CurrentUnitedHealthcarePolicy N/A

Step therapy requirement for Talzenna (talazoparib)

Defines UnitedHealthcare's step therapy program requiring trial of Lynparza (olaparib) before coverage of Talzenna for germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer; applies to members subject to the payer's pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy requirement for Talzenna (talazoparib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionRequire trial of Lynparza (olaparib) before authorizing Talzenna unless contraindicated or provider attests Lynparza is inappropriate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

Step therapyprogram type

Lynparzarequired prior agent

<19 autoage-based exception

Coverage Criteria

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Breast Cancer

Covered when ANY of the following are met (for breast cancer indication)

Lynparza contraindication or intolerance: Patient has a contraindication or history of intolerance to Lynparza (olaparib)

Provider attestation of inappropriateness: Provider attests that the patient is not an appropriate candidate based on the patient's clinical status or comorbidities for Lynparza (olaparib)

Continuation of therapy: As continuation of therapy AND patient has not received a manufacturer supplied sample at no cost from a prescriber's office, or any form of assistance from the Pfizer Oncology Together sponsored Co-Pay Savings Program or a 30-day free trial from a pharmacy as a means to establish as a current user of Talzenna

Authorization will be issued for 12 months

Coverage criteria in this policy may be affected by state and federal requirements and by the terms of a member’s benefit plan. Some state mandates may supersede these criteria, including mandates that require coverage for certain off‑label uses or require reference to specific drug compendia. Federal regulatory requirements and individual member benefit plan provisions can also alter coverage determinations and will take precedence where applicable.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Talzenna (talazoparib) requires prior authorization for members age 19 and older. Members under age 19 may be auto-processed when eligibility and clinical criteria are met; providers should still submit supporting documentation when applicable.

Affected product: Talzenna (talazoparib)
Auto-processing for members < 19 when criteria satisfied

Step Therapy

Step Therapy Requirement

Step therapy: A trial of Lynparza (olaparib) is required before Talzenna will be approved for treatment of germline BRCA‑mutated, HER2‑negative locally advanced or metastatic breast cancer, unless the patient meets an allowed exception.

Required prior agent: Lynparza (olaparib)
Indication: gBRCAm, HER2‑negative locally advanced or metastatic breast cancer

Documentation Required

Required Supporting Documentation

Documentation Required for Exceptions: If the patient has not tried Lynparza, providers must submit one of the following: 1) documentation of contraindication or history of intolerance to Lynparza, or 2) a provider attestation that the patient is not an appropriate candidate for Lynparza based on clinical status or comorbidities. Include relevant clinical notes, test results, and prior therapy history.

Acceptable documentation: clinical notes, allergy/intolerance history, provider attestation
Provider attestation must explain why Lynparza is inappropriate for this patient

Denial Risk

Denial Risk — Step Therapy Not Met

Step Therapy Failure or Exception Required: Requests for Talzenna for patients who have not tried Lynparza will be denied unless there is a documented contraindication/intolerance or a provider attestation that Lynparza is inappropriate. Members currently documented on Talzenna in claims history may continue therapy.

Denial risk if no Lynparza trial and no documented exception
Members on Talzenna per claims history may continue without meeting step requirement

Definitions

gBRCAm (germline BRCA‑mutated) — definition/key facts

Termgermline BRCA-mutated

AbbreviationgBRCAm

Clinical definitionDeleterious or suspected deleterious germline BRCA mutation associated with HER2-negative locally advanced or metastatic breast cancer

Relevance to policyIndication required for step therapy: Lynparza must be tried prior to Talzenna for treatment of gBRCAm, HER2‑negative breast cancer

Age scopeApplies to adult patients for labeled indications; separate processing rules exist for members under 19 years of age

Initial Therapy Criteria

Initial therapy

Initial therapy for breast cancer

Prior Lynparza trial or exception: Member has tried Lynparza (olaparib) OR has a contraindication/intolerance to Lynparza OR provider attests Lynparza is inappropriate

Prior authorization required for new-to-therapy members

Continuation Criteria

Continuation of Talzenna

Continuation approvals

Continuation without assistance-established sample: Patient is continuing Talzenna and has not received a manufacturer supplied sample at no cost from a prescriber's office or assistance from Pfizer Oncology Together or a 30-day free trial from a pharmacy to establish current user status

Authorization will be issued for 12 months

Step Therapy Requirements

Step	Requirement	Exceptions / Notes
1
Member must trial Lynparza (olaparib) prior to Talzenna (talazoparib) for the indicated gBRCAm, HER2-negative locally advanced or metastatic breast cancer
Exceptions: patient has a contraindication or history of intolerance to Lynparza; provider attestation that Lynparza is not appropriate based on clinical status or comorbidities. Members currently on Talzenna documented in claims may continue per continuation rules.

Background

Talzenna (talazoparib) and Lynparza (olaparib) are members of the PARP inhibitor drug class used in patients with deleterious or suspected deleterious germline BRCA‑mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Lynparza’s labeled uses include patients who have received prior chemotherapy and, for HR‑positive disease, prior endocrine therapy or when endocrine therapy is not appropriate. Clinical guidance (for example, NCCN) supports use of both agents in this setting.

Within this policy’s step therapy program, coverage of Talzenna for the breast cancer indication requires a trial of Lynparza (olaparib) first unless the patient meets an exception: documented contraindication or history of intolerance to Lynparza or a provider attestation that Lynparza is not an appropriate option based on the patient’s clinical status or comorbidities. For members new to Talzenna, prior authorization is required and approval is contingent on meeting the step therapy requirement or an allowed exception.

For patients continuing Talzenna, authorization may be granted when the patient has not been established on therapy through a manufacturer‑supplied sample or Pfizer Oncology Together co‑pay assistance or a 30‑day free trial from a pharmacy; continuation approvals are issued for 12 months. Additionally, prescriptions for members under age 19 will automatically process without a coverage review per the benefit rules.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy requirement for Talzenna (talazoparib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionRequire trial of Lynparza (olaparib) before authorizing Talzenna unless contraindicated or provider attests Lynparza is inappropriate.

SourceLink

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