This guideline was developed by a multidisciplinary expert panel: Down S et al with the support of an educational grant from Mylan. See end of summary for full disclaimer

Rationale for this guideline

  • Insulin is classified as a high-risk medication, as it can cause severe side-effects such as hypoglycaemia, and its use is more complex than with most other drugs. This complexity can lead to clinical inertia from healthcare professionals in progressing with insulin therapy, e.g. increasing the dose or switching to a ‘new’ insulin such as a biosimilar. Lack of awareness of, familiarity with, and confidence in biosimilars can also lead to reluctance to use these products. Clinicians may also anticipate that individuals will be reluctant to take biosimilars, but they are often more receptive than might be anticipated—especially if they feel they are helping the NHS to get value for money.
  • At the time of writing, national guidance for biosimilar insulin use in the UK is restricted to a position statement from Diabetes UK and an evidence review from NICE on Abasaglar (biosimilar insulin glargine).
  • The NICE review concluded that evidence from two phase 3 studies in type 1 and type 2 diabetes—ELEMENT 1 and ELEMENT 2, respectively—showed that biosimilar insulin glargine was as effective as the originator insulin glargine (Lantus) at reducing HbA1c levels in people with type 1 and type 2 diabetes, and with a safety profile comparable to that of the originator. The same results were later obtained in two additional studies, INSTRIDE 1 and INSTRIDE 2 for Semglee▼ (biosimilar insulin glargine) compared to the originator.  
  • Setting a precedent, a NICE review of the use of human growth hormone when a biosimilar is available recommends that ‘the choice of product should be made on an individual basis after informed discussion between the responsible clinician and the patient and/or their carer about the advantages and disadvantages of the products available, taking into consideration therapeutic need and the likelihood of adherence to treatment. If, after that discussion, more than one product is suitable, the least costly product should be chosen’.
  • With this in mind, there is a clear need to support primary care clinicians with practice guidance on when and how to use biosimilar basal insulins. 

Guideline for the managed introduction of biosimilar insulin

  • Figure 1 provides an algorithm summarising the working party group’s consensus guideline for the managed introduction of biosimilar basal insulin. It is intended to offer concise, easy-to-follow, practical guidance to inform and support primary care clinicians to initiate or transfer suitable individuals to biosimilar insulin glargine. It is intended to be used for people with type 2 diabetes who are deemed suitable for analogue basal insulin initiation; although biosimilar insulins are suitable for people with type 1 diabetes, this guideline is not intended for use in this population, whose insulin should be managed by their specialist.
  • In its position statement, Diabetes UK recommends against switching people well controlled on an insulin to a biosimilar; however, given the equivalent efficacy and safety demonstated by biosimilar insulins in comparison to the originator, the working party group believes that appropriately selected individuals in this cohort may be suitable from switching to a biosimilar insulin glargine.
  • Switching stable individuals with diabetes to a biosimilar insulin would also support the NHS England commissioning framework, which aims to achieve savings by switching at least 80% of existing patients to a biosimilar within 12 months from launch, in a proactive, systematic and safe way. To avoid increasing costs by scheduling extra consultations, healthcare professionals can discuss the switch during the individual’s annual review or during group consultations of suitable individuals.
  • Current guidelines recommend switching individuals with poor control on their current insulin, and the group feels that a straightforward switch to a biosimilar of that insulin is reasonable, as long as reasons for suboptimal control are identified and addressed as part of the switch. 

Managed introduction of biosimilar basal insulin

Figure 1: Managed introduction of biosimilar basal insulin

Who should be prescribing biosimilar insulins?

  • The guideline aims to support initiation of and switches to biosimilar basal insulins by primary care clinicians who usually prescribe basal insulins, including physicians, nurses, pharmacists, non-medical prescribers, and medicine optimisation teams. All prescribers should also have the competencies defined in Diabetes UK’s competency framework for healthcare professionals working with people with diabetes, as determined by the local lead.

Who should be receiving biosimilar insulins?

  • Biosimilar insulins should never be introduced as part of a whole-population switch. Insulin prescribing should be tailored to each individual. This position is supported by Diabetes UK. The working party group therefore recommends a phased introduction of biosimilar insulins:
  1. New starters who are naïve to basal insulin analogue 
  2. Individuals who are ‘optimised’ on basal insulin (no blood glucose levels <4 mmol/l in past 2 weeks; no signs or symptoms of hypoglycaemia [see Box 1], individualised glycosylated haemoglobin [HbA1c] target met, and individualised blood glucose levels within target ranges)
  3. Individuals with suboptimal control (blood glucose levels <4 mmol/l in past 2 weeks, signs or symptoms of hypoglycaemia [see Box 1], individualised HbA1c target not met, or individualised blood glucose levels not within target ranges).
  • Switching could include people currently on neutral protamine Hagedorn (NPH) with increasing frailty in whom de-escalation of therapy to relax HbA1c targets is appropriate, as well as individuals on twice-daily NPH administered by district nurses. Indeed, the latter is an important easy target for cost savings, as an audit of district nurse visits in one trust found that nurses were making more than 300 visits per day to administer insulin twice daily in individuals who had been historically receiving this formulation for years without review and whose circumstances had changed to require district nurse administration. In this trust, the systematic review of this patient cohort and switching to a biosimilar where clinically indicated, from either a twice daily NPH or glargine, produced a saving of £473,000 simply by reducing the number of district nurse visits to 166 per day.

Box 1. Most common symptoms of hypoglycaemia

  • Sweating 
  • Trembling
  • Hunger
  • Palpitations
  • Confusion
  • Drowsiness
  • Lack of coordination
  • Difficulty speaking.

NB Elderly people, frail individuals, or people with longstanding diabetes or frequent hypoglycaemia may not experience or recognise these symptoms.

New initiation of biosimilar glargine

  • In individuals naïve to analogue insulin, initiate and titrate biosimilar insulin glargine as per local policy 
  • Monitor as per local policy 
  • Issue an insulin passport 
  • Report any adverse reactions to the MHRA. 

Switching to biosimilar glargine

  • Individuals currently taking insulin glargine who may be suitable for a switch to biosimilar insulin glargine may be identified during their next diabetes review or during a proactive search to identify those suited to a switch 
  • The working party group feels it is important to minimise additional work involved in switching, which may mean identifying multiple individuals suitable for switching and arranging group consultations to discuss and implement the switch
  • Once individuals suitable for switching have been identified, it is important to determine whether current glycaemic control is optimal, as the steps for those with optimal and suboptimal control differ; optimal control is defined as:
    • no blood glucose levels <4 mmol/l in past 2 weeks
    • no signs or symptoms of hypoglycaemia (see Box 1)
    • individualised HbA1c target met
    • individualised blood glucose within target ranges
  • The biosimilar delivery device should be considered as part of the decision, as switching to a different type of device can cause problems, although reteaching is often straightforward
  • A new insulin passport should be issued and the previous passport should be destroyed
  • Box 2 provides practical tips for making the switch; Box 3 provides points to discuss with individuals before a switch is agreed and after the switch; and Box 4 provides suggestions on how to position the switch with individuals.

Box 2: Practical tips

  • Give the individual an information sheet (e.g. Semglee▼ patient information leaflet: www.medicines.org.uk/emc/files/pil.9815.pdf; Abasaglar patient information leaflet: www.medicines.org.uk/emc/files/pil.6901.pdf)
  • Tell the person what to look out for 
  • Tell the person what to do if there is a problem
    • avoid initiating any new drug just before or over a weekend, so they can access help if they have any problems or questions
  • Ensure the person can visually recognise their insulin and device.

Box 3: Discussion points for individuals

The switch should be discussed in a way that gives the individual confidence in the new drug.

Pre-decision

  • Explain the rationale for the switch, as relevant:
    • offer information on biosimilars that is appropriate to the individual 
    • explain that the switch will allow cost savings with no anticipated difference in day-to-day control, without compromising efficacy or safety
  • Allow the individual to raise and address their concerns.

Post-switch

  • Emphasise that it is good practice to be vigilant after any change in medication.

Box 4: Reasons for suboptimal control on insulin

  • Poor or suboptimal adherence 
  • Poor injection technique (e.g. storage, site selection, site rotation, injection process) 
  • Injection timing
  • Psychological causes 
  • Presence of lipohypertrophy
  • Diet and lifestyle
  • Intercurrent or concurrent illness
  • Interacting drugs, e.g. recent steroid therapy or antipsychotic drugs.

Switching to biosimilar glargine in individuals with optimal control on insulin glargine 

  • Agree the switch with the individual and obtain and document consent 
  • Initiate at a 10% lower dose than usual dose for 4 days
  • Advise the individual to: 
    • continue to monitor as per recommended monitoring guidelines
    • titrate back to the original dose if indicated after 4 days
    • contact their HCP if they perceive they have a problem 
  • Issue a new insulin passport and destroy the old passport 
  • Report any adverse reactions to the MHRA.

Switching to biosimilar glargine in individuals with suboptimal control on insulin glargine 

  • Identify reasons why control is suboptimal (see Box 4) and address as appropriate 
  • Agree the switch with the individual and obtain and document consent 
  • Undertake minimum 4-day baseline blood glucose monitoring—at least fasting, pre-meal, and pre-bed—to identify blood glucose profiles
  • If an individual is regularly below individualised blood glucose target levels and/or HbA1c:
    • initiate at a 20% lower dose than usual dose for 4 days
    • advise the individual to: 
      • continue to monitor as per recommended monitoring
      • titrate as indicated after 4 days
      • contact their HCP if they perceive they have a problem 
  • Further dose reductions may be indicated if the person experiences hypoglycaemic episodes; if there is no clear reason for these, decrease the dose immediately by 10–20%
  • Issue a new insulin passport and destroy the old passport 
  • If an individual has any ongoing high in-day variability:
    • extend baseline monitoring 
    • consider referral for specialist advice
  • If an individual is regularly above their individualised blood glucose target levels and/or HbA1c:
    • initiate at the same dose for 4 days
    • advise the individual to: 
      • continue to monitor as per recommended monitoring guidelines
      • escalate their dose as indicated per local guidelines
      • contact their healthcare professional if they perceive they have a problem
  • Issue a new insulin passport and destroy the old passport 
  • Report any adverse reactions to the MHRA.

Useful resources

For healthcare professionals

For individuals with diabetes

About this working party guideline

Sponsor:  This working party guideline was developed by MGP Ltd, the publisher of Guidelines, and the working party group chair and members were chosen and convened by them. The content is independent of and not influenced by Mylan who checked the final document for technical accuracy only.

Group members: Su Down (Chair, Diabetes Nurse Consultant), Hannah Beba (Senior Pharmacist for Diabetes and Endocrinology), Pam Brown (General Practitioner with an interest in diabetes), Jane Diggle (Specialist Practitioner Practice Nurse), Sonica Goel (General Practitioner), Nicola Milne (Community Diabetes Specialist Nurse).

Further information: Call MGP Ltd (01442 876100) for further information and a copy of the full guideline.

Date of preparation: October 2019