summary of consultee and commentator responses
Comments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and
to promote understanding of how recommendations are developed. The comments are published as a record of the submissions that
NICE has received, and are not endorsed by NICE, its officers or advisory committees.
Respondent: Roche Products
Comment from Technology Appraisals
Response to proposal: Disagree (with proposal to update TA107)
Thank you for notifying us of the factually
inaccurate statement regarding the
biosimilars of trastuzumab. The proposal
paper (appendix B) has been updated
accordingly.
We have noticed an erratum in both your email and appendix B where it is stated that:
‘As generic formulations of these three formulations are now available, the forthcoming
clinical guideline is the appropriate setting to consider their use within their clinical context.’
It is true that generic formulations of docetaxel and paclitaxel are and have been available
in Europe for a number of years and as such it is reasonable that the guideline should
incorporate this. However, as Herceptin is a biologic medicine, it is not possible to
manufacture identical, generic versions of that medicine. Generic formulations of Herceptin
are not and never will be available.
We believe that this error may be due to a confusion of terminology: biosimilar formulations
of trastuzumab may be available in the market in the future but not a generic formulation.
The NHS England document, ‘What is a Biosimilar?’ (available at
https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf) provides an
explanation of the differences between generic and biosimilar medicines. It is most
important to note that biosimilar medicines, including biosimilars of trastuzumab, are
NICE is unable to issue guidance on
technologies (including biosimilar) that do
not have marketing authorisation in the
UK.
The clinical guideline is the appropriate
setting to consider the use of the
treatments included within the existing
technology appraisals within their clinical
context, and as such we propose that
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required to undergo regulatory approval with the EMA and cannot be made available via
any route until a marketing authorisation is granted.
TA107, TA108 and TA109 be updated in
the forthcoming clinical guideline.
Given this situation, we believe that it is misleading to state that biosimilar versions of
Herceptin are now available. Currently, the EMA has accepted a filing for biosimilar
trastuzumab from two companies (Mylan on 25 August 2016 and Samsung Bioepis on 3
October 2016). The regulatory submissions are anticipated to last approximately 1 year
and as there has been no approval of biosimilars for oncology indications to date, the
precise details of the marketing authorisation are difficult to anticipate.
The clinical guideline programme will
indicate whether an assessment of
biosimilars are included within the
development of the guideline.
While we appreciate the potential savings generics and biosimilars bring to the NHS, we
do not feel it is appropriate for NICE to consider biosimilar trastuzumab as part of the
clinical guideline at this point in time given the uncertainty regarding marketing
authorisation approval and language. We recommend that either biosimilar trastuzumab
should be out of scope of this update or that updating the guideline should be postponed
until the first biosimilar trastuzumab has been granted marketing authorisation.
Respondent: Association of Breast Surgery
Comment from Technology Appraisals
Response to proposal: Agree
Thank you for your response.
The Association of Breast Surgery is happy that these drugs should be evaluated as part
of the update of Guideline CG80.
Respondent: Breast Cancer Now
Comment from Technology Appraisals
Response to proposal: No comment
Thank you for your response.
We have no comments to submit on this proposal. It sounds like a sensible idea.
Paper signed off by:
Jenniffer Prescott, 21 November 2016
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Contributors to this paper:
Technical Lead:
Wendy Gidman
Technical Adviser:
Jasdeep Hayre
Project Manager:
Samantha Shannon
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