Exenatide
Type 2 diabetes mellitus in patients with inadequate glycaemic control on metformin and/or a sulfonylurea, for use as second- or third-line therapy.
Decisions on record
- Meeting Mar 2019 Not recommended Type 2 diabetes mellitus (T2DM)
- Meeting Mar 2016 Recommended Type 2 diabetes mellitus (dual and triple therapy)
- Meeting Jul 2015 Recommended Type 2 diabetes mellitus
- Meeting Mar 2015 Recommended Type 2 diabetes mellitus
- Meeting Nov 2013 Recommended 2 mg, power for injection, vial Bydureon® Bristol-Myers Squibb Australia Pty Ltd Major submission Type 2 diabetes Resubmission to request an Authority Required (STREAMLINED) listing for the treatment of Type 2 diabetes as: 1) Dual combination therapy with metformin or a sulfonylurea; and 2) Triple c
- Meeting Jul 2013 Not recommended Type 2 diabetes no PSD
- Meeting Nov 2011 Recommended Type 2 diabetes no PSD
- Meeting Jul 2011 Not recommended Type 2 diabetes
3 earlier decisions
- Jul 2010 Recommended Diabetes no PSD
- Nov 2008 Recommended Type 2 Diabetes
- Jul 2007 Not recommended Type 2 diabetes
Access path
- Jul 2007Not recommended
High and uncertain cost-effectiveness; ICER highly sensitive to disutility assumptions for weight gain; weight loss…
- Jul 2007Not recommended
high and uncertain cost-effectiveness, concerns about non-inferiority to rosiglitazone, higher incidence of adverse…
- ↻ resubmittedMar 2008Recommended
Comparator changed: rosiglitazone and insulin glargine → insulin glargine
- Nov 2008Recommended · restricted
- Jul 2011Not recommended
Comparator changed: insulin glargine → exenatide twice daily
- ↻ resubmittedNov 2013Recommended · restricted
Comparator changed: exenatide twice daily → exenatide 10mcg twice daily
- Mar 2015Recommended · restricted
Comparator changed: exenatide 10mcg twice daily → insulin intensification using…
- Jul 2015Recommended · restricted
Comparator changed: insulin intensification using rapid-acting or short-acting insulin…
- Mar 2016Recommended · restricted
Evidence: RCT → Cost-minimisation
- Mar 2019Not recommended
Comparator changed: exenatide 10 mcg twice daily → exenatide 2 mg once weekly dual…
From the public summary
7.1 The PBAC did not recommend exenatide 2 mg once weekly autoinjector for the treatment of type 2 diabetes mellitus (T2DM) on the basis that the indirect treatment comparison (ITC) presented in the submission did not support the claim that exenatide autoinjector was non-inferior in effectiveness to the currently PBS-listed exenatide dual chamber pen (DCP).PSD · Mar 2019
7.2 The PBAC considered that the requested listing was appropriately aligned with exenatide DCP.PSD · Mar 2019
6.24 The submission presented a cost-minimisation analysis of exenatide autoinjector versus the exenatide DCP. The result of the cost minimisation analysis is presented in Table 6.PSD · Mar 2019
Table 6: Results of the cost minimisation analysis Exenatide once weekly Exenatide once weekly DCP autoinjector Equi-effective dose 2 mg 2 mg Administration frequency Once weekly Once weekly Drug cost (pack of 4 injections) (DPMQ) $131.15 $131.15 Drug cost (pack of 4 injections) (AEMP) $111.44 $111.44a Drug cost (pack of 4 injections) (Effective AEMP) $''''''''''''' $''''''''''''''b Doses per year 52 52 Annual drug cost per patient $1448.72 $1,448.72 …PSD · Mar 2019
6.20 The submission described exenatide 2mg once weekly autoinjector as non-inferior in terms of effectiveness and safety compared with exenatide 2mg once weekly DCP.PSD · Mar 2019
6.21 The therapeutic conclusion presented in the submission was not adequately supported by the evidence presented in the submission because the upper 95% confidence interval for the change from baseline in HbA1c per cent from the indirect comparison did not meet the non-inferiority margin of 0.4%.PSD · Mar 2019
6.2 The PBAC noted and welcomed the input from an individual (1) and a health care professional (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with exenatide once weekly including the acceptability to patients who are eager to avoid injectables, better compliance and fewer side effects.PSD · Jul 2015
6.33 The sponsor sought a special pricing arrangement (SPA) for exenatide once weekly autoinjector at an effective ex-manufacturer price of $'''''''''', which is the same as current effective ex-manufacturer price for exenatide once weekly DCP. The sponsor advised that after the PBS listing of exenatide once weekly autoinjector, ''''''''''''''''' '''''''''' ''''''''''''''' '''''''' ''''''''''''' ''''' '''''''''''''''''''''''''''.PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
At its July 2015 meeting, the PBAC re-endorsed its November 2013 recommendation (of cost-minimisation basis with a partial cost offset for reduce needle use) and had recommended exenatide 2 mg once weekly presentation on the basis of potential health benefits from likely improved adherence by a small number of high clinical need populations. PBAC · 2016
Decision context
PopulationPatients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin and/or a sulfonylurea, requiring additional therapy as second- or third-line treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Not recommended | exenatide 2 mg once weekly dual chamber pen (exenatide DCP) | — | RCT · Surrogate |
| Mar 2016 | Recommended · restricted | exenatide 10 mcg twice daily | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Recommended · restricted | exenatide 10 mcg twice daily | — | RCT · HbA1c reduction |
| Mar 2015 | Recommended · restricted | insulin intensification using rapid-acting or short-acting insulin (basal-bolus regimen) | — | RCT · HbA1c |
| Nov 2013 | Recommended · restricted | exenatide 10mcg twice daily | — | RCT · HbA1c |
| Jul 2011 | Not recommended | exenatide twice daily | — | RCT · HbA1c reduction |
| Nov 2008 | Recommended · restricted | insulin glargine | — | RCT · HbA1c |
| Mar 2008 | Recommended | insulin glargine | $15k–45k | RCT · HbA1c |
| Jul 2007 | Not recommended | rosiglitazone and insulin glargine | $15k–45k | RCT · HbA1c |
| Jul 2007 | Not recommended | rosiglitazone and insulin glargine | $15k–45k | RCT · HbA1c |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Study 108 (DURATION-5) | Ph 3 | 254 | Change in HbA1c From Baseline to Week 24 | completed |
| LEAD-6 | Ph 3 | 467 | Change in Glycosylated A1c (HbA1c) at Week 26 | completed |
Consumer voice
An individual and a healthcare professional submitted comments describing benefits of exenatide once weekly including better acceptability, improved compliance, and fewer side effects compared to twice-daily formulation, though the PBAC noted the efficacy claims were not fully supported by the submission data.
The comments described a range of benefits of treatment with exenatide once weekly including the acceptability to patients who are eager to avoid injectables, better compliance and fewer side effects. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate control on metformin and/or sulfonylurea, requiring second- or third-line therapy; TGA label covers all type 2 diabetes without these restrictions.