Ensuring familiarity with the area

Pharmacy teams and individuals planning on using the natalizumab biosimilar should prepare themselves carefully. Make sure you are aware of, and where necessary read and understand, the following.

National commissioning policy

Ensure you are familiar with:

• Treatment algorithm for multiple sclerosis disease-modifying therapies (NHS England)

National guidance

Ensure you are familiar with:

• Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis (NICE TA127)

Product characteristics

Ensure you are familiar with:

• The Summary of Product Characteristics for Tyruko

SPS resources on biosimilar background

SPS resources on pipeline medicines

Be aware too of information on pipeline natalizumab biosimilars. Detail is available from:

• Our annual new medicines summary

Developing an implementation plan

Developing an implementation plan will require working collaboratively across integrated care systems. This will include work within pharmacy as well as with prescribing clinicians, specialist nurses, business managers, finance and contracting teams, and the pharmaceutical industry.

Identify patients receiving natalizumab

This work will need to be undertaken with clinicians. You should have an understanding of the number of patients in your organisation receiving natalizumab currently.

Identify patients eligible for natalizumab biosimilar

Continue working with clinicians to identify the opportunity for biosimilar introduction. Identify those patients suitable for natalizumab biosimilar as well as those for whom it would be clinically inappropriate to use the biosimilar. Refer to the treatment algorithm for multiple sclerosis disease-modifying therapies (NHS England)

Ensure use in local pathway of care

To ensure the natalizumab biosimilar can be used within a local care pathway, you should consider a number of factors across the integrated care system; these include:

Staff familiarity

Ensure everyone is comfortable with the Understanding biological and biosimilar medicines and The licence and supporting evidence for natalizumab biosimilar. Give opportunity to identify, discuss and address any clinician concerns with both the evidence and its implementation.

Service capacity

Extra capacity may be required to support additional work associated with the introduction so that existing services are not adversely affected.

Consider the potential effects for:

• The number of clinic visits, injections, and the ability to deliver services safely.
• The operational impact for clinicians and specialist nurses on other related clinical services.
• Pharmacy capacity to dispense and store the medicine.
• Pharmacy capacity to support, implement and monitor the introduction.

Processes

• Establish processes with clinicians and patients to ensure shared decision making is possible supported by written materials, information sessions, education and patient alert cards.
• Ensuring staff responsible for implementation prepare themselves using any necessary materials, including information sessions and education.
• Ensure a workable process for actions to take when reviewing, switching and discontinuing disease modifying therapies.

Savings

Ensure savings can be used effectively to offset costs, incentivise change and improve patient care.