Transcript presentation

Healthcare Improvement Scotland
• Healthcare Improvement Scotland is supporting clinical engagement
with NHS board Area Drug and Therapeutics Committees (ADTCs)
to develop collaborative approaches to complex medicine
governance issues. This approach aligns with the Healthcare
Improvement Scotland Strategic Delivery Plan for Medicines 20152018.
Biological medicines
• By expenditure, eight of the top 10 drugs used in Europe are
biological medicines, many of which will lose patent protection within
the next five years and may face competition from biosimilar
medicines. The current NHSScotland spend on biological medicines
that are expected to be available as biosimilar medicines within the
next five years is approximately £100m/annum (Personal
communication: NHS National Services Scotland).
• Biological medicines are medicines that are made by or derived
from a biological source, such as a bacterium, yeast or blood. They
can consist of relatively simple molecules, such as human insulin or
erythropoietin, or complex molecules such as monoclonal
antibodies.
Biosimilar medicines
•
A biosimilar medicine is a biological medicine that is similar to
another biological medicine which has already been granted
marketing authorisation. The standard approach to licensing of a
generic medicine, where the medicine must demonstrate
bioequivalence (that is the bioavailability of the generic medicine
must not differ significantly when given at the same dosage under
similar conditions), is not sufficient for biosimilar medicines. For
licensing in the European Union, the manufacturer of the biosimilar
medicine must demonstrate that the medicine is:
1. similar to the original reference product, and
2. does not have any meaningful differences from the
original reference product in terms of quality, safety or
efficacy.2
2
European Medicines Agency (2015). Biosimilar medicines. Available at
www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp
The prescribing framework
This contains prescribing principles to:
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promote the safe introduction of biosimilar medicines
promote prescriber confidence
encourage a consistent approach across NHSScotland
support National Procurement
support the review of the Scottish Medicines Consortium
policy on biosimilar medicines, and
recognise the potential savings that can be achievable
within NHSScotland by the use of biosimilar medicines.
The prescribing framework
The prescribing framework is presented in the format of a series of
frequently asked questions, with additional supportive detail.
These FAQs are summarised in the next few slides.
For full information please refer to the prescribing framework
document.
Healthcare Improvement Scotland facilitated collaboration between
ADTCs and an expert advisory group to develop the framework.
– A series of meetings were held and consultation with ADTCs
– Advisory group members were drawn from relevant specialist clinical
areas across NHS Scotland
Frequently asked questions
Q:
Should biosimilar medicines be used in NHSScotland?
A:
NHSScotland is supportive of the use of biosimilar medicines
and agrees that they should be considered as a treatment
option for appropriate patients for whom a biological medicine
is being considered as part of their treatment pathway.
Q:
Can patients established on a biological medicine be
switched to another biological medicine, for example a
biosimilar?
A:
Individual patients may be switched to another biological
medicine, including a biosimilar medicine, as part of a clinicianled management programme which has appropriate monitoring
in place.
Q:
Are different approaches to the use of biosimilar
medicines required in different clinical specialties?
A:
There are differing clinical characteristics within specialties
which may be important to consider when using biosimilar
medicines.
While practice is evolving, some specialties may consider that
it is most appropriate to use biosimilar medicines in new
patients.
Q:
Are there any specific efficacy or safety concerns
associated with the use of biosimilar medicines?
A:
There are no specific efficacy or safety concerns identified for
biosimilar medicines but, as for all biological medicines, clinical
experience with biosimilar medicines is still emerging to guide
their use.
As for all new medicines, adverse drug reactions to biosimilar
medicines should be reported through the Yellow Card
Scheme.
Q:
How should biological medicines, including biosimilar
medicines, be monitored?
A:
Clinical outcomes for individual patients on any biological
medicine should be measured using established recognised
systems for monitoring disease activity and response to
treatment.
Clinical registries are being established for a number of
biological medicines. It would be appropriate to explore the
expansion of these databases to capture details of biosimilar
medicines.
Q:
How should biological and biosimilar medicines be
prescribed and product details recorded?
A:
Biological medicines, including biosimilar medicines, should be
prescribed by both generic and brand name and the brand
name and batch number should be recorded on the patient’s
prescription, case record or other appropriate clinical system.
Q:
What information should be provided to patients?
A:
The manufacturer’s patient information leaflet should be
supplied to all patients receiving any medicine, including a
biosimilar medicine.