ModifiedHealth NetPolicy CP CPA.123

Desloratadine (Clarinex) and Desloratadine/Pseudoephedrine (Clarinex-D) prior authorization

This policy governs prior authorization and coverage criteria for desloratadine (Clarinex) and desloratadine/pseudoephedrine (Clarinex-D 12 Hour) for commercial lines of business under Health Net/Centene Corporation.

Policy Summary

PayerHealth Net

PolicyDesloratadine (Clarinex) and Desloratadine/Pseudoephedrine (Clarinex-D) prior authorization

Policy CodePolicy CP CPA.123

Change TypeApproval duration revisedgeneric inclusionbrand redirection

Effective Date08.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, prior antihistamine trials or contraindications, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

Revised policy/criteria section to also include generic desloratadine.

For brand requests, added redirection to generic.

12 monthsapproval duration for initial and continued therapy

5 mg/daymax desloratadine dose (Clarinex)

5 mg/240 mgmax Clarinex-D dose

Commercial

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Clarinex ≥6 mo; Clarinex-D ≥12 yrage restrictions

3Q 2025most recent annual review

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Approval:

Initial Approval - Indication: Diagnosis of allergic rhinitis OR chronic idiopathic urticaria.

Initial Approval - Age requirements: Age requirement met: Clarinex (desloratadine) for members >= 6 months OR Clarinex-D 12 Hour (desloratadine/pseudoephedrine) for members >= 12 years.

Initial Approval - Brand/generic requirement: If the request is for brand Clarinex, the member must use generic desloratadine unless contraindicated or clinically significant adverse effects are experienced.

Provider must submit documentation supporting criteria.

Initial Approval - Prior therapy: Failure of two oral antihistamines (e.g., cetirizine, loratadine) at up to maximally indicated doses unless clinically significant adverse effects occur or all alternatives are contraindicated.

Initial Approval - Dose limits and duration: Requested dose does not exceed: Clarinex 5 mg per day OR Clarinex-D 12 Hour 5 mg desloratadine / 240 mg pseudoephedrine per day. Approval duration: up to 12 months or duration of request, whichever is less.Clarinex 5 mg/day; Clarinex-D 5 mg/240 mg per day

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Continuation Therapy - Eligibility: Member is currently receiving the medication via the Centene benefit or previously met the policy's initial approval criteria; continuity of care provisions may apply per state/product.

Continuation Therapy - Clinical response: Member is responding positively to therapy as documented by the provider.

Continuation Therapy - Brand/generic requirement: If request is for brand Clarinex, member must use generic desloratadine unless contraindicated or clinically significant adverse effects are experienced.

Provider must submit documentation supporting continuation.

Continuation Therapy - Dose limits and duration: If a dose increase is requested, the new dose must not exceed Clarinex 5 mg per day OR Clarinex-D 12 Hour 5 mg desloratadine / 240 mg pseudoephedrine per day. Approval duration: up to 12 months or duration of request, whichever is less.

Utilization management limits

Policy-level coverage and utilization management notes

Commercial approval duration: Authorization for desloratadine and desloratadine/pseudoephedrine for Commercial members is limited to 12 months or the duration of the request, whichever is less.12 months

Brand redirection: Brand product requests may be redirected to generic desloratadine; providers should expect substitution for brand requests as a utilization management action noted in the 3Q 2025 review.

Not a clinical exclusion but a utilization management action.

Documentation requirement: Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Lack of adequate documentation may trigger denial.

Non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the off‑label use policy (CP.CPA.09) for commercial members or the member’s evidence of coverage documents.

No clinical exclusions are specified in the provided excerpts of this policy. Providers should follow professional judgment and any applicable contractual or product‑specific provisions when considering treatment decisions for members.

Within the provided document excerpts there are no explicit statements listing conditions as "not medically necessary." Decisions regarding medical necessity should follow the policy criteria and supporting documentation requirements.

Coding and Dosing Limits

Affected codes (unspecified in this excerpt)mixed

affected codes

Policy references prior authorization and approval duration affecting unspecified pharmacy/provider codes (document portion did not list specific CPT/HCPCS/NDC).

Maximum daily doses — dosing limits

Clarinex (desloratadine) maximum daily dose5 mg per day

Clarinex-D 12 Hour (desloratadine/pseudoephedrine) maximum daily dose5 mg desloratadine / 240 mg pseudoephedrine per day

Pediatric dosing (Clarinex) — 12 years and older5 mg once daily

Pediatric dosing (Clarinex) — 6–11 years2.5 mg once daily

Pediatric dosing (Clarinex) — 1–5 years1.25 mg per day

Pediatric dosing (Clarinex) — 6–11 months1 mg per day

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and granted when the member meets the policy's initial or continuation criteria, including diagnosis, age, dosing limits, and step-therapy requirements. Approval duration for Commercial prior authorizations is up to 12 months or the duration of the request, whichever is less. Requests for brand Clarinex (desloratadine) may be redirected to generic desloratadine; brand will only be approved if the generic is contraindicated or causes clinically significant adverse effects.

Approval duration: 12 months or duration of request (Commercial)
Brand-to-generic redirection: brand Clarinex requests may be redirected to generic desloratadine; exceptions require contraindication or clinically significant adverse effects
Age limits: Clarinex ≥ 6 months; Clarinex-D 12 Hour ≥ 12 years
Dose limits: Clarinex 5 mg/day; Clarinex-D 12 Hour 5 mg/240 mg per day

Documentation Required

Background

Desloratadine is a second‑generation antihistamine indicated for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. Combination product Clarinex‑D (desloratadine/pseudoephedrine) provides additional relief for nasal congestion and is indicated for appropriate patients per product labeling.

Definitions

Clarinex-D 12 Hour — definition

Product descriptionClarinex-D 12 Hour is a combination product of desloratadine and pseudoephedrine indicated for relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients 12 years of age and older.

Active ingredientsDesloratadine and pseudoephedrine

Indication ageAdults and adolescents 12 years of age and older for seasonal allergic rhinitis with nasal congestion

Desloratadine — definition

DefinitionDesloratadine: a second‑generation antihistamine used for allergic rhinitis and chronic idiopathic urticaria as referenced by prescribing information and clinical guidelines.

Common indicationsSeasonal and perennial allergic rhinitis; chronic idiopathic urticaria

Policy Summary

PayerHealth Net

PolicyDesloratadine (Clarinex) and Desloratadine/Pseudoephedrine (Clarinex-D) prior authorization

Policy CodePolicy CP CPA.123

Change TypeApproval duration revisedgeneric inclusionbrand redirection

Effective Date08.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, prior antihistamine trials or contraindications, and dosing within policy limits.

SourceLink

On This Page

Clarinex 5 mg/day; Clarinex-D 5 mg/240 mg per day; 12 months

Standard approval duration12 months or duration of request, whichever is less

ApplicabilityCommercial line of business (per policy history revisions)

Provider expectationAuthorization will not exceed the lesser of 12 months or the requested duration

Providers must submit documentation (office chart notes, lab results, or other clinical information) that supports the member meets all approval criteria. Expect documentation requests to reflect policy updates (for example, brand redirection rules and approval-duration changes) and to be required to process prior authorization requests.

Acceptable documentation: office chart notes, lab results, other relevant clinical information
Documentation should demonstrate diagnosis, prior trials, contraindications, or adverse reactions to generics when applicable
Policy history may prompt additional documentation requests after updates (e.g., redirection to generic)

Denial Risk

Denial Triggers

Denial may occur if documentation is not provided or does not support the requested indication or required criteria (including diagnosis, age, dose limits, or prior therapy). Brand requests that are not justified per the redirection policy (no contraindication or clinically significant adverse effect to generic) may be denied.

Missing or insufficient clinical documentation
Indication not covered by policy (see non‑authorized indications)
Failure to meet step-therapy requirements or dosing limits
Unjustified brand request when generic alternatives are available

Step Therapy

Step Therapy Requirements

Step therapy requires failure of two oral antihistamines at up to maximally indicated doses (e.g., cetirizine, loratadine) unless contraindicated or clinically significant adverse effects are experienced. Document prior trials and dosing to demonstrate that step-therapy requirements have been met.

Required: failure of two oral antihistamines at maximally indicated doses
Exceptions: contraindication or clinically significant adverse effects to alternatives
Therapeutic alternatives and dosing guidance are listed in Appendix B

Dosage referencePrescribing information and dosing tables (see Dosage and Administration) provide age‑based dosing and maximum doses