CurrentBlue Cross Blue Shield - IowaPolicy 05.02.22

Siliq (brodalumab) — prior authorization and coverage criteria for moderate to severe plaque psoriasis

Defines prior authorization, clinical criteria, and coverage conditions for Siliq (brodalumab) for treatment of moderate to severe plaque psoriasis for Wellmark/Blue Cross and Blue Shield members; affects prescribing dermatologists and pharmacy/medical benefit adjudication.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySiliq (brodalumab) drug policy for plaque psoriasis

Policy CodePolicy 05.02.22

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit chart documentation of BSA, affected areas, prior therapies and clinical rationale as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

3 syringesinitiation qty limit

2 syringes/28dmaintenance qty limit

>=10% BSAseverity threshold

12 monthsTB screening window

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Coverage criteria for Siliq (brodalumab)

Initial Therapy - Moderate to Severe Plaque Psoriasis

Covered when ONE of the following is met (and required documentation provided):

Initial Approval Conditions: Member meets at least one of the following: (a) inadequate response to treatment or intolerable adverse event with Cosentyx and another preferred product (Adalimumab-aacf, Enbrel, Otezla, Otulfi (ustekinumab-aauz), Skyrizi, Tremfya); (b) clinical reason to avoid Enbrel and Adalimumab-aacf AND inadequate response or intolerable adverse event with Cosentyx and another preferred product (Otezla, Otulfi (ustekinumab-aauz), Skyrizi, Tremfya); (c) member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.

Submission of chart notes detailing treatment outcomes, intolerable adverse events, contraindications, or exclusions to preferred products is required where applicable.

Initial Therapy - Disease Severity

Authorization of 12 months may be granted when ANY of the following disease-severity criteria are met:

Severity Criteria: (a) Crucial body areas affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); (b) at least 10% body surface area (BSA) affected; (c) at least 3% BSA affected AND member has either (i) inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin, OR (ii) a clinical reason to avoid methotrexate, cyclosporine, or acitretin (see Appendix B).

Authorization duration stated as 12 months for qualifying members.

Continuation Therapy

Continuation covered when members achieve or maintain positive clinical response as evidenced by ANY of the following:

Continuation Criteria: Reduction in body surface area (BSA) affected from baseline OR improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain).

Authorization of 12 months may be granted for members meeting these criteria.

Safety Requirements

Safety requirements that must be met for any indication:

Safety and Concomitant Use: (1) Documented negative tuberculosis (TB) test (TST or IGRA) within 12 months prior to initiating therapy for members naive to biologic or targeted synthetic drugs; if screening is positive, further evaluation to exclude active disease is required and latent TB must be treated before initiation. (2) The requested medication must not be used concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Do not administer to members with active TB infection.

Do not administer the requested medication to members with active tuberculosis (TB) infection. For biologic‑naïve patients, a documented negative TB screening test (TST or IGRA) within the prior 12 months is required before initiation; if screening is positive, further evaluation to exclude active disease (for example, chest x‑ray) is required and latent TB must be treated prior to starting therapy.

Siliq (brodalumab) is considered not medically necessary for members who do not meet the coverage criteria and safety requirements described above.

Coding, disease metrics, and screening

Procedures and billing codesmixed

No codes listed

inv-08: Body Surface Area (BSA) — >=10% OR >=3% with additional criteria.

BSA threshold — primary>=10% of body surface area (BSA)

BSA threshold — alternate>=3% of BSA PLUS additional criteria (see below)

Additional criteria for >=3% BSAMember must have inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or to methotrexate, cyclosporine, or acitretin, OR have a clinical reason to avoid those pharmacologic treatments (see Appendix B)

Authorization durationAuthorization of 12 months may be granted when disease-severity criteria are met

inv-09: TB screening — Negative TST or IGRA within 12 months for biologic-naïve patients.

Required TB screening

Prior authorization, documentation, and step therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization for moderate to severe plaque psoriasis may be granted when the criteria in the policy are met. Quantity limits apply: Initiation — 3 syringes per first 14 days; Maintenance — 2 syringes per 28 days. Typical authorization duration: 12 months when criteria met.

Prior authorization required for Siliq for covered indications.
Quantity limits: Initiation: 3 syringes per first 14 days; Maintenance: 2 syringes per 28 days.
Authorization duration commonly 12 months when criteria are met.

Step Therapy

Preferred-Product Step Therapy

Policy requires use of two of the plan's preferred products before use of a non-preferred product unless clinical circumstances exclude preferred products, the member is already receiving and benefiting from the non-preferred product, or only one preferred product exists for the indication. Preferred products include Adalimumab-aacf, Enbrel, Entyvio, Cosentyx, Otezla, Otulfi (ustekinumab-aauz), Rinvoq, Skyrizi, Tremfya, Velsipity, and Xeljanz/Xeljanz XR.

Key definitions and indication

inv-16: FDA-Approved Indication — Treatment of moderate to severe plaque psoriasis (PsO) in adult patients who are candidates for systemic therapy or phototherapy.

IndicationTreatment of moderate to severe plaque psoriasis (PsO) in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

PopulationAdults with moderate to severe plaque psoriasis

ContextAligned with product labeling and targeted at patients who are candidates for systemic therapy or phototherapy

inv-17: Disease severity definitions — Crucial body areas and BSA thresholds (>=10% or >=3% with additional criteria).

Crucial body areasHands, feet, face, neck, scalp, genitals/groin, intertriginous areas (affection of these areas qualifies for authorization)

Background on Siliq (brodalumab)

Siliq (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The policy aligns use with product labeling and clinical guidance and requires meeting specified clinical and safety criteria prior to authorization, including TB screening and restrictions on concomitant use with other biologic or targeted synthetic drugs for the same indication.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySiliq (brodalumab) drug policy for plaque psoriasis

Policy CodePolicy 05.02.22

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit chart documentation of BSA, affected areas, prior therapies and clinical rationale as required.

SourceLink

On This Page

Documented negative TB test (TST or IGRA) within 12 months for patients naïve to biologic or targeted synthetic drugs

If TB test positiveFurther evaluation to exclude active disease (e.g., chest x-ray) is required before initiation

Active TBDo not administer the requested medication to members with active TB infection

Latent TBIf latent disease present, TB treatment must be started before initiation of the requested medication

Two preferred products must be tried unless clinical exclusion applies.
Exceptions: clinical exclusion, current positive therapeutic outcome on non-preferred product, or only one preferred product for indication.

Documentation Required

Required Documentation

Submit chart notes or medical records to initiate prior authorization. For initial requests, provide documentation of affected area(s) and body surface area (BSA); prior medications tried and responses, or clinical reasons to avoid those therapies. For continuation requests, provide documentation of decreased BSA and/or improvement in signs and symptoms. When avoidance of preferred products is claimed, submit chart notes detailing intolerable adverse events, contraindications, or other clinical reasons (see Appendix A and Appendix B as applicable). Also include tuberculosis screening results per policy.

Initial requests: chart notes documenting affected area(s) and BSA; records/claims showing prior medications tried and response, or clinical reason to avoid.
Continuation requests: chart notes showing decreased BSA and/or symptom improvement.
When claiming avoidance of preferred products: submit chart notes documenting intolerable adverse events, contraindications, or other clinical reasons (see Appendices A and B).
Include TB screening (TST or IGRA within 12 months) and follow-up testing if positive; do not administer if active TB.

Documentation Required

Clinical Reasons Documentation

When clinical reasons are cited to avoid preferred products, provide detailed chart documentation of the specific reason(s) (e.g., intolerable adverse events, contraindications such as history of demyelinating disorder or congestive heart failure for TNF-inhibitors, or conditions listed in Appendix B for systemic agents). Primary failure to respond to a TNF-inhibitor alone is not sufficient to justify avoidance of other TNF-inhibitors.

Document specific intolerable adverse events or contraindications when requesting non-preferred product.
Appendix A lists clinical reasons to avoid TNF-inhibitors (e.g., demyelinating disorder, CHF, hepatitis B, autoantibody formation/lupus-like syndrome, risk of lymphoma).
Appendix B lists examples of clinical reasons to avoid methotrexate/cyclosporine/acitretin (e.g., liver disease, breastfeeding, pregnancy, drug interactions, significant comorbidity).
Note: Primary failure to a TNF-inhibitor does not preclude trial of another TNF-inhibitor.

Denial Risk

Not Meeting Criteria

Siliq is considered not medically necessary for members who do not meet the criteria in this policy.

>=10% of body surface area affected (qualifies for authorization)

BSA minor threshold with qualifiers>=3% of BSA affected AND the member has either (i) inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin OR (ii) a clinical reason to avoid those pharmacologic treatments

Authorization length tied to severityAuthorization of 12 months may be granted when any of these disease-severity criteria are met