The Introduction of Biosimilar Monoclonal Antibodies into
Developed Markets: What are payers concerned about?
Sewak NPS , Whitcher C , Neophytou I
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1
[email protected]
1
www.doublehelixconsulting.com
Background and Overview
Methods
The introduction of biosimilar monoclonal
antibodies (mAbs) into the market is thought to be
eagerly awaited by payers. This is motivated by
the need to constrain prescribing costs due to the
ever burdening pressure on healthcare budgets.
Secondary research was conducted via a thorough literature review identifying the currently available
regulatory position and national guidance on the introduction of biosimilar monoclonal antibodies
(mAbs).
Four key themes were identified (Table 1), from which a series of potential implications for healthcare
professionals were developed. Primary research was conducted with key payer stakeholders to
understand their perceptions towards the introduction of biosimilar mAbs, evaluate the identified
potential implications, and understand which areas of uncertainty exist that pharmaceutical
companies need to address to ensure the successful introduction of biosimilar mAbs into healthcare
systems.
With a number of originator mAbs products
approaching patent expiry, biosimilar mAbs will
be a reality in the near future.
Four key themes were determined for the
introduction of biosimilar mAbs. From these,
payers identified two main priority areas;
interchangeability and pharmacovigilance that
they believe biosimilar manufacturers need to
address and should work with both national
regulators and specialist hospital centres to
support the successful roll-out of biosimilar mAbs.
Double Helix Consulting, London UK
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Table 1: Key themes identified for the introduction of biosimilar mAbs
Theoretical considerations for Health Care Professionals (HCPs)
The manufacturing processes of the originator biologic are
proprietary knowledge not available in the public domain. Biosimilar
Manufacture of biosimilar manufacturers must develop their own manufacturing processes
mAbs
which are inevitably different to that of the originator product. As
such they are similar, but not identical products, with potentially
different clinical and safety profiles.
A biosimilar licence may include indications for which there is little
clinical data and it would not be evident which indications these are.
Extrapolation of clinical data This is important as mAbs are used in disease settings with a
different risk benefit profile (e.g. adjuvant vs. metastatic settings)
where their treatment aims may be different.
Unlike generics, biosimilar mAbs are not exact copies of the
Generic substitution/
originator product and therefore may not be identical in function or
Interchangeability
safety. Therefore, automatic substitution in practice for generics,
may not be appropriate for biosimilar mAbs.
As all therapeutic proteins can induce a level of antibody response,
unwanted immunogenicity is a major concern, where the immune
Pharmacovigilance
reaction can vary with consequences from none to life threatening
for the patient.
In addition, payers noted that the utilisation of biosimilar mAbs may be greater given their expected
lower launch price compared to the originator product, therefore they strongly recommended the
use of electronic prescribing systems to ensure appropriate patient tracking is in place in case of
potential adverse events.
Although cases could be made for the potential theoretical HCP considerations with the introduction
of biosimilar mAbs, payers identified more relevant practical considerations that biosimilar
manufacturers should take into account (Table 2).
Table 2: Practical considerations for the identified key themes
Key themes
Practical Considerations For Health Care Professionals
Interchangeability
• Switching between an originator product and a biosimilar may be
necessary in some circumstances.
• However, formulary decisions to adopt biosimilars instead of
originator products should take into account supply availability.
• HCPs should be aware that biosimilar companies may not have
multiple manufacturing sites and so may not be able to guarantee
uninterrupted supply.
• They should ensure biosimilar manufacturers have contingency plans
if they choose to adopt biosimilars on to their formulary.
Pharmacovigilance
• Immunogenicity is considered to be an issue with biosimilar mAbs
• There is the potential of having multiple biosimilar and originator
products in use within formularies and HCPs should ensure that
adequate prescription monitoring systems are in place so that the
appropriate recording of the originator product or biosimilar is
documented, and can be traced back to an individual patient.
Manufacture of
biosimilar mAbs
• HCPs are aware that biosimilars are not produced by the same cell
lines as originator products, but must be mindful that these different
cells may produce similar, but not identical products to the original
cells.
Key themes
Results
Overall, payers were supportive of the introduction of biosimilar mAbs. They believed that their
introduction would help them manage their prescribing budgets more effectively and potentially
treat more patients for the same or lower overall cost.
• In practice, health care professionals trust the regulatory process and
decision in terms of safety, efficacy and approved indications. The
decision to use a biosimilar is ultimately cost driven and if a biosimilar
Extrapolation of clinical
receives a licence for multiple indications, it will be used for these
data
indications.
• HCPs should be aware that there may be no efficacy or safety data in
a licensed indication and they should proactively check before making
a decision to prescribe a biosimilar in that indication.
Payers did not believe the manufacture and extrapolation of data for biosimilar mAbs were areas of
uncertainty since they expected regulatory approval to be sufficient to mitigate these concerns.
Conclusions
However, payers identified interchangeability and pharmacovigilance to be priority areas, as they are
closely interlinked, and believed they needed to be tackled at both a national and local level. Payers
believed there may be a risk of immunogenicity reactions given the long acting nature of biosimilar
mAbs and were concerned that patients may move between hospitals or dispensing services may
be tendered out to a third party, where both originator products and biosimilar mAbs from various
manufacturers may be used.
Payers are supportive of the introduction of biosimilars due to pressure on healthcare budgets.
Biosimilar manufacturers need to be mindful of the key themes which are of concern to payers,
particularly interchangeability and pharmacovigilance, and work with national regulators and
specialist hospital centres to help mitigate these.
Presented at the ISPOR International Conference 2013 at New Orleans, USA