Siliq_Medical_Necessity_Criteria

Coverage Summary

Covered with criteria for plaque psoriasis in adults (≥ 18) when initial or continuation criteria are met (initial: approve for 3 months; continuation: approve for 1 year for patients established on therapy ≥ 3 months); not medically necessary for other uses including Crohn's disease and rheumatoid arthritis. A boxed warning and REMS for risk of suicidal ideation and behavior apply.

Key thresholds

Age≥ 18 years

Prior trial of traditional systemic agent≥ 3 months

Established on therapy for continuation≥ 3 months

Lookback for suicidal ideation/behavior historyNo history within past 5 years (initial therapy)

Initial Therapy Criteria

FDA-Approved Indication: Plaque Psoriasis

Approve when ONE of the following (A or B) is met:

A) Initial Therapy

Patient is ≥ 18 years of age
ii
- Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months, unless intolerant
  Examples include methotrexate, cyclosporine, or acitretin. A 3-month trial of psoralen plus ultraviolet A light (PUVA) also counts. An exception to the requirement for a trial of one traditional systemic agent for psoriasis can be made if the patient has already had a 3-month trial or previous intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR (apremilast tablets/extended-release tablets), or Sotyktu (deucravacitinib tablets). A biosimilar of the requested biologic does not count. A patient who has already tried a biologic for psoriasis, Otezla/Otezla XR, or Sotyktu is not required to 'step back' and try a traditional systemic agent for psoriasis.
- According to the prescriber, the patient has a contraindication to methotrexate

Prior Authorization

Prior authorization required

Prior authorization required; initial approval duration: 3 months.

Approvals are for 3 months for initial therapy per the Initial Therapy criteria.
Prior authorization is recommended for prescription benefit coverage of Siliq.

Documentation Required

Prescriber attestation and specialist involvement

Several prescriber attestation fields are documented "According to the prescriber" including evaluation for suicide risk vs benefits, absence of moderately severe to severe depression, and no history of suicidal ideation or behavior within the past 5 years. The prescriber must also confirm contraindications to methotrexate when applicable and confirm that Siliq is prescribed by or in consultation with a dermatologist.

Prescriber attests that evaluation for risks of suicidal ideation or behavior versus benefits of therapy was performed.
Prescriber attests that the patient does not have moderately severe to severe depression.
Prescriber attests that within the past 5 years the patient does not have a history of suicidal ideation or suicidal behavior.
Prescriber documents contraindication to methotrexate when claiming that pathway.
Prescriber documents that Siliq is prescribed by or in consultation with a dermatologist.

Continuation Therapy Criteria

FDA-Approved Indication: Plaque Psoriasis

B) Patient is Currently Receiving Siliq

Patient has been established on therapy for at least 3 months≥ 3 months
A patient who has received < 3 months of therapy or who is restarting therapy is reviewed under Initial Therapy
According to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy
According to the prescriber, the patient does not have moderately severe to severe depression
According to the prescriber, the patient does not have suicidal ideation or suicidal behavior

Unproven / Exclusions (Not Medically Necessary)

Conditions Not Covered (Not Medically Necessary)

Siliq is considered not medically necessary for ANY other use(s) including but not limited to:

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory conditionNo concurrent biologic or targeted synthetic oral small molecule therapy
Crohn's Disease - Siliq is contraindicated due to worsening disease and lack of efficacy (Phase II study terminated early)Contraindicated
Rheumatoid Arthritis - Efficacy has not been established (Phase II study did not demonstrate improvement)Not established

Applicable Codes

Drug (brand)NDCCovered

No codes listed

Related biologic and oral therapy examples (Appendix)mixed

Adalimumab SC Products	Humira and biosimilars - examples listed in appendix
Cimzia	certolizumab pegol SC injection
Etanercept SC Products	Enbrel and biosimilars
Infliximab IV Products	Remicade and biosimilars
Zymfentra	infliximab-dyyb SC injection
Simponi / Simponi Aria	golimumab SC/IV
Tocilizumab Products	Actemra IV/SC
Kevzara	sarilumab SC injection
Orencia	abatacept IV/SC
Rituximab	Rituxan IV products

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Provider Actions & REMS Requirements

Documentation Required

REMS and limited distribution requirements

Prescribers and pharmacies must be certified in the Siliq REMS program. Patients must sign a patient-prescriber agreement and be counseled to seek care for new or worsening suicidal thoughts or behavior, depression, anxiety, or mood changes. Siliq carries a boxed warning and has a REMS and limited distribution program due to risks of suicidal ideation and behavior.

Documentation Required

Prescriber attestation and specialist involvement

Initial approval requires the medication to be prescribed by or in consultation with a dermatologist and prescriber attestations are required. Attestation checklist:

According to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy.
According to the prescriber, the patient does not have moderately severe to severe depression.

Clinical Evidence & Safety

Evidence sources include the Siliq prescribing information (Valeant; August 2024), the AAD‑NPF joint guidelines (2019) that list Siliq as a monotherapy option for moderate to severe plaque psoriasis, and safety evidence noting a Phase II Crohn's study terminated early for worsening disease and lack of efficacy and a RA Phase II trial that did not demonstrate efficacy.

Background & Definitions

Siliq (brodalumab) is indicated for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It carries a boxed warning and REMS for risks of suicidal ideation and behavior; the REMS requires prescribers and pharmacies to be REMS‑certified, patients to sign a patient‑prescriber agreement, and counseling about seeking care for new or worsening suicidal thoughts, depression, anxiety, or mood changes.

Term	Definition
Traditional systemic agent
Examples include methotrexate, cyclosporine, acitretin; a 3-month trial of PUVA also counts.
Conventional synthetic DMARDs
e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine; permitted in combination with Siliq

Revision History

2025-07-16document_effective_dateLatest

Document effective date 2025-07-16 (policy effective). (Covers Siliq prior authorization and criteria.)

2025-06-04criteria_change

Material change: Exception to trial of a traditional systemic agent added — a 3-month trial or prior intolerance to Otezla/Otezla XR or Sotyktu was added as an acceptable exception to stepping to a traditional systemic agent. (EMPHASIZED: material)

2025-06-04criteria_change