SonidegibODOMZO
Treatment of metastatic or locally advanced basal cell carcinoma (BCC) in patients inappropriate for surgery and curative radiotherapy.
Decisions on record
- Meeting Jul 2023 Noted Metastatic or locally advanced basal cell carcinoma (BCC)
- Meeting Nov 2017 Recommended Basal cell carcinoma (BCC)
Access path
- TGA registered · ODOMZO
TGA label equal than the PBS population
- Nov 2017Recommended · restricted
vs vismodegib
- Jul 2023Noted
Evidence: Single-arm → Cost-minimisation
- PBS listing · Restricted
From the public summary
5.1 The PBAC advised that a continued Risk Sharing Arrangement (RSA) was required for sonidegib (Odomzo®) and vismodegib (Erivedge®) for the treatment of metastatic or locally advanced BCC. 4PSD · Jul 2023
5.2 In providing this advice, the PBAC noted that the current BCC market was small but not yet stable and reiterated its previous concerns from its consideration of Tranche 2 of the Review of Authority Required listings, regarding the risk of use outside the current PBS restricted population, the comparatively high cost of these medicines, and the financial implications to government.PSD · Jul 2023
6.30 The submission presented a cost-minimisation analysis based on the claim that sonidegib was non-inferior to vismodegib in terms of both effectiveness and safety.PSD · Nov 2017
The cost-minimisation analysis presented in the submission was based on the published price for vismodegib.PSD · Nov 2017
4.4 The submission considered it is unlikely that sonidegib and vismodegib would be used in patients outside the PBS indication. The submission argued that patients are required to satisfy multiple measures of disease activity to qualify for initial treatment with sonidegib and vismodegib as per the Authority Required listing and the submission claimed that the risk of use outside the reimbursed restriction is therefore low.PSD · Jul 2023
6.42 The PBAC advised that sonidegib should be included in the existing RSA agreement for vismodegib as the two medicines treat the same patient population.PSD · Nov 2017
For more detail on PBAC’s view, see section 7 PBAC outcome 18PSD · Nov 2017
Cost-effectiveness
Cost-minimisation basis only; no new ICER calculated in this submission (Category 3 submission regarding Risk Sharing Arrangement and pricing only).
The cost-minimisation analysis presented in the submission was based on the published price for vismodegib. PSD · 2017
Decision context
PopulationPatients with metastatic or locally advanced basal cell carcinoma who are inappropriate for surgery and curative radiotherapy due to the type, size, location, depth of penetration of the lesions and extent of the disease.
Risk sharingContinued Risk Sharing Arrangement (RSA) with subsidisation caps required. PBAC advised a one-off increase of 10% applied to the most recent Deed Year cap would be reasonable, maintaining the shared cap arrangement with vismodegib.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Noted | vismodegib | — | Cost-minimisation |
| Nov 2017 | Recommended · restricted | vismodegib | — | Single-arm · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| BOLT | Ph 2 | 230 | Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Ad… | completed |
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC indication restates TGA label with additional clinical detail about reasons for inappropriateness; no substantive population restriction added.