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“Stop. Are you sick?”
She says she’s in touch with other nervous mothers in the same situation.
“People are terrified, quite frankly.”
Those anxious mothers are caught in a paradox.
Every province has a set of criteria to determine which infants qualify for the drug.
And every winter, there are babies who don’t qualify.
The drug was available through special access in 1998, then approved in Canada in 2002. It is marketed by U.S.-based AbbVie.
AbbVie declined a request for an interview to discuss the price of the drug.
“The cost actually to develop a single gram of antibody is a known price, and it’s estimated to be between $ 100 and $ 130 US per gram,” said Robin Sparrow at the WHO’s Technology Transfer Initiative in Geneva. She said her group believes it will be able to produce a full treatment of Synagis for $ 250 US.
“You should be able to produce it for $ 100 to $ 200 per treatment,” said Prof. Han van den Bosch of the Utrecht Centre for Affordable Biotherapeutics in the Netherlands.
A Manitoba doctor who’s responsible for deciding which babies in his province get the drug says the criteria vary from province to province.
“Every year it is controversial when we talk about a product that is only given to a select group of patients,”said Dr. Aaron Chiu.
Adding to the controversy is AbbVie’s active role in distributing the product through patient education campaigns and handling the administrative paperwork in some provinces.
“We do support general RSV education through an immunoprophylaxis program in which we provide support to 43 different programs, mainly hospitals, across the country,” AbbVie said in an email. “The programs that receive these grants determine for themselves how they employ the funding.”
The Canadian Paediatric Society (CPS) has expressed concern about the risk of conflict of interest because some doctors involved in administering the Synagis program also receive research funding from AbbVie.
In 2015, CPS published a position statement on Synagis that makes it clear doctors involved in manufacturer-funded research should not be involved in deciding who gets the drug.
Chiu says the CPS statement makes a valid point, but it’s difficult to be completely independent from AbbVie, the sole distributor of Synagis in Canada.
“I have regular contact with the company, from product manager to regional representative, to discuss shipment issues, cold-chain breaks, invoices, etc.,” he said.
“It’s the only pharmaceutical company I’ve ever had contact with up in Nunavut. I haven’t had any others contact me,” Barker said.
“We’ve got one of the highest RSV rates, so they see us a good candidate to maintain the purchasing of the product,” she said, adding that company sales representatives fly to the territory at least once a season.
Barker believes AbbVie is trying to encourage Nunavut to give the drug to more babies.
“It’s largely driven by them trying to convince us that we’re not providing appropriate care to Nunavummiut infants, and trying to convince us of the need, and some of the potential areas of benefit, if we were to make it universal.”
In an email, AbbVie said, “We work with all Canadian provinces and territories based on their own self-determined eligibility criteria for utilization. We abide by the Innovative Medicines Canada code of business conduct.”
AbbVie processes all the enrolment forms and informs family doctors which infants qualify and which ones are rejected, Health Ministry spokesperson David Jensen said in an email.
Although the cost of Synagis is out of reach for many families, the drug is available for private purchase. McKesson Specialty Pharmacy, which has locations across Canada, can fill the prescription. It’s not clear how many families try to buy the drug themselves. McKesson wouldn’t disclose sales numbers, or the price it charges for the drug.
“We are bound by contractual rules with the manufacturer,” McKesson said in an email. “The sales data belongs to the manufacturer and therefore McKesson Canada can’t provide you with this information.”
“You can’t blame the company for trying to make as much profit as they can before a better product comes along,” said Robinson. She added that there is disagreement about how widely used the drug would be if the cost was lower.
In the meantime, O’Dwyer-Manual won’t relax until summer.
RSV: Respiratory syncytial virus (RSV) sends more infants and toddlers to hospital than any other bug. And the virus causes 200,000 deaths in toddlers and infants around the world every year, according to the World Health Organization. It’s especially dangerous to premature infants and babies with heart and lung conditions. Everyone in the world is eventually infected with RSV, experts say, but most people don’t notice because the virus causes only mild cold symptoms in healthy people.
ABBVIE SALES FIGURES: According to AbbVie’s 2016 annual report to shareholders, international sales (net revenues) of Synagis were $ 730 million in 2016. AbbVie’s total net revenues from drug sales in Canada were $ 624 million. Synagis is one of 19 AbbVie drugs approved in the Canadian market.