CurrentmeridianPolicy MDN.CP.PMN.298

Tirzepatide (Zepbound)

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Defines medical necessity, initial and continuing coverage criteria, dosing limits, exclusions, and documentation requirements for Zepbound (tirzepatide) when used to treat moderate to severe obstructive sleep apnea in Meridian Illinois Medicaid members.

Policy Summary

Payermeridian

PolicyTirzepatide (Zepbound) coverage for obstructive sleep apnea

Policy CodePolicy MDN.CP.PMN.298

Change TypeNo material changes

Effective DateDec 20, 2024

Last ReviewJun 25, 2026

Next Review DateJun 25, 2026

Key ActionSubmit prior authorization with documentation confirming AHI ≥15, BMI ≥30 kg/m2, baseline weight, PAP adherence or candidacy, and dose/titration plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AHI ≥ 15AHI threshold

BMI ≥ 30BMI threshold

6 monthsApproval length

15 mgMax dose

1/week

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CurrentmeridianPolicy MDN.CP.PMN.298

Tirzepatide (Zepbound)

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Policy Summary

Payermeridian

PolicyTirzepatide (Zepbound) coverage for obstructive sleep apnea

Policy CodePolicy MDN.CP.PMN.298

Change TypeNo material changes

Effective DateDec 20, 2024

Last ReviewJun 25, 2026

Next Review DateJun 25, 2026

Key ActionSubmit prior authorization with documentation confirming AHI ≥15, BMI ≥30 kg/m2, baseline weight, PAP adherence or candidacy, and dose/titration plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AHI ≥ 15AHI threshold

BMI ≥ 30BMI threshold

6 monthsApproval length

15 mgMax dose

1/week

Coverage Criteria — Zepbound (tirzepatide) for Obstructive Sleep Apnea

Initial Therapy

Covered when ALL of the following are met for Initial Approval — Obstructive Sleep Apnea:

Initial Approval: OSA: 1. Diagnosis of moderate to severe OSA confirmed by polysomnography or home sleep apnea test with an apnea-hypopnea index (AHI) ≥ 15 respiratory events per hour; 2. Age ≥ 18 years; 3. BMI ≥ 30 kg/m2; 4. Member does not have central or mixed sleep apnea; 5. For members with concurrent type 2 diabetes mellitus: failure of ≥ 3 consecutive months of Ozempic tablets, Trulicity, and Victoza unless clinically significant adverse effects or contraindications; if member is currently receiving a GLP-1 receptor agonist and requests switching to Zepbound, medical justification supports the switch (intolerance due to common GLP-1 adverse effects alone is not acceptable justification); 6. Documentation supports participation in a physician-directed weight loss program (reduced calorie diet, increased physical activity, behavioral modification); 7. Member meets one of the following: (a) continued symptoms of OSA despite adherence to positive airway pressure (PAP) therapy (adherence defined as ≥4 hours/night for ≥70% of nights), or (b) documentation that member is not a candidate for PAP therapy; 8. If request is for the pre-filled single-use pen formulation, member must use the Zepbound KwikPen formulation; 9. Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s); 10. Documentation of member baseline body weight in kg is provided; 11. Dosing/titration follows the step-up schedule (weeks 1–24) to a maximum of 15 mg once weekly; quantity limited to one pen or vial per week.

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy — Obstructive Sleep Apnea:

Continued Therapy: OSA: 1. Member is currently receiving medication via the plan benefit or previously met initial approval criteria, or continuity-of-care regulations apply; 2. Member is responding positively to therapy: (a) For the first renewal, documentation supports both: (i) ≥5% loss of baseline body weight, and (ii) improvement in one of the following: AHI reduction from baseline, improvement in SASHB score, or improvement in a sleep-related patient-reported outcome (e.g., ESS, SAQLI, FOSQ, PROMIS); (b) For second or subsequent renewals, documentation supports weight loss and/or maintenance and stabilization or improvement in AHI, SASHB, or patient-reported outcomes; 3. Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s); 4. If request is for the pre-filled single-use pen formulation, member must use the Zepbound KwikPen formulation; 5. Documentation that member is actively enrolled in a physician-directed weight loss program (reduced calorie diet, increased physical activity, behavioral modification); 6. Dose does not exceed 15 mg once weekly; maintenance dose after escalation is ≥5 mg once weekly; requested quantity does not exceed one pen or vial per week.

Not Authorized / Exclusions

Not authorized uses / exclusions

Weight Management Exclusion: Use of Zepbound for the treatment of weight management is a benefit exclusion and will not be authorized.

listed as explicit exclusion

Non-FDA indications: Non-FDA approved indications not addressed in this policy are not authorized unless off-label policy CP.PMN.53 is satisfied or evidence of coverage documents allow it.

See related policies

Coverage criteria (summary)

Covered when criteria align with FDA labeling and policy updates

Dose escalation: Start 2.5 mg subcutaneously once weekly for 4 weeks then increase by 2.5 mg every 4 weeks during dose-escalation until maximum tolerated dose (up to 10 mg or 15 mg per labeling); maximum 15 mg once weekly.max 15 mg/week

From dosing regimen for OSA

Evidence and documentation: Documentation must be provided in initial and continuing criteria; references include the Zepbound prescribing information and supporting clinical trials as cited in policy.

Policy notes requirement for documentation in initial and continuing criteria

PAP therapy consideration: PAP criterion updated to require continued symptoms of OSA despite adherence to PAP therapy unless the member is not a candidate; PAP trial/adherence should be documented where clinically appropriate.

Indicates PAP therapy trial/adherence should be documented where applicable

Use of Zepbound (tirzepatide) for the treatment of weight management is an explicit benefit exclusion under this policy and will not be authorized.

No additional exclusions are explicitly listed in this document segment.

Non-FDA approved indications that are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off‑label use policy CP.PMN.53 for Medicaid or unless allowed by applicable evidence of coverage documents.

There are no explicit statements in these chunks designating particular uses as not medically necessary beyond the exclusions and off‑label language already noted.

Coding and Clinical Thresholds

HCPCS Codes (informational)HCPCS

C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs

AHI threshold for moderate OSA

AHI threshold for moderate OSAAHI ≥ 15 respiratory events per hour

Severity classification referenceAASM: Moderate OSA defined as AHI ≥ 15 to < 30 events/hour

Diagnostic methodConfirmed by polysomnography or home sleep apnea test

BMI threshold

BMI threshold for OSA indicationBMI ≥ 30 kg/m2

Age requirement contextApplies in adults (age ≥ 18 years) with obesity per initial criteria

BMI calculation reference

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — demonstrate all OSA initial criteria

Prior authorization is required for Zepbound when requested for the OSA indication. The provider must demonstrate that the member meets all initial approval criteria for obstructive sleep apnea (diagnostic confirmation with AHI ≥ 15 by polysomnography or home sleep apnea test, age ≥ 18, BMI ≥ 30 kg/m2, exclusion of central/mixed sleep apnea, participation in a physician-directed weight loss program, PAP adherence or documented PAP ineligibility, baseline body weight in kg, adherence to dosing/titration and quantity limits, and non-concurrent use of other tirzepatide/GLP-1 agents).

Must confirm OSA diagnosis with polysomnography or home sleep apnea test showing AHI ≥ 15 (see initial criteria).
Document age ≥ 18 and BMI ≥ 30 kg/m2.
Show exclusion of central or mixed sleep apnea.
Provide evidence of participation in a physician-directed weight loss program and baseline body weight (kg).
Document PAP adherence (≥4 hrs/night for ≥70% nights) with continued symptoms OR document that member is not a PAP candidate.
Dose/titration and quantity limits (step-up to max 15 mg/week; one pen or vial per week) must be followed.

Initial Therapy Criteria — Zepbound for Obstructive Sleep Apnea

Initial Therapy — Zepbound for OSA

Initial approval criteria for OSA — Zepbound (tirzepatide):

Initial Therapy Nodes (Zepbound for OSA): See Initial Therapy criteria: diagnostic confirmation with AHI ≥15, age ≥18, BMI ≥30 kg/m2, exclusion of central/mixed sleep apnea, GLP-1 trial requirements for concurrent T2DM if applicable, participation in physician-directed weight loss program, documentation of PAP adherence or ineligibility, KwikPen requirement for single-use pen, non-concurrent GLP-1 use, baseline weight documented, stepwise titration to a max of 15 mg weekly, quantity limit one pen/vial per week.

Initial therapy dosing

Initial dosing regimen for OSA per labeling:

Starting dose: Start 2.5 mg subcutaneously once weekly for 4 weeks.

From Appendix D: Dosage and Administration

Continuation Therapy Criteria — Zepbound for Obstructive Sleep Apnea

Continued Therapy — Zepbound for OSA

Continued therapy requirements for OSA — Zepbound (tirzepatide):

Continued Therapy Nodes (Zepbound for OSA): See Continued Therapy criteria: continuity of care or prior meeting of initial criteria; documented positive response (first renewal: ≥5% baseline weight loss plus improvement in AHI, SASHB, or sleep-related PRO; subsequent renewals: weight loss/maintenance and stabilization or improvement in AHI/SASHB/PROs); not prescribed with other tirzepatide-containing products or GLP-1 RAs; KwikPen requirement if applicable; active enrollment in weight loss program; dosing ≤15 mg weekly with maintenance dose ≥5 mg after escalation; quantity ≤1 pen or vial per week.

Continuation therapy — documentation requirement

Continuation/renewal requires documentation (policy updated to require documentation in initial and continuing criteria):

Documentation for continuation: Documentation must be provided for continuing therapy per policy update; failure to submit required documentation (office notes, labs, or other clinical information) may trigger denial.

Chunk 24 notes updates requiring documentation in initial and continuing criteria

Step Therapy and Treatment Trials

Step	Requirement	Duration / Notes
1
For members with concurrent type 2 diabetes mellitus: failure of ≥ 3 consecutive months of Ozempic (semaglutide) tablets, Trulicity (dulaglutide), and Victoza (liraglutide) unless clinically significant adverse effects or contraindications. If switching from a GLP-1 receptor agonist, medical justification must support the switch to Zepbound.
Required prior to approval of Zepbound for the OSA indication; medical justification may support an exception. Documented treatment history (duration and reason for failure/intolerance) should be provided.

Step	Requirement	Documentation / Notes
1
Trial of positive airway pressure (PAP) therapy with documented adherence when clinically appropriate: adherence defined as ≥ 4 hours/night for ≥ 70% of nights; OR documentation that the member is not a candidate for PAP therapy (e.g., anatomic reasons).
Policy update requires documentation of continued OSA symptoms despite PAP adherence unless member is not a candidate. Providers should include PAP adherence data or justification for PAP ineligibility with the prior authorization request.

Quantity Limits and Product Presentation

Zepbound (tirzepatide) — quantity limit

Quantity limitOne pen or vial per week (quantity limit)

Week-based dispensingQuantity aligns with weekly dosing schedule (one pen/vial covers one weekly dose)

Continuation quantity constraintRequested quantity must not exceed one pen or vial per week for renewals

Zepbound (tirzepatide) — dosing strengths & presentations

Available strengths2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg per pen or vial

PresentationsPre-filled, single-dose pens and pre-filled, single-dose vials (KwikPen required for single-use pen requests)

Definitions and Clinical Measures

AHI

DefinitionApnea–hypopnea index (AHI): index used to classify obstructive sleep apnea severity

Use in policyRequired to confirm diagnosis (AHI ≥ 15 for coverage) via polysomnography or home sleep apnea test

Severity categoriesPolicy references AASM AHI cutoffs for mild/moderate/severe OSA

PAP adherence

PAP adherence definitionPAP adherence = ≥ 4 hours of use per night for ≥ 70% of nights

Role in coverageContinued symptoms despite PAP adherence must be documented or member must be a PAP candidate exception

Documentation requirement

Background — Drug and Indication Context

Tirzepatide (Zepbound) is described in the policy context as a dual glucose‑dependent insulinotropic polypeptide (GIP) and glucagon‑like peptide‑1 (GLP‑1) receptor agonist indicated with diet and exercise to reduce excess body weight and to treat moderate to severe obstructive sleep apnea in adults with obesity; product availability notes include pre‑filled pens and vials. (See dosing and product availability in the policy appendices.)

Site of Care

Note

No site-of-care restriction stated

The policy does not impose a site-of-care restriction; product availability lists pre-filled pens and vials for home use and no specific site limitation is stated.

Product available as pre-filled pens and vials in multiple strengths (chunk 21)
Policy notes no site-of-care restriction in the site-of-care module and coding section (chunk 24)

References and Informational Codes

No coverage or coding notes are explicitly listed in this document segment beyond the informational coding guidance that referenced HCPCS codes are provided for billing reference only and do not guarantee coverage.

Policy Summary

Payermeridian

PolicyTirzepatide (Zepbound) coverage for obstructive sleep apnea

Policy CodePolicy MDN.CP.PMN.298

Change TypeNo material changes

Effective DateDec 20, 2024

Last ReviewJun 25, 2026

Next Review DateJun 25, 2026

Key ActionSubmit prior authorization with documentation confirming AHI ≥15, BMI ≥30 kg/m2, baseline weight, PAP adherence or candidacy, and dose/titration plan.

SourceLink

On This Page

BMI formula provided in Appendix D: BMI = 703 x [weight (lbs)/height (inches)^2]

Maximum dose

Maximum weekly dose15 mg once weekly

Titration schedule summaryStart 2.5 mg once weekly and increase by 2.5 mg every 4 weeks up to 15 mg/week

Maintenance dose requirement for continuationAfter escalation, maintenance dose must be ≥ 5 mg once weekly (for continuation)

Billing Rule

Prior authorization implied; coding listed for information only

Prior authorization is implied by this policy and providers should be aware of the informational HCPCS codes listed; inclusion or exclusion of codes in the policy does not guarantee reimbursement and current coding guidance must be used when submitting claims.

HCPCS codes listed for informational purposes: C9399 (Unclassified drugs or biologicals) and J3490 (Unclassified drugs).
Inclusion/exclusion of codes does not guarantee coverage; reference up-to-date professional coding guidance prior to claim submission.

Step Therapy

GLP-1 trial required before Zepbound for members with T2DM

For members with concurrent type 2 diabetes mellitus, the provider must document failure of ≥ 3 consecutive months of the listed GLP-1 agents (Ozempic tablets, Trulicity, and Victoza) unless clinically significant adverse effects or contraindications exist; if switching from a current GLP-1, medical justification supporting the switch to Zepbound is required.

Failure of ≥ 3 months of Ozempic tablets, Trulicity, and Victoza is required unless adverse effects or contraindications.
If member is currently receiving a GLP-1 and requests switching to Zepbound, provide medical justification; intolerance from common GI adverse effects alone is not acceptable justification.

Step Therapy

Document PAP trial/adherence or documented PAP ineligibility

Providers must document a trial of PAP therapy when clinically appropriate: member must have continued OSA symptoms despite adherence to PAP (defined as ≥ 4 hours/night on ≥ 70% of nights) or documentation that the member is not a candidate for PAP therapy.

PAP adherence defined as ≥ 4 hours per night for ≥ 70% of nights.
If not a PAP candidate, document reason (e.g., upper airway anatomic abnormalities).

Documentation Required

Required supporting documentation to accompany PA requests

Submit supporting clinical documentation with the prior authorization: office chart notes, lab results, documentation of baseline body weight in kg, evidence of participation in a physician-directed weight loss program, prior therapies (including GLP-1 trial history), PAP adherence or contraindication, and objective/PRO measures used for renewal decisions.

Office chart notes and lab results confirming diagnosis and baseline weight (kg).
Documentation of enrollment/participation in a physician-directed weight loss program.
Records of prior GLP-1 therapy trials and any medical justification for switching.
PAP adherence data or documentation of PAP ineligibility.
Objective outcome data for renewals (e.g., ≥5% baseline weight loss at first renewal, AHI or SASHB improvement, or improved patient-reported outcomes).

Denial Risk

Denial risk if required documentation is not submitted

Failure to provide required documentation (office notes, labs, PAP adherence records, prior therapy history, baseline weight, or other clinical information) that the member meets all approval criteria may result in denial of the request.

Missing initial or continuing documentation may trigger claim or authorization denial.
Documentation is required for both initial approvals and renewals per policy updates.

Documentation Required

Documentation required for initial and continuing requests

Per the policy update, providers must supply documentation for both initial and continued therapy requests; the policy explicitly states that documentation must be provided in initial and continuing criteria.

Ensure supporting records are included with initial PA and with renewal requests.
Policy revisions note documentation requirement was added/updated for initial and continuing criteria.

Billing Rule

Coding/billing caution — inclusion/exclusion of codes does not guarantee coverage

The HCPCS codes included in the policy (C9399, J3490) are informational only — their presence or absence in this document does not guarantee coverage; providers must use current professional coding guidance when submitting claims.

Codes referenced: C9399 (Unclassified drugs or biologicals), J3490 (Unclassified drugs).
Reference the most up-to-date coding guidance prior to claim submission as code lists in the policy are not coverage guarantees.

Increase by 2.5 mg every 4 weeks during dose-escalation until the maximum tolerated dose of 10 mg or 15 mg (maximum 15 mg/week).

From Appendix D: Dosage and Administration

Dosing range for titration

Dosing escalates from 2.5 mg up to 15 mg weekly per schedule

Provider must submit documentation supporting PAP adherence or documentation that member is not a candidate for PAP

Patient-reported sleep measures

Instruments referencedValidated instruments include SAQLI, ESS, FOSQ, and PROMIS sleep measures

Use in continuation criteriaImprovements in AHI, SASHB, or patient-reported outcomes (e.g., ESS, SAQLI, FOSQ, PROMIS) are required evidence of response

Interpretation noteEach instrument has specified score interpretations per Appendix D (higher/lower scores indicate direction of impairment/improvement)

Sleep apnea-specific hypoxic burden (SASHB)

DefinitionSleep apnea-specific hypoxic burden (SASHB) = area under the oxygen desaturation curve measured during an overnight sleep study

Clinical significanceHigher SASHB values are associated with increased cardiovascular risk and mortality

Use in policyImprovement in SASHB can be used as an objective metric of response for continuation criteria