Clostridium difficile infection (CDI), a serious illness resulting from infection of the internal lining of the colon by Clostridium difficile bacteria is estimated to cost the ?3 billion (Euro) per year. Specialists expect that CDI will almost double over the next four decades.[1]
The bacteria produce toxins that cause inflammation of the colon, diarrhea and, in some cases, death.[18] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing Clostridium difficile (C. difficile) bacteria to flourish.[19] The infection is the leading cause of hospital acquired (nosocomial) diarrhea in industrialised countries[20] and the risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.[21] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.[14],[15],[16] ESCMID, the European Society of Microbiology and Infectious Diseases, has identified recurrence as being the most important problem in the treatment of CDI.[22]
Infections with Clostridium difficile are very common in cancer patients, leading to substantial morbidity and increased health care costs.
…this is a huge economic and societal burden and causes additional and unnecessary suffering to already sick patients so there is clearly more that needs to be done to improve patient care and management…
Now new data presented at ICAAC, the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, being held September 5 – 9, 2014, Washington DC, USA, shows that overall treatment costs for cancer patients with clostridium difficile infection (CDI), based on a decision tree analyst, are lower with fidaxomicin (Dificid?; Cubist Pharmaceuticals/Dificlir?; Astellas Pharma Europe Ltd.), a macrolide antibacterial drug indicated in adults ?18 years of age for treatment of C.difficile-associated diarrhea, compared to the current standard of care with vancomycin(Vancocin?; ViroPharma), resulting in a potential cost saving of ?5,600 per patient.[2]
Generally, patients who have received chemotherapy and those with solid tumors can be particularly susceptible to CDI due to their long hospital stays and exposure to many antibiotics and chemotherapeutic agents.[3] These patients are also prone to recurrent episodes of CDI.[4]
Treatment related costs
The pharmacoeconomic model combined data from a study exploring the resolution of CDI in cancer patients treated with either fidaxomicin or vancomcyin[2][4] and a recent cost-of-illness analysis on CDI conducted at the University Hospital of Cologne.[2][5] The analysis explored direct cost parameters including drug costs, treatment on the general ward and intensive care unit as well as microbiological diagnostics for clostridium difficile.[2] Mean overall treatment costs per patient treated with fidaxomicin and vancomycin were ?22,200 vs ?27,800.[2] The lower costs associated with fidaxomicin are primarily due to the significantly lower rate of recurrence in patients treated with fidaxomicin compared to vancomycin.[2][4]
A vulnerable population
“Patients with cancer represent a vulnerable population who are at high risk of CDI, often resulting from their compromised immune system. CDI can be a devastating addition for patients who are already battling pre-existing conditions. We have already seen the superior reductions in CDI recurrence with fidaxomicin so we are pleased to see it also clearly demonstrating cost effectiveness” said Sebastian Heimann, health economist at the University Hospital of Cologne, Germany and lead investigator of the study.
The cost effectiveness of fidaxomicin has also been clearly demonstrated in a first of its kind study conducted recently at St George’s Hospital in London.[6] The study looked at a year’s experience using fidaxomicin as a first-line treatment for all adults confirmed to have CDI, including populations not previously studied in randomised controlled Phase III trials.[6],[7]
Treatment with fidaxomicin led to a reduction in recurrence for patients with CDI and a saving of over ?48,000 in the financial year to the UK’s NHS versus standard of care treatment (vancomycin or metronidazole).[8]
In other data presented at ICAAC, physician perceptions of the burden of CDI and the negative health impact of recurrent infection were assessed.[9] Nearly all of the 1,567 healthcare professionals surveyed accept that a recurrence of CDI would have a medium or strong impact on patient health in particular immunocompromised patients and those with a severe underlying disease.[9] Despite this, the majority (60%) do not very often consider this impact in their treatment decisions.[9]
Increasing prevalence
Additionally, only 26% of respondents in this survey always request a laboratory test for patients presenting with unexplained diarrhea that is not clearly attributable to an underlying condition or therapy,[9] despite recent epidemiological data suggesting the incidence of CDI is increasing in Europe.[10] Interestingly, physicians believed 25% of clinically-significant CDI cases remain undiagnosed in a hospital setting increasing to as much as 45% in the community.[9] This is supported by a recent epidemiological study which revealed that as many as 39,000 cases of CDI may be missed each year in Europe.[10]
“There is a growing body of evidence that supports the increasing prevalence of CDI in Europe yet there is still a significant lack of clinical suspicion and standardization of laboratory testing, meaning cases may be being missed” comments Professor Oliver Cornely, University Hospital Cologne, Germany. “CDI is a huge economic and societal burden and causes additional and unnecessary suffering to already sick patients so there is clearly more that needs to be done to improve patient care and CDI management.”
CDI is one of the most common causes of antibiotic-associated diarrhoea and severe cases can lead to bowel surgery and even death.[11] Hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[12],[13] Recurrence is a major challenge in CDI treatment, 25% of CDI patients suffer a recurrence within one month[14],[15],[16]and patients who have already had one recurrence have a 40% risk of a further episode of CDI.[17]
For more information:
[1] Kuijper EJ et al. ESCMID study group for Clostridium difficile. Emergence of Clostridium difficile associated disease in North America and Europe. Clin Microbiol Infect. 2006;12:2-18.
[2] Heimann SM et al. Pharmacoeconomical Decision-Tree Analysis of Clostridium difficile-associated Diarrhea in Patients with Cancer Treated with Fidaxomicin or Vancomycin. Presented at ICAAC 2014.
[3] Chopra T, et al. Clostridium difficile Infection in Cancer Patients and Hematopoietic Stem Cell Transplant Recipients. Expert Rev Anti Infect Ther. 2010;8(10):1113-1119.
[4]. Cornely OA et al. Resolution of Clostridium difficile-Associated Diarrhea in Patients With Cancer Treated With Fidaxomicin or Vancomycin. J Clin Oncol 2013;31: 2493-9.
[5]. Heimann SM et al. Clostridium Difficile Associated Diarrhea: A Comprehensive Cost-of-Illness Analysis of Inpatient Cases. PO789 Presented at ECCMID 2014.
[6]. Planche T, et al. Cost-effectiveness of fidaxomicin as first-line treatment for Clostridium difficile infection. Oral presentation O256 Presented at ECCMID 2014.
[7]. Cornely OA, et al. Fidaxomicin versus vancomycin for infection with C
lostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Diseases. 2012:12;281-289.
[8]. Astellas Data on File DIF14036UK.
[9]. Bradshaw, D. et al. Physician perceptions of the burden of Clostridium difficile infection in Europe and the impact of recurrence. Presented at ICAAC 2014.
[10]. Davies KA, et al. Second report from the EUropean, multi-centre, prospective bi-annual point prevalence study of CLostridium difficile Infection in hospitalised patients with Diarrhoea (EUCLID) PO753. Presented at ECCMID 2014.
[11]. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.
[12]. Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.
[13] Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect Dis. 2013;56:1108-16.
[14] Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. N Engl J Med. 2010;362;3:197-205.
[15] Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4.
[16] Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422-31.
[17]. Kelly CP, LaMont JT. Clostridium difficile – more difficult than ever. N Engl J Med. 2008;359(18):1932?1940.
[18]. Poutanen SM, et al. Clostridium difficile-associated diarrhoea in adults. CMAJ. 2004;171:51-8.
[19]. Kelly CP, et al. Clostridium difficile infection. Ann Rev Med. 1998;49:375-390.
[20]. Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Micro Infect. 2009;15:1053-1066.
[21]. Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005;40:1591-7.
[22]. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009;15:1067-79.
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