CurrentCignaPolicy IP0371

Ophthalmology - Xipere

Policy governing prior authorization and coverage criteria for Xipere for treatment of macular edema associated with uveitis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOphthalmology - Xipere

Policy CodePolicy IP0371

Change TypeRevised

Effective Date

Next Review DateMay 15, 2025

Key ActionObtain prior authorization and document that the patient meets FDA‑approved criteria (age ≥18, non-infectious uveitis, ophthalmologist involvement, and preferred product requirement) for approval up to 6 months.

SourceLink

POLICY UPDATE CHANGES

Policy title updated from 'Triamcinolone Acetonide Ophthalmic' to 'Ophthalmology - Xipere' and adult age (≥ 18 years) criteria added.

6 monthsinitial approval duration

≥18age requirement

J3299primary HCPCS

Prior Authauthorization

Coverage Criteria for Xipere

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Macular Edema Associated with Uveitis (FDA-Approved)

Approve for 6 months if the patient meets ALL of the following (A, B, C, and D):

FDA-Approved Indication - All required: A) Patient is ≥ 18 years of age; AND B) Patient has non-infectious uveitis (i.e., pan, anterior, intermediate, or posterior); AND C) The medication is prescribed by, or in consultation with, an ophthalmologist; AND D) Preferred product criteria is met for the product as listed in the tables

Approval duration: 6 months

Preferred Product / Step Therapy

Preferred product requirement — meet ONE of the following:

Preferred Product - Employer Plans: 1. Patient has tried Triesence ophthalmic injectable suspension; OR 2. Patient has already started on Xipere and requires Xipere to complete the course of treatment.

Employer plan criteria

Preferred Product - Individual and Family Plans: 1. Patient has tried Triesence ophthalmic injectable suspension; OR 2. Patient has already started on Xipere and requires Xipere to complete the course of treatment.

Individual/Family plan criteria

Concomitant use of Xipere with another intravitreally administered corticosteroid is considered not medically necessary. The policy specifically notes there is no evidence to support concurrent administration of Xipere with intravitreal corticosteroids and lists examples of such intravitreally administered corticosteroids, including Ozurdex®, Yutiq®, Retisert®, and Triesence®.

Use of Xipere for any indication other than macular edema associated with uveitis is considered not medically necessary. The policy clarifies that other uses are not covered and that the list of non‑covered uses may be updated as new published data become available.

Prescriber Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of Xipere. All approvals are provided for the duration noted below. Approvals require Xipere to be prescribed by, or in consultation with, a physician who specializes in the condition being treated.

Prior authorization required — approve for 6 months when FDA‑approved indication criteria are met (see policy).
Prescriber requirement: must be prescribed by or in consultation with an ophthalmologist (specialist in condition).
Documentation must demonstrate patient is ≥ 18 years, has non‑infectious uveitis, and meets preferred product/step therapy criteria.

Step Therapy

Preferred Product / Step Therapy

Step therapy / preferred product criteria apply and differ by plan type. Document prior use of alternative products or that the patient is already receiving Xipere and needs continuation to complete the course.

Employer Plans: Approve if patient has tried Triesence ophthalmic injectable suspension, OR patient has already started on Xipere and requires completion of therapy.
Individual & Family Plans: Approve if patient has tried Triesence ophthalmic injectable suspension, OR patient has already started on Xipere and requires completion of therapy.
Receipt of sample product does not satisfy step therapy or prior‑use requirements.

Documentation Required

Prescriber and Documentation Requirements

Prescriber specialty and specific documentation are required for approval. Include clinical information supporting diagnosis, prior treatments tried, and reason for use of Xipere (or rationale for continuation if already started).

Prescriber: Ophthalmologist or consultation with an ophthalmologist documented in the medical record.
Clinical documentation: age (≥ 18 years), confirmation of non‑infectious uveitis subtype (pan, anterior, intermediate, or posterior), prior therapy history (including Triesence or other intravitreal corticosteroids), and treatment start date if requesting continuation.
Medical justification if requesting use outside FDA‑approved indication or concomitant corticosteroid therapy (concomitant intravitreal corticosteroids considered not medically necessary).

Denial Risk

Coding / Claims Denial Risk

Common reasons for claim denial include missing prior authorization, lack of required prescriber specialty/consultation documentation, failure to meet step therapy (no trial of Triesence), patient age < 18, or requests for non‑covered uses (including concomitant intravitreal corticosteroids). When billing, use appropriate diagnosis and procedure codes that reflect the covered indication and site of care.

Denial risks: No PA on file; missing documentation of ophthalmology prescriber/consult; no evidence of prior Triesence trial or documentation that patient previously started Xipere; patient younger than 18; requests for concomitant intravitreal corticosteroid use.
Billing guidance: Submit most appropriate diagnosis codes for macular edema due to non‑infectious uveitis and procedure/service codes for suprachoroidal injection as of date of service. Ensure supporting clinical documentation is available upon request.

Definitions

inv-12: Definition — Macular edema associated with uveitis

Definition — Macular edema associated with uveitisMacular edema is the most common complication of noninfectious uveitis and, if left untreated, may damage photoreceptors and cause permanent vision loss.

Clinical contextOccurs with non-infectious uveitis types (anterior, intermediate, posterior, or panuveitis); affects central retina (macula).

Treatment options (examples)Ophthalmic corticosteroids (e.g., Ozurdex, Yutiq, Retisert, Triesence) and Xipere; ophthalmic NSAIDs may also be used.

inv-13: Definition — Suprachoroidal injection

Definition — Suprachoroidal injectionAn injection administered between the choroid and sclera (suprachoroidal space).

Xipere formulationDelivered as a 40 mg/mL suspension for suprachoroidal administration (0.1 mL = 4 mg).

Clinical noteSuprachoroidal route used for targeted delivery of triamcinolone acetonide in treating macular edema associated with uveitis.

OpenPayer

Ophthalmology - Xipere

Coverage Criteria for Xipere

Coding and Dose Information

Prescriber Requirements, Prior Authorization, and Billing Guidance

Background

Definitions