Apo-Lenalidomide

Myelodysplastic Syndrome

Initial criteria:
For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria:
1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration
2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing
3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1
4. Symptomatic anemia (transfusion dependent or non-transfusion dependent)

Renewal criteria:
There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response.

Renewal Duration: 1 year

Recommended dose: 10mg daily adjusted based on clinical and laboratory findings.

Multiple Myeloma (maintenance treatment following stem cell transplant)

Initial criteria:
For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression.

Renewal criteria:
Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide

Renewal Duration: 1 year

Recommended Dosage: Initial dose of 10mg daily

Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/ responses.

Multiple Myeloma

Initial criteria
For the treatment of patients with multiple myeloma who meet ALL the following criteria:
1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND
2. Patient has good performance status; AND
3. Lenalidomide is being used in ONE of the following situations:
a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3) OR
b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second- or third-line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR
c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second- or third-line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3).

Renewal criteria:
Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen.

Renewal Duration: 1 year

Exclusion Criteria:
Patients meeting the following are not eligible for funding:
1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment.
2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment.
3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma.
4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis.

Recommended Dose: 25mg daily as a single 25mg capsule

Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day.

Notes (Multiple Myeloma):
1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression).

Relapsed/Progressive disease is defined as having one or more of the following:
i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours).
ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels).
iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting.

3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP).

4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP.

Multiple Myeloma – Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma

Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles.

Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule

Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day.

Lenalidomide

• Brand(s): Revlimid and generics (see formulary for funded OFIs)
• Dosage Form/Strength: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule
• Updated: August 19, 2022

Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary.

Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis.

Lenalidomide sensitive is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen.

Refractory disease is defined as:

1. disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); OR
2. progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; OR
3. non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression)

Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide.

Progressive disease is defined as having one or more of the following:

1. An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours).
2. An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels).
3. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
4. Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Lenalidomide

• Brand(s): Revlimid
• Dosage Form/Strength: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule

Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary.

EAP Drug Request Form:

Standard Form for EAP Drug Requests