CurrentmhnPolicy HNCA.CP.CPA.359

Clinical Policy: Tirzepatide (Zepbound)

Policy defines medical necessity criteria, initial and continued approval requirements, dosing limits, exclusions, documentation and program participation requirements for coverage of tirzepatide (Zepbound) for weight management and obstructive sleep apnea (OSA) across specified lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Tirzepatide (Zepbound)

Policy CodePolicy HNCA.CP.CPA.359

Change TypeAdded OSA indication; criteria updates; product availability updates

Effective DateSep 24, 2024

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria including BMI, ≥6 months weight loss program participation, and recent height/weight within 30 days.

SourceLink

POLICY UPDATE CHANGES

Added OSA as FDA-approved indication and OSA-specific criteria including option for home sleep apnea test and AHI ≥15.

Updated initial criteria to require documentation of enrollment in weight loss program for at least 6 months and requirement to continue behavioral modification.

Added concurrent diabetes criteria with redirection to preferred GLP-1/GIP-GLP-1 agents prior to Zepbound.

Added new multidose single-patient use vial and KwikPen formulations following FDA approvals in January 2026.

Changed required documentation timing and follow-up and clarified grandfathering and gap-in-therapy windows (90 days) for transitions between benefits.

Added exclusion: compounded medications and samples are excluded from coverage.

Covered indications (weight management, OSA)

15OSA AHI threshold (events/hour)

5%First renewal weight loss threshold

15 mg/weekMaximum allowed dose

Coverage Summary

Coverage stance: covered_with_criteria for Zepbound (tirzepatide) consistent with FDA-approved indications to reduce excess body weight (in combination with a reduced-calorie diet and increased physical activity) and to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. Policy number: HNCA.CP.CPA.359. Effective date: 09.24. Last review date: 02.26.

Requirements and limits: coverage requires documentation of participation in a qualifying lifestyle/weight loss program (including reduced calorie diet, increased physical activity, and behavioral modification) with active participation for at least 6 months; diagnostic criteria and response criteria for the relevant indication (including recent BMI/weight documentation within the last 30 days); specified dosing titration and maximum dose limits (initial escalation per label with a maximum of 15 mg once weekly and indication-specific maintenance doses); exclusion of concurrent prescription of other tirzepatide-containing products or any other GLP-1 receptor agonist(s); and OSA-specific requirements including documentation of polysomnography or home sleep apnea test within the past 12 months with an AHI ≥ 15 events/hour and PAP adherence/candidacy criteria.

Policy alignment: the policy explicitly aligns coverage to the FDA indications and to labeled dosing/administration recommendations and incorporates OSA-specific criteria and lifestyle program participation as required components of medical necessity determinations.

Key thresholds

BMI thresholdSee Appendix B WHO classification (e.g., Obese = BMI ≥ 30 kg/m2) and plan-specific group thresholds

OSA severity (AHI)AHI ≥ 15 respiratory events per hour (moderate to severe OSA) confirmed by polysomnography or home sleep apnea test within last 12 months

PAP adherenceAdherence defined as ≥4 hours/night for ≥70% of nights, or documentation member is not a candidate for PAP therapy

First renewal weight lossMember must have lost ≥5% of baseline body weight at first renewal

Maximum doseDose does not exceed 15 mg once weekly (maximum)

Initial Approval Criteria — Weight Management

Initial Approval Criteria - Weight Management

Covered when ALL of the following are met:

Initial Approval Criteria — Obstructive Sleep Apnea (OSA)

Initial Approval Criteria - Obstructive Sleep Apnea (OSA)

Covered when ALL of the following are met:

ALL of the following

OSA diagnostic and severity: Diagnosis of moderate to severe OSA confirmed by recent polysomnography or home sleep apnea test within the past 12 months with an apnea-hypopnea index (AHI) ≥ 15 respiratory events per hourAHI ≥ 15 events/hour
Age ≥ 18 years
BMI ≥ 30 kg/m²
Exclude central/mixed:

Other Diagnoses / Indications

Other diagnoses/indications

When covered:

ANY of the following

Recent label change: If drug label changed within last 6 months not reflected in policy, follow no coverage or non-formulary policy CP.CPA.190 as applicable
Off-label referral: If requested use is not specifically listed under section III and criterion 1 does not apply, refer to off-label use policy CP.CPA.09

Continued Therapy — Weight Management

Continued Therapy - Weight Management

Covered when ALL of the following are met:

ALL of the following

Member status (grandfathering/transition)
- Incomplete initial therapy: If member has not completed 4 months of initial therapy, refer to Initial Therapy criteria
- Compounded/samples/LilyDirect: For members who received compounded tirzepatide, samples, or LilyDirect® self-pay Zepbound, refer to Initial Therapy criteria
- Previously met initial criteria: Currently receiving medication via Centene benefit or member has previously met initial approval criteria

Continued Therapy — OSA

Continued Therapy - OSA

Covered when ALL of the following are met:

ALL of the following

Member status
- Incomplete initial therapy: If member has not completed 4 months of initial therapy, refer to Initial Therapy criteria
- Compounded/samples/LilyDirect: For members who received compounded tirzepatide, samples, or LilyDirect® self-pay Zepbound, refer to Initial Therapy criteria
- Currently receiving/previously met criteria: Currently receiving medication via Centene benefit or member has previously met initial approval criteria

Diagnoses / Indications Not Authorized

Diagnoses/Indications NOT authorized

Not covered unless exception applies:

Non-FDA indications not authorized: Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation per off-label use policy CP.CPA.09 or evidence of coverage documents is provided

Provider Actions

Prior Authorization

Prior authorization required with documentation

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria including BMI and weight loss program participation; prior authorization may be required for certain criteria.

Documentation Required

Weight and BMI documentation

Document baseline and current body weight and height for BMI calculation within the last 30 days; documentation of enrollment and active participation in an approved weight loss program (including reduced calorie diet, increased physical activity, and behavioral modification) for at least 6 months prior to therapy is required and member must agree to continue the program during treatment.

Applicable Codes

Informational HCPCS codes referencedHCPCS

C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs

Clinical Evidence & Guidelines

Evidence summary: key clinical trials and guideline references cited in the policy include SURMOUNT-1 and SURMOUNT-2 (major phase 3 obesity trials), and the NEJM 2024 trial of tirzepatide for obstructive sleep apnea. The policy also references guideline sources including the Endocrine Society, AACE/ACE, and the American Academy of Sleep Medicine (AASM).

The policy notes that these trials and guidelines support tirzepatide's efficacy for weight reduction and improvement in OSA-related endpoints, and uses those references to define diagnostic thresholds and response criteria for continued coverage.

Background

Background: Zepbound (tirzepatide) is a GIP and GLP-1 receptor agonist FDA-indicated in combination with a reduced-calorie diet and increased physical activity to (1) reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight with at least one weight-related comorbidity, and (2) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. The label advises against coadministration with other tirzepatide-containing products or any GLP-1 receptor agonist.

Policy alignment and requirements: the coverage policy aligns to the FDA indications and label-based dosing/titration. It requires documentation of enrollment and active participation in a weight loss program (reduced calorie diet, increased physical activity, behavioral modification) for at least 6 months prior to use and continued participation while on therapy. For OSA, the policy requires diagnostic confirmation by polysomnography or home sleep apnea test within the prior 12 months with an AHI ≥ 15 events/hour and either continued symptoms despite PAP adherence or documented candidacy issues for PAP.

Definitions (glossary): Weight loss plateau — cessation of weight loss before reaching goal at around 6 to 9 months despite clinical interventions, including pharmacologic assistance.

AHI — apnea-hypopnea index; the number of apnea and hypopnea events per hour used to classify OSA severity.

Revision History

2024-09-24policy_effective

Policy effective date (clinical policy HNCA.CP.CPA.359) established.

2026-02-26policy_reviewLatest

Last review date recorded for the policy.

02.14.25added

Added OSA as FDA-approved indication and OSA-specific criteria including option for home sleep apnea test and AHI ≥ 15.

Policy Summary

Payermhn

PolicyClinical Policy: Tirzepatide (Zepbound)

Policy CodePolicy HNCA.CP.CPA.359

Change TypeAdded OSA indication; criteria updates; product availability updates

Effective DateSep 24, 2024

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria including BMI, ≥6 months weight loss program participation, and recent height/weight within 30 days.

SourceLink

On This Page

Member does not have central or mixed sleep apnea

Concurrent type 2 diabetes mellitus requirements (if applicable)

Step therapy agents failed: Failure of ≥ 3 consecutive months each of all of the following unless clinically significant adverse effects or contraindications: (i) Ozempic or Rybelsus; (ii) Trulicity; (iii) Liraglutide (Victoza); (iv) Mounjaro
Switch justification: If member is currently receiving a GLP-1 receptor agonist and requesting to switching to Zepbound, medical justification supports necessity for Zepbound
Not acceptable justification: Intolerance due to common adverse effects of the GLP-1 receptor agonists class such as gastrointestinal symptoms is not considered acceptable medical justification

Weight loss program participation

Program documentation: Documentation supports member's participation in a Health Net approved weight loss program (e.g., Weight Watchers, Active&Fit) or other lifestyle modification plan recommended by the prescriber
Duration prior to use: Active participation in a weight loss program for at least 6 months prior to use of Zepbound
Ongoing participation: Will continue to be actively enrolled in a weight loss program or lifestyle modification plan while concomitantly prescribed Zepbound

PAP adherence or candidacy

PAP adherence: Member has continued symptoms of OSA despite adherence to positive airway pressure (PAP) therapy, defined as ≥ 4 hours of use per night for ≥ 70 percent of nightsPAP ≥4 hrs/night, ≥70% nights
PAP not candidate: Member is not a candidate for PAP therapy (e.g., upper airway anatomic abnormalities, etc.)

Concurrent therapy exclusion: Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s)

Baseline weight documentation: Documentation of member's baseline body weight within the last 30 days

Dose limits for OSA

Titration schedule: Week 1-4: 2.5 mg once weekly; Week 5-8: 5 mg once weekly; Week 9-12: 7.5 mg once weekly; Week 13-16: 10 mg once weekly
Pen quantity: One pen per week

New members transitioning to Health Net from another health plan will not be grandfathered unless they have at least one indicator of increased cardiovascular risk or another obesity-related medical condition (e.g., sleep apnea)

Higher BMI grandfathering: Current Health Net members transitioning to a new benefit plan that has higher BMI threshold may be grandfathered; if member stops taking drug for > 90 days since last refill date, a new authorization will be required at their current benefit

Continuity of care: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)

Response to therapy

First renewal response: If first renewal request, member has lost ≥ 5% of baseline body weight≥5%
Subsequent renewal response: If second or subsequent renewal request, member has lost weight and/or maintained weight loss on therapy

Documentation of current weight: Documentation of member's current weight within the last 30 days

Follow-up visits: Followup visits are planned to assess adherence and response

Concurrent therapy exclusion: Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s)

Active weight loss program enrollment: Documentation that member is actively enrolled in a Health Net approved weight loss program or lifestyle modification plan recommended by the prescriber

Request requirements

Max dose: Dose does not exceed 15 mg once weekly≤15 mg/week
Maintenance dose: After initial dose escalation period, maintenance dose is ≥ 5 mg once weekly≥5 mg/week
Quantity limit: Requested quantity does not exceed one pen per week1 pen/week

Continuity of care: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)

Response to therapy for OSA

First renewal: Member has lost ≥ 5% of baseline body weight AND any of the following: (1) AHI reduction from baseline; (2) Improvement from baseline in SASHB score; (3) Improvement from baseline in any one sleep-related patient reported outcome scores (e.g., ESS, Calgary SAQLI, FOSQ, PROMIS)≥5% and improvement in at least one OSA metric
Second or subsequent renewal: Member has lost weight and/or maintained weight loss on therapy AND stabilization or improvement in any of: (1) AHI; (2) SASHB; (3) Sleep-related patient reported outcome scores (e.g., ESS, Calgary SAQLI, FOSQ, PROMIS)weight loss/maintenance and stabilization or improvement in OSA metrics

Concurrent therapy exclusion: Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s)

Active program enrollment: Documentation that member is actively enrolled in a Health Net approved weight loss program or other lifestyle modification plan recommended by the prescriber

Request requirements for OSA continued therapy

Max dose: Dose does not exceed 15 mg once weekly≤15 mg/week
Maintenance dose: After initial dose escalation period, maintenance dose is ≥ 10 mg once weekly≥10 mg/week
Quantity limit: Requested quantity does not exceed one pen per week1 pen/week

Denial Risk

Concurrent therapy exclusion

Claims may be denied if Zepbound is prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s); Zepbound must not be prescribed concurrently with these agents per policy and label limitations.

Billing Rule

Quantity limit

Requested quantity must not exceed one pen per week; dosing must follow initial titration schedule and the dose must not exceed 15 mg once weekly (maintenance/continued therapy).

Step Therapy

Preferred GLP-1 agonists for members with T2DM

For members with concurrent type 2 diabetes mellitus, failure of each preferred agent (Ozempic® or Rybelsus®, Trulicity®, Liraglutide [Victoza®], and Mounjaro®) for ≥ 3 consecutive months is required prior to Zepbound unless clinically significant adverse effects or contraindications exist.

Documentation Required

OSA diagnostic test requirement

For the OSA indication, provide a recent polysomnography or home sleep apnea test performed within the past 12 months showing an apnea-hypopnea index (AHI) ≥ 15 events per hour.

Documentation Required

PAP adherence documentation for OSA

Document continued symptoms of OSA despite adherence to positive airway pressure (PAP) therapy, defined as ≥ 4 hours of use per night for ≥ 70% of nights, or provide documentation that the member is not a candidate for PAP therapy (e.g., upper airway anatomic abnormalities).

05.09.25revised

Updated initial criteria to require documentation of enrollment in weight loss program for at least 6 months, required continuation of behavioral modification, and added Rybelsus to preferred GLP-1 agents for concurrent diabetes.

08.22.25added

Added exclusion of compounded medications and samples from coverage; added BMI and dose titration exceptions for members switching from Wegovy due to weight plateau; revised approval durations and temporary dosing limits.

11.10.25revised

For OSA, updated PAP criterion to require continued symptoms despite PAP adherence or documentation that member is not a candidate; added HIM line of business and clarified grandfathering and gap-in-therapy windows.

01.07.26 - 01.20.26added

Added new multidose single-patient-use vial and KwikPen formulations following FDA approvals in January 2026 (new product availability entries).