TABLE 2

Study Outcomes

Author, yCountry or Original Currency, yICER (Original)ICER (Adjusted), 2017 USDOutcome MeasureResults (Context)Type of Sensitivity AnalysisStudy Conclusions
Banerji et al24 2016 CAD 2011 4633 4073 Cost per HA Scenario B, Nunavut without Iqaluita 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, Nunavuta
15 601 13 716  Scenario B, Nunavika
22 954 20 180  Scenario A, Kivalliq regiona
28 580 25 126  Scenario A, Nunavut without Iqaluita
30 230 26 577  Scenario A, Nunavika
41 404 36 401  Scenario A, Nunavuta
105 259 92 539  Scenario B, Qikiqtaaluk region without Iqaluita
133 407 117 286  Scenario B, Qikiqtaaluk regiona
166 600 146 468  Scenario A, Qikiqtaaluk region without Iqaluita
211 444 185 893  Scenario A, Qikiqtaaluk regiona
326 441 286 993  Scenario B, NWTa
545 115 479 242  Scenario A, NWTa
Dominant Dominant  Scenario A, Kitikmeot regiona
Dominant Dominant  Scenario B, Kitikmeot regiona
Dominant Dominant  Scenario B, Kivalliq regiona
Bentley et al35 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 al46 2018 Netherlands 2015 214 748 272 654 Cost per QALY gained Preterm (32–35 wGA) Deterministic; probabilistic —
Chirico et al47 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 al44 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 al48 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 al49 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 al50 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 al45 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 al52 2012 USD 2010 44 774 50 369 Cost per QALY gained Group 2, preterm (32–35 wGA) with risk factorsb 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 factorsb
464 476 522 514  Group 4, preterm (32–35 wGA) with risk factorsb
Dominant Dominant  Group 1, preterm (<32 wGA)b
McGirr et al25 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 al26 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 al30 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 al29 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 Wittenberg28 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 al27 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 al31,32 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 al33 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 al34 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 factorsc
52 838 79 678  Group C, preterm (<35 wGA), with risk factorsc
204 684 308 658  Group D, preterm (<35 wGA), with risk factorsc
Salinas-Escudero et al36 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 al37 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 al38 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 al39,51 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 al40 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 al41 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 al14 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 al42 2012 USD 2010 16 037 18 041 Cost per QALY gained Base-case group 2, preterm (32–34 wGA), with risk factorse 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 factorse 281 892 317 115 Base-case group 4, preterm (32–35 wGA), with risk factorse Dominant Dominant Base-case group 1, preterm (<32 wGA)e Yount and Mahle43 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, yCountry or Original Currency, yICER (Original)ICER (Adjusted), 2017 USDOutcome MeasureResults (Context)Type of Sensitivity AnalysisStudy Conclusions Banerji et al24 2016 CAD 2011 4633 4073 Cost per HA Scenario B, Nunavut without Iqaluita 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, Nunavuta 15 601 13 716 Scenario B, Nunavika 22 954 20 180 Scenario A, Kivalliq regiona 28 580 25 126 Scenario A, Nunavut without Iqaluita 30 230 26 577 Scenario A, Nunavika 41 404 36 401 Scenario A, Nunavuta 105 259 92 539 Scenario B, Qikiqtaaluk region without Iqaluita 133 407 117 286 Scenario B, Qikiqtaaluk regiona 166 600 146 468 Scenario A, Qikiqtaaluk region without Iqaluita 211 444 185 893 Scenario A, Qikiqtaaluk regiona 326 441 286 993 Scenario B, NWTa 545 115 479 242 Scenario A, NWTa Dominant Dominant Scenario A, Kitikmeot regiona Dominant Dominant Scenario B, Kitikmeot regiona Dominant Dominant Scenario B, Kivalliq regiona Bentley et al35 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 al46 2018 Netherlands 2015 214 748 272 654 Cost per QALY gained Preterm (32–35 wGA) Deterministic; probabilistic — Chirico et al47 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 al44 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 al48 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 al49 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 al50 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 al45 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 al52 2012 USD 2010 44 774 50 369 Cost per QALY gained Group 2, preterm (32–35 wGA) with risk factorsb 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 factorsb 464 476 522 514 Group 4, preterm (32–35 wGA) with risk factorsb Dominant Dominant Group 1, preterm (<32 wGA)b McGirr et al25 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 al26 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 al30 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 al29 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 Wittenberg28 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 al27 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 al31,32 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 al33 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 al34 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 factorsc 52 838 79 678 Group C, preterm (<35 wGA), with risk factorsc 204 684 308 658 Group D, preterm (<35 wGA), with risk factorsc Salinas-Escudero et al36 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 al37 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 al38 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 al39,51 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 al40 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 al41 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 al14 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 al42 2012 USD 2010 16 037 18 041 Cost per QALY gained Base-case group 2, preterm (32–34 wGA), with risk factorse 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 factorse
281 892 317 115  Base-case group 4, preterm (32–35 wGA), with risk factorse
Dominant Dominant  Base-case group 1, preterm (<32 wGA)e
Yount and Mahle43 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 A24: 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 152: <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 A34: 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 142: <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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