426 Form

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Pharmacy Medical Policy Topical Ocular Hydrating Agents Table of Contents Authorization Information Coverage Criteria
Appendix Policy History References Endnotes Policy Number: 426 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 4/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

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This is a comprehensive policy covering prior authorization criteria and quantity limit requirements for topical ocular hydrating agents. Please refer to the chart below for the formulary and status of the medications affected by this policy: Drug Formulary Status (BCBSMA Commercial Plan) Requirement
Formulary, Preferred Cyclosporine Single Use Vials PA, QCD Prior authorization required. See criteria below.
Eysuvis (loteprednol etabonate) PA Miebo (perfluorohexyloctane) PA, QCD Verkazia (cyclosporine) PA, QCD Xiidra (lifitegrast) PA, QCD Formulary, Non-Preferred Lacrisert (hydroxypropyl cellulose) PA, QCD Prior authorization required. See criteria below. Restasis (cyclosporine) Single Use Vials PA, QCD Non-Formulary, Non-Covered Cequa (cyclosporine) NFNC, PA, QCD Prior authorization required. See criteria below. Restasis (cyclosporine) Multidose NFNC, PA, QCD Tryptyr (acoltremon) NFNC, PA Tyrvaya nasal spray ™ (varenicline) NFNC, PA, QCD Vevye (cyclosporine) NFNC, PA, QCD QCD - Quality Care Dosing (policy #621B); PA – Prior authorization; NFNC – Non-formulary, Non-formulary, Non-Covered Approval Length: 12 months, unless otherwise specified in Clinical Guideline Coverage Criteria Clinical Coverage Criteria: Cyclosporine Single Use Vials Cyclosporine Single Use Vials may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:

1. Definite diagnosis of moderate or severe keratoconjunctivitis sicca AND

2. Age 16 years of age or older AND
3. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist Clinical Coverage Criteria: Xiidra Xiidra (lifitegrast) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:
4. Definite diagnosis of moderate or severe dry eye disease (DED) AND
5. Age 17 years of age or older AND

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3. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist. Clinical Coverage Criteria: Cequa, Restasis (single & multi-dose), Tyrvaya, Vevye Cequa (cyclosporine,), Restasis Multidose (cyclosporine), Restasis Single use vials (cyclosporine), Tyrvaya nasal spray (varenicline) or Vevye (cyclosporine) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:
4. Definite diagnosis of moderate or severe keratoconjunctivitis sicca AND
5. Age 18 years of age or older AND
6. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist AND

7. Previous use of, or evidence of BCBSMA paid claims for BOTH Xiidra (lifitegrast) AND Cyclosporine (including all formulations)

   NOTE: Restasis (cyclosporine) has safety data to include ages 16 and older.
   Clinical Coverage Criteria: Eysuvis Eysuvis (loteprednol etabonate) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:

8. Definite diagnosis of moderate or severe dry eye disease (DED) AND
9. Age 18 years of age or older AND
10. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist AND

11. The patient does NOT have glaucoma or any other eye issues, such as infection.

    Clinical Coverage Criteria: Miebo
    Miebo (perfluorohexyloctane) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:

12. A definite diagnosis and experiencing signs and symptoms of dry eye disease (DED) AND
13. Age 18 years of age or older Length of Approval: If approved, a prior authorization for Eysuvis will be granted for TWO (2) weeks.

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AND

3. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist

   Clinical Coverage Criteria: Lacrisert Lacrisert (hydroxypropyl cellulose) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:

4. Definite diagnosis of severe dry eye disease (DED) AND
5. Age 18 years of age or older AND

6. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist

   Clinical Coverage Criteria: Tryptyr Tryptyr (acoltremon) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met:

7. Definite diagnosis of [moderate or severe] Dry Eye Disease (DED) AND
8. Age 18 years of age or older AND
9. Prescribed by a board-certified ophthalmologist, board eligible ophthalmologist, board-certified optometrist, or board eligible optometrist.
   AND

10. There has been previous use of at least two preferred alternatives (e.g. cyclosporine, Eysuvis, Miebo, Verkazia, Xiidra) and failure or clinical rationale for not using the preferred medications.

    Clinical Coverage Criteria: Verkazia Verkazia (cyclosporine) may be covered and considered MEDICALLY NECESSARY when ALL of the following criteria are met: Length of Approval: If approved, a prior authorization for Lacrisert will be granted for up to SIX (6) months Length of Approval: If approved, a prior authorization for Meibo will be granted for up to SIX (6) months

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1. Definite diagnosis of moderate or severe vernal keratoconjunctivitis (VKC) AND

2. Age 4 years of age or older. Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
   If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
   Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
   To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines

   Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

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Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

Policy History

Date Action 4/2026 Clarified diagnosis criteria for Miebo. 1/15/2026 November P&T: Tryptyr added to the policy. 1/2026 Updated Miebo to preferred brand. Added QCD to Lacrisert and Verkazia. Updated formatting. 7/2024 Updated to add Lacrisert ® (hydroxypropyl cellulose) to the policy. 3/2023 Updated to add Vevye ®(cyclosporine) to the policy as non-covered. 10/2023 Updated to add Miebo ® (perfluorohexyloctane) to the policy. Reformatted policy.
9/2023 Clarified FE criteria when using cyclosporin and updated IC section to align with 118E MGL § 51A. 7/2023 Reformatted Policy. 6/2023 Updated Criteria for Cyclosporine, Xiidra ™, and Eysuvis ™ and added Auth lengths for the drug groupings. 7/2022 Updated to include Verkazia to the policy.
4/2022 Updated to add Generic Restasis ® and move Restasis ® to a non-preferred status.
2/2022 updated to add Tyrvaya nasal spray™ to the policy. 4/2021 Clarified age for Xiidra ™. 1/2021 Updated to add Eysuvis™ to the policy. 1/2020 Updated criteria for Restasis ® Multidose to not covered. 10/2019 Updated to clarify Cequa ™ coverage 2/2019 Updated to add Cequa ™ to the policy. 6/2017 Updated address for Pharmacy Operations. 11/2016 Updated to add Xiidra ™ to the policy. 7/2014 Updated policy to include prior use of over the counter preparations, requiring a diagnosis of moderate or severe keratoconjunctivitis sicca, and requiring prescription by a board/eligible ophthalmologist or board/eligible optometrist. Also to remove Blue Value from policy. 8/2013
Reviewed and updated drug sample exclusion language. 1/2013 New policy effective 1/1/13.

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References

1. American Academy of Ophthalmology Corneal/External Disease Panel. Preferred Practice Pattern® Guidelines. Dry Eye Syndrome –Limited Revision. San Francisco, CA: American Academy of Ophthalmology; 2011.
2. American Academy of Ophthalmology/External Disease Panel. Preferred Practice Pattern® Guidelines. Dry Eye Syndrome. San Franciso, CA; American Academy of Ophthalmology; 2013.
3. Gumas, K. et al, The role of inflammation and anti-inflammation therapies in keratoconjunctivitis sicca. Clinical Ophthalmology 2009:3 57–67
4. Restasis [package insert]. Irvine, CA: Allergan, Inc.: 2010.
5. Xiidra [package insert]. Lexington, MA: Shire US, Inc.: 2016.
6. Cequa [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.: Aug 2018.
7. Eysuvis [package insert]. Watertown, MA: Kala Pharmaceuticals, Inc.: Nov 2020.
8. Miebo [package insert]. Bridgewater, NJ: Bausch & Lomb Americas Inc.: May 2023.
9. Vevye [package insert]. Nashville, TN: Harrow, Inc.: November 2023.
10. Lacrisert [package insert]. Bridgewater, NJ Bausch Health US, LLC.: October 2019.
11. Lacrisert [package insert]. Fort Worth, TX. Alcon Laboratories, Inc.: 5/2025.