Clinical Policy: Anti-Obesity Medications
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Defines Delaware First Health (Medicaid) coverage, medical necessity criteria, and prior authorization requirements for specified anti-obesity medications for adults and pediatric members, and for indications including weight loss, MASH, and prevention of MACE.
Addition of Zepbound to the list of covered/managed anti-obesity agents.
Updated initial approval duration to 6 months and added criteria for MASH and MACE; removed Contrave, Xenical, and phentermine products from criteria.
Revised to align with Delaware Medicaid State Plan requirement for BMI plus a qualifying co-morbid condition and FDA-consistent use for anti-obesity medications.
Coverage and Medical Necessity Criteria
Initial Therapy - Weight Loss (Adults)
Covered when ALL of the following are met
Approval duration: 6 months in ≤ 30‑day supplies
Initial Therapy - Pediatrics
Covered when ALL of the following are met
Approval duration: 6 months in ≤ 30‑day supplies
Initial Therapy - MASH
Covered when ALL of the following are met
Approval duration: 6 months
Initial Therapy - MACE Prevention
Covered when ALL of the following are met
Approval duration: 6 months in ≤ 30‑day supplies
Continuation - Weight Loss
Continued coverage for Weight Loss is approved when the following are met
Continuation approvals up to 6 months, dispensed in ≤ 90‑day supplies
Continuation - MASH and MACE
Continued coverage for MASH or MACE is approved when the following are met
Per state guidance, reauthorization for MASH and MACE does not require resubmission of (unspecified) documentation
Per the most recent policy revisions, Contrave, Xenical, and phentermine products have been removed from this policy's managed anti-obesity medication list and are no longer included in the coverage criteria. This change aligns the policy with the Posted Drug List (PDL) and Delaware Medicaid State Plan updates implemented in 1Q2026, including the addition of new agents such as Zepbound and adjustments to initial approval durations.
Coverage is limited to uses that are consistent with FDA-approved labeling. Uses that are inconsistent with FDA-labeled indication, dose, route, frequency, or that involve an FDA-labeled contraindication—unless the prescriber documents and justifies that the clinical benefits outweigh the risks where labeling permits clinical judgment—do not meet medical necessity per this policy. Prescribers are expected to review the full FDA-approved prescribing information for each product and consider the contraindications and precautions summarized in the policy when requesting prior authorization.
Managed Medications and Thresholds
| NDC (not specified) | Listed products: Saxenda (liraglutide), liraglutide, Wegovy (semaglutide), Zepbound (tirzepatide) — specific NDCs not provided in document. |
Provider Requirements, Prior Authorization, and Denial Triggers
Prior authorization required for listed anti‑obesity agents
Prior authorization is required for the following anti‑obesity medications: Saxenda (liraglutide), liraglutide, Wegovy (semaglutide), and Zepbound (tirzepatide). Approvals for initial and specified indications are issued for 6 months (initial supplies ≤30 days; continuation supplies per criteria).
Step‑therapy: two preferred products required before non‑preferred agents
For adult members prescribed non‑preferred anti‑obesity products, the prescriber must document trial and failure of two (2) preferred products unless the member experienced clinically significant adverse effects or all preferred products are contraindicated.
- Trial/failure of two preferred products required for non‑preferred agents
- Exception: clinically significant adverse effects or contraindications
Required documentation to support prior authorization
Submit the member's relevant medical records and/or pharmacy profile plus appropriate baseline diagnostic and safety laboratory, biopsy, and/or noninvasive test results that demonstrate FDA‑labeled indication, required BMI criteria, and presence of any qualifying co‑morbid condition.
- Medical records and/or pharmacy profile
- Baseline diagnostic and safety labs, biopsy, and/or noninvasive test results
- Documentation must support FDA‑labeled use, BMI criteria, and qualifying co‑morbid condition
Triggers that may result in denial of prior authorization
Prior authorization may be denied if submitted documentation does not support FDA‑labeled use, the required BMI and qualifying co‑morbid condition per the Delaware Medicaid State Plan, failure to document required trials of preferred products for non‑preferred agents, missing baseline labs/tests/diagnostic results, or if continuation weight‑loss thresholds are not met.
- Lack of documentation supporting FDA‑labeled indication, dose, route, or frequency
- BMI not meeting >30 kg/m2 or >27 kg/m2 with qualifying co‑morbid condition where required
- No documented trial/failure of two preferred products for non‑preferred agents
- Missing baseline biopsy, lab, or noninvasive test results
- Continuation requests failing to show ≥5% adult (≥4% adolescent) weight loss from baseline
Clinical Definitions
Background and Clinical Context
Anti-obesity medications are intended as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. They may also be used for specified clinical indications such as treatment of MASH with moderate to advanced fibrosis or for prevention of major adverse cardiovascular events in eligible populations, when the member meets the policy’s BMI and comorbidity thresholds and all other coverage criteria. Prior authorization is required for listed agents, approvals are issued for 6 months per the updated approval durations, and continuation criteria require documentation of ongoing clinical benefit (including weight-loss thresholds where applicable).
Policy Revision History
Zepbound (tirzepatide) was added to the list of managed anti-obesity agents requiring prior authorization.
Policy revised per DMMA (Delaware Medicaid) revisions effective 2025-01-06.
Policy updated to match the Posted Drug List (PDL).
1Q2026 revisions to align with Delaware Medicaid State Plan and FDA labeling: clarified requirement for BMI plus qualifying co-morbid condition and FDA-consistent use of anti-obesity medications.
Initial approval duration updated to 6 months; criteria for MASH and MACE were added; Contrave, Xenical, and phentermine products were removed from the policy's managed anti-obesity medication list.
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