CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lynparza (olaparib) coverage and prior authorization criteria

Defines covered FDA-approved and compendial indications for olaparib (Lynparza), required documentation, initial and continuation authorization criteria, duration limits, and special conditions (e.g., companion diagnostic selection). Governs prior authorization determinations for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLynparza (olaparib) coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with laboratory reports confirming BRCA and/or HRR mutation status and HR/HER2 status as applicable; approvals typically granted for 12 months with indication-specific duration limits.

POLICY UPDATE CHANGES

No material clinical/coverage changes

5Covered Major Indications (FDA-listed)

1Compendial indication(s) listed

12 moTypical initial/authorization duration

Coverage Summary & Covered Indications

Coverage stance: covered_with_criteria for Lynparza (olaparib) across listed FDA-approved and compendial indications. The policy defines covered uses for ovarian (first-line maintenance, maintenance for recurrent disease, HRD-positive first-line maintenance with bevacizumab), breast (adjuvant high‑risk early and metastatic settings), pancreatic (germline BRCA‑mutated maintenance), prostate (HRR gene‑mutated mCRPC), and a compendial uterine leiomyosarcoma indication when approval criteria are met and no exclusions apply.

Covered Indications (FDA-Approved and Compendial) - General

The indications below are covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy:

Ovarian

First-line maintenance of BRCA-mutated advanced ovarian cancer: Adult patient with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer; In complete or partial response to first-line platinum-based chemotherapy; Select patients based on an FDA-approved companion diagnostic for Lynparza
Maintenance treatment of recurrent ovarian cancer: Adult patient with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; In complete or partial response to platinum-based chemotherapy
First-line maintenance HRD-positive advanced ovarian cancer (with bevacizumab): Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy; Cancer is associated with homologous recombination deficiency (HRD) positive status defined by genomic instability or other FDA-approved definition; Select patients based on an FDA-approved companion diagnostic for Lynparza

Breast

Adjuvant treatment of high-risk early breast cancer: Adult patient with deleterious or suspected deleterious germline BRCA mutation (gBRCAm); HER2-negative high-risk early breast cancer; Patient has been treated with neoadjuvant or adjuvant chemotherapy; Select patients based on an FDA-approved companion diagnostic for Lynparza
Metastatic breast cancer: Adult patient with deleterious or suspected deleterious germline BRCA mutation (gBRCAm), HER2-negative metastatic breast cancer; Treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; For HR-positive disease, patient should have been treated with prior endocrine therapy or be inappropriate for endocrine therapy; Select patients based on an FDA-approved companion diagnostic for Lynparza

Pancreatic

Pancreatic adenocarcinoma (maintenance): Adult patient with deleterious or suspected deleterious germline BRCA mutation metastatic pancreatic adenocarcinoma; Disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen; Select patients based on an FDA-approved companion diagnostic for Lynparza>= 16 weeks

Prostate

Prostate cancer (mCRPC): Adult patient with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC); Patient has progressed following prior treatment with enzalutamide or abiraterone; Patient is receiving concurrent therapy with a gonadotropin-releasing hormone (GnRH) analog or has had bilateral orchiectomy; Requested medication will be used as a single agent (concurrent GnRH analog allowed); Select patients based on an FDA-approved companion diagnostic for Lynparza

ULMS

Uterine leiomyosarcoma (compendial use): BRCA-altered uterine leiomyosarcoma (ULMS); Used as second-line therapy as a single agent

Initial Authorization Criteria

Documentation required for prior authorization

Submission of the following is necessary to initiate prior authorization review:

Documentation

BRCA mutation report: Laboratory report confirming BRCA mutation status, where applicable
HRR gene mutation report: Laboratory report confirming germline or somatic HRR gene mutation, where applicable
HR/HER2 status: Documentation of hormone receptor (HR) and HER2 status, where applicable

Indication-Specific Authorization & Duration Criteria

Epithelial ovarian, fallopian tube, or primary peritoneal cancer - maintenance

Recurrent disease after >=2 platinum lines: Member has completed two or more lines of platinum-based therapy for recurrent disease and will be using the medication as a single agent
BRCA-mutated advanced disease: Member has a deleterious or suspected deleterious germline or somatic BRCA mutation and will use as single agent or in combination with bevacizumab for advanced (stage II-IV) disease
Prior bevacizumab for advanced disease: Member has received primary therapy that includes bevacizumab for advanced (stage II-IV) disease and will use medication in combination with bevacizumab

Breast cancer - treatment/adjuvant

Adjuvant high-risk criteria (any)

Reauthorization / Continuation Criteria

Continuation (Reauthorization) Criteria

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen:

Reauthorization general criteria

Specific duration limits
- First-line maintenance BRCA-mutated advanced ovarian cancer: authorization allowed; no additional max duration specified here
- First-line maintenance with bevacizumab - max 2 years: First-line maintenance advanced ovarian cancer in combination with bevacizumab in complete response: maximum treatment duration is 2 years2 years
- Adjuvant breast - max 1 year: Adjuvant treatment of early-stage, HER2-negative, BRCA-mutated breast cancer with high risk of recurrence: maximum treatment duration is 1 year1 year

Numeric thresholds

Pancreatic chemotherapy duration>= 16 weeks of first-line platinum-based chemotherapy

Breast tumor size threshold>= 2 cm

Breast positive lymph nodes threshold>= 4 positive lymph nodes

CPS+EG score threshold>= 3

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required with documentation

Submit prior authorization request including laboratory report confirming BRCA mutation status (where applicable), laboratory report confirming germline or somatic HRR gene mutation (where applicable), and documentation of hormone receptor (HR) and HER2 status (where applicable). Prior authorization approvals are typically granted for 12 months, with indication-specific duration limits applied per policy.

Documentation Required

Companion diagnostic selection

Select patients for Lynparza therapy using an FDA‑approved companion diagnostic when indicated (e.g., BRCA or HRD testing as applicable).

Billing Rule

Authorization duration constraints

Be aware of indication-specific maximum treatment durations: up to 2 years for first-line maintenance advanced ovarian cancer given in combination with bevacizumab in complete response; up to 1 year for adjuvant treatment of early-stage, HER2‑negative, BRCA‑mutated high‑risk breast cancer.

Denial Risk

Denial risk for inadequate documentation or progression

Reauthorization may be denied if there is evidence of disease progression or unacceptable toxicity while on therapy, or if required mutation or HR/HER2 status documentation is not provided.

Background and Evidence References

Mechanism: Lynparza (olaparib) is a PARP inhibitor indicated for cancers associated with deleterious or suspected deleterious BRCA mutations or other homologous recombination repair (HRR) gene alterations; patient selection should be guided by FDA‑approved companion diagnostics.

FDA‑approved indications include: maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA‑mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (first‑line and recurrent maintenance), first‑line maintenance of HRD‑positive advanced ovarian cancer in combination with bevacizumab, adjuvant treatment of deleterious gBRCAm HER2‑negative high‑risk early breast cancer, treatment of deleterious gBRCAm HER2‑negative metastatic breast cancer, maintenance treatment of deleterious gBRCAm metastatic pancreatic adenocarcinoma after ≥16 weeks of first‑line platinum chemotherapy, and treatment of deleterious or suspected deleterious germline or somatic HRR gene‑mutated mCRPC after progression on enzalutamide or abiraterone.

Compendial uses: include additional breast and ovarian settings (e.g., recurrent/metastatic BRCA1/2 germline mutated breast cancer, adjuvant high‑risk BRCA1/2 germline mutated early breast cancer after neoadjuvant/adjuvant therapy), ovarian maintenance with bevacizumab after primary therapy that included bevacizumab, and BRCA‑altered uterine leiomyosarcoma (ULMS) as second‑line single‑agent therapy.

Documentation: Prior authorization requires submission of laboratory reports confirming BRCA mutation status and/or germline or somatic HRR gene mutation as applicable, and HR/HER2 status when relevant.

Primary product reference: Lynparza Tablets [package insert], AstraZeneca; August 2022.

Guidance reference: NCCN Drugs & Biologics Compendia 2022.

Key Definitions

gBRCAm / sBRCAm: Deleterious or suspected deleterious germline or somatic BRCA mutation. Examples: BRCA1/2 germline or somatic alterations used to select patients for ovarian, breast, pancreatic, and other indications; selection should be based on an FDA‑approved companion diagnostic when applicable.

HRD: Homologous recombination deficiency as defined by an FDA‑approved companion diagnostic (e.g., genomic instability) used to identify patients eligible for first‑line maintenance of HRD‑positive advanced ovarian cancer in combination with bevacizumab.

HRR gene mutation: Mutations in homologous recombination repair genes (examples include BRCA1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D) that may confer eligibility for indications such as HRR‑mutated mCRPC; testing should follow an FDA‑approved companion diagnostic where indicated.

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