CurrentCignaPolicy N/A

Talzenna (talazoparib) prior authorization

Prior authorization requirements for Talzenna (talazoparib capsules and liquid-filled soft gelatin capsules) for Cigna-administered health benefit plans; applies to providers requesting prescription benefit coverage.

Policy Summary

PayerCigna

PolicyTalzenna (talazoparib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 28, 2026

Key ActionSubmit prior authorization documentation to confirm age, diagnosis, biomarker status, and regimen to obtain coverage for Talzenna.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA indications

1 yrApproval duration

18+Min age

EnumeratedHRR gene list

Coverage Criteria for Talzenna (talazoparib)

FDA-Approved Indications

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Breast Cancer approval

A: Patient is >= 18 years of age>=18
B: Patient has recurrent or metastatic breast cancer
C: Patient has germline BRCA mutation-positive disease

Prostate Cancer approval

A: Patient is >= 18 years of age>=18
B: Patient has metastatic castration resistant prostate cancer
C
- C.i: Medication is used concurrently with a gonadotropin-releasing hormone (GnRH) analog
- C.ii: Patient has had a bilateral orchiectomy
D: Patient has homologous recombination repair (HRR) gene-mutated disease
E: Medication is used in combination with Xtandi (enzalutamide)

Regimen	Indication	Notes
Talzenna (talazoparib) in combination with Xtandi (enzalutamide)	Metastatic castration-resistant prostate cancer with a homologous recombination repair (HRR) gene mutation	Approve for 1 year when ALL criteria met: patient ≥ 18 years; metastatic castration‑resistant prostate cancer; documentation of HRR gene‑mutated disease (including listed HRR genes); medication used in combination with enzalutamide; concurrent GnRH analog use or bilateral orchiectomy documented when applicable. NCCN recommends Talzenna + Xtandi for BRCA or other HRR mutations in mCRPC (useful in certain circumstances).

Drug Product and Coding Details

Denial Risk

Coverage depends on benefit plan and coding — claims without covered diagnosis/procedure codes or not in accordance with the applicable benefit plan may be denied

Prior authorization and reimbursement depend on the member's specific benefit plan and accurate coding. Providers must submit claims with covered diagnosis and/or procedure codes consistent with the applicable benefit plan; claims submitted without covered code(s) or not in accordance with the benefit plan may be denied. In addition, when requesting coverage, include tumor-specific documentation: for breast cancer requests, document recurrent or metastatic disease and positive germline BRCA mutation status; for prostate cancer requests, document metastatic castration-resistant prostate cancer, HRR gene mutation status (eg, ATM, ATR, BRCA1/2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C), evidence of concurrent use of a GnRH analog or bilateral orchiectomy, and that therapy will be used in combination with enzalutamide (Xtandi).

Ensure submitted diagnosis codes support the FDA‑approved indication being requested (breast or prostate cancer).
Include genetic testing reports confirming germline BRCA mutation for breast cancer.
Include HRR gene mutation testing results for prostate cancer.
Document concurrent androgen‑deprivation therapy (GnRH analog) or bilateral orchiectomy for prostate cancer, and plan for combination use with enzalutamide.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required for Talzenna

Prior authorization is recommended for prescription benefit coverage of Talzenna; approvals are provided for the durations noted in the policy (typically 1 year for the FDA-approved indications).

Step Therapy

Guideline context — no explicit step therapy

NCCN guideline context notes Talzenna as a preferred PARP regimen in selected breast and prostate cancer settings, but this policy does not impose explicit step-therapy requirements.

Documentation Required

Prostate cancer — required documentation

Document that the patient has metastatic castration-resistant prostate cancer, an HRR gene mutation from the enumerated list, and that Talzenna is being used in combination with enzalutamide; if applicable, document concurrent use of a GnRH analog or prior bilateral orchiectomy.

Confirm patient is ≥ 18 years of age.
Confirm metastatic castration-resistant prostate cancer diagnosis.
Document ONE of: concurrent GnRH analog use OR bilateral orchiectomy.
Document HRR gene-mutated disease (e.g., ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C).
Document combination use with Xtandi (enzalutamide).

Documentation Required

Breast cancer — required documentation

Document that the patient has recurrent or metastatic breast cancer and a germline BRCA mutation to support coverage under the breast cancer indication.

Confirm patient is ≥ 18 years of age.
Document recurrent or metastatic breast cancer.
Document germline BRCA mutation-positive disease.

Biomarker and Genetic Testing Requirements

inv-13: germline BRCA1/2

Required biomarker for breast cancer indicationDeleterious or suspected deleterious germline BRCA mutation (germline BRCA1/2)

Clinical contextApplies to recurrent or metastatic HER2-negative locally-advanced or metastatic breast cancer in adults

Documentation requirementDocumentation must support germline BRCA mutation-positive disease

inv-14: HRR gene mutations (incl BRCA1/2, ATM, etc.)

Required HRR gene status for prostate cancer indicationPresence of an HRR gene mutation (HRR gene‑mutated mCRPC) is required

Combination requirementMedication must be used in combination with Xtandi (enzalutamide) for this indication

Concomitant androgen‑deprivation supportPatient must be receiving a GnRH analog concurrently or have had bilateral orchiectomy

inv-11: HRR gene mutations

Enumerated HRR genes (partial list)ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C

Definition sourceHRR gene mutations defined in policy note accompanying prostate cancer criteria

Use casePresence of one of these HRR gene mutations satisfies the HRR mutation requirement for mCRPC indication

Background on Talzenna and Clinical Context

Talzenna (talazoparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in oncology for specific, biomarker-defined settings. FDA-approved indications in this policy include treatment of germline BRCA-mutated, HER2‑negative locally-advanced or metastatic breast cancer as a single agent, and treatment of certain HRR (homologous recombination repair) gene-mutated metastatic castration‑resistant prostate cancers when used in combination with enzalutamide (Xtandi).

Policy Revision History

2026-01-28Policy reviewLatest

Policy last reviewed on 2026-01-28 with no material changes to the clinical policy statements.

2025-12-04Guideline update cited

NCCN Prostate Cancer Guidelines (version 4.2026) dated December 4, 2025 were referenced for regimen recommendations including Talzenna + enzalutamide.