CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lynparza (olaparib) — Coverage Criteria

Defines prior authorization, documentation, and medical necessity criteria for Lynparza (olaparib) across FDA-approved and compendial oncology indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLynparza (olaparib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit laboratory reports documenting BRCA and relevant HRR/HRD testing to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

2 yearsmax duration — ovarian (CR)

1 yearmax duration — adjuvant breast

BRCA & HRRmolecular docs

Coverage Criteria and Authorization Rules

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Ovarian maintenance criteria: (1) Member has completed two or more lines of platinum-based therapy for recurrent disease, has a deleterious or suspected deleterious germline or somatic BRCA mutation and will be using Lynparza as a single agent; OR (2) Member has a deleterious or suspected deleterious germline or somatic BRCA mutation and will be using Lynparza as a single agent for advanced (stage II-IV) disease; OR (3) Member received primary therapy that included bevacizumab for advanced (stage II-IV) disease, will be using Lynparza in combination with bevacizumab AND either has HRD-positive disease OR has a deleterious or suspected deleterious germline or somatic BRCA mutation.

Breast cancer - Adjuvant and metastatic

Authorization of 12 months may be granted for breast cancer when the following criteria are met:

Breast cancer metastatic/adjuvant criteria: (1) Treatment for unresectable recurrent (local or regional) or metastatic breast cancer as a single agent in members with deleterious or suspected deleterious germline BRCA mutations; OR (2) Adjuvant treatment of HER2-negative, germline BRCA-mutated high-risk early breast cancer after completion of neoadjuvant/adjuvant chemotherapy in any of the following settings: hormone receptor-negative with any residual disease; OR hormone receptor-negative with tumor >= 2 cm or any involved axillary nodes; OR hormone receptor-positive with >= 4 positive lymph nodes; OR hormone receptor-positive with any residual disease and CPS+EG score >= 3 following preoperative therapy.

Prostate cancer - Treatment

Authorization of 12 months may be granted for metastatic castration-resistant prostate cancer (mCRPC) when EITHER of the following criterion groups are met:

mCRPC single-agent criteria: Requested as a single agent (concurrent LHRH agonist/antagonist allowed) AND member has a deleterious or suspected deleterious germline or somatic HRR gene mutation (includes BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L) AND member has progressed on prior androgen receptor-directed therapy AND member is receiving concurrent LHRH agonist/antagonist or has had bilateral orchiectomy.

mCRPC combination with abiraterone: Requested in combination with abiraterone (or fine-particle abiraterone) plus concurrent steroids AND member has a deleterious or suspected deleterious BRCA mutation AND member has not progressed on prior novel hormone therapy (e.g., abiraterone, enzalutamide, darolutamide, or apalutamide) AND member is receiving concurrent LHRH agonist/antagonist or has had bilateral orchiectomy.

Continuation of therapy and maximum durations

Continuation of therapy reauthorization requirements and duration limits:

Continuation: Reauthorization for indications listed may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Duration limits: Maximum treatment durations: 2 years for first-line BRCA-mutated ovarian maintenance in complete response (single agent or with bevacizumab as specified); 1 year for adjuvant treatment of early-stage HER2-negative BRCA-mutated high-risk breast cancer.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit clinical documentation to support the request; incomplete documentation may result in denial or delay.

Prior authorization required for all non‑compendial uses and for indications listed in this policy where authorization criteria apply.

Step Therapy

Therapy Sequencing for mCRPC

For metastatic castration‑resistant prostate cancer (mCRPC), sequencing requirements apply. The requested PARP inhibitor will be authorized only when the specified prior therapies and molecular findings are documented.

Requested medication used as a single agent: Member must have a deleterious or suspected deleterious germline or somatic HRR gene mutation (including BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L). Member must have progressed on prior androgen receptor‑directed therapy. Member must be receiving concurrent GnRH analog therapy (LHRH agonist/antagonist) or have had bilateral orchiectomy.
Requested medication used in combination with abiraterone (or fine‑particle abiraterone) plus concurrent steroids: Member must have a deleterious or suspected deleterious BRCA mutation and must NOT have progressed on prior novel hormone therapy (e.g., abiraterone, enzalutamide, darolutamide, apalutamide).

Documentation Required

Required Molecular and Pathology Documentation

Provide molecular and pathology documentation with the prior authorization submission. Authorization cannot be completed without the necessary laboratory/pathology reports.

Laboratory report confirming BRCA mutation status (germline or somatic) when applicable.
Laboratory report confirming germline or somatic HRR gene mutation when applicable.
Documentation of homologous recombination deficiency (HRD) status when applicable.
Pathology reports documenting hormone receptor (HR) and HER2 status when applicable.
For mCRPC requests, include specific HRR gene test results naming the mutated gene(s) (e.g., BRCA1, BRCA2, ATM, PALB2, etc.) and the test type (germline vs somatic).

Denial Risk

Non‑compendial Indications — Experimental/Investigational

Uses not supported by compendia or not meeting documented molecular/therapy‑sequencing criteria are considered experimental/investigational and are not medically necessary.

All indications not listed as compendial (e.g., outside ovarian, breast, pancreatic, prostate with criteria met, uterine leiomyosarcoma BRCA2‑altered) are considered experimental/investigational.
Requests lacking required molecular or pathology documentation may be denied as not meeting medical necessity.

Background

Olaparib (Lynparza) is a poly (ADP‑ribose) polymerase (PARP) inhibitor referenced here with compendial listings for multiple tumor types including breast, ovarian (including fallopian tube and primary peritoneal), uterine leiomyosarcoma, and prostate cancer. Selection for therapy commonly depends on documented molecular alterations (for example, deleterious or suspected deleterious BRCA mutations or other HRR/HRD abnormalities) and companion diagnostic results; uses not covered by FDA approval or compendial listing are considered experimental/investigational and not medically necessary.

Definitions and Key Terms

deleterious or suspected deleterious BRCA mutation

DefinitionGermline or somatic BRCA1/BRCA2 genetic alterations identified by an FDA‑approved companion diagnostic used to select patients for olaparib therapy.

Role in indicationsSelection criterion for ovarian, breast, pancreatic, prostate (combination) and uLMS indications where specified.

Actionable requirementProvide laboratory report confirming BRCA mutation status to support prior authorization

HRD-positive

DefinitionHomologous recombination deficiency (HRD)‑positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability per an FDA‑approved companion diagnostic.

Clinical useRequired to select patients for first‑line maintenance of advanced ovarian cancer in combination with bevacizumab.

DocumentationProvide laboratory report confirming HRD status to support prior authorization

first-line (line of therapy)

First-line ovarian maintenance: Maintenance after response to first-line platinum-based chemotherapy; select patients based on companion diagnostic; maximum duration 2 years for complete response.

salvage (line of therapy)

Maintenance after multiple lines: Maintenance for recurrent ovarian disease after completion of two or more lines of platinum-based therapy when BRCA-mutated and used as single agent.

salvage (line of therapy)

mCRPC after AR-directed therapy: Treatment for mCRPC after progression on prior androgen receptor-directed therapy, with required deleterious or suspected deleterious HRR mutation for single-agent use, or BRCA mutation when given in combination with abiraterone; concurrent LHRH agonist/antagonist or orchiectomy required.

Molecular Testing and Biomarker Documentation

BRCA (germline or somatic)

BiomarkerDeleterious or suspected deleterious germline or somatic BRCA1/BRCA2 mutation (gBRCAm or sBRCAm)

Indications requiring BRCAFirst‑line and recurrent ovarian maintenance, adjuvant and metastatic breast cancer, maintenance pancreatic adenocarcinoma, select prostate combination therapy, BRCA2‑altered uLMS

Documentation requiredLaboratory report confirming BRCA mutation status must be submitted for prior authorization

HRD

Definition/thresholdHRD‑positive by an FDA‑approved companion diagnostic defined as either a deleterious BRCA mutation and/or genomic instability

Required forFirst‑line ovarian maintenance when used in combination with bevacizumab

DocumentationLaboratory report confirming HRD status must be submitted for prior authorization

HRR gene panel (includes ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L)

Panel componentsIncludes ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L

ThresholdDeleterious or suspected deleterious mutation in any listed HRR gene

Clinical useRequired to select patients for single‑agent use in metastatic castration‑resistant prostate cancer (mCRPC)

Covered Regimens and Indication-Specific Use

Regimen	Indication	Coverage
Lynparza monotherapy after response to first-line platinum-based chemotherapy; select patients with an FDA‑approved companion diagnostic
First‑line maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA‑mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first‑line platinum‑based chemotherapy
Covered with criteria (authorization typically 12 months; select patients by companion diagnostic)

Regimen	Indication	Coverage
Lynparza in combination with bevacizumab after response to first‑line platinum‑based chemotherapy
First‑line maintenance treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that is HRD‑positive (defined by deleterious/suspected BRCA mutation and/or genomic instability) and in complete or partial response to first‑line platinum‑based chemotherapy
Covered with criteria (authorization typically 12 months; select patients by FDA‑approved companion diagnostic)

Regimen	Indication	Coverage
Adjuvant Lynparza after completion of neoadjuvant/adjuvant chemotherapy
Adjuvant treatment of HER2‑negative, germline BRCA‑mutated high‑risk early breast cancer in specified settings: HR‑negative with any residual disease; HR‑negative with tumor ≥2 cm or any positive axillary nodes; HR‑positive with ≥4 positive lymph nodes; HR‑positive with any residual disease and CPS+EG score ≥3 following preoperative therapy
Covered with criteria (authorization typically 12 months; adjuvant maximum duration 1 year)

Regimen	Indication	Coverage
Lynparza monotherapy after ≥16 weeks of first‑line platinum‑based chemotherapy if disease has not progressed
Maintenance treatment of deleterious or suspected deleterious germline BRCA‑mutated metastatic pancreatic adenocarcinoma in members whose disease has not progressed on at least 16 weeks of a first‑line platinum‑based chemotherapy regimen
Covered with criteria (authorization typically 12 months)

Regimen	Indication / Requirements	Coverage
Lynparza as single agent with concurrent LHRH agonist/antagonist (or after bilateral orchiectomy)
mCRPC: single‑agent use for members with deleterious or suspected deleterious germline or somatic HRR gene mutation (includes BRCA1/2 and specified HRR genes); member must have progressed on prior androgen receptor‑directed therapy and be receiving concurrent LHRH agonist/antagonist or have had bilateral orchiectomy
Covered with criteria (authorization typically 12 months)

Regimen	Indication / Requirements	Coverage
Lynparza in combination with abiraterone plus concurrent steroids
mCRPC: combination use with abiraterone (or fine‑particle abiraterone) plus prednisone/prednisolone/methylprednisolone for members with deleterious or suspected deleterious BRCA mutation who have not progressed on prior novel hormone therapy; concurrent LHRH agonist/antagonist or bilateral orchiectomy required
Covered with criteria (authorization typically 12 months)

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