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)

ALOGLIPTIN

SAXAGLIPTIN

 

Total list (T)

LINAGLIPTIN

  • For use in renal impairment.

 

Sodium Glucose Co-Transporter 2 Inhibitors (SGLT2 Inhibitors)

Preferred list (P)

EMPAGLIFLOZIN (Jardiance®)

CANAGLIFLOZIN (Invokana®)

DAPAGLIFLOZIN (Forxiga®)

Prescribing Notes:

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 Guideline: 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.

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.

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®)

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.