The ORA EAP Committee met with the MOHLTC last year and submitted a request to have ondansetron funded for pediatric patients with rheumatic diseases who are receiving weekly oral or subcutaneous methotrexate. It was annonced on Tuesday, January 29 that the Ministry reviewed our submission and that a decision was made to include funding for ondansetron in the requested population through the Exceptional Access Program (EAP). The EAP funding criteria, which will be implemented on January 31, is outlined below:

For the treatment of methotrexate induced nausea and vomiting in pediatric patients (18 years and younger) meeting all the following criteria:

i)      Patient has a demonstrated episode of nausea/emesis after receiving a dose of oral or injectable methotrexate*; AND

ii)     Patient is receiving oral or injectable methotrexate for a chronic condition; AND

iii)    Requested by a prescriber with expertise in the use of ondansetron in this pediatric population.

*EAP request applications should provide a description of the intolerance as it relates to the dosing of methotrexate and should include the dose and planned duration of use of methotrexate.  Other concomitant medications used by the patient should also be provided.

Case-by-case consideration may be provided for individuals older than 18 years.

Recommended dose:

Refer to ondansetron prescribing information for appropriate dosing within the treated population.

In general, 2 to 8 mg per dose administered one hour prior to methotrexate with 1 to 2 additional doses as needed post-methotrexate dosing. 

Approval duration: 2 years

 

From the MOHLTC:

Zofran (ondansetron) & Generics 4mg, 8mg Tab (GSK, APX, CCP, COB, JPC, MAR, MIN, MYL, NAT, PMS, RAN, SDZ, SET, TEV, VAN); 4mg, 8mg ODT/Film (GSK, SDZ, TAK); 4mg/5mL O/L (GSK, AAP) – Effective Date: January 31, 2019

For the treatment of nausea and vomiting associated with low-emetogenic chemotherapy and methotrexate-associated nausea/vomiting in pediatric patients according to clinical criteria.

The reimbursement criteria for the above products will be included on the list of Frequently Requested Drugs, which can be found on the Ministry’s website:

http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/frequently_requested_drugs.pdf