PA reviewers require confirmation of no contraindicated concomitant agents

Prior authorization reviewers will require confirmation that none of the agents listed as “Contraindicated as Concomitant Therapy” or “Agents NOT to be used Concomitantly” are being used concurrently with omalizumab.

• Example listed agents include depemokimab-ulaa (Exdensur), benralizumab (Fasenra), various adalimumab products (Hadlima, Hulio, Humira, Hyrimoz), vedolizumab (Entyvio), canakinumab (Ilaris), mepolizumab (Nucala), baricitinib (Olumiant), ruxolitinib (Opzelura), rituximab products, ustekinumab products, and many others explicitly named in the policy.

PA must exclude use of agents on the prohibited list

Prior authorization submissions must account for contraindicated concomitant therapies; requests that list or permit use of any agent on the policy’s prohibited list are not acceptable for approval.

• The policy repeatedly states prior authorization must exclude use with agents listed as contraindicated for concomitant therapy.
• Requests permitting listed agents are considered contraindicated and subject to denial.

PA must exclude concomitant use with listed agents

When requesting prior authorization, exclude use of any agent named in the policy’s “Agents NOT to be used Concomitantly” list; PA determinations are made only if the request demonstrates the patient is not receiving those agents.

• The policy instructs that prior authorization for omalizumab should account for and exclude use with the agents listed as contraindicated for concomitant therapy.
• A long, explicit list of biologic and targeted agents is provided that must not be used concomitantly.

PA must state indication and IgE/weight‑based dosing

Prior authorization must include the indication and the selected dosing determined by pre‑treatment total serum IgE and body weight, per the policy’s IgE‑by‑weight dosing tables.

• Indication examples include moderate‑to‑severe persistent asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE‑mediated food allergy.
• Dose and dosing frequency are determined by serum total IgE measured before treatment and body weight; use the tables to select dose (e.g., 75–600 mg every 2 or 4 weeks as applicable).

Prior authorization expected/considered per NQTL factors

Prior authorization is considered appropriate for omalizumab given indication, safety/efficacy considerations, and drug cost; use the NQTL checklist factors when applying PA.

• Appendix A concludes indication, safety/efficacy, and cost are factors to “Consider for PA.”

Verify absence of prohibited concomitant agents for PA

Verify and document that the patient is not prescribed any agent on the policy’s prohibited list when submitting or renewing PA; do not request approval to co‑administer listed agents.

• Requests that propose concomitant use of any agent listed as contraindicated are not acceptable and may be denied.
• Providers must confirm absence of listed agents at the time of PA review.

State explicitly in PA that listed agents are not being used

Include explicit statements in the PA that the member is not receiving any agents listed under “Agents NOT to be used Concomitantly”; PA that permits or lists such agents should be modified or will be considered contraindicated.

• The policy repeats that concomitant use of named agents (e.g., mepolizumab, baricitinib, omalizumab-igec, mirikizumab, ruxolitinib, abatacept, apremilast, ustekinumab products) is contraindicated.
• If concomitant therapy is documented, the request may be denied per the policy.

Do not request PA for concomitant administration of named agents

Do not submit PA requests that seek approval to use omalizumab concurrently with any named biologic/targeted agents; PA determinations require exclusion of listed concomitant therapies.

• The document provides extensive, repeated lists of agents that should not be co‑administered with Xolair; requests allowing those combinations are contraindicated.
• Provider submissions must demonstrate the patient is not on those agents before approval.

Provide rationale if requesting an exception for concomitant use (may still be contraindicated)

If a provider requests concomitant use despite the listing, include clinical rationale and supporting documentation; however, the policy indicates such combinations are contraindicated and may not be approved.

• The policy notes a long list of contraindicated agents and instructs documentation if attempting combinations despite the listing.
• Even with rationale, listed agents are identified as ‘Contraindicated as Concomitant Therapy.’

Include HCPCS J2357 and reference NDC(s) on PA/claims

For PA and claims, include HCPCS code J2357 (injection, omalizumab, 5 mg) with appropriate units and reference the product NDC when identifying the administered preparation.

• HCPCS: J2357 — Injection, omalizumab, 5 mg; 1 billable unit = 5 mg.
• Available NDCs listed: 50242-0214-xx (75 mg), 50242-0215-xx (150 mg syringe), 50242-0040-xx (150 mg vial), 50242-0227-xx (300 mg).

Perform medication reconciliation and document absence of contraindicated agents

Perform medication reconciliation and document the current medication list to confirm the patient is not concurrently receiving any agent explicitly listed as contraindicated for concomitant therapy with Xolair.

• The policy requires documentation that the patient is not receiving agents listed as 'Contraindicated as Concomitant Therapy.'
• Medication reconciliation must be completed prior to initiating or continuing therapy.

Document prescriber attestation that prohibited agents are not being used

Prescribers must document, in the PA request or medical record, that none of the listed agents are being used concomitantly with omalizumab when requesting or continuing therapy.

• The policy explicitly states the prescriber must document absence of listed agents when requesting or continuing omalizumab.
• This documentation is required for PA review and coverage determinations.

Document current medication list and provide rationale if attempting listed combinations

Document the patient’s current medications and ensure they are not receiving any agents listed as “Agents NOT to be used Concomitantly”; if attempting a combination, provide justification though the policy lists these as contraindicated.

• The policy instructs providers to document current medications and to provide rationale if attempting combination therapy despite the listing.
• Absent documentation of exclusion, PA may be denied.

Obtain baseline total IgE and body weight for dose selection

Obtain pre‑treatment serum total IgE (IU/mL) and measure body weight (kg) to determine the appropriate omalizumab dose and dosing frequency per the policy tables before initiating therapy.

• Dose determination for many indications is based on serum total IgE measured before starting treatment and body weight; tables specify doses from 75 to 600 mg every 2 or 4 weeks depending on IgE and weight.
• Some table entries are labeled “Do Not Dose” for very high IgE/weight combinations and must be respected.

Use J2357 (5 mg units) on claims and reference NDCs

Include the HCPCS code J2357 with the appropriate number of 5‑mg units on claims and may reference the listed NDCs to identify the administered product.

• J2357 — Injection, omalizumab, 5 mg; 1 billable unit = 5 mg.
• Reference NDCs for product presentation as listed in the policy.

PA/coverage may be denied if patient is on contraindicated agents

Requests where the member is prescribed any agent on the policy’s contraindicated concomitant therapy lists may be denied; ensure documentation shows the patient is not receiving those agents.

• The prior authorization and denial risk language states such requests “may be denied” when a member is prescribed listed agents.
• Providers should resolve any concurrent prescriptions for listed agents before submission.

Concomitant initiation/use of listed agents may trigger denial

Initiation or use of any agent named in the document concurrently with Xolair may trigger denial or be considered contraindicated; do not initiate listed therapies while seeking omalizumab coverage.

• The policy warns that use or initiation of listed agents concomitantly with omalizumab may trigger denial per the 'Agents NOT to be used Concomitantly' section.
• Requests to continue or initiate concomitant therapy are considered contraindicated.

Requests to co‑administer listed agents may be denied

Because the policy explicitly lists many agents as ‘Agents NOT to be used Concomitantly,’ requests proposing co‑administration may be denied; do not propose concurrent therapy with any named agent in PA submissions.

• Repeated, explicit lists of prohibited agents are provided and are grounds for denial if concomitant use is proposed.
• PA reviewers require confirmation that those agents are not being used.

Concurrent use with named biologic/targeted agents is contraindicated

Use of any named biologic or targeted agent concomitantly with omalizumab is contraindicated; claims or requests for concurrent therapy with these agents may be denied per the policy.

• The policy repeatedly identifies numerous biologic, anti‑TNF/anti‑IL, and JAK inhibitors as contraindicated for concomitant use with Xolair.
• Claims seeking payment for concurrent therapy with these agents may be affected.

High‑weight/IgE combinations labeled “Do Not Dose” may lead to denial

Respect dosing table entries labeled “Do Not Dose”; very high body weight and IgE combinations flagged as “Do Not Dose” are excluded from dosing recommendations and could lead to denial if billed.

• The dosing tables include entries indicating “Do Not Dose” for specific high IgE/weight combinations.
• Coverage requires dosing within the table ranges and avoidance of 'Do Not Dose' combinations.