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mhn Olaparib (Lynparza) Coverage Update | OpenPayer

ModifiedmhnPolicy CP.PHAR.360

Olaparib (Lynparza) clinical coverage criteria

Defines medical necessity criteria, documentation, and authorization requirements for Olaparib (Lynparza) across multiple cancer indications for Centene-affiliated health plans (Commercial, HIM, Medicaid) and specifies approval durations and dose limits.

Policy Summary

Payermhn

PolicyOlaparib (Lynparza) clinical coverage criteria

Policy CodePolicy CP.PHAR.360

Change TypeMultiple substantive and operational revisions (material and non-material)

Effective DateOct 3, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation of indication, CLIA diagnostic-confirmed BRCA/HRR status, prior therapies, and required attestation for withdrawn ovarian indication where applicable.

SourceLink

POLICY UPDATE CHANGES

Prescriber attestation requirement was added for use in gBRCAm ovarian cancer after ≥ 3 lines of chemotherapy due to withdrawal of that FDA-approved indication.

Approval duration for Commercial line of business was revised to 12 months or duration of request, whichever is less.

Template language added redirecting to generic olaparib if available for oral oncology agents.

Adjuvant therapy duration for breast cancer clarified: total duration does not exceed 1 year.

Updated maintenance indication for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer to clarify use with deleterious or suspected deleterious germline or somatic BRCA mutations.

For breast cancer, removed 'HER2 negative' requirement because NCCN supports use in HER2-positive, BRCA1/2 germline-mutated disease (level 2A evidence); Appendix D updated.

For ovarian cancer, updated criteria for newly diagnosed stage II-IV disease and first-line platinum-based chemotherapy response per NCCN; added off-label criteria for uterine neoplasms; removed NCCN supplemental info in Appendix D.

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Coverage Criteria for Olaparib (Lynparza)

Initial Approval — Ovarian Cancer

Covered when ALL of the following are met

Ovarian Initial: 1. Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 5. Member meets one of the following (a, b, c, or d): a) Completed ≥2 platinum-based chemotherapy regimens and is in a complete or partial response; b) Both i and ii: i. Documentation of a deleterious or suspected deleterious germline or somatic BRCA mutation as confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); ii. Completed a platinum-based chemotherapy regimen and is in a complete or partial response; c) Both i and ii: i. Disease is HRD-positive defined by one of the following: 1) Documentation of a deleterious or suspected deleterious BRCA mutation confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx) or 2) Documentation of genomic instability; ii. Both of the following: 1) Completed a bevacizumab- and platinum-based chemotherapy regimen as first-line therapy and is in a complete or partial response; 2) Lynparza is prescribed in combination with bevacizumab; d) Both i and ii: i. Newly diagnosed stage II-IV disease; ii. Completed first-line platinum-based chemotherapy regimen and is in a complete or partial response; 6. Member has not previously received a PARP inhibitor (e.g., Rubraca, Talzenna, Zejula); 7. Request meets one of the following: a) Dose does not exceed 600 mg per day or 4 tablets per day; b) Dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).age ≥18; dose ≤600 mg/day

Initial Approval — Breast Cancer

Covered when ALL of the following are met

Breast Initial: 1. Diagnosis of breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 5. Disease has BOTH: a) Deleterious germline BRCA1/2 mutation confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); and b) High risk, metastatic, or recurrent disease; 6. Member has not previously received a PARP inhibitor (e.g., Rubraca, Talzenna, Zejula); 7. Request meets one of the following: a) Dose does not exceed 600 mg per day or 4 tablets per day; b) Dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).age ≥18; BRCA1/2 germline mutation (CLIA)

Initial Approval — Pancreatic Adenocarcinoma

Covered when ALL of the following are met

Pancreatic Initial: 1. Diagnosis of pancreatic adenocarcinoma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 5. Documentation of a deleterious or suspected deleterious germline BRCA mutation as confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); 6. Received >16 weeks of platinum-based chemotherapy with no disease progression; 7. Member has not previously received a PARP inhibitor (e.g., Rubraca, Talzenna, Zejula); 8. Request meets one of the following: a) Dose does not exceed 600 mg per day or 4 tablets per day; b) Dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).>=16 weeks platinum-based chemotherapy; BRCA germline (CLIA)

Initial Approval — Prostate Cancer (mCRPC)

Covered when ALL of the following are met

Prostate Initial: 1. Diagnosis of metastatic castration-resistant prostate cancer; 2. Prescribed by or in consultation with an oncologist or urologist; 3. Age ≥ 18 years; 4. Documentation of a deleterious or suspected deleterious germline or somatic HRR gene mutation (including BRCA) confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); 5. One of the following: a) Member has a BRCA mutation and Lynparza is prescribed in combination with abiraterone and either prednisone or prednisolone; OR b) Both i and ii: i. Documentation of disease progression despite bilateral orchiectomy or other androgen deprivation therapy; ii. Failure of abiraterone or enzalutamide unless contraindicated or significant adverse effects; 6. Member does not have a PPP2R2A gene mutation; 7. For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 8. Member will use a GnRH analog concurrently or has had a bilateral orchiectomy; 9. Member has not previously received a PARP inhibitor (e.g., Rubraca, Talzenna, Zejula); 10. Request meets one of the following: a) Dose does not exceed 600 mg per day or 4 tablets per day; b) Dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).HRR mutation (CLIA); prior AR-targeted therapy failure or combination with abiraterone for BRCA

Initial Approval — Uterine Neoplasms (off-label)

Covered when ALL of the following are met

Uterine Off-label Initial: 1. Diagnosis of uterine sarcoma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 5. Mutations in the BRCA genes; 6. Prescribed as single-agent subsequent therapy; 7. Member has not previously received a PARP inhibitor (e.g., Rubraca, Talzenna, Zejula); 8. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).BRCA mutation; subsequent single-agent therapy

Continuation (Renewal) Criteria — All Indications

Covered when ALL of the following are met

Continuation: 1. Member is currently receiving Lynparza via the Centene benefit or documentation supports current receipt and member has received Lynparza for at least 30 days; 2. For ovarian cancer: provider attestation acknowledging withdrawal of the indication for adult patients with deleterious or suspected deleterious gBRCAm advanced ovarian cancer treated with ≥3 prior lines of chemotherapy is required where applicable; 3. For HRD‑positive ovarian cancer within the first 15 months of combination therapy with bevacizumab: documentation of continued bevacizumab therapy is required unless contraindicated or clinically significant adverse effects have developed; 4. Member is responding positively to therapy; 5. For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 6. For adjuvant breast cancer, total duration of therapy does not exceed 1 year; 7. If request is for a dose increase, new dose must not exceed 600 mg per day or 4 tablets per day, or the increase must be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).>=30 days prior use; clinical response required

General continuation and universal coverage criteria

Covered when ALL of the following are met:

Universal requirements: 1) Member is currently receiving Lynparza via the Centene benefit or documentation supports current receipt and member has received Lynparza for at least 30 days; 2) Member is responding positively to therapy; 3) For brand requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 4) For adjuvant breast cancer, total duration of therapy does not exceed 1 year; 5) If request is for a dose increase, new dose must not exceed 600 mg per day or 4 tablets per day OR be supported by practice guidelines or peer-reviewed literature; Prescribed regimen must be FDA-approved or recommended by NCCN.

Applies to all indications in Section I

Ovarian cancer — post‑withdrawal and HRD/bevacizumab conditions

Additional conditions specific to ovarian cancer:

Ovarian cancer special conditions: A) For ovarian cancer: If request is for an adult with deleterious or suspected deleterious germline BRCA mutation (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy, provider attestation acknowledging the voluntary withdrawal of that FDA-approved indication due to potential detrimental effect on overall survival (see Appendix E) is required; B) For HRD‑positive ovarian cancer within the first 15 months of combination therapy with bevacizumab: documentation of continued bevacizumab therapy is required unless contraindicated or clinically significant adverse effects have developed.

Reflects withdrawal and HRD/bevacizumab continuity requirement

Coverage criteria updates and referenced indications

Policy covers olaparib when indication-specific clinical criteria per updated prescribing information and NCCN compendium are met.

Updated ovarian maintenance indication: Use for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer clarified to include deleterious or suspected deleterious germline or somatic BRCA mutations.

per updated prescribing information (09.25.23)

Breast cancer indication update: Removed 'HER2 negative' requirement; supports use in HER2-positive, BRCA1/2 germline-mutated disease per NCCN level 2A evidence.

1Q 2024 annual review

Ovarian first-line maintenance: Updated criteria require newly diagnosed stage II-IV disease who have completed first-line platinum-based chemotherapy and are in a complete or partial response as supported by NCCN.

1Q 2025 annual review

If the drug label has changed within the last 6 months and those updates are not yet incorporated into this policy, follow the applicable formulary or non‑formulary policy provisions or refer to the off‑label use policy for requests not specifically listed. This ensures the plan applies the most current regulatory status while adjudicating requests.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded unless the provider submits sufficient documentation of safety and efficacy according to the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid). Providers must supply supporting clinical evidence (e.g., peer‑reviewed literature, guideline recommendations, or detailed chart documentation) when requesting coverage for off‑label uses.

Coverage determinations are subject to the member's contract, evidence of coverage, and any plan exclusions, limitations, or administrative policies. When state Medicaid provisions conflict with this clinical policy, the state Medicaid requirements take precedence. Providers and adjudicators must apply benefit terms and applicable law or regulation when finalizing coverage decisions.

Requests for initial therapy are not eligible for approval if the member has previously received any PARP inhibitor (for example, Rubraca, Talzenna, or Zejula). The policy requires documentation that the member has not had prior PARP inhibitor exposure as a condition of initial authorization across indications.

Because AstraZeneca voluntarily withdrew the FDA‑approved indication for Lynparza in adult patients with deleterious or suspected deleterious germline BRCA‑mutated advanced ovarian cancer after ≥3 prior lines of chemotherapy due to possible detrimental overall survival in that subgroup, the policy advises that physicians should not initiate Lynparza in this setting. For continuation requests in previously treated patients, the policy requires prescriber attestation acknowledging the withdrawal and its potential OS risk (see Appendix E).

Covered Regimens and Dosing

Regimen	Indication	Coverage status
{"text":"Olaparib combined with abiraterone and prednisone/prednisolone","status":""},{"text":"Metastatic castration‑resistant prostate cancer (mCRPC) with documented deleterious or suspected germline or somatic HRR gene mutation (including BRCA); combination regimen when member has a BRCA mutation","status":""},{"text":"Covered with criteria","status":"covered"}

Regimen	Indication / biomarker requirement	Coverage status
{"text":"Olaparib plus bevacizumab (combination maintenance)","status":""},{"text":"Maintenance treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first‑line platinum‑based chemotherapy when cancer is HRD‑positive defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability; olaparib must be prescribed in combination with bevacizumab per criteria","status":""},{"text":"Covered with criteria","status":"covered"}

Dosing regimen	Applicable indications	Maximum / daily limit
{"text":"300 mg PO twice daily (BID)","status":""},{"text":"Breast, ovarian, pancreatic, and prostate cancers listed in this policy","status":""},{"text":"Maximum 600 mg/day (or 4 tablets/day)","status":""}

Coding and Dose Limits

No explicit CPT/HCPCS/NDC codes in this segmentmixed

No codes listed

Maximum daily dose

Maximum daily dose600 mg per day

Tablet equivalent4 tablets per day

Typical dosing regimen300 mg PO BID (refer to dosing and administration)

Maximum daily dose

Maximum daily dose (alternate wording)600 mg/day

Maximum tablets/day4 tablets/day

Standard dose schedule300 mg PO twice daily

Provider Actions, Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must demonstrate criterion-specific requirements including diagnosis, prescriber specialty, age (≥ 18 years), and other indication-specific criteria listed in Section I. Requests for brand Lynparza should default to generic olaparib if available unless contraindicated or clinically significant adverse effects are documented.

Apply clinical criteria from Section I (ovarian, breast, pancreatic, prostate) as applicable
Prescriber must be an oncologist or in consultation with an oncologist (urologist acceptable for prostate when specified)
Age ≥ 18 years for all indications unless otherwise stated

Prior Authorization

Prior Authorization Duration and Requirement

Approval durations differ by benefit type. Document duration requested and ensure submitted duration does not exceed program limits.

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

Line-of-Therapy Categories

maintenance | subsequent

maintenance | subsequent: Olaparib is used as maintenance after response to platinum-based chemotherapy for ovarian and pancreatic cancers; adjuvant use in high-risk early breast cancer; treatment in metastatic BRCA-mutated breast and prostate cancers per criteria; uterine usage listed as subsequent single-agent therapy off-label.

mixed

mixed: Policy notes changes related to line-of-therapy indications including voluntary withdrawal of the ≥3 prior lines gBRCAm ovarian indication and updates clarifying first-line and maintenance sequencing per NCCN.

first-line

First-line ovarian maintenance: Completed first-line platinum-based chemotherapy regimen and is in a complete or partial response (applies to newly diagnosed stage II-IV ovarian disease per updated NCCN-supported criteria).

Biomarker and Diagnostic Requirements

BRCA (germline or somatic)

RequirementBRCA (germline or somatic) must be confirmed on a CLIA-approved diagnostic test

Examples of CLIA diagnosticsFoundationOne CDx, BRACAnalysis CDx

Applicable indicationsOvarian, breast, pancreatic, prostate, and select off-label uterine indications where BRCA status is required

HRD (homologous recombination deficiency) / genomic instability

DefinitionHRD-positive defined by deleterious or suspected deleterious BRCA mutation and/or genomic instability

Use caseRequired for olaparib + bevacizumab maintenance in ovarian cancer

Background

Olaparib (Lynparza) is an oral PARP inhibitor indicated for maintenance or active treatment across several BRCA‑ or HRR‑associated malignancies, including ovarian, breast, pancreatic and prostate cancers. Typical dosing referenced in the policy is 300 mg orally twice daily (maximum 600 mg/day), with tablet strengths and regimen details aligned to prescribing information. Use is biomarker‑directed in many settings — for example, requiring confirmation of deleterious or suspected deleterious germline or somatic BRCA or other HRR gene mutations on a CLIA‑approved diagnostic test where specified — and maintenance indications commonly follow a documented response to platinum‑based chemotherapy.

Definitions and Abbreviations

PARP inhibitor

Class definitionA medication class that inhibits poly (ADP-ribose) polymerase (PARP) enzymes

Example agentOlaparib (Lynparza) is a PARP inhibitor

Clinical roleUsed as maintenance or active treatment in BRCA- or HRR-associated cancers

CLIA-approved diagnostic

DefinitionLaboratory tests performed in CLIA-certified laboratories used to confirm deleterious or suspected deleterious BRCA or HRR gene mutations

ExamplesFoundationOne CDx, BRACAnalysis CDx

Purpose

Quick Action Items for Providers

Provider actions — Authorization & documentation

Note

Prior authorization required

Note

Approval duration

Note

Required documentation and attestation

Note

Genetic testing documentation

Note

Policy Revision History

2024-11-18criteria_revisionLatest

Updated ovarian cancer criteria for newly diagnosed stage II–IV disease requiring completion of first-line platinum-based chemotherapy and response per NCCN; added off-label criteria for uterine neoplasms and removed NCCN supplemental information in Appendix D (1Q 2025 annual review recorded 11.18.24).

2023-10-25criteria_revision

Removed 'HER2 negative' requirement for breast cancer to support use in HER2‑positive, BRCA1/2 germline‑mutated disease per NCCN (1Q 2024 annual review recorded 10.25.23; P&T approval 02.24).