Biological medicines have revolutionised patient treatment by offering new and effective treatments for a range of conditions.
Derived from living cells or organisms, biological medicines differ from generic medicines and are highly complex in their structure. A biosimilar medicine is a biological medicine that is similar to another biological medicine that is already available. The biosimilar medicine must demonstrate that it is similar to the original product and does not have any meaningful quality, safety or efficacy differences.
Eight of the top 10 medicines by expenditure used in the hospital setting in Scotland in the year to 31 March 2017 were biological medicines such as adalimumab, etanercept, and infliximab for a range of conditions including, autoimmune diseases, cancer and enzyme deficiencies.
“Biological medicines have revolutionised patient treatment by offering new and effective treatments for a range of conditions. Derived from living cells or organisms, biological medicines differ from generic medicines and are highly complex in their structure.”
Some biological medicines have lost patent protection within the last three years, with others due to expire in coming years, meaning there is competition from biosimilar medicines. This offers the opportunity to maintain the quality of care for patients but with a reduction in cost for the NHS. Biological medicines now have biosimilars available and a further £46m of current biological medicine spend is expected to face biosimilar competition for the first time within the next 3 years.
To help manage this change, Healthcare Improvement Scotland developed a prescribing framework in 2015 aligned with the ambitions of the NHSScotland Healthcare Quality Strategy which aims to ensure the most appropriate treatments, interventions, support and services are provided at the right time to everyone who will benefit, and to eradicate wasteful or harmful variation in how the medicines are used across NHSScotland.
We recently updated the prescribing framework, building upon the principles of the previous document.
The framework prescribing principles are to:
- promote the safe use of biosimilar medicines
- promote prescriber confidence
- ensure a shared decision-making approach between clinician and patient.
- encourage a consistent approach across NHSScotland
- support National Procurement
- recognise the potential savings that can be achievable within NHSScotland by the use of biosimilar medicines, and
- provide guidance on implementing the use of biosimilar medicines.
To help guide NHS Boards in their decision making, we also published a number of case studies alongside key learning points.
“Some biological medicines have lost patent protection within the last three years, with others due to expire in coming years, meaning there is competition from biosimilar medicines. This offers the opportunity to maintain the quality of care for patients but with a reduction in cost for the NHS.”
The case studies outline the experiences, challenges and lessons learned to date by NHS Boards such as NHS Grampian, NHS Highland, NHS Greater Glasgow and Clyde and NHS Lothian – their experiences demonstrating that it is possible to maintain the highest level of care for the patient and make financial savings.
In collaboration with National Procurement we will continue to support NHS Boards with the introduction of biosimilars as they become available, and as our experience of prescribing these medicines grows.
Mandy Mackintosh Clinical Advisor, Area Drug and Therapeutics Committee (ADTC) Collaborative, Medicines and Pharmacy Team, Healthcare Improvement Scotland
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