Zepbound (tirzepatide) drug quantity limits — Per Days
Defines per-days drug quantity limits and exception criteria for Zepbound (tirzepatide) for Cigna-administered health benefit plans; applies to pharmacy dispensing at retail and home delivery.
Quantity limits for multiple Zepbound strengths were changed to 2 mL (4 pens or vials) per 28 days at retail and 6 mL (12 pens or vials) per 84 days at home delivery.
Quantity limits for 2.5 mg pens and vials were clarified to accumulate across both dosage forms.
New quantity limits were added for multiple vial strengths (including 5, 7.5, 10, 12.5, 15 mg) at retail and home delivery.
Override criteria were removed for updated quantity limits; no clinical overrides apply.
Coverage Criteria
Quantity limits and exceptions
Covered when the following per‑days quantity limits are not exceeded; certain limited exceptions may be allowed as medically necessary when criteria are met.
Limits apply across pens and vials where specified.
No clinical overrides apply to the Per Days quantity limits except as explicitly stated.
Any request for an exception to the stated quantity limits that does not meet the specific exception criteria detailed in this policy is considered not medically necessary.
Requests that exceed the specified per‑days dispensing limits for Zepbound without meeting the policy’s explicit one‑time exception criteria are not medically necessary; there are no overrides to the Per Days quantity limits except as explicitly described.
Provider Actions and Billing Guidance
Coding / coverage mismatch — denial risk
Claims submitted for services that are not accompanied by covered diagnosis or procedure code(s) under the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of submission. Review coding carefully to avoid denial for coding/coverage mismatch.
- Claims submitted without covered codes will be denied.
Quantity limit exceedance — denial risk
Zepbound quantity limits are enforced by per‑days thresholds for retail and home delivery. Requests that exceed the per‑days quantity limits shown in this policy will be denied. No clinical overrides apply to these per‑days quantity limits.
- Retail maximum = 2 mL (4 pens or vials) per 28 days.
- Home Delivery maximum = 6 mL (12 pens or vials) per 84 days.
- No clinical overrides to the Per Days quantity limits.
Historic step / claim limit note
Historic note: The prior claim‑based limit that allowed approval of one claim collectively for one GLP‑1 or GLP‑1/GIP agonist every 21 days was previously included; that historical 21‑day claim‑limit reference has been removed from the active limits in this policy. See the HISTORY section for earlier revisions and context.
- Reference to prior claim‑based 21‑day limit removed (historical context).
General documentation expectations
Documentation submitted with a request must align with the member's benefit plan and include standard supporting clinical information sufficient to support medical necessity. Ensure documentation clearly justifies any exception requests and matches the codes and quantities billed.
- Documentation must align with the applicable benefit plan.
- Support clinical information should justify medical necessity and any exception requests.
Quantity Limits (Per-Days)
Step Therapy / Historical Limits
| Historic policy element | Action taken |
|---|---|
| One-claim per 21 days limit for GLP-1 or GLP-1/GIP agonists (collective: one claim for one GLP-1 or GLP-1/GIP agonist every 21 days at retail or home delivery) | Removed from this policy; retained instead in a separate 'Claim Per Days' policy (refer to Weight Loss - Glucagon-Like Peptide-1 Agonists Drug Quantity Management Policy - Claim Per Days) |
Definitions
Background
Zepbound (tirzepatide) is a GLP‑1/GIP receptor agonist indicated as an adjunct to a reduced‑calorie diet and increased physical activity for chronic weight management in adults with overweight plus at least one weight‑related comorbidity and for adults with obesity; dosing begins at 2.5 mg subcutaneously once weekly with planned titration to maintenance doses up to a maximum of 15 mg weekly. The policy defines per‑days dispensing limits for all Zepbound strengths and formulations (pens and vials) — including a retail maximum of 2 mL (4 pens or vials) per 28 days and a home delivery maximum of 6 mL (12 pens or vials) per 84 days — and notes that exceptions are limited and only covered as medically necessary when the policy’s specific criteria are met.
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