General Notes

Fixed dose combination oral therapy could be considered for those tolerant on the individual medicines for at least 6 months and a clinical benefit has been demonstrated. Fixed dose combination oral therapy can be useful to reduce tablet burden and improve compliance with treatment.

Ongoing shortages of GLP-1 receptor agonists used in the management of Type 2 Diabetes

There are very limited, intermittent supplies of injectable GLP-1 RAs licensed in the management of Type 2 Diabetes Mellitus.
Supply is not expected to return to normal until at least the end of 2024. Since supply may be intermittent, new patient initiations of injectable GLP-1 RAs cannot be supported.

Summary

  • There are very limited, intermittent supplies of all glucagon-like peptide-1 receptor agonists (GLP-1 RAs) licensed in the management of Type 2 Diabetes Mellitus (T2DM).
  • This includes:  
    • Ozempic® (semaglutide) 0.5mg and 1mg solution for injection
    • Trulicity® (dulaglutide) 0.75mg, 1.5mg, 3mg and 4.5mg solution for injection
    • Victoza® (liraglutide) 6mg/ml solution for injection
    • Bydureon BCise® (exenatide) 2mg/0.85ml solution for injection.
    • Exenatide (Byetta®) 5micrograms/0.02ml and 10micrograms/0.04ml pre-filled pens will be
      discontinued at the end of March 2024.
  • The supply issues have been caused by an increase in demand for these products.
  • At all times, GLP-1 RAs should only be prescribed for their licensed indication.

Please refer to the NHS Lanarkshire document: 'GLP-1 Receptor Agonist (GLP-1RA) initiation / switching due to supply issues' (issued April 2024)  which details suggested actions to be taken until supply issues have resolved.

Biguanides

Preferred list (P)

METFORMIN

  • Recommended maximum daily dose 2g daily.

 

Total list (T)

METFORMIN modified-release tablets

  • Restriction: For use in patients who are intolerant of standard-release metformin.

Sulfonylureas (SU)

Preferred list (P)

GLICLAZIDE

Thiazolidinediones

Preferred list (P)

PIOGLITAZONE

 

Dipeptidylpeptidase-4 Inhibitors (DPP-4 Inhibitors)

Preferred list (P)

SITAGLIPTIN

  • See British National Formulary for dose adjustments when prescribing in renal impairment.

Sodium Glucose Co-Transporter 2 Inhibitors (SGLT2 Inhibitors)

Preferred list (P)

EMPAGLIFLOZIN (Jardiance®)

CANAGLIFLOZIN (Invokana®)

DAPAGLIFLOZIN (Forxiga®)

Prescribing Notes:

See NICE Technology appraisal guidance (TA390) for restrictions on use of canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes.

Further information and guidance on prescribing the above medications for patients with type 2 diabetes mellitus (T2DM) in the presence of co-morbidities can be found in the NHS Lanarkshire Guidelines Management of patients with T2DM and CV disease, Heart Failure or Diabetic Kidney Disease.

Rare but serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis have been reported in patients on SGLT2 inhibitor treatment. These medications should be stopped in intercurrent illness where there is a risk of dehydration (acute serious medical conditions) or when major surgical procedures are required. Treatment may be restarted when the patient’s condition has stabilised.

NHS Lanarkshire also has guidance on the use of Sodium Glucose Co-Transporter 2 Inhibitors in 

Glucagon-Like Peptide-1 Receptor Agonists (INJECTABLE)

There are very limited, intermittent supplies of injectable GLP-1 RAs licensed in the management of Type 2 Diabetes Mellitus.
Supply is not expected to return to normal until at least the end of 2024. Since supply may be intermittent, new patient initiations of injectable GLP-1 RAs cannot be supported.

Please refer to the NHS Lanarkshire document: 'GLP-1 Receptor Agonist (GLP-1RA) initiation / switching due to supply issues' (issued April 2024)  which details suggested actions to be taken until supply issues have resolved.

Specialist initiation (S1)

SEMAGLUTIDE (Ozempic®)

  • Administration: once weekly
  • SMC restriction: In addition to other oral anti-diabetic medicines, or as an add-on to basal insulin, as an alternative glucagon-like peptide-1 receptor agonist option.
  • As per BNF, Semaglutide must be prescribed and dispensed by brand name. Different brands of Semaglutide have different licensed clinical indications and thus this medicine should not be prescribed generically. 

DULAGLUTIDE (Trulicity®)

  • Administration: once weekly
  • SMC restriction: as part of a triple therapy in patients with inadequate glycaemic control on two oral anti-diabetic drugs, as an alternative glucagon-like peptide 1 (GLP-1) agonist option.
  • Supplied as single-use pre-filled pen. May be beneficial in healthcare professional administration; device is pre-loaded and needle automatically retracts after administration.

LIRAGLUTIDE (Victoza®)

TIRZEPATIDE (Mounjaro®)

  • Administration: once weekly
  • See NHS Lanarkshire guidance "Use of Tirzepatide (Mounjaro®)" for further guidance and eligibility criteria.
  • SMC restriction: in addition to other oral anti-diabetic medicines as an option when glucagon-like peptide-1 (GLP-1) receptor agonists would be considered. 

Glucagon-Like Peptide-1 Receptor Agonists (ORAL)

Preferred list (P)

SEMAGLUTIDE (Rybelsus®)

  • Indication: type 2 diabetes mellitus
  • SMC restriction: In addition to other oral anti-diabetic medicines, or as an add-on to basal insulin, as an alternative glucagon-like peptide-1 receptor agonist option.
  • NOTE: Due to the high pharmacokinetic variability of oral semaglutide, the effect of switching between oral and subcutaneous semaglutide cannot be easily predicted. Please refer to SPC for more information.

Combination: Insulin Degludec & Glucagon-Like Peptide-1 Receptor Agonists

Specialist initiation (S1)

INSULIN DEGLUDEC WITH LIRAGLUTIDE (Xultophy®)

  • A fixed combination therapy of insulin degludec + liraglutide.
  • Restrictions: for use in patients who are uncontrolled on basal insulin analogues (glycosylated haemoglobin [HbA1c] >59mmol/mol [7.5%]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin to obtain glucose control.

NHSL Joint Adult Formulary Key

To indicate the category of a formulary medicine, updated sections adopt the following key:

Preferred list (P): First-line formulary choices.

Total list (T): Alternative choices when preferred list options not effective/not tolerated, or not indicated.

Specialist initiation (S1): Specialist initiation, or on the advice of a Consultant or Specialist Practitioner in this therapeutic area. Continuation in primary care is acceptable.

Specialist use only (S2): Supply via hospital, Homecare Service or a hospital based prescription (HBP) for dispensing by community pharmacy. Not prescribed in primary care setting.

Editorial Information

Last reviewed: 31/01/2022

Author(s): NHSL.

Version: Please refer to the introduction section for an explanation of the review dates above.

Approved By: ADTC

Reviewer name(s): ADTC.