Download Etanercept biosimilar (Benepali® ) for the treatment of the following

March 2016
Etanercept biosimilar (Benepali®▼) for the treatment of the
following diseases: Rheumatoid arthritis (RA), Axial
spondylitis (AS), Psoriatic arthritis and Plaque psoriasis
(adults only)
The New Therapies Subgroup discussed the above at its meeting on 15th
March 2016. The recommendation of this subgroup is as follows:*
Drug/Indication
Etanercept Biosimilar 50mg (Benepali®▼) once-weekly
Recommendation The group recommends the use of etanercept biosimilar
Benepali® as an option for use in adults where the originator
product (Enbrel®) would normally be prescribed.
The group agreed that the etanercept biosimilar should be
considered as a first line option in new patients suitable for treatment
with etanercept. For existing patients consideration should be given
to switching where it is clinically appropriate and as part of a clinician
led management programme.
According to set criteria Benepali® was deemed to be a high
priority for funding.
Clinical Trial Data The clinical trial program demonstrating biosimilarity consisted of a
phase III efficacy and safety study in patients with active rheumatoid
– Efficacy
arthritis and a phase I pharmacokinetic (PK) study in healthy
volunteers. The phase III study was carried out in those patients
with moderate to severe RA despite methotrexate therapy.
Benepali® was shown to have equivalent efficacy to that of Enbrel®
in the primary outcome of ACR20 response at week 24. Secondary
efficacy outcomes at week 24 also support the primary findings and
response rates were sustained to a similar degree in both treatment
groups up to week 52. The EMA therefore concluded that similarity
has been convincingly demonstrated enabling extrapolation of
Benepali® approval to all other indications for which the reference
product Enbrel® is approved, except the paediatric indications due to
the dose available.
Clinical Trial Data The type and incidence of treatment-emergent adverse events
observed in the clinical studies was generally similar between the
– Safety
two treatment groups and were in line with the well-characterised
safety profile of Enbrel®. The majority of adverse events were mild
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to moderate in severity with no significant new safety signals
reported. There were no marked differences in the immunogenicity
profile and the impact of antibodies on efficacy and safety was
comparable between treatment arms.
Cost
Effectiveness/
Affordability
Benepali® has a NHS list price of £656 for 4x 50mg which is 10%
lower than the list price of Enbrel® (£715 for 4x50mg).
However, the actual cost of Enbrel® and the biosimilar product
may differ from list prices due to locally negotiated
procurement discounts.
Patient
perspective
The administration devices differ in that the Benepali® pen is an auto
injector device whereas the Enbrel® pen requires the patient to
press a button to inject the dose. The Benepali® needle sheath is
latex free.
Commissioning
Impact
Unfortunately, high cost drug data received from some trusts
contains insufficient granularity to separate use of 50mg from other
strengths but from those trusts where this is available, 50mg
accounts for between 76% and 98% of usage.
Taking 90% as a GM average, total GM spend on etanercept 50mg
injections is estimated at £7.96M and so a 10% saving on this would
equate to around £0.8M per annum if a total switch was agreed and
patients were able to use the different pre-filled syringes or pen
device.
Commissioners would expect the biosimilar to be used first line for all
new patients.
* * This recommendation is valid unless it is has been superseded by a NICE TA or national guidance.
The recommendation will only be reviewed when there is substantial new data that may change the
initial recommendation. For recommendations that are >24 months old please note that there may be
new data available and this should be checked prior to prescribing.
▼ Newly marketed drugs and vaccines are intensively monitored for a minimum of two years, in order to
confirm the risk / benefit profile of the product. Healthcare professionals are encouraged to report all
suspected adverse drug reactions regardless of the severity of the reaction.
References available on request.
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