CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy program for Talzenna (talazoparib)

This document defines step therapy requirements for coverage of Talzenna (talazoparib), primarily requiring trial or documented inappropriateness of Lynparza (olaparib) for members with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer; applies to members of the payer starting 7/1/2025.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy program for Talzenna (talazoparib)

Policy CodePolicy N/A

Change TypeClarified wordingno material clinical change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionProvider must document prior use of Lynparza or a contraindication/intolerance to Lynparza or attest the patient is not an appropriate candidate for Lynparza.

SourceLink

POLICY UPDATE CHANGES

Revised wording without change to clinical intent.

12 monthsauthorization duration for approved requests

Step therapyprogram type

Lynparza requiredpreferred agent before Talzenna

2025-07-01policy effective date

Coverage Criteria

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Coverage criteria

Covered when criteria below are met:

Pediatric approval: Member is less than 19 years of age

Authorization issued for 12 months

Breast cancer step therapy

One of the following
- Contraindication or intolerance to Lynparza: Patient has a contraindication or history of intolerance to Lynparza (olaparib)
- Provider attestation: Provider attests that the patient is not an appropriate candidate for Lynparza (olaparib) based on clinical status or comorbidities
- Continuation exception: 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 Co-Pay Savings Program (including sample cards or 30-day free pharmacy trial) as a means to establish current user status
  Patients established solely via manufacturer sample or Pfizer assistance must meet initial authorization criteria as if new to therapy.

Other indications: Talzenna will be approved for other indications as allowed by state mandates and the member specific benefit plan

Authorization issued for 12 months

Patients who were established on therapy solely through receipt of a manufacturer-supplied sample at no cost from a prescriber’s office, or through any form of assistance from the Pfizer Oncology Together co-pay savings program (including a sample card redeemable at a pharmacy or a 30‑day free trial from a pharmacy), are treated as new-to-therapy for authorization purposes. Such patients must meet the initial authorization criteria rather than be eligible for continuation approval. Authorization for patients who meet criteria will be issued for 12 months.

Initial Therapy Criteria

Initial therapy

Initial authorization for breast cancer indication

Initial therapy options: (1) Contraindication or history of intolerance to Lynparza (olaparib) OR (2) Provider attests that the patient is not an appropriate candidate for Lynparza based on clinical status or comorbidities OR (3) Documentation meeting continuation exception (see continuation rules): continuation of therapy and patient has not received a manufacturer supplied sample at no cost or assistance from the Pfizer Oncology Together Co-Pay Savings Program (including sample cards or 30-day free pharmacy trial)

Authorization issued for 12 months

Continuation Criteria

Continuation

Continuation rules and restrictions

Continuation of therapy: Continuation allowed provided patient is an existing user and has not been established solely via a manufacturer supplied sample at no cost from a prescriber's office or assistance from the Pfizer Oncology Together Co-Pay Savings Program (e.g., sample card redeemable at a pharmacy) or a 30-day free pharmacy trial used to establish current user status

Patients who were established on therapy solely via manufacturer sample or Pfizer Oncology Together co-pay assistance must meet initial authorization criteria as if new to therapy. Authorization issued for 12 months.

Step Therapy Requirements

Step	Required prior therapy or exception	Notes
1
Trial of Lynparza (olaparib) is required prior to Talzenna (talazoparib) for germline BRCA‑mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer unless one of the following documented exceptions is met: (1) contraindication or history of intolerance to Lynparza; (2) provider attestation that Lynparza is not appropriate based on clinical status or comorbidities; or (3) continuation/other documented exception per policy.
Authorization will be issued for 12 months when criteria are met; members <19 years auto‑process per pediatric criteria or continuation rules may apply.

Provider Actions & Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for Talzenna (except when the member is under 19, which is auto-processed). Authorization, when approved, will be issued for 12 months.

Authorization duration: 12 months
Automatic processing: members < 19 years

Step Therapy

Step Therapy Requirement — Try Lynparza First

Step therapy requirement: Members new to therapy must try Lynparza (olaparib) prior to coverage of Talzenna for germline BRCA‑mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer, consistent with the plan's step therapy program to encourage lower‑cost alternatives.

Applies to new-to-therapy members
Indication: gBRCAm, HER2‑negative locally advanced or metastatic breast cancer

Denial Risk

Step Therapy Prerequisite and Exceptions

Step therapy prerequisite — exceptions: A request for Talzenna may be approved without prior Lynparza when one of the following is documented: (1) the patient has a contraindication or history of intolerance to Lynparza; OR (2) the provider attests the patient is not an appropriate candidate for Lynparza based on clinical status or comorbidities; OR (3) the request is for continuation of therapy for a member already documented on Talzenna in claims history.

Contraindication or intolerance to Lynparza
Provider attestation of clinical unsuitability for Lynparza
Continuation of therapy for members already on Talzenna per claims history

Documentation Required

Required Documentation and Verification

Required documentation: Providers must document prior use of Lynparza or provide documentation supporting a contraindication/intolerance, or submit a clinical attestation that Lynparza is inappropriate for the patient. Additionally, providers must confirm the member was not established on Talzenna via a free manufacturer sample, Pfizer Oncology Together assistance, or a 30‑day free pharmacy trial (such members seeking initial authorization will be evaluated as new-to-therapy).

Document prior Lynparza use or contraindication/intolerance
Provider clinical attestation if Lynparza is inappropriate
Confirm member was not established on Talzenna via free samples or assistance programs

Definitions

inv-08: Definition of gBRCAm, HER2-negative locally advanced or metastatic breast cancer

TermgBRCAm, HER2-negative locally advanced or metastatic breast cancer

DefinitionBreast cancer with deleterious or suspected deleterious germline BRCA mutation and negative HER2 status in locally advanced or metastatic stages.

Relevant agentsPARP inhibitors: Talzenna (talazoparib) and Lynparza (olaparib)

Clinical contextIndication applies to adult patients; Lynparza has specific prior chemotherapy and endocrine therapy considerations for HR-positive disease.

Policy action (most actionable)Step therapy requires trial of Lynparza (olaparib) before Talzenna for this diagnosis unless contraindication, intolerance, or provider attestation that Lynparza is inappropriate.

Background

Talzenna (talazoparib) and Lynparza (olaparib) are both PARP inhibitors used to treat certain patients with deleterious or suspected deleterious germline BRCA‑mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Lynparza is the preferred first-line PARP inhibitor under this program for the specified breast cancer indication and, except for defined exceptions, a trial of Lynparza is required before Talzenna. Both agents are supported by clinical guidance (e.g., NCCN) for use in this setting, and program rules reflect that Talzenna coverage is contingent on meeting the step‑therapy and documentation requirements described in this policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy program for Talzenna (talazoparib)

Policy CodePolicy N/A

Change TypeClarified wordingno material clinical change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionProvider must document prior use of Lynparza or a contraindication/intolerance to Lynparza or attest the patient is not an appropriate candidate for Lynparza.

SourceLink

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