Alberta Health Services
reimbursement criteria1:
Waldenström’s Macroglobulinemia (WM)
Zanubrutinib for the treatment of adult patients with relapsed or refractory (RR) Waldenström’s macroglobulinemia (WM). Must have received at least one prior line of therapy. Must meet at least 1 criterion for treatment according to IWWM-7 consensus panel criteria. Must NOT have progressed on a prior exposure to a BTK inhibitor (may be intolerant to prior BTK inhibitor) or must NOT have disease transformation. Continue treatment until disease progression or unacceptable toxicity.1
To access the complete listing, click here.
Saskatchewan Cancer Agency Drug Formulary
reimbursement criteria1:
Relapsed or refractory Waldenström’s macroglobulinemia after at least 1 prior line of therapy
- Patients with CNS lymphoma secondary to Waldenström’s macroglobulinemia are eligible
- Patients with evidence of disease transformation to a higher-grade lymphoma are
not eligible
- Patients who have experienced disease progression on treatment with a BTK inhibitor (e.g., ibrutinib) are
not eligible; if a patient discontinued an alternate BTK inhibitor for reasons of intolerance, they remain eligible for zanubrutinib
To access the complete listing, click here.
Manitoba Drug Benefits Formulary
reimbursement criteria1:
For the treatment of adult patients:
-
With relapsed/refractory Waldenström’s macroglobulinemia (WM) AND
-
Who received at least 1 prior line of therapy AND
-
Who meet at least 1 criterion for treatment initiation as recommended by the International Workshop WM AND
- With a good performance status
Exclusion criteria:
- Prior exposure to a BTK inhibitor
- Disease transformation
To access the complete listing, refer to the CancerCare Manitoba (CCMB) Formulary.
Ontario Public Drug Programs – Exceptional Access Program
reimbursement criteria1:
For the treatment of relapsed or refractory Waldenström's macroglobulinemia (WM), in patients who have at least 1 prior line of treatment for WM, have good performance status, have not progressed on another BTK inhibitor for WM, and have no disease transformation to another form of cancer.
Drug Regimen:
320 mg orally daily* or 160 mg twice a day.
Cycle Frequency:
CONTINUOUS TREATMENT
Until disease progression or unacceptable toxicity.
To access complete listing, click here.
Régie de l’assurance maladie du Québec (RAMQ)* List of Medications (Exception Drug Status)
reimbursement criteria1:
- As monotherapy, for treatment of relapsed or refractory Waldenström’s macroglobulinemia, in persons whose ECOG performance status is ≤2
The maximum duration of each authorization is four months.
When requesting continuation of treatment, the physician must provide evidence of a beneficial clinical effect by the absence of disease progression according to the International Workshop for Waldenström’s Macroglobulinemia (IWWM) criteria.
To access the complete listing, click here.
Nova Scotia Pharmacare
reimbursement criteria1:
Relapsed or refractory Waldenström’s macroglobulinemia
For the treatment of adult patients with relapsed or refractory Waldenström’s macroglobulinemia who have received at least one prior therapy and have not experienced disease progression on a Bruton’s tyrosine kinase inhibitor.
Clinical notes:
- Patients should have a good performance status and no evidence of disease transformation
- Treatment should be discontinued upon disease progression or unacceptable toxicity
To access the complete Nova Scotia Pharmacare Drug List, click here.
New Brunswick Drug Plans Formulary
reimbursement criteria1:
For the treatment of adult patients with relapsed or refractory Waldenström’s macroglobulinemia who have received at least one prior therapy and have not experienced disease progression on a Bruton’s tyrosine kinase inhibitor.
Renewal criteria:
- Written confirmation that the patient has responded to treatment and there is no evidence of disease progression
Clinical notes:
- Patients must meet at least one criterion for treatment as per IWWM consensus panel.
- Patients must have a good performance status and no evidence of disease transformation.
Treatment should be discontinued upon disease progression or unacceptable toxicity.
To access the complete New Brunswick Drug Plans Formulary listing, click here.
PEI Drug Plans Formulary reimbursement criteria1:
For the treatment of adult patients with relapsed or refractory Waldenström’s macroglobulinemia who have received at least one prior therapy and have not experienced disease progression on a Bruton’s tyrosine kinase inhibitor.
Clinical Notes:
- Patients must meet at least one criterion for treatment as per IWWM consensus panel.
- Patients must have a good performance status and no evidence of disease transformation.
- Treatment should be discontinued upon disease progression or unacceptable toxicity.
Patients must apply for coverage under the High-Cost Drug Program.
To access the complete Health PEI Formulary Drugs for Oncology Drug List, click here.
Newfoundland and Labrador Prescription Drug Program (NLPDP)
reimbursement criteria1:
For the treatment of adult patients with relapsed or refractory Waldenström’s macroglobulinemia who have received at least one prior therapy and have not experienced disease progression on a Bruton’s tyrosine kinase inhibitor.
Renewal criteria:
- Written confirmation that the patient has responded to treatment and there is no evidence of disease progression
Clinical notes:
- Patients must meet at least one criterion for treatment as per International Workshop on WM (IWWM) consensus panel.
- Patients must have a good performance status and no evidence of disease transformation.
- Treatment should be discontinued upon disease progression or unacceptable toxicity.
Claim Note:
To access the complete Newfoundland and Labrador Prescription Drug Program (NLPDP) Drug List, click here.
Non-Insured Health Benefit (NIHB)
(Limited Use) criteria1:
Coverage Criteria/Therapeutic Notes
Initial coverage criteria (6 months):
For the treatment of adult patient with relapsed or refractory (R/R) Waldenström’s macroglobulinemia (WM) who meet all of the following criteria:
- For the treatment of adult patient with relapsed or refractory (R/R) Waldenström’s macroglobulinemia (WM) who meet all of the following criteria:
- Patient has received at least 1 prior line of therapy; AND
- Patient meets at least 1 criterion for treatment according to International Workshop on WM (IWWM) consensus panel criteria; AND
- Patient does not have prior exposure to a BTK inhibitor and/or disease transformation; AND
- Patient has good performance status.
Renewal coverage criteria (12 months):
Treatment with zanubrutinib should be discontinued upon the occurrence of any of the following:
- Progression of disease according to IWWM response assessment criteria
- Unacceptable toxicity
To access the complete listing, click here.
