Last Review Date: 09/01/2022

Date of Origin: 12/02/2021

Dates Reviewed: 12/2021, 09/2022

1. Length of Authorization ^4,6

Allergic Conjunctivitis

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

Post-Op Inflammation and Pain

• Coverage will be provided for 1 implant and may not be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Dextenza 0.4 mg intracanalicular insert: 2 inserts every 1 month

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

     Allergic Conjunctivitis

• 8 billable units every 1 month

   Post-Op Inflammation and Pain

• 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:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient is free of ocular infections; AND
• Must not be used in combination with sustained-release intravitreal corticosteroids (e.g., fluocinolone acetonide or dexamethasone implants); AND
• Patient’s intraocular pressure is measured at baseline and periodically throughout therapy; AND

Ocular Inflammation and Pain Following Ophthalmic Surgery †

Itching Associated with Allergic Conjunctivitis †

• 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.)
  • Topical antihistamines (e.g., azelastine, olopatadine, ketotifen, epinastine, 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 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, etc.; AND

Itching Associated with Allergic Conjunctivitis

• Disease response as indicated by a decrease in ocular itching

Ocular Inflammation and Pain Following Ophthalmic Surgery

• May not be renewed

5. Dosage/Administration ^1,4,6

6. Billing Code/Availability Information

HCPCS Code:

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

NDC:

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

7. References

1. Dextenza [package insert]. Bedford, MA; Ocular Therapeutix, Inc.; October 2021. Accessed August 2022.
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.

Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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