MercaptopurineALLMERCAP
Recommended HaematologyUnrestricted
Treatment of acute lymphoblastic leukaemia in paediatric patients when the tablet form is unsuitable.
1
Submissions
2014–14
On the record
—
ICER range
Not modelled
Cost basis
Decision on record
- Meeting Nov 2014 Recommended oral suspension 20 mg/mL, 100 mL Allmercap® Link Healthcare Pty Ltd New listing (Minor submission) Acute lymphoblastic leukaemia Authority Required listing for the treatment of acute lymphoblastic leukaemia in paediatric patients when the tablet form is unsuitable.
Access path
- TGA registered · ALLMERCAP
TGA label narrower than the PBS population
- Nov 2014Recommended
vs mercaptopurine 50 mg tablets
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended listing mercaptopurine oral suspension as an unrestricted benefit on the basis of a clinical need existing for this particular dose form.PSD · Nov 2014
7.2 The PBAC considered that the level of clinical evidence presented in the minor submission to be reasonable in the context of a listing for which the likely volume and proportion of use is expected to be small. The PBAC noted that the submission’s main focus was to justify the clinical need for an oral dose form suitable for paediatric patients. The PBAC accepted the justification provided.PSD · Nov 2014
Economic analysis
6.7 A cost-analysis was presented in the submission as part of the estimates of the netPSD · Nov 2014
Clinical claim
6.6 The submission claimed that the oral suspension and tablets have been shown to be bioequivalent for pharmacokinetic parameter of area under curve (AUC), and so can be expected to behave similarly in therapeutic use. The submission further noted that the liquid formulation is absorbed more rapidly than the tablet, but claimed that this is unlikely to be of any clinical significance.PSD · Nov 2014
For more detail on PBAC’s view, see section 7 “PBAC outcome”.PSD · Nov 2014
Cost-effectiveness
Cost-analysis presented for financial implications only; no ICER calculated (minor submission).
Cost-effectiveness accepted
Decision context
PopulationPaediatric patients with acute lymphoblastic leukaemia for whom the solid dose form of mercaptopurine is unsuitable.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended | mercaptopurine 50 mg tablets | — | Single-arm · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to paediatric patients where tablet form is unsuitable, narrowing the broad TGA label.