CurrentNeighborhood Health Plan of Rhode IslandPolicy 1810-A

Lynparza Sgm 1810 A P2025

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLynparza Sgm 1810 A P2025

Policy CodePolicy 1810-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit laboratory reports confirming BRCA and when applicable HRR, HR, HER2, and HRD status to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material changes — policy has no listed updates.

7Covered Indications Listed

3Maximum duration rules specified

1Prior authorization requirement

Coverage Summary & Criteria

Defines covered indications, prior authorization documentation requirements, authorization durations, continuation and maximum treatment durations, and compendial/excluded uses for olaparib (Lynparza) across ovarian, breast, pancreatic, prostate cancers and uterine leiomyosarcoma for Neighborhood Health Plan of Rhode Island (CVS Caremark authored policy). The policy coverage stance is covered_with_criteria. Primary reference sources include the Lynparza package insert (Nov 2023) and the NCCN Drugs & Biologics Compendium (2024).

Covered Indications / Authorization Criteria

Authorization of 12 months may be granted when ALL of the following indication-specific criteria are met:

Covered Indications (one of)

Prostate mCRPC pathways (one of)
- ALL of the following
  - Member has 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).
  - Member has progressed on prior androgen receptor-directed therapy.
  - Member is receiving concurrent LHRH agonist/antagonist or has had bilateral orchiectomy.
- ALL of the following
  - Member has deleterious or suspected deleterious BRCA mutation.
  - Member has not progressed on prior novel hormone therapy (e.g., abiraterone, enzalutamide, darolutamide, or apalutamide).
  - Member is receiving concurrent LHRH agonist/antagonist or has had bilateral orchiectomy.
First-line maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients based on an FDA-approved companion diagnostic.
Maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients based on an FDA-approved companion diagnostic.
First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab for adult patients in complete or partial response to first-line platinum-based chemotherapy whose cancer is HRD-positive defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability. Select patients based on an FDA-approved companion diagnostic.
Adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients based on an FDA-approved companion diagnostic.
Treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. For HR-positive disease, prior endocrine therapy or consideration that endocrine therapy is inappropriate is required. Select patients based on an FDA-approved companion diagnostic.
Maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose 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.>= 16 weeks
Treatment of BRCA2-altered uterine leiomyosarcoma (uLMS) as subsequent therapy when used as a single agent for advanced, recurrent, metastatic, or inoperable disease.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Specific Criteria

Authorization of 12 months may be granted when ALL of the following specific scenarios are met (one of):

ANY of the following

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.
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.
Member has received primary therapy that includes bevacizumab for advanced (stage II-IV) disease, will be using Lynparza in combination with bevacizumab, and either member has HRD-positive disease OR member has a deleterious or suspected deleterious germline or somatic BRCA mutation.

Breast Cancer Specific Criteria

Authorization of 12 months may be granted for treatment when ALL of the following are met (one of the following settings for adjuvant use):

ANY of the following

ALL of the following
- Hormone receptor-negative breast cancer with any residual disease.
- Hormone receptor-negative breast cancer with tumor size >= 2 cm or any involved axillary nodes.>= 2 cm
- Hormone receptor-positive breast cancer with >= 4 positive lymph nodes.>= 4
- Hormone receptor-positive breast cancer with any residual disease and a CPS+EG score >= 3 following preoperative therapy.>= 3
Treatment of breast cancer with no response to preoperative systemic therapy, or for recurrent unresectable (local or regional) or metastatic breast cancer as a single agent in members with deleterious or suspected deleterious germline BRCA mutations.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required with documentation

Submit laboratory report confirming BRCA mutation status, and when applicable germline or somatic HRR gene mutation, HR and HER2 status, and HRD status, to initiate prior authorization review.

Documentation Required

Companion diagnostic selection

Select patients using an FDA‑approved companion diagnostic as specified per indication.

Denial Risk

Not covered if indication not listed

Claims for indications not listed in the policy are considered experimental/investigational and may be denied.

Billing Rule

Authorization duration

Authorizations typically granted for 12 months; adhere to maximum treatment durations specified per indication.

First-line ovarian (complete response): maximum 2 years
First-line ovarian with bevacizumab (complete response): maximum 2 years
Adjuvant early-stage BRCA-mutated breast cancer (high risk): maximum 1 year
Pancreatic: disease must not have progressed on at least 16 weeks (>= 16 weeks) of first-line platinum-based chemotherapy prior to maintenance

Background, Definitions & References

This policy enumerates FDA-approved and compendial uses of olaparib (Lynparza) and establishes required documentation and authorization durations. Primary prescribing and indication language is drawn from the Lynparza package insert (Nov 2023) and compendial guidance from the NCCN Drugs & Biologics Compendium (2024). The policy is authored for Neighborhood Health Plan of Rhode Island / CVS Caremark and lists covered indications across ovarian, breast, pancreatic, prostate cancers and BRCA2-altered uterine leiomyosarcoma with specified authorization and continuation rules.

HRD: Homologous recombination deficiency; defined in the policy as deleterious or suspected deleterious BRCA mutation and/or genomic instability.

HRR gene mutation: Includes BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L as listed in the policy.

CPS+EG: Clinical stage, pathologic stage, estrogen receptor status and tumor grade score used for adjuvant breast cancer risk assessment (CPS+EG) as referenced for breast cancer adjuvant criteria.

References: Primary references include Lynparza® Tablets [package insert], November 2023, and The NCCN Drugs & Biologics Compendium® 2024.

OpenPayer

Lynparza Sgm 1810 A P2025

Coverage Summary & Criteria

Prior Authorization & Documentation Requirements

Code References

Background, Definitions & References

Treatment Duration & Thresholds

Clinical Evidence & Compendial Support

Revision History