CurrentCignaPolicy N/A

Drug Quantity Management Policy — Vitrakvi (larotrectinib)

Defines per-prescription quantity limits and medically necessary exceptions for Vitrakvi (larotrectinib capsules and oral solution) for Cigna-administered health benefit plans; applies to pharmacy dispensing (retail and home delivery).

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Vitrakvi (larotrectinib)

Policy CodePolicy N/A

Change TypeQuantity limit and override criteria update

Effective DateN/A

Next Review DateMay 2, 2025

Key ActionApprove higher per-dispensing quantities when the patient is taking a moderate or strong CYP3A4 inducer, as specified for each formulation.

SourceLink

POLICY UPDATE CHANGES

Override criteria were updated to approve an additional quantity if the patient is taking a moderate or strong cytochrome P450 (CYP)3A4 inducer (previously limited to strong inducers only).

Home delivery maximum quantities were aligned with existing quantity limits and reflected in the policy.

180Retail max per Rx (25 mg)

540Home delivery max per Rx (25 mg)

60Retail max per Rx (100 mg)

180Home delivery max per Rx (100 mg)

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Vitrakvi (larotrectinib)

Policy CodePolicy N/A

Change TypeQuantity limit and override criteria update

Effective DateN/A

Next Review DateMay 2, 2025

Key ActionApprove higher per-dispensing quantities when the patient is taking a moderate or strong CYP3A4 inducer, as specified for each formulation.

SourceLink

On This Page

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Retail max per Rx (20 mg/mL)

900Home delivery max per Rx (20 mg/mL)

Coverage Criteria and Exceptions

Drug quantity limits and override criteria

Quantity limits apply per dispensing; exceptions are allowed when ALL of the following override criteria are met as noted below.

Base quantity limits

Vitrakvi 25 mg standard limits: Retail max 180 capsules per Rx; Home Delivery max 540 capsules per Rx180 retail; 540 home
see policy
Vitrakvi 100 mg standard limits: Retail max 60 capsules per Rx; Home Delivery max 180 capsules per Rx60 retail; 180 home
see policy
Vitrakvi 20 mg/mL oral solution standard limits: Retail max 300 mL per Rx; Home Delivery max 900 mL per Rx300 mL retail; 900 mL home
see policy

Override for moderate or strong CYP3A4 inducer use

25 mg capsules override: Approve 360 capsules per dispensing at retail or 1,080 capsules per dispensing at home delivery when patient is taking a moderate or strong CYP3A4 inducer360 retail; 1080 home
see policy
100 mg capsules override: Approve 120 capsules per dispensing at retail or 360 capsules per dispensing at home delivery when patient is taking a moderate or strong CYP3A4 inducer120 retail; 360 home
see policy
20 mg/mL oral solution override: Approve 600 mL per dispensing at retail or 1,800 mL per dispensing at home delivery when patient is taking a moderate or strong CYP3A4 inducer600 mL retail; 1800 mL home

Any exception to the per‑dispensing quantity limits for Vitrakvi (larotrectinib) that is not specifically described in the policy’s listed override criteria is considered not medically necessary.

Requests for quantities that exceed the stated retail or home delivery maximums for Vitrakvi and that do not meet the documented override criteria (for example, concurrent use of a moderate or strong CYP3A4 inducer when specified) are considered not medically necessary.

Per‑Prescription Quantity Limits

Vitrakvi 25 mg capsules (retail max per Rx)

Retail maximum per Rx180 capsules

UnitCapsules

Applies toVitrakvi 25 mg capsules

Vitrakvi 25 mg capsules (home delivery max per Rx)

Home delivery maximum per Rx540 capsules

UnitCapsules

Applies toVitrakvi 25 mg capsules

Provider Requirements and Operational Rules

Prior Authorization

Authorization duration and point-of-service rule

All approvals are provided for 1 year in duration. Quantity limits apply at the point of service; if the Drug Quantity Management rule is not met for the requested medication at the point of sale, coverage will be determined by the criteria in this policy and the request may be denied.

Authorization duration: Approvals are valid for 1 year from the date of approval.
Point-of-service rule: Quantity limits are enforced at the point of service; noncompliance with the Drug Quantity Management rule at dispensing may result in denial and necessitates review under the policy criteria.

Step Therapy

Step therapy

This quantity management policy does not impose any step therapy requirements.

No step therapy required under this quantity management policy.

Key Definitions

NTRK fusion-positive tumors — definition/key term

DefinitionNTRK gene fusion-positive solid tumors

Clinical contextIncludes tumors without a known acquired resistance mutation, that are metastatic or where surgery would cause severe morbidity, or when no satisfactory alternatives exist

TestingPatients should be selected for therapy based on an FDA-approved test

Background and Indications

Vitrakvi (larotrectinib) is a kinase inhibitor indicated for adult and pediatric patients with solid tumors harboring an NTRK gene fusion (without a known acquired resistance mutation) for metastatic disease or when surgical resection would likely result in severe morbidity, or when no satisfactory alternatives exist. Patients should be selected using an FDA‑approved test. Quantity limits for Vitrakvi (capsules and oral solution) apply per prescription; standard retail and home delivery maximums are specified in the policy, with limited overrides described for concurrent use of CYP3A4 inducers.

Vitrakvi 100 mg capsules (retail max per Rx)

Retail maximum per Rx60 capsules

UnitCapsules

Applies toVitrakvi 100 mg capsules

Vitrakvi 100 mg capsules (home delivery max per Rx)

Home delivery maximum per Rx180 capsules

UnitCapsules

Applies toVitrakvi 100 mg capsules

Vitrakvi 20 mg/mL oral solution (retail max per Rx)

Retail maximum per Rx300 mL

UnitmL (20 mg/mL oral solution)

Applies toVitrakvi 20 mg/mL oral solution

Vitrakvi 20 mg/mL oral solution (home delivery max per Rx)

Home delivery maximum per Rx900 mL

UnitmL (20 mg/mL oral solution)

Applies toVitrakvi 20 mg/mL oral solution

Vitrakvi 25 mg capsules (override quantities: retail and home)

Override retail maximum per Rx360 capsules

Override home delivery maximum per Rx1,080 capsules

Condition for overrideApproved when patient is taking a moderate or strong CYP3A4 inducer

Vitrakvi 100 mg capsules (override quantities: retail and home)

Override retail maximum per Rx120 capsules

Override home delivery maximum per Rx360 capsules

Condition for overrideApproved when patient is taking a moderate or strong CYP3A4 inducer

Vitrakvi 20 mg/mL oral solution (override quantities: retail and home)

Override retail maximum per Rx600 mL

Override home delivery maximum per Rx1,800 mL

Condition for overrideApproved when patient is taking a moderate or strong CYP3A4 inducer

Documentation Required

Required documentation and review basis

Coverage determinations require review of the applicable benefit plan, any applicable laws/regulations, and relevant collateral materials (including this coverage policy). Medical directors will exercise clinical judgment when appropriate.

Review basis: Applicable benefit plan language in effect on the date of service, applicable laws/regulations, and relevant collateral materials including this policy.
Clinical discretion: Medical directors may apply clinical judgment in individual coverage determinations.

Denial Risk

Quantity limit noncompliance may lead to denial

If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the policy criteria and the request may be denied.

Noncompliance at point of service may result in denial per policy criteria.
Exceptions to published quantity limits are considered medically necessary only when the specified criteria are met; all other exceptions are not medically necessary.