ModifiedHealth NetPolicy CP PHAR.360

Olaparib (Lynparza) coverage

Policy governs medical necessity criteria, prior authorization, and approval durations for olaparib (Lynparza) across multiple oncologic indications for Health Net lines of business (Commercial, HIM, Medicaid). It affects prescribers, pharmacists, and prior authorization reviewers.

Policy Summary

PayerHealth Net

PolicyOlaparib (Lynparza) coverage

Policy CodePolicy CP PHAR.360

Change TypeCriteria updates & attestation added

Effective Date

Next Review Date

Key ActionSubmit prior authorization with CLIA-approved diagnostic confirmation and required documentation; attest when requesting for gBRCAm ovarian cancer after ≥3 lines of chemotherapy.

SourceLink

POLICY UPDATE CHANGES

Prescriber attestation requirement was added for use in gBRCAm ovarian cancer after 3 or more lines of chemotherapy due to withdrawal of the FDA indication.

Redirect to generic for oral oncology agents (use generic olaparib if available) was added to continued therapy criteria.

Updated ovarian cancer criteria to reflect newly diagnosed stage II-IV first-line settings per NCCN and added off-label uterine neoplasm criteria.

For breast cancer, removed the 'HER2 negative' criterion and updated Appendix D to include HER2-positive, BRCA1/2 germline-mutated disease per NCCN compendium.

For ovarian cancer, updated criteria for newly diagnosed stage II-IV disease to align with NCCN (completed first-line platinum-based chemotherapy and in complete or partial response); added off-label criteria for uterine neoplasms and removed NCCN supplemental info in Appendix D.

References reviewed and updated.

MultipleIndications

6/12 mo

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Coverage Criteria

inv-01: Initial Therapy Criteria by Indication

Covered when ALL of the following are met for each indication (indication-specific criteria follow):

Ovarian Cancer - Initial Approval: 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) Completed >= 1 platinum-based chemotherapy regimen and is in a complete or partial response, or completed >= 2 platinum-based chemotherapy regimens as specified for particular indications; 6) Documentation of a deleterious or suspected deleterious germline or somatic BRCA mutation confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx) OR documentation of HRD-positive disease (genomic instability) when required for combination with bevacizumab; 7) Member has not previously received a PARP inhibitor (e.g., rucaparib, niraparib, talazoparib); 8) Dose does not exceed FDA limits (e.g., 600 mg/day or 4 tablets/day) or is supported by guidelines for off-label use.

Breast Cancer - Initial Approval: 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) Documentation of deleterious germline BRCA1/2 mutation as confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); 6) Disease is high risk, metastatic, or recurrent as defined by policy; 7) Member has not previously received a PARP inhibitor; 8) Dose does not exceed 600 mg/day or 4 tablets/day or is supported by practice guidelines/peer-reviewed literature for relevant off-label use; 9) Prescribed regimen must be FDA-approved or recommended by NCCN.

Pancreatic Adenocarcinoma - Initial Approval: 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) Received approximately 16 weeks of platinum-based chemotherapy with no disease progression; 6) Documentation of deleterious or suspected deleterious germline BRCA mutation confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); 7) Member has not previously received a PARP inhibitor; 8) Dose does not exceed 600 mg/day or 4 tablets/day or is supported by guidelines; 9) Prescribed regimen must be FDA-approved or recommended by NCCN.

Prostate Cancer - Initial Approval: 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 mutation (including BRCA) confirmed on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx); 5) If BRCA mutation present and combination therapy indicated, Lynparza prescribed with abiraterone plus prednisone/prednisolone OR prior failure of abiraterone or enzalutamide unless contraindicated or intolerant; 6) Member must use a GnRH analog concurrently or have had bilateral orchiectomy; 7) Member has not previously received a PARP inhibitor; 8) Dose does not exceed 600 mg/day or 4 tablets/day or is supported by guidelines; 9) Member does not have a PPPZRZA gene mutation (exclusion).

Uterine Neoplasms (off-label) - Initial Approval: 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 documented; 6) Prescribed as single-agent subsequent therapy (see Appendix B); 7) Member has not previously received a PARP inhibitor; 8) Dose is within FDA maximum limit or supported by practice guidelines/peer-reviewed literature for off-label use (prescriber must submit supporting evidence); 9) Prescribed regimen must be FDA-approved or recommended by NCCN for analogous use.

inv-02: Continued Therapy

Continuation therapy is allowed when ALL of the following are met:

Continued Therapy: 1) Member is currently receiving Lynparza via the Centene benefit or documentation supports that the member has been receiving Lynparza for at least 30 days; 2) Ongoing use remains consistent with the indication-specific requirements and dosing limits established at initial approval; 3) For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced.

inv-03: Continued Therapy — Continued therapy: Covered when ALL of the following are met

Continued therapy: Covered when ALL of the following are met

Continued therapy general: Member is currently receiving Lynparza via the Centene benefit or documentation supports current receipt and has received Lynparza for at least 30 days.30 days

Response: Member is responding positively to therapy.

Ovarian cancer post-3 lines attestation: If request is for an adult member with deleterious or suspected deleterious gBRCAm advanced ovarian cancer treated with 3 or more lines of chemotherapy, the provider must attest acknowledgment of the voluntary withdrawal of this FDA indication due to potential detrimental effect on overall survival; physicians should not initiate new treatment for this indication per Appendix E.

For the prostate cancer indication, coverage requires documentation of a qualifying HRR mutation (germline or somatic) on a CLIA-approved diagnostic test. Members who have a PPPZRZA gene mutation are excluded from coverage for this indication and requests documenting this mutation should be denied per policy.

Non–FDA-approved (off-label) indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety per the applicable off-label use policy. Refer to the relevant off-label policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) when evaluating requests for off-label uses.

This clinical policy is an evidence-based guide for medical necessity determinations but does not supersede the terms, exclusions, or limitations in members' coverage documents. State Medicaid provisions and applicable legal or regulatory requirements take precedence when they conflict with this policy.

If the requested use is listed on the plan formulary/PDL but falls under the plan's no-coverage criteria, or if the product is non‑formulary, adjudication should follow the referenced internal policies for the applicable line of business (for example, CP.CPA.190, HIM.PA.33, CP PMN.255 or the non-formulary policies). Coverage may not be authorized unless the conditions of those policies or applicable exceptions are met.

Initiation of Lynparza for adult patients with deleterious or suspected deleterious germline BRCA‑mutated (gBRCAm) advanced ovarian cancer who have received three or more lines of chemotherapy is not recommended following voluntary withdrawal of that FDA indication. Providers must acknowledge the withdrawal: physicians should not initiate new treatment in this setting, and prescribers currently treating such patients should discuss the withdrawal with their patients. For continuation requests, documentation must show the member has been receiving Lynparza for at least 30 days and is deriving clinical benefit.

Initial Therapy Requirements

inv-27: Initial Therapy Requirements

Initial approval requirements are indication-specific and require clinician attestation, diagnostic confirmation, prior therapy history, and dosing limits.

Initial Approval Requirements (general): 1) Prescribed by or in consultation with an appropriate specialist (oncologist or urologist as indicated); 2) Age >= 18 years (unless otherwise specified); 3) Documentation of relevant diagnostic testing: CLIA-approved confirmation of deleterious or suspected deleterious germline or somatic BRCA/HRR/HRD mutation when required (e.g., FoundationOne CDx or BRACAnalysis CDx); 4) Prior therapy history consistent with the indication (e.g., prior platinum-based chemotherapy or specified duration of platinum therapy for pancreatic cancer); 5) Member has not previously received a PARP inhibitor; 6) For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed FDA maximum limits (e.g., 600 mg/day or 4 tablets/day) or is supported by practice guidelines/peer-reviewed literature for off-label uses; 8) Prescribed regimen must be FDA-approved or recommended by NCCN when required.

Continuation / Continued Therapy

inv-28: Continuation

Criteria to continue therapy

Continuation: 1) Member is currently receiving the medication via the Centene benefit or documentation supports receipt for at least 30 days; 2) Clinical rationale for ongoing therapy remains consistent with the covered indication and prior authorization criteria; 3) Required concurrent therapies (e.g., continued bevacizumab for certain ovarian cancer combination regimens) are being continued unless contraindicated or discontinued for clinically significant adverse effects; 4) For brand Lynparza requests, member must use generic olaparib if available unless contraindicated or intolerant.

inv-29: Continuation Therapy

Continuation covered when criteria met

Current therapy: Member currently receiving Lynparza via benefit or documentation supports ongoing use and at least 30 days of therapy has been received.>=30 days

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Requests for Lynparza (olaparib) are subject to prior authorization. Providers must demonstrate that the member meets all applicable clinical criteria in this policy for the requested indication and submit supporting documentation (e.g., office chart notes, lab results, CLIA-approved diagnostic test results). Failure to provide sufficient documentation may result in denial or delay of the request.

Prior authorization required for initial and continued therapy requests.
Supporting documentation must include confirmation of mutation testing on a CLIA-approved diagnostic test when applicable (e.g., Foundation One CDx, BRACAnalysis CDx).
If documentation is incomplete, the request may be denied or returned for more information.

Documentation Required

Off‑Label Use & Prescriber Attestation

Prescriber attestation and off‑label documentation — Requests for indications that are non‑FDA approved or withdrawn from FDA approval require sufficient supporting documentation. Off‑label uses not addressed in this policy will be denied unless documentation demonstrates efficacy and safety consistent with the plan’s off‑label use policies and evidence of coverage.

Coding & Dosing

Referenced internal policy codesmixed

CP.CPA.190	No coverage criteria policy for commercial formulary redirection
HIM.PA.33	No coverage criteria policy for health insurance marketplace - formulary
CP PMN.255	No coverage criteria policy for Medicaid formulary
HIM.PA.154	Off-label use policy (health insurance marketplace)
CP.PMN.53	Off-label use policy (Medicaid)

Maximum daily dose

Maximum daily dose600 mg/day

Equivalent tablet limit4 tablets per day

Applies toBreast, ovarian, pancreatic, and prostate cancer dosing limits in policy

Step Therapy / Substitution

Step	Requirement	Notes
1
For brand Lynparza (olaparib) requests, the member must use generic olaparib if available
Applies unless the member has a contraindication or clinically significant adverse effects to the generic; consistent across ovarian, breast, pancreatic and prostate indication criteria

Policy	Action	Scope
Redirect to generic for oral oncology agents
When a generic formulation of olaparib is available, redirect brand requests to the generic product
Template language added to apply to oral oncology agents; intended to standardize generic redirection across applicable indications

Quantity Limits

Lynparza (olaparib) — 600 mg

Drug name (brand)Lynparza (olaparib)

Therapeutic classPARP inhibitor

Usage noteBrand requests must default to generic olaparib if available unless contraindicated or intolerant

Lynparza (olaparib) — 4

Maximum tablets per day4 tablets per day

Indications referencing tablet limitBreast, pancreatic, prostate, and ovarian indication criteria list 4 tablets/day as a dose limit

Alternate dosing guidance

Definitions & Diagnostics

PARP inhibitor / Companion diagnostic

DefinitionOlaparib (Lynparza) is a poly (ADP-ribose) polymerase (PARP) inhibitor.

Companion diagnosticSelect patients for therapy based on an FDA-approved companion diagnostic for Lynparza (e.g., BRACAnalysis CDx).

Test requirementMutation confirmation on a CLIA-approved diagnostic test (e.g., FoundationOne CDx or BRACAnalysis CDx) is required where indicated in the criteria.

mutations in the germline BRCA genes — gBRCAm

TermgBRCAm

DefinitionMutations in the germline BRCA genes

Use in policy

Background

Olaparib (Lynparza) is a poly(ADP‑ribose) polymerase (PARP) inhibitor with FDA‑approved and guideline‑supported indications across BRCA‑ or HRR/HRD‑related malignancies, including ovarian, breast, pancreatic, and prostate cancers. Use is typically guided by demonstration of deleterious or suspected deleterious BRCA/HRR/HRD mutations via an FDA‑approved or CLIA‑approved companion diagnostic (for example, BRACAnalysis CDx or FoundationOne CDx), and may be used as maintenance therapy after response to platinum‑based chemotherapy or as part of other regimen-specific approvals.

Policy Summary

PayerHealth Net

PolicyOlaparib (Lynparza) coverage

Policy CodePolicy CP PHAR.360

Change TypeCriteria updates & attestation added

Effective Date

Next Review Date

Key ActionSubmit prior authorization with CLIA-approved diagnostic confirmation and required documentation; attest when requesting for gBRCAm ovarian cancer after ≥3 lines of chemotherapy.

SourceLink

On This Page

Billing Rule

Generic‑First / Redirection to Generic

Generic redirection requirement — When a generic formulation of olaparib is available, brand Lynparza will be redirected to generic olaparib unless the provider documents a contraindication or clinically significant adverse effect to the generic product.

Applicable to initial and continued therapy requests across covered indications.
Provider must document contraindication or intolerance to generic olaparib to justify brand dispensing.
Pharmacy-level redirection may occur per plan formulary and step/generic‑first rules.