Table 1.
Economic evaluations (EEs) included in the systematic literature review
EE | Interventions studied | Type of analysis and results | EE conclusion | |||
---|---|---|---|---|---|---|
Fidaxomicin | Vancomycin | Metronidazole | FMT | |||
Alowayesh 2012 [36] Abstract USA |
✓ | ✓ | CEA Fidaxomicin did not dominate |
Vancomycin is the preferred choice as it is less costly and only slightly less effective Fidaxomicin cure rates would have to be 97% for it to be preferred |
||
Bartsch 2013 [37] Full publication USA |
✓a | ✓b | ✓c | CUA ‘No fidaxomicin’ is the dominant strategy based on a cost-effectiveness threshold of US$50,000/QALY Fidaxomicin was the optimal strategy if the cost of one course was <US$496 and NAP1/B1/027 probability <48% Fidaxomicin based on strain typing, >US$43.7 million/QALY |
Fidaxomicin is not a cost-effective treatment option in the current epidemiologic CDI conditions, unless its cost is reduced to ≤US$150 for all CDI cases or US$160–US$400 for patients with a non-NAP1/B1/027 strain | |
Bott 2012 [39] Abstract North America |
✓ | ✓ | CEA Vancomycin dominated fidaxomicin Fidaxomicin becomes more cost-effective if >25.7 days spent in hospital for relapse or if cure rate for vancomycin falls below 75.6% |
Fidaxomicin was not cost-effective compared with vancomycin Fidaxomicin may be cost-effective in older patients, those with comorbidities, recurrent CDI or a high risk of relapse |
||
Brodszky 2014 [40] Poster Hungary |
✓ | ✓ | CEA Cost per recurrence avoided with fidaxomicin: €5489 Chance of fidaxomicin being cost-effective 95% if the WTP threshold ≥€7000 |
Cost per recurrence avoided with fidaxomicin: €5489 | ||
Gallagher 2015 [42] Full publication USA |
✓ | ✓ | CEA ICER not reported |
Reduced recurrence rate led to overall savings of US$3047 per patient treated with fidaxomicin | ||
Heimann 2014 [43] Poster Germany |
✓ | ✓ | CEA ICER not reported |
Fidaxomicin is cost-effective for CDAD treatment in patients at high risk of recurrence, such as patients with cancer | ||
Karkow 2015 [44] Poster USA |
✓ | ✓ | CEA FMT unavailable for recurrent episodes Vancomycin dominant FMT available for recurrent episodes Vancomycin dominant |
Vancomycin was cost-effective compared with metronidazole for the treatment of initial episodes of mild-to-moderate CDI regardless of FMT availability | ||
Konijeti 2014 [46]; {Konijeti 2013 [45]} Full publication; {abstract} USA |
✓ | ✓ | ✓ | ✓ | CUA Fidaxomicin vs. vancomycin US$184,023/QALY Metronidazole vs. vancomycin Vancomycin dominant FMT via colonoscopy vs. vancomycin US$17,016 Fidaxomicin or metronidazole vs. FMT via colonoscopy FMT via colonoscopy dominant |
FMT via colonoscopy was the most cost-effective strategy In settings where FMT was not available, vancomycin was the most cost-effective treatment when compared with fidaxomicin and metronidazole |
Lamotte 2013 [47] Poster Belgium |
✓ | ✓ | ✓ | CUA Fidaxomicin dominated vancomycin and metronidazole in overall population, in those with severe CDI and in those with a first recurrence Based on cost-effectiveness threshold of €30,000/QALY, cost-effectiveness acceptable in 80% of all CDI cases |
Fidaxomicin was dominant compared to vancomycin and metronidazole, generating additional QALYs with cost-savings in all CDI patients, and in subgroups of severe CDI and first recurrence CDI patients | |
Lapointe-Shaw 2016 [48] Full publication Canada |
✓d | ✓d | ✓d | ✓e | CUA FMT via colonoscopy vs. other treatments FMT via colonoscopy dominant Fidaxomicin vs. metronidazole Fidaxomicin cost-effective (CAN$25,968/QALY) based on WTP threshold of CAN$50,000/QALY Fidaxomicin vs. vancomycin Fidaxomicin dominant |
FMT via colonoscopy was the most cost-effective strategy and dominated all other treatment strategies In settings where FMT was not available, fidaxomicin was cost-effective vs. metronidazole and vancomycin |
Madkour 2012 [49] Abstract USA |
✓ | ✓ | ✓ | CEA Vancomycin dominant vs. metronidazole Vancomycin cost-effective probability if WTP threshold US$0/additional cure, 40% Fidaxomicin more cost-effective if WTP threshold >US$22,000/additional cure |
Vancomycin is the most cost-effective treatment for CDAD if WTP threshold ≤ US$22,000/additional cure; fidaxomicin is cost-effective over this WTP threshold | |
Marković 2014 [50] Full publication Serbia |
✓ | ✓ | CEA Fidaxomicin Cost/LYS = 2,977,621.51 RSD/LYS (SD 29,733.10) [95% CI 2,947,888.41–3,000,354.62] Cost-effective based on threshold of 53,307,040.00 RSD/LYS Cost per colectomy avoided = 10,175,146.97 RSD (SD 101,310.61) [95% CI 10,073,536.36–10,276,757.50] |
For the treatment of CDIC, fidaxomicin appeared cost-effective compared with vancomycin based on life-years saved, but not based on avoided colectomies | ||
Massachi 2014 [51] Poster USA |
✓ | ✓ | ✓ | ✓ | CUA Mild-to-moderate CDI FMT dominant FMT favoured to fidaxomicin if: FMT cost <US$4515 Cure rate: FMT >0.883; fidaxomicin <0.955 Recurrence rate: FMT <0.185; fidaxomicin >0.02 When FMT unavailable: fidaxomicin vs. metronidazole US$4636/QALY; vancomycin dominated Severe CDI FMT dominant FMT favoured to vancomycin if: FMT cost <US$4860 Cure rate: FMT >0.79 Recurrence rate: FMT <0.36 When FMT unavailable: vancomycin dominant |
FMT is the most cost-effective treatment option for mild-to-moderate, or severe CDI Fidaxomicin is the best alternative to FMT in mild-to-moderate CDI, and vancomycin is the best alternative to FMT in severe CDI |
Nathwani 2014 [26]; {McCrea 2014 [52]} Full publication; {poster} UK |
✓ | ✓ | CUA At WTP thresholds of £20,000 and £30,000/QALY, fidaxomicin was cost-effective vs. vancomycin in severe CDI (£16,529/QALY) and dominated vancomycin for first recurrence The probability that fidaxomicin was cost-effective at a WTP threshold of £30,000/QALY was 60% for severe CDI and 68% in a first recurrence |
Fidaxomicin is cost-effective in patients with severe CDI and in patients with a first CDI recurrence vs. vancomycin | ||
Patel 2014 [54] Abstract USA |
✓ | ✓ | ✓ | ✓ | CUA First recurrence FMT most cost-effective, US$1819/QALY (based on ICER threshold of US$5000) Metronidazole second choice provided FMT cure rate >82% Second recurrence FMT most cost-effective, provided FMT cure rate >50% |
FMT was the most cost-effective treatment strategy for recurrent CDI |
Perras 2011 [55] CADTH report Canada |
✓ | ✓ | CEA Vancomycin CAN$1161/clinical cure Pre-NAP1 epidemic CAN$946/clinical cure NAP1 strain CAN$2,413/clinical cure |
Vancomycin is cost-effective compared with metronidazole for the treatment of moderate to severe CDI, although the incremental cost is likely to increase as more virulent strains appear | ||
Petryszyn 2014 [56] Abstract Poland |
✓ | ✓ | CUA Fidaxomicin dominated vancomycin |
Fidaxomicin resulted in more QALYs at lower costs for treating patients with severe CDI in Poland, so was considered cost-effective | ||
Planche 2014 [57]; Nesnas 2014 [53] Abstractf; abstract UK |
✓ | ✓ | ✓ | CEA Cost associated with fidaxomicin was £9469/case prevented |
Acquisition cost of fidaxomicin justified by savings from reduced recurrence | |
Rubio-Terrés 2015 [58]; {Cobo Reinoso 2014 [41]} Full publication; {poster} Spain |
✓ | ✓ | CUA Fidaxomicin dominated vancomycin in all subgroups |
When fidaxomicin is compared to vancomycin in CDI patients with cancer, treated with concomitant antibiotic therapy or with renal impairment, the use of fidaxomicin would be expected to result in increased QALYs for patients and reduced overall costs | ||
Singh 2014 [59] Abstract USA |
✓ | ✓g | ✓ | ✓h | CEA Metronidazole cost-effective FMT via colonoscopy cost-effective All other interventions were dominated |
Only metronidazole and FMT via colonoscopy were cost-effective strategies for the treatment of primary CDI in patients in the ICU |
Stranges 2013 [28] Full publication USA |
✓ | ✓ | CUA Fidaxomicin US$67,576/QALY Outpatient US$38,571/QALY Inpatient US$75,111/QALY Mild-to-moderate CDI US$32,020/QALY Severe CDI US$352,994/QALY NAP1/B1/027 strains Dominated Concomitant AMT US$1487/QALY Metronidazole in mild-to-moderate CDI US$40,513/QALY WTP threshold = US$100,000/QALY |
Fidaxomicin was cost-effective in most scenarios compared with vancomycin for treatment of CDI based on a WTP threshold of US$100,000/QALY, and was shown to be robust in sensitivity analyses | ||
Trevor 2015 [61]; {Trevor 2014 [60]} Poster; poster France |
✓ | ✓ | CUA WTP threshold = €50,000/QALY All patients Fidaxomicin cost-effective (€24,242/QALY) The cost per recurrence avoided = €1877 Cost per faecal transplant avoided = €8967 Subgroups Fidaxomicin cost-effective in all subgroups (severe CDI, first CDI recurrence, cancer, elderly, renal failure) except those using concomitant antibiotics |
Fidaxomicin represents both a clinically effective and cost-effective treatment for patients with CDI | ||
van Engen 2015 [62]; {van Engen 2013 [63]} Full publication; {poster} Ireland |
✓ | ✓ | ✓ | CUA All patients Fidaxomicin dominated vancomycin and/or metronidazole At a WTP threshold of €45,000/QALY, the probability of fidaxomicin being cost-effective was 82% Subgroups Fidaxomicin dominated in all subgroups (non-severe CDI, severe CDI and CDI recurrence) |
Fidaxomicin was dominant to the current standard-of-care therapy for CDI | |
van Engen 2014 [64] Poster Sweden |
✓ | ✓ | CUA Fidaxomicin was cost-effective vs. vancomycin in severe CDI: (€9,072/QALY) and dominated vancomycin in severe recurrent CDI |
First-line administration of fidaxomicin in severe CDI and severe recurrent CDI has the potential to improve patient outcomes as well as reduce the healthcare costs associated with CDI in Sweden | ||
Varier 2014 [65]; {Biltaji 2014 [38]} Full publication; {poster} USA |
✓ | ✓ | ✓ | CUA FMT vs. metronidazole US$124,964/QALY FMT vs. vancomycin FMT dominant At a WTP threshold of US$100,000/QALY, metronidazole was favoured in ~55% of model iterations and FMT in 38% |
FMT and vancomycin are more effective than metronidazole, but are also more costly FMT is only considered cost-effective with a high WTP threshold |
|
Wagner 2014 [29] Full publication Canada |
✓ | ✓ | CEA Fidaxomicin CAN$13,202/recurrence avoided First recurrence of CDI at CEA entry CAN$18,190/second recurrence avoided Non-NAP1/B1/027 CDI strains ≥CAN$10,504/recurrence avoided NAP1/B1/027 CDI strains ≤CAN$83,295/recurrence avoided |
Fidaxomicin is more costly for the Canadian healthcare system compared with vancomycin, and clinical benefits depend on the proportion of patients with the NAP1/B1/027 CDI strain | ||
Watt 2016 [27]; {Watt 2015 [66]} Full publication; {poster} Germany |
✓ | ✓ | CUA WTP threshold = €50,000/QALY ≥1 recurrence Fidaxomicin cost-effective Severe CDI Fidaxomicin cost-effective Concomitant antibiotics Fidaxomicin cost-effective ≥65 years Fidaxomicin cost-effective Renal impairment Fidaxomicin cost-effective Cancer Fidaxomicin dominant |
In patient subgroups with CDI at increased recurrence risk, fidaxomicin was cost-effective vs. vancomycin, and less costly and more effective in patients with cancer |
Citations in curly brackets are posters or abstracts that have subsequently been published in full
AMT anti-microbial treatment, CADTH Canadian Agency for Drugs and Technologies in Health, CDAD Clostridium difficile-associated diarrhoea, CDI Clostridium difficile infection, CDIC Clostridium difficile-induced colitis, CEA cost-effectiveness analysis, CUA cost-utility analysis, FMT faecal microbiota transplant, ICER incremental cost-effectiveness ratio, LYS life-years saved, QALY quality-adjusted life-year, RSD Republic of Serbia dinars, SD standard deviation, WTP willingness to pay
aTwo treatment arms: fidaxomicin, or fidaxomicin based on strain typing results
bVancomycin given in ‘no fidaxomicin’ treatment arm if CDI severe or ‘fidaxomicin based on strain typing’ arm if positive for NAP1/B1/027 and CDI severe
cMetronidazole given in ‘no fidaxomicin’ treatment arm if CDI non-severe or in ‘fidaxomicin based on strain typing’ arm if positive for NAP1/B1/027 and CDI non-severe
dFollowed by 6-week taper pulse course of vancomycin for subsequent recurrences
eThree treatment arms: vancomycin plus FMT via enema; vancomycin plus FMT via nasogastric tube; vancomycin plus FMT via colonoscopy
fOral presentation, press release, and financial analysis also available from Astellas for Planche 2014 [57]
gTwo treatment arms: high-dose vancomycin or low-dose vancomycin
hTwo treatment arms: FMT via colonoscopy or FMT via nasogastric tube