CurrentCignaPolicy N/A

Antiemetics -Serotonin Receptor Antagonists (Oral and Transdermal) Drug Quantity Management -Per Rx

Defines per-dispensing quantity limits and medically necessary overrides for oral and transdermal 5-HT3 receptor antagonists (granisetron and ondansetron products, including Sancuso) across retail and home delivery channels for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAntiemetics -Serotonin Receptor Antagonists (Oral and Transdermal) Drug Quantity Management -Per Rx

Policy CodePolicy N/A

Change TypeAnnual and Early Annual revisions (no criteria changes; product removals/ODT limits added)

Effective Date

Next Review Date

Key ActionIf requested quantity exceeds program quantity limits at point of service, document that one of the specified medical necessity criteria is met to receive an override approval (approvals provided for 1 year).

POLICY UPDATE CHANGES

Annual Revision noted 'No criteria changes' on 12/21/2023.

Early Annual Revision 09/11/2024 removed brand Zofran 4 mg and 8 mg tablets, ondansetron 24 mg tablets, Zuplenz soluble films (obsolete); generics remain.

Annual Revision noted 'No criteria changes' on 09/24/2025.

2Main drug classes listed (granisetron, ondansetron)

MultipleAge-stratified pediatric thresholds

1Standard approval duration (years)

Coverage Summary

Defines per-dispensing quantity limits and medically necessary overrides for oral and transdermal 5-HT3 receptor antagonists (granisetron and ondansetron, including the transdermal Sancuso) across retail and home delivery channels for Cigna-administered health benefit plans. Coverage is managed via quantity limits with specified medically necessary overrides (e.g., chemotherapy, radiation, pregnancy, and other emesis-related indications) and approvals are generally provided for 1 year when criteria are met.

General Program Criteria

General Program

All approvals are provided for 1 year in duration unless otherwise noted. Exceptions to quantity limits are covered as medically necessary when specified criteria are met; any other exception is not medically necessary.

General Program rules

Point of service: If the Drug Quantity Management rule is not met for the requested medication at point of service, coverage will be determined by the Criteria below
Providers must document medical necessity criteria to receive an override (approvals provided for 1 year)

Granisetron (1 mg tablets) — Quantity Overrides

Granisetron 1 mg tablets (generic only) - Overrides

ONE of

Prevention for multiple chemotherapy courses: Patient receiving granisetron for prevention of nausea and vomiting associated with multiple courses or multiple days of cancer chemotherapy within 1 month
Approve requested quantity, not to exceed 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery
Treatment - listed non-chemotherapy indications
- Listed conditions: prevention or treatment of radiation-induced emesis; delayed nausea and vomiting (>24 hours following chemotherapy or radiation therapy); as needed for nausea and vomiting after chemotherapy; anticipatory nausea and vomiting; vertigo or motion-induced nausea and vomiting; opioid-induced nausea and vomiting; treatment of postoperative nausea and vomiting; pregnancy-induced nausea and vomiting; drug-induced (non-chemotherapy) nausea and vomiting; nausea and vomiting due to other etiologies including idiopathic

Program note: Granisetron 1 mg tablets (generic only) - exceptions to base quantity limits are allowed only as specified above

Sancuso Transdermal System — Quantity Overrides

Sancuso 34.3 mg (3.1 mg/24 hr) transdermal system - Overrides

Sancuso chemotherapy override: Patient receiving Sancuso for prevention of nausea and vomiting associated with multiple courses or multiple days of cancer chemotherapy within 1 month

Approve requested quantity, not to exceed 4 patches per dispensing at retail or 16 patches per dispensing at home delivery

Ondansetron 4 mg Tablets / ODT — Quantity Overrides

Ondansetron 4 mg tablets and 4 mg orally-disintegrating tablets (generic only) - Overrides

ONE of

Prevention - multiple chemotherapy courses: Patient receiving ondansetron for prevention of nausea and vomiting associated with multiple courses or multiple days of chemotherapy within 1 month
Approve requested quantity, not to exceed 90 tablets/orally-disintegrating tablets per dispensing at retail or 270 tablets/orally-disintegrating tablets per dispensing at home delivery
Prevention - radiation multiple courses: Patient receiving ondansetron for prevention of radiation-induced nausea and vomiting associated with multiple courses or multiple days of radiation within 1 month
Approve requested quantity, not to exceed 90 tablets/orally-disintegrating tablets per dispensing at retail or 270 tablets/orally-disintegrating tablets per dispensing at home delivery
Pregnancy-induced nausea: Patient receiving ondansetron for pregnancy-induced nausea and vomiting
Approve requested quantity, not to exceed 90 tablets/orally-disintegrating tablets per dispensing at retail or 270 tablets/orally-disintegrating tablets per dispensing at home delivery (three tablets per day) for 6 months
Treatment indications (non-chemotherapy): Patient receiving ondansetron for treatment of listed conditions (radiation-induced emesis; delayed emesis; as-needed post-chemotherapy; anticipatory; vertigo/motion; opioid-induced; postoperative; drug-induced non-chemotherapy; idiopathic)
Approve requested quantity, not to exceed 60 tablets/orally-disintegrating tablets per dispensing at retail or 180 tablets/orally-disintegrating tablets per dispensing at home delivery (two tablets per day) for 6 months

Program note: Ondansetron 4 mg tablets and 4 mg orally-disintegrating tablets (generic only) - overrides limited to the scenarios above

Ondansetron 8 mg Tablets / ODT — Quantity Overrides

Ondansetron 8 mg tablets and 8 mg orally-disintegrating tablets (generic only) - Overrides

ONE of

Prevention for multiple chemotherapy courses: Patient is ≥ 12 years of age AND receiving ondansetron for prevention of nausea and vomiting associated with multiple courses or multiple days of chemotherapy within 1 month
Approve requested quantity, not to exceed 90 tablets/orally-disintegrating tablets per dispensing at retail or 270 tablets/orally-disintegrating tablets per dispensing at home delivery
Radiation-induced prevention/treatment: Patient is ≥ 12 years of age AND receiving ondansetron for prevention or treatment of radiation-induced nausea and vomiting
Approve requested quantity, not to exceed 90 tablets/orally-disintegrating tablets per dispensing at retail or 270 tablets/orally-disintegrating tablets per dispensing at home delivery
Pregnancy-induced nausea: Patient receiving ondansetron for pregnancy-induced nausea and vomiting
Approve requested quantity, not to exceed 90 tablets/orally-disintegrating tablets per dispensing at retail or 270 tablets/orally-disintegrating tablets per dispensing at home delivery (three tablets per day) for 6 months
Treatment indications (age ≥ 12): Patient is ≥ 12 years of age AND is receiving ondansetron for treatment of one of the listed conditions (delayed emesis; as-needed post-chemotherapy; anticipatory; vertigo/motion; opioid-induced; postoperative; drug-induced non-chemo; idiopathic)
Approve requested quantity, not to exceed 60 tablets/orally-disintegrating tablets per dispensing at retail or 180 tablets/orally-disintegrating tablets per dispensing at home delivery (two tablets per day) for 6 months

Program note: Ondansetron 8 mg tablets and 8 mg orally-disintegrating tablets (generic only) - age ≥12 requirements apply for specific overrides

Ondansetron Oral Solution — Quantity Overrides & Pediatric Thresholds

Ondansetron 4 mg/5 mL oral solution (generic only) - Overrides

ONE of

Chemotherapy - patients ≥ 12 years: Patient receiving ondansetron for prevention of nausea and vomiting associated with multiple courses or multiple days of chemotherapy within 1 month; patient is ≥ 12 years of age
Approve requested quantity, not to exceed 900 mL per dispensing at retail or 2,700 mL per dispensing at home delivery; accommodates up to 30 mL (24 mg) per day; round up to whole 50 mL bottles
Chemotherapy - patients ≤ 11 years: Patient receiving ondansetron for prevention of nausea and vomiting associated with multiple courses or multiple days of chemotherapy within 1 month; patient is ≤ 11 years of age
Approve requested quantity, not to exceed 450 mL per dispensing at retail or 1,350 mL per dispensing at home delivery; accommodates up to 15 mL (12 mg) per day; round up to whole 50 mL bottles
Radiation multiple courses: Patient receiving ondansetron for prevention of radiation-induced nausea and vomiting associated with multiple courses or multiple days of radiation within 1 month
Patients ≥12: approve up to 900 mL retail / 2,700 mL home delivery for 6 months (accommodates 30 mL/day). Patients ≤11: approve up to 450 mL retail / 1,350 mL home delivery for 6 months (accommodates 15 mL/day)
Treatment indications - patients ≥ 12: Patient is ≥ 12 years AND receiving ondansetron for treatment of one of the listed conditions (radiation-induced emesis; delayed emesis; as-needed post-chemotherapy; anticipatory; vertigo/motion; opioid-induced; postoperative; pregnancy-induced; drug-induced non-chemo; idiopathic)
Approve requested quantity, not to exceed 600 mL per dispensing at retail or 1,800 mL per dispensing at home delivery (allow 20 mL [16 mg] per day) for 6 months
Treatment indications - patients ≤ 11: Patient is ≤ 11 years AND receiving ondansetron for treatment of one of the listed conditions
Approve requested quantity, not to exceed 300 mL per dispensing at retail or 900 mL per dispensing at home delivery (allow 10 mL [8 mg] per day) for 6 months

Rounding guidance: When approving ondansetron oral solution, round up quantity to accommodate whole 50 mL bottle sizes per policy examples

Example: required 270 mL -> approve 300 mL (six 50 mL bottles)

Applicable Products / Codes

Included products (listed by name)mixed

granisetron 1 mg tablets	generic granisetron tablets
Sancuso 34.3 mg patch	granisetron transdermal system (3.1 mg/24 hours)
ondansetron 4 mg tablets	generic ondansetron tablets
ondansetron 4 mg orally disintegrating tablets	generic orally disintegrating tablets
ondansetron 8 mg tablets	generic ondansetron tablets
ondansetron 8 mg orally disintegrating tablets	generic orally disintegrating tablets
ondansetron 16 mg orally disintegrating tablets	branded ondansetron ODT (16 mg)
ondansetron 4 mg/5 mL oral solution	generic oral solution

Provider Actions & Documentation Requirements

Prior Authorization

Quantity limit overrides require medical necessity criteria

If requested quantity exceeds program quantity limits at point of service, provider must document that one of the specified medical necessity criteria (e.g., multiple chemotherapy courses within 1 month, listed treatment indications) is met to receive an override approval (approvals provided for 1 year).

Documentation Required

Document indication and duration

Providers must document the indication (e.g., chemotherapy schedule, radiation courses, pregnancy-induced nausea) and expected duration to support overrides, including age for pediatric thresholds.

Chemotherapy schedule (e.g., multiple courses or multiple days within 1 month; specific days/doses)
Radiation courses (e.g., number of fractions or multiple days of radiation within 1 month)
Pregnancy-induced nausea (state indication and expected duration; pregnancy as listed treatment indication)
Pediatric age to establish applicable volume thresholds (specify patient age to determine mL limits)

Billing Rule

Round up oral solution to whole bottle sizes

When approving ondansetron oral solution, round up the approved quantity to accommodate whole 50 mL bottle package sizes. Examples in policy: if required total is 270 mL, approve 300 mL (six 50 mL bottles); if required total is 135 mL, approve 150 mL (three 50 mL bottles).

Background

This Drug Quantity Management program aims to promote the safe, effective, and economic use of oral and transdermal 5-HT3 receptor antagonists. The policy sets per-dispensing quantity limits for retail and home delivery and defines specific medically necessary overrides for chemotherapy, radiation, pregnancy, and other emesis-related indications. If the quantity rule is not met at point of service, coverage is determined by the listed criteria and any approved override is provided for 1 year unless otherwise noted.

Definitions: MEC = Moderate emetogenic chemotherapy; HEC = Highly emetogenic chemotherapy; PONV = Post-operative nausea and vomiting.

Revision History

12/21/2023Annual Revision - clarified

Annual Revision noted 'No criteria changes'.

09/11/2024Early Annual Revision - material

Ondansetron 16 mg orally-disintegrating tablets: new quantity limits added of 2 tablets per dispensing at retail and 6 tablets per dispensing at home delivery with no clinical overrides; Brand Zofran 4 mg and 8 mg tablets, ondansetron 24 mg tablets, and Zuplenz soluble films were removed (obsolete); generics remain.

09/24/2025Annual Revision - clarifiedLatest

Annual Revision noted 'No criteria changes'.

Policy Summary

PayerCigna

PolicyAntiemetics -Serotonin Receptor Antagonists (Oral and Transdermal) Drug Quantity Management -Per Rx

Policy CodePolicy N/A

Change TypeAnnual and Early Annual revisions (no criteria changes; product removals/ODT limits added)

Effective Date

Next Review Date

On This Page

OpenPayer

Antiemetics -Serotonin Receptor Antagonists (Oral and Transdermal) Drug Quantity Management -Per Rx

Coverage Summary

General Program Criteria

Granisetron (1 mg tablets) — Quantity Overrides

Sancuso Transdermal System — Quantity Overrides

Ondansetron 4 mg Tablets / ODT — Quantity Overrides

Ondansetron 8 mg Tablets / ODT — Quantity Overrides

Ondansetron Oral Solution — Quantity Overrides & Pediatric Thresholds

Ondansetron 16 mg ODT (Branded) — Exceptions / No Overrides

Applicable Products / Codes

Provider Actions & Documentation Requirements

Background

Clinical Evidence

Revision History