CurrentCentenePolicy CP PMN.273

Varenicline (Tyrvaya) nasal spray for dry eye disease

Defines medical necessity, prior authorization and coverage criteria for Tyrvaya (varenicline nasal spray) for treatment of signs and symptoms of dry eye disease for Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyVarenicline (Tyrvaya) nasal spray for dry eye disease

Policy CodePolicy CP PMN.273

Change TypeNo material changes

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit documentation supporting that the member meets all approval criteria, including prior therapy failures and current diagnosis, when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2maximum dosing per day

2maximum dispensed per 30 days

6initial approval duration (months)

12continued approval duration (months)

Medical Necessity Criteria for Tyrvaya (varenicline) Nasal Spray

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Diagnosis of dry eye disease (DED)

Patient age 18 years or older>= 18 years

Prior therapy trials

Failure of at least one ophthalmic anti-inflammatory agent at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects experienced
See Appendix B for examples; prior authorization may be required for ophthalmic anti-inflammatory agents
Failure of an artificial tears agent at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects experienced
See Appendix B for examples (OTC artificial tears)
Failure of generic cyclosporine ophthalmic emulsion 0.05% (generic Restasis) unless contraindicated or clinically significant adverse effects experienced
Prior authorization may be required for cyclosporine ophthalmic emulsion

Requested dose does not exceed 2 nasal spray bottles per 30 days<= 2 bottles/30 days

Continued Therapy

Approval for continued therapy requires meeting one of the following:

ANY of the following

Member currently receiving medication via Centene benefit and has previously met initial approval criteria
Member currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums)

ALL of the following

Member is responding positively to therapy
If request is for an increase, new dose does not exceed 2 nasal spray bottles per 30 days<= 2 bottles/30 days

Approval duration: 12 months

Not Authorized

Coverage is not authorized for:

ANY of the following

Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per off-label policies

Refer to off-label use policies CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP PMN.53 (Medicaid) for documentation requirements

Other Diagnoses/Indications (routing rules)

If requested use falls outside the listed indications or formulary status, follow the applicable formulary/non-formulary or off-label policy for the relevant line of business:

ANY of the following

For drugs on the formulary/PDL, refer to no coverage criteria policies: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP PMN.255 (Medicaid)
For drugs not on the formulary/PDL, refer to non-formulary policies: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP PMN.16 (Medicaid)
If requested use is not listed under Diagnoses/Indications for which coverage is NOT authorized and prior rules do not apply, refer to off-label use policies: CP CPA.09 (commercial), HIM.PA.154 (marketplace), CP PMN.53 (Medicaid)

Prior Authorization and Documentation Requirements

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria, including prior therapy failures and the current diagnosis of dry eye disease. Examples of acceptable documentation include office visit notes, prior medication records, and relevant diagnostic test results.

Office chart notes documenting diagnosis and symptoms
Records of prior medications and trials (including ophthalmic anti-inflammatory agents, artificial tears, cyclosporine if applicable)
Laboratory or diagnostic test results relevant to DED

Prior Authorization

Prior authorization may be required for comparator agents

Prior authorization may be required for ophthalmic anti-inflammatory agents and for cyclosporine ophthalmic emulsion; providers should confirm PA requirements when documenting prior therapy failures noted in the approval criteria.

Appendix B lists examples of ophthalmic anti-inflammatory agents that may require authorization
Generic cyclosporine ophthalmic emulsion 0.05% (generic Restasis) may require prior authorization

Documentation Required

Therapy response for continued approval

For continued therapy, the provider must document that the member is responding positively to therapy or that continuity of care rules apply for members previously receiving medication via a Centene benefit or enrolled in a state/product with continuity regulations.

Evidence of clinical improvement on therapy (progress notes, symptom assessment)
Documentation of prior Centene benefit use or applicable state continuity of care enrollment, when relevant

Clinical Background

Tyrvaya (varenicline) nasal spray is an FDA-approved cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). The product is formulated as a nasal spray delivering 0.03 mg of varenicline per 0.05 mL spray and is administered in each nostril twice daily with a maximum of 2 sprays per nostril per day (see dosing and product availability).

Standard initial management for DED per American Academy of Ophthalmology guidance begins with artificial tears for all severities of disease. If lubricating drops are inadequate, the next step in therapy is typically an ophthalmic anti-inflammatory agent (for example topical corticosteroids or lifitegrast), and in many cases a trial of cyclosporine ophthalmic emulsion 0.05% (generic Restasis) is considered before initiating Tyrvaya. Providers should document prior trials of these agents or contraindications/adverse effects when seeking coverage.

Policy Summary

PayerCentene

PolicyVarenicline (Tyrvaya) nasal spray for dry eye disease

Policy CodePolicy CP PMN.273

Change TypeNo material changes

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit documentation supporting that the member meets all approval criteria, including prior therapy failures and current diagnosis, when requesting coverage.

SourceLink

On This Page

OpenPayer

Varenicline (Tyrvaya) nasal spray for dry eye disease

Medical Necessity Criteria for Tyrvaya (varenicline) Nasal Spray

Drug Product and Coding

Prior Authorization and Documentation Requirements

Clinical and Quantity Limits

Clinical Background

Defined Terms

Varenicline (Tyrvaya) nasal spray for dry eye disease

Medical Necessity Criteria for Tyrvaya (varenicline) Nasal Spray

Drug Product and Coding

Prior Authorization and Documentation Requirements

Clinical and Quantity Limits

Clinical Background

Defined Terms

Cross-References