CurrentUnitedHealthcarePolicy N/A

Talzenna (talazoparib) prior authorization

Prior authorization and notification criteria for coverage of Talzenna (talazoparib) for specified oncology indications, affecting prescribers and pharmacists for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyTalzenna (talazoparib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Next Review DateAug 1, 2025

Key ActionObtain prior authorization for Talzenna except for members under age 19 whose prescriptions auto-process.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsTypical authorization duration

Age <19Auto-approve age group

2Primary covered indications

through 8/2025P&T approval dates

Coverage Criteria for Talzenna (talazoparib)

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Reauthorization - Breast Cancer

Covered when ALL of the following are met

Breast cancer reauth: Patient does not show evidence of progressive disease while on Talzenna therapy

Authorization issued for 12 months

Initial Therapy - Metastatic Castration-Resistant Prostate Cancer

Covered when ALL of the following are met

mCRPC initial: (1) Diagnosis of metastatic castration-resistant prostate cancer AND (2) Presence of homologous recombination repair (HRR) gene mutations AND (3) Used in combination with Xtandi (enzalutamide) AND (4) Either used in combination with a gonadotropin-releasing hormone (GnRH) analog OR patient has had bilateral orchiectomy

Authorization issued for 12 months

Patients less than 19 years of age

Covered when the following is met

Pediatrics auto-approve: Patient is less than 19 years of age

Authorization will be issued for 12 months; prescriptions for members under 19 automatically process without coverage review

State mandates and an individual member’s benefit plan can affect coverage determinations. Some states may mandate coverage for off‑label uses or require use of specific compendia, and where applicable those mandates supersede the language in this policy. Providers should verify applicable state requirements and the member’s benefit plan before assuming coverage.

Initial Therapy — Approval Criteria by Indication

Initial therapy

Initial approval criteria by indication

Initial breast: See coverage Initial Therapy - Breast Cancer (adults)

Authorization issued for 12 months

Initial mCRPC: See coverage Initial Therapy - Metastatic Castration-Resistant Prostate Cancer

Authorization issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Reauthorization/continuation criteria

Continuation: Patient does not show evidence of progressive disease while on Talzenna therapy

Authorization issued for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Talzenna for members age 19 and older. Prescriptions for members under age 19 will automatically process and are approved for 12 months without coverage review.

Prior authorization required for members ≥ 19 years
Members < 19 years: automatic approval for 12 months

Denial Risk

Denial-risk Conditions

Requests that do not meet the specified indication or mutation criteria may be denied. Examples include absence of a documented germline BRCA mutation for breast cancer or absence of an HRR gene mutation when Talzenna is requested for mCRPC in combination with enzalutamide.

Breast cancer requests must document locally advanced or metastatic disease and a germline BRCA mutation
mCRPC requests must document HRR gene mutation and use in combination with enzalutamide (and appropriate castration via GnRH analog or bilateral orchiectomy)

Documentation Required

Required Documentation

Documentation must include diagnosis, disease stage, mutation testing results, and prior therapies as applicable to support medical necessity.

Diagnosis (e.g., breast cancer, metastatic castration-resistant prostate cancer)
Disease stage (locally advanced or metastatic for breast cancer; metastatic castration-resistant for prostate cancer)
Genetic testing results (germline BRCA mutation for breast cancer; HRR gene mutation for mCRPC)
Concomitant therapy documentation (e.g., enzalutamide; GnRH analog or orchiectomy status)
Prior therapy history where applicable

Step Therapy

Step Therapy and Additional Clinical Rules

Step therapy or other utilization management rules may apply per UnitedHealthcare programs; automated approvals based on prior claim/medication history, diagnosis codes, and claim logic are possible. Supply limits may also be in place.

Step therapy may be enforced according to other utilization management programs
Automated approval or reauthorization may occur based on claim history and diagnosis codes
Supply limits may apply

Step	Requirement
1	Step therapy may be in place per broader utilization management programs.

Background

Talzenna (talazoparib) is a poly (ADP‑ribose) polymerase (PARP) inhibitor indicated as monotherapy for adult patients with deleterious or suspected deleterious germline BRCA‑mutated HER2‑negative locally advanced or metastatic breast cancer, and indicated in combination with enzalutamide for homologous recombination repair (HRR) gene‑mutated metastatic castration‑resistant prostate cancer. Selection of appropriate patients is based on FDA‑approved companion diagnostic testing; guideline sources such as NCCN also support use in BRCA‑associated advanced breast cancer.

Definitions

Deleterious or suspected deleterious germline BRCA mutation (gBRCAm)

DefinitionDeleterious or suspected deleterious germline BRCA mutation (gBRCAm).

Indication (breast cancer)Talzenna is indicated as a single agent for adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

Diagnostic selectionAppropriate patients are selected based on an FDA‑approved companion diagnostic for Talzenna.

Homologous recombination repair (HRR) gene‑mutated

DefinitionHomologous recombination repair (HRR) gene‑mutated (HRR gene mutations).

Indication (prostate cancer)Talzenna is indicated in combination with Xtandi (enzalutamide) for adult patients with HRR gene‑mutated metastatic castration‑resistant prostate cancer (mCRPC).

Use requirements for mCRPCFor initial authorization, talazoparib must be used with enzalutamide and either a GnRH analog or after bilateral orchiectomy.

Policy Summary

PayerUnitedHealthcare

PolicyTalzenna (talazoparib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Next Review DateAug 1, 2025

Key ActionObtain prior authorization for Talzenna except for members under age 19 whose prescriptions auto-process.

SourceLink

On This Page

OpenPayer

Talzenna (talazoparib) prior authorization

Coverage Criteria for Talzenna (talazoparib)

Initial Therapy — Approval Criteria by Indication

Reauthorization / Continuation Criteria

Provider Actions and Documentation Requirements

Step Therapy / Utilization Management

Quantity Limits and Supplies

Background

Definitions