ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1182-11

Alecensa® (alectinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization/notification criteria for coverage of Alecensa (alectinib) across UnitedHealthcare commercial plans, specifying initial and reauthorization clinical criteria for multiple labeled and NCCN-recognized indications including NSCLC, adjuvant NSCLC, Erdheim-Chester Disease, ALCL, large B-cell lymphoma, CNS cancers, pediatric diffuse high-grade glioma, and inflammatory myofibroblastic tumor. Policy includes age-based automatic processing for members <19 and notes state mandate supersessions.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAlecensa® (alectinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1182-11

Change TypeAdded adjuvant NSCLC and pediatric diffuse high-grade glioma; multiple NCCN indication additions

Effective DateSep 1, 2025

Next Review Date

Key ActionCoverage of Alecensa requires prior authorization/notification per the listed initial or reauthorization clinical criteria; authorization will generally be issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Effective 9/1/2025 policy includes Alecensa and lists P&T approval history through 6/2025.

Added criteria for adjuvant treatment following tumor resection of ALK-positive NSCLC per FDA label (6/2024 change reflected).

Added criteria for pediatric diffuse high-grade gliomas per NCCN guidelines (6/2025).

Updated background and references; added multiple NCCN-based indications over time including histiocytic neoplasms, T-cell lymphomas, B-cell lymphoma, CNS cancers, and IMT.

Annual reviews noted with no changes to clinical criteria on some dates (9/2019, 9/2020, 8/2023).

Explicit covered indications listed

12 monthsTypical authorization duration

Auto for <19Pediatric auto-processing policy

2025-09-01Policy effective date

Coverage Summary

Alecensa (alectinib) is covered with clinical criteria across multiple labeled and NCCN-recognized indications. Covered indications include ALK-positive non-small cell lung cancer (NSCLC) — including adjuvant use following tumor resection for ALK-positive NSCLC (tumors ≥ 4 cm or node positive) — as well as NCCN-recommended ALK-driven malignancies such as symptomatic Erdheim‑Chester Disease, anaplastic large cell lymphoma (ALCL), ALK-positive large B‑cell lymphoma, central nervous system (CNS) cancers including metastatic brain metastases from NSCLC and pediatric diffuse high‑grade glioma, and inflammatory myofibroblastic tumor (IMT).

For members under 19 years of age prescriptions will automatically process without a coverage review and an authorization will be issued for 12 months. For other indications, when criteria are met authorization is generally issued for 12 months. The policy notes that applicable state mandates may supersede the benefit language where required.

Key policy facts

Policy number2025 P 1182-11

Scope summaryPrior authorization/notification criteria for Alecensa (alectinib) across UnitedHealthcare commercial plans for multiple labeled and NCCN-recognized ALK-positive indications, including NSCLC (metastatic and adjuvant), Erdheim-Chester Disease, ALCL, large B‑cell lymphoma, CNS cancers and pediatric diffuse high‑grade glioma, and inflammatory myofibroblastic tumor; includes pediatric automatic processing for members <19 and notes state mandate supersessions.

Policy effective date2025-09-01

Last review2025-06

Typical authorization duration12 months

Pediatric auto-processingAutomatic processing for members <19 (authorization issued for 12 months)

Initial Therapy Criteria

Non-small cell lung cancer (NSCLC) - Initial Authorization

Alecensa will be approved based on all of the following criteria:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease is anaplastic lymphoma kinase (ALK)-positive
One of the following
- Disease state
  - Recurrent

Continuation / Reauthorization Criteria

Non-small cell lung cancer (NSCLC) - Reauthorization

Alecensa will be approved for reauthorization when:

Patient does not show evidence of progressive disease while on Alecensa therapy

Authorization will be issued for 12 months.

Symptomatic Erdheim-Chester Disease - Reauthorization

Alecensa will be approved for reauthorization when:

Patient does not show evidence of progressive disease while on Alecensa therapy

Authorization will be issued for 12 months.

Anaplastic large cell lymphoma (ALCL) - Reauthorization

Alecensa will be approved for reauthorization when:

Provider Actions & Billing

Prior Authorization

Prior authorization required

Coverage of Alecensa requires prior authorization/notification per the listed initial or reauthorization clinical criteria. When criteria are met, an authorization will generally be issued for 12 months.

Documentation Required

ALK biomarker documentation required

For applicable indications, documentation must show the tumor is ALK-positive as detected by an FDA‑approved test or equivalent diagnostic evidence per the FDA label and NCCN. For inflammatory myofibroblastic tumor (IMT) the presence of an ALK translocation is specifically required.

Applicable Codes

ICD-10 diagnosis codes (used for automated approval/coverage logic)ICD-10

No codes listed

Clinical Evidence & References

References: Genentech Alecensa package insert, April 2024; NCCN Drugs and Biologics Compendium (accessed May 9, 2025).

The NCCN Compendium includes recommendations that support several of the listed indications in the policy background.

Background: Alecensa (alectinib) is a kinase inhibitor indicated for adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test and for adjuvant treatment in adult patients following tumor resection of ALK-positive NSCLC (tumors ≥ 4 cm or node positive). In addition to the labeled NSCLC indications, the NCCN recommends alectinib for multiple other ALK-driven conditions, including relapsed/refractory symptomatic Erdheim‑Chester Disease, ALK-positive anaplastic large cell lymphoma (ALCL) as initial palliative or subsequent therapy, relapsed/refractory ALK-positive large B‑cell lymphoma, ALK-positive metastatic brain cancer from NSCLC, ALK‑rearrangement positive pediatric diffuse high‑grade glioma, and inflammatory myofibroblastic tumors (IMT) with ALK translocation.

Definitions

ALK-positive: Tumor displays anaplastic lymphoma kinase (ALK) rearrangement or fusion as detected by an FDA-approved test or equivalent diagnostic evidence.

Revision History

2025-09-01addedLatest

Effective 9/1/2025 policy includes Alecensa; program number 2025 P 1182-11 and P&T approval history updated through 6/2025.

6/2024added

Added criteria for adjuvant treatment following tumor resection of ALK-positive NSCLC per FDA label.

6/2025added

Added criteria for pediatric diffuse high-grade gliomas per NCCN guidelines (pediatric diffuse high-grade glioma listed as eligible CNS indication when ALK-positive).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAlecensa® (alectinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1182-11

Change TypeAdded adjuvant NSCLC and pediatric diffuse high-grade glioma; multiple NCCN indication additions

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

Used as adjuvant treatment following tumor resection

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Members less than 19 years of age

Alecensa will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age
Authorization will be issued for 12 months.

Automatic processing for pediatric members per policy

Prescription will automatically process without a coverage review for members under 19; authorization issued for 12 months.

Symptomatic Erdheim-Chester Disease - Initial Authorization

Alecensa will be approved based on all the following criteria:

ALL of the following

Diagnosis of symptomatic Erdheim-Chester Disease
Used as targeted therapy for ALK-fusion
Disease status
- Relapsed
- Refractory

Authorization will be issued for 12 months.

Anaplastic large cell lymphoma (ALCL) - Initial Authorization

Alecensa will be approved based on all the following criteria:

ALL of the following

Diagnosis of anaplastic large cell lymphoma (ALCL)
Used as initial palliative intent therapy or second-line and subsequent therapy
Disease status
- Relapsed
- Refractory
Anaplastic lymphoma kinase (ALK)-positive

Authorization will be issued for 12 months.

Large B-Cell Lymphoma - Initial Authorization

Alecensa will be approved based on all the following criteria:

ALL of the following

Diagnosis of large B-Cell lymphoma
Disease status
- Relapsed
- Refractory
Anaplastic lymphoma kinase (ALK)-positive

Authorization will be issued for 12 months.

Central Nervous System (CNS) Cancers / Pediatric Diffuse High-Grade Glioma - Initial Authorization

Alecensa will be approved based on both of the following criteria:

ALL of the following

One of the following diagnoses
- Diagnosis of metastatic brain cancer from NSCLC
- Diagnosis of pediatric diffuse high-grade glioma
Tumor is anaplastic lymphoma kinase (ALK)-positive

Authorization will be issued for 12 months.

Inflammatory Myofibroblastic Tumor (IMT) - Initial Authorization

Alecensa will be approved based on both of the following criteria:

ALL of the following

Diagnosis of inflammatory myofibroblastic tumor (IMT)
Presence of ALK translocation

Authorization will be issued for 12 months.

NCCN Recommended Regimens

Alecensa will be approved when recognized by NCCN with appropriate categories:

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Patient does not show evidence of progressive disease while on Alecensa therapy

Authorization will be issued for 12 months.

Large B-Cell Lymphoma - Reauthorization

Alecensa will be approved for reauthorization when:

Patient does not show evidence of progressive disease while on Alecensa therapy

Authorization will be issued for 12 months.

CNS Cancers / Pediatric Diffuse High-Grade Glioma - Reauthorization

Alecensa will be approved for reauthorization when:

Patient does not show evidence of progressive disease while on Alecensa therapy

Authorization will be issued for 12 months.

Inflammatory Myofibroblastic Tumor (IMT) - Reauthorization

Alecensa will be approved for reauthorization when:

Patient does not show evidence of progressive disease while on Alecensa therapy

Authorization will be issued for 12 months.

Documentation Required

Progression documentation for reauthorization

For reauthorization, clinicians must document that the patient does not show evidence of progressive disease while on Alecensa therapy; reauthorizations issued when this criterion is met (authorization generally for 12 months).

Prior Authorization

Automatic processing for pediatric members

For members under 19 years of age the prescription will automatically process without a coverage review; an authorization will be issued for 12 months.

Billing Rule

Supply limits and automated approvals may apply

Supply limits may be in place, and UnitedHealthcare may approve initial authorization or reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic via automated processes.

2016-2025revised

Updated background and references; multiple NCCN-based indications added over time including histiocytic neoplasms, T‑cell lymphomas, B‑cell lymphoma, CNS cancers, IMT, and other ALK-driven malignancies.

9/2019, 9/2020, 8/2023revised

Administrative/reference annual reviews with no changes to clinical coverage criteria noted (non-material administrative updates).