Erleada

Apalutamide

• Brand(s): Erleada
• Dosage Form/Strength: 60 mg capsule
• Updated: November 18, 2021

Initiation Criteria for metastatic castration sensitive prostate cancer (mCSPC):

For the treatment metastatic castration sensitive prostate cancer (mCSPC) in patients who meet all of the following criteria:

1. Apalutamide is used in combination with androgen deprivation therapy (ADT)¹; AND

2. Metastatic lesions detected on technetium-99m bone scan, computed tomography (CT), and/or magnetic resonance imaging (MRI); AND

3. Castration sensitive as defined by the patient being treatment naïve to an ADT OR ADT initiated within the prior 6 months before start of therapy with apalutamide OR ADT used in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more prior to start of apalutamide; AND

4. Has not experienced disease progression with another androgen receptor axis targeted therapy (ARAT) for castration sensitive prostate cancer; AND

5. Patient has good performance status.

¹ADT is not required for patients with bilateral orchiectomy

Definitions for the purpose of the EAP funding criteria:

ADT – A first generation androgen deprivation therapy (e.g., goserelin, leuprolide, triptorelin, buserelin, degarelix)

ARI - A second generation androgen receptor inhibitor (e.g., apalutamide, darolutamide, enzalutamide)

ARAT- An androgen receptor axis targeted therapy (e.g., abiraterone, apalutamide, darolutamide, enzalutamide)

The following baseline levels are to be provided with the initial application:

• Number of metastatic lesions on bone scan and in soft tissues
• Testosterone level
• Baseline (pre-treatment) PSA level
• Pre-treatment Gleason score (optional)

Notes:

1. Patients who have previously progressed on an ARI for prostate cancer will not be eligible for apalutamide in mCSPC. The Ministry will fund only one of apalutamide or enzalutamide in patients with mCSPC.
2. Patients treated with enzalutamide or darolutamide as part of a clinical trial may be eligible for apalutamide and will be considered on a case-by-case basis.
3. Patients who are currently on a treatment regimen with an ARAT for prostate cancer, must meet the initiation criteria if they wish to switch to publicly funded apalutamide for mCSPC.
4. Time limited funding consideration will be provided on a case-by-case basis for those patients who are using docetaxel in combination with ADT as long as there has been no progression and the treatment regimen has not been used for more than 6 months.

Approved Dosage for Initials and Renewals: 240 mg administered orally once daily.

Renewal Criteria:

Renewals will be considered in patients until disease progression (i.e., PSA elevation in addition to radiographic disease progression, or PSA progression in addition to clinical symptoms associated with cancer progression), development of castration resistant disease, or experiencing unacceptable toxicity while on apalutamide.

Exclusion Criteria: (Patients meeting any of the following will not be funded.)

• Patients who have previously experienced disease progression on apalutamide or another ARI used in the setting of prostate cancer.
• Apalutamide will not be funded as combination therapy with another ARAT.

Duration of initial and renewal approvals: 1 year

Initiation criteria for Non-metastatic Castrate Resistant Prostate Cancer (nmCRPC):

For the treatment of high-risk non-metastatic castration resistant prostate cancer (nmCRPC) in patients who meet all the following criteria:

1. Patient using apalutamide in combination with androgen deprivation therapy (ADT); AND

2. Has no detectable distant metastases as determined by CT, MRI, or technetium-99m bone scan; AND

3. Patient has castration resistant disease based on meeting all the following indicia observed while on continuous ADT treatment or post orchiectomy:
a) Castrate serum testosterone levels;
AND
b) Biochemical progression defined as Three (3) prostate-specific antigen (PSA) rises at least 1 week apart, with the last PSA greater than 2ng/mL;

AND

4. Patient is at high risk for developing metastatic disease based on a Prostate-specific antigen doubling time (PSADT) of less than or equal to 10 months during continuous ADT; AND

5. Has Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

Exclusion criteria: The following will not be reimbursed.

• The patient received prior chemotherapy for the treatment of prostate cancer unless it was in the adjuvant or neoadjuvant setting.
• The patient has previously experienced disease progression on prior treatment with enzalutamide or darolutamide used for prostate cancer.

Definitions for the purpose of the EAP funding criteria:

ADT – A first generation androgen deprivation therapy (e.g., goserelin, leuprolide, triptorelin, buserelin, degarelix).

ARI- A second generation androgen receptor inhibitor (e.g., apalutamide, darolutamide, enzalutamide).

Notes:

1. The Ministry will fund only one second generation androgen receptor inhibitor (ARI) in patients with non-metastatic castrate resistant prostate cancer.
2. Requests for apalutamide in patients who have initiated another ARI therapy in the nmCRPC setting and who have not experienced disease progression will be considered on a case-by-case basis.
3. Patients treated with an ARI as part of a clinical trial may be eligible for apalutamide and will be considered on a case-by-case basis.

Approved Dosage: 240 mg administered orally once daily.

Renewal Criteria:

Renewals will be considered in patients without evidence of radiographic disease progression or unacceptable toxicity while on apalutamide therapy.

Duration of initial and renewal approvals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests