Is PrVELPHORO® publicly reimbursed?
VELPHORO is publicly reimbursed for the following (criteria exist):
THROUGH PROVINCIAL FORMULARIES
- Ontario via Exceptional Access Program (EAP)1
- Quebec RAMQ* under Exceptional Medications† (Code VA109)2
- Saskatchewan Drug Plan as exception drug status3
- Manitoba Drug Plan as exception drug status4
- New Brunswick Drug Plans as special authorization5
- Nova Scotia Pharmacare as exceptional status drugs6
- Newfoundland and Labrador Prescription Drug Program as special authorization7
- Prince Edward Island Pharmacare as special authorization8
THROUGH NON-PROVINCIAL COVERAGE
- Veterans Affairs Canada (VAC) as Standard Benefit9
- Non-Insured Health Benefits (NIHB) program as limited use benefit10
Criteria in provincial formularies may vary.
For listing criteria, check with individual provincial programs. Coverage restrictions in addition to the indicated condition may apply.
PrVELPHORO® (sucroferric oxyhydroxide) is indicated for the control of serum phosphorus levels in adult patients with end-stage renal disease (ESRD) on dialysis.11
* Official mark of the Régie de l’assurance maladie du Québec.
† RAMQ coverage criteria as a phosphate binder in persons suffering from severe renal failure, where a calcium salt is contraindicated, is not tolerated, or does not make it possible to optimally control the hyperphosphatemia. It must be noted that taking this medication concomitantly with sevelamer or lanthanum hydrate is not authorized.2
Important Safety Information
- Clinical use:
- Efficacy and safety in pediatric population (<18 years of age) have not been evaluated.
- No overall differences in safety or efficacy were observed between subjects ≥65 and younger subjects.
- Contraindications:
- Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
- Patients with hemochromatosis or any other iron accumulation disorders.
- Relevant warnings and precautions:
- Diabetes, hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase insufficiency
- Caution in patients with gastrointestinal issues
- VELPHORO may cause black stools which may mask gastrointestinal bleeding
- Patients with hepatic/biliary/pancreatic disorders/disease
- Monitoring and laboratory tests regarding serum phosphorus and iron
- Pregnant or nursing women
- Less common clinical trial or post-market adverse reactions:
- In the 6-week and 55-week clinical studies, tooth discolouration and product taste were some of the less common (<1%), treatment-related treatment emergent adverse events reported in more than one patient.
- Eosinophilic peritonitis has been listed in post-market spontaneous reports.
- For more information:
- Please consult the Product Monograph at http://velphoromonograph.ca for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-877-341-9245.
EFFICACY DATA
SAFETY AND TOLERABILITY PROFILE
DOSING AND ADMINISTRATION
- References:
1. Ontario Ministry of Health. Formulary: Exceptional Access Program (EAP). 2. Régie de l’assurance maladie du Québec. List of Medications. 3. Government of Saskatchewan. Saskatchewan Drug Plan (Search Formulary: Velphoro). 4. Manitoba Health. Bulletin #108: Manitoba Drug Benefits and Interchangeability Formulary Amendments. 5. Government of New Brunswick. New Brunswick Drug Plans Formulary. 6. Nova Scotia Pharmacare. Appendix III – Criteria for Coverage of Exception Status Drugs. 7. Newfoundland and Labrador Prescription Drug Program. NLPDP Drug Product Database. 8. PEI Pharmacare. PEI Pharmacare formulary. 9. Government of Canada. Veterans Affairs Canada. Drug formulary search form. 10. Non-Insured Health Benefits: Drug benefit list. 11. VELPHORO Product Monograph. Otsuka Canada Pharmaceutical Inc.