In the last two years the issue on biologics and biosimilars has received a lot of attention from the medical, regulatory and patient community. Licensing rights of biological medicines used in the treatment not only of IBD but also other autoimmune modulated diseases are coming to an end and “biosimilar” medicines are being developed to compete with original biological treatment options. In various countries in the EU and elsewhere biosimilars have already entered the market.
EFCCA understands the market forces that are in place right now and welcomes the idea and necessity of affordable treatment options to be developed. However we believe that under no circumstances should patient safety be compromised. Within this framework and as part of our work programme, in 2015/16 we have organized a series of events around patient safety and information sharing as well as targeted training sessions to enhance knowledge and skills for people with IBD.
In late 2014 we launched a survey entitled BAB – Biologics and Biosimilars to assess patients knowledge about biosimilars and to find out to what extent patients are aware of the issues involved around biosimilars medicines. The scientific coordinator of the BAB survey is Professor Laurent Peyrin- Biroulet - from the Department of Hepato-Gastroenterology CHU in Nancy, France.
The online survey consisted of 14 questions and was translated into nine languages (English, French, Italian, German, Spanish, Russian, Greek, Turkish, Hebrew). The survey was available between November 2014 and October 2015 on the website of EFCCA an member patient associations of EFCCA were sharing informing about the survey to their members.
In total we collected 1181 responses which were mostly from Europe and included 55.6% of people with Crohn’s disease, 34.1% with ulcerative colitis, 6.4% with rheumatic diseases and 3.9% with other diseases.
Below you have some of the results that emerged from the survey:
On the issue of the lower costs of biosimilars, the majority of respondents thought that the lower cost should not come before their safety and efficacy. However 31 % of respondents believed that the lower cost would enable more patients to receive treatment with biologics.
On the subject of extrapolation (applying data from one clinical trial in one disease group to another) most respondents would prefer disease-specific data and 24.5% are waiting for more IBD-specific data before accepting a biosimilar for treating their IBD. Only a very small amount of respondents thought that extrapolation makes sense.
As concerns interchangeability of the two drugs most respondents would accept the substitution of reference drugs with biosimilars under certain conditions: with the approval of their treating physician (28.3%), if evidence-based data was available (27.0%), or if the patient was systematically informed (21.8%).
On “Naming of biosimilars and distinguishing them from reference drugs” a vast majority of respondents would want to know whether they are receiving the reference drug or the biosimilar or have all necessary information in writing before the drug is administered.
On the subject of biosimilar versus generic drugs most respondents believed that biosimilars are like generic drugs or close to generic drugs and only a small amount believed that biosimilars are not at all like generic drugs.
These finding show some alarming figures. First of all what strikes most is that most respondents to the survey (61.6%) had never heard of biosimilars. For clarification we would like to mention that only those who had heard of biosimilars (ie 449 respondents) were then asked to respond the remaining answers of the survey.
Of these responses another striking figures is that most respondents had doubts and concerns about the safety and efficacy of biosimilars even if they were prescribed and explained by the treating physician. A small proportion of respondents would even go so far as not to accept treatment. Only 25.2% had no specific concerns about biosimilars.
These results clearly show that there is a lack of knowledge on the issue of biosimilars and an urgent need for patients to be systematically informed and involved in decision-making concerning biosimilars. Informing patients via therapeutic education programs is advisable, and this could be implemented with patient organization support.
The survey has been designed in collaboration with Prof. Laurent Peyrin-Biroulet and his team at the department of Hepatitis-Gastroenterology CHU in Nancy. The translations, technical tools and dissemination materials are under a unrestricted grant from the pharmaceutical company Abbvie.
This is the Executive Summary of the Patient Advocacy Workshop on Patient Safety which took place in Barcelona from 4-6 February 2016 and gathered over 60 patient representatives from a wide range of immune modulate disease groups.