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

 

Guideline for the managed introduction of biosimilar bolus insulin

Algorithm 1 provides an algorithm summarising the working party group’s consensus guideline for the managed introduction of biosimilar bolus insulin. 

Biosimilar insulin algorithm (summary)

Algorithm 1: Guideline for the managed introduction of biosimilar bolus insulin

Who should be prescribing biosimilar insulins?

  • The guideline aims to support initiation of and switches to biosimilar bolus insulins in individuals with type 2 diabetes by primary care clinicians who are competent to prescribe bolus insulins, including physicians, nurses, pharmacists, and other non-medical prescribers, and medicine optimisation teams 
  • All prescribers should have the competencies defined in Diabetes UK’s competency framework for healthcare professionals working with people with diabetes, as determined by the local lead and in line with local policies
  • The working party group strongly recommends that insulin prescribers, especially those in primary care, undertake mandatory training via the Six Steps programme (or a similar accredited programme).

Considerations when selecting a biosimilar

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’. 

Who should be receiving biosimilar bolus insulins?

  • The working party group recommends a phased introduction of biosimilar bolus insulins:
    • new starters naïve to bolus insulin who are identified during diabetes review as highly likely to need bolus insulin due to optimal fasting glucose with suboptimal glycosylated haemoglobin (HbA1c) or other markers of poor postprandial glycaemic control
    • individuals who are ‘optimised’ on bolus insulin who are identified during diabetes review or via a search for originator insulin + type 2 diabetes (to exclude patients taking insulin for other indications):
      • 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 levels within target ranges
    • individuals with suboptimal control (either above or below individualised targets) on bolus insulin who are identified during diabetes review or via a search for originator insulin + type 2 diabetes (to exclude patients taking insulin for other indications): 
      • blood glucose levels <4 mmol/l in past 2 weeks
      • signs or symptoms of hypoglycaemia (see Box 1)
      • individualised HbA1c target not met
      • individualised blood glucose levels not within target ranges

Box 1: Most common symptoms of hypoglycaemia

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

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

New initiation of bolus insulin

All bolus insulin-naïve individuals with type 2 diabetes suitable for starting bolus insulin may be initiated on biosimilar bolus insulin.

  • Identify individuals on optimised basal insulin who may require new initiation of a bolus insulin through diabetes review:
    • have a high level of suspicion of requiring bolus insulin due to:
      • optimal fasting glucose with suboptimal HbA1c
      • other markers of poor postprandial glycaemic control, e.g. post-prandial self-monitored blood glucose
  • Undertake targeted testing — before and 2 hours after one or all meals — to establish which meal or meals would benefit from bolus insulin 
  • Identify potential reasons why postprandial glucose is suboptimal (Box 2) and address, where possible, before initiating biosimilar bolus insulin
  • When addition of biosimilar bolus insulin is indicated:
    • agree rationale for initiation of new drug with individual
      • Box 3 provides discussion points and Box 4 provides practical tips
    • start with 4 units to be given 20 minutes before the start of eating
    • titrate dose according to local protocol until postprandial glucose is within individual’s target range
  • Targeted testing should be encouraged until optimal glycaemic control is achieved
    • the ongoing need for increased monitoring after optimal control is achieved should be discussed and agreed with individual
    • ensure the individual has an adequate supply of monitoring equipment to meet increased needs
  • Review and follow up at 3 months.

Box 2: Reasons for suboptimal glycaemic control

  • Adherence 
  • Diet – carbohydrate intake in particular and alcohol consumption
  • Activity levels
  • Injection technique/site 
  • Injection timing
  • Psychological causes 
  • Intercurrent or concurrent illness
  • Interacting drugs, e.g. recent steroid therapy or antipsychotic drugs

Switching to biosimilar bolus insulin

  • 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
  • Identify individuals with type 2 diabetes on optimised basal insulin plus bolus insulin who are suitable for the switch to biosimilar bolus insulin via diabetes review or via a search for originator insulin + type 2 diabetes (to exclude patients taking insulin for other indications)
  • Assess current glycaemic control using the following questions: 
    • any blood glucose levels <4 mmol/ml in past 2 weeks?
    • any signs or symptoms of hypoglycaemia (see Box 1)
    • is individualised HbA1c target NOT being met?
    • are individualised blood glucose levels NOT within target ranges?
      • if the answer to ANY of the above questions is YES, the individual should be managed as having suboptimal control

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 comprising efficacy or safety 
  • Allow individual to raise and address their concerns

Post-switch

  • Emphasise that it is good practice to be vigilant after any change to medicines

Box 4: Practical tips

Give the individual an information sheet (e.g. Truapi patient information leaflet: www.medicines.org.uk/emc/files/pil.12738.pdf; Insulin Lispro Sanofi patient information leaflet: www.medicines.org.uk/emc/files/pil.9264.pdf)

  • Increased risk of hypoglycaemia with addition of intensified regimen
    • discuss need for increased monitoring to maintain safe levels of glucose 
    • revisit sick day rules, Driver Vehicle and Licensing Authority (DVLA) guidance, and management of hypoglycaemia
  • Tell them 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 they can visually recognise their insulin and device 
  • Make sure not to mix different insulins

Well-controlled diabetes

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 demonstrated by biosimilar bolus insulins in comparison to their originators, the working party group believes that appropriately selected individuals in this cohort may be suitable from switching to a biosimilar bolus insulin. 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 individuals to a biosimilar within 12 months from launch, in a proactive, systematic and safe way.

  • In individuals with optimal control, switch only to the biosimilar for the originator product they are currently using:
    • agree the switch with the individual and obtain and document the discussion (see Boxes 3 and 4 for discussion points and practical tips) 
    • switch dose for dose
  • Continue with usual monitoring and titrate, where indicated
    • it is good practice to be vigilant after any change to medicines
  • Review and follow up as per standard of care 

Poorly-controlled diabetes 

Although guidelines recommend switching individuals with poor control on their current insulin, the working party group feels that the complex reasons for suboptimal control (see Box 3), the challenges associated with adjusting bolus insulins, and the fact that non-insulin drugs may be indicated means that referral for specialist advice and guidance should be considered, depending on the prescriber’s competencies, experience, and confidence with bolus insulins.

Box 5 provides current guidance during the COVID-19 pandemic, and Box 6 lists some useful resources.

Box 5: Diabetes during the COVID-19 pandemic

  • The COVID-19 pandemic forced practices (and community teams) to focus on delivering acute care, often at the expense of chronic disease management, including diabetes reviews
    • there is a risk that fear of exposure to COVID-19 or difficulty accessing clinical services may contribute to late clinical presentations or assessment of diabetes complications
    • many practices find that many people’s HbA1c has risen significantly during lockdown
  • As the acute phase of the pandemic recedes, teams now face significant backlogs of diabetes reviews, and it is likely to take at least 6–12 months for services to catch up
    • practices should maintain clinically important diabetes reviews
    • it is important to prioritise care delivery to those who need more urgent reviews
      • as higher HbA1c increases the risk of worse outcomes and mortality from COVID-19 and the risk of diabetes-related complications, prioritisation by HbA1c may be a good place to start
      • practices should collaborate with local specialist diabetes teams to maximise opportunity for reviewing people with diabetes whilst minimising duplication
  • Some people with diabetes, including those not previously diagnosed, may be discharged from hospital on higher doses or additional glucose-lowering therapies, including insulin, that may need adjustment in subsequent days or weeks
    • where possible, follow-up and de-escalation should be picked up by specialist services, but where not possible (due to demands of supporting the acute pandemic response), clear communication and collaboration between specialists and primary care or community teams is vital
  • People with diabetes report additional stress and increasing concern about access to routine diabetes care as a consequence of the pandemic
    • stress may be made worse by a lack of communication about local service provision and how to access care in the event of clinical concern
    • practices should recognise that some people with diabetes may be concerned about attending for face-to-face review because of the risks associated with COVID-19
    • people with diabetes should be supported in preparation for their review and afterwards 
    • use telephone, video and e-consultation tools to support attendance
    • make use of remotely gathered information (e.g. self-reported weight, home capillary glucose or blood pressure data) ensuring that face-to-face consultations continue to be offered where clinically appropriate or for those with limited digital access

Box 6: Useful resources

For healthcare professionals

For individuals with diabetes 

About this working party guideline

Founding company:  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 Sanofi Ltd 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), Sarah Davies (GP with Special Interest in Diabetes), Jane Diggle (Specialist Practitioner Practice Nurse), Sonica Goel (General Practitioner).

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

Date of preparation: July 2021