CurrentCignaPolicy N/A

Diabetes GLP‑1 and GLP‑1/GIP agonists quantity limits (Claim Per Days)

Defines Claim Per Days drug quantity management limits and one-time override rules for several GLP‑1 and GLP‑1/GIP agents for Cigna health benefit plans; affects pharmacy benefit adjudication for listed products.

Policy Summary

PayerCigna

PolicyDiabetes GLP‑1 and GLP‑1/GIP agonists quantity limits (Claim Per Days)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 30, 2024

Key ActionApprove a one-time override for one additional claim when a patient is switching strengths or switching to a listed GLP‑1/GLP‑1‑GIP agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9+GLP-1 / GLP-1‑GIP agents listed

Claim Per DaysQuantity limit type applied

One-timeSwitching allowed

10/30/2024Policy review date

Coverage and Exception Criteria

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Claim Per Days baseline: The drug is one of the GLP-1 or GLP-1/GIP agonists listed in the policy and prescribed within the Claim Per Days quantity limits as applied (may be combined with product-specific Per Days limits).per product-specific limits

See product table for forms/strengths

One-time override: switching strengths of same product: If the patient is switching from one strength of the same product to another strength, approve a one-time override for one additional claim at retail or home delivery.one-time

Applies to listed products (e.g., Byetta, Mounjaro, Ozempic, Rybelsus, Trulicity).

One-time override: switching agents: If the patient is switching from another GLP-1 agonist or GLP-1/GIP agonist to the listed product, approve a one-time override for one additional claim at retail or home delivery.one-time

Applies across listed GLP-1 / GLP-1/GIP agents (policy lists other agents in notes).

Any exception to the Claim Per Days quantity limits that does not meet the criteria specified in this policy is considered not medically necessary. The Claim Per Days rule applies to the GLP‑1 and GLP‑1/GIP agents listed in the policy (see Appendix/Table) and, where noted, only applies to claims for a supply of ≥ 28 days.

Provider Actions, Documentation, and Billing

Denial Risk

Denial risk for excess quantity

Any claim exceeding the Claim Per Days quantity limits or exceptions not meeting the listed criteria is considered not medically necessary and may be denied. Providers should verify the approved quantity limits for the specific GLP‑1 or GLP‑1/GIP product and submit supporting documentation when requesting quantities above the limit.

Applies to all listed GLP‑1 and GLP‑1/GIP products
Excess quantities may be denied at point-of-sale or during claim review

Documentation Required

Documentation & review standards

Coverage determinations require consideration of the applicable benefit plan document, relevant laws/regulations, any pertinent collateral materials (including coverage policies), and the specific facts of the situation. Medical directors have discretion to make individual determinations. Providers must submit clinical documentation sufficient to demonstrate medical necessity for requested quantities, including diagnosis, prior treatments, dosing history, and rationale for exceeding standard per‑product or Claim Per Days limits.

Include copies of the patient’s benefit plan when relevant
Provide prior therapy history and objective clinical data supporting need
Attach prescribing information showing dose and quantity requested

Step Therapy

Step therapy not specified

This Claim Per Days policy focuses on quantity limits and one-time overrides where specified; it does not establish a step therapy sequence or require failure of other agents before coverage under this Claim Per Days rule. If a separate product‑specific policy contains step therapy, those requirements remain applicable.

No step therapy sequence or prerequisite failures specified in this Claim Per Days policy
Check individual product policies for any step therapy requirements

Prior Authorization

Claim Per Days quantity limits — application and exceptions

The Claim Per Days quantity limits apply to the GLP‑1 agonists and GLP‑1/GIP agonists listed in Appendix A and may be enforced alone or together with product‑specific Per Days limits. Exceptions (such as one-time overrides noted in product policies) must be documented and justified in the medical record; unsupported exceptions will be treated as not medically necessary.

Limits may be applied in conjunction with per‑product limits
One-time overrides require documentation and justification
Refer to Appendix A for included drugs

Background

GLP‑1 receptor agonists and GLP‑1/GIP agonists addressed by this policy are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. This Claim Per Days drug‑quantity management program defines product‑specific maximums and one‑time overrides; where noted the Claim Per Days rule applies only to claims for a supply of ≥ 28 days and coverage determinations follow the criteria listed in this policy.

Definitions and Drug Class

inv-09: GLP-1 / GLP-1/GIP agonists — Therapeutic class

DefinitionTherapeutic class of injectable and oral agents used to improve glycemic control in type 2 diabetes; includes GLP-1 receptor agonists and GLP-1/GIP agonists listed in Table 1.

Included products (examples)Byetta, Bydureon BCise, Mounjaro, Ozempic, Rybelsus, Trulicity, Victoza, Adlyxin, Saxenda, Wegovy, Zepbound (listed in Table 1).

Clinical roleIndicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes; some agents have pediatric or cardiovascular indications per prescribing information.

Combination useGLP-1 and GLP-1/GIP agonists should not be combined with each other or with any other GLP-1 agonists or GLP-1/GIP agonists.

One-time Overrides for Initial Claims

One-time overrides for switches

One-time overrides for initial claims when switching strengths or agents

Byetta overrides: Approve a one-time override for one additional claim when switching strengths of Byetta or switching to Byetta from another GLP-1/GLP-1-GIP agent.

Bydureon BCise overrides: Approve a one-time override for one additional claim when switching to Bydureon BCise from another GLP-1/GLP-1-GIP agent.

Mounjaro overrides: Approve a one-time override for one additional claim when switching strengths of Mounjaro or switching to Mounjaro from another GLP-1/GLP-1-GIP agent.

Ozempic overrides: Approve a one-time override for one additional claim when switching strengths of Ozempic or switching to Ozempic from another GLP-1/GLP-1-GIP agent.

Rybelsus overrides: Approve a one-time override for one additional claim when switching strengths of Rybelsus or switching to Rybelsus from another GLP-1/GLP-1-GIP agent.

Trulicity / Victoza overrides: Approve a one-time override for one additional claim when switching strengths of Trulicity or switching to Trulicity or liraglutide (Victoza) from another GLP-1/GLP-1-GIP agent.

Continuation Therapy

Continuation therapy

Approvals are provided for the duration noted in each product-specific Per Days policy where applicable.

Continuation: Ongoing therapy must remain within Claim Per Days and product Per Days limits; no separate continuation criteria specified in this document.

Step Therapy

Step	Requirement
0	No specific step therapy steps are defined in this Claim Per Days policy; the program focuses on Claim Per Days quantity limits and permitted one-time overrides when switching strengths or agents. For product-specific Per Days limits, refer to each product's Per Days Drug Quantity Management policy. All approvals are provided for the duration noted in the applicable policy.

Product-specific Quantity Limits

inv-13: Multiple listed GLP-1 / GLP-1-GIP products — Claim Per Days maxima

ScopeProduct-specific Claim Per Days maximum quantities apply to the GLP-1 and GLP-1/GIP products listed in the policy (see product entries/table for per-product maxima).

Unit of measureLimits are expressed as Claim Per Days maximum quantities; units and maximums vary by product, form, and strength.

ApplicationQuantity limits apply to retail and home delivery claims as specified per product entry.

Reference for included drugsRefer to Appendix/Table 1 for the full list of drugs included in these Claim Per Days limits.

inv-14: Byetta — Claim Per Days rule for ≥28-day claims

ApplicabilityThis Claim Per Days rule for Byetta applies to claims for a supply of ≥ 28 days (per note α/β).

Product form/strengths listedByetta prefilled pens available as 5 mcg/0.02 mL (1.2 mL) and 10 mcg/0.04 mL (2.4 mL) dose pens; see Table 1 for details.

One-time overrideApprove a one-time override for one additional claim when switching strengths of Byetta or switching to Byetta from another GLP-1/GLP-1-GIP agent.

Claims processingQuantity limits and the ≥28-day supply restriction apply to retail and home delivery adjudication for Byetta as specified in the policy.