Last Review Date: 05/05/2025

Date of Origin: 12/02/2021

Dates Reviewed: 12/2021, 09/2022, 09/2023, 06/2024, 05/2025

1. Length of Authorization

Itching Associated with Allergic Conjunctivitis

• Coverage will be provided for 6 months and may be renewed annually thereafter.

Ocular Inflammation and Pain Following Ophthalmic Surgery

• Coverage will be provided for 1 insert per eye and may not be renewed.

2. Dosing Limits

      Max Units (per dose and over time) [HCPCS Unit]:

Itching Associated with Allergic Conjunctivitis

• 8 billable units every 1 month

Ocular Inflammation and Pain Following Ophthalmic Surgery

• 8 billable units one time only

(Quantity Limits/Max units are based on administration to BOTH eyes)

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

Universal Criteria ¹

• Patient is free of ocular or periocular infections (including active epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella, mycobacterial infections, fungal diseases, and dacryocystitis, etc.); AND
• Patient has not received a sustained-release corticosteroid in the same eye; AND
• Patient’s intraocular pressure is measured at baseline and periodically throughout therapy; AND

Ocular Inflammation and Pain Following Ophthalmic Surgery † ¹

Itching Associated with Allergic Conjunctivitis † ^1,5-9

• Patient is at least 2 years of age; AND
• Will not be used in pediatric patients that require sedation for the insertion procedure; AND
• Patient avoids or reduces contact with known allergens; AND
• Patient has experienced intolerable side effects or lack of therapeutic response from one of the following topical therapies:
  • Mast cell stabilizers (e.g., cromolyn, nedocromil, lodoxamide, etc.)
  • Antihistamines (e.g., azelastine, olopatadine, ketotifen, epinastine, bepotastine, alcaftadine, etc.)
  • Vasoconstrictors (e.g., naphazoline, etc.)
  • NSAIDs (e.g., ketorolac tromethamine); AND
• Patient has had a lack of therapeutic response from short-term topical corticosteroids

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and indication specific criteria as identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: bacterial, viral, and/or fungal infections, increased intraocular pressure, delayed healing, etc.; AND

Itching Associated with Allergic Conjunctivitis

• Disease response as indicated by a decrease in ocular itching

Ocular Inflammation and Pain Following Ophthalmic Surgery

• Duration of authorization has not been exceeded (refer to section 1)

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J1096 – Dexamethasone, lacrimal ophthalmic insert, 0.1 mg; 1 billable unit = 0.1 mg

NDC:

• Dextenza 0.4 mg intracanalicular insert: 70382-0204-xx

7. References

1. Dextenza [package insert]. Bedford, MA; Ocular Therapeutix, Inc.; April 2025. Accessed April 2025.
2. Walters TR, Bafna S, Vold S, et al. Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies. J Clin Exp Ophthalmol. 2016;7(4):1-11.
3. Tyson SL, Bafna S, Gira JP, et al. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. [published correction appears in J Cataract Refract Surg. 2019;45(6):895]. J Cataract Refract Surg. 2019;45(2):204-212.
4. McLaurin EB, Evans D, Repke CS, et al. Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis. A J Ophthal. 229;Sep2021.288-300. https://doi.org/10.1016/j.ajo.2021.03.017
5. American Academy of Ophthalmology Preferred Practice Pattern Cornea/External Disease Committee. Conjunctivitis PPP – 2018. Nov 2018. Accessed at: Conjunctivitis PPP - 2018 - American Academy of Ophthalmology (aao.org).
6. Miyazaki D, Takamura E, Uchio E, et al. Japanese guidelines for allergic conjunctival diseases 2020, Allergology International, Volume 69, Issue 3, 2020, Pages 346-355, ISSN 1323-8930, https://doi.org/10.1016/j.alit.2020.03.005.
7. Bielory L, Delgado L, Katelaris CH, et al. ICON: Diagnosis and management of allergic conjunctivitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):118-134. doi: 10.1016/j.anai.2019.11.014. Epub 2019 Nov 21. PMID: 31759180.
8. American Academy of Ophthalmology Preferred Practice Pattern Cornea/External Disease Committee. Conjunctivitis PPP – 2023. June 2023. Accessed at: Conjunctivitis PPP - 2023 - American Academy of Ophthalmology (aao.org)
9. American Academy of Ophthalmology Preferred Practice Cornea/External Disease Committee. Conjunctivitis PPP – 2024. April 2024. Accessed at Conjunctivitis PPP - 2024 - American Academy of Ophthalmology (aao.org)

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A