| Formulary Chapter 6: Endocrine system - Full Chapter
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| Notes: |
| Unless explicitly stated, any brand names included in brackets next to a drug's generic name are there solely to aid searching and identification, and should not be considered to limit use to that specific brand. |
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| Details... |
| 06.01.02.03 |
Other antidiabetic drugs |
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Alogliptin (Vipidia®)
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First Choice
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Supported for use in adult patients with Type 2 diabetes, to improve glycaemic control in combination with other glucose lowering medicinal products including insulin
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 NICE NG28:Type 2 diabetes in adults: management (May 2017)
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Sitagliptin (Januvia®)
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First Choice
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Supported as first-line monotherapy choice for patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
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Risk of acute pancreatitis:MHRA update Sept 12
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Linagliptin (Trajenta®)
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Second Choice
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Use supported for the treatment of type 2 diabetes, as an alternative to sitagliptin, in patients with moderate to severe renal impairment. Specialist recommendation use only.
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Saxagliptin (Onglyza®)
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Formulary
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Specialist recommendation use only.
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DSU: Dipeptidylpeptidase-4 inhibitors: risk of acute pancreatitis (September 2012)
 Serious hypersensitivity reactions & acute pancreatitis - Dear HCP Letter (March 2012)
FDA warning: Heart failure risk (February 2014)
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Exenatide (Byetta®, Bydureon®)
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 Restricted
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Exenatide pre-filled pens 250micrograms/mL - Byetta®
- Specialist Initiation Only
Exenatide MR Injection 2mg - Bydureon®
- For patients who have already been established on the TWICE DAILY formulation and who would benefit from a change to ONCE WEEKLY preparation.
- Supported for use in-line with NICE NG28 (May 2017)
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DSU: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued (June 2019)
NG28:Type 2 diabetes in adults: management (May 2017)
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Semaglutide (Ozempic®)
(Pre-filled Pen)
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Formulary
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- Semaglutide Pre-filled Pen
First line long acting GLP-1 receptor agonist, in-line with NG28.
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Dulaglutide (Trulicity®)
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Restricted
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Supported for the treatment of type 2 diabetes as an alternative to exenatide LA for patients already established on a daily GLP-1 agonist who would benefit from once-weekly dosing and who are unable to receive treatment with exenatide LA
Specialist initiation only
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DSU: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued (June 2019)
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Liraglutide (Victoza®)
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Restricted
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- Liraglutide should be started only if patients have persistent nausea when on exenatide.
- Supported for use in-line with NG28 (May 2017)
 Liraglutide (Saxenda) for the treatment of obesity. Not routinely commissioned.
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DSU: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued (June 2019)
NICE NG28: Type 2 diabetes in adults: management (May 2017)
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Lixisenatide subcutaneous injection (Lyxumia®)
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Restricted
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For the treatment of Type 2 diabetes in-line with NICE recommendations for the use of a GLP-1 agonist and as a cost effective alternative to exenatide or liraglutide.
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Acarbose
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Formulary
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Acarbose 50mg tablets
For existing patients only.
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Canagliflozin (Invokana®)
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Formulary
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Approved for use for type two diabetes as an alternative to dapagliflozin in patients with poor renal function and in line with NICE TA315.
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Drug Safety Update: Canagliflozin (Invokana, Vokanamet): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients (June 2016)
Drug Safety Update: SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis (June 2015)
Drug Safety Update: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) (February 2019)
Drug Safety Update; SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness (March 2020)
EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes (February 2016)
EMA: SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information (February 2017)
MHRA Drug Safety Update: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes) (March 2017)
NICE TA315: Canagliflozin in combination therapy for treating type 2 diabetes (June 2014)
NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes. (May 2016)
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Dapagliflozin (Forxiga®)
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Restricted
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For use by the diabetic team as dual therapy for the treatment of type 2 diabetes in-line with NICE TA288,TA390 and TA418.
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Drug Safety Update: SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis (June 2015)
Drug Safety Update: SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness (March 2020)
Drug Safety Update: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) (February 2019)
EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes (February 2016)
EMA: SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information (February 2017)
MHRA Drug Safety Update: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes) (March 2017)
NICE TA288: Type 2 diabetes - Dapagliflozin combination therapy (June 2013)
NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016)
NICE TA418: Dapagliflozin in triple therapy for treating type 2 diabetes (Nov 2016)
NICE TA597: Dapagliflozin with insulin for treating type 1 diabetes (August 2019
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Empagliflozin (Jardiance®)
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Formulary
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For the treatment of type two diabetes in-line with NICE TA336.
Use restricted to Specialist initiation only.
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Drug safety update: SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis (June 2015)
Drug Safety Update: SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness (March 2020)
Drug Safety Update: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) (February 2019)
Drug safety update: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes) (March 2017)
EMA: EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes (February 2016)
EMA: SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information (February 2017)
NICE TA336: Empagliflozin in combination therapy for treating type 2 diabetes (March 2015)
NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016)
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Ertugliflozin (Steglatro®)
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Formulary
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For as monotherapy or in combination with metformin treatment of Type 2 diabetes in-line with NICE TA572.
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Drug Safety Update; SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness (March 2020)
NICE TA572: Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes (March 2019)
NICE TA583: Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes (June 2019)
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Pioglitazone
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Formulary
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Diabetes
- Glitazones should only be tried if HbA1C not reducing on metformin and sulphonylurea, and should be stopped if HbA1C is not reduced by 6mmol within six months.
Non-Alcoholic Fatty Liver Disease (NAFLD)
- Pioglitazone is recommended as an option for treating NAFLD. See NICE guidance link below. Note: this is an off-label use of pioglitazone.
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DSU:Risk of bladder cancer (August 2011)
Risk of cardiac failure when combined with insulin (MHRA safety update Jan 2011)
NICE NG49: Non-alcoholic fatty liver disease (NAFLD): assessment and management (July 2016)
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| Non Formulary Items |
Insulin degludec/liraglutide (100units + 3.6mg/mL) (Xultophy®)
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Non Formulary
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Not routinely commissioned. Fixed-dose ratio of the combination product does not allow for the insulin and GLP-1 analogue doses to be titrated separately, and additional clinical benefit over using separate products concomitantly has not been demonstrated. |
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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Cancer Drugs Fund
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
| Status |
Description |
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Green - Drugs suitable for generalised use in accordance with position summary.
Inform primary care of need to prescribe using a TTO chart if in patient or Treatment Advice Note (TAN) if Outpatient.
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Amber - these drugs require specialist initiation or recommendation |
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Amber Share Care - Drugs suitable for generalist use, in accordance with position summary, normally following specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP by a Shared Care Guideline (SCG). If no SCG in place status reverts to red. |
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Red - Drugs for specialist use only, in accordance with position summary. GP’s should not be asked to prescribe these products. |
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Red ULM - Unlicensed medicines for specialist use only, in accordance with position summary. GP’s should not be asked to prescribe these products. |
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Grey drugs - No formal commissioning position. Check appropriate CCG /NHSE commissioning list or contact CCG/NHSE Medicines Management team for advice. Fill in individual funding request for appropriate CCG/NHSE. This will need to be signed by the Chief Pharmacist and a copy of the relevant DTC submission attached. |
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Black - Drugs not routinely commissioned so should not usually be prescribed |
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