Reimbursement Recommendation

Olaparib

Reimbursement request: For the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated locally advanced unresectable or metastatic pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy

Requester: Public drug programs

Final recommendation: Reimburse with conditions

What Is the Reimbursement Recommendation for Olaparib?

The Formulary Management Expert Committee (FMEC) recommends that olaparib be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, provided certain conditions are met.

What Are the Conditions for Reimbursement?

Olaparib may be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, provided the following conditions are met: no progression after at least 16 weeks of first-line systemic chemotherapy and good performance status. Olaparib should be discontinued if there is disease progression or unacceptable toxicities. Olaparib should be priced no higher than the least costly therapy available for this population.

Why Did Canada’s Drug Agency Make This Recommendation?

FMEC reviewed 1 trial of olaparib versus placebo and a cost comparison of olaparib versus other treatments used in Canada. Overall, the evidence demonstrates that, compared to placebo, olaparib maintenance therapy provides a clinically meaningful improvement in progression-free survival (PFS), does not contribute to a decline in health-related quality of life (HRQoL), and has a tolerable safety profile.

FMEC concluded that there is a significant unmet need in BRCA-mutated pancreatic adenocarcinoma, given the rarity of BRCA mutations and poor prognosis of this condition. FMEC also concluded that it is uncertain whether olaparib demonstrates acceptable clinical value versus appropriate comparators; however, olaparib would potentially address significant nonclinical needs (e.g., treatment burden, travel requirements, out-of-pocket costs, access inequities). FMEC noted that economic considerations are important to address when implementing olaparib.

Review Background

What Is Pancreatic Cancer?

Pancreatic ductal adenocarcinoma is an aggressive exocrine malignancy arising from the ductal cells of the pancreas and accounts for more than 90% of all pancreatic cancers. It is characterized by late presentation, rapid disease progression, and poor prognosis. It is the third leading cause of cancer-related death in Canada, responsible for approximately 7% of all cancer deaths. In 2024, an estimated 7,100 people in Canada were diagnosed with pancreatic cancer, and 6,100 died from it, with a 5-year net survival of about 10%. Approximately 5% of patients with pancreatic ductal adenocarcinoma carry a germline BRCA1 (gBRCA1) mutation or germline BRCA2 (gBRCA2) mutation.

What Are the Current Treatment Options?

The current first-line systemic treatment options in Canada are FOLFIRINOX (leucovorin [folinic acid], fluorouracil, irinotecan, and oxaliplatin) or gemcitabine, alone or in combination with nab-paclitaxel. A platinum-containing regimen such as FOLFIRINOX is generally preferred for patients with a known germline BRCA1 or gBRCA2 mutation, because their disease is more sensitive to DNA-damaging agents. Patients whose disease remains stable after first-line platinum-based chemotherapy often continue on some form of modified maintenance, such as reduced-dose FOLFIRINOX, a combination of folinic acid, fluorouracil, and irinotecan (FOLFIRI), or an infusion of 5-fluorouracil and leucovorin.

What Is the Treatment Under Review?

Olaparib is a targeted poly-(ADP-ribose) polymerase inhibitor administered orally at a dose of 300 mg (two 150 mg tablets) twice daily until disease progression or unacceptable toxicity. Health Canada has approved olaparib as monotherapy for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy, with confirmed gBRCA mutation before treatment initiation. The reimbursement-requested indication is broader than the Health Canada–approved indication. Specifically, whereas the Health Canada indication is limited to patients with metastatic pancreatic adenocarcinoma whose disease has not progressed following a minimum of 16 weeks of first-line platinum-based chemotherapy, the reimbursement request broadens the population to include patients with locally advanced unresectable or metastatic disease, does not include a minimum duration requirement for prior chemotherapy, and does not restrict prior systemic therapy to platinum-based regimens.

Why Did We Conduct This Review?

At the request of the participating public drug programs, Canada’s Drug Agency (CDA-AMC) reviewed the available evidence for olaparib to inform a recommendation on whether it should be reimbursed for the maintenance treatment of adults with deleterious or suspected deleterious gBRCA-mutated locally advanced unresectable or metastatic pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy. The data protection for olaparib has expired, so this drug is eligible for a nonsponsored reimbursement review, per the Procedures for Reimbursement Reviews. Of note, at the time of the review, there are 3 generic drug submissions for olaparib under review by Health Canada.

Highlights of Input from Interested Parties

• One clinician group, the Ontario Health (Cancer Care Ontario) Gastrointestinal Cancer Drug Advisory Committee, indicated that the goals of treatment for patients with metastatic pancreatic cancer are to delay disease progression, prolong life, and improve or maintain quality of life.

• Public drug plans inquired about the evidence for olaparib to inform a recommendation about whether it should be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA-mutated locally advanced unresectable or metastatic pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy. The public drug plans outlined implementation questions related to relevant comparators, initiation of therapy, discontinuation, generalizability, and care provision.

Person With Lived Experience

A person with lived experience from Ontario shared her father’s 2-year treatment journey with pancreatic cancer. Her father was diagnosed with pancreatic cancer in 2024 following an investigation for unexplained weight loss. He underwent 3 lines of chemotherapy (which included 3 cycles of gemcitabine plus nab-paclitaxel, 10 cycles of FOLFIRI, and 2 cycles of FOLFOX [leucovorin (folinic acid), fluorouracil, and oxaliplatin]), followed by radiation and oral capecitabine. Each line of therapy failed. She noted that despite the few good moments, pancreatic cancer had taken almost everything her father loved: his health, his independence, his hobbies, his social life, and even his ability to enjoy food. Cancer became a full-time job — appointments, bloodwork, long drives, treatments every other week, and days attached to a pump. Over the 2 years, he only had a handful of days when he felt remotely like himself. She emphasized that the greatest challenge of pancreatic cancer was the lack of options. Every treatment decision came with a trade-off. She described how her father had to weigh whether a few more months of life were worth the physical toll, the exhaustion, and the loss of dignity that often accompanied treatment. Side effects were not just uncomfortable, they were life-altering and included severe fatigue, neuropathy, nausea, brain fog, and balance issues. These side effects were not just isolated to a few days but were persistent and cumulative. As the disease progressed, her father was no longer asking, “Will this cure me?” He was asking, “Will this allow me to feel like myself, even briefly?” Her father did not want to spend his remaining time in hospitals, attached to machines, or recovering from side effects that stripped away his energy and clarity. She stressed that treatments are needed that do not just extend life but allow people to live it. The few options patients have to live even marginally longer require them to give up almost everything else. She noted that although the oral regimen her father had taken did not work for him, that option allowed him to preserve energy for living. She emphasized that an at-home, oral treatment meant less time spent in hospitals and more time spent with family, however long that was. It is about dignity, autonomy, and allowing patients to engage with their lives, not just their disease.

Disclaimer: The perspectives shared by people with lived experience who present to the committee reflect their individual experiences and are not necessarily representative of all people with the same condition or course of treatment. Their insights provide valuable context about what a patient, support person, or caregiver might go through when facing this condition or treatment, helping to inform the committee’s deliberations. These narratives complement other forms of evidence and input and should be considered as part of a broader understanding of the condition and treatment under review. When gender or gendered pronouns are used in these narratives, they are included with the permission of the individual.

Recommendation

With a vote of 8 to 1, FMEC recommends that olaparib, for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, be reimbursed if the conditions presented in Table 1 are met.

Table 1: Conditions, Reasons, and Guidance

FMEC = Formulary Management Expert Committee; FOLFIRINOX = leucovorin (folinic acid), fluorouracil, irinotecan, and oxaliplatin; PARP = poly-(ADP-ribose) polymerase; PFS = progression-free survival.

Summary of Deliberation

FMEC deliberated on all domains of value of the deliberative framework before developing its recommendation: clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on health systems. For further information on the domains of value, please refer to the Expert Committee Deliberation at Canada’s Drug Agency document.

FMEC considered the following key discussion points, organized by the 5 domains of value.

Clinical Value

• FMEC concluded that it is uncertain whether olaparib demonstrates acceptable clinical value versus appropriate comparators in Canada.

• Through reflection on the insights shared by people with lived experience, FMEC members noted that patients want effective and tolerable treatments that delay progression, provide time with good quality of life, and maintain or improve quality of life.

• FMEC members highlighted the following discussion points:

  • Appropriate comparators. The committee agreed that it is difficult to determine the clinical benefits of olaparib based on a placebo-controlled trial, given that in clinical practice, patients do receive active chemotherapy. Evidence against an active comparator would be needed to better understand the true impact of olaparib.

  • Outcomes assessed. The committee agreed that the outcomes assessed in the POLO trial (PFS, overall survival, time to second progression, and HRQoL) were important to patients, given the palliative nature of the condition. It was noted that no patient group input was submitted.

  • Efficacy compared to appropriate comparators. FMEC noted that there is no standard-of-care direct comparison agent or regimen for this specific patient population, but in clinical practice, various IV chemotherapy options are used; however, evidence for those regimens in the maintenance setting is lacking. Compared to placebo, the POLO trial showed improved PFS but no changes in HRQoL or overall survival.

  • Harms. The committee agreed that olaparib offers a treatment option that does not contribute to the treatment-limiting, long-term peripheral neuropathy from platinum-based IV chemotherapy. The committee agreed that there may be more adverse events with olaparib compared to placebo; however, these adverse events are manageable.

  • Level of certainty in clinical value. The committee agreed that there is significant uncertainty in the clinical value of olaparib due to the lack of an active comparator, the other anticancer therapies patients were exposed to after drug discontinuation, and trial design shortcomings.

  • FMEC heard from the guest specialist that the platinum-based regimen used in Canada is FOLFIRINOX. Patients need to have a good functional baseline to receive this treatment. The median PFS with FOLFIRINOX is 6.4 months based on clinical trial data in the first-line setting (i.e., results of the PRODIGE 4/ACCORD 11 randomized controlled trial).

  • The treatment burden to the patient is high, including travelling to the hospital to receive IV chemotherapy for 4.5 hours in the chair and then receiving continuous infusion of 5-fluorouracil via pump for another 2 days. Patients either learn to disconnect themselves from the infusion pump or they go back to the hospital to have the pump removed. Adverse events include cumulative peripheral neuropathy due to platinum and cold-induced dysesthesia due to oxaliplatin (which has a negative impact on HRQoL but is not measured on any scale). Therefore, for patients to have an oral option that does not contribute to the treatment-limiting peripheral neuropathy side effect would be highly desired by patients.

Unmet Clinical Need

• FMEC concluded that there is a significant clinical need arising from BRCA-mutated pancreatic adenocarcinoma.

• Through reflection on the insights shared by a person with lived experience, FMEC heard that pancreatic cancer is a bleak and hopeless diagnosis for patients and their families. First-line chemotherapy treatments are difficult due to their significant and severe adverse effects. One of the challenges for patients is the lack of treatment options.

• FMEC members highlighted the following discussion points:

  • Availability of treatment options. The committee agreed that alternative IV chemotherapy regimens, and potentially oral capecitabine, may be used in clinical practice, but there is no strong clinical evidence supporting their use in patients with BRCA germline mutations as maintenance therapy. Platinum-based IV chemotherapy regimens carry the risk of cumulative-dose peripheral neuropathy.

  • Severity of the disease. The committee agreed that metastatic pancreatic cancer carries a high mortality rate with very low rates of long-term survival, with PFS usually measured in months, and that the intent of all therapies as maintenance is viewed as palliative.

  • Significant unmet clinical need. The committee recognized that patients would value a more effective, more tolerable, and less burdensome oral therapy. FMEC members agreed that there was some clinical evidence for olaparib therapy in the POLO trial with respect to maintenance therapy, in patients with BRCA germline mutations, and that the trial did show benefit with respect to PFS. FMEC agreed that olaparib therapy may have a higher overall rate of adverse effects that are manageable, but it does not contribute to the treatment-limiting peripheral neuropathy that continued platinum-based regimens can cause.

  • Evidence generation. The committee acknowledged that pancreatic cancer is not a rare condition; however, only approximately 5% of patients have BRCA germline mutations. Given the late-stage diagnosis and rapid progression of disease, obtaining long-term data in this patient population is not expected.

  • While there is no evidence on advanced local nonresectable pancreatic cancer, according to the guest specialist, it is managed in the same manner in clinical practice as metastatic pancreatic adenocarcinoma.

Distinct Social and Ethical Considerations

• FMEC concluded that olaparib would potentially address a significant nonclinical need arising from BRCA-mutated pancreatic adenocarcinoma.

• FMEC did not identify any important measures that should be implemented to ensure that the use of olaparib addresses relevant social and ethical implications.

• Through reflection on the insights shared by a person with lived experience, FMEC members noted that pancreatic cancer treatment can consume a patient’s life and take a financial toll (e.g., travel, hospital parking, and out-of-pocket costs for testing). At-home treatments would reduce treatment burden.

• FMEC members highlighted the following discussion points:

  • Unmet nonclinical needs. The committee agreed that an oral therapy such as olaparib would be less burdensome for patients and their families, given that it requires less travel to the hospital and to clinics, does not require prolonged IV access, and would address inequitable access to funding for oral cancer drugs.

  • Social and ethical considerations. The committee agreed that there is inequitable access to BRCA testing, given that some patients who cannot afford out-of-pocket costs may not be able to access tests. FMEC noted that inequitable access to BRCA testing also impacts first-line therapy options.

  • FMEC heard from the guest specialist that there is limited and inconsistent access to BRCA testing across Canada. There is variation in testing availability and turnaround times across provinces. Some provinces currently lack local testing altogether, which would necessitate out-of-province testing, which may result in longer turnaround times. The testing criteria in certain provinces can be very restrictive. The guest specialist emphasized that the BRCA mutation is rare and that they have yet to identify a patient with a BRCA mutation.

Economic Considerations

• FMEC concluded that there are economic considerations that are important to address when implementing olaparib.

• FMEC members highlighted the following discussion points:

  • At publicly available prices, the reimbursement of olaparib is expected to increase patient drug acquisition costs compared with all relevant comparators.

  • The reimbursement of olaparib is expected to increase diagnostic genetic testing costs, if not already funded by the province, and decrease treatment administration costs.

  • Based on the available evidence, the clinical effectiveness of olaparib compared with relevant comparators is unknown.

  • The cost-effectiveness of olaparib compared with relevant comparators is unknown.

  • One published cost-utility analysis of olaparib for this population was conducted in Canada. The study was based on the POLO trial and included only placebo as a comparator to olaparib. Therefore, it does not reflect the current standard of care in Canada and does not provide relevant information on the cost-effectiveness of olaparib relative to its comparators.

  • Given that olaparib is associated with higher drug acquisition costs and unknown clinical benefit compared with relevant comparators, it should be priced no higher than the least costly therapy available for this population.

Impacts on Health Systems

• FMEC concluded that there are impacts on health systems that are important to address when implementing olaparib.

• FMEC members highlighted the following discussion points:

  • Impacts on health systems. FMEC agreed that BRCA genetic testing is reported to have inconsistent and variable access criteria and delayed turnaround times across Canada, with some patients needing to travel for testing or pay out of pocket.

  • Considerations for health system sustainability. The committee agreed that oral olaparib therapy would reduce oncology clinic visits and does not need chair time. Less frequent bloodwork monitoring is required, but imaging requirements would be unchanged.

  • Equity implementation. The committee agreed that equitable access to BRCA genetic testing remains a significant barrier and noted that patients resort to paying out of pocket for private testing.

Sources of Information Used by the Committee

To make its recommendation, the committee considered the following information (links to the full documents for the review can be found on the project webpage):

• the CDA-AMC review of the clinical and pharmacoeconomic evidence related to olaparib (refer to the Main Report and the Supplemental Material document)

• input from a person with lived experience who delivered a brief presentation and answered questions from the committee (refer to the Person with Lived Experience section earlier in this document)

• input from by 1 clinician group, the Ontario Health (Cancer Care Ontario) Gastrointestinal Cancer Drug Advisory Committee

• input from public drug programs that participate in the reimbursement review process (refer to the FMEC Responses to Questions from the Drug Program document)

• input from 2 guest specialists with expertise in the management of pancreatic cancer, consulted by CDA-AMC.

Feedback on Draft Recommendation

CDA-AMC received feedback from 1 clinician group (the Ontario Health [Cancer Care Ontario] Gastrointestinal Cancer Drug Advisory Committee), the drug manufacturer (AstraZeneca Canada), and the public drug programs. All groups agreed with the recommendation. The public drug programs requested editorial revisions to clarify the indication and conditions for initiation. Both the drug plans and the drug manufacturer requested editorial revisions to clarify the acceptability of germline or somatic testing. Based on the clinician group feedback regarding implementation issues brought forward by the drug programs, editorial revisions were made to the Drug Program Input Table document.

All feedback received in response to the draft recommendation is available on the CDA-AMC project webpage.

FMEC Information

Members of the Committee

Dr. Emily Reynen (Chair), Dr. Zaina Albalawi, Ms. Marilyn Barrett, Dr. Hardit Khuman, Ms. Valerie McDonald, Dr. Bill Semchuk, Dr. Jim Silvius, Dr. Marianne Taylor, Dr. Maureen Trudeau, Dr. Dominika Wranik. Two guest specialists from British Columbia and the Prairies participated in this review.

Regrets: One guest specialist did not attend the meeting. Two clinical experts were consulted for the clinical and pharmacoeconomic report.

Meeting date: January 22, 2026

Conflicts of interest: None

Special thanks: CDA-AMC extends special thanks to Caitlin Purssell, who presented directly to FMEC on behalf of her father, and to Pancreatic Cancer Canada, which represents and supports the community of people living with pancreatic cancer.

Note: CDA-AMC makes every attempt to engage with people with lived experiences as closely to the indication and treatments under review as possible; however, at times, CDA-AMC is unable to do so and instead engages with individuals with similar treatment journeys or experience with comparators under review to ensure lived experience perspectives are included and considered in Reimbursement Reviews. CDA-AMC is fortunate to be able to engage with individuals who are willing to share their treatment journeys with FMEC.