Pharmacy Prior Authorization Criteria

Lynparza (olaparib)

Indications for Prior Authorization

Lynparza (olaparib)

• For diagnosis of First-line maintenance treatment of BRCA-mutated advanced ovarian cancer
  Indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor 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 for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of Maintenance treatment of BRCA-mutated recurrent ovarian cancer
  Indicated for the 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 for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab
  Indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of Germline BRCA-mutated HER2-negative high risk early breast cancer
  Indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCA-mutated, HER2-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of Germline BRCA-mutated HER2-negative metastatic breast cancer
  Indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCA-mutated, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of First-line maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma
  Indicated for the 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 for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of HRR gene-mutated metastatic castration-resistant prostate cancer
  Indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

• For diagnosis of BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)
  Indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Criteria

Lynparza

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Epithelial ovarian, Fallopian tube, or Primary peritoneal cancer

• Diagnosis of one of the following:
• Epithelial ovarian cancer
• Fallopian tube cancer
• Primary peritoneal cancer

Lynparza

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast cancer

• Diagnosis of breast cancer

Lynparza

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pancreatic adenocarcinoma

• Diagnosis pancreatic adenocarcinoma

Lynparza

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic castration-resistant prostate cancer (mCRPC)

• Diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
AND
• Presence of a deleterious or suspected deleterious BRCA-mutation or homologous recombination repair (HRR) gene mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• For BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), Lynparza is used in combination with abiraterone and one of the following:
• prednisone
• prednisolone

Lynparza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications listed above

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-03-14, 2023-07-21, 2023-06-05, 2023-03-02, 2022-10-04, 2022-05-04, 2022-03-03, 2021-09-27, 2021-05-21, 2021-03-19, 2020-06-30, 2020-03-04

References

1. Lynparza Tablets prescribing information. AstraZeneca Pharmaceuticals LP, Inc. Wilmington, DE. November 2023.
2. Lynparza FDA Medical Review. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000MedR.pdf. Accessed on June 12, 2015.
3. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed March 9, 2021.
4. Robson M, Im SA, Senkus E, et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533
5. U.S. Food and Drug Administration [website]: List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm Accessed 3/7/2018

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End Notes

1. Lynparza (olaparib) tablets were approved for use in patients with a germline BRCA mutation and human epidermal growth factor receptor type 2 (HER2) negative metastatic breast cancer based on results from the OlympiAD clinical trial. OlympiAD (N= 305) was a randomized, open-label, phase 3 trial in which Lynparza (olaparib) monotherapy was compared with standard therapy (one of three pre-specified chemotherapy regimens). Enrolled patients were required to have received neoadjuvant, adjuvant treatment or treatment for metastatic disease with an anthracycline (unless it was contraindicated) and a taxane. Also, patients with hormone receptor positive breast cancer had received at least one endocrine therapy, unless the patient was not an appropriate candidate for therapy. The assigned treatment was continued until disease progression or unacceptable toxicity. The primary end point was progression-free survival, which was defined as the time from randomization to objective radiologic disease progression or death from any cause. Study results reported that the median progression-free survival was significantly longer in the olaparib group than in the standard-therapy group (7.0 months vs. 4.2 months; hazard ratio for disease progression or death, 0.58; 95% confidence interval [CI], 0.43 to 0.80; P<0.001) [4].
2. In OlympiAD, the BRCA mutation was detected by central testing with BRACAnalysis (Myriad Genetics) in 297 patients and by local testing in 167 patients (with confirmation by central testing with BRACAnalysis in all but 5 of those patients) [4].
3. For patients with metastatic castration-resistant prostate cancer (mCRPC), examples of homologous recombination repair (HRR) gene mutations include: BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. [1, 3]

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Revision History

• 2024-03-14: 2024 Annual Review - background and references updated
• 2023-07-21: update guideline
• 2023-06-05: Program update to remove clinical criterion and only require diagnosis and prescriber requirements.
• 2023-03-02: 2023 Annual Review - updated references
• 2022-10-04: Updated to remove withdrawn indication of advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
• 2022-05-04: Addition of new indication for high risk early breast cancer
• 2022-03-03: 2022 Annual Review.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-19: Annual Review - Updated references.
• 2020-06-30: Added criteria for new indications of HRD-positive ovarian cancer and HRR gene-mutated prostate cancer; consolidated reauth criteria into one section.
• 2020-03-04: Added criteria for new indication of pancreatic adenocarcinoma and annual review updates.

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