Optimalisatie van de werkingsprocessen van het Bijzonder ... - KCE

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26 Special Solidarity Fund KCE Reports 133 Patient organizations To select Belgian patient organizations to be contacted for the qualitative research, we started with Rare Disease Organization Belgium (Radiorg.be), established in January 2008 and recognized by Eurordis. Radiorg.be, the Belgian alliance for rare diseases is an umbrella organization, representing more than 80 Belgian rare disease organizations (http://www.radiog.be). To further extent the number of patient organizations we used the following criteria: • The patient organization has to be known at international level. We limit ourselves to the members of the European organization for rare diseases. • The patient organizations represent a variety of SSF submissions. o The decentralized SSF procedure Since 2001 the decentralized SSF procedure is applicable to patients with EB (Epidermolysis Bullosa). The treatments reimbursed via the SSF procedure are mostly ointments, bandages,… Therefore the decision was taken to include their patient organization, Debra Belgium. o The centralized procedure One patient organization needed to represent patients for whom the treatment was mainly focused on expensive drugs. Therefore we included PH Belgium, the patient organization for pulmonary hypertension. SSF files are mostly related to the reimbursement of the very expensive drugs Remodulin® and/or Flolan® . One patient organization needed to focus on children. BOKS, the patient organization for adults and children with metabolic diseases has a clear focus on children as more then 80% of their families/members are linked to illness of children. As a last patient organization, we included NEMA, the patient organization for neuromuscular diseases, as the organization covers a huge group of rare diseases and a neurological focus was not yet realized via the other patient organizations. The 5 selected patient organizations were contacted by phone to ask for their collaboration. All organizations confirmed their participation and meetings were scheduled. The initial idea to include also patient organizations representing rare diseases, often confronted with a rejection of SSF submissions was not possible. The necessary data to identify and select these patient organizations could not be extracted from the SSF database. Pharmaceutical industry representatives During the project execution the question was raised to include representatives of the pharmaceutical industry in the qualitative data collection. The project team contacted pharma.be, the Belgian pharmaceutical industry organization, who distributed an email to the members of their “orphan drug working group” as these member companies are often confronted with the SSF. Thirteen companies reacted positively (prepared to cooperate by means of an interview) of which 4 indicated they had never or seldom experience with the SSF. Due to time restrictions, it was decided to meet a small number of representatives of the pharmaceutical industry. From the remaining 9 companies, the project team selected 4 companies, who were contacted to schedule a telephone interview. This selection was made following the advice of the general adjunct director of pharma.be, who indicated the companies that are most familiar with the SSF thanks to their professional experience or because they produce orphans or cancer drugs for which requests to the SSF are frequently introduced.
KCE Reports 133 Special Solidarity Fund 27 The interview topics to be covered are: reimbursement agreements between the NIHDI and pharmaceutical companies, development and registration of new drugs, specific problems related to drugs for rare diseases, off label use of drugs for rare diseases, compassionate use programs and medical urgency need programs and their view on the SSF (conceptual and operational). We also received a general comment on the SSF from Pharma.be, the Belgian organization of the pharmaceutical industry. 4.2.2.4 Data collection Tool We used a semi-structured interview guideline, specific for each kind of respondent, consisting of a number of orienting generic questions and a number of sub-questions in order to clarify or expand the view of the interviewee has been elaborated and discussed by the project team. Questions aim to respond to the objectives of the survey. It was tested in two interviews and, in function of the results, further adjusted. The interview guidelines are included in annex 9.7., 9.8. and 9.9. to this report. Interview processing Each interview was conducted by one or two persons. When the interview was conducted by two persons, one person leaded and moderated the interview while the other person took notes and supported the moderator when issues needed further elaboration. Additionally, the interviews were digitally recorded with the consent of the respondents (all respondents consented). The recordings were destroyed after processing. The interviews were conducted by the external consultants and took place in the native language of the respondents. Following the interview, both the moderator of the interview and the assisting researcher wrote down their individual preliminary impressions on the interview in short debriefing notes. Secondly, the digital record was used to perform a thorough analysis. The researchers developed and filled up a grid, in which the interviews were analyzed at a descriptive level: a descriptive account of what was said (by whom) related to particular topics and questions. In this grid, the unit of analysis were the respondents and the units of record the questions or topics. Based on the notes taken during the interview and the grid developed after the interview, the note taker made a draft non-literal transcript. The moderator complemented this draft and added additional information. Unclear aspects or issues were discussed by both researchers. Findings were illustrated by several quotations. Confidentiality was respected because no idea or result should be related to nominative persons. 4.2.3 Quantitative approach: the SSF sample The SSF sample data were used to illustrate where possible the description of the SSF by means of univariate and multivariate descriptive statistics and graphs. As the SSF sample available to the current study has certain limitations (as discussed above), a hypothesis testing statistical approach to assess the propositions found in the qualitative survey was not performed.
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