Pasireotide
Treatment of acromegaly in patients inadequately controlled with either octreotide LAR 30mg or lanreotide autogel 120mg.
Decision on record
- Meeting Nov 2015 Recommended Inadequately controlled acromegaly
Access path
- Nov 2015Recommended · restricted
vs octreotide LAR 30mg or lanreotide ATG 120mg
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of pasireotide as second-line therapy for the treatment of patients with acromegaly, on the basis that it should be available only under special arrangements under Section 100 (Highly Specialised Drugs Program).PSD · Nov 2015
In making this recommendation, the PBAC recommended that the price be reduced to offset the cost associated with treating hyperglycaemia and diabetes attributable to treatment with pasireotide.PSD · Nov 2015
6.21 The submission presented a cost-minimisation analysis, despite the claim of superiority in efficacy and inferior safety and a proposed place in therapy after failure of treatment with the comparators, due to difficulties in quantifying the benefits of pasireotide in terms of quality-adjusted life years (QALYs).PSD · Nov 2015
6.22 The equi-effective doses were assumed to be the doses used in Trial C2402: pasireotide LAR 40mg or 60mg every 28 days of ongoing therapy; and either octreotide LAR 30mg or lanreotide ATG 120mg every 28 days of ongoing therapy.PSD · Nov 2015
6.18 The submission described pasireotide LAR as superior in terms of comparative effectiveness and inferior in terms of comparative safety over the continued use of octreotide LAR or lanreotide ATG for the treatment of patients with inadequately controlled acromegaly. This claim may be adequately supported in terms of biochemical efficacy, and is adequately supported in terms of safety.PSD · Nov 2015
6.19 The PBAC considered that the claim of superior comparative effectiveness was reasonable.PSD · Nov 2015
6.29 The sponsor requested a special pricing arrangement where the published price for pasireotide LAR is higher than the effective price charged to Government. To implement this price difference, the sponsor acknowledged that a Deed of Agreement would be required.PSD · Nov 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. ESC considered cost-minimisation analysis may not be appropriate given superior efficacy and greater toxicity.
The ESC considered that the superior biochemical efficacy and greater toxicity of pasireotide than the comparators suggest that this is not an appropriate basis to determine an equi-effective dose and that a cost-minimisation analysis may not be appropriate here. PSD · 2015
Decision context
PopulationAdult patients with acromegaly inadequately controlled on maximum doses of octreotide LAR 30mg or lanreotide ATG 120mg, with mean growth hormone level greater than 2.5 micrograms per litre and IGF-1 >1.3 x upper limit of normal.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended · restricted | octreotide LAR 30mg or lanreotide ATG 120mg | — | RCT · Biochemical control |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| C2402 (PAOLA) | Ph 3 | 198 | Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalizat… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to inadequate control on maximum doses of specific somatostatin analogues with defined biochemical thresholds; TGA allows broader patient eligibility.