Product Details

Accel-Sevelamer

Sevelamer Carbonate
800 mg
Tablet


DIN/PIN/NPN

02461501

Manufacturer

Accel Pharma Inc.

Formulary Listing Date

2021-06-07  

Unit Price

1.2634

Amount MOH Pays

1.2634

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

V03AE02

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02354586 Renvela 1.3125 1.2634
02461501 Accel-Sevelamer 1.2634 1.2634
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Chronic Renal Failure Drugs – Telephone Request Service (TRS) Drugs

Lanthanum

  • Brand(s): Fosrenol and Generics
  • Dosage Form/Strength: 250 mg, 500 mg, 750 mg, 1000 mg Chewable tablet

Sevelamer Hydrochloride

  • Brand(s): Renagel
  • Dosage Form/Strength: 800 mg tablet

Sevelamer Carbonate

  • Brand(s): Accel-Sevelamer
  • Dosage Form/Strength: 800 mg tablet

  • Brand(s): Renvela
  • Dosage Form/Strength: 800 mg tablet, 0.8 g powder sachet, 2.4 g powder sachet

Updated: June 7, 2021

  1. For the treatment of hyperphosphatemia associated with end-stage renal disease (ESRD) where patients are on dialysis and have a sustained serum phosphate > 1.8 mmol/L AND adjusted serum calcium > 2.65 mmol/L;

    OR

  1. For dialysis patients experiencing hyperphosphatemia (sustained serum phosphate levels >1.8 mmol/L) who have calciphylaxis and/or evidence of coronary artery calcification.

Notes:

  1. Calcium and phosphate levels provided to demonstrate sustained elevations should be at least 4 weeks apart.

  1. Patients who demonstrate reduction of phosphate levels while on a calcium binder but who experience adjusted serum calcium > 2.65 mmol/L must provide supporting laboratory levels before treatment and while on treatment and should include the dose(s) of calcium-based binder used.

Exclusion Criteria: 

Sevelamer will not be reimbursed in the following cases: 

  • Use in combination therapy with another funded non-calcium-based phosphate binder (e.g., lanthanum carbonate hydrate, sucroferric oxyhydroxide, other sevelamer formulations)

Duration of approval: lifetime 

On a case-by-case basis, requests may be considered for sevelamer under the EAP for a patient with serum phosphate less than 1.8mmol/L and calcium values less than 2.65 mmol/L.

Product Monograph

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