Ensuring familiarity with the area

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

National services

The National Paroxysmal Nocturnal Haemoglobinuria (PNH) Service website provides details of designated centres and outreach clinics. It also provides information for healthcare professionals and patients. The service aims to review and monitor all patients with PNH for potential changes and complications. In England, eculizumab is funded, prescribed and administered to patients via the PNH service.

The National Renal Complement Therapeutics Centre (NRCTC) website provides information about the atypical haemolytic uraemic syndrome (aHUS) service and the C3 Glomerulopathy (C3G) service. These services provide diagnostic support and treatment recommendations for aHUS and C3G, including authorising use of eculizumab, funded by NHS England, where appropriate. Day-to-day care and prescribing of eculizumab is carried out by local nephrology teams, with oversight and expert advice provided by the NRCTC, using a shared care model.

National guidelines

Ensure you are familiar with:

• Eculizumab for treating atypical haemolytic uraemic syndrome (NICE HST1)

National commissioning policies

Ensure you are familiar with NHS England clinical commissioning policies:

• Eculizumab in the treatment of recurrence of C3 glomerulopathy post kidney transplant (all ages)
• Rituximab and eculizumab for the prevention and management of delayed haemolytic transfusion reactions and hyperhaemolysis in patients with haemoglobinopathies

Product characteristics

Ensure you are familiar with the Summary of Medicinal Product Characteristics for each of the biosimilars:

• Bekemv 300mg concentrate for solution for infusion
• Epysqli 300mg concentrate for solution for infusion

SPS resources on biosimilar background

SPS has produced materials to help understand the background to biological and biosimilar medicines in general as well as the evidence for eculizumab biosimilar specifically.

SPS resources on pipeline medicines

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

• Our annual planning advice for new medicines

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, national services. business managers, finance and contracting teams, pharmaceutical industry and homecare providers.

Identify patients receiving eculizumab

This work will need to be undertaken with clinicians. You should understand the number of patients in your organisation receiving eculizumab currently and the indication it is used for.

Identify patients eligible for eculizumab biosimilar

Continue working with clinicians and where appropriate national services, to identify the opportunity for biosimilar introduction. Identify patients suitable for eculizumab biosimilar as well as those for whom it would be clinically inappropriate to use the biosimilar, such as those receiving eculizumab for an indication still covered by the Soliris patent.

Ensure use in local pathway of care

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

Staff familiarity

Ensure everyone is comfortable with Understanding biological and biosimilar medicines and the license and supporting evidence for eculizumab 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:

• operational aspects associated with changing homecare provider
• the number of clinic visits, infusions, 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 drug
• pharmacy capacity to support, implement and monitor the introduction

Processes

Consider the need to:

• involve homecare leads early – most of the current usage of eculizumab is delivered by homecare and change of provider may be necessary
• 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

Savings

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

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