IsotretinoinAPO-ISOTRETINOIN
Recommended DermatologyRestrictedNot applicable line 💬 consumer voice
Treatment of severe cystic acne that is unresponsive to other therapy, including systemic antibiotics.
2
Submissions
1 resub
2018–19
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Nov 2019 Recommended Severe cystic acne
- Meeting Nov 2018 Recommended Severe cystic acne
- Meeting Mar 2011 Not recommended Severe acne no PSD
- Meeting Nov 2006 Recommended Severe cystic acne no PSD
- Meeting Nov 2006 Recommended Severe cystic acne no PSD
Access path
- TGA registered · APO-ISOTRETINOIN
TGA label equal than the PBS population
- Nov 2018Recommended
vs isotretinoin 10 mg capsule
- Nov 2019Recommended · restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of isotretinoin, in the form of 30mg capsule, for the treatment of patients with severe cystic acne. The PBAC considered that the new listing may reduce the pill burden for patients.PSD · Nov 2019
6.2 The PBAC noted the submission requested the price of the 30 mg strength of isotretinoin be based on the '''''''''' ''''''''' '''''' ''''''''''''''''' '''' ''''''' ''''' ''''''' '''''''''''''''''. The PBAC noted that the 40 mg capsule is less costly on a per milligram basis compared with the 20 mg capsule.PSD · Nov 2019
Economic analysis
5.3 The prices for the current 5 mg, 10 mg, 20 mg and 40 mg strengths and the proposed pricing for the 30 mg strength are provided in Table 1. The submission requested the ''''''''''' ''''''''' ''''''' ''''''''''''''''''' '''' '''''' ''''' ''''''' ''''''''''''''''' and noted that the requested price per milligram is lower than the 10 mg capsule.PSD · Nov 2019
Table 1: Oratane (isotretinoin) current and proposed PBS pricing Total milligrams per Price per Oratane capsule strength Capsules per pack AEMP pack milligram 5 mg 60 300 $11.01 $0.0367 10 mg 60 600 $22.02 $0.0367 20 mg 60 1,200 $34.32* $0.0286 30 mg 60 1,800 $''''''''''''' $''''''''''''''' 40 mg 30 1,200 $30.98 $0.0258 Abbreviations: AEMP = approved ex-manufacturer price.PSD · Nov 2019
Cost-effectiveness
Not modelled; this is a minor submission for a new formulation/strength (30 mg capsule) of an already-listed drug. No economic evaluation was performed.
The PBAC considered there would be a small net cost to the PBS because of the listing, due to reduced patient co-payments. PBAC · 2019
Cost-effectiveness accepted
Decision context
PopulationPatients with severe cystic acne unresponsive to conventional therapy, including systemic antibiotics; dose-optimisation population requiring 30 mg daily dose.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | — | — | Cost-minimisation |
| Nov 2018 | Recommended | isotretinoin 10 mg capsule | — | Cost-minimisation · Cost-minimisation |
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 — Both specify severe cystic acne unresponsive to conventional therapy including systemic antibiotics; PBAC adds specific dosing detail but does not restrict the population.