Copyright
©The Author(s) 2017.
World J Gastroenterol. Sep 14, 2017; 23(34): 6294-6305
Published online Sep 14, 2017. doi: 10.3748/wjg.v23.i34.6294
Published online Sep 14, 2017. doi: 10.3748/wjg.v23.i34.6294
Table 1 Clinical and reimbursement guidelines
Country | Guideline | Source, organization, last update, web-link |
The Czech Republic | Clinical | Bortlík et al[25] 2016 by IBD Working Group of the Czech Society of Gastroenterology |
Reimbursement | Reimbursement criteria of the SUKL1; Edited by: SUKL, http://www.sukl.cz | |
France | Clinical | ECCO guidelines, Crohn's Disease Guidelines (2010), Check list ANTI TNF, Check list VEDOLIZUMAB by GETAID2https://www.getaid.org/recommandations.html |
Reimbursement | No | |
Germany | Clinical | German Guidelines on Crohn’s disease; DGVS German Society of Gastroenterology (2014) |
Reimbursement | No | |
Hungary | Clinical | Miheller et al[26] 2009 |
Reimbursement | The diagnostic and treatment of Crohn’s disease] by NHIFA3 (2013) http://www.oep.hu/data/cms989735/0626_a_felnottkori_crohn_betegseg_diagnosztikajanak_es_kezelesenek_finanszirozasi_protokollja.pdf | |
Latvia | Clinical | No national guideline, but following the ECCO guideline |
Reimbursement | National Health Service of Latvia. No specific document, but part of the general regulations on medication reimbursement.(2016) | |
Poland | Clinical | [The treatment of Crohn’s Disease (ICD-10 K 50)], National Health Fund, (2014) http://onkologia-online.pl/upload/obwieszczenie/2015.10.28/b/b.32.pdf |
Reimbursement | No | |
Romania | Clinical | National Insurance Fund Protocol (2013) http://www.cnas.ro/default/index/index/lang/EN |
Reimbursement | National Insurance Fund protocol (2013) http://www.cnas.ro/default/index/index/lang/EN | |
Slovakia | Clinical | No national guideline, but following the ECCO guideline |
Reimbursement | Protocol for starting and continuing the biological treatment. Date first approvals: infliximab 2005, adalimumab 2008, vedolizumab 2016; The Slovakian Gastroenterology Association and The Union of Health Insurance Companies. | |
Spain | Clinical | Guidelines for biologics by GETECCU4 (2013) http://geteccu.org/formacion/guias-y-documentos-de-consenso; Cabriada et al[27] 2013 |
Reimbursement | No | |
Sweden | Clinical | (1) National Guidelines for the treatment of Crohn’s disease; The Swedish Society of Gastroenterology (2017) http://www.svenskgastroenterologi.se/sites/default/files/pagefiles/Riktlinjer_Lakemedelsbehandling_vid_Crohns_2012.pdf |
(2) The use of IFX biosimilar in patients with IBD; Swedish Society of Gastroenterology (2017) http://www.svenskgastroenterologi.se/sites/default/files/pagefiles/SGF_riktlinjer_Biosimilarer_150903.pdf | ||
(3) The Medical Product Agency: Drug treatment of IBD, novel recommendations by the Medical Product Agency, Sweden (2012) https://lakemedelsverket.se/upload/halso-och-sjukvard/behandlingsrekommendationer/L%C3%A4kemedelsbehandling%20vid%20inflammatorisk%20tarmsjukdom%20-%20ny%20rekommendation_bokm%C3%A4rken.pdf | ||
Reimbursement | No |
Table 2 Clinical and administrative requirements of biological treatment (2016)
Cz | Fr | D | Hu | Lv | Pl | Ro | Sk | Es | Se | |
Required level of disease activity (such as CDAI) or disease severity required for initiation of biological treatment | ||||||||||
Not specified (0 point) | x | x | x | x | x | |||||
CDAI > 220 (1 point) | x | x | ||||||||
CDAI > 300 (2 points) | x | x | x | |||||||
Required failure of /intolerance to non-biological treatment before a patient is eligible for a biological | ||||||||||
Steroids (1 point) | x | |||||||||
Immunosuppressive (1 point) | x | |||||||||
Steroids OR immunosuppressive (1 point) | x | x | x | x | ||||||
Steroids AND Immunosuppressive (2 points) | x | x | x | x | ||||||
Other procedures required after the indication of a biological treatment | ||||||||||
No other procedures (0 point) | x | x | x | x | x | x | x | x | ||
Other requirements (e.g., approval or authorization by the health insurance fund) (1 point) | x | x | ||||||||
Approved centers necessary for a biological treatment | ||||||||||
No restriction to approved centers (0 point) | x | x | x | |||||||
Restriction to approved centers (1 point) | x | x | x | x | x | x | x | |||
Specialists who may indicate and prescribe biologicals for the treatment of CD in adults | ||||||||||
Gastroenterologist, immunologist and GP/other (0 point) | x | x | ||||||||
Gastroenterologist and immunologist (1 point) | x | |||||||||
Only gastroenterologist (2 points) | x | x | x | x | x | x | x | |||
Total availability score (min 0 to max 8) | 4 | 4 | 1 | 7 | 5 | 7 | 6 | 7 | 4 | 1 |
Table 3 Affordability of biologicals - annual costs and annual costs (2016) as a percentage of gross domestic product per capita (2014)
Cz | Fr | D | Hu | Lv | Pl | Ro | Sk | Es | Se | |
Annual total drug cost per patient (€) | ||||||||||
Remicade | 11925 | 13439 | 29081 | 15204 | 11202 | 10638 | 15469 | 12020 | 16591 | 16169 |
Remsima | 11925 | 13439 | 23915 | 13694 | 11202 | 10638 | 12375 | 12020 | 12443 | 9157 |
Inflectra | 11925 | 13439 | 22213 | 10674 | 11201 | 10638 | 12375 | 12020 | 12443 | 6841 |
Humira | 11131 | 10625 | 24402 | 12326 | 14050 | 14800 | 24360 | 13697 | 12209 | 15286 |
Entyvio | - | - | 24651 | - | - | - | 22275 | 20207 | 30218 | 19243 |
Annual cost, % of GDP (Affordability ratio) | ||||||||||
Remicade | 69% | 36% | 69% | 124% | 80% | 84% | 176% | 74% | 73% | 31% |
Remsima | 69% | 36% | 57% | 111% | 80% | 84% | 141% | 74% | 55% | 18% |
Inflectra | 69% | 36% | 53% | 87% | 80% | 84% | 141% | 74% | 55% | 13% |
Humira | 65% | 28% | 58% | 100% | 101% | 117% | 277% | 84% | 54% | 30% |
Entyvio | - | - | 59% | - | - | - | 253% | 124% | 133% | 37% |
Average, without Entyvio | 68% | 34% | 59% | 106% | 85% | 92% | 184% | 77% | 59% | 23% |
Average, all drugs | 68% | 34% | 59% | 106% | 85% | 92% | 198% | 86% | 74% | 26% |
Table 4 Number of Crohn’s disease patients and the use of biologicals
Country | Estimated number of CD patients/source | Number of patients on biologicals1/source | Patients on biologicals per 100000 population (calculated) | Patients on biologicals per 1000 patients (calculated) | ||
Cz | 8768 | Rencz et al[3], 2015 (based on estimation) | 990 | Rencz et al[3], 2015 | 9.4 | 112.9 |
Fr | 72522 | Kirchgesner et al[28], 2017 (administrative database) | 22671 | Estimation based on Kirchgesner et al[28], 2017 | 34.0 | 312.6 |
D | 180000 | Estimate by the collaborating expert based on CD incidence and prevalence in two regional cohort studies from the 90ties. | 27000 | Estimation (based on the estimated % of patients on biologicals and the total number of CD patients) | 32.9 | 150.0 |
Hu | 9775 | Rencz et al[3], 2015 (based on epidemiology study) | 1870 | Rencz et al[3], 2015 | 19.0 | 191.3 |
Lv | 1695 | Rencz et al[3], 2015 (based on estimation) | 3 | Rencz et al[3], 2015 | 0.2 | 1.8 |
Pl | 32049 | Rencz et al[3], 2015 (based on estimation) | 888 | Rencz et al[3], 2015 | 2.3 | 27.7 |
Ro | 11000 | Estimate for 2016 by the collaborating expert based on National database including 13 IBD centers | 253 | Rencz et al[3], 2015 | 1.3 | 23.0 |
Sk | 3687 | Rencz et al[3], 2015 (epidemiology study) | 690 | Rencz et al[3], 2015 | 12.7 | 187.1 |
Es | 60000 | Arin Letamendia et al[29], 2008 (prospective, population-based study) | 15000 | Estimation (based on the estimated % of patients on biologicals from the ENEIDA database2 and the total number of CD patients) | 32.3 | 250.0 |
Se | 34318 | SWIBREG3 combined with the Swedish National Patient Register | 5270 | SWIBREG3 combined with The Prescribed Drug Register | 53.5 | 153.6 |
Table 5 Correlation matrix
No. of patients on biologicals per 100000 population | Availability score | Affordability ratio | GDP per capita | % of public health expenditure in the total health expenditure | % of general government expenditure in public health expenditure | |
No. of patients on biologicals per 100000 population | 1.0000 | - | - | - | - | - |
-0.7497 | 1.0000 | - | - | - | - | |
Availability score | (P = 0.0125) | - | - | - | - | - |
Affordability ratio | -0.6920 | 0.5989 | 1.0000 | - | - | - |
(P = 0.0266) | (P = 0.0673) | - | - | |||
GDP per capita | 0.9077 | -0.8810 | -0.7464 | 1.0000 | - | - |
(P = 0.0003) | (P = 0.0008) | (P = 0.0132) | - | - | - | |
% of public health expenditure in the total health expenditure | 0.3879 | -0.5338 | -0.1553 | 0.4907 | 1.0000 | - |
(P = 0.2680) | (P = 0.1120) | (P = 0.6683) | (P = 0.149) | - | - | |
% of general government expenditure in public health expenditure | 0.6661 | -0.4384 | -0.3741 | 0.4233 | 0.1547 | 1.0000 |
(P = 0.0713) | (P = 0.2772) | (P = 0.3612) | (P = 0.296) | (P = 0.7146) | - |
- Citation: Péntek M, Lakatos PL, Oorsprong T, Gulácsi L, Pavlova M, Groot W, Rencz F, Brodszky V, Baji P, Crohn’s Disease Research Group. Access to biologicals in Crohn’s disease in ten European countries. World J Gastroenterol 2017; 23(34): 6294-6305
- URL: https://www.wjgnet.com/1007-9327/full/v23/i34/6294.htm
- DOI: https://dx.doi.org/10.3748/wjg.v23.i34.6294