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 Formulary Chapter 6: Endocrine system - Full Chapter
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06.01.02.03  Expand sub section  Other antidiabetic drugs
Dapagliflozin 5mg, 10mg
(tablet)
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Restricted Drug Restricted

Green  Use in accordance with NICE TA 288, NICE TA 390, NICE TA 418 and the Management of Type 2 Diabetes: Blood-Glucose Lowering Therapy Guideline (BHTCG 667FM) (see link above)

2nd line SGLT2 inhibitor for glycaemic control in patients with or without cardiovascular disease (CVD).

 

Amber Recommentation Restricted - prescribing on the recommendation of the Heart failure team or GP with special interest in Cardiology, continuation by GPs.  For treatment of symptomatic chronic heart failure with reduced ejection fraction in accordance with NICE TA 679 and the Dapagliflzon for heart failure guideline (guideline awaiting approval).  

 
Link  MHRA Drug Safety Update - February 2019: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
Link  MHRA Drug Safety Update - March 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes)
Link  MHRA Drug Safety Update - April 2016 - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis
Link  NICE TA 288: Dapagliflozin in combination therapy for treating type 2 diabetes
Link  NICE TA 390: Canagliflozin, dapagliflozin, empagliflozin as monotherapies for treating Type 2 diabetes
Link  NICE TA 418: Dapagliflozin in triple therapy for treating type 2 diabetes
Link  NICE TA 679: Dapagliflozin for treating chronic heart failure with reduced ejection fraction
   
Empagliflozin 10mg, 25mg
(tablet)
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Restricted Drug Restricted
Green

Use in accordance with NICE TA 336, NICE TA 390 and the Management of Type 2 Diabetes: Blood-Glucose Lowering Therapy guideline (BHTCG 667FM) (see link above)


Joint 1st line SGLT2 inhibitor (with canagliflozin) for glycaemic control in patients with or without established cardiovascular disease (CVD)

 
Link  MHRA Drug Safety Update - February 2019: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
Link  MHRA Drug Safety Update - March 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes)
Link  MHRA Drug Safety Update - April 2016 - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis
Link  NICE TA336: Empagliflozin in combination therapy for treating Type 2 diabetes
Link  NICE TA390: Canagliflozin, dapagliflozin, empagliflozin as monotherapies for treating Type 2 diabetes
   
Canagliflozin 100mg, 300mg
(tablet)
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Restricted Drug Restricted
Green

Use in accordance with NICE TA 315, NICE TA 390 and the Management of Type 2 Diabetes: Blood-Glucose Lowering Therapy guideline (BHTCG 667FM) (see link above)


Joint 1st line SGLT2 inhibitor (with empagliflozin) for glycaemic control in patients with or without established cardiovascular disease (CVD)

 
Link  MHRA Drug Safety Update - February 2019: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
Link  MHRA Drug Safety Update - March 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes)
Link  MHRA Drug Safety Update - April 2016 - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis
Link  MHRA Drug Safety Update - June 2016 - Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients
Link  NICE TA315: Canagliflozin in combination therapy for treating Type 2 diabetes
Link  NICE TA390: Canagliflozin, dapagliflozin, empagliflozin as monotherapies for treating Type 2 diabetes
   
Exenatide 2mg  (Bydureon® BCise)
(prolonged release suspension for injection in pre-filled pen)
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Restricted Drug Restricted
Green

Green 

Treatment of adults with type 2 diabetes in accordance with NICE NG 28 and 109FM GLP-1 agonists for adults with type 2 diabetes guideline.

For existing patients meeting glycaemic and weight loss goals without side effects.

If existing patients do not meet treatment goals or do not tolerate exenatide, consider switching to another GLP-1 agonist as per ‘new patient’ choices.

Prescribing by Diabetes consultants or Diabetes Specialist Nurses (DSN)s or by primary care health professionals who have received training and are operating under the direct award for insulin.

 

Note  Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen is being replaced with  Bydureon BCise 2 mg prolonged-release suspension for injection in pre-filled pen from Dec 31st 2020.  From January 1st  2021, patients should be prescribed Bydureon BCise 2 mg prolonged-release suspension for injection in pre-filled pen and trained on the use of the new device. 

 
Link  MHRA Drug Safety Update - June 2019: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
Link  Glucagon-like peptide-1 (GLP-1) Agonists for Adults with Type 2 Diabetes - Primary/ Secondary Care guideline (BHT CG109FM)
Link  NICE NG28: Type 2 diabetes in adults: management
   
Exenatide 5micrograms/dose, 10micrograms/dose (Byetta®)
(injection)
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Restricted Drug Restricted
Green

Green 


 Treatment of adults with type 2 diabetes in accordance with NICE NG 28 and 109FM GLP-1 agonists for adults with type 2 diabetes guideline.


For existing patients meeting glycaemic and weight loss goals without side effects.


If existing patients do not meet treatment goals or do not tolerate exenatide, consider switching to another GLP-1 agonist as per ‘new patient’ choices.


Prescribing by Diabetes consultants or Diabetes Specialist Nurses (DSN)s or by primary care health professionals who have received training and are operating under the direct award for insulin.

 
Link  MHRA Drug Safety Update - June 2019: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
Link  Glucagon-like peptide-1 (GLP-1) Agonists for Adults with Type 2 Diabetes - Primary/ Secondary Care guideline (BHT CG109FM)
   
Sitagliptin 25mg, 50mg, 100mg (Januvia®(tablet)
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Formulary
Green

1st line DPP-4 inhibitor. Use in accordance with Type 2 Diabetes blood glucose-lowering therapy guideline (BHTCG 667FM) (see link above) and NICE MG 87 Management of Type 2 Diabetes.
 

 
   
Dapaglifozin (Forxiga®)
(film coated tablet)
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Formulary
Amber Recommended

For treatment of Type 1 Diabetes as an adjunct to insulin in accordance with NICE TA 597.


Prescribing on the recommendation of consultant Diabetologists, continuation by GPs.


https://www.nice.org.uk/guidance/TA597

 
   
Dulaglutide 0.75mg, 1.5mg (Trulicity®)
(injection, pre-filled pen)
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Formulary
Green

Treatment of adults with type 2 diabetes in accordance with NICE NG 28 and 109FM GLP-1 agonists for adults with type 2 diabetes guideline.


2nd choice GLP-1 agonist for type 2 diabetes without athersclerotic cardiovascular disease (ASCVD).


3rd choice for type 2 diabetes with ASCVD.


Initiation by Diabetes consultants or Diabetes Specialist Nurses (DSN)s or by primary care health professionals who have received training and are operating under the direct award for insulin.

 
   
Ertugliflozin 5mg, 10mg
(tablets)
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Restricted Drug Restricted
Green

Use in accordance with NICE TA 572, NICE TA 583 and the Management of Type 2 Diabetes: Blood-Glucose Lowering Therapy Guideline (BHTCG 667FM) (see link above)


Joint 2nd line SGLT2 inhibitor (with dapagliflozin) for glycaemic control in patients without established cardiovascular disease (CVD)

 
Link  NICE TA 572: Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes
Link  NICE TA 583: Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes
   
Linagliptin 5mg (Trajenta®)
(tablet)
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Formulary
Green

2nd line DPP-4 inhibitor for patients with renal impairment (eGFR <60ml/min/1.73m2) and declining renal function.


Use in accordance with Type 2 Diabetes blood glucose-lowering therapy guideline (BHTCG 667FM) (see link above) and NICE MG 87 Management of Type 2 Diabetes

 
   
Liraglutide 6mg/mL (Victoza®)
(injection, 3mL prefilled pen)
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Formulary
Green

Treatment of adults with type 2 diabetes in accordance with NICE  NG 28 and 109FM GLP-1 agonists for adults with type 2 diabetes guideline.


Liraglutide 1.8mg daily is 1st choice for type 2 diabetes with ASCVD.


Liraglutide 1.2mg daily is 3rd choice GLP-1 agonist for type 2 diabetes without athersclerotic cardiovascular disease (ASCVD). 


Initiation by Diabetes consultants or Diabetes Specialist Nurses (DSN)s or by primary care health professionals who have received training and are operating under the direct award for insulin. Not to be used for weight management in non-diabetics.

 
Link  MHRA Drug Safety Update - June 2019: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
Link  Glucagon-like peptide-1 (GLP-1) Agonists for Adults with Type 2 Diabetes - Primary/ Secondary Care guideline (BHT CG109FM)
Link  NICE NG28: Type 2 Diabetes in adults: management
   
Pioglitazone 15mg, 30mg, 45mg
(tablet)
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Restricted Drug Restricted
Green
Restricted - to be used in accordance with NICE Clinical Guideline 87 Management of Type 2 Diabetes and Type 2 Diabetes blood glucose-lowering guideline (BHTCG 667FM) (see link above).
NOTE: Rosiglitazone was withdrawn from the market by the EMEA in Sept 2010. Please follow the advice of the Association of British Clinical Diabetologists. All patients on rosiglitazone should have a medication review and the drug should be stopped. All new patients requiring a thiazolidinedione should be prescribed Pioglitazone. Prior evidence of heart failure and impairment of left ventricular function remains a strict contraindication for the use of thiazolidinediones 
   
Repaglinide 500micrograms, 1mg, 2mg
(tablet)
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Restricted Drug Restricted
Green
In secondary care restricted - to Consultant Only prescribing 
   
Semaglutide 0.25mg,0.5mg,1mg (Ozempic®) (injection, pre-filled pen)
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Formulary
Green

Treatment of adults with type 2 diabetes in accordance with NICE NG 28 and 109FM GLP-1 agonists for adults with type 2 diabetes guideline.


1st choice GLP-1 agonist for type 2 diabetes without athersclerotic cardiovascular disease (ASCVD).


2nd choice for type 2 diabetes with ASCVD.


Initiation by Diabetes consultants or Diabetes Specialist Nurses (DSN)s or by primary care health professionals who have received training and are operating under the direct award for insulin.

 
   
Sotagliflozin 200mg
(tablets)
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Formulary
Amber Initiation

With insulin for the treatment of type 1 diabetes in accordance with NICE TA 622.


Initiation and stabilization of treatment by consultant Diabetologists before continuation of prescribing by GPs. Patients receive structured education about management and monitoring for DKA and the use ketone meters. They are regularly followed up by the specialists.

 
Link  NICE TA 622: Sotagliflozin with insulin for treating type 1 diabetes
   
Acarbose 50mg
(tablet)
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Formulary
Green
 
   
 ....
 Non Formulary Items
Alogliptin
(tablet)

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Non Formulary
 
Linagliptin/ metformin  (Jentadueto®)

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Non Formulary
 
Liraglutide 6mg/mL  (Saxenda®)

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Non Formulary
Black
Link  MHRA Drug Safety Update - June 2019: GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
 
Nateglinide  (Starlix®)

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Non Formulary
 
Pioglitazone and Metfomin  (Competact®)

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Non Formulary
 
Rosiglitazone and Metformin  (Avandamet®)

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Non Formulary
 
Saxagliptin  (Onglyza®)

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Non Formulary
 
Sitagliptin and Metformin  (Janumet®)

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Non Formulary
 
Vildagliptin

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Non Formulary
 
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Black

Not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.
Drugs which have been evaluated and rejected by the Medicines Value Group (MVG)
Drugs defined as ‘Low Priority’ by the South Central Priorities Committee
New drugs which have not as yet been evaluated by the MVG
Any drug not listed in the Buckinghamshire Formulary  

Red

Drugs which should only be prescribed in secondary care by a specialist.
Require specialist knowledge and/or equipment for patient selection and initiation
Require long term on-going monitoring and dose adjustment to ensure efficacy and minimise toxicity by a specialist
Designated as “hospital only“ by product licence, NICE, DoH or BNF
May need further evaluation by a specialist
Are hospital initiated clinical trial materials  

Red Specialist Centre

As for ‘red’ (above) with the addition of the following:
Designated by NHS England to require initiation by or in prior agreement with a Specialist Centre. Continuation where appropriate by BHT (or other secondary care provider)
Detailed requirements for Specialist Centre initiation to be described in the wording of the formulary restriction  

Amber Protocol

Drugs which should be initiated in secondary care by the specialist with follow-on prescription and monitoring according to a drug specific Shared Care Protocol(SCP). Prescribing may be continued in primary care following the SCP
Require specialist knowledge and/or equipment for patient selection and initiation
Require short or medium term (eg. 3 to 6 months) specialist monitoring of efficacy or toxicity. The need for stabilisation will vary with different drugs and patients, but is usually a minimum of 2 months (see principles for shared care)
Require significant long term monitoring
Require ongoing communication between the GP and the specialist
Have clearly defined consultant, GP and patient responsibilities documented in a shared care protocol (see responsibilities for amber protocol drugs)  

Amber Initiation

Drugs suitable for primary care prescribing following specialist initiation
Require specialist knowledge and/or equipment for patient selection
Monitoring does not require specialist knowledge or equipment
If the drug is one with which the primary care prescriber is unfamiliar the specialist is expected to provide sufficient information on the drug indication, dose, duration , monitoring and any further necessary dose adjustments
Require the first prescription to be written by the specialist  

Amber Recommended

Drugs suitable for primary care prescribing following specialist recommendation
As for amber initiation except that:- The first prescription may be written by the GP after specialist recommendation.  

Green

Drugs for which primary care prescribers would normally take full responsibility for prescribing and monitoring
Drugs not included in the Traffic Light list but included on joint formulary.
New drugs classified as red or amber but as greater experience regarding their safety and efficacy is established may move to Green after re-consideration by the MVG and APC.  

netFormulary