LanreotideSomatuline Autogel
Treatment of acromegaly, functional carcinoid tumour, and non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET).
Decisions on record
- Meeting Mar 2026 Recommended Acromegaly, functional carcinoid tumour, non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
- Meeting Jul 2024 Recommended Acromegaly, functional carcinoid tumour, non-functional gastroenteropancreatic neuroendocrine tumour
- Meeting Nov 2022 Recommended Acromegaly, functional carcinoid tumour, non-functional gastroenteropancreatic neuroendocrine tumour
- Meeting Mar 2019 Recommended Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NETs)
- Meeting Jul 2018 Recommended Non-functional gastroentero-pancreatic neuroendocrine tumours (GEP-NETs). no PSD
- Meeting Nov 2017 Recommended Acromegaly and functional carcinoid tumour
- Meeting Nov 2017 Deferred Non-functional gastroentero- pancreatic neuroendocrine tumours (GEP-NETs)
- Meeting Jul 2017 Not recommended Lanreotide is indicated for the treatment of acromegaly when circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory; symptoms of carcinoid syndrome associated with carcinoid tumours; and gastroente
1 earlier decision
- Nov 2016 Not recommended Lanreotide is indicated for the treatment of acromegaly when circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory; symptoms of carcinoid syndrome associated with carcinoid tumours; and gastroente
Access path
- TGA registered · Somatuline Autogel
TGA label narrower than the PBS population
- Nov 2015Not recommended
Uncertain overall survival benefit (no statistically significant OS difference), immature trial data with incomplete OS…
- Nov 2016Not recommended
Listing: Restricted → Authority Required
- Jul 2017Not recommended
ICER dropped $105,000 → $45,000 (-57%)
- ↻ resubmittedNov 2017Recommended
Comparator changed: placebo (watchful waiting) → watchful waiting
- Mar 2019Recommended · restricted
Evidence: RCT → Cost-minimisation
- Nov 2022Recommended · restricted
- Jul 2024Recommended · restricted
Evidence: Cost-minimisation → Other
- Mar 2026Recommended
Evidence: Other → Cost-minimisation
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended changes to the Section 100 (HSD) Community Access (CA), Authority Required (STREAMLINED) listings of lanreotide 60 mg/0.5 mL, 90 mg/0.5 mL and 120 mg/0.5 mL injection forms to allow the initiation of the treatment of acromegaly and functional carcinoid tumours under s100 HSD CA.PSD · Jul 2024
7.2 The PBAC considered that allowing CA initiation would improve access for patients, particularly those in rural and remote areas.PSD · Jul 2024
5.13 As a minor submission, the submission did not provide a new economic model. At its July 2017 meeting, the PBAC considered that any future major resubmission would require a new economic model to provide a reliable estimate of cost-effectiveness.PSD · Nov 2017
5.14 The resubmission did not provide a revised incremental cost-effectiveness ratio based on the model included in the July 2017 resubmission incorporating the proposed effective AEMP. This is appropriate given the PBAC considered the economic model provided in the July 2017 resubmission (as well as the previous submissions) to be fundamentally unreliable for estimating the cost-effectiveness of lanreotide for the requested listing.PSD · Nov 2017
5.4 The submission claimed that Mytolac is a generic version of Somatuline Autogel and that the active component is chemically identical. In the Mytolac approval letter, the 3PSD · Nov 2022
5.5 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable. Estimated PBS utilisation and financial implicationsPSD · Nov 2022
6.2 The PBAC noted and welcomed the input from individuals (3) and health care professionals (2) via the Consumer Comments facility on the PBS website. The comments from the individuals described a range of benefits to treatment with lanreotide including its efficacy at reducing disease progression and improving quality of life.PSD · Jul 2024
5.26 The resubmission proposed a risk sharing arrangement (RSA) where an annual cap is applied, with a rebate for expenditure above that amount. The resubmission 9PSD · Nov 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Net financial impact estimated as $0 over six years.
The PBAC considered the economic model and utilisation estimates to be reasonable. The PBAC noted that the recommended listing was made as a cost minimisation and would be cost neutral to the PBS. PBAC · 2026
Decision context
PopulationAdults with acromegaly (with persistent elevation of mean growth hormone >2.5 micrograms per litre after surgery/radiotherapy or in dopamine agonist-refractory patients), functional carcinoid tumour (with intractable symptoms refractory to other agents), or non-functional GEP-NET (WHO grade 1 or 2, unresectable locally advanced or metastatic disease).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended | Somatuline Autogel | — | Cost-minimisation |
| Jul 2024 | Recommended · restricted | — | — | Other |
| Nov 2022 | Recommended · restricted | Somatuline Autogel | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Recommended · restricted | — | — | Cost-minimisation |
| Nov 2017 | Recommended | watchful waiting | — | RCT · PFS |
| Jul 2017 | Not recommended | placebo (watchful waiting) | $15k–45k | RCT · PFS |
| Nov 2016 | Not recommended | watchful waiting (placebo) | $75k–105k | RCT · PFS |
| Nov 2015 | Not recommended | watchful waiting (placebo) | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CLARINET | Ph 3 | 264 | Progression-Free Survival (PFS) | completed |
Consumer voice
Three individuals and two healthcare professionals provided comments highlighting lanreotide's efficacy in reducing disease progression and improving quality of life, while noting some manageable side effects. Healthcare professionals emphasised the importance of community access for patients in rural and remote areas.
The comments from the individuals described a range of benefits to treatment with lanreotide including its efficacy at reducing disease progression and improving quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific severity thresholds (GH >2.5 μg/L, intractable carcinoid symptoms, WHO grade 1-2 GEP-NETs) not stated in TGA label.