Prior Authorization Questionnaire for GLP-1 Receptor Agonists (Wegovy, Zepbound)
Forms and clinical criteria for prior authorization of Wegovy and Zepbound for specific indications (cardioprotection, NASH/MASH, and obstructive sleep apnea) affecting prescribers and pharmacy prior authorization reviewers for UnitedHealthcare NC Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria and Indication-Specific Requirements
Initial request — Wegovy for cardioprotection
Covered when ALL of the following are met
Form items 1-7 capture these requirements
Initial request — Wegovy for NASH/MASH
Covered when ALL of the following are met
Form items 1-13 capture these requirements
Initial request — Zepbound for obstructive sleep apnea (OSA)
Covered when ALL of the following are met
Form items 1-9 capture these requirements
Continuation requests for Wegovy and Zepbound
Covered when ALL of the following are met
Continuation forms (chunks 7 and 9) list these items
The following conditions are exclusionary or contraindicating for initiation or continuation of GLP-1 receptor agonist therapy in the covered indications: a personal or family history of medullary thyroid carcinoma and a diagnosis of multiple endocrine neoplasia type 2 (MEN2). These exclusions are explicitly queried on the Wegovy cardioprotection and NASH/MASH forms and on the Zepbound sleep apnea form where FDA-labeled contraindications (including medullary thyroid cancer and MEN2) are listed and must be absent prior to approval (see form items asking about personal/family history of medullary thyroid carcinoma and MEN2, and the FDA‑labeled contraindications item for Zepbound).
Therapy is considered not medically necessary for continuation when supporting documentation is missing or the clinical requirements are not met. Specifically, continuation requests must include evidence that the beneficiary was previously approved through Medicaid prior authorization (or completed an initial evaluation review) and must include medical documentation that the beneficiary has improved while on the medication and that individual clinical goals are being met. Absence of prior approval when required, lack of documentation of improvement, failure to meet individual clinical goals, or use that is outside the FDA‑approved indication, age, weight, or dosing limits may render continued therapy not medically necessary.
Initial Therapy Requirements
Initial therapy requirements
Initial therapy requests must document the following baseline assessments, testing, exclusions, and lifestyle modification efforts:
Form items capture required measurements and tests
See chunks 4, 5, and 8
Form items 6, 7 (chunk 4); items on lifestyle and specialist consultation (chunks 5, 6, and 8)
Continuation Therapy Requirements
Continuation therapy requirements
Continuation requests require documentation that prior approval was obtained when applicable and that the beneficiary is deriving ongoing clinical benefit.
Chunks 7 and 9 capture continuation requirements
Key Coding & Demographic Thresholds
Provider Actions, Prior Authorization & Documentation
NC Medicaid Prior Authorization Required
Prior authorization through NC Medicaid is required for beneficiaries when the requested agent is a Medicaid-covered product. Ensure the beneficiary has an active prior approval in NC Medicaid for the requested agent for the covered indication(s); beneficiaries not previously approved will require an initial evaluation review and may need full PA documentation.
- Confirm prior approval exists for the requested agent through NC Medicaid prior authorization.
- If no prior approval exists, include complete initial evaluation documentation per NC Medicaid requirements.
Step / Previous Approval Check
Check whether step-therapy or previous authorization requirements apply and document prior approvals or trials. Confirm and record whether the beneficiary was previously approved for the same agent and indication and whether any required step or prior-authorization criteria were met before this request.
- Has the beneficiary been previously approved for the requested agent through Medicaid PA? (Yes/No)
- If step-therapy applies, document prior medication trials and outcomes.
- If prior approvals exist, attach approval details (authorization number, dates, indication).
Required Supporting Clinical Documentation
Submit comprehensive clinical documentation to support the medical necessity of the request. Include baseline measures, diagnostic test results, risk factors, and records demonstrating adherence to required nonpharmacologic interventions. Tailor supporting documents to the indication (e.g., cardioprotection, NASH/MASH, sleep apnea) as shown below.
- Baseline weight and BMI with dates.
- Relevant diagnostic test results: cardiac history for CVD, FIB-4 score, liver biopsy/VCTE/ELF/MRE for NASH/MASH, sleep study documentation for OSA.
- Age documentation when age limits apply (e.g., ≥18 or ≥45 as specified).
- Documentation of at least 3 months of lifestyle modification prior to therapy when required, and ongoing structured nutrition/physical activity plan.
- Documentation of exclusion criteria screening (personal/family history of medullary thyroid carcinoma, MEN2, contraindications, pregnancy/lactation).
- Medication review showing evaluation for dose reductions or discontinuations of comorbid condition drugs if applicable.
- Individual clinical goals and evidence of improvement/progress toward goals if this is a continuation or renewal request.
Medicaid Prior Approval and Improvement Documentation
If no prior Medicaid approval is present or documentation of clinical improvement/ongoing benefit is not provided for continuation requests, the request may be denied. Ensure improvement and goal attainment are documented for continuation/renewal submissions.
- Include objective evidence of improvement or progress toward individualized clinical goals for continuation requests.
- Absence of prior approval for the agent or missing improvement documentation may result in denial.
- For continuation, explicitly answer whether clinical goals are being met and whether adequate progress continues.
Definitions and Diagnostic Criteria
Step Therapy and Prior Approval History
| Step | Requirement / Action | Documentation to provide | Coverage status |
|---|---|---|---|
| 1 | Confirm whether beneficiary was previously approved through Medicaid prior authorization for the requested agent (beneficiaries not previously approved will require an initial evaluation review) | Answer to prior approval question on PA form; copy of prior approval or prior authorization decision if available | Previously approved: continue to continuation criteria; Not previously approved: initial review required |
| 2 | Provide medical documentation that beneficiary has improved while on the medication | Clinical notes showing objective improvement, weight/BMI trends, symptom improvement, or relevant test results | Documentation of improvement required for continuation |
| 3 | Confirm individual clinical goals set by provider are being met | Care plan or progress notes specifying goals and evidence that goals are met | Must demonstrate goals met to support continued coverage |
| 4 | Confirm beneficiary is continuing to make adequate progress toward treatment goals | Ongoing progress notes, follow-up visit documentation, or objective measures over time | Required to justify continued therapy |
| 5 | Verify product remains prescribed per FDA-approved indication, age, weight, and dosing limits | Prescription details and prescriber attestation that dosing/indication/age/weight align with FDA labeling | Required for coverage continuation |
| 6 | Confirm continued lifestyle modification (structured nutrition and physical activity) unless not clinically appropriate | Documentation of counseling, referrals to nutrition/behavioral programs, or clinician notes describing lifestyle interventions | Expected as part of ongoing management |
| 7 | Confirm the agent is not being used concomitantly with another GLP-1 receptor agonist | Medication list showing no concurrent GLP-1 or provider statement if combination clinically justified (but generally not allowed) | Concurrent GLP-1 use not permitted for continuation |
| 8 | Confirm absence of any FDA‑labeled contraindications to the requested agent | Relevant clinical history or test results documenting no contraindications (e.g., pregnancy, lactation, medullary thyroid carcinoma, MEN2 where applicable) | Presence of FDA‑labeled contraindication may render therapy not covered |
| 9 | Provide documentation that provider reviewed medication list for possible dose reductions or discontinuations of comorbid condition drugs as appropriate | Medication reconciliation notes specifying changes or planned monitoring for dose adjustments | Required as part of continued therapy review |
Background
This document collects the baseline and monitoring information required to support prior authorization requests for GLP‑1 receptor agonists (Wegovy and Zepbound) in UnitedHealthcare NC Medicaid. It is designed to capture indication‑specific eligibility criteria (cardioprotection with Wegovy, noncirrhotic NASH/MASH with Wegovy, and obstructive sleep apnea with Zepbound), baseline metrics such as age and baseline weight/BMI, required diagnostic testing (e.g., liver biopsy, VCTE, ELF, MRE for NASH/MASH; sleep apnea testing for Zepbound), presence or absence of exclusionary conditions (for example, medullary thyroid carcinoma or MEN2), documentation of prior lifestyle modification, and evidence of specialist involvement when specified. The collected information will be used by prior authorization reviewers to determine whether the coverage criteria for initial or continuation therapy have been met.
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