Zejula

Niraparib

• Brand(s): Zejula
• Dosage Form/Strength: 100 mg capsule
• Effective date: December 21, 2021

Initiation Criteria:

For the maintenance treatment of newly diagnosed or recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who meet the following criteria:

1. 1. Patients are diagnosed with high grade serous or endometrioid tumours classified as stage III or IV disease according to the International Federation of Gynecology and Obstetrics (FIGO) criteria at the time of their initial diagnosis; AND
2. Patient is using niraparib as maintenance therapy immediately after one course of first line platinum-based therapy in which radiological response (complete or partial) is demonstrated after completing between 6 and 9 cycles of treatment,¹ OR
   Patient is using niraparib as maintenance therapy in recurrent disease after having received at least two prior courses of chemotherapy in which platinum sensitive disease² was demonstrated with at least one completed prior treatment course AND radiological response (complete or partial) must be demonstrated after completing at least 4 cycles of their most recent course of chemotherapy³;
   AND
3. Patients using niraparib as maintenance as first line or in the recurrent/relapsed setting must initiate niraparib within 12 weeks of the final dose of the chemotherapy;⁴
   AND
4. Niraparib must be used as monotherapy for maintenance therapy; AND
5. Patient has good performance status.

¹Case-by-case consideration will be provided for newly diagnosed patients who are unable to complete 6 cycles of a platinum-based treatment OR who are unable to use a platinum-based chemotherapy but have achieved complete or partial radiological response after treatment with alternative, non-platinum-based chemotherapy.

²Platinum-sensitive disease is defined as disease progression/recurrence/relapse occurring at least 6 months following completion of a platinum-based chemotherapy in which an initial response had been demonstrated.

³Case-by-case consideration will be provided for patients with recurrent disease who are unable to use a platinum-based chemotherapy after having demonstrated platinum-sensitive disease to an earlier line of treatment after achieving complete or partial radiological response with their most recent course of treatment with alternative, non-platinum-based chemotherapy.

⁴If more than 8 weeks have elapsed from the last chemotherapy treatment, consideration should be given to exclude disease progression before start of therapy.

Exclusion Criteria:

1. Patients who have previously progressed while on niraparib maintenance therapy will not be funded.
2. Patients who have experienced disease progression while on treatment with a prior PARP inhibitor regardless of treatment line (i.e., first line or recurrent/relapsed setting) will not be funded for niraparib.
3. Patients who have developed disease progression before start of niraparib maintenance therapy will not be funded.
4. Patients with symptomatic, uncontrolled brain metastases will not be funded.
5. Niraparib is not funded when used as combination therapy with chemotherapy.
6. Niraparib retreatment will not be funded in those who have completed 3 years of maintenance therapy and experienced disease progression.

Renewal Criteria:

Niraparib maintenance therapy after first line platinum-based treatment:
Ongoing funding will be considered until disease progression or development of unacceptable toxicity or up to a maximum of 3 years if there is no evidence of disease recurrence.

Niraparib maintenance therapy in recurrent platinum-sensitive disease:
Ongoing funding will be considered until disease progression or development of unacceptable toxicity

Notes:

1. Niraparib funding will not be considered for patients with histologies other than serous or endometroid unless the patient is BRCA mutated. Patients presenting with non-mucinous histology should be BRCA tested.
2. Imaging to rule out disease progression is required for patients delayed in starting maintenance therapy with niraparib. (Note: CA-125 clinical assessments may be considered case-by-case where imaging is not available).
3. Cancer antigen 125 (CA-125) and clinical assessments should be done at least every 3 to 4 months to monitor for disease recurrence or progression.
4. Patients with no evidence of disease after chemotherapy who are initiated niraparib in the first line maintenance setting will be funded for a maximum of 3 years.
5. Time-limited access to niraparib will be provided for patients already on maintenance bevacizumab who wish to switch to niraparib monotherapy as long as other criteria are met and there is no evidence of disease progression.
6. Patients on another PARP treatment may switch to niraparib if they have developed intolerances or allergies and if they have not experienced disease progression.
7. Niraparib will not be funded as maintenance therapy in patients who have previously progressed on niraparib or another PARP used as maintenance therapy after one or more lines of chemotherapy.
8. Retreatment with maintenance niraparib will not be funded in patients who previously completed 3 years of niraparib maintenance therapy after first line platinum-based chemotherapy, and then subsequently experienced disease progression.
9. Patients who have used a non-PARP maintenance therapy after first line chemotherapy may be funded for niraparib as maintenance in a subsequent line as long as disease progression had not occurred for 6 months after stopping maintenance therapy with the prior treatment AND upon meeting the initiation criteria again. Note that the ministry will only fund one PARP therapy (i.e., niraparib or olaparib) in the maintenance setting upon meeting all initiation criteria.

Recommended dose: 200 mg to 300 mg daily (Refer to the product monograph for dosing information)

Approval duration of initials and renewals: 1 year
Reimbursement will be provided up to a maximum of 3 years if there is no evidence of disease recurrence.