| 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)
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: 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: 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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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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