CurrentCignaPolicy N/A

Drug Quantity Management — Tasigna (nilotinib) capsules

Defines quantity limits and exception criteria for Tasigna (nilotinib capsules) for Cigna-administered health benefit plans, including retail and home delivery dispensing rules and approvals lasting one year.

Policy Summary

PayerCigna

PolicyDrug Quantity Management — Tasigna (nilotinib) capsules

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJun 3, 2025

Key ActionApprove exceptions to quantity limits for up to 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120Retail max / Rx (50 mg)

360Home delivery max / Rx (50 mg)

112Retail max / Rx (150/200 mg)

336Home delivery max / Rx (150/200 mg)

1 yrApproval duration

Coverage and Exception Criteria

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Drug Quantity Limits and Allowed Exceptions

Quantity limits apply per strength/form; exceptions are covered when the specified criteria are met. Approvals are provided for 1 year.

Standard limits: For Tasigna 50 mg capsules: Retail maximum 120 capsules per Rx; Home Delivery maximum 360 capsules per Rx. For Tasigna 150 mg capsules: Retail maximum 112 capsules per Rx; Home Delivery maximum 336 capsules per Rx. For Tasigna 200 mg capsules: Retail maximum 112 capsules per Rx; Home Delivery maximum 336 capsules per Rx.see values

Standard per‑Rx quantity limits as listed.

Exceptions for Tasigna 50 mg: If the patient requires 250 mg twice daily, approve 300 capsules per dispensing at retail or 900 capsules per dispensing at home delivery; if the patient requires 350 mg twice daily, approve 420 capsules per dispensing at retail or 1,260 capsules per dispensing at home delivery.dose‑based overrides

Overrides apply only to 50 mg strength when dose requirements match.

No overrides for 150 mg and 200 mg: No quantity‑limit overrides are recommended for Tasigna 150 mg or 200 mg capsules.none

Exceptions other than those listed are considered not medically necessary.

Approval duration: All approvals for exceptions or quantity‑limit requests are provided for 1 year in duration.1 year

Policy statement: all approvals are provided for 1 year.

Any exception to the quantity limits listed in this policy that is not explicitly described as covered is considered not medically necessary.

Only the specific dose-based overrides described for Tasigna 50 mg — namely the provisions for patients requiring 250 mg twice daily or 350 mg twice daily — are considered covered exceptions. All other requests for quantities or dosing regimens not explicitly listed for the 50 mg strength are considered not medically necessary.

Drug Quantity Limits by Strength and Dispensing Channel

inv-11: Tasigna 50 mg capsules — retail max capsules per Rx

Retail maximum per Rx120 capsules

Applies toTasigna (nilotinib) 50 mg capsules

Approval duration for exceptionsApprovals are provided for 1 year when exception criteria are met

inv-12: Tasigna 50 mg capsules (home delivery) — home delivery max capsules per Rx

Home delivery maximum per Rx360 capsules

Applies toTasigna (nilotinib) 50 mg capsules (home delivery)

Approval duration for exceptionsApprovals are provided for 1 year when exception criteria are met

inv-13: Tasigna 150 mg capsules — retail max capsules per Rx

Retail maximum per Rx112 capsules

Applies toTasigna (nilotinib) 150 mg capsules

OverridesNo overrides recommended for 150 mg strength

inv-14: Tasigna 150 mg capsules (home delivery) — home delivery max capsules per Rx

Home delivery maximum per Rx336 capsules

Applies toTasigna (nilotinib) 150 mg capsules (home delivery)

OverridesNo overrides recommended for 150 mg strength

inv-15: Tasigna 200 mg capsules — retail max capsules per Rx

Retail maximum per Rx112 capsules

Applies toTasigna (nilotinib) 200 mg capsules

OverridesNo overrides recommended for 200 mg strength

inv-16: Tasigna 200 mg capsules (home delivery) — home delivery max capsules per Rx

Home delivery maximum per Rx336 capsules

Applies toTasigna (nilotinib) 200 mg capsules (home delivery)

OverridesNo overrides recommended for 200 mg strength

inv-17: Tasigna 50 mg — override for 250 mg BID (retail/home delivery override quantities)

Retail override quantity per dispensing300 capsules

Home delivery override quantity per dispensing900 capsules

Condition for overridePatient requires 250 mg twice daily dosing

inv-18: Tasigna 50 mg — override for 350 mg BID (retail/home delivery override quantities)

Retail override quantity per dispensing420 capsules

Home delivery override quantity per dispensing1,260 capsules

Condition for overridePatient requires 350 mg twice daily dosing

Provider Actions and Authorization Details

Prior Authorization

Quantity limit approvals — 1 year

Quantity limit approvals are issued for a 1-year duration. If an exception to the Drug Quantity Management rule is approved, the authorization will be valid for 12 months from the date of approval. Note dispensing channel limits: Retail maximum quantities per prescription and Home Delivery maximums apply as specified by the Drug Quantity Limits (e.g., retail and home delivery caps for Tasigna by strength).

Approvals valid for 1 year
Dispensing channel rules: Retail vs Home Delivery maximums apply

Note

Coverage determination considerations

Providers should submit requests in accordance with the applicable benefit plan document and include clinical documentation supporting the need for a quantity exception. When billing, use the most appropriate codes as of the date of service. Coverage determinations require review of: the terms of the applicable benefit plan document, any applicable laws/regulations, relevant collateral materials (including coverage policies), and the specific facts of the individual case. Medical Directors may exercise clinical judgment in individual coverage determinations.

Follow the member's benefit plan document; that document governs in case of conflict
Include supporting clinical documentation for quantity exceptions
Coverage is determined case-by-case considering laws, plan terms, and collateral materials

Documentation Required

Provider action

(Provider action) Ensure all prior authorization requests for quantity exceptions include the diagnosis, requested quantity, justification for exceeding limits, and pertinent clinical notes or lab results. Missing or incomplete information may delay review or result in denial.

Include diagnosis, requested quantity and justification
Attach relevant clinical notes and test results to the request

Denial Risk

Quantity rule noncompliance — action when rule not met

If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the policy criteria; payment may be denied at point of sale. Confirm eligibility and submit an exception request with documentation for consideration.

Noncompliance at point of service triggers review under policy criteria
Submit exception request with supporting documentation to avoid denial

Key Definitions and Dosing

inv-09: Indication — Chronic myeloid leukemia (CML), Ph+

IndicationChronic myeloid leukemia (CML), Philadelphia chromosome–positive (Ph+)

Included populationsNewly diagnosed adults and pediatric patients ≥ 1 year; patients with resistance or intolerance to prior therapy

Drug classTyrosine kinase inhibitor (nilotinib)

inv-10: Dosing — BID dosing at ~12-hour intervals on an empty stomach; capsules may be dispersed in applesauce if patient cannot swallow

Dosing frequencyTwice daily (BID) at approximately 12-hour intervals on an empty stomach

Administration noteCapsules should be swallowed whole or dispersed in 1 teaspoon of applesauce if patient cannot swallow

Treatment durationContinue as long as clinical benefit is observed or until unacceptable toxicity

OpenPayer

Drug Quantity Management — Tasigna (nilotinib) capsules

Coverage and Exception Criteria

Drug Quantity Limits by Strength and Dispensing Channel

Provider Actions and Authorization Details

Key Definitions and Dosing

Clinical Background