Approval for use

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

ICS requirements

Integrated care systems 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 natalizumab biosimilar may also be useful.

Procurement and supply

When planning a go-live date for the natalizumab 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 originator 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 originator products.

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 support any accessibility needs.

Patient information sheet

SPS has produced a patient information sheet that can be adapted locally.

• Natalizumab biosimilar Patient Information Sheet · Word · 27 KB

Use in pregnancy

The natalizumab biosimilar is not expected to have any clinically significant differences in efficacy and safety when compared with the original biological medicine regarding fertility and use in pregnancy.

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

The natalizumab biosimilar is only supplied as vials. These require dilution prior to administration by intravenous infusion over approximately one hour. Patients should be observed during and for one hour after the completion of the infusion.

These recommendations are the same for the Tysabri infusion.

Storage

The natalizumab biosimilar needs to be stored in the fridge and has the same storage temperature requirements as Tysabri.

The diluted natalizumab biosimilar needs to be used as soon as possible and within 24 hours of dilution. These are the same requirements as Tysabri.

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 the natalizumab biosimilar. Determine if any additional local monitoring is required for patients who are switched from originator to the natalizumab biosimilar.

Anti-JCV antibody testing

Perform a quantitative serum anti-JCV antibody test and magnetic resonance imaging prior to starting natalizumab to support risk stratification for progressive multifocal leukoencephalopathy (PML). Further details regarding the anti-JCV antibody testing for the natalizumab biosimilar will be provided when available.

The frequency of testing and imaging during natalizumab treatment will be dependent on the anti-JCV antibody status and other risk factors. The MHRA natalizumab drug safety update provides further monitoring advice for Tysabri which would also be applicable to the natalizumab biosimilar.

Pharmacovigilance

Report all Adverse Drug Reactions (ADRs) to 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 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

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.

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