Product Details
Reddy-Lenalidomide
Lenalidomide2.5 mg
Capsule
DIN/PIN/NPN
02484714
Manufacturer
Dr. Reddy's Laboratories Inc.
Formulary Listing Date
2021-10-29
Unit Price
82.3750
Amount MOH Pays
82.3750
Coverage Status
Limited Use Product Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L04AX04
Interchangeable Products
DIN/ PIN/ NPN | Brand name | Unit Price | Amount MOH pays |
---|---|---|---|
02459418 | Revlimid | 329.5000 | 82.3750 |
02518562 | Sandoz Lenalidomide | 82.3750 | 82.3750 |
02484714 | Reddy-Lenalidomide | 82.3750 | 82.3750 |
02493837 | Nat-Lenalidomide | 82.3750 | 82.3750 |
02507927 | Apo-Lenalidomide | 82.3750 | 82.3750 |
02506130 | Jamp Lenalidomide | 82.3750 | 82.3750 |
02507862 | Taro-Lenalidomide | 82.3750 | 82.3750 |
LU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
Note: Pharmacists and prescribers should be informed of a drug product’s official indications and recommended dosage as set out in Health Canada’s approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer’s funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. | ||
630 | 6 months | Myelodysplastic Syndrome Initial criteria: Renewal criteria: Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. |
631 | 1 year | Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: Renewal criteria: Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/ responses. |
632 | 1 year | Multiple Myeloma Initial criteria Renewal criteria: Renewal Duration: 1 year Exclusion Criteria: 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): Relapsed/Progressive disease is defined as having one or more of the following: 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. |
659 | 1 year | 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. |
EAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Oncology Drugs | Lenalidomide
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:
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:
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: |
Anemia | Lenalidomide
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: |