1. No category

Rheumatology Prescribing of Biosimilars
Proposed mechanism to introduce biosimilar infliximab with the Greater Manchester
Region.
1. When will rheumatologists prescribe biosimilar infliximab?
a) When a clinician prescribes Remicade®, biosimilar infliximab (Remsima® or
Inflectra®, brand to be decided locally) should be the preferred drug.
b) If biosimilar infliximab is not prescribed in patients initiating infliximab therapy, the
reasons why must be given/documented.
c) There is no expectation that patients currently prescribed Remicade® should be
transferred to biosimilar infliximab.
d) Clinicians will be encouraged to enroll all patients starting biosimilar infliximab in to
National Biologics Registers (BSRBR-RA, BSRBR-AS).
2. What is the mechanism to facilitate biosimilar infliximab prescribing in
GMMMG region?
a) The GMMMG Harmonised Pathways for Biologics in Rheumatoid Arthritis and
Spondyloarthropathies will act as the prescribing guidance for rheumatologists.
b) A statement recommending use of biosimilar infliximab when prescribing infliximab
has been inserted into the pathway.
c) Preferred brand names will not be specifically referred to within the pathway
3. What are the gain share arrangements for any cost savings in biologic
prescribing?
a) A gain share arrangement will be in place between CCGs and Trusts, as per local
arrangements, likely to be 50:50.
b) This means that 50% of any savings on biologic prescribing, through whatever
mechanism (such as biosimilar use, reduced wastage, dose reduction), will be
passed back to NHS Trusts.
c) The mechanism for facilitating this gain share arrangement will be confirmed
between individual Trusts and CCGs. It is expected that a business case will need
to be developed by Trusts that will include predicted cost savings annually based
on current biologic utilization. Details on how savings are to be generated will also
need to be included.
d) How this gain share is utilized within individual Trusts will be decided locally;
however, the principle of gain share will apply across the GMMMG region.
4. How will the introduction of other biosimilars be managed in the future?
a) The principles agreed above (1-3) will be applied to each subsequent biosimilar
that comes to market.
b) The GMMMG harmonised biologics pathways will be the mechanism for guiding
rheumatologist’s biologic prescribing decisions.
c) The harmonised biologics pathways will be reviewed and updated annually.
d) Patient need/characteristics and clinician recommendation should guide choice of
biologic. This should be documented.
e) The ‘cheapest drug first’ principle will still apply within the pathways, but cost alone
will not be the guiding principle when prescribing biologic therapies.
f) The approval mechanism for revised pathways within GMMMG/CCGs will be
reviewed to ensure that revised pathways are reviewed and approved promptly.
g) There will be no expectation that patients on parent products will be transferred to
the biosimilar, unless the patient and their rheumatologist feel this is appropriate.
h) As data from clinical trials and safety registers regarding outcomes of transferring
patients from parent product to biosimilar become available, the biologics
pathways will review recommendation 4 (g) for individual therapies. However,
patients/prescriber will not be obliged to transfer products.
i) There is the opportunity for both rheumatologists and GMMMG/CCGs to request a
review of these principles (1-4), should their potential impact be exceptional.
Approved by GMMMG: 23rd April 2015.