CurrentCignaPolicy 1201

Quantity Limitations for Drugs and Biologics

Defines Cigna's product-specific quantity limits, exception criteria, and one-time override rules for medications and biologics for covered health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyQuantity Limitations for Drugs and Biologics

Policy CodePolicy 1201

Change TypeMultiple product removals, additions, and quantity updates

Effective DateFeb 15, 2026

Next Review Date

Key ActionIf a Quantity Limitation rule is not met at point of service, submit a request for coverage review—one-time approvals are provided for 30 days.

SourceLink

POLICY UPDATE CHANGES

Stelara removed from the policy.

Cosentyx removed from the policy.

Added quantity limits for Xifaxan 200 mg and updated quantity limits for Xifaxan 550 mg.

Adalimumab quantity limit exception criteria removed and relocated to a new policy DQM005.

Added quantity limits for Qelbree, Symbravo, and Zoryve foam.

Tremfya, Cimzia, Kineret, Rinvoq/Rinvoq LQ removed and some relocated to separate DQM policies.

~60+products with product-specific quantity limits listed

30 daysstandard one-time approval duration

2026-02-15effective date

1201policy identifier

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Exceptions

Exceptions to Quantity Limit

Drugs and Biologics are considered medically necessary to exceed generally accepted quantity limitations when EITHER of the following are met:

Allowed exceptions: Dosage, frequency, site of administration, and duration of therapy is supported by the FDA product information (Label)

Supportive evidence examples include FDA product information (Label).

Allowed exceptions: Dosage, frequency, site of administration, and duration of therapy are reasonable, clinically appropriate, and supported by evidence-based literature or standard medical compendia

Supportive evidence examples include standard compendia (for example, AHFS-DI); adjustments may be based on severity, alternative treatments, and previous response to therapy.

Product-specific Limits

Product-specific Quantity Limitations and Additional Exceptions (selected examples):

Aciphex (rabeprazole): 5 mg: 4 sprinkle caps/day; 10 mg: 2 sprinkle caps/day; 20 mg: 1 tablet/day

Additional exceptions: Zollinger-Ellison syndrome — additional quantities for doses between 60 mg and 120 mg/day; Helicobacter pylori — additional quantities up to 80 mg/day for up to 14 days.

Enbrel (etanercept): 25 mg: 8 vials or pre-filled syringes per 28 days; 50 mg: 4 Sureclicks or pre-filled syringes per 28 days

Additional exception: induction for plaque psoriasis — quantity limit to FDA recommended dose.

Budesonide/Formoterol (Symbicort): 1 inhaler per month

If used as reliever therapy for asthma, approve up to 2 inhalers per dispensing.

Budesonide nebulizer suspension (Pulmicort Respules): 0.25 mg/2 mL and 0.5 mg/2 mL: 60 respules; 1 mg/2 mL: 30 respules

Overrides: for esophageal eosinophilia/eosinophilic esophagitis approve up to 60 respules; age ≥11 with prescriber‑required >1 mg/day approve up to 120 respules; chronic COPD exacerbation — one‑time override up to 240 respules.

Qelbree (viloxazine ER): 100 mg: 1 capsule/day; 150 mg: 2 capsules/day; 200 mg: 3 capsules/day

If patient is 6–11 years and titrating, approve a one‑time override for up to 70 capsules; no overrides recommended for 150 mg or 200 mg strengths.

Xifaxan (rifaximin): 200 mg: 9 tablets/30 days (27/90 days); 550 mg: 42 tablets/30 days (126/90 days)

Exceptions: chronic antibiotic‑dependent pouchitis — approve up to 300 tablets per dispensing (retail) or 900 tablets (home delivery); for hepatic encephalopathy the 550 mg quantity limit does not apply.

Paxlovid (nirmatrelvir/ritonavir): One course of treatment every 120 days

A one‑time override for a second course is available if BOTH: A) patient has a repeat COVID‑19 diagnosis (a second distinct diagnosis), AND B) at least 90 days have elapsed since completion of the initial course.

Ingrezza (valbenazine): 40 mg, 60 mg and 80 mg: 30 capsules per Rx; Initiation Blister Pack: 28 capsules per Rx

If initiating therapy and increasing daily dose from 40 mg to 80 mg, approve a one‑time override for the requested quantity not to exceed 60 capsules (retail and home delivery).

Symbravo (meloxicam and rizatriptan): 9 tablets per 28 days

If used intermittently for acute migraine (not continuous/daily prevention), approve a one‑time quantity override for an additional 9 tablets (retail or home delivery).

Vtama / Zoryve (topical products): Vtama: 1 tube (60 g) per 30 days; Zoryve cream: 1 tube (60 g) per 30 days; Zoryve foam: 1 can (60 g) per 30 days

If treating greater than specified % body surface area, approve larger quantity up to policy caps (e.g., Vtama/Zoryve cream up to 180 g; Zoryve foam up to 240 g depending on formulation).

Any exception not listed in the product-specific table or supported by the FDA product information, standard medical compendia, or evidence-based literature is considered not medically necessary. Product-specific additional exceptions are noted in the tables; requests that rely on exceptions outside those tables must include supporting documentation showing conformity with the FDA label or recognized compendia/literature to be considered.

Requests to exceed published quantity limitations that do not meet either FDA product labeling support or backing from evidence-based literature or standard compendia will be considered not medically necessary and are subject to denial. Documentation must demonstrate that the requested dosage, frequency, site of administration, and duration align with these sources to justify an exception.

Product-Specific Quantity Limits

Aciphex (rabeprazole) — per-product daily limits

Aciphex 5 mg4 sprinkle caps per day

Aciphex 10 mg2 sprinkle caps per day

Aciphex 20 mg1 tablet per day

Budesonide nebulizer suspension (Pulmicort Respules) — per-product package limits

Pulmicort Respules 0.25 mg/2 mL60 respules per dispensing

Pulmicort Respules 0.5 mg/2 mL60 respules per dispensing

Pulmicort Respules 1 mg/2 mL30 respules per dispensing

Coding and Dispensing Details

Covered Codes (general instruction)mixed

No codes listed

Product-specific daily/dispensing limits

Aciphex 20 mg1 tablet per day

Enbrel 50 mg4 pre-filled syringes per 28 days

Qelbree 200 mg3 capsules per day

Xifaxan 550 mg42 tablets per 30 days

Pulmicort Respules 0.5 mg/2 mL60 respules per dispensing

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization for Overrides

If the Quantity Limitation rule is not met at the point of service, the request will be reviewed against the policy criteria and may be approved as a one-time override for up to 30 days when criteria are satisfied.

One-time approvals provided for 30 days in duration.
Overrides considered only when dosage/frequency/site/duration are supported by FDA labeling or evidence-based literature.

Note

Providers may be required to take specific actions at the time of service or during prior authorization submission to facilitate review and payment.

Submit prior authorization requests when dispensing quantities exceed the program limits.
Use most appropriate and current procedure/diagnosis codes when billing.

Initiation and One-Time Approval Rules

Initiation exceptions

One-time approvals and special initiation allowances:

Paxlovid second course override: One-time override available for a second course if patient has a repeat COVID-19 diagnosis and at least 90 days have elapsed since completion of the initial Paxlovid course.

One-time approvals are provided for 30 days in duration.

Ingrezza initiation dose escalation: If initiating therapy and increasing daily dose from 40 mg to 80 mg, approve a one-time override for the requested quantity not to exceed 60 capsules (retail and home delivery).

One-time approvals are provided for 30 days in duration.

Qelbree pediatric titration: For patients aged 6–11 years titrating Qelbree, approve a one-time override up to 70 capsules.

One-time approvals are provided for 30 days in duration.

Induction and Step Therapy Rules

Product	Induction (allowed) / One-time allowance	Maintenance / Routine quantity rule
Skyrizi (risankizumab-rzaa)	Induction: quantity per FDA recommended dose for plaque psoriasis induction (additional quantities allowed).	Maintenance: 75 mg — 1 kit per 84 days (2 syringes); 150 mg — 1 syringe/pen per 84 days.
Siliq (brodalumab)	Induction: quantity per FDA recommended dose for plaque psoriasis induction (additional quantities allowed).	Maintenance: 2 syringes per 28 days.
Simponi (golimumab)	Induction: quantity per FDA recommended dose for ulcerative colitis induction (additional quantities allowed).	Maintenance: 50 mg — 1 pen or pre-filled syringe per 28 days; 100 mg — 1 pen or pre-filled syringe per 28 days.
Taltz (ixekizumab)	Induction: follow FDA recommended induction dosing for plaque psoriasis (additional quantities allowed).	Maintenance: 1 auto-injector per 28 days.
Enbrel (etanercept)	Induction: quantity limit may be set to FDA recommended induction dosing for plaque psoriasis (additional quantities allowed).	Maintenance: 25 mg — 8 vials or pre-filled syringes per 28 days; 50 mg — 4 pre-filled syringes per 28 days.

Site of Care Considerations

Note

Site-of-care relevance limited to FDA‑supported dosing/frequency

Site of care is considered only insofar as dosage, frequency, and administration supported by FDA labeling and the plan terms; it does not independently change coverage beyond those parameters.

Background and Rationale

Quantity limits are established to promote the safe, effective, and economical use of medications and biologics. Limits and frequency restrictions are set in accordance with FDA dosing and product information, standard medical reference compendia, and the evidence-based literature to ensure appropriate dosing, reduce preventable adverse events, and support clinically appropriate therapy adjustments.

Definitions

One-time approval definition

DefinitionOne-time approval is a temporary override provided for 30 days when the Quantity Limitation rule is not met.

PurposeTemporary coverage to allow initiation or short-term deviation from standard limits

TriggerRequested medication exceeds Quantity Limitation at point of service