CrisaboroleStaquis
Mild to moderate atopic dermatitis in patients aged at least 2 years who have failed to achieve satisfactory disease control with, are contraindicated or intolerant to topical corticosteroids.
Decisions on record
- Meeting Nov 2020 Not recommended Crisaborole is indicated for the treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.
- Meeting Nov 2018 Not recommended Atopic dermatitis
Access path
- TGA registered · Staquis
TGA label narrower than the PBS population
- Nov 2018Not recommended
inconsistent definition of target population, inadequate justification of proposed quantity and repeats, proposed…
- Nov 2020Not recommended
Listing: Restricted → Authority Required
From the public summary
The PBAC did not recommend crisaborole for mild to moderate atopic dermatitis in patients who have failed to achieve satisfactory disease control with, are contraindicated to, or intolerant to topical corticosteroids (TCS). The PBAC considered TCS are effective in patients with mild to moderate disease when used appropriately, 46PSD · Nov 2020
The requested indication for a subset of patients who are failing, are intolerant or contraindicated to TCS is narrower than the TGA indication and clinical evidence that included a broader atopic dermatitis population. The PBAC noted that patients frequently do not receive an adequate level of standard care, including adequate use of TCS, despite adverse events associated with TCS being very rare.PSD · Nov 2020
The resubmission presented a cost-minimisation analysis for the comparison versus pimecrolimus for the face and eyelids, and a cost-effectiveness analysis versus standard management for the rest of the body. A weighted price for crisaborole was calculated based on an estimated distribution of use between the two areas of the body.PSD · Nov 2020
Cost-minimisation analysis versus pimecrolimus The table below presents the results of the cost-minimisation analysis. The approach used in the resubmission was unchanged from the November 2018 submission, with an additional analysis for the 30 g formulation of crisaborole.PSD · Nov 2020
The PBAC previously considered that overall the claim of superior effectiveness compared with standard management was not adequately supported by the data and noted that no safety data were provided comparing crisaborole with standard management but that the vehicle ointment may be a reasonable proxy (paragraph 7.6, crisaborole, PSD, November 2018 PBAC meeting).PSD · Nov 2020
The resubmission described crisaborole as superior in terms of efficacy and inferior in terms of safety to standard management. The ESC considered that the additional data presented in the resubmission did not substantially change the evidence base due to potential differences between the study population and the PBS population.PSD · Nov 2020
The PBAC noted and welcomed the input from individuals (3), health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the substantial impact on quality of life, physical and mental health outcomes associated with atopic dermatitis and the financial burden of managing the disease.PSD · Nov 2020
In November 2018, the PBAC agreed with the sponsor (as noted in the pre-PBAC response) that a risk-sharing agreement would be required to address the likelihood of leakage outside the restriction (paragraph 7.11, crisaborole, Public Summary Document, November 2018 PBAC meeting).PSD · Nov 2020
Cost-effectiveness
Cost-minimisation analysis compared to pimecrolimus; cost-effectiveness analysis compared to standard management. Numeric ICER values not stated in the document.
The ESC considered that there were unresolved discrepancies in the circumstances of use of crisaborole between the requested restriction, clinical evidence, economic evaluation and financial estimates. PSD · 2020
Decision context
PopulationPatients aged ≥2 years with mild to moderate atopic dermatitis (with erythematous patches and induration/papulation) who have failed maximum tolerated doses of topical corticosteroids (including intermittent use), or are intolerant or contraindicated to topical corticosteroids.
Risk sharingRSA mentioned as potentially required to address likelihood of leakage outside the restriction. Sponsor stated willingness to consider an RSA based on estimates of use, but detailed estimates were not provided.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2020 | Not recommended | pimecrolimus (face and eyelids) and standard management (rest of body) | — | RCT · ISGA |
| Nov 2018 | Not recommended | pimecrolimus (face and eyelids) and standard management (rest of body) | — | RCT · Efficacy and safety in atopic dermatitis |
Consumer voice
Consumer input described the substantial impact of atopic dermatitis on quality of life and mental health, along with the financial burden of managing the disease. Comments noted that while some patients can access crisaborole, others cannot afford it, and highlighted crisaborole's benefits for long-term use and application to sensitive skin areas.
The comments described the substantial impact on quality of life, physical and mental health outcomes associated with atopic dermatitis and the financial burden of managing the disease. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed, are intolerant, or contraindicated to topical corticosteroids; TGA label has no such requirement.