CurrentHawaii Medical Service Association (HMSA)Policy N/A

Prior authorization criteria for omalizumab (Xolair) across indications

Defines prior authorization questions and documentation requirements used by CVS Caremark/HMSA for coverage decisions for omalizumab (Xolair) for allergic asthma, chronic spontaneous urticaria, nasal polyps, and IgE-mediated food allergy. Affects prescribers seeking drug authorization for HMSA members.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyPrior authorization criteria for omalizumab (Xolair) across indications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the indication-specific prior authorization questionnaire to CVS Caremark Specialty Programs at 1-866-237-5512 with required clinical attachments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4indications with tailored question sets

≥2antihistamine courses required for CSU

6 IU/mLallergen-specific IgE threshold

30 IU/mLserum IgE threshold

Yesdocumentation required

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Coverage Criteria for Omalizumab (Xolair)

Allergic asthma — Initial and reauthorization

Covered when ALL of the following are met for initial requests:

Asthma initial criteria: 1) Diagnosis of allergic asthma; 2) Specialty of the practitioner documented (allergist, immunologist, pulmonologist, or other); 3) Documentation of baseline asthma severity (mild intermittent, mild persistent, moderate persistent, or severe persistent); 4) Asthma inadequately controlled on optimized inhaled corticosteroid therapy (attach medication list with doses) and inadequate control on an optimized long-acting beta agonist if applicable (attach medication list with doses); 5) Patient weight documented for dosing; 6) Pre-treatment total serum IgE documented (attach level) or documented absence of pre-treatment IgE, and prescribed dose follows FDA-approved dosing recommendations based on pretreatment IgE and body weight; 7) Prior to initiation, positive skin or in vitro reactivity to at least one perennial aeroallergen (attach testing); 8) Failure of environmental control and immunotherapy documented OR documentation that immunotherapy is contraindicated; 9) Pre-treatment FEV1 documented and comorbidities evaluated and treated (attach FEV1 and clinical notes); 10) Rescue short-acting beta2-agonist available to the patient (documented).

Providers must attach documentation for current medications (including doses), pre-treatment serum IgE, allergen testing, FEV1, weight, and failure of environmental controls or immunotherapy.

IgE-mediated food allergy — Initial and continuation

Covered when ALL of the following are met for initial requests:

Food allergy initial criteria: 1) Diagnosis of IgE-mediated food allergy; 2) Specialty of the practitioner documented (allergist, immunologist, or other); 3) Confirmation of IgE-mediated food allergy by ONE of: pre-treatment allergen-specific serum IgE ≥ 6 IU/mL (attach result), skin-prick test wheal diameter ≥ 4 mm (attach result), a positive physician‑controlled oral food challenge (attach documentation), OR a history of systemic reaction to the food (attach documentation); 4) Pre-treatment total serum IgE may be documented (≥ 30 IU/mL noted when provided); 5) For continuation, member must have achieved or maintained a positive clinical response to therapy (e.g., decreased hypersensitivity symptoms) and will continue to maintain an allergen-avoidance diet as applicable.

Attach allergen-specific IgE, skin test results, oral food challenge or reaction documentation, and pre-treatment serum IgE if available.

Chronic spontaneous urticaria (CSU) — Initial and continuation

Covered when ALL of the following are met for initial requests:

CSU initial criteria: 1) Diagnosis of chronic spontaneous urticaria (CSU); 2) Specialty of the practitioner documented (allergist, immunologist, dermatologist, or other); 3) Duration of urticaria documented (≥ 3 months preferred; attach notes); 4) Evaluation for other causes of urticaria performed (attach notes); 5) Patient remained symptomatic despite at least two distinct courses of different high‑dose second‑generation H1 antihistamines (each course continuous for ≥ 2 weeks) OR specified combination regimens OR documented contraindication to these therapies (attach trial documentation); 6) If applicable, trial of first‑generation H1 or H2 antihistamine in combination with a high‑dose second‑generation H1 antihistamine has been attempted (each course ≥ 2 weeks); 7) For continuation/reauthorization, documentation of complete or partial clinical response to therapy is required; lack of response will not support further authorization.

High‑dose defined as twice daily dosing of standard daily dosing; attach clinical notes documenting antihistamine trials, durations, and response.

Nasal polyps — Initial and reauthorization

Covered when ALL of the following are met for initial requests:

Nasal polyps initial criteria: 1) Diagnosis of nasal polyps; 2) Specialty of the practitioner documented (allergist, immunologist, otolaryngologist, or other); 3) Baseline nasal polyp score (NPS) documented (total and per nostril) with values attached; 4) Documented inadequate response to nasal corticosteroids as evidenced by a weekly average nasal congestion score (NCS) > 1 despite nasal corticosteroid therapy (attach NCS and treatment documentation); 5) Requested product intended as add‑on maintenance therapy and member is currently receiving and will continue nasal corticosteroid therapy.

Attach NPS (per nostril and total), NCS, documentation of nasal corticosteroid use and inadequate response.

The prior authorization questionnaire includes an Other diagnosis checkbox that, when selected, directs the form to no further questions. The form does not list explicit coverage exclusions tied to that selection on the questionnaire itself; providers selecting Other will not be prompted for indication-specific documentation within this form.

For reauthorization requests, the form requires documentation of clinical benefit since therapy initiation (for example, comparative FEV1 for asthma, documented complete or partial response for CSU, or improvement in NPS/NCS for nasal polyps). The questionnaire states that a response of no improvement or sustained improvement may lead to no further authorization, and providers must attach supporting documentation when indicating improvement to support continuation of therapy.

Coding, Scores, and Laboratory Thresholds

Allergen-specific IgE threshold (food allergy)

Threshold value>= 6 IU/mL (pre-treatment allergen-specific serum IgE)

Alternate confirmationSkin-prick test wheal >= 4 mm or positive physician-controlled oral food challenge

Action requiredAttach documentation of pre-treatment allergen-specific IgE level from the medical record

Serum IgE threshold

Serum total IgE threshold>= 30 IU/mL (pre-treatment total serum IgE)

Form actionAttach documentation of pre-treatment serum IgE (IU/mL)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Complete the indication-specific prior authorization questionnaire and fax to CVS Caremark at 1-866-237-5512. Prior authorization is required for coverage; approvals may be subject to dosing limits per FDA labeling and evidence-based guidelines. For questions regarding prior authorization contact CVS Caremark at 1-808-254-4414.

Fax: 1-866-237-5512
Phone (prior auth questions): 1-808-254-4414
Specialty Customer Care / CaremarkConnect for eligibility/copay/delivery: 1-800-237-2767

Step Therapy

Step Therapy Requirement for CSU

For chronic spontaneous urticaria (CSU), members must have remained symptomatic despite treatment with at least two distinct courses of different high‑dose second‑generation H1 antihistamines. Each course must be continuous for at least 2 weeks. High‑dose is defined as twice‑daily dosing of standard daily dosing.

Required trials (examples of standard agents at high dose): Cetirizine 10 mg twice daily; Levocetirizine 5 mg twice daily; Fexofenadine 180 mg twice daily; Loratadine 10 mg twice daily; Desloratadine 5 mg twice daily

Background on Omalizumab and Indications

Omalizumab (Xolair) is evaluated across multiple IgE-mediated conditions on the authorization form, including allergic asthma, chronic spontaneous urticaria (CSU), nasal polyps, and IgE‑mediated food allergy. The form collects condition‑specific baseline measures and prior-treatment information—such as pre-treatment total or allergen-specific IgE, skin or in vitro allergy testing, FEV1 for asthma, nasal polyp score (NPS) and nasal congestion score (NCS) for nasal polyps, and documentation of prior medication trials—to assess medical necessity and dosing considerations.

Definitions and Measurement Thresholds

Pre-treatment serum IgE — serum total or allergen-specific IgE measurement requested prior to therapy; thresholds referenced

DefinitionSerum total or allergen-specific IgE level measurement requested prior to initiating therapy

Thresholds referenced>= 30 IU/mL for total serum IgE; allergen-specific IgE thresholds (see food allergy) may be >= 6 IU/mL

Documentation requirementAttach documentation of pre-treatment serum IgE (IU/mL) to the prior authorization request

Nasal Polyp Score (NPS) — clinician-documented score for nasal polyp burden used to assess severity

DefinitionClinician-documented Nasal Polyp Score (NPS) used to assess nasal polyp burden prior to initiating therapy

Scoring elements