ImatinibARX-IMATINIB
Listing of imatinib 600 mg tablets under the same circumstances as existing PBS-listed imatinib 100 mg and 400 mg tablets for multiple indications including chronic myeloid leukaemia, Philadelphia chromosome-positive acute lymphoblastic leukaemia, and other haematologic and solid malignancies.
Decisions on record
- Meeting Nov 2021 Recommended Chronic myeloid leukaemia; Philadelphia chromosome positive acute lymphoblastic leukaemia; Myelodysplastic/myeloproliferative disorder; Aggressive systemic mastocytosis; Chronic eosinophilic leukaemia; Hypereosinophilic syndrome; Dermatofibrosarcoma protuberans; Gastrointestinal stromal tumour
- Meeting Mar 2015 Not recommended Gastrointestinal stromal tumor
- Meeting Nov 2012 Recommended Gastrointestinal cancer
- Meeting Mar 2012 Not recommended Anti-cancer drug
- Meeting Mar 2011 Recommended Anti-cancer drug
- Meeting Jul 2010 Recommended Anti-cancer drug
- Meeting Jul 2010 Not recommended Anti-cancer drug
- Meeting Nov 2009 Not recommended Anti-cancer drug
1 earlier decision
- Jul 2008 Recommended Metastatic or unresectable malignant gastrointestinal stromal tumour (GIST) no PSD
Access path
- TGA registered · ARX-IMATINIB
TGA label narrower than the PBS population
- Nov 2009Not recommended
uncertain clinical benefit, uncertain cost-effectiveness ratio, no statistically significant overall survival benefit…
- Jul 2010Not recommended
uncertain clinical benefit (insufficient evidence that adjuvant therapy prevents or delays disease recurrence, short…
- Jul 2010Not recommended
uncertain clinical benefit, unacceptably high and uncertain cost-effectiveness ratio, insufficient evidence to…
- ↻ resubmittedMar 2011Recommended
ICER dropped $75,000 → $45,000 (-40%)
- Mar 2012Not recommended
uncertainty regarding the magnitude of the survival benefit, unacceptably high cost-effectiveness ratio, extensive…
- Mar 2012Not recommended
uncertainty regarding the magnitude of the survival benefit, unacceptably high cost-effectiveness ratio, extensive…
- ↻ resubmittedNov 2012Recommended · restricted
ICER dropped $200,000 → $75,000 (-62%)
- Mar 2015Not recommended
No established benefit for adherence and wastage over currently available pack sizes; magnitude of benefit not…
- ↻ resubmittedJul 2018Recommended · restricted
Listing: Not applicable → Authority Required
- Nov 2021Recommended
Evidence: Other → Cost-minimisation
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of imatinib (Imatab) 600 mg tablets on a cost- minimisation basis to PBS listed imatinib 100 mg and 400 mg tablets.PSD · Nov 2021
6.2 The PBAC recommended the listing under the same circumstances as the imatinib 100 mg and 400 mg listings that allow for a daily dose of 600 mg, with the exception of not allowing prescribers to request an increase to the maximum quantity, as this would result in patients receiving a supply greater than the maximum daily dose.PSD · Nov 2021
5.7 The submission presented a cost-minimisation analysis of imatinib 600 mg compared with imatinib 100 mg and 400 mg.PSD · Nov 2021
5.8 As a Committee Secretariat submission, the cost-minimisation analysis was not independently evaluated.PSD · Nov 2021
5.5 The submission did not anticipate any alterations to the current clinical treatment algorithm; other than to offer more flexible dosing through the PBS and reduce the pill burden for patients who have been prescribed a dose of 600 mg per day. The PBAC considered this to be reasonable as the introduction of a new strength was not expected to change the recommended dose for any of the indications.PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC recommended listing imatinib 600 mg on a cost-minimisation basis to the 100 mg and 400 mg at a 1:1 unit equivalence (i.e. the same AEMP per mg). PBAC · 2021
Decision context
PopulationPatients with chronic myeloid leukaemia, Philadelphia chromosome-positive acute lymphoblastic leukaemia, myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic leukaemia, dermatofibrosarcoma protuberans, and gastrointestinal stromal tumours requiring imatinib therapy at doses up to 600 mg daily.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended | imatinib 100 mg and 400 mg tablets | — | Cost-minimisation · Cost-minimisation |
| Jul 2018 | Recommended · restricted | — | — | Other |
| Mar 2015 | Not recommended | — | — | Other |
| Nov 2012 | Recommended · restricted | imatinib treatment for 12 months | $45k–75k | RCT · RFS |
| Mar 2012 | Not recommended | imatinib treatment for 12 months | $45k–75k | RCT · RFS, OS |
| Mar 2012 | Not recommended | imatinib treatment for 12 months | $15k–200k | RCT · RFS |
| Mar 2011 | Recommended | placebo | $15k–45k | RCT, Other (published results from a randomised trial) · Other (response and survival outcomes) |
| Jul 2010 | Not recommended | placebo | $45k–75k | RCT · recurrence-free survival |
| Jul 2010 | Not recommended | placebo | $45k–75k | RCT · RFS |
| Nov 2009 | Not recommended | placebo (watchful waiting) | $45k–75k | RCT · RFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC covers multiple indications but omits adjuvant GIST treatment and treatment failure criteria specified in TGA label.