It is quite clear that palivizumab reduces the incidence of RSV disease, and probably also the severity, among those who still get it nevertheless. It is just as clear that it is extremely expensive.
If RSV is likely to make you very sick and end up in hospital then there is a definite cost saving from administration, other benefits are much harder to cost. This is probably the first time I have written about health care costs in this blog, but it was stimulated by a new publication ‘Yoshihara S, Kusuda S, Mochizuki H, Okada K, Nishima S, Simões EAF: Effect of palivizumab prophylaxis on subsequent recurrent wheezing in preterm infants. Pediatrics 2013, 132(5):811-818′ This was a prospective observational study funded by Abbott, which followed 349 late preterm infants who received three doses of palivizumab and 95 who received none. Recurrent wheezing occurred much more frequently in the untreated than in those who received the prophylaxis. Although this appears effective, and the study design is a reasonable second best compared to an RCT, the cost implications are enormous.
Earlier this year a proper masked RCT was published in the PNEJM (Blanken MO, Rovers MM, Molenaar JM, Winkler-Seinstra PL, Meijer A, Kimpen JL, Bont L, Dutch RSVNN: Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. The Prestigious New England journal of medicine 2013, 368(19):1791-1799). That study (also funded by Abbott) also showed a significant reduction in the onset of recurrent wheezing, of a slightly smaller magnitude (11% vs 21%). The diagnosis of recurrent wheezing is not necessarily the best way to determine the benefit of the RSV prophylaxis: in the first year of life the controls wheezed for 4.5% of the days of the year, the treated babies for 1.8%. That is a 61% relative reduction, but a modest actual benefit.
An editorial in Pediatrics accompanying the new article is worth a read (Meissner HC, Kimberlin DW: RSV immunoprophylaxis: Does the benefit justify the cost? Pediatrics 2013, 132(5):915-918). For anyone who does not have full text access, I summarize: palivizumab is horrendously expensive, it is not at all clear that the benefits are worth it.
A number of cost-effectiveness analyses have been published regarding palivizumab prophylaxis with dramatically different conclusions. Cost-analyses sponsored by the manufacturer generally show cost neutrality or even cost saving. Among independently conducted cost analyses, the cost of prophylaxis with palivizumab is generally found to far exceed the economic benefit of hospital avoidance, even among infants at highest risk.
The authors of this commentary note the following among high risk groups, in whom for every 19 affected children there is one fewer hospital admission:
The acquisition cost of palivizumab is $202 635 to save $8530 in hospitalization cost.
In many jurisdictions there are ‘rebates’ which can be given in many different ways. I personally am very concerned about the way this works in Quebec. We pay an enormous amount for this medication, making huge profits for the manufacturer, in order to ensure that all the eligible infants receive their palivizumab the company then gives a subsidy to the hospital to support the salary of an ‘RSV nurse’ whose job is to ensure that no-one is missed. This is touted as being a public benefit, a ‘good deed’ on behalf of the manufacturer (I wouldn’t be surprised if it is tax-deductible). So, even in our public health care system, the manufacturers are themselves ensuring that they have the maximum uptake.
Currently in Québec there are guidelines in place, which assign risk scores to late preterm infants to decide which ones are eligible for palivizumab. The risk scores are a way of determining which infants are at highest risk of developing RSV and being hospitalized for it, but I am not at all sure that they discriminate according to whether there is a cost-benefit or not. In these days of cuts in our health care budget, this should be re-scrutinized.
On the other hand these new studies support the long held idea that RSV causes long lasting pulmonary dysfunction, and finding better, cheaper, ways to prevent it would be a good thing.