TABLE 2

Author, y . | Country or Original Currency, y . | ICER (Original) . | ICER (Adjusted), 2017 USD . | Outcome Measure . | Results (Context) . | Type of Sensitivity Analysis . | Study Conclusions . |
---|---|---|---|---|---|---|---|

Banerji et al^{24} 2016 | CAD 2011 | 4633 | 4073 | Cost per HA | Scenario B, Nunavut without Iqaluit^{a} | Deterministic | Palivizumab was cost-effective in the Kitikmeot and Kivalliq regions and in Nunavik. Scenario B (compared with Scenario A) was more cost-effective in all regions except the Kitikmeot region. |

14 545 | 12 787 | Scenario B, Nunavut^{a} | |||||

15 601 | 13 716 | Scenario B, Nunavik^{a} | |||||

22 954 | 20 180 | Scenario A, Kivalliq region^{a} | |||||

28 580 | 25 126 | Scenario A, Nunavut without Iqaluit^{a} | |||||

30 230 | 26 577 | Scenario A, Nunavik^{a} | |||||

41 404 | 36 401 | Scenario A, Nunavut^{a} | |||||

105 259 | 92 539 | Scenario B, Qikiqtaaluk region without Iqaluit^{a} | |||||

133 407 | 117 286 | Scenario B, Qikiqtaaluk region^{a} | |||||

166 600 | 146 468 | Scenario A, Qikiqtaaluk region without Iqaluit^{a} | |||||

211 444 | 185 893 | Scenario A, Qikiqtaaluk region^{a} | |||||

326 441 | 286 993 | Scenario B, NWT^{a} | |||||

545 115 | 479 242 | Scenario A, NWT^{a} | |||||

Dominant | Dominant | Scenario A, Kitikmeot region^{a} | |||||

Dominant | Dominant | Scenario B, Kitikmeot region^{a} | |||||

Dominant | Dominant | Scenario B, Kivalliq region^{a} | |||||

Bentley et al^{35} 2013 | GBP 2010 | 3845 | 6165 | Cost per QALY gained | Preterm infants (<29 wGA) | Deterministic; probabilistic | Prophylactic palivizumab represents an economically viable use of NHS resources for infants (aged <24 mo) with CHD, infants (aged <24 mo) with CLD, preterm infants born at ≤32 wGA, and preterm infants born 33–35 wGA when additional risk factors are considered. |

19 168 | 30 734 | Infants with CLD | |||||

30 205 | 48 430 | ||||||

33 216 | 53 258 | Infants with CHD | |||||

99 056 | 158 824 | Preterm infants (33–35 wGA) | |||||

Blanken et al^{46} 2018 | Netherlands 2015 | 214 748 | 272 654 | Cost per QALY gained | Preterm (32–35 wGA) | Deterministic; probabilistic | — |

Chirico et al^{47} 2009 | Italy 2007 | 2732 | 3984 | Cost per QALY gained | BPD | Deterministic | Compared with no prophylaxis, palivizumab is cost-effective in the prevention of RSV infection among high-risk preterm infants. |

8677 | 12 653 | Preterm (<35 wGA, mix) with BPD | |||||

9380 | 13 679 | Preterm (<33 wGA) | |||||

14 937 | 21 783 | Preterm (33–35 wGA) | |||||

Elhassan et al^{44} 2006 | USD 2002 | 103 053 | 140 341 | Cost per QALY gained | Base case, preterm (26 wGA), targeted use policy | Deterministic | Our model supports implementing more restrictive guidelines for palivizumab prophylaxis. Palivizumab was cost-effective for some infants in an analysis used to account for increased risk of severe asthma after RSV infection. We found evidence that long-term health consequences of RSV are central to the determination of the cost-effectiveness of the intervention. |

216 830 | 295 287 | Base case, preterm (28 wGA), targeted use policy | |||||

280 083 | 381 427 | Base case, preterm (29–30 wGA), targeted use policy | |||||

675 780 | 920 300 | Base case, preterm (29–30 wGA) | |||||

830 152 | 1 130 530 | Base case, preterm (26 wGA) | |||||

1 212 497 | 1 651 220 | Base case, preterm (31 wGA) | |||||

1 295 781 | 1 764 639 | Base case, preterm (27 wGA) | |||||

1 500 351 | 2 043 230 | Base case, preterm (28 wGA) | |||||

1 855 000 | 2 526 203 | Base case, preterm (32 wGA) | |||||

Hampp et al^{48} 2011 | USD 2010 | 302 103 | 339 852 | Cost per HA | Preterm (<32 wGA) | Deterministic; probabilistic | The cost of immunoprophylaxis with palivizumab far exceeded the economic benefit of preventing hospitalizations, even in infants at highest risk for RSV infection. |

361 727 | 406 926 | Preterm (<32 wGA) and CHD | |||||

368 048 | 414 037 | Preterm (<32 wGA) and CLD | |||||

522 490 | 587 777 | Term, CLD, and CHD | |||||

823 868 | 926 813 | Term and CHD only | |||||

920 033 | 1 034 994 | Any risk factor (indication) | |||||

1 322 422 | 1 487 663 | Term and CLD only | |||||

2 138 870 | 2 406 129 | No risk factor (indication) | |||||

Harris et al^{49} 2011 | CAD 2007 | 8292 | 8077 | Cost to treat 1 child per RSV season | Base case | Deterministic | With our study, we contribute to the growing body of literature in which it is suggested that palivizumab is not cost-effective in children <2 y old with hemodynamically significant CHD. |

15 513 | 15 111 | Cost to prevent 1 d of hospitalization | Base case | ||||

Hascoet et al^{50} 2008 | France 2006 | 10 172 | 13 798 | Cost per LYG | Preterm (<32 wGA), with BPD (health care) | Deterministic; probabilistic | Prophylaxis with palivizumab for RSV in premature children with BPD or hemodynamically significant CHD can be considered cost-effective in France. |

20 788 | 28 198 | Preterm (<32 wGA), with cardiopathy (societal) | |||||

27 255 | 36 971 | Preterm (<32 wGA), with BPD (societal) | |||||

Lofland et al^{45} 2000 | USD 2000 | 1008 | 1434 | Cost per RSV-infection episode avoided | Base case, preterm (NR wGA), 81% reduction incidence of RSV infection (5% vs 26%) | Deterministic | The incremental cost per RSV-infection episode avoided ranged from $0 (cost savings) to $39 591 for palivizumab prophylaxis costs of $2500 and from $2702 to $79 706 for palivizumab prophylaxis costs of $4500. Clinicians may use this information to help determine if prophylactic palivizumab therapy is cost-effective in their clinical practice setting. |

39 591 | 56 313 | Preterm (NR wGA), 50% reduction incidence of RSV infection (5% vs 10%) | |||||

Dominant | Dominant | Preterm (NR wGA), 83% reduction incidence of RSV infection (5% vs 28%) | |||||

Mahadevia et al^{52} 2012 | USD 2010 | 44 774 | 50 369 | Cost per QALY gained | Group 2, preterm (32–35 wGA) with risk factors^{b} | Deterministic | Palivizumab remained cost-effective for guideline-eligible high-risk infants across both public and private sectors. Guideline-eligible infants included infants of <32 wGA, 32–34 wGA with 2009 AAP risk factors, and 32–35 wGA with 2006 AAP risk factors. Palivizumab was not cost-effective in infants of 32–35 wGA with 1 risk factor. |

79 477 | 89 408 | Group 3, preterm (32–35 wGA) with risk factors^{b} | |||||

464 476 | 522 514 | Group 4, preterm (32–35 wGA) with risk factors^{b} | |||||

Dominant | Dominant | Group 1, preterm (<32 wGA)^{b} | |||||

McGirr et al^{25} 2017 | CAD 2013 | 157 332 | 135 207 | Cost per QALY gained | High-risk CF <2 y (high risk for severe RSV disease) | Deterministic | Palivizumab is not cost-effective in Canada by commonly used thresholds. However, given the rarity of CF and the relatively small budget impact, consideration may be given. |

652 560 | 560 792 | All CF < 2 y | |||||

Neovius et al^{26} 2011 | SEK 2009 | 148 293 | 19 000 | Cost per QALY gained | Preterm (<29 wGA), adding wheezing to asthma | Deterministic; probabilistic | On the basis of a willingness-to-pay threshold of 500 000 SEK per QALY, palivizumab was found to be cost-effective compared with no prophylaxis for infants born at <29 wk if severe RSV infection was assumed to increase subsequent asthma or mortality risk. |

195 420 | 25 038 | Base case, preterm (<29 wGA) | |||||

383 825 | 49 178 | Preterm (<29 wGA), excluding indirect effect on asthma | |||||

492 430 | 63 093 | Preterm (<29 wGA), excluding indirect effect on mortality | |||||

8 856 829 | 1 134 793 | Preterm (<29 wGA), excluding the indirect effect of mortality and asthma | |||||

Nuijten et al^{30} 2009_DEU | Germany 2006 | 2221 | 3180 | Cost per QALY gained | Base case, Cardiac Study parameters, societal | Deterministic; probabilistic | This analysis revealed that palivizumab represents a cost-effective means of prophylaxis against severe RSV infection requiring hospitalization in infants with hemodynamically significant CHD. |

9528 | 13 643 | Base case, Cardiac Study parameters, including asthma, payer | |||||

9529 | 13 644 | Base case, societal | |||||

11 126 | 15 931 | Base case, Cardiac Study parameters, excluding asthma, payer | |||||

16 673 | 23 874 | Base case, direct medical costs (including asthma), payer | |||||

18 266 | 26 155 | Base case, direct medical costs (excluding asthma), payer | |||||

123 439 | 176 749 | Base case, excluding mortality, societal | |||||

Nuijten et al^{29} 2009_NLD | Netherlands 2006 | 7067 | 9837 | Cost per QALY gained | Base case: CHD | Deterministic; probabilistic | Palivizumab provides cost-effective prophylaxis against RSV in high-risk infants. The use of palivizumab in these children results in positive short- and long-term health-economic benefits. |

11 336 | 15 779 | Base case: preterm (<35 wGA, mix), with BPD (total costs, societal) | |||||

18 563 | 25 838 | Preterm (<35 wGA, mix) | |||||

20 236 | 28 167 | Base case: preterm (<35 wGA, mix), with BPD | |||||

23 461 | 32 655 | Subpopulations with BPD | |||||

Dominant | Dominant | Base case: CHD (total costs, societal) | |||||

Nuijten and Wittenberg^{28} 2010 | Spain 2006 | 6498 | 10 715 | Cost per QALY gained | Base case, preterm (<32 wGA), inclusion of costs of sequelae treatment | Deterministic; probabilistic | Palivizumab provides a cost-effective method of prophylaxis against severe RSV disease among preterm infants in Spain. |

12 814 | 21 130 | Base case, preterm (<32 wGA) | |||||

Dominant | Dominant | Base case, preterm (<32 wGA), societal perspective | |||||

Nuijten et al^{27} 2007 | GBP 2003 | 6664 | 12 733 | Cost per QALY gained | CHD | Deterministic; probabilistic | This study reveals that palivizumab prophylaxis against severe RSV infection in children at high risk may be cost-effective from the NHS perspective |

11 494 | 21 962 | Base case, preterm (<35 wGA), with indirect costs (societal) | |||||

14 883 | 28 438 | Preterm (<35 wGA) | |||||

16 720 | 31 948 | Base case, preterm (<35 wGA), with BPD | |||||

20 953 | 40 036 | BPD only | |||||

Resch et al^{31}^{,}^{32} 2008, 2012 | Austria 2010 | 3045 | 4071 | Cost per QALY gained | Base case, CHD, including recurrent wheezing treatment, societal | Deterministic | Our results, which are based on nationwide long-term epidemiological data, reveal that palivizumab is cost-effective in the prevention of RSV disease in high-risk infants. |

7818 | 10 452 | Base case, CHD, including recurrent wheezing treatment | |||||

8484 | 11 343 | Base case, CHD | |||||

15 800 | 21 124 | Base case, for all preterm (<35 wGA, mix), including recurrent wheezing treatment, societal | |||||

15 992 | 21 380 | Base case, preterm (33–35 wGA), including recurrent wheezing treatment, societal | |||||

17 554 | 23 469 | Base case, BPD, including recurrent wheezing treatment, societal | |||||

18 133 | 24 243 | Base case, preterm (<33 wGA), including recurrent wheezing treatment, societal | |||||

21 669 | 28 970 | Base case, for all preterm (<35 wGA, mix), including recurrent wheezing treatment | |||||

21 862 | 29 228 | Base case, preterm (33–35 wGA), including recurrent wheezing treatment | |||||

22 515 | 30 101 | Base case, BPD, including recurrent wheezing treatment | |||||

23 833 | 31 863 | Base case, preterm (<33 wGA), including recurrent wheezing treatment | |||||

24 392 | 32 611 | Base case, preterm (33–35 wGA) | |||||

24 654 | 32 961 | Base case, BPD | |||||

26 212 | 35 044 | Base case, for all preterm (<35 wGA, mix) | |||||

26 292 | 35 151 | Base case, preterm (<33 wGA) | |||||

Rietveld et al^{33} 2010 | Netherlands 2000 | 13 190 | 21 066 | Cost per HA | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (December) | Deterministic | Every mo, costs per HA were higher for children without BPD and children with higher gestational ages. Incremental costs per HA were always high. Passive immunization was always most cost-effective in December. A restrictive immunization policy requiring immunization of only children with BPD in high-risk months is therefore recommended. The costs of passive immunization would have to be considerably reduced to achieve cost-effectiveness. |

30 795 | 49 184 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (January) | |||||

31 055 | 49 599 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (November) | |||||

47 145 | 75 297 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (February) | |||||

105 120 | 167 892 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (March) | |||||

395 860 | 632 245 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (April) | |||||

833 695 | 1 331 529 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (October) | |||||

Roeckl-Wiedmann et al^{34} 2003 | Germany 2000 | 6639 | 10 011 | Cost per HA | Group A, preterm (<35 wGA)^{c} | Deterministic | Because of the findings of our cost-effectiveness analysis, we would recommend a restricted use of palivizumab prophylaxis in premature infants with CLD in their risk combination. The results of this cost-effectiveness analysis do not justify the widespread use of palivizumab among preterm infants. Palivizumab was most cost-effective among male infants with CLD who had siblings visiting day care groups and who were discharged between October and December. |

25 288 | 38 134 | Group B, preterm (<35 wGA), with risk factors^{c} | |||||

52 838 | 79 678 | Group C, preterm (<35 wGA), with risk factors^{c} | |||||

204 684 | 308 658 | Group D, preterm (<35 wGA), with risk factors^{c} | |||||

Salinas-Escudero et al^{36} 2012 | USD 2009 | 4539 | 5188 | Cost per QALY gained | Partial coverage, preterm (<29 wGA) | Deterministic; probabilistic | Palivizumab prophylaxis for preterm newborn patients born at ≤32 wk resulted in a cost-effective alternative. When evaluating the ICER per QALY and LYG against the USD $50 000 threshold, all age groups within the prophylaxis group are cost-effective. |

7294 | 8337 | Partial coverage, preterm (29–32 wGA) | |||||

17 532 | 20 038 | Full coverage, preterm (<29 wGA) | |||||

20 760 | 23 728 | Full coverage, preterm (29–32 wGA) | |||||

Sanchez-Luna et al^{37} 2017 | Spain 2016 | 11 550 | 17 792 | Cost per QALY gained | Subgroup A (payer)^{d} | Deterministic; probabilistic | Of 1000 Monte Carlo simulations, 85.7% of the cases presented an ICUR <€30 000 per QALY. Palivizumab is efficient for preventing RSV infections in preterm infants 32 1/7 to 35 0/7 wGA in Spain, including specific high-risk subgroups. |

14 177 | 21 839 | Subgroup B (payer)^{d} | |||||

17 153 | 26 424 | Base case (societal), preterm (32–35 wGA) | |||||

18 938 | 29 173 | Subgroup C (payer)^{d} | |||||

19 698 | 30 344 | Base case (payer), preterm (32–35 wGA) | |||||

Schmidt et al^{38} 2017 | Spain 2016 | 15 748 | 24 259 | Cost per QALY gained | Base case | Deterministic; probabilistic | PSA revealed that the probability of palivizumab prophylaxis being cost-effective at a €30 000-per-QALY threshold was 92.7%. The ICER remained below this threshold for most extreme-scenario analyses. Palivizumab prophylaxis was shown to be a cost-effective health care intervention according to the commonly accepted standards of cost-effectiveness in Spain (ICER below the threshold of €30 000 per QALY). |

Smart et al^{39}^{,}^{51} 2010 | CAD 2010 | 192 | 177 | Cost per QALY gained | Preterm (32–35 wGA), ≥4 risk factors | Deterministic; probabilistic | Palivizumab ICERs remained fairly stable from 2007 to 2010. The original recommendation stating that palivizumab is cost-effective in infants born between 32 and 35 wGA with ≥2 risk factors or in infants who are at a moderate to high risk on the basis of a risk-assessment model, does not change. |

5274 | 4859 | Preterm (32–35 wGA), risk-scoring tool, high risk (65–100 score) | |||||

20 814 | 19 175 | Base case, preterm (32–35 wGA), including asthma | |||||

26 701 | 24 598 | Preterm (32–35 wGA), 3 risk factors | |||||

31 360 | 28 890 | Base case, preterm (32–35 wGA), excluding asthma | |||||

34 438 | 31 726 | Preterm (32–35 wGA), risk-scoring tool, medium risk (49–64 score) | |||||

48 495 | 44 675 | Base case, preterm (32–35 wGA), mortality rate (1.2%) | |||||

50 434 | 46 462 | Base case, preterm (32–35 wGA), mortality rate (1.0%) | |||||

82 732 | 76 216 | Preterm (32–35 wGA), 2 risk factors | |||||

146 218 | 134 701 | Preterm (32–35 wGA), 1 risk factor | |||||

183 561 | 169 103 | Preterm (32–35 wGA), risk-scoring tool, low risk (0–48 score) | |||||

820 701 | 756 060 | Preterm (32–35 wGA), 0 risk factors (preterm only) | |||||

Tam et al^{40} 2009 | CAD 2007 | 334 | 325 | Cost per QALY gained | High risk area (defined as having hospitalization rates over 500/1000 live births) and <1 y | Deterministic; probabilistic | Palivizumab is a cost-effective option for the prevention of RSV for Inuit infants on Baffin Island, is highly cost-effective in Arctic infants <1 y of age specifically residing outside of Iqaluit, and is a dominant strategy for those <6 mo of age in remote areas. However, palivizumab is not cost-effective compared with no treatment of infants of all ages residing in Iqaluit. |

7822 | 7619 | Infants from Baffin Island <6 mo, societal | |||||

10 190 | 9926 | Infants from Baffin Island <6 mo | |||||

22 383 | 21 803 | Outside of Iqaluit (remote areas) <1 y, societal | |||||

24 750 | 24 109 | Outside of Iqaluit (remote areas) <1 y | |||||

37 070 | 36 110 | All infants from Baffin Island <1 y, societal | |||||

39 435 | 38 414 | All infants from Baffin Island <1 y | |||||

100 872 | 98 260 | Residing in Iqaluit <6 mo, societal | |||||

103 235 | 100 561 | Residing in Iqaluit <6 mo | |||||

149 782 | 145 903 | Residing in Iqaluit <1 y, societal | |||||

152 145 | 148 205 | Residing in Iqaluit <1 y | |||||

Dominant | Dominant | Infants in remote areas <6 mo | |||||

Dominant | Dominant | High-risk areas, <6 mo | |||||

Dominant | Dominant | High-risk areas, <1 y, societal | |||||

Dominant | Dominant | Infants in remote areas <6 mo, societal | |||||

Dominant | Dominant | High-risk areas, <6 mo, societal | |||||

Vogel et al^{41} 2002 | NZD 2000 | 28 700 | 28 265 | Cost per case averted | Preterm (32–35 wGA), with CLD, discharged from the hospital on oxygen | Deterministic | If value is placed on preventing morbidity, the priority groups for palivizumab prophylaxis are preterm infants discharged from the hospital on oxygen followed by preterm infants of ≤28 wk gestation. |

32 000 | 31 515 | Preterm (≤28 wGA), no CLD | |||||

60 000 | 59 091 | Total cohort, preterm (32–35 wGA), with CLD, societal | |||||

65 000 | 64 016 | Preterm (≤28 wGA), with CLD | |||||

98 000 | 96 516 | Preterm (29–31 wGA), no CLD | |||||

166 700 | 164 176 | Preterm (29–31 wGA), with CLD | |||||

Wang et al^{14} 2008 | GBP 2006 | 51 800 | 90 261 | Cost per HA | Preterm infants (<35 wGA) and children without CLD | Deterministic | According to this model, prophylaxis with palivizumab is not a cost-effective strategy for preterm infants and children with CHD compared with no prophylaxis from both an NHS perspective and a societal perspective. These findings are robust to probabilistic and other sensitivity analyses. Prophylaxis with palivizumab is also not a cost-effective strategy for preterm infants or infants with CLD who have no other risk factors. Subgroup analyses revealed that prophylaxis with palivizumab for children with CLD may be cost-effective at a willingness-to-pay threshold of £30 000 per QALY. |

63 800 | 111 171 | Cost per QALY gained | Preterm infants (<35 wGA) and children with CLD | ||||

66 900 | 116 573 | Preterm infants (<35 wGA) and children with CLD (societal) | |||||

67 600 | 117 792 | Cost per HA | Preterm infants (<35 wGA) and children with CLD | ||||

78 600 | 136 960 | CHD | |||||

79 800 | 139 051 | Cost per QALY gained | CHD | ||||

83 200 | 144 975 | CHD (societal) | |||||

454 100 | 791 265 | Preterm infants (<35 wGA) and children without CLD | |||||

475 600 | 828 728 | Preterm infants (<35 wGA) and children without CLD (societal) | |||||

Weiner et al^{42} 2012 | USD 2010 | 16 037 | 18 041 | Cost per QALY gained | Base-case group 2, preterm (32–34 wGA), with risk factors^{e} | Deterministic; probabilistic | Palivizumab, when dosed consistently with the FDA-approved labeling, was either cost saving or cost-effective among current guideline-eligible infants in the Medicaid population. Palivizumab did not reveal cost-effectiveness in infants of 32–35 wGA with ≤1 risk factor. |

38 244 | 43 023 | Base-case group 3, preterm (32–35 wGA), with risk factors^{e} | |||||

281 892 | 317 115 | Base-case group 4, preterm (32–35 wGA), with risk factors^{e} | |||||

Dominant | Dominant | Base-case group 1, preterm (<32 wGA)^{e} | |||||

Yount and Mahle^{43} 2004 | USD 2002 | 114 337 | 155 708 | Cost per QALY gained | Base case, term, CHD | Deterministic | The cost of palivizumab prophylaxis was high relative to benefits realized. Given the large No. CHD patients who might be considered candidates for RSV prophylaxis (>6000 patients per y in the United States), routine use of palivizumab in young children with CHD needs to be evaluated further. |

Author, y . | Country or Original Currency, y . | ICER (Original) . | ICER (Adjusted), 2017 USD . | Outcome Measure . | Results (Context) . | Type of Sensitivity Analysis . | Study Conclusions . |
---|---|---|---|---|---|---|---|

Banerji et al^{24} 2016 | CAD 2011 | 4633 | 4073 | Cost per HA | Scenario B, Nunavut without Iqaluit^{a} | Deterministic | Palivizumab was cost-effective in the Kitikmeot and Kivalliq regions and in Nunavik. Scenario B (compared with Scenario A) was more cost-effective in all regions except the Kitikmeot region. |

14 545 | 12 787 | Scenario B, Nunavut^{a} | |||||

15 601 | 13 716 | Scenario B, Nunavik^{a} | |||||

22 954 | 20 180 | Scenario A, Kivalliq region^{a} | |||||

28 580 | 25 126 | Scenario A, Nunavut without Iqaluit^{a} | |||||

30 230 | 26 577 | Scenario A, Nunavik^{a} | |||||

41 404 | 36 401 | Scenario A, Nunavut^{a} | |||||

105 259 | 92 539 | Scenario B, Qikiqtaaluk region without Iqaluit^{a} | |||||

133 407 | 117 286 | Scenario B, Qikiqtaaluk region^{a} | |||||

166 600 | 146 468 | Scenario A, Qikiqtaaluk region without Iqaluit^{a} | |||||

211 444 | 185 893 | Scenario A, Qikiqtaaluk region^{a} | |||||

326 441 | 286 993 | Scenario B, NWT^{a} | |||||

545 115 | 479 242 | Scenario A, NWT^{a} | |||||

Dominant | Dominant | Scenario A, Kitikmeot region^{a} | |||||

Dominant | Dominant | Scenario B, Kitikmeot region^{a} | |||||

Dominant | Dominant | Scenario B, Kivalliq region^{a} | |||||

Bentley et al^{35} 2013 | GBP 2010 | 3845 | 6165 | Cost per QALY gained | Preterm infants (<29 wGA) | Deterministic; probabilistic | Prophylactic palivizumab represents an economically viable use of NHS resources for infants (aged <24 mo) with CHD, infants (aged <24 mo) with CLD, preterm infants born at ≤32 wGA, and preterm infants born 33–35 wGA when additional risk factors are considered. |

19 168 | 30 734 | Infants with CLD | |||||

30 205 | 48 430 | ||||||

33 216 | 53 258 | Infants with CHD | |||||

99 056 | 158 824 | Preterm infants (33–35 wGA) | |||||

Blanken et al^{46} 2018 | Netherlands 2015 | 214 748 | 272 654 | Cost per QALY gained | Preterm (32–35 wGA) | Deterministic; probabilistic | — |

Chirico et al^{47} 2009 | Italy 2007 | 2732 | 3984 | Cost per QALY gained | BPD | Deterministic | Compared with no prophylaxis, palivizumab is cost-effective in the prevention of RSV infection among high-risk preterm infants. |

8677 | 12 653 | Preterm (<35 wGA, mix) with BPD | |||||

9380 | 13 679 | Preterm (<33 wGA) | |||||

14 937 | 21 783 | Preterm (33–35 wGA) | |||||

Elhassan et al^{44} 2006 | USD 2002 | 103 053 | 140 341 | Cost per QALY gained | Base case, preterm (26 wGA), targeted use policy | Deterministic | Our model supports implementing more restrictive guidelines for palivizumab prophylaxis. Palivizumab was cost-effective for some infants in an analysis used to account for increased risk of severe asthma after RSV infection. We found evidence that long-term health consequences of RSV are central to the determination of the cost-effectiveness of the intervention. |

216 830 | 295 287 | Base case, preterm (28 wGA), targeted use policy | |||||

280 083 | 381 427 | Base case, preterm (29–30 wGA), targeted use policy | |||||

675 780 | 920 300 | Base case, preterm (29–30 wGA) | |||||

830 152 | 1 130 530 | Base case, preterm (26 wGA) | |||||

1 212 497 | 1 651 220 | Base case, preterm (31 wGA) | |||||

1 295 781 | 1 764 639 | Base case, preterm (27 wGA) | |||||

1 500 351 | 2 043 230 | Base case, preterm (28 wGA) | |||||

1 855 000 | 2 526 203 | Base case, preterm (32 wGA) | |||||

Hampp et al^{48} 2011 | USD 2010 | 302 103 | 339 852 | Cost per HA | Preterm (<32 wGA) | Deterministic; probabilistic | The cost of immunoprophylaxis with palivizumab far exceeded the economic benefit of preventing hospitalizations, even in infants at highest risk for RSV infection. |

361 727 | 406 926 | Preterm (<32 wGA) and CHD | |||||

368 048 | 414 037 | Preterm (<32 wGA) and CLD | |||||

522 490 | 587 777 | Term, CLD, and CHD | |||||

823 868 | 926 813 | Term and CHD only | |||||

920 033 | 1 034 994 | Any risk factor (indication) | |||||

1 322 422 | 1 487 663 | Term and CLD only | |||||

2 138 870 | 2 406 129 | No risk factor (indication) | |||||

Harris et al^{49} 2011 | CAD 2007 | 8292 | 8077 | Cost to treat 1 child per RSV season | Base case | Deterministic | With our study, we contribute to the growing body of literature in which it is suggested that palivizumab is not cost-effective in children <2 y old with hemodynamically significant CHD. |

15 513 | 15 111 | Cost to prevent 1 d of hospitalization | Base case | ||||

Hascoet et al^{50} 2008 | France 2006 | 10 172 | 13 798 | Cost per LYG | Preterm (<32 wGA), with BPD (health care) | Deterministic; probabilistic | Prophylaxis with palivizumab for RSV in premature children with BPD or hemodynamically significant CHD can be considered cost-effective in France. |

20 788 | 28 198 | Preterm (<32 wGA), with cardiopathy (societal) | |||||

27 255 | 36 971 | Preterm (<32 wGA), with BPD (societal) | |||||

Lofland et al^{45} 2000 | USD 2000 | 1008 | 1434 | Cost per RSV-infection episode avoided | Base case, preterm (NR wGA), 81% reduction incidence of RSV infection (5% vs 26%) | Deterministic | The incremental cost per RSV-infection episode avoided ranged from $0 (cost savings) to $39 591 for palivizumab prophylaxis costs of $2500 and from $2702 to $79 706 for palivizumab prophylaxis costs of $4500. Clinicians may use this information to help determine if prophylactic palivizumab therapy is cost-effective in their clinical practice setting. |

39 591 | 56 313 | Preterm (NR wGA), 50% reduction incidence of RSV infection (5% vs 10%) | |||||

Dominant | Dominant | Preterm (NR wGA), 83% reduction incidence of RSV infection (5% vs 28%) | |||||

Mahadevia et al^{52} 2012 | USD 2010 | 44 774 | 50 369 | Cost per QALY gained | Group 2, preterm (32–35 wGA) with risk factors^{b} | Deterministic | Palivizumab remained cost-effective for guideline-eligible high-risk infants across both public and private sectors. Guideline-eligible infants included infants of <32 wGA, 32–34 wGA with 2009 AAP risk factors, and 32–35 wGA with 2006 AAP risk factors. Palivizumab was not cost-effective in infants of 32–35 wGA with 1 risk factor. |

79 477 | 89 408 | Group 3, preterm (32–35 wGA) with risk factors^{b} | |||||

464 476 | 522 514 | Group 4, preterm (32–35 wGA) with risk factors^{b} | |||||

Dominant | Dominant | Group 1, preterm (<32 wGA)^{b} | |||||

McGirr et al^{25} 2017 | CAD 2013 | 157 332 | 135 207 | Cost per QALY gained | High-risk CF <2 y (high risk for severe RSV disease) | Deterministic | Palivizumab is not cost-effective in Canada by commonly used thresholds. However, given the rarity of CF and the relatively small budget impact, consideration may be given. |

652 560 | 560 792 | All CF < 2 y | |||||

Neovius et al^{26} 2011 | SEK 2009 | 148 293 | 19 000 | Cost per QALY gained | Preterm (<29 wGA), adding wheezing to asthma | Deterministic; probabilistic | On the basis of a willingness-to-pay threshold of 500 000 SEK per QALY, palivizumab was found to be cost-effective compared with no prophylaxis for infants born at <29 wk if severe RSV infection was assumed to increase subsequent asthma or mortality risk. |

195 420 | 25 038 | Base case, preterm (<29 wGA) | |||||

383 825 | 49 178 | Preterm (<29 wGA), excluding indirect effect on asthma | |||||

492 430 | 63 093 | Preterm (<29 wGA), excluding indirect effect on mortality | |||||

8 856 829 | 1 134 793 | Preterm (<29 wGA), excluding the indirect effect of mortality and asthma | |||||

Nuijten et al^{30} 2009_DEU | Germany 2006 | 2221 | 3180 | Cost per QALY gained | Base case, Cardiac Study parameters, societal | Deterministic; probabilistic | This analysis revealed that palivizumab represents a cost-effective means of prophylaxis against severe RSV infection requiring hospitalization in infants with hemodynamically significant CHD. |

9528 | 13 643 | Base case, Cardiac Study parameters, including asthma, payer | |||||

9529 | 13 644 | Base case, societal | |||||

11 126 | 15 931 | Base case, Cardiac Study parameters, excluding asthma, payer | |||||

16 673 | 23 874 | Base case, direct medical costs (including asthma), payer | |||||

18 266 | 26 155 | Base case, direct medical costs (excluding asthma), payer | |||||

123 439 | 176 749 | Base case, excluding mortality, societal | |||||

Nuijten et al^{29} 2009_NLD | Netherlands 2006 | 7067 | 9837 | Cost per QALY gained | Base case: CHD | Deterministic; probabilistic | Palivizumab provides cost-effective prophylaxis against RSV in high-risk infants. The use of palivizumab in these children results in positive short- and long-term health-economic benefits. |

11 336 | 15 779 | Base case: preterm (<35 wGA, mix), with BPD (total costs, societal) | |||||

18 563 | 25 838 | Preterm (<35 wGA, mix) | |||||

20 236 | 28 167 | Base case: preterm (<35 wGA, mix), with BPD | |||||

23 461 | 32 655 | Subpopulations with BPD | |||||

Dominant | Dominant | Base case: CHD (total costs, societal) | |||||

Nuijten and Wittenberg^{28} 2010 | Spain 2006 | 6498 | 10 715 | Cost per QALY gained | Base case, preterm (<32 wGA), inclusion of costs of sequelae treatment | Deterministic; probabilistic | Palivizumab provides a cost-effective method of prophylaxis against severe RSV disease among preterm infants in Spain. |

12 814 | 21 130 | Base case, preterm (<32 wGA) | |||||

Dominant | Dominant | Base case, preterm (<32 wGA), societal perspective | |||||

Nuijten et al^{27} 2007 | GBP 2003 | 6664 | 12 733 | Cost per QALY gained | CHD | Deterministic; probabilistic | This study reveals that palivizumab prophylaxis against severe RSV infection in children at high risk may be cost-effective from the NHS perspective |

11 494 | 21 962 | Base case, preterm (<35 wGA), with indirect costs (societal) | |||||

14 883 | 28 438 | Preterm (<35 wGA) | |||||

16 720 | 31 948 | Base case, preterm (<35 wGA), with BPD | |||||

20 953 | 40 036 | BPD only | |||||

Resch et al^{31}^{,}^{32} 2008, 2012 | Austria 2010 | 3045 | 4071 | Cost per QALY gained | Base case, CHD, including recurrent wheezing treatment, societal | Deterministic | Our results, which are based on nationwide long-term epidemiological data, reveal that palivizumab is cost-effective in the prevention of RSV disease in high-risk infants. |

7818 | 10 452 | Base case, CHD, including recurrent wheezing treatment | |||||

8484 | 11 343 | Base case, CHD | |||||

15 800 | 21 124 | Base case, for all preterm (<35 wGA, mix), including recurrent wheezing treatment, societal | |||||

15 992 | 21 380 | Base case, preterm (33–35 wGA), including recurrent wheezing treatment, societal | |||||

17 554 | 23 469 | Base case, BPD, including recurrent wheezing treatment, societal | |||||

18 133 | 24 243 | Base case, preterm (<33 wGA), including recurrent wheezing treatment, societal | |||||

21 669 | 28 970 | Base case, for all preterm (<35 wGA, mix), including recurrent wheezing treatment | |||||

21 862 | 29 228 | Base case, preterm (33–35 wGA), including recurrent wheezing treatment | |||||

22 515 | 30 101 | Base case, BPD, including recurrent wheezing treatment | |||||

23 833 | 31 863 | Base case, preterm (<33 wGA), including recurrent wheezing treatment | |||||

24 392 | 32 611 | Base case, preterm (33–35 wGA) | |||||

24 654 | 32 961 | Base case, BPD | |||||

26 212 | 35 044 | Base case, for all preterm (<35 wGA, mix) | |||||

26 292 | 35 151 | Base case, preterm (<33 wGA) | |||||

Rietveld et al^{33} 2010 | Netherlands 2000 | 13 190 | 21 066 | Cost per HA | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (December) | Deterministic | Every mo, costs per HA were higher for children without BPD and children with higher gestational ages. Incremental costs per HA were always high. Passive immunization was always most cost-effective in December. A restrictive immunization policy requiring immunization of only children with BPD in high-risk months is therefore recommended. The costs of passive immunization would have to be considerably reduced to achieve cost-effectiveness. |

30 795 | 49 184 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (January) | |||||

31 055 | 49 599 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (November) | |||||

47 145 | 75 297 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (February) | |||||

105 120 | 167 892 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (March) | |||||

395 860 | 632 245 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (April) | |||||

833 695 | 1 331 529 | Male infant, preterm (<28 wGA), birth wt <2500 g, with BPD (October) | |||||

Roeckl-Wiedmann et al^{34} 2003 | Germany 2000 | 6639 | 10 011 | Cost per HA | Group A, preterm (<35 wGA)^{c} | Deterministic | Because of the findings of our cost-effectiveness analysis, we would recommend a restricted use of palivizumab prophylaxis in premature infants with CLD in their risk combination. The results of this cost-effectiveness analysis do not justify the widespread use of palivizumab among preterm infants. Palivizumab was most cost-effective among male infants with CLD who had siblings visiting day care groups and who were discharged between October and December. |

25 288 | 38 134 | Group B, preterm (<35 wGA), with risk factors^{c} | |||||

52 838 | 79 678 | Group C, preterm (<35 wGA), with risk factors^{c} | |||||

204 684 | 308 658 | Group D, preterm (<35 wGA), with risk factors^{c} | |||||

Salinas-Escudero et al^{36} 2012 | USD 2009 | 4539 | 5188 | Cost per QALY gained | Partial coverage, preterm (<29 wGA) | Deterministic; probabilistic | Palivizumab prophylaxis for preterm newborn patients born at ≤32 wk resulted in a cost-effective alternative. When evaluating the ICER per QALY and LYG against the USD $50 000 threshold, all age groups within the prophylaxis group are cost-effective. |

7294 | 8337 | Partial coverage, preterm (29–32 wGA) | |||||

17 532 | 20 038 | Full coverage, preterm (<29 wGA) | |||||

20 760 | 23 728 | Full coverage, preterm (29–32 wGA) | |||||

Sanchez-Luna et al^{37} 2017 | Spain 2016 | 11 550 | 17 792 | Cost per QALY gained | Subgroup A (payer)^{d} | Deterministic; probabilistic | Of 1000 Monte Carlo simulations, 85.7% of the cases presented an ICUR <€30 000 per QALY. Palivizumab is efficient for preventing RSV infections in preterm infants 32 1/7 to 35 0/7 wGA in Spain, including specific high-risk subgroups. |

14 177 | 21 839 | Subgroup B (payer)^{d} | |||||

17 153 | 26 424 | Base case (societal), preterm (32–35 wGA) | |||||

18 938 | 29 173 | Subgroup C (payer)^{d} | |||||

19 698 | 30 344 | Base case (payer), preterm (32–35 wGA) | |||||

Schmidt et al^{38} 2017 | Spain 2016 | 15 748 | 24 259 | Cost per QALY gained | Base case | Deterministic; probabilistic | PSA revealed that the probability of palivizumab prophylaxis being cost-effective at a €30 000-per-QALY threshold was 92.7%. The ICER remained below this threshold for most extreme-scenario analyses. Palivizumab prophylaxis was shown to be a cost-effective health care intervention according to the commonly accepted standards of cost-effectiveness in Spain (ICER below the threshold of €30 000 per QALY). |

Smart et al^{39}^{,}^{51} 2010 | CAD 2010 | 192 | 177 | Cost per QALY gained | Preterm (32–35 wGA), ≥4 risk factors | Deterministic; probabilistic | Palivizumab ICERs remained fairly stable from 2007 to 2010. The original recommendation stating that palivizumab is cost-effective in infants born between 32 and 35 wGA with ≥2 risk factors or in infants who are at a moderate to high risk on the basis of a risk-assessment model, does not change. |

5274 | 4859 | Preterm (32–35 wGA), risk-scoring tool, high risk (65–100 score) | |||||

20 814 | 19 175 | Base case, preterm (32–35 wGA), including asthma | |||||

26 701 | 24 598 | Preterm (32–35 wGA), 3 risk factors | |||||

31 360 | 28 890 | Base case, preterm (32–35 wGA), excluding asthma | |||||

34 438 | 31 726 | Preterm (32–35 wGA), risk-scoring tool, medium risk (49–64 score) | |||||

48 495 | 44 675 | Base case, preterm (32–35 wGA), mortality rate (1.2%) | |||||

50 434 | 46 462 | Base case, preterm (32–35 wGA), mortality rate (1.0%) | |||||

82 732 | 76 216 | Preterm (32–35 wGA), 2 risk factors | |||||

146 218 | 134 701 | Preterm (32–35 wGA), 1 risk factor | |||||

183 561 | 169 103 | Preterm (32–35 wGA), risk-scoring tool, low risk (0–48 score) | |||||

820 701 | 756 060 | Preterm (32–35 wGA), 0 risk factors (preterm only) | |||||

Tam et al^{40} 2009 | CAD 2007 | 334 | 325 | Cost per QALY gained | High risk area (defined as having hospitalization rates over 500/1000 live births) and <1 y | Deterministic; probabilistic | Palivizumab is a cost-effective option for the prevention of RSV for Inuit infants on Baffin Island, is highly cost-effective in Arctic infants <1 y of age specifically residing outside of Iqaluit, and is a dominant strategy for those <6 mo of age in remote areas. However, palivizumab is not cost-effective compared with no treatment of infants of all ages residing in Iqaluit. |

7822 | 7619 | Infants from Baffin Island <6 mo, societal | |||||

10 190 | 9926 | Infants from Baffin Island <6 mo | |||||

22 383 | 21 803 | Outside of Iqaluit (remote areas) <1 y, societal | |||||

24 750 | 24 109 | Outside of Iqaluit (remote areas) <1 y | |||||

37 070 | 36 110 | All infants from Baffin Island <1 y, societal | |||||

39 435 | 38 414 | All infants from Baffin Island <1 y | |||||

100 872 | 98 260 | Residing in Iqaluit <6 mo, societal | |||||

103 235 | 100 561 | Residing in Iqaluit <6 mo | |||||

149 782 | 145 903 | Residing in Iqaluit <1 y, societal | |||||

152 145 | 148 205 | Residing in Iqaluit <1 y | |||||

Dominant | Dominant | Infants in remote areas <6 mo | |||||

Dominant | Dominant | High-risk areas, <6 mo | |||||

Dominant | Dominant | High-risk areas, <1 y, societal | |||||

Dominant | Dominant | Infants in remote areas <6 mo, societal | |||||

Dominant | Dominant | High-risk areas, <6 mo, societal | |||||

Vogel et al^{41} 2002 | NZD 2000 | 28 700 | 28 265 | Cost per case averted | Preterm (32–35 wGA), with CLD, discharged from the hospital on oxygen | Deterministic | If value is placed on preventing morbidity, the priority groups for palivizumab prophylaxis are preterm infants discharged from the hospital on oxygen followed by preterm infants of ≤28 wk gestation. |

32 000 | 31 515 | Preterm (≤28 wGA), no CLD | |||||

60 000 | 59 091 | Total cohort, preterm (32–35 wGA), with CLD, societal | |||||

65 000 | 64 016 | Preterm (≤28 wGA), with CLD | |||||

98 000 | 96 516 | Preterm (29–31 wGA), no CLD | |||||

166 700 | 164 176 | Preterm (29–31 wGA), with CLD | |||||

Wang et al^{14} 2008 | GBP 2006 | 51 800 | 90 261 | Cost per HA | Preterm infants (<35 wGA) and children without CLD | Deterministic | According to this model, prophylaxis with palivizumab is not a cost-effective strategy for preterm infants and children with CHD compared with no prophylaxis from both an NHS perspective and a societal perspective. These findings are robust to probabilistic and other sensitivity analyses. Prophylaxis with palivizumab is also not a cost-effective strategy for preterm infants or infants with CLD who have no other risk factors. Subgroup analyses revealed that prophylaxis with palivizumab for children with CLD may be cost-effective at a willingness-to-pay threshold of £30 000 per QALY. |

63 800 | 111 171 | Cost per QALY gained | Preterm infants (<35 wGA) and children with CLD | ||||

66 900 | 116 573 | Preterm infants (<35 wGA) and children with CLD (societal) | |||||

67 600 | 117 792 | Cost per HA | Preterm infants (<35 wGA) and children with CLD | ||||

78 600 | 136 960 | CHD | |||||

79 800 | 139 051 | Cost per QALY gained | CHD | ||||

83 200 | 144 975 | CHD (societal) | |||||

454 100 | 791 265 | Preterm infants (<35 wGA) and children without CLD | |||||

475 600 | 828 728 | Preterm infants (<35 wGA) and children without CLD (societal) | |||||

Weiner et al^{42} 2012 | USD 2010 | 16 037 | 18 041 | Cost per QALY gained | Base-case group 2, preterm (32–34 wGA), with risk factors^{e} | Deterministic; probabilistic | Palivizumab, when dosed consistently with the FDA-approved labeling, was either cost saving or cost-effective among current guideline-eligible infants in the Medicaid population. Palivizumab did not reveal cost-effectiveness in infants of 32–35 wGA with ≤1 risk factor. |

38 244 | 43 023 | Base-case group 3, preterm (32–35 wGA), with risk factors^{e} | |||||

281 892 | 317 115 | Base-case group 4, preterm (32–35 wGA), with risk factors^{e} | |||||

Dominant | Dominant | Base-case group 1, preterm (<32 wGA)^{e} | |||||

Yount and Mahle^{43} 2004 | USD 2002 | 114 337 | 155 708 | Cost per QALY gained | Base case, term, CHD | Deterministic | The cost of palivizumab prophylaxis was high relative to benefits realized. Given the large No. CHD patients who might be considered candidates for RSV prophylaxis (>6000 patients per y in the United States), routine use of palivizumab in young children with CHD needs to be evaluated further. |

CAD, Canadian dollar; CF, Cystic fibrosis; FDA, Food and Drug Administration; GBP, Great Britain pound; ICUR, Incremental cost-utility ratio; NR, not reported; NWT, Northwest Territories; NZD, New Zealand dollar; PSA, Probabilistic sensitivity analysis; SEK, Swedish krona; —, not applicable.

a

Scenario A^{24}: universal palivizumab prophylaxis for all healthy term infants who were <6 mo of age as of January 1, 2009, was compared with no prophylaxis; Scenario B: palivizumab prophylaxis for infants up to 5 mo of age only (for 6 mo of protection) was compared with no prophylaxis.

b

Group 1^{52}: <32 wGA and <6 mo chronological age; group 2: 32–34 wGA and ≤3 mo chronological age, with 2009 AAP risk factors; group 3: 32–35 wGA and ≤6 mo chronological age, with 2006 AAP risk factors; group 4: 32–35 wGA and ≤6 mo chronological age, with ≤1 risk factor.

c

Group A^{34}: Male infants, siblings in day care, discharged between October and December, CLD; group B: male infants, siblings in day care, discharged between October and December; group C: male infants, siblings in day care; group D: male infants.

d

Subgroup A: preterm (32–35 wGA), with risk factors (2 major, 2 minor); Subgroup B: preterm (32–35 wGA), with risk factors (2 major, 1 minor); Subgroup C: preterm (32–35 wGA), with risk factors (2 major risk factors)

e

Base-case group 1^{42}: <32 wGA and ≤6 mo chronological age; base-case group 2: 32–34 wGA and ≤3 mo chronological age, with 2009 AAP risk factors (ie, having siblings <5 y of age and/or attending day care); base-case group 3: 32–35 wGA and ≤6 mo chronological age, with 2006 AAP risk factors (any 2 of the following: exposure to environmental air pollutants, congenital abnormalities of the airways, severe neuromuscular disease, school-aged siblings, and day care attendance); base-case group 4: 32–35 wGA and ≤6 mo chronological age, with ≤1 risk factor.

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