Ensuring familiarity with the area
Pharmacy teams and individuals planning to use ustekinumab biosimilar should prepare themselves carefully. Make sure you are aware of, and where necessary read and understand, the following.
National guidelines
Ensure you are familiar with:
- Ustekinumab for the treatment of adults with moderate to severe psoriasis (NICE TA180)
- Ustekinumab for treating active psoriatic arthritis in adults (NICE TA340)
- Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people (NICE TA455)
- Ustekinumab for moderately to severely active Crohn’s disease after previous treatment in adults (NICE TA456)
The same guidance will apply to the biosimilar where NICE has already recommended the reference biological medicine
National commissioning policies
Ensure you are familiar with NHS England clinical commissioning policies:
- Ustekinumab for refractory Crohn’s disease in pre-pubescent children
- Commissioning medicines for children in specialised services
Incoming changes with ustekinumab
Ustekinumab is currently marketed in the UK under the brand name Stelara (Janssen). It is used in the treatment of psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults. It is also used in treatment of plaque psoriasis in adults and children over 6 years of age. Stelara (Janssen) is in phase 3 trials for paediatric use in Crohn’s disease and ulcerative colitis.
Patent
Stelara loses its patent exclusivity on 19th July 2024. After this date biosimilar ustekinumab can be marketed in the UK for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.
Anticipated biosimilar licence
Biosimilar ustekinumab products are not approved for use in ulcerative colitis, however, this is currently the subject of a legal challenge. Biosimilars are expected to be approved for all other reference product indications.
Products coming soon
The national NHS framework for ustekinumab procurement is due to commence 1st September 2024. Details of final awards will be available around four weeks prior to the start of the framework.
The following biosimilar ustekinumab products are licensed in the UK:
Uzpruvo (Stada, Thornton & Ross)
Product information available via EMC website
Wezenla (Amgen)
Product information available via MHRA website
Pyzchiva (Sandoz)
Product information available via MHRA website
Additional biosimilars are anticipated to be available prior to 1st September 2024.
Variation in presentations available from different manufacturers is expected. Manufacturers have indicated they do not intend launching some ustekinumab presentations until 2025. SPS pages will be updated as and when new products or formulations become available.
SPS resources on use of biosimilars
SPS has produced materials to help understand the background to biological and biosimilar medicines in general.
Understanding biological and biosimilar medicines
Coming soon
SPS are producing articles outlining evidence for ustekinumab biosimilars, differences between products, as well as good governance principles for the introduction of ustekinumab biosimilar.
SPS resources on pipeline medicines
Be aware of information on pipeline ustekinumab biosimilars. Detail is available from:
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, pharmaceutical industry and homecare providers.
Identify patients receiving ustekinumab
This work will need to be undertaken with clinicians. You should understand the number of patients in your organisation receiving ustekinumab, indications, formulations and route of supply.
Identify patients eligible for ustekinumab biosimilar
Continue working with clinicians to identify the opportunity for biosimilar introduction. Identify patients suitable for ustekinumab biosimilar as well as those for whom it would be clinically inappropriate to use the biosimilar.
Identify patients with ulcerative colitis who would not be able to use ustekinumab biosimilar initially.
Ensure use in local pathway of care
To ensure ustekinumab biosimilar can be used within a local care pathway, you should consider several factors across the integrated care system.
Service capacity
Extra capacity may be required to support additional work associated with the biosimilar introduction so that existing services are not adversely affected.
Consider the potential effects for:
- operational aspects associated with changing homecare provider
- the number of clinic visits, 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 of a biosimilar
Processes
Consider the need to:
- engage and involve homecare leads early to understand how many patients are being treated, delivery frequencies and number of patients receiving ongoing nurse support
- engage with the chosen homecare provider to determine if an efficient transfer of patients between brands is possible
- 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 treatments in line with the national recommendations for these medicines
- obtain patient consent, a template patient information sheet is available from SPS
Savings
Ensure savings can be used effectively to offset costs, incentivise change and improve patient care.
Patient information sheet
SPS has produced a patient information sheet that can be adapted locally.