Aims: To register hospitalizations for respiratory syncytial virus (RSV) infections and estimate costs of prophylaxis with humanized monoclonal antibodies (palivizumab) against RSV, compared to hospital care, in cases with congenital heart defects (CHDs). Methods: Population based study with prospective registration of CHDs. Costs for hospital treatment of RSV- infections in CHD- patients calculated by means of the Norwegian Diagnosis Related Groups system. Results: In 43 470 infants live born in the population through the 18- year period 1987- 2004 a structural CHD was diagnosed in 527 (1.2% ). A total of 898 (2.1% ) hospitalizations for RSV- infections occurred in the study population 1987- 2005. The hospital admittance rate was significantly higher for CHD- cases (4.8% ) than for children without CHD (2% ) (P = 0.002). Severe CHDs (need for surgery or catheter intervention) had a higher admittance rate (9.2% ) compared to the group of remaining CHDs (3.3% ) (P = 0.01). Number needed to treat with palivizumab to avoid one hospitalization for RSV- infection in cases of severe CHDs was calculated to 24, at costs of US＄ 195 000. The expenses for palivizuamab prophylaxis in severe CHDs were 31 times that of hospital treatment. Conclusion: Prophylaxis with palivizumab in severe CHDs is not cost- effective.
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