Product Details

Seacalphyx

Sodium Thiosulfate
250 mg/mL
Solution for Injection
Vial Pack (Preservative-Free)

DIN/PIN/NPN

02386666

Manufacturer

Seaford Pharmaceuticals Inc.

Formulary Listing Date

2017-03-28  

Unit Price

2.7500

Amount MOH Pays

2.7500

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

V03AB06

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Nephrology Treatments

Sodium Thiosulfate

  • Brand(s): Seacalphyx DIN 02386666 and Hope Pharmaceuticals DIN 02428393
  • Dosage Form/Strength: 250mg/mL Injection; 12.5 g/50 mL Injection
  • Effective date: March 28, 2017

Approval of sodium thiosulfate for the treatment of calciphylaxis will be provided where all of the following criteria have been met: 

Patients with G4 or G5 chronic kidney disease; AND 

  1. Have been diagnosed with calciphylaxis either by:
    a)
    99m Technicium scintigraphy (bone scan) showing deposits that correspond to clinical lesions;
    OR

    b)
    Biopsy;
    OR

    c)
    Where scintigraphy negative and biopsy is not feasible, then diagnosis must be confirmed by nephrologist with submission of anonymized photographs of lesions AND a differential diagnosis checklist (e.g., warfarin-induced necrosis if on warfarin; lipohypertrophy if on insulin; cellulitis, nephrogenic sclerosing dermopathy, emboli, thrombi, fibrointimal hyperplasia and so on which depends on the site of lesion);

    AND 

  1. Patient has either:
    a)
    Ulcerated lesions;
    OR

    b)
    Non-ulcerated lesions which have not improved after 2 weeks of multimodal treatment with replacement of calcium-containing phosphate binders with non- calcium containing binders (i.e. sevelamer), discontinuation of vitamin D analogs and initiation of calcimimetic (i.e., cinacalcet), changes in dialysis prescription (reduction in dialysate calcium; consideration of increased dialysis intensity), replacement of warfarin with alternative anticoagulants where possible, wound management strategies, and analgesia for lesion pain. 

Requests for patients with calciphylaxis who do not meet the above criteria will be considered on a case-by-case basis. 

Duration of Approval: 2 months 

Renewals will be considered for patients responding to treatment with improved pain control AND reduction in lesion number or size, reduction in ulcer size, or complete ulcer healing. 

Recommended dose: 25g three times weekly. 

Duration of Approval: Two months at a time until lesions are completely resolved, and for additional 2 months after complete healing.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

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