Healthy Skepticism Library item: 2252

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Klassen TP.
Economic evaluations of immunoprophylaxis in infants at high risk for respiratory syncytial virus: shedding light or creating confusion?
Arch Pediatr Adolesc Med 2002 Dec; 156:(12):1180-1
http://archpedi.ama-assn.org/cgi/content/full/156/12/1180

Abstract:

Bronchiolitis has huge resource costs. Three RCTs have examined the effectiveness of immunoprophylaxis with RSV-IGIV or palivizumab in high-risk infants. The primary observed benefit was reduction of hospitalization burden. No significant benefit was observed in mortality. Economic evaluations could help decide whether to adopt a passive immunization strategy. However, many evaluations are sub-standard. Hill et al. examined 326 analyses submitted to the Australian Pharmaceutical Benefits Scheme. 67% had significant problems. Evans argued that guidelines may give the illusion of scientific rigor and respectability, while funding influence may still distort conclusions and recommendations, because there is too much subjectivity and choice about methods. Kamal-Bahl et al. (2002) systematically reviewed 12 economic evaluations of RSV-IGIV and palivizumab. Results ranged from cost savings to considerable incremental costs per hospitalization avoided. Studies comparing the two agents reported mixed results about relative cost-effectiveness. More disturbingly, all four studies with pharmaceutical support reported possible cost-effectiveness or cost-savings with prophylaxis in the entire high-risk infant population vs zero of the eight studies without such funding (P = .002). It is astounding that 3 RCTs spawned 12 economic evaluations. The debate would have been clarified by larger RCTs using mortality or severe morbidity. Economic evaluations must be methodologically sound and sufficiently transparent. Sponsorship disclosure should be mandatory, but is probably not sufficient. As Lewis has stated, “Some bargains are Faustian and some horses are Trojan. Dance carefully with the porcupine, and know in advance the price of intimacy.” (p. 785)

Keywords:
Antibodies, Monoclonal/economics Antibodies, Monoclonal/therapeutic use* Humans Immunoglobulins, Intravenous/therapeutic use* Infant, Newborn Randomized Controlled Trials Respiratory Syncytial Virus Infections/economics Respiratory Syncytial Virus Infections/prevention & control* Risk *editorial Australia immunoprophylaxis pharmacoeconomic analysis Pharmaceutical Benefits Scheme INFORMATION FROM INDUSTRY: PHARMACOECONOMIC ANALYSIS PROMOTIONAL TECHNIQUES: PHARMACOECONOMIC DATA SPONSORSHIP: RESEARCH