ModifiedCentenePolicy CP.PHAR.409

Talazoparib (Talzenna) Coverage Criteria

Defines medical necessity and prior authorization criteria for talazoparib (Talzenna) for commercial, HIM, and Medicaid lines of business, covering initial and continued use for breast cancer and mCRPC and other indications per off-label policies.

Policy Summary

PayerCentene

PolicyTalazoparib (Talzenna) Coverage Criteria

Policy CodePolicy CP.PHAR.409

Change TypeMaterial revisions to indications, dosing limits, and approval duration

Effective Date03.01.19

Next Review Date

Key ActionSubmit prior authorization with diagnosis, mutation status, prescriber specialty, dosing within policy limits, and clinical documentation to support criteria.

SourceLink

POLICY UPDATE CHANGES

mCRPC indication added (talazoparib in combination with enzalutamide) and new capsule strengths introduced.

Quantity limit requirement added: request must not exceed health-plan approved quantity limit and limited to maximum dose per day and 1 capsule per day.

Commercial approval duration standardized to 12 months or duration of request, whichever is less; Medicaid/HIM extended to 12 months.

For breast cancer, required that talazoparib be prescribed as a single agent and HER2-negative documentation removed.

For prostate cancer, added requirement that member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy per NCCN compendium.

For breast cancer, added 'prescribed as a single agent' to align with FDA indication and NCCN compendium.

Added new soft gelatin capsule formulation.

For continued therapy, changed maximum dosing criteria from 'does not exceed both of the following' to 'does not exceed any of the following' to allow variability in maximum daily dose reduction per prescriber information.

Removed requirement for documentation of HER2-negative disease for breast cancer.

Added requirement that request does not exceed health-plan approved quantity limit and revised quantity limit to maximum dose per day and 1 capsule per day.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

Initial Therapy - Breast Cancer

Covered for breast cancer when ALL of the following are met

Breast Cancer Initial: 1. Diagnosis of recurrent, locally advanced, or metastatic breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Talzenna requests, member must use generic talazoparib, if available, unless contraindicated or clinically significant adverse effects are experienced; 5. Prescribed as a single agent; 6. Documentation of deleterious or suspected deleterious BRCA1/2 mutation; 7. Member has not previously received a PARP inhibitor (e.g., Lynparza, Rubraca, Zejula, Akeega); 8. Request does not exceed health-plan approved quantity limit; 9. Request meets one of the following (a or b): a) Dose does not exceed both of the following: i) 1 mg per day; ii) 1 capsule per day; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Initial Therapy - Prostate Cancer (mCRPC)

Covered for metastatic castration-resistant prostate cancer (mCRPC) when ALL of the following are met

Prostate Cancer Initial: 1. Diagnosis of metastatic castration-resistant prostate cancer (mCRPC), evidenced by disease progression despite bilateral orchiectomy or other androgen deprivation therapy (ADT); 2. Prescribed by or in consultation with an oncologist or urologist; 3. Age ≥ 18 years; 4. For brand Talzenna requests, member must use generic talazoparib, if available, unless contraindicated or clinically significant adverse effects are experienced; 5. Documentation of a homologous recombination repair (HRR) gene mutation; 6. Prescribed concurrently with enzalutamide (Xtandi); 7. Prescribed concurrently with systemic ADT or member has had a bilateral orchiectomy; 8. Member has not previously received a PARP inhibitor (e.g., Lynparza, Rubraca, Zejula, Akeega); 9. Request does not exceed health-plan approved quantity limit; 10. Request meets one of the following (a or b): a) Dose does not exceed both of the following: i) 0.5 mg per day; ii) 1 capsule per day; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Initial Therapy Criteria

Initial approval criteria per indication

Breast Initial: See Initial Therapy - Breast Cancer (Section I.A).

Prostate Initial: See Initial Therapy - Prostate Cancer (mCRPC) (Section I.B).

Continued Therapy

Continued therapy (all indications in Section I) when ALL of the following are met

Continued Therapy: 1. Member is currently receiving talazoparib via Centene benefit, or documentation shows member has received talazoparib for at least 30 days; 2. Member is responding positively to therapy; 3. For brand Talzenna requests, member must use generic talazoparib, if available, unless contraindicated or clinically significant adverse effects are experienced; 4. Request does not exceed health-plan approved quantity limit; 5. If request is for a dose increase, request meets one of the following: a) For breast cancer: new dose does not exceed 1 mg per day and 1 capsule per day; b) For mCRPC: new dose does not exceed 0.5 mg per day and 1 capsule per day; c) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Continued Therapy Note: Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Continued Therapy — dosing variability

Continued therapy dosing criteria updated to permit variability in maximum daily dose reductions

Continued therapy dosing: Dosing must not exceed any of the specified maximums (revised from 'does not exceed both of the following' to 'does not exceed any of the following') to allow variability in maximum daily dose reduction per prescriber information.

RT4 change

Other/Off-label Use Pathway

Other diagnoses/indications

Other Indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, new dosing), refer to either the no coverage or non‑formulary policy for the relevant line of business as specified (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); 2. If the requested use is not listed in Section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Follow referenced line-of-business policies for determination.

Updated Coverage Criteria

Policy updated to include indication-specific requirements and revised dosing/quantity limits.

Prostate cancer indication: Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently OR has had a bilateral orchiectomy.

Added per NCCN compendium (1Q 2024).

Breast cancer indication: Talazoparib is prescribed as a single agent; documentation of HER2-negative disease requirement removed.

Aligned with FDA indication and NCCN compendium (1Q 2024–1Q 2025).

Quantity and duration: Request does not exceed health-plan approved quantity limit; quantity limit revised to maximum dose per day and 1 capsule per day; Medicaid/HIM initial approval duration extended to 12 months.1 capsule per day

1Q 2026 annual review.

Requests for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient clinical documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

Use of talazoparib after prior PARP inhibitor therapy is considered unsupported due to limited evidence. Most pivotal PARP inhibitor trials excluded patients with prior PARP inhibitor exposure, randomized controlled trial data are lacking, and NCCN provides no explicit recommendations for consecutive PARP inhibitor use (except limited commentary for ovarian cancer). Absent robust evidence, requests for sequential PARP inhibitors are typically not authorized.

What Providers Must Submit / Actions Required

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required with documentation of diagnosis, mutation status, and prescriber information. Provider must submit clinical documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Documentation must include mutation status (BRCA1/2 for breast; HRR gene for prostate) and evidence of prior therapies where applicable.
Prescriber must be an oncologist (breast) or oncologist/urologist (prostate) or in consultation with one.

Denial Risk

Prior PARP Inhibitor Exclusion

Prior PARP inhibitor exclusion — Member must not have previously received a PARP inhibitor for the requested indication.

Examples include Lynparza®, Rubraca®, Zejula®, Akeega®.

Dosing, Limits, and Coding Summary

Maximum daily dose / capsule limit — Talazoparib

Breast cancer maximum daily dose≤ 1 mg per day and ≤ 1 capsule per day

mCRPC maximum daily dose≤ 0.5 mg per day and ≤ 1 capsule per day

Breast cancer renal impairment adjustmentsModerate renal impairment: 0.75 mg PO QD; Severe renal impairment: 0.5 mg PO QD

Quantity limit

Quantity limit (all indications)Requests must not exceed the health‑plan approved quantity limit

Capsule limitLimit of 1 capsule per day applies

Dose-based limit

Key Terms and Abbreviations

Androgen deprivation therapy (ADT) definition

DefinitionAndrogen deprivation therapy (ADT): therapy to suppress or block androgens, including bilateral orchiectomy or LHRH agonists/antagonists (see Appendix D).

ExamplesIncludes bilateral orchiectomy (surgical castration) and luteinizing hormone-releasing hormone (LHRH) analogs given with or without an antiandrogen.

Context in policyADT requirement used to establish progression to metastatic CRPC for talazoparib eligibility.

Germline BRCA mutation (gBRCAm) definition

DefinitionGermline BRCA mutation (gBRCAm): mutations in the germline BRCA genes (BRCA1/2).

Companion diagnosticFDA-approved companion diagnostic BRACAnalysis CDx® referenced for identifying gBRCAm.

Prior Therapy / Step Requirements

Step	Requirement
1	Prior PARP inhibitor therapy excludes authorization: member must not have previously received a PARP inhibitor (e.g., Lynparza, Rubraca, Zejula, Akeega) for the requested indication.

Step	Requirement
1	No step therapy requirements specified in these chunks.

Quantity Limit Rules

Talazoparib — Maximum dose and capsule limit

Talazoparib dosing summaryBreast cancer: 1 mg PO QD (maximum 1 mg/day; 1 capsule/day)

mCRPC dosing summarymCRPC: 0.5 mg PO QD with enzalutamide (maximum 0.5 mg/day; 1 capsule/day)

Quantity/capsule limitPolicy limits to a maximum dose per day and 1 capsule per day across indications.

talazoparib — mCRPC maximum dose and capsule limit

mCRPC maximum dose0.5 mg per day (maximum)

Capsule limit1 capsule per day

Must not exceed health-plan quantity limit

Clinical Background

Talazoparib is a PARP inhibitor with FDA‑approved indications that include treatment of germline BRCA‑mutated locally advanced or metastatic breast cancer and use in HRR gene‑mutated metastatic castration‑resistant prostate cancer in combination with enzalutamide. The FDA‑approved breast cancer indication references the BRACAnalysis CDx® companion diagnostic. NCCN guidance supports talazoparib as a single‑agent option in select breast cancer scenarios and notes considerations for use in mCRPC; examples of androgen deprivation therapy (ADT) referenced by guidelines include bilateral orchiectomy and luteinizing hormone‑releasing hormone (LHRH) analogs with or without an antiandrogen.

Billing Rule

Quantity Limits and Approval Duration

Quantity limits and approval duration — Requests must not exceed the health‑plan approved quantity limit. The revised quantity limit is expressed as the maximum dose per day and a maximum of 1 capsule per day. Initial approval duration: Medicaid/HIM = 12 months; Commercial = 12 months or duration of request, whichever is less.

Dose limits by indication: breast — maximum 1 mg per day and 1 capsule per day (or supported by guidelines/literature for off‑label dosing with evidence submission).
Prostate — maximum 0.5 mg per day and 1 capsule per day (or supported by guidelines/literature for off‑label dosing with evidence submission).
Requests that exceed the health‑plan approved quantity limit or the revised quantity limit require justification and may be denied.

Documentation Required

Indication‑Specific Documentation

Indication‑specific documentation — For prostate cancer requests, provider must document that the member will use a GnRH analog concurrently or has had a bilateral orchiectomy. For breast cancer requests, document diagnosis of recurrent, locally advanced, or metastatic disease and, when applicable, that talazoparib is prescribed as a single agent.

Prostate: evidence of metastatic castration‑resistant prostate cancer and concurrent Xtandi® and systemic ADT use, or documentation of bilateral orchiectomy.
Breast: documentation of deleterious or suspected deleterious BRCA1/2 mutation and that talazoparib is prescribed as a single agent.