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
6.1 The PBAC recommended the listing of lanreotide (LACREO), for the treatment of acromegaly, functional carcinoid tumour and non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET) on the basis that it should be available only under special arrangements under the Section 100 Highly Specialised Drugs (HSD) Program Community Access under the same circumstances as PBS-listed originator brand Somatuline Autogel®.PSD · Mar 2026
6.2 The PBAC advised the equi-effective doses to be 1 mg LACREO equals 1 mg Somatuline Autogel.PSD · Mar 2026
5.4 The submission presented a cost-minimisation approach of LACREO compared with Somatuline Autogel. The equi-effective doses were estimated as: 5 OFFICIALPSD · Mar 2026
5.5 The requested price was based on the AEMP of Somatuline Autogel, in February 2026.PSD · Mar 2026
5.3 The submission’s request was based on bioequivalence to the originator brand, Somatuline Autogel. The Therapeutic Goods Administration (TGA) provided an approval letter establishing that LACREO is bioequivalent on 19 September 2025.PSD · Mar 2026
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
5.27 The pre-PBAC response provided revised annual caps which adjusted for 90% compliance with lanreotide and the use of 13 packs per patient per year consistent with the July 2017 resubmission. The pre-PBAC response also proposed new annual caps and rebates. The revised annual caps and new annual caps and rebates are presented in Table 3 below. The financial estimates provided in the Pre-PBAC response have not been verified.PSD · 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.
Listed in law
PBS listings commencing 1 Aug 2023 were made by these 4 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 67 of 2023 | 27 Jul 2023 | Repealed | PDF ↗ |
| PB 69 of 2023 | 27 Jul 2023 | Repealed | PDF ↗ |
| PB 77 of 2023 | 27 Jul 2023 | Repealed | PDF ↗ |
| PB 78 of 2023 | 31 Jul 2023 | Repealed | PDF ↗ |