Approval for use
There may be variations in the process required to obtain approval for use.
ICS requirements
Integrated care systems (ICS) should consider their internal requirements for biosimilar approval. Some Drug and Therapeutic Committees (DTC) may require a full formulary application, whilst others have a policy to accept biosimilars without requiring a full review. Most systems will require some assurance on safety and risk management prior to introduction of new biosimilars.
Actions for implementation leads
Implementation leads should check with their DTC for local requirements, making them aware of details such as:
- the choice of brand of biosimilar, including details and evidence
- the potential for ongoing switching between a range of biosimilars
- updates required to online formulary systems to reflect the choice of biosimilar by brand
To support approval, our article on The licence and supporting evidence for eculizumab biosimilar may also be useful.
Procurement and supply
When planning a go-live date for eculizumab biosimilar, systems will need to have considered procurement and supply carefully first. Good practice includes:
Manufacturer liaison
Liaise with the manufacturer to ensure they can supply the volumes required on an ongoing basis.
Pharmacy systems
Give time to ensure set-up on the pharmacy system(s) and for any financial checks to be undertaken.
Stock level monitoring
Carefully monitor the stock levels of the reference product and the biosimilar, and use this to place appropriate orders for products.
Contractual frameworks
Be familiar and have in place contractual frameworks that ensure appropriate pricing and availability.
Minimising dispensing errors
In order to help minimise dispensing errors, consider processes to avoid inadvertent switching between biologics if the Trust stocks both the biosimilar and reference products.
Homecare considerations
Involve the homecare lead early in the process to ensure all appropriate governance processes are in place as a change to homecare provider is likely.
Communication
Ensure all members of pharmacy staff are aware that a new biosimilar for eculizumab is used within the Trust.
Prescribing and administration
Note the following points when prescribing biosimilars:
Prescribing by brand name
Biological medicines, including biosimilars, must be prescribed by brand name.
The decision to prescribe
The decision to prescribe should be a shared one between prescriber and patient.
Patient engagement
Patient engagement is important. Giving information and creating materials for patients should be done in ways that are accessible to them.
Patient information sheet
SPS has produced a patient information sheet that can be adapted locally.
Using paper or electronic prescribing systems
Where Trusts use paper drug charts, they should ensure the correct measures are applied.
For Trusts using electronic prescribing systems, consider medication build required to safely prescribe, dispense, and document administration. Also consider the requirements for controlling stock. The record should be built by brand name and include the ability to enter batch number and expiry dates as well as standardising to dm+d and Snomed codes. Systems should also encourage the medication administration records to document administration.
Administration
Eculizumab biosimilars are supplied as a 300mg in 30mL vial which requires dilution prior to infusion. This is the same as Soliris.
Storage
There are differences in storage and in-use stability information. The licence and supporting evidence for eculizumab biosimilar provides specific information.
Documentation
Batch numbers and expiry dates must be recorded at the point of administration using the patient’s medication record.
Monitoring
Appropriate monitoring is required to ensure patient safety and assess the cost-effectiveness of biosimilar eculizumab. Determine if any local monitoring is required for patients who are switched from the reference product to the biosimilar.
Pharmacovigilance
Report all Adverse Drug Reactions (ADRs) to the MHRA (Medicines and Healthcare Products Regulatory Agency) via the Yellow Card Scheme to monitor the safety of all health products in the UK.
The biosimilar medicines and newly licensed biologics are black triangle medicines, which must be reported in this way.
Patient registries
Patient registries are important because they provide a clear method to trace patient level information related to the medication prescribed. They also allow clinical teams to address concerns about pharmacovigilance. For example, when patients are switched between different biosimilars of the same drug, it can be very difficult to ascertain if there are safety signals with a particular biosimilar.
Registries enable us to:
- ensure that patients prescribed biologics and biosimilars can be identified locally
- register patients via specialist clinical areas if a national registry is available
- report medication incidents to the local Trust via incident portal
For best value
A robust tool for reporting is needed to monitor the improved value from the biosimilar programs via platforms such as Model Health Systems dashboard, and for commissioners and finance teams if available. Blueteq or group prior approval on paper (specific to local Trust) are required to ensure transparency within the system.