Desloratadine (Clarinex) and Desloratadine/Pseudoephedrine (Clarinex-D) prior authorization
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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.
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.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for Initial Approval:
Provider must submit documentation supporting criteria.
Continuation Therapy
Covered when ALL of the following are met for Continued Therapy:
Provider must submit documentation supporting continuation.
Utilization management limits
Policy-level coverage and utilization management notes
Not a clinical exclusion but a utilization management action.
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 | Policy references prior authorization and approval duration affecting unspecified pharmacy/provider codes (document portion did not list specific CPT/HCPCS/NDC). |
Provider Actions and Requirements
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
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 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 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
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
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