Information intended for UK healthcare professionals only.

This formulary decision guide was developed from content provided by MSD UK Ltd in a format developed by Guidelines in Practice.

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Key points

  • Ertugliflozin is indicated in adults (≥18 years of age) with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control1
  • Ertugliflozin significantly reduced HbA1c, body weight*, and systolic blood pressure* compared with placebo and reductions were sustained over the course of the VERTIS clinical trial programme2
  • Switching patients on other SGLT-2 inhibitors to Steglatro® could generate estimated potential annual savings of £17,485 per 100,000 people, and of £51,243 for an average CCG (see assumptions).3,4

* Ertugliflozin is not indicated for body weight or systolic blood pressure reduction

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Drug name

Steglatro® (Ertugliflozin)

Indication

  • Ertugliflozin is indicated in adults (≥18 years of age) with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control:1
    • as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications
    • in addition to other medicinal products for the treatment of diabetes.

Dosage

  • The recommended starting dose of ertugliflozin is 5 mg once daily—the dose can be increased to 15 mg once daily if additional glycaemic control is needed1
  • Renal impairment:1
    • do not initiate in patients with an eGFR < 60 ml/min/1.73m2 or creatinine clearance (CrCl) < 60 ml/min
    • discontinue when eGFR is persistently < 45 ml/min/1.73m2 or CrCl is persistently < 45 ml/min
  • When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or of the insulin secretagogue may be required to reduce the risk of hypoglycaemia1
  • In patients with volume depletion, correcting this condition prior to initiation of ertugliflozin is recommended.1

Cardiovascular safety

  • The VERTIS-CV trial achieved its primary endpoint of non-inferiority for major adverse cardiovascular events compared with placebo in patients with type 2 diabetes mellitus and established atherosclerotic cardiovascular (CV) disease (Hazard ratio [HR]: 0.97 [95.6% CI: 0.85–1.11], p < 0.001)2
  • The key secondary endpoints were not met. Statistical significance was not reached for the secondary composite endpoint of CV death or hospitalisation for heart failure (HHF); no further testing could be performed due to the hierarchical statistical testing method employed2
  • HHF was a pre-specified secondary endpoint but did not have an associated hypothesis and was not part of the hierarchical statistical plan; a relative risk reduction of 30% was observed (absolute risk reduction = 1.1%, 2.5% pooled ertugliflozin group vs 3.6% placebo) (HR: 0.70 [95% CI: 0.54–0.90])2
  • Ertugliflozin was generally well tolerated, with a safety profile consistent with the SGLT-2 inhibitor class2
  • The incidence of adverse events, serious adverse events, and discontinuation due to adverse events was similar between ertugliflozin and placebo treatment arms, consistent with that observed across the VERTIS programme2 
  • The incidences of symptomatic hypoglycaemia, hypovolemia, pancreatitis and bone fracture were low and similar in the ertugliflozin and placebo treatment arms2
  • No adverse events of Fournier’s gangrene were reported2
  • The frequencies of urinary tract infections and genital mycotic infections were higher with ertugliflozin vs. placebo2
  • The incidence of amputations, was numerically higher with ertugliflozin vs. placebo.2

Budgetary implications

  • Ertugliflozin offers an opportunity to realise cost savings when prescribing an SGLT-2 inhibitor 
  • Ertugliflozin list price is approximately 20% lower than all other SGLT-2 inhibitors3
SGLT-2 inhibitor28 days supply3

Ertugliflozin

£29.40

Dapagliflozin

£36.59

Canagliflozin

£36.59

Empagliflozin

£36.59

  • In 2017, 3799 packs of SGLT-2 inhibitors were used per 100,000 people at the cost of £36.59 per pack;3,4 this represents a cost of £88,979 in patients without established cardiovascular disease (eCVD). Switching patients without eCVD to ertugliflozin could generate estimated potential savings of £17,485 per 100,000 people and £51,243 for an average clinical commissioning group (CCG)
  • Estimate the potential savings for your CCG using this budget impact model (this link will take you to an MSD promotional website).  

 The costs were calculated using the following data:
a. annual sales of SGLT-2 inhibitors (2017) = 2,523,000 in the UK
b. current costs at £36.59 per pack3
c. Steglatro® costs at £29.40 per pack3
d. type 2 diabetes mellitus population without established cardiovascular disease = 64%5
e. average CCG population = 293,0746

Evidence for use

  • Ertugliflozin provides significant HbA1c reductions as well as body weight and systolic blood pressure reductions, consistent across the VERTIS clinical trial program7–9
  • Steglatro® is not licensed for body weight or blood pressure reduction.
 Placebo-adjusted LS mean reduction from baseline at week 26:
Therapy and study Dose (mg) HbA1c (%)  Body weight (Kg)  Systolic blood pressure (mmHg) 
Monotherapy
VERTIS-mono7
n=461
5
15
-0.99
-1.16
-1.76
-2.16
-3.31*
-1.71* 
Dual therapy
(+ metformin)
VERTIS-met8
n=621
5
15 
-0.7
-0.9
-1.7
-1.6
-3.7 
-4.5
Triple therapy
(+metformin +sitagliptin)
VERTIS-sita29
n=464
5
15 
-0.7
-0.8
-2.0
-1.7 
-2.9
-3.9 

*superiority over placebo not statistically significant

Safety profile

  • Ertugliflozin should not be used in patients with type 1 diabetes mellitus1
  • Very common reported adverse reactions are vulvovaginal mycotic infections and other female genital mycotic infections1
  • Common adverse events include: balanitis candida and other male genital mycotic infections, hypoglycaemia, volume depletion, increased urination, vulvovaginal pruritus, thirst, serum lipids changed, haemoglobin and blood urea nitorgen increase1
  • Serious diabetic ketoacidosis occurs rarely1
  • Ertugliflozin may add to the diuretic effect of diuretics and may increase the risk of dehydration and hypotension1
  • Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue; therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with ertugliflozin1
  • Please refer to the summary of product characteristics for a full list of safety information.1

References

  1. Merck Sharp & Dohme Limited. Steglatro 5 mg film-coated tablets—summary of product characteristics. July 2020. www.medicines.org.uk/emc/product/9803/smpc 
  2. Pratley at al. Presented at 80th ADA, Virtual scientific sessions. June 12–18 2020.
  3. NHS Business Services Authority. Drug Tariff 2020. www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff 
  4. IQVIA. Retail dispensing audit—units MAT. December 2017.
  5. Lautsch D et al. Diabetes Ther 2019; 10: 2131–2137.
  6. Office for National Statistics. Population estimates by output areas, electoral, health and other geographies, England and Wales: mid-2018. Available at: www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/bulletins/annualsmallareapopulationestimates/previousReleases 
  7. Terra S et al. Diabetes Obes Metab 2017; 19 (5): 721–728.
  8. Rosenstock J et al. Diabetes Obes Metab 2018; 20 (3): 520–529.
  9. Dagogo-Jack S et al. Diabetes Obes Metab 2018; 20 (3): 530–540.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to MSD, UK (Tel: 01992 467272). By clicking the above link you will leave the MSD website and be taken to the MHRA website. 

GB-STE-00368

Date of preparation: August 2020