Lanreotide AcetateSomatuline Autogel
Extension of listing for acromegaly and functional carcinoid tumour to allow prescription in community settings (previously hospital-only).
Decisions on record
- Meeting Nov 2015 Not recommended Gastroenteropancreatic neuroendocrine tumours
- Meeting Mar 2007 Recommended Peptide analogue used in the treatment of acromegaly and carcinoid syndrome no PSD
Access path
- TGA registered · Somatuline Autogel
TGA label narrower than the PBS population
- Jul 2005Recommended · restricted
vs octreotide acetate (Sandostatin LAR)
- Nov 2017Recommended · restricted
Evidence: Single-arm → Other
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended to extend the current listing for lanreotide acetate 60 mg/0.5 mL, 90 mg/0.5 mL and 120 mg/0.5 mL pre-filled syringes, Somatuline Autogel pre-filled syringe from Section 100 Highly Specialised Drugs program (HSD) to a Section 100 HSD Community Access, Authority Required (STREAMLINED) for patients with acromegaly and functional carcinoid tumour under the conditions noted below.PSD · Nov 2017
6.2 The PBAC recommended that the continuing phase of treatment should be available under Section 100 - Highly Specialised Drugs Program (Community Access), whilst the initial phase of treatment should remain unchanged under Section 100 – Highly Specialised Drugs Program (Public and Private Hospitals).PSD · Nov 2017
Cost-effectiveness
Minor submission with no economic evaluation; cost-minimisation analysis not conducted. Financial impact presented as estimated net savings to PBS/RPBS.
The PBAC accepted that, in view of the orphan status of the requested listing, the evidence presented across a series of indirect comparisons was sufficient to accept listing on a cost-minimisation basis. PBAC · 2005
Decision context
PopulationAdults aged 18 years or older with acromegaly (with persistent elevation of mean growth hormone levels >2.5 micrograms per litre and failure of other therapies) or functional carcinoid tumour (with intractable symptoms including ≥3 episodes per day of diarrhoea and/or flushing despite use of anti-histamines, anti-serotonin agents, and anti-diarrhoea agents).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | — | — | Other |
| Jul 2005 | Recommended · restricted | octreotide acetate (Sandostatin LAR) | — | Single-arm · Surrogate |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to acromegaly with GH >2.5 micrograms/litre and failed prior therapies; excluded GEP-NETs and unspecified carcinoid tumours.