ApremilastOtezla
Severe chronic plaque psoriasis in patients who have failed treatment with, or who are contraindicated or intolerant to, methotrexate.
Decisions on record
- Meeting Nov 2023 Recommended Severe chronic plaque psoriasis
- Meeting Mar 2023 Not recommended Psoriatic arthritis (PsA) in patients who have failed conventional synthetic disease modifying anti-rheumatic drugs or are ineligible for biologics
- Meeting May 2022 Recommended Severe chronic plaque psoriasis no PSD
- Meeting Mar 2022 Recommended Severe chronic plaque psoriasis
- Meeting Jul 2020 Recommended Plaque psoriasis
- Meeting Mar 2018 Not recommended Indicated for the treatment of: signs and symptoms of active psoriatic arthritis in adult patients adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
- Meeting Nov 2017 Deferred Moderate to severe plaque psoriasis
- Meeting Mar 2017 Not recommended Apremilast is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients; and the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
4 earlier decisions
- Nov 2016 Not recommended Apremilast is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients; and the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
- Nov 2015 Not recommended Apremilast is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients, and the treatment of adult
- Mar 2015 Not recommended Moderate to severe plaque psoriasis
- Mar 2015 Not recommended Psoriatic arthritis
Access path
- TGA registered · Otezla
TGA label narrower than the PBS population
- Mar 2015Not recommended
uncertain comparative effectiveness versus cyclosporin (non-inferiority margin unclear, indirect comparison with wide…
- Mar 2015Not recommended
Non-inferiority versus leflunomide not convincingly established; clinical claim of superior safety not adequately…
- Nov 2015Not recommended
Inferior clinical effectiveness compared to adalimumab (bDMARDs), unproven benefit in the 'eligible but unwilling'…
- Nov 2016Not recommended
Comparator changed: adalimumab → cyclosporin
- Mar 2017Not recommended
evidence did not support claims of superior comparative efficacy or safety versus cyclosporin; non-randomised…
- Nov 2017Deferred
Evidence: Single-arm → Meta-analysis
- Mar 2018Not recommended
Evidence: Meta-analysis → Cost-minimisation
- ↻ resubmittedJul 2020Recommended · restricted
Evidence: Cost-minimisation → Meta-analysis
- Mar 2022Recommended
Evidence: Meta-analysis → Other
- Mar 2023Not recommended
Evidence: Other → RCT
- ↻ resubmittedNov 2023Recommended
Evidence: RCT → Other
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the following changes to the treatment criteria of apremilast (Otezla®) for the treatment of severe chronic plaque psoriasis (CPP) in patients who have failed treatment with, or who are contraindicated or intolerant, to methotrexate:PSD · Nov 2023
• To allow rheumatologists and general physicians to initiate treatment (in addition to dermatologists).PSD · Nov 2023
The submission presented a cost-utility analysis based on the ACTIVE trial. This was implemented using a Markov model with three health states (apremilast, BSC, and dead). This is consistent with the clinical claim of superior effectiveness.PSD · Mar 2023
Table 14 summarises the model structure, key inputs, and rationale. Although the economic models considered in March 2015 and November 2015 were based on different clinical positioning (and therefore different comparators, see Table 2), a comparison to the economic model in the resubmission is presented in Table 14. 20PSD · Mar 2023
• In terms of safety, apremilast has inferior short-term safety compared to placebo plus BSC d Source: Table 1-1, p4 of the submission; paragraphs 2.1 & 3.3, apremilast, Public Summary Document (PSD), November 2015 PBAC meeting; apremilast submission for the November 2015 PBAC meeting.PSD · Mar 2023
The resubmission described apremilast as superior in terms of effectiveness compared to placebo based on the outcomes of ACR20, ACR50 and HAQ-DI. The ESC considered this claim was adequately supported. Apremilast demonstrated superior efficacy in terms of the primary outcome (ACR20) in all included trials.PSD · Mar 2023
4.2 The PBAC noted and welcomed the input from health care professionals (10) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from health care professionals described a range of benefits of treatment with apremilast for CPP, including its effectiveness in individuals where other treatments have failed or are contraindicated, reduction in the need for prescribing biological disease modifying anti-rheumatic drugs …PSD · Nov 2023
Rationale for request Workforce shortages and rural and remote challenges faced by patients with psoriasis.PSD · Nov 2023
Cost-effectiveness
This is a Category 3 submission requesting changes to treatment criteria only (expansion of eligible prescriber types); no new economic evaluation was undertaken.
The PBAC noted that, given the treatment criteria changes to Otezla are not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2022
Decision context
PopulationAdults aged 18 years or older with severe chronic plaque psoriasis who have failed treatment with, or are contraindicated or intolerant to, methotrexate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | — | — | Other |
| Mar 2023 | Not recommended | placebo plus best supportive care | — | RCT |
| Mar 2022 | Recommended | — | — | Other |
| Jul 2020 | Recommended · restricted | cyclosporin | — | Meta-analysis · PASI-75 |
| Mar 2018 | Not recommended | cyclosporin | — | Cost-minimisation · Cost-minimisation |
| Nov 2017 | Deferred | cyclosporin | — | Meta-analysis · PASI-75 |
| Mar 2017 | Not recommended | cyclosporin | — | Single-arm · PASI 75 |
| Nov 2016 | Not recommended | cyclosporin | $15k–45k | RCT · PASI 75 |
| Nov 2015 | Not recommended | adalimumab | — | RCT |
| Mar 2015 | Not recommended | cyclosporin | — | RCT · PASI75 |
| Mar 2015 | Not recommended | leflunomide | — | RCT · ACR20 |
Clinical evidence
Consumer voice
Healthcare professionals and organisations provided input on apremilast for chronic plaque psoriasis, highlighting its effectiveness and safety while noting access barriers due to specialist shortages in rural areas. Consumer organisation Creaky Joints Australia supported expanded prescriber access but raised concerns about adequate training and awareness of side effects.
The comments from health care professionals described a range of benefits of treatment with apremilast for CPP, including its effectiveness in individuals where other treatments have failed or are contraindicated, reduction in the need for prescribing biological disease modifying anti-rheumatic drugs (bDMARDs), and utility in treating both psoriatic arthritis and CPP. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe plaque psoriasis with prior methotrexate failure/intolerance; TGA label includes moderate-to-severe without treatment history requirement.