Requests for Palivizumab: Palivizumab (Synagis®)

The referring physician completes the Nova Scotia RSV Prophylaxis Request Form 2022-2023. This form requires that the referring physician indicate that the parent/guardian was informed and consented to their child’s demographic information being shared with AstraZeneca Canada Inc. in Mississauga (AstraZeneca) for the purpose of ordering “product” (ie. palivizumab prophylaxis ), and that the health condition that puts the child at high risk for complicated RSV be indicated (check box). AstraZeneca shares the demographic information with IWK Health for the purposes of monitoring costs/utilization of palivizumab. The Provincial Palivizumab Working Group conducts this review yearly prior to establishing provincial prophylaxis guidelines. Nova Scotia also contributes to the national body of evidence/knowledge/practice regarding RSV prophylaxis by sharing aggregate data. Although direct identifiers are not shared, the Nova Scotia Personal Health Information Act requires consent for release of any personal health information, including demographics.

In all cases, to order palivizumab, the requesting physician should fax a fully completed Nova Scotia RSV Prophylaxis request form to AstraZeneca. The request form now includes an area to indicate if this is the first time product is requested (ie “initial” dose) or if it is a request for additional product (ie “subsequent” dose). For subsequent requests, the patient reference number assigned by AstraZeneca upon “initial” request must be provided. This will insure each infant/child has a unique reference number and only one file. As palivizumab is sold on a “non-returnable” and “non-refundable” basis, pharmacies or offices having inventory from last season should still submit a request form to AstraZeneca but reduce doses requested so remaining inventory may be used first to eliminate expiry of product. Those requests that are for “other” children considered to be at high risk for complicated RSV should be faxed to AstraZeneca along with the two appropriate letters providing medical justification for ordering the product.

Palivizumab funding will be limited to 5 doses per season as outlined in Table 1. The RSV season has been noted to be different during the COVID-19 pandemic, with many areas seeing an earlier and more widespread local outbreak. RSV has arrived earlier in Nova Scotia as well, so the program will begin in the coming weeks (November) rather than waiting until December 6, the previously determined date. The initial dose should be given in  November   and every 4 weeks to a maximum of 5 doses. The defined Nova Scotia RSV season typically in the past has been  January to May (ie the higher risk season when the annual RSV outbreak occurs). Nova Scotia epidemiology experts will continue to monitor this defined season. Table 1 outlines the number of doses required dependent on the date of request for palivizumab.

Table 1: Guidance for number of doses depending on request date - (Dose is 15 mg/kg as per package insert)

It is recommended that palivizumab be delivered to hospital pharmacy services due to strict storage requirements, and be administered to patients through same-day, centralized clinics wherever possible. Infants in the Halifax (formerly the Halifax Regional Municipality) may receive palivizumab through the IWK RSV Prevention Clinic. Infants in Colchester County and the Municipality of East Hants may receive palivizumab through the Colchester East Hants Health Center (contact the Maternal/Child Unit at (902) 893-5544). Infants in the region of Cape Breton may receive palivizumab through a clinic at the Cape Breton Regional Hospital by contacting (902) 567-7844. Requests for indications that meet the provincial guidelines and do not require medical consultation will be immediately dispensed by AstraZeneca.

Requests that require medical consultation ("cardiac indications" and "other" children considered at high risk for complicated  RSV") will be faxed to the IWK Health Centre Utilization Monitoring Program (IWKUMP) by AstraZeneca. The IWKUMP will refer these requests for consultation to the appropriate clinical specialists at IWK Health and once approved will request dispensing of palivizumab by AstraZeneca.