Approval for use

There may be variations in the process required to obtain approval for use at different organisations.

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 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 biosimilar brand, 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 ustekinumab biosimilars may be useful.

Procurement and supply

When planning a go-live date for ustekinumab biosimilar, systems will first need to carefully consider procurement and supply issues. Good practice includes:

Homecare consideration

Involve the homecare lead early in the process to ensure all appropriate governance processes are in place as a change in homecare provider is likely.

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

Have in place and be familiar with contractual frameworks that ensure appropriate pricing and availability.

Minimising dispensing errors

To help minimise dispensing errors, consider processes to avoid inadvertent switching between ustekinumab products. Before dispensing a biosimilar ustekinumab check the indication as only Stelara is currently licensed for ulcerative colitis.

Communication

Ensure all members of pharmacy staff are aware that a new biosimilar for ustekinumab 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. SPS has produced a patient information sheet that can be adapted locally. This is available at the bottom of the preparing to use ustekinumab biosimilar article.

Patients need to receive suitable training before they are able to self administer a ustekinumab biosimilar.

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.

Administration

The following ustekinumab biosimilar formulations are licensed.

Vials (for intravenous administration)

Steqeyma, Pyzchiva, Wezenla are available as vials for further dilution and infusion over one hour. The licence and supporting evidence for ustekinumab biosimilars provides details of suitable diluents.

Vials (for subcutaneous administration)

Wezenla is available as 45mg vials for injection.

Pre-filled syringes

Steqeyma, Pyzchiva, Uzpruvo and Wezenla are available as 45mg and 90mg pre-filled syringes.

Pre-filled pens

There are currently no approved biosimilars in pen formulations.

Storage

There are differences in storage and in-use stability information. The licence and supporting evidence for ustekinumab biosimilars provides specific information.

Documentation

Batch numbers and expiry dates must be recorded at the point of administration (or supply for homecare) as per local policy.

Monitoring

Appropriate monitoring is required to ensure patient safety and assess the cost-effectiveness of biosimilar ustekinumab. Determine if any local monitoring is required for patients who are switched from the reference product to the biosimilar.

Exfoliative dermatitis

Patients prescribed ustekinumab biosimilar or reference product for skin disorders should be told to report symptoms of exfoliative dermatitis or erythrodermic psoriasis.

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.

Biosimilar medicines and newly licensed biologics are black triangle medicines, as such, all identified ADRs should be reported.

Patient registries

Patient registries are important because they provide a clear method of tracing patient level data relating to 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 unless there is adequate recording.

Registries enable us to:

• ensure 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 programmes 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.

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