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Coal Tar Prepared

Recommended DermatologyUnrestrictedNot applicable line

Treatment of psoriasis. Scytera® Foam provides coal tar in a foam formulation designed to improve patient adherence through easier application and cosmetic acceptability.

2
Submissions
1 resub
2005–14
On the record
ICER range
Not modelled
Cost basis

Decision on record

1 decision
  • Meeting Nov 2014 Recommended foam aerosol, 2% (20 mg/g), 100 g, Scytera® Foam Dr Reddy’s Laboratories Australia Pty Ltd New Listing (Minor submission) Psoriasis Unrestricted benefit listing.

Access path

2 submissions · public record
  1. Jul 2005
    Recommended

    vs extemporaneous coal tar preparations

  2. Nov 2014
    Recommended

    Comparator changed: extemporaneous coal tar preparations → Exorex™ (coal tar prepared 1%…

  3. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended the listing of coal tar prepared 2% foam as an unrestricted benefit for the treatment of psoriasis based on the equi-effectiveness of 1 g of Scytera® to 1 mL of Exorex™.PSD · Nov 2014
6.2 The PBAC recommended that the Safety Net 20 Day Rule should apply for Scytera®.PSD · Nov 2014
Clinical claim
5.7 The submission claimed that Scytera® foam will provide patients with the clinical benefits of prepared coal tar (in a demonstrated effective and tolerable strength) in a patient-preferred formulation (foam) which is likely to improve patient adherence to therapy and resultant effectiveness. PricingPSD · Nov 2014
5.8 Scytera® (prepared coal tar 2% w/w) foam may be considered therapeutically equivalent to the comparator Exorex™ (prepared coal tar 1% w/w) lotion.PSD · Nov 2014

Cost-effectiveness

Not modelled; this is a minor submission (formulation change/cost-minimisation). No economic evaluation was conducted.

The PBAC recommended the listing of coal tar prepared 2% foam as an unrestricted benefit for the treatment of psoriasis based on the equi-effectiveness of 1 g of Scytera® to 1 mL of Exorex™. PBAC · 2014
Surrogate endpointCost-effectiveness accepted ×2

Decision context

PopulationPatients with psoriasis requiring topical coal tar therapy.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Nov 2014 Recommended Exorex™ (coal tar prepared 1% lotion) Single-arm · Other
Jul 2005 Recommended extemporaneous coal tar preparations RCT · Psoriasis severity (Total Sign Score / Psoriasis Severity Index)

Similar precedents

By decision profile

Regulatory · TGA

Label equal than PBS population — Both indicate treatment of psoriasis patients; PBAC adds formulation detail and adherence rationale but does not restrict the patient population.