For referral information, please see adult weight management pathway:

• Western locality
• South Devon and Torbay

Obesity is associated with many health problems including cardiovascular disease, diabetes mellitus, gallstones and osteoarthritis. Factors that aggravate obesity may include depression, other psychological problems and some drugs.

The main treatment of the obese individual is a suitable diet, carefully explained to the individual, with appropriate support and encouragement; the individual should also be advised to increase physical activity.

Severe obesity should be managed in an appropriate setting by staff that have been trained in the management of obesity; the individual should receive advice on diet and lifestyle modification and be monitored for changes in weight as well as in blood pressure, blood lipids and other associated conditions. Drug therapy must only be offered as part of a package of care if there is demonstrated weight loss prior to treatment.

Naltrexone-bupropion

• NICE TA494: Naltrexone-bupropion is not recommended for managing overweight and obesity in adults alongside a reduced-calorie diet and increased physical activity (December 2017).

Centrally acting appetite suppressants

Phentermine and diethylpropion are central stimulants; they are not recommended for the treatment of obesity. Phentermine has been associated with a risk of pulmonary hypertension.

Sibutramine, dexfenfluramine, and fenfluramine have been withdrawn from the market because the benefit of treatment does not outweigh the risk of serious adverse effects.

Lipase inhibitors

Orlistat

• Capsules 120mg (£23.88 = 84 capsules)

Notes

1. NICE CG43: (December 2006) recommends that orlistat should be prescribed under the following conditions:
   1. Part of an overall plan for managing obesity in adults who have a body mass index (BMI) of 28kg/m² or more with associated risk factors, or
   2. a BMI of 30kg/m² or more.
2. Treatment should be continued beyond three months only if the person has lost at least 5% of their initial body weight since starting drug treatment (although less strict goals may be appropriate for people with type 2 diabetes).
3. Therapy should only be continued beyond twelve months (usually for weight maintenance) only after discussing potential benefits and limitations with the patient.
4. Co-prescribing with other drugs for weight reduction is not recommended.

Melanocortin 4 receptor agonist

Setmelanotide

• Solution for injection vials 10mg/1ml

Notes

1. NICE HST21: Setmelanotide (Imcivree) is recommended, within its marketing authorisation, as an option for treating obesity and controlling hunger caused by pro-opiomelanocortin (POMC) deficiency, including proprotein convertase subtilisin/kexin type 1 or leptin receptor (LEPR) deficiency in people 6 years and over, only if the company provides setmelanotide according to the commercial arrangement (July 2022).
2. NICE HST31: Setmelanotide (Imcivree) is recommended as an option for treating obesity and hyperphagia in genetically confirmed Bardet-Biedl syndrome (BBS) in people aged 6 years and over, only if they are aged between 6 and 17 years when treatment starts. These people can carry on having setmelanotide as adults until they need to stop. Setmelanotide is only recommended if the company provides it according to the commercial arrangement (May 2024).

Glucagon-like peptide-1 receptor agonists (GLP-1 mimetics)

MHRA Drug Safety Update (October 2024): GLP-1 receptor agonists: reminder of the potential side effects and to be aware of the potential for misuse

• Inform patients upon initial prescription and when increasing the dose about the common risk of gastrointestinal side effects which may affect more than 1 in 10 patients.
• Hypoglycaemia can occur in non-diabetic patients using some GLP-1RAs for weight management; ensure patients are aware of the symptoms and signs of hypoglycaemia and know to urgently seek medical advice should they occur
• Warn patients of the risk of falsified GLP-1 RA medicines for weight loss if not prescribed by a registered healthcare professional, and be aware that some falsified medicines have been found to contain insulin
  • The legitimacy of a pharmacy, including those on-line, can be verified by referring to the GPhC website pharmacy registry.
• Refer to the safety update for advice to give to patients

Saxenda

(Liraglutide)

• Solution for injection 3ml pre-filled pens 6mg/ml

Indications

• As an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults who meet the criteria in NICE TA664 (see note 3)

Notes

1. For information on referral to adult weight management service, please see links at top of page.
2. Prescribe by brand (to aid identification where products contain multiple ingredients, or to prevent confusion where multiple brands contain similar ingredients and / or have different licensed indications and dosing regimens):
   1. Saxenda is licensed for weight management
   2. Victoza is licensed for the treatment of type 2 diabetes mellitus and should not be prescribed for weight management, see section 6.1.2 Antidiabetic drugs.
3. NICE TA664: Liraglutide (Saxenda) is recommended as an option for managing overweight and obesity alongside a reduced-calorie diet and increased physical activity in adults (December 2020), only if:
   1. they have a body mass index (BMI) of at least 35kg/m² (or at least 32.5kg/m² for members of minority ethnic groups known to be at equivalent risk of the consequences of obesity at a lower BMI than the white population) and
   2. they have non-diabetic hyperglycaemia (defined as a haemoglobin A1c level of 42 mmol/mol to 47 mmol/mol [6.0% to 6.4%] or a fasting plasma glucose level of 5.5 mmol/litre to 6.9 mmol/litre) and
   3. they have a high risk of cardiovascular disease based on risk factors such as hypertension and dyslipidaemia and
   4. it is prescribed in secondary care by a specialist multidisciplinary tier 3 weight management service and
   5. the company provides it according to the commercial arrangement.
4. The safety and efficacy of liraglutide for weight management have not been established in the following patients. Use in these patients is not recommended; aged 75 years or more, treated with other products for weight management, with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain, with severe renal impairment, with severe hepatic impairment (see SmPC for more details).
5. For use of liraglutide (Victoza) in the treatment Type 2 diabetes mellitus, see section 6.1.2 Antidiabetic drugs.

Wegovy

(Semaglutide)

• FlexTouch solution for injection pre-filled pens 0.25mg/0.37ml (1.5ml), 0.5mg/0.37ml (1.5ml), 1mg/0.75ml (3ml), 1.7mg/0.75ml (3ml), 2.4mg/0.75ml (3ml)

Indications

• As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults who meet the criteria in NICE TA875 (see note 3)

Notes

1. For information on referral to adult weight management service, please see links at top of page.
2. Prescribe by brand (to aid identification where products contain multiple ingredients, or to prevent confusion where multiple brands contain similar ingredients and / or have different licensed indications and dosing regimens):
   1. Wegovy is licensed for weight management
   2. Ozempic and Rybelsus are licensed for the treatment of type 2 diabetes mellitus and should not be prescribed for weight management, see section 6.1.2 Antidiabetic drugs.
3. NICE TA875: Semaglutide (Wegovy) is recommended as an option for weight management, including weight loss and weight maintenance, alongside a reduced-calorie diet and increased physical activity in adults (March 2023), only if:
   1. it is used for a maximum of 2 years, and within a specialist weight management service providing multidisciplinary management of overweight or obesity (including but not limited to tiers 3 and 4), and
   2. they have at least 1 weight-related comorbidity and:
      1. body mass index (BMI) of at least 35.0kg/m², or
      2. BMI of 30.0kg/m² to 34.9kg/m² and meet the criteria for referral to specialist weight management services in NICE's guideline on obesity: identification, assessment and management and
   3. the company provides it according to the commercial arrangement.
   4. Use lower BMI thresholds (usually reduced by 2.5kg/m²) for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds.
   5. Consider stopping semaglutide if less than 5% of the initial weight has been lost after 6 months of treatment.
4. No dose adjustment needed in elderly patients, hepatic impairment, or those with mild to moderate or severe renal impairment. Semaglutide is not recommended for use in patients with end-stage renal disease (see SmPC for more details).
5. For use of semaglutide (Ozempic or Rybelsus) in the treatment Type 2 diabetes mellitus, see section 6.1.2 Antidiabetic drugs.

GIP / GLP-1 receptor agonists

Tirzepatide for weight management

• Tirzepatide for weight management is subject to NICE TA1026 criteria (see note 3 below). Implementation of TA1026 is determined by NICE and NHS England (see here). The national plan for the future is for a phased delivery to patient cohorts in other settings, including primary care-based services, based on NHS England prioritisation criteria.
• Until further communication, use of tirzepatide for weight management purposes remains with the specialist weight management service.
• The formulary entry and traffic light classification for tirzepatide will be reviewed in the future when more information is available.

For use of tirzepatide in the treatment of Type 2 diabetes mellitus, see section 6.1.2 Antidiabetic drugs.

Tirzepatide

• KwikPen solution for injection 2.4ml pre-filled pens
  • 2.5mg/0.6ml, 5mg/0.6ml (£92.00 = 1 pen (4 doses)); 7.5mg/0.6ml, 10mg/0.6ml (£107.00 = 1 pen (4 doses)); 12.5mg/0.6ml, 15mg/0.6ml ((£122.00 = 1 pen (4 doses))
  • Needles are not provided and will need to be prescribed, see section 6.1.1 for pen needles

Indications

• For weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in adults who meet the criteria in NICE TA1026 (see note 3)

Notes

1. For information on referral to adult weight management service, please see links at top of page.
2. Contraception: Tirzepatide is not recommended during pregnancy and in women of childbearing potential not using contraception (SmPC). The FSRH has issued recommendations on contraception for patients receiving tirzepatide:
   1. Individuals using tirzepatide and oral contraception should switch to a non-oral contraceptive method, or add a barrier method of contraception, for four weeks after initiation and for four weeks after each dose increase.
   2. In the event of severe diarrhoea or vomiting during use of tirzepatide, refer to formulary guidance Contraception, Drug Interactions with hormonal contraceptives for appropriate contraceptive methods.
3. NICE TA1026 (December 2024): Tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity in adults, only if they have:
   1. an initial body mass index (BMI) of at least 35 kg/m2 and
   2. at least 1 weight-related comorbidity.
   3. Use a lower BMI threshold (usually reduced by 2.5 kg/m2) for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds.
   4. If less than 5% of the initial weight has been lost after 6 months on the highest tolerated dose, decide whether to continue treatment, taking into account the benefits and risks of treatment for the person.