Initiating biologics and biosimilars in practice: approach and consultation guidance

Biologic medicines are prescribed for the treatment of autoimmune diseases, such as Crohn’s disease, ulcerative colitis, psoriasis, rheumatoid arthritis and psoriatic arthritis​[1–5]​. More recent indications include severe migraines, age-related macular degeneration and coronavirus infection​[6]​.  

A biologic is a protein molecule that attaches to and deactivates inflammatory cells. Biological medicines (e.g. monoclonal antibodies, growth hormone and insulin) are produced in or derived from living systems and are referred to as originator or reference products​[7]​. The size and complexity of biological medicines, as well as the way in which they are produced, may result in a degree of natural variability in molecules of the same active substance, particularly in different batches of the medicines​[7]​.

The active substance of a biosimilar and its reference medicine is essentially the same biological substance; however, just like the reference medicine, the biosimilar has a degree of natural variability. When approved, biosimilars are shown to have comparable quality, safety and efficacy profile to the originator product. Biosimilar medicines introduced to the UK market are authorised by the European Medicines Agency (EMA)​[8]​. Biologic and biosimilar medicines are currently prescribed and monitored in a secondary care setting and are often high cost​[9,10]​. 

Biologics are now commissioned to treat both severe and moderate disease. Since the expiry of some patents, such as infliximab, etanercept, rituximab, and adalimumab, the manufacture of biosimilar medicines has reduced the cost of procurement of these medicines​[11]​. This has led to better access to biologics for patients and is part of an ongoing focus for the pharmacy medicines optimisation strategic objectives on a local, regional and system-wide level​[2]​. The Medicines Value Programme — set up by NHS England to optimise health outcomes from medicines and reduce medicines spending — has allowed the realisation of these savings. The use of biosimilars allows optimisation of choice of medicine through balancing various factors; for example, efficacy, cost, waste reduction, patient acceptability and availability​[11]​.

Current NHS practice follows National Institute for Health and Care Excellence (NICE) guidance, where evidence is appraised and guidance provided in the form of a technology appraisal or NHS England commissioning policy on the use of biologics. This is aligned with commissioning agreements, which informs clinicians and patients of biologic funding and indications. Within the hospital setting, best practice for prescribing these medicines is agreed in a multidisciplinary setting with support from a pharmacist.

This article will outline the process of initiating a biologic or biosimilar medicine, with consideration for the mechanism of action and indication, the clinical pathway and how to support and communicate with the patient during a consultation before, during and after commencing on a biologic or biosimilar medicine in an outpatient setting.

The tables below include examples of biologics used in autoimmune diseases​[12–28]​.

Process for initiating a biologic for any condition

Relevant clinical policy and guidelines should be consulted for each disease and indication when considering the initiation of a biologic. It is important to understand which indications are funded and the licensed medicines available.

The following steps should be followed when initiating a biologic:

• Confirm that the considered biologic medication is on the local formulary and commissioning pathway;
• Ensure a route of supply has been established (e.g. outpatient pharmacy or homecare);
• Each hospital will have a process to ensure the medication can be prescribed (e.g. paper prescriptions or via electronic prescribing systems);
• Every intravenous and subcutaneous biologic/biosimilar must be prescribed by brand and brand of choice is guided by trust policy;
• Ensure that the batch numbers and expiry dates can be recorded either on paper prescription or electronically on the medication administration record when administering biologics and biosimilars on site;
• Ensure all adverse drug reactions are reported to the Medicines and Healthcare products Regulatory Agency via the yellow card scheme; 
• If homecare is the selected route, purchase orders need to be raised and invoices processed by a multidisciplinary pharmacy team (e.g. pharmacists, pharmacy technicians and pharmacy assistants);
• Invite patient to a biologics consultation clinic with a specialist nurse or pharmacist;
• Demonstrate administration of medication as each device differs;
• Obtain consent verbally or written from patient to proceed with the consultation, prescribing of the medication and to pass on personal details to the homecare company via a signature on a consent or registration form if this is the chosen route of supply. This should be asked for clearly and documented in the patient’s medical notes;
• Arrange pre-screening of the necessary blood tests and investigations, which include full blood count, liver function tests, creatinine, C-reactive protein, urea and electrolytes, varicella zoster virus, HIV, hepatitis B and C, Mycobacterium tuberculosis and chest X-ray. Results should be confirmed as satisfactory before medication is prescribed;
• At present, the completion of Blueteq (commissioning software/paperwork) is required to ensure the patient has received funding for their agreed medication to enable reimbursement. From July 2022, the budgets of the clinical commissioning groups (CCGs) and primary care, as well as many of the specialised commissioning budgets, will come under a ‘single-pot’ led by integrated care systems, which may change the way CCGs account for use of high-cost drugs​[29,30]​. 

Other considerations for the initiation of a biologic are the resources for clinical screening, as well as clinical review of the patient post initiation of treatment.

Schedule patients in for review appointments three months after initiating biologic treatment in line with NICE guidelines (or following local hospital guidance), then every six months, and annual review is required​[1–5]​.

Patient-centred care

The process and clinical pathway are critical to successful treatment but will only be effective if patients are engaged in discussions about all aspects of treatment. Patient’s values, beliefs and preferences will determine the effectiveness of individualised treatment plans, supported by clinician judgement and expertise. There are unique challenges to initiation and maintenance of biologics and biosimilars, and concordant conversations to support optimal adherence are a critical step in the biologics journey. Examples of areas that concern patients, in relation to change, include fear of the implication of change on disease control (especially if person is stable on current medicines), fear of potential side effects of a new medication and concern about how well a new medicine has been tested (i.e. feeling like a “guinea pig”). In addition, some patients may believe that biosimilars being cheaper than the originator medicine may be less effective. Even when a patient agrees to moving to a biosimilar or alternative treatment, support may be required to manage different dose, route, timing, storage, formulation and how the medication will fit in to the patient’s life. Effective shared decision-making conversations are central to the Medicines Value Programme, balancing risks and benefits of medicines for the patient as well as from the clinician’s perspective​[37]​.

Specific counselling points to consider when consulting with patients who are being switched to a biosimilar medicine include:

• Determining how much information the patient already knows and wants to know;
• If required, explaining the reasoning for switching to a biosimilar medicine and reassuring the patient that the clinical trials that are required for licensing must show that the medicine has been used in practice since 2006;
• Exploring any concerns if the patient has any;
• Reassuring the patient that they will be monitored after switching to the new medication in the same way as their current treatment, and encouraging any feedback in change in symptoms or side effects as you would when initiating any new therapy;
• Explaining any changes in the route of supply, if any, and ensuring they are comfortable about how to obtain the new treatment.

Best practice points

• Work closely and keep an open dialogue within the multidisciplinary team to ensure collaboration and joined up working;
• Work collaboratively and keep an open dialogue with the clinical commissioning group colleagues (soon to be integrated care systems);
• Horizon scan and plan for budget setting, resource and pathways for new medications coming to market;
• Ensure planning with operations and finance colleagues within pharmacy and the clinical teams to ensure the resource to deliver an expanding service is commissioned;
• Remember that each patient is different and brings with them various concerns, past experience and level of knowledge, so each consultation cannot be approached in the same way;
• Ensure joined up working between hospital, community pharmacy and primary care colleagues (i.e. provision of information if patient consents).

• The tables in this article were updated on 11 July 2022 to clarify the information included in them