ModifiedCignaPolicy N/A

Xalkori (crizotinib) Drug Quantity Management Policy

Defines drug quantity limits and medically necessary overrides for Xalkori (crizotinib capsules and pellets) for Cigna-administered health benefit plans; applies to prescribers and pharmacy benefit adjudication.

Policy Summary

PayerCigna

PolicyXalkori (crizotinib) Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limits and override criteria updated

Effective DateMay 24, 2023

Next Review DateJun 3, 2025

Key ActionSubmit prior authorization documenting diagnosis, patient age, body surface area, and dosing rationale to request approval for quantities above per-dispensing limits.

SourceLink

POLICY UPDATE CHANGES

Policy was updated to reflect existing quantity limits when a product is obtained via home delivery and to add/modify override criteria for pediatric IMT and ALCL based on body surface area.

New quantity limits for Xalkori 20 mg, 50 mg, and 150 mg pellets were added, including retail and home delivery maximums.

Override criteria were added to approve requested quantities up to specified limits for pediatric patients (<18 years) with inflammatory myofibroblastic tumor and certain body surface area thresholds.

Override criteria for Xalkori 200 mg capsules were updated to increase the body surface area threshold from ≥1.17 m2 to ≥1.34 m2 for additional quantity approvals.

New quantity limits for Xalkori 20 mg, 50 mg, 150 mg pellets were added (120 pellets retail / 360 pellets home delivery) with specific override rules for some strengths.

60Retail maximum — 200/250 mg capsules

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Coverage Criteria for Xalkori (crizotinib)

Drug quantity override criteria

Exceptions to quantity limits are covered as medically necessary when the following criteria are met (approvals = 1 year):

Xalkori 200 mg capsules - ALCL override: Patient has anaplastic large cell lymphoma AND body surface area >= 1.34 m2BSA >= 1.34 m2

Approve not to exceed 120 capsules per dispensing at retail or 360 capsules per dispensing at home delivery

Xalkori 200 mg capsules - pediatric IMT override: Patient is < 18 years of age AND has inflammatory myofibroblastic tumor AND body surface area >= 1.34 m2BSA >= 1.34 m2

Approve not to exceed 120 capsules per dispensing at retail or 360 capsules per dispensing at home delivery

Xalkori 250 mg capsules - ALCL override: Patient has anaplastic large cell lymphoma AND body surface area >= 1.70 m2BSA >= 1.70 m2

Approve not to exceed 120 capsules per dispensing at retail or 360 capsules per dispensing at home delivery

Xalkori 250 mg capsules - pediatric IMT override: Patient is < 18 years of age AND has inflammatory myofibroblastic tumor AND body surface area >= 1.70 m2BSA >= 1.70 m2

Approve not to exceed 120 capsules per dispensing at retail or 360 capsules per dispensing at home delivery

Xalkori 20 mg pellets - dose reduction override to 80 mg BID: Patient has anaplastic large cell lymphoma OR (is < 18 years of age AND has inflammatory myofibroblastic tumor) AND requires a dose reduction to 80 mg twice dailydose = 80 mg BID

Approve not to exceed 240 pellets per dispensing at retail or 720 pellets per dispensing at home delivery

Xalkori 50 mg pellets: No clinical override criteria apply

Quantity limits apply as listed (120 pellets retail / 360 pellets home delivery)

Xalkori 150 mg pellets - override: Patient has anaplastic large cell lymphoma OR (is < 18 years of age AND has inflammatory myofibroblastic tumor) AND body surface area >= 1.52 m2BSA >= 1.52 m2

Approve not to exceed 180 pellets per dispensing at retail or 540 pellets per dispensing at home delivery

Quantity limits and override criteria

Covered with quantity limits; overrides allowed when ALL specified conditions are met for pediatric patients or specific diagnoses.

Standard per-dispensing limits: Default quantity limits: 120 capsules or pellets per dispensing at retail and 360 per dispensing at home delivery (exceptions listed separately)

Applies to multiple strengths unless an override is met

Pediatric IMT override for 200 mg and 250 mg capsules: Patient is < 18 years of age AND has inflammatory myofibroblastic tumor AND meets BSA threshold for the strength (200 mg: BSA >= 1.34 m2; 250 mg: BSA >= 1.70 m2)BSA >= 1.34 m2 (200 mg); BSA >= 1.70 m2 (250 mg)

If met, approve requested quantity up to 120 per dispensing at retail or 360 per dispensing at home delivery

Dose-reduction override for 20 mg pellets: Patient requires dose reduction to 80 mg twice daily (e.g., dosing scenario for ALCL or pediatric IMT)dose reduction to 80 mg BID

Exceptions to the quantity limits listed in this policy are covered as medically necessary only when they meet the specific override criteria detailed in the criteria sections (approvals are valid for 1 year). Any exception to the listed quantity limits that does not satisfy those specified override criteria is considered not medically necessary.

No clinical override criteria are provided for Xalkori 50 mg pellets; the newly added per-dispensing quantity limits (120 pellets at retail and 360 pellets for home delivery) apply and larger quantities will not be approved via clinical override.

Any request for a quantity that exceeds the policy’s stated per-dispensing maximums that does not meet one of the defined override criteria (for example, the pediatric or BSA-based rules) will be treated as not medically necessary and will not be approved.

Drug Strengths, Codes, and Quantity Rules

Drug strengths with quantity rulesNDC | mixed

200 mg	Xalkori capsules strength — Retail maximum per Rx = 60 capsules; Home Delivery maximum per Rx = 180 capsules
250 mg	Xalkori capsules strength — Retail maximum per Rx = 60 capsules; Home Delivery maximum per Rx = 180 capsules
20 mg	Xalkori pellets strength — Retail maximum per Rx = 120 pellets; Home Delivery maximum per Rx = 360 pellets
50 mg	Xalkori pellets strength — Retail maximum per Rx = 120 pellets; Home Delivery maximum per Rx = 360 pellets
150 mg	Xalkori pellets strength — Retail maximum per Rx = 120 pellets; Home Delivery maximum per Rx = 360 pellets

Drug strengths with quantity rules (summary)mixed

200 mg	Retail: 60 capsules per Rx; Home delivery: 180 capsules per Rx
250 mg	Retail: 60 capsules per Rx; Home delivery: 180 capsules per Rx
20 mg	Retail: 120 pellets per Rx; Home delivery: 360 pellets per Rx
50 mg	Retail: 120 pellets per Rx; Home delivery: 360 pellets per Rx
150 mg	Retail: 120 pellets per Rx; Home delivery: 360 pellets per Rx

inv-07: Body surface area thresholds for overrides

200 mg capsulesBSA ≥ 1.34 m2 required to approve quantities above default limits (approve up to 120 capsules retail or 360 capsules home delivery)

250 mg capsulesBSA ≥ 1.70 m2 required to approve quantities above default limits (approve up to 120 capsules retail or 360 capsules home delivery)

150 mg pelletsBSA ≥ 1.52 m2 required for pediatric ALCL/IMT to approve larger quantities (approve up to 180 pellets retail or 540 pellets home delivery)

inv-08: Per-dispensing quantity limits

Retail per-dispensing maximum120 capsules or pellets per dispensing (standard retail limit)

Home delivery per-dispensing maximum

Provider Actions and Documentation Requirements

Prior Authorization

Drug quantity override approvals

Approvals for overrides of the drug quantity limits are provided for 1 year in duration and require meeting the specified criteria. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the applicable plan terms and a medical necessity review.

All override approvals are valid for 1 year from the approval date.
Coverage when DQM rule not met: subject to plan terms, laws/regulations, and medical necessity review.

Prior Authorization

Quantity-limit overrides

Prior authorization (or an override) is required to approve quantities exceeding the standard per-dispensing limits. Requests must document the applicable diagnosis and demonstrate that the override criteria are met.

Document the diagnosis that justifies exceeding the per-dispensing limit.
Provide clinical rationale and any supporting records when requesting an override.

Background and Indications

Xalkori (crizotinib) is an oral kinase inhibitor approved for multiple ALK‑positive malignancies, including anaplastic large cell lymphoma (ALCL) in pediatric patients ≥1 year and young adults, ALK‑positive unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) in patients ≥1 year, and certain adult indications such as metastatic ALK‑ or ROS1‑positive non–small cell lung cancer. Dosing and formulation (capsules or pellets) vary by indication, age, and body surface area; pellets are provided for patients who cannot swallow capsules.

Definitions and Formulation Notes

inv-18: Xalkori (crizotinib)

Generic name / brandcrizotinib (Xalkori)

Primary indicationsALK-positive anaplastic large cell lymphoma (pediatric ≥1 year and young adults), ALK-positive inflammatory myofibroblastic tumor (IMT) ≥1 year, and metastatic ALK- or ROS1-positive NSCLC in adults

Dosage formsCapsules: 200 mg and 250 mg; Pellets: 20 mg, 50 mg, 150 mg

inv-19: Pellets (20 mg, 50 mg, 150 mg)

Available pellet strengths20 mg, 50 mg, and 150 mg oral pellets supplied in bottles of 60 pellets

Do not swallow shellPellets are supplied encapsulated in shells but should not be swallowed in the shell

Line of Therapy Considerations

Line-of-therapy context for use

Informational: Xalkori dosing is specified by indication and BSA; dosing guides use BSA-based calculations for pediatric patients.

Line-of-therapy context: Dosing is per indication: ALCL and pediatric IMT use BSA-based dosing (e.g., 280 mg/m2 BID); adult IMT and NSCLC use fixed dosing (250 mg BID); treat until disease progression or unacceptable toxicitydose per indication

See prescribing information for dose-to-BSA conversions and dose-reduction guidance

Biomarker Requirements

inv-22: ALK, ROS1

Biomarker requirement for NSCLCALK- or ROS1-positive as detected by an FDA-approved test for metastatic NSCLC in adults

ALK for ALCL/IMTALK-positive status required for ALCL and IMT per prescribing information

Purpose of testingBiomarker positivity defines eligibility for Xalkori therapy by indication

inv-23: ALK

Marker notedALK biomarker specified as the drug-class descriptor for ALK-positive agents in the policy name and indications

ContextPolicy references ALK positivity for ALCL and IMT and ALK testing for NSCLC per prescribing information

Dosing and Regimens Covered

Indication	Recommended dose	Formulation notes / duration
Anaplastic large cell lymphoma (ALCL) — pediatric ≥1 year and young adults	280 mg/m2 twice daily (BID)	Capsules or pellets per prescribing information; continue until disease progression or unacceptable toxicity
Inflammatory myofibroblastic tumor (IMT)	Adults: 250 mg twice daily (BID); Pediatric: 280 mg/m2 twice daily (BID)	Capsules or pellets per prescribing information; continue until disease progression or unacceptable toxicity
Metastatic ALK‑positive or ROS1‑positive non‑small cell lung cancer (NSCLC)	250 mg twice daily (BID)	For adults unable to swallow capsules: 250 mg BID using 2 × 50 mg pellets + 1 × 150 mg pellet per dose; continue until disease progression or unacceptable toxicity

Policy Summary

PayerCigna

PolicyXalkori (crizotinib) Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limits and override criteria updated

Effective DateMay 24, 2023

Next Review DateJun 3, 2025

Key ActionSubmit prior authorization documenting diagnosis, patient age, body surface area, and dosing rationale to request approval for quantities above per-dispensing limits.

SourceLink

On This Page

Denial Risk

Quantity limit exceedance

Requests that exceed specified per-dispensing quantity limits without meeting override criteria are subject to denial or manual review. Typical per-dispensing limits are 120 units at retail and 360 units at home delivery unless specific override criteria apply.

Retail per-dispensing limit (typical): 120 units.
Home delivery per-dispensing limit (typical): 360 units.
Requests over these limits must meet documented override criteria or may be denied.

Note

Coverage determination considerations

Coverage determinations require consideration of the terms of the applicable benefit plan document, any applicable laws and regulations, relevant collateral materials (including coverage policies), and the specific facts of the individual case. Medical directors have discretion to exercise clinical judgment in individual determinations.

Review the member's benefit plan document in effect on the date of service.
Consider applicable federal/state laws and coverage policy guidance.
Decisions must be individualized; medical necessity review may apply.

Documentation Required

Required documentation for overrides

When requesting an override, provide required documentation showing the prescription was evaluated against per-dispensing quantity limits and that one or more override criteria apply (for example: age < 18 years, diagnosis of inflammatory myofibroblastic tumor or anaplastic large cell lymphoma, body surface area thresholds, or documented dose reductions).

State the clinical override criterion met (e.g., patient < 18 years with IMT or ALCL).
Provide measured BSA when BSA thresholds are used (report numeric BSA and calculation date).
Document dose reductions and the clinical reason when larger quantities are requested for reduced-dose regimens.
Specify formulation and strength (e.g., Xalkori 200 mg capsules, 50/150/250 mg pellets) and the requested quantity per dispensing.

inv-20: Override criteria definition

DefinitionOverride criteria are the documented clinical conditions that permit approval of quantities above the default per-dispensing limits (examples: patient age <18 years, specific diagnosis such as ALCL or IMT, specified BSA thresholds, or defined dose-reduction scenarios)

PurposeUsed to justify prior authorization or approval for quantities exceeding standard retail (120) or home delivery (360) limits

Examples of qualifying conditionsAge <18 with IMT plus required BSA threshold; ALCL with specified BSA thresholds; dose reduction to 80 mg BID for 20 mg pellets