PA: Check for listed contraindicated concomitant agents

Prior authorization reviewers must verify whether the member is receiving any agents listed as “Agents NOT to be used Concomitantly”; the PA decision must consider those agents when adjudicating a request for Xolair (omalizumab).

• PA must flag concomitant use of any agent in the policy's “Agents NOT to be used Concomitantly” list.

PA: Account for explicitly named contraindicated agents

Prior authorization review must account for the specific agents named in the policy as explicitly contraindicated as concomitant therapy (for example: ustekinumab/Stelara/Steqeyma/Wezlana variants, ixekizumab/Taltz, tezepelumab/Tezspire, golimumab/Simponi ARIA, risankizumab/Skyrizi, deucravacitinib/Sotyktu, tofacitinib/Xeljanz, tocilizumab/Tofidence/Tyenne, rituximab/Truxima, guselkumab/Tremfya, natalizumab/Tysabri/Tyruko, etrasimod/Velsipity, and others listed).

• Include named biologics, JAK inhibitors, and other listed products when checking for contraindicated concomitant therapy.

Concomitant therapy check required at PA

At prior authorization, confirm the requested Xolair will not be given together with any product designated in the policy as “Agents NOT to be used Concomitantly” or labeled “Contraindicated as Concomitant Therapy.”

• If the member is receiving any listed agent, PA should not approve concomitant administration per the policy designation.

PA must include pre-treatment IgE and body weight for dosing/frequency

Document pre-treatment total serum IgE (IU/mL) and current body weight (kg) with the PA request, since dose (mg) and dosing frequency (every 2 or 4 weeks) are determined by those baseline values.

• Include measured pre-treatment total serum IgE (IU/mL).
• Include current body weight (kg).
• State the dose and proposed frequency tied to the IgE/weight table.

PA: Follow pediatric weight/IgE dosing table for ages 6 to <12

For children who begin omalizumab at ages 6 to <12, prior authorization must reference and match the pediatric pre-dosing body weight and IgE-based dosing tables (including specified mg doses and frequency every 2 or 4 weeks and any ‘Do Not Dose’ designations in the table).

• PA dosing must align to the pediatric weight/IgE tables provided in the policy.
• Do Not Dose or blank table cells indicate dosing is not supported for that combination and should be reflected in the PA decision.

PA must be tied to covered diagnoses and PA rationale

Prior authorization determinations are guided by clinical indication, safety/efficacy, and cost considerations; ensure the submitted diagnosis matches a covered ICD‑10 diagnosis listed in Appendix 1 when applicable.

• Confirm the indicated ICD‑10 code corresponds to the policy's covered diagnoses in Appendix 1 (e.g., J45.40, J45.50, J33.x, L50.x, Z91.0x, etc.).
• Apply PA criteria considering indication, safety/efficacy, and cost per the NQTL assessment.

Step therapy: none specified in this section

No step therapy requirements are specified in this segment; the policy section lists agents contraindicated for concomitant use but does not impose step therapy sequencing for Xolair.

• Do not require prior failure of other listed agents as a step-therapy condition — none is specified here.

Step therapy not provided (no step therapy guidance)

This policy segment contains no step therapy guidance; reviewers should not apply step-therapy controls based on this concomitant-use list alone.

• Focus PA review on contraindicated concomitant agents and dosing rules rather than step therapy sequencing.

Step therapy: not specified

No step therapy requirements are stated in these chunks; the content is limited to products that must not be used concomitantly with Xolair.

• Step therapy controls are not defined in this document segment.

NQTL considerations: PA design informed by NQTL checklist

The policy's NQTL checklist documents that PA was applied after considering factors such as indication, safety/efficacy, and drug cost; reviewers should follow the PA processes informed by that NQTL assessment.

• Indication = consider for PA; Safety and efficacy = consider for PA; Cost = consider for PA (Appendix A).

Utilization management application per NQTL checklist

Utilization management (including prior authorization) was applied across benefits per the NQTL checklist; apply utilization management consistently when adjudicating Xolair requests.

• The NQTL checklist indicates utilization management methods (eg, PA) were considered and applied comparably across MH/SUD and M/S drug benefits.

Document absence of contraindicated concomitant agents for PA

Include clinical documentation that the member is not receiving any agent listed in the policy’s “Agents NOT to be used Concomitantly” when submitting a PA; the policy requires documentation demonstrating absence of the contraindicated agents.

• Explicitly state in the chart/PA submission that the member is not on any listed biologic, JAK inhibitor, or other named product.
• Supply medication history or attestations showing absence of listed agents.

PA documentation must show member is not on contraindicated agents

Clinical documentation submitted with the PA must demonstrate the member is not receiving any listed contraindicated agents (the policy lists numerous biologics and immunomodulators that are contra‑indicated as concomitant therapy).

• Provide med list, recent clinic notes, or pharmacy fill history showing the member is not on the listed agents.

Document absence of contraindicated concomitant therapy

When requesting Xolair, ensure documentation specifically reflects that the patient is not receiving any agent designated as “Contraindicated as Concomitant Therapy” in the policy.

• Document absence of tofacitinib/Xeljanz, ustekinumab/Stelara variants, natalizumab/Tysabri, rituximab/Truxima, and other listed products as applicable.

Require baseline IgE and body weight for dosing

Obtain and include pre-treatment total serum IgE (IU/mL) and body weight (kg) with the PA request because these baseline labs are required to determine dose and dosing frequency per the policy tables.

• Pre-treatment total serum IgE (IU/mL) must be measured before start of treatment.
• Body weight (kg) must be provided to select the appropriate dose/frequency from the tables.

Billing: use HCPCS J2357 and include NDC

Submit billing using HCPCS code J2357 (injection, omalizumab, 5 mg — 1 billable unit = 5 mg) and include the appropriate Xolair NDC when applicable (policy provides NDC examples for 75 mg, 150 mg, and 300 mg presentations).

• Bill units of J2357 corresponding to total mg administered (1 unit = 5 mg).
• Include NDC from the policy (eg, 50242-0214-xx; 50242-0215-xx; 50242-0040-xx; 50242-0227-xx) when required for product identification.

Medicare members: follow NCDs/LCDs/LCAs and CMS guidance

For Medicare members, follow applicable Medicare policies (Medicare Benefit Policy Manual, NCDs/LCDs/LCAs) and any referenced local coverage articles when making coverage and documentation decisions for outpatient Part B claims.

• Medicare NCDs/LCDs/LCAs apply and must be followed where relevant; the policy's preceding information is intended for non‑Medicare determinations.

Denial risk: concomitant use may trigger denial

Use of any agent listed in the policy's “Agents NOT to be used Concomitantly” with Xolair may lead to denial of the request; prior authorization reviewers should consider concomitant use a denial risk per the policy.

• If documentation shows concurrent use of a listed agent, PA may be denied because concomitant therapy is designated contraindicated.

Concomitant use designated contraindicated — denial basis

The policy designates concomitant use of the listed agents with Xolair as contraindicated; requests that propose co-administration with those agents can be a basis for denial of authorization.

• Concomitant biologics, JAK inhibitors, and other named immunomodulators are listed as contraindicated and may prompt denial if present.

Denial risk: listed agents flagged as contraindicated

The policy repeatedly specifies that listed agents are “Contraindicated as Concomitant Therapy”; use of any of those agents with Xolair is a denial risk and should be documented and reviewed accordingly.

• Review medication history for any agents labeled “Contraindicated as Concomitant Therapy” (eg, tofacitinib/Xeljanz, ustekinumab variants, natalizumab, tocilizumab, guselkumab, rituximab).

Concomitant therapy contraindications can lead to denial

Requests that involve concomitant use of agents listed in the policy may be denied; reviewers should treat proposed co‑administration with the listed biologics/JAK inhibitors/targeted agents as contraindicated and document the rationale for denial if applicable.

• If member is on a listed product, document the contraindication and basis for denial per the policy.

Out‑of‑table dosing (Do Not Dose/blank cells) may be denied

If a requested dose/frequency is outside the policy’s dosing tables — including combinations labeled “Do Not Dose” or blank cells in the pediatric tables — the request may be denied for lack of table-supported dosing.

• Table cells labeled “Do Not Dose” or left blank indicate dosing is not supported and may result in billing or clinical denial for out‑of‑table dosing requests.

PA rationale: consider indication, safety/efficacy, and cost

Prior authorization may be applied based on clinical indication, safety/efficacy, and cost considerations as documented in the policy; reviewers should apply PA consistent with those rationales.

• Apply PA where indication, safety/efficacy, or cost considerations were identified as reasons to consider PA in the NQTL checklist.