Dabrafenib, capsules, 50 mg and 75 mg Tafinlar - July 2013
ADDENDUM – July 2013
Product: Dabrafenib, capsules, 50 mg and 75 mg Tafinlar®
Sponsor: GlaxoSmithKline Australia Pty Ltd
Date of PBAC Consideration: July 2013
1. Purpose of Application
The re-submission provided a revised pricing proposal following the PBAC’s deferral of a March 2013 submission requesting listing for the treatment of patients with BRAF V600 mutation positive advanced (unresectable stage III) or metastatic (stage IV) melanoma.
2. Background
At the March 2013 meeting, the Committee deferred a major submission in order to:
- be informed of the TGA Delegate’s proposed actions with regards to registration and rationale;
- enable the Department to consider an appropriate arrangement for data collection relating to the clinical utilisation of BRAF testing, the epidemiology of V600 mutations and effectiveness of dabrafenib in mutations other than V600E subtypes; and enable the Department to negotiate a lower price.
3. Registration Status
Dabrafenib was TGA registered on 27 August 2013 for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.
4. PBAC consideration of the evidence
No new trial data were presented.
The TGA Delegate’s overview and TGA Clinical Evaluation Report were provided prior to the PBAC’s July 2013 meeting. The PBAC noted that the Evaluator proposed to limit dabrafenib’s indication to mutation sub-type (i.e. V600E and V600K) but the Delegate did not propose limiting the indication to a particular mutation at position V600. The TGA Delegate proposed the following indication:
‘TAFINLAR is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage IIIC or metastatic (Stage IV) melanoma.’
The PBAC noted that a meeting of PBAC, MSAC, Departmental and NHMRC representatives on data collection was held on 17 June 2013 and that plans for the proposed data collection are under development.
The PBAC noted that compared to the effective price considered at the March 2013 PBAC meeting, a further price reduction was proposed by the sponsor. The resulting new incremental cost per QALY gained was between $45,000 to $75,000, which the PBAC considered to be acceptable. The ICER appeared to be robust to PBAC’s sensitivity analysis.
5. Estimated PBS Usage and Financial Implications
The PBAC noted that it is difficult to estimate the population size before the relevant data are collected on the prevalence of the BRAF mutation sub-types in the Australian population
The PBAC noted that there may be some cost offsets for the use of ipilimumab if 30 – 40 % of patients with melanoma are treated with a BRAF inhibitor as first line treatment.
6. Recommendation and Reasons
The PBAC accepted that the updated ICER is cost effective and recommended the PBS listing of dabrafenib.
In relation to the restriction, the PBAC advised:
- Its March 2013 advice on the restriction remains relevant;
- Grandfathered patients are satisfactorily covered in the Secretariat’s revised restriction for continuing PBS-subsidised treatment;
- PBS-eligible patients must be previously untreated and have a tumour which harbours a BRAF V600 mutation;
- PBS-eligibility should extend to patients severely intolerant of other BRAF inhibitors, should other drugs become PBS-listed;
- The administrative advice (formerly a NOTE) could omit the specific details of the RECIST criteria for disease progression because the criteria for continued treatment states that the patient must have stable or responding disease; and
- The financial risk of use of dabrafenib beyond progression is dealt with by the proposal for a cap in a risk-sharing arrangement.
The PBAC noted the sponsor’s request for a special pricing arrangement and that the proposed price had not been finalised.
The PBAC considered that the sponsor needs to contribute to the cost of the proposed post market data collection, and also needs to provide updated overall survival data to the PBAC, when it is available, from the BREAK-3 randomised trial.
The PBAC noted that MSAC has supported the MBS listing of the co-dependent BRAF mutation test and was scheduled to consider providing advice to the Minister to this effect at its August 2013 meeting.
The PBAC considered that vemurafenib and dabrafenib are therapeutically interchangeable. It foreshadowed that, if a resubmission is lodged for vemurafenib, a cost-minimisation approach would be appropriate.
Outcome:
Recommended.
Recommended listing:
|
Name, Restriction, Manner of administration and form |
Max. Qty |
No. of Rpts |
Dispensed Price for Max. Qty | Proprietary Name | Manufacturer |
|---|---|---|---|---|---|
| DABRAFENIB | |||||
| Capsule 50 mg | 120 | 3 | $To be finalised | Tafinlar | GK |
| Capsule 75 mg | 120 | 3 | $To be finalised | Tafinlar | GK |
|
Indication: Severity |
Unresectable Stage III or Stage IV |
||||||
|---|---|---|---|---|---|---|---|
|
Indication: Condition |
Malignant melanoma |
||||||
|
Treatment phase:
|
Initial treatment
|
||||||
|
Restriction:
|
Authority Required TO BE FINALISED |
||||||
|
Name, Restriction, Manner of administration and form |
Max. Qty |
No. of Rpts |
Dispensed Price for Max. Qty | Proprietary Name | Manufacturer |
|---|---|---|---|---|---|
| DABRAFENIB | |||||
| Capsule 50 mg | 120 | 3 | $To be finalised | Tafinlar | GK |
| Capsule 75 mg | 120 | 3 | $To be finalised | Tafinlar | GK |
|
Indication: Severity |
Unresectable Stage III or Stage IV |
|---|---|
|
Indication: Condition |
Malignant melanoma |
|
Treatment phase: |
Continuing treatment
|
|
Restriction: |
Authority Required TO BE FINALISED |
10.Context for Decision
The PBAC helps decide whether and, if so, how medicines should be subsidised in Australia. It considers submissions in this context. A PBAC decision not to recommend listing or not to recommend changing a listing does not represent a final PBAC view about the merits of the medicine. A company can resubmit to the PBAC or seek independent review of the PBAC decision.
11. Sponsor’s Comment
GlaxoSmithKline welcomes the PBAC recommendation and will work with the Government
to ensure listing of dabrafenib for the treatment of patients with V600 mutation positive
unresectable Stage III or Stage IV malignant melanoma in a timely manner.
