Product Details

M-Cinacalcet

Cinacalcet
30 mg
Tablet


DIN/PIN/NPN

02481987

Manufacturer

Mantra Pharma Inc.

Formulary Listing Date

2021-09-30  

Unit Price

10.1947

Amount MOH Pays

10.1947

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

H05BX01

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02441624 Teva-Cinacalcet 10.1947 10.1947
02257130 Sensipar 12.0533 10.1947
02434539 Mylan-Cinacalcet 10.1947 10.1947
02481987 M-Cinacalcet 10.1947 10.1947
02480298 Mar-Cinacalcet 10.1947 10.1947
02500094 Jamp Cinacalcet 10.1947 10.1947
02478900 Auro-Cinacalcet 10.1947 10.1947
02452693 Apo-Cinacalcet 10.1947 10.1947
02524880 Cinacalcet 10.1947 10.1947
02517604 PMS-Cinacalcet 10.1947 10.1947
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Nephrology Treatments

Cinacalcet

  • Brand(s): Sensipar and generics
  • Dosage Form/Strength: 30 mg, 60 mg, 90 mg tablets

For the treatment of severe hyperparathyroidism* in patients with chronic kidney disease who are on dialysis who meet the following criteria:

  1. the patient is refractory to other treatments; AND 

  1. the patient has symptoms clearly related to hyperparathyroidism that are causing significant impairment in quality of life (e.g., calciphylaxis or bone pain); AND 

  1. additionally, ONE of the following criteria is present:
    a)     the patient has been reviewed by a surgeon, anesthetist or nephrologist and has been deemed to not be a candidate for parathyroidectomy due to high surgical risk or anesthetic risk. [Please note: This must be accompanied by a clinical note explaining the high surgical risk or anesthetic risk and the patient’s parathyroid hormone (PTH) level];
    OR
    b)     the patient has been wait-listed for a parathyroidectomy and requires Sensipar for bridge therapy;
    OR
    c)     the patient is awaiting an imminent renal transplant and a nephrologist indicates a preference for pre-transplant treatment with Sensipar instead of a parathyroidectomy. 

*Severe hyperparathyroidism is considered to be patients with PTH levels greater than 88 pmol/L confirmed on two laboratory tests for PTH taken at least 1 month apart. 

Exclusion Criteria:
Patients with primary hyperparathyroidism or parathyroid carcinoma. 

Initial Approval durations: 

  • Patients meeting the above criteria and 3 a) above – 1 year 

  • Patients who meet the above criteria and 3 b) above – period of time until the estimated date of the parathyroidectomy 

  • Patients wait-listed for a parathyroidectomy requiring bridge therapy with Sensipar or awaiting an imminent renal transplant will be approved to the estimated date of the surgery.

Duration of Approval: 1 year or to the estimated date of the procedure for those using for bridge therapy and awaiting surgery 

Renewals will be considered for patients who are not candidates for parathyroidectomy and who continue to benefit from therapy. Requests for renewals should include the patient’s PTH level. 

Renewals will NOT be considered for patients who have had a parathyroidectomy. 

Duration of Approval: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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