CurrentCignaPolicy N/A

Oncology (Oral - PARP Inhibitor) - Lynparza Prior Authorization Policy

Cigna prior authorization policy describing coverage criteria, approvals, and restrictions for Lynparza (olaparib tablets) across FDA‑approved oncology indications and select supportive-evidence uses; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology (Oral - PARP Inhibitor) - Lynparza Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revisions and additions (material)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, diagnosis-specific biomarker status (BRCA, HRD/HRR, PALB2 where required), prior therapies, and response to platinum-based chemotherapy when indicated.

SourceLink

POLICY UPDATE CHANGES

Ovarian maintenance monotherapy criteria were changed to require response to at least one platinum-based chemotherapy regimen (removing prior language requiring response to first-line only or two regimens).

Wording 'germline and/or somatic' and 'as confirmed by an approved test' were removed from BRCA and HRD/HRR mutation requirements in certain ovarian and prostate criteria.

Breast cancer recurrent/metastatic criteria were updated to include germline PALB2 mutation-positive disease as an alternative to BRCA mutation.

7+FDA-approved and supportive evidence indications listed

1 yrTypical approval duration

≥18

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 Criteria for Lynparza (olaparib)

FDA-Approved Indications

Covered for FDA-approved indications when ALL specified criteria are met; approvals typically granted for 1 year.

Breast Cancer - Adjuvant Therapy: Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient has germline BRCA mutation–positive breast cancer; AND C) Patient has HER2‑negative breast cancer; AND D) Patient has tried neoadjuvant or adjuvant therapy.

Breast Cancer - Recurrent or Metastatic: Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent or metastatic disease; AND C) Patient meets ONE of the following: i) Patient has BRCA mutation–positive breast cancer; OR ii) Patient has germline PALB2 mutation–positive breast cancer.

Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - Maintenance, Monotherapy: Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient has BRCA mutation–positive disease; AND C) Patient is in complete or partial response to at least one platinum‑based chemotherapy regimen.

Examples of platinum-based chemotherapy include carboplatin with gemcitabine, carboplatin with paclitaxel, cisplatin with gemcitabine.

Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - Maintenance, Combination (with bevacizumab): Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Medication is used in combination with bevacizumab; AND C) Patient has homologous recombination deficiency (HRD)–positive disease (note: HRD includes BRCA mutation–positive disease); AND D) Patient is in complete or partial response to first‑line platinum‑based chemotherapy regimen.

Examples of first‑line platinum regimens include carboplatin with paclitaxel, carboplatin with doxorubicin, docetaxel with carboplatin.

Pancreatic Adenocarcinoma - Maintenance Therapy: Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient has germline BRCA mutation–positive metastatic disease; AND C) Disease has not progressed on at least 16 weeks of treatment with a first‑line platinum‑based chemotherapy regimen.16 weeks

Prostate Cancer - Metastatic Castration‑Resistant Prostate Cancer (mCRPC): Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient has metastatic castration‑resistant prostate cancer; AND C) Patient meets ONE of the following: i) medication is used concurrently with a gonadotropin‑releasing hormone (GnRH) analog; OR ii) patient has had a bilateral orchiectomy; AND D) Patient meets ONE of the following: i) BOTH a) patient has homologous recombination repair (HRR) gene‑mutated disease (examples: BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L) AND b) patient has been previously treated with at least one androgen‑receptor‑directed therapy; OR ii) BOTH a) patient has a BRCA mutation AND b) medication is used in combination with abiraterone plus prednisone or prednisolone.

Examples of GnRH analogs: leuprolide, triptorelin, goserelin, histrelin, degarelix, relugolix.

Other Uses With Supportive Evidence

Other uses supported by evidence (coverage with criteria).

Uterine Leiomyosarcoma: Approve for 1 year if ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient has BRCA2‑altered disease; AND C) Patient has tried at least one systemic regimen.

Examples of systemic regimens include dacarbazine, docetaxel, doxorubicin, epirubicin, gemcitabine, ifosfamide, trabectedin.

Lynparza (olaparib tablets) is not medically necessary for any use(s) that are not specifically described in this policy. Requests for indications, regimens, or patient populations outside the FDA‑approved indications or the policy’s listed supportive‑evidence uses will be denied as not medically necessary unless and until the policy is updated to include them.

Any use of Lynparza that is not listed in the policy’s FDA‑Approved Indications section or the Other Uses With Supportive Evidence section is considered not medically necessary. Coverage will be limited to the indications and criteria explicitly specified in this policy and will be updated only when new published evidence warrants a change.

Coding and Billing

Drug - referencedmixed

NDC or CPT not specified

Policy references Lynparza (olaparib tablets - AstraZeneca) but does not list specific billing codes in the document.

inv-06: Minimum age

Minimum agePatient is ≥ 18 years of age.

ScopeApplies to all listed FDA-approved and supportive-evidence indications in this policy.

Documentation requiredProvider must document patient age as part of required clinical documentation for prior authorization.

inv-07: Pancreatic chemotherapy duration

Pancreatic chemo duration requirementDisease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy.

Indication contextThis requirement applies to maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma.

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lynparza. Approvals are generally issued for 1 year when indication-specific criteria are met.

Prior authorization required; approvals generally for 1 year when indication-specific criteria met.
Claims submitted without covered diagnosis or procedure codes per the policy will be denied as not covered.
Use of Lynparza for any indication not specified in the policy is considered not medically necessary and may be denied.

Step Therapy

Prior Therapy Requirements

Certain FDA-approved and other supported indications require prior lines of therapy before approval (for example: adjuvant breast cancer requires prior neoadjuvant or adjuvant therapy; ovarian maintenance requires response to at least one platinum-based chemotherapy; pancreatic maintenance requires no progression after ≥16 weeks of first-line platinum-based chemotherapy; uterine leiomyosarcoma requires at least one prior systemic regimen; prostate cancer requires prior androgen-receptor-directed therapy for some HRR-mutated patients).

Background

Lynparza (olaparib) is an oral poly(ADP‑ribose) polymerase (PARP) inhibitor used in oncology for multiple tumor types associated with BRCA or homologous recombination repair/deficiency (HRR/HRD) alterations. It is employed both as maintenance therapy (for example, in ovarian and pancreatic cancer following response to platinum‑based chemotherapy) and as treatment in specific breast and prostate cancer settings; select additional uses (such as BRCA2‑altered uterine leiomyosarcoma) are included based on supportive evidence. Prior authorization is required and approvals are granted according to the indication‑specific criteria in this policy.

Definitions and Biomarker Terms

inv-14: HRR gene-mutated disease

HRR gene listHRR gene-mutated disease includes BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L.

Usage exampleHRR gene mutation requirement is used for mCRPC eligibility pathways requiring HRR gene-mutated disease plus prior androgen-receptor-directed therapy.

History noteWording regarding 'germline and/or somatic' was removed in recent revisions; list remains as the defined HRR genes in the policy.

inv-15: HRD-positive

Definition of HRD-positiveHomologous recombination deficiency (HRD)-positive disease includes a deleterious or suspected deleterious BRCA mutation and/or genomic instability.

Clinical contextHRD-positive status is an eligibility requirement for ovarian maintenance when used in combination with bevacizumab.

Line of Therapy Criteria

maintenance

Maintenance Therapy Criteria: Disease has not progressed on at least 16 weeks of a first‑line platinum‑based chemotherapy regimen.16 weeks

Applies to pancreatic maintenance; see indication‑specific nodes for ovarian maintenance response requirements.

first-line | subsequent

First‑line or Subsequent Therapy: Preferred or supported as first‑line or subsequent therapy in select germline BRCA or PALB2 patients per guideline recommendations; policy requires prior relevant therapies as specified per indication (e.g., neoadjuvant/adjuvant chemotherapy for adjuvant breast indication, prior androgen‑receptor‑directed therapy for certain prostate HRR‑mutated pathways).

See FDA‑Approved Indications for indication‑specific prior therapy requirements.

Biomarker and Mutation Requirements

inv-18: BRCA1/BRCA2

BRCA requirement overviewBRCA mutation-positive disease (BRCA1 or BRCA2) is required for multiple indications including ovarian maintenance monotherapy, pancreatic maintenance (germline BRCA), and certain breast and prostate indications.

Breast indicationAdjuvant breast therapy requires germline BRCA mutation-positive and HER2-negative disease.

Ovarian/ pancreatic specificsOvarian maintenance monotherapy requires BRCA mutation-positive disease and response to at least one platinum regimen; pancreatic maintenance requires germline BRCA mutation-positive metastatic disease with no progression after ≥16 weeks of first-line platinum.

inv-19: PALB2 (germline)

PALB2 (germline) acceptanceGermline PALB2 mutation-positive breast cancer is accepted as an alternative biomarker for approval in recurrent or metastatic breast cancer.

Covered Regimens and Combinations

Regimen	Indication / Key criteria	Coverage status
Lynparza in combination with bevacizumab	Ovarian, fallopian tube, or primary peritoneal cancer — maintenance combination: patient ≥ 18 years; HRD‑positive disease (including BRCA mutation); in complete or partial response to first‑line platinum‑based chemotherapy; used in combination with bevacizumab.	Covered

Regimen	Indication / Key criteria	Coverage status
Lynparza in combination with abiraterone plus prednisone or prednisolone	Metastatic castration‑resistant prostate cancer (mCRPC) — patient ≥ 18 years; patient has a BRCA mutation; medication used in combination with abiraterone plus prednisone or prednisolone (one approval pathway per policy).	Covered