DasatinibDasatinib-Teva
Newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in combination with chemotherapy or corticosteroids for induction and consolidation therapy.
Decisions on record
- Meeting Mar 2019 Recommended Acute lymphoblastic leukaemia (ALL)
- Meeting Jul 2016 Recommended Chronic myeloid leukaemia
- Meeting Jul 2014 Not recommended 20 mg, 50 mg, 70 mg,100 mg Sprycel® Bristol Myers Squibb Australia Pty Ltd Change to listing (Minor submission) Chronic myeloid leukaemia The submission sought provision for second and subsequent dasatinib Authority required applications to be made via telephone (as opposed to current written-only
- Meeting Jul 2011 Recommended Chronic myeloid leukaemia
- Meeting Mar 2009 Recommended Anti-cancer drug no PSD
- Meeting Jul 2008 Recommended Chronic myeloid leukaemia (CML) no PSD
- Meeting Jul 2008 Deferred Chronic myeloid leukaemia (CML) Acute lymphoblastic leukaemia (ALL) no PSD
- Meeting Jul 2007 Recommended Acute lymphoblastic leukaemia
1 earlier decision
- Mar 2007 Not recommended Anti cancer drug
Access path
- TGA registered · Dasatinib-Teva
TGA label narrower than the PBS population
- Mar 2007Recommended · restricted
vs imatinib
- Mar 2007Recommended
- Mar 2007Recommended · restricted
- Mar 2007Recommended
- Jul 2007Recommended · restricted
Comparator changed: imatinib → imatinib and salvage chemotherapy
- Jul 2007Recommended · restricted
Comparator changed: imatinib → imatinib and salvage chemotherapy
- Jul 2011Recommended · restricted
Comparator changed: salvage chemotherapy and imatinib → imatinib 400 mg
- Jul 2014Not recommended
written-only Authority approval arrangements are not a barrier to prescribing dasatinib; drug utilisation data on…
- ↻ resubmittedJul 2016Recommended · restricted
Evidence: Cost-minimisation → Registry
- Mar 2019Recommended
Evidence: Registry → Single-arm
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended extending the existing listing of dasatinib for the condition of Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) to include the treatment of patients who are newly diagnosed. The PBAC’s recommendation for listing was based on, among other matters, its assessment, as described above, that the cost-effectiveness of dasatinib in this indication would be acceptable if it were cost-minimised against imatinib.PSD · Mar 2019
6.2 The PBAC considered the claim that dasatinib in combination with chemotherapy or corticosteroids is comparable in both efficacy and safety to imatinib in combination with chemotherapy or corticosteroids for the first-line treatment of patients with Ph+ ALL to be reasonable although based on limited clinical evidence. The PBAC considered dasatinib may be a better treatment option for some patients given its penetration into the central nervous system.PSD · Mar 2019
5.6 Based on a claim of comparable efficacy and safety to imatinib, the submission presented a cost-minimisation analysis (CMA). The key assumptions and components of the CMA are presented in Table 2. 6PSD · Mar 2019
Therapeutic claim: Dasatinib in combination with chemotherapy and imatinib combined with chemotherapy are safety assumed to have comparable safety.PSD · Mar 2019
5.5 The submission claimed it is reasonable to conclude that dasatinib in combination with chemotherapy or corticosteroids is comparable in both efficacy and safety to imatinib in combination with chemotherapy or corticosteroids in the first-line setting for patients with Ph+ ALL. The PBAC noted it had previously considered the evidence supported this claim (see Table 1).PSD · Mar 2019
5.3 Four Phase II studies were provided in the TGA registration dossier as the pivotal clinical data supporting the indication for patients with newly diagnosed Ph+ ALL.PSD · Mar 2019
These studies collectively represent 247 adult patients treated with dasatinib as part of their first-line treatment. The minor submission does not present any clinical data, noting the PBAC has previously acknowledged the available information supports the use of dasatinib in the first-line setting. The TGA Clinical Evaluation Report (CER) was provided to support dasatinib’s place in clinical therapy. 5PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as equivalent efficacy and safety assumed.
Based on a claim of comparable efficacy and safety to imatinib, the submission presented a cost-minimisation analysis (CMA). PSD · 2019
Decision context
PopulationAdults aged 18 years and over with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia, treated with dasatinib in combination with chemotherapy or corticosteroids for induction and consolidation therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended | imatinib | — | Single-arm · Other |
| Jul 2016 | Recommended · restricted | imatinib | — | Registry · Cost-minimisation |
| Jul 2014 | Not recommended | imatinib | — | Cost-minimisation |
| Jul 2011 | Recommended · restricted | imatinib 400 mg | — | RCT · CCyR |
| Jul 2007 | Recommended · restricted | imatinib and salvage chemotherapy | $45k–105k | RCT · OS | PFS |
| Jul 2007 | Recommended · restricted | salvage chemotherapy and imatinib | $15k–105k | Single-arm · OS |
| Mar 2007 | Recommended · restricted | imatinib | — | RCT | Single-arm · OS | PFS | DFS | ORR | QoL | Surrogate |
| Mar 2007 | Recommended | imatinib | — | RCT | Single-arm · Major Haematological Response (MaHR), Complete Haematological Response (CHR), Major Cytogenetic Response (MCyR), Complete Cytogenetic Response (CCyR) |
| Mar 2007 | Recommended · restricted | imatinib mesylate | — | RCT · MCyR |
| Mar 2007 | Recommended | imatinib | — | Single-arm |
Consumer voice
Three health care professionals and the Leukaemia Foundation supported listing dasatinib for newly diagnosed Ph+ALL, citing its ability to penetrate the central nervous system, better tolerability compared to imatinib, and alignment with current treatment guidelines.
The health care professionals were supportive of listing dasatinib for newly diagnosed Ph+ALL and considered it a better treatment option for most patients due to its ability to penetrate the central nervous system and better tolerability profile compared to imatinib. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to newly diagnosed Ph+ ALL first-line with chemotherapy/corticosteroids; TGA label also includes resistant/intolerant populations and CML.