BACKGROUND: In middle-income countries, access to biological therapy is limited in ulcerative colitis in terms of the number of patients and the length of therapy. Because of their cost advantages, biosimilars have the potential to improve access to therapy, but physicians have concerns toward their use because of the lack of evidence from randomized clinical trials. OBJECTIVES: To explore the preferences of gastroenterologists for biosimilar drugs in ulcerative colitis as well as to compare our results with results of previous studies on gastroenterologists' preferences toward biosimilars. METHODS: A discrete choice experiment was carried out involving 51 Hungarian gastroenterologists treating patients with inflammatory bowel disease in May 2014 with the following attributes: type of treatment (biosimilar/originator), severity of disease, availability of continuous medicine supply, and the stopping rule (whether the treatment is covered after 12 months). A conditional logit model was used to estimate the probabilities of choosing a given profile. RESULTS: According to the results, the stopping rule was the most important attribute. The type of treatment mattered only for patients already on biologicals. The probabilities of choosing the biosimilar option with all the benefits offered in the discrete choice experiment over the originator option under the present reimbursement conditions are 85% for new patients and 63% for patients already treated. CONCLUSIONS: Most gastroenterologists have concerns about using biosimilars. They, however, are willing to consider the use of biosimilars if they could reallocate the potential savings to provide their patients better access to biological treatment.
- MeSH
- biosimilární léčivé přípravky terapeutické užití MeSH
- Crohnova nemoc MeSH
- gastroenterologové * MeSH
- gastrointestinální látky MeSH
- idiopatické střevní záněty MeSH
- infliximab MeSH
- lékařská praxe - způsoby provádění * MeSH
- lidé MeSH
- monoklonální protilátky MeSH
- ulcerózní kolitida farmakoterapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Maďarsko MeSH
OBJECTIVE: To explore preferences of gastroenterologists for biosimilar drugs in Crohn's disease. MATERIAL AND METHODS: Discrete choice experiment was carried out involving 51 Hungarian gastroenterologists in May 2014. The following attributes were used to describe hypothetical choice sets: 1) type of the treatment (biosimilar/originator), 2) severity of disease, 3) availability of continuous medicine supply, 4) frequency of the efficacy check-ups. Multinomial logit model was used to differentiate between three attitude types: 1) always opting for the originator, 2) willing to consider biosimilar for biological-naïve patients only, 3) willing to consider biosimilar treatment for both types of patients. Conditional logit model was used to estimate the probabilities of choosing a given profile. RESULTS: Men, senior consultants, working in inflammatory bowel disease center and treating more patients were more likely willing to consider biosimilar for biological-naïve patients only. Treatment type (originator/biosimilar) was the most important determinant of choice for patients already treated with biologicals, and the availability of continuous medicine supply in case of biological-naïve patients. The probabilities of choosing the biosimilar with all the benefits offered over the originator under current reimbursement conditions are 89% versus 11% for new patients, and 44% versus 56% for patients already treated with biological. CONCLUSIONS: For gastroenterologist, the continuous medical supply would be one of the major benefits of biosimilars. However, benefits offered in the scenarios do not compensate for the change from the originator to the biosimilar treatment of patients already treated with biologicals.
- MeSH
- biosimilární léčivé přípravky ekonomika terapeutické užití MeSH
- Crohnova nemoc farmakoterapie ekonomika MeSH
- dospělí MeSH
- infliximab ekonomika terapeutické užití MeSH
- lékaři MeSH
- lékařská praxe - způsoby provádění statistika a číselné údaje MeSH
- lidé středního věku MeSH
- lidé MeSH
- monoklonální protilátky ekonomika terapeutické užití MeSH
- průzkumy a dotazníky MeSH
- senioři MeSH
- výběrové chování * MeSH
- zdraví - znalosti, postoje, praxe * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Maďarsko MeSH
INTRODUCTION: CT-P13 is the first biosimilar to infliximab that has been approved for the same indications as its originator infliximab. No data are available on the effect of infliximab biosimilar on mucosal healing. The aim of this study was to evaluate the efficacy of CT-P13 induction therapy on mucosal healing in patients with ulcerative colitis [UC]. PATIENTS AND METHODS: UC patients, who received CT-P13 therapy from its local introduction at three Hungarian and one Czech inflammatory bowel disease centres, were prospectively enrolled. Sigmoidoscopy was performed after the end of the induction therapy at week 14. Mucosal healing was defined as Mayo endoscopic subscore 0 or 1. Complete mucosal healing was defined as Mayo endoscopic subscore 0. Trough level of CT-P13 was measured at week 14. RESULTS: Sixty-three UC patients who underwent CT-P13 induction therapy were enrolled in the study. Indication for the therapy was acute, severe flare up and chronic, refractory activity in 24 and 39 patients, respectively. Cumulative clinical response and steroid-free remission at week 14 were achieved in 82.5% and 47.6% of the patients, respectively. Sigmoidoscopy revealed steroid-free mucosal healing in 47.6% of the patients, and complete mucosal healing was present in 27%. Mayo endoscopic subscore decreased significantly at week 14 compared to baseline. Trough levels of infliximab correlated with mucosal healing. CONCLUSION: This is, to our knowledge, the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. The results indicate that mucosal healing is achieved in two-thirds of UC patients by the end of the induction treatment with CT-P13.
- MeSH
- biosimilární léčivé přípravky terapeutické užití MeSH
- dospělí MeSH
- gastrointestinální látky terapeutické užití MeSH
- infliximab terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- monoklonální protilátky terapeutické užití MeSH
- prospektivní studie MeSH
- senioři MeSH
- střevní sliznice patologie MeSH
- ulcerózní kolitida farmakoterapie patologie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH