APREMILAST TAB,ORAL

Clinical Criteria Summary

Concomitant therapy with strong CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin), which may cause loss of efficacy of apremilast
Untreated or unstable depression or suicidality, unless a mental health consultant concurs with apremilast treatment

Prescribed and monitored by a VA/VA Community Care rheumatologist or locally-designated expert
Adult (18 years of age or older) with recurrence of 2 or more oral ulcers associated with Behçet's disease

Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy

Concomitant therapy with strong CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin), which may cause loss of efficacy of apremilast.
Untreated or unstable depression or suicidality unless mental health consultation concurs with apremilast treatment.

Prescribed and monitored by a VA/VA Community Care dermatologist or locally-designated expert.
Diagnosis of plaque psoriasis.
Phototherapy is medically inadvisable, not available, not feasible, not tolerated, or not adequate.

Documented mild to moderate disease AND tried and had an inadequate response to ≥ 3 classes of topical therapies (≥ 1 month per class) or intolerance unless medically inadvisable (prior trials not required).
Documented moderate to severe disease, impaired function or quality of life, or involvement of special areas AND 1 conventional immunomodulator and 2 classes of targeted immunomodulators are medically inadvisable (prior trials not required).

Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy.

Treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
FDA-approved for mild to moderate plaque psoriasis (expanded indication December 2021)

Inadequate response to 2 or more topical therapies (e.g., corticosteroids in different potencies, vitamin D analogs such as calcipotriene or calcitriol, calcineurin inhibitors such as tacrolimus or pimecrolimus for sensitive areas, or retinoids such as tazarotene)
Phototherapy is medically inadvisable, not available, not feasible, not tolerated, or not adequate

Initiated with a 5-day upward dosage titration to a maintenance dose of 30 mg orally twice daily starting on Day 6
Slowly up-titrate dosage

Used as monotherapy
Appropriate for patients who prefer to avoid frequent injections and lab monitoring and are willing to accept delayed onset and lower chance of skin clearance
Alternative systemic therapies (methotrexate, cyclosporine, retinoids, targeted biologic agents including TNF inhibitors, IL-12/23 inhibitors, IL-17A inhibitors, IL-17A receptor inhibitor, and IL-23 inhibitors) may be considered for mild to moderate psoriasis recalcitrant to therapies approved for mild–moderate plaque psoriasis including apremilast

Concomitant therapy with strong CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin), which may cause loss of efficacy
Untreated or unstable depression or suicidality, unless a mental health consultant concurs with apremilast treatment

Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist, or locally designated expert
Nonsevere or predominantly oligoarticular peripheral inflammatory disease and a definite or provisional diagnosis of active psoriatic arthritis (note: ineffective for joint erosions and axial disease)
Conventional synthetic immunomodulator (methotrexate, leflunomide or sulfasalazine) is medically inadvisable, not tolerated, or not adequate after 12 weeks
Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable

Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy

Conventional synthetic immunomodulator: Adequate trial requires NO or partial treatment benefit after 12 weeks at doses of 15–25 mg/wk (or lower if limited by toxicity); for inadequate responders, consider switching to subcutaneous methotrexate. For other immunomodulators, require NO or partial treatment benefit after 12 weeks at recommended doses (or lower if limited by toxicity).
TNFI therapy: Prior trial is not required but should be recommended if medically advisable. For TNFI inadequate/nonresponders, consider switching to a second TNFI, another biologic, or tofacitinib rather than apremilast monotherapy.
TNFI may be medically inadvisable due to heart failure, demyelinating disease, multiple sclerosis in first-degree relative, lupus, recurrent infections, serious infections, etc.
Aversity to injections or barriers to in-clinic administration (e.g., travel) should be adjudicated case by case as a reason why a TNFI is medically inadvisable.