PropranololAPO-PROPRANOLOL
Treatment of proliferating infantile hemangioma requiring systemic therapy, including life-threatening hemangioma, ulcerated hemangioma with pain and/or lack of response to simple wound care measures, and hemangiomas with a risk of permanent scars or disfigurement.
Decisions on record
- Meeting Nov 2015 Not recommended Infantile hemangioma
- Meeting Mar 2015 Recommended Infantile hemangioma
Access path
- TGA registered · APO-PROPRANOLOL
TGA label equal than the PBS population
- Mar 2015Recommended · restricted
vs Auspman propranolol solution and compounded propranolol…
- Nov 2015Not recommended
Proposed price unsubstantiated; premium factor over compounded propranolol liquid unjustified; price significantly…
- Jul 2017Not recommended
unsubstantiated cost consequence method, unacceptably high proposed price, unjustified price advantage over compounded…
From the public summary
6.1 The PBAC rejected the request for a higher price and reaffirmed its recommendation from the March 2015 meeting.PSD · Jul 2017
6.2 The PBAC considered that the resubmission’s cost consequence method used to derive the proposed price was unsubstantiated and resulted in a price that was unacceptably high. The PBAC considered that while the resubmission’s proposed DPMQ is '''''% lower than the DPMQ proposed in the November 2015 submission, the magnitude of the price advantage of resubmission’s proposed DPMQ over the price of compounded propranolol liquid remained significant and was …PSD · Jul 2017
5.4 The minor resubmission presented a cost consequence analysis which compared the cost of treatment with Hemangiol® to the current options for accessing propranolol oral liquid (Auspman propranolol solution and compounded propranolol). The requested price for Hemangiol® is shown in Table 1 below. 3PSD · Jul 2017
5.5 The minor resubmission stated that the proposed DPMQ is a '''''% decrease from the DPMQ proposed in the March 2015 major submission ($'''''''''''').PSD · Jul 2017
6.8 The submission claimed that Hemangiol had demonstrated superior efficacy over placebo, with a satisfactory safety profile.PSD · Mar 2015
For more detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Mar 2015
5.3 The current minor resubmission reiterated the clinical need for a TGA approved propranolol oral liquid. The minor resubmission claimed that the Auspman propranolol liquid was only legally available in WA and emphasised that the limited number of compounding pharmacies in Australia make access for some patients difficult.PSD · Jul 2017
Cost-effectiveness
Cost consequence analysis; no ICER calculated. Economic evaluation focused on pricing comparison rather than cost-effectiveness ratio.
The PBAC considered that Hemangiol should be cost minimised against the currently available Auspman propranolol solution with a modest price premium to be negotiated between the sponsor and the Department in acknowledgement that Hemangiol is a commercially available product which is likely to have benefits for patients in terms of access. PBAC · 2015
Decision context
PopulationInfants with proliferating infantile hemangioma requiring systemic therapy
Why it was knocked back
- unsubstantiated cost consequence method, unacceptably high proposed price, unjustified price advantage over compounded propranolol liquid, inappropriate attribution of costs to quality assurance and risk minimisation measures, adequate access to alternative therapies
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Not recommended | Auspman propranolol solution and compounded propranolol liquid | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Not recommended | Auspman propranolol solution and compounded propranolol liquid | — | Cost-minimisation · Cost-minimisation |
| Mar 2015 | Recommended · restricted | Auspman propranolol solution and compounded propranolol liquid | — | RCT · Complete or near complete remission at week 24; change in haemangioma volume |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC indication explicitly lists all three TGA categories (life-threatening, ulcerated, permanent scar/disfigurement risk) with identical clinical criteria.