2. 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 2015- 2018. Healthcare Improvement Scotland

3. 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. Biological medicines

4. 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 2European Medicines Agency (2015). Biosimilar medicines. Available at www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp Biosimilar medicines

5. This contains prescribing principles to: –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

6. 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 The prescribing framework

7. 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. Frequently asked questions

8. 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 clinician- led management programme which has appropriate monitoring in place.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.