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62 Interventions in Alzheimer’s Disease KCE Reports 111 6 ANALYSIS OF BELGIAN DRUG PRESCRIPTION DATA (2002 – 2006) 6.1 INTRODUCTION AND RESEARCH GOALS 6.1.1 Medicines Reimbursed in Belgium In Belgium the ChEIs (Aricept/donepezil, Reminyl/galantamine, and Exelon/rivastigmine) are reimbursed by the RIZIV/INAMI for mild to moderately severe AD (MMSE > 11) starting mid 2002. Memantine (trade name Ebixa) is reimbursed in moderately severe and severe AD (MMSE >2, 11). Ginkgo biloba is not included in this evaluation because robust trial data are lacking. The number of patients receiving prescriptions for this drug is also limited (as detailed in Pharmanet data below). 6.1.2 Research Goals The aim was to explore the use of new diagnostic tests and medications in AD patients in Belgium based on the “permanente steekproef / échantillon permanent” (PS/EP) database. In particular this exploration will help to answer the following research goals: • To quantify the routine use of new proposed diagnostic markers for clinical diagnosis 20 in the 2002-2006 period in Belgium in patients who received a ChEI prescription. • To describe the patients treated with ChEIs or memantine in Belgium in terms of number, age, gender, place of residence, duration of treatment, comedication (antipsychotics and antidepressants), and mortality. As the population of patients receiving prescriptions for memantine is lower, data exploration was limited for this group. 6.2 METHODS 6.2.1 Database “permanente steekproef / échantillon permanent” In Belgium, registered inhabitants in principle have a compulsory health insurance provided by one of the seven national sickness funds and funded by social security contributions withhold on wages and earned incomes. For all sickness funds health care reimbursement data of their members are joined into a large database at the IMA (Intermutualistisch Agentschap/ Agence Intermutualiste). From this population a sample of 1/40 was selected among subjects aged 65 or younger (random selection stratified for age and sex) and a sample of 1/20 among subjects of 66 years and older (random selection stratified for age and sex). This sample contains about 300 000 individuals and was started in 2002. The database was updated every year since and is referred to as “permanente steekproef or échantillon permanent” (PS/EP). For all the individuals in the sample demographic and socio-economic information is updated, in addition to the detailed information on health care expenditures. For reimbursed drug prescriptions two data streams exist and were used for the analyses: the Pharmanet datastream (www.inami.fgov.be/drug/fr/statistics-scientificinformation/pharmanet/introduction/pdf/analyticalreport_eng.pdf) which includes prescriptions out of the hospital setting and the Health datastream containing
KCE Reports 111 Interventions in Alzheimer’s Disease 63 prescriptions handled by the hospital pharmacy, as well as all other health expenditures covered by the compulsory health insurance. Most prescriptions for patients in elderly homes (also referred to as ROB/RVT or MR/MRS) are included into Pharmanet, a small part (5% to 12%, depending on the source) of the elderly homes however obtain their medication through a linked hospital pharmacy and are thus included in Health. The codes defining the medication prescribed differ between Pharmanet (APB-CNK code) and Health (RIZIV/INAMI code). 6.2.2 Selection of study population and variables for analysis We first selected patients included in the PS/EP who had at least one reimbursed prescription for a ChEI or Ebixa/memantine in the 2002-2006 period. The demographic data analysed for these patients are • year of birth, • gender, • year and month of death (if this occurred in the 2002-2006 period) • residence type (home, ROB/RVT-MR/MRS). As stays in an elderly home (ROB/RVT-MR/MRS) are also in part paid by the health insurance (invoiced after each three months period, unless a change of service occurs earlier), it is possible to define the type of residence over time. We studied individual dates of prescriptions of specific medication for AD (ChEIs and Ebixa), as well as concomitant prescriptions of antipsychotics and antidepressants. Benzodiazepine prescriptions could not be evaluated as these drugs are not reimbursed by the RIZIV/INAMI. ChEI reimbursement started mid 2002. Ebixa reimbursement started in 2004. A few earlier prescriptions were identified in the database and included. After the data analyses had been completed and were being validated by a second analyst, it was seen that a small number of prescriptions with the Pharmanet code were unexpectedly present in the dataset Health. It was decided not to repeat the analyses as it concerned a relatively small number of prescriptions and because of the high proportion (a third) of ChEI treatment gaps of over 200 days among the additional patients. The reason for this difference of coding was not clear at the time of writing of the report. 6.2.3 Statistical analyses The following analyses are performed: 1. Incident cases of patients on ChEl per year from 2002-2006 (number of new patients), and prevalent cases in 2006 (number of patients who received prescriptions in 2006). An extrapolation of the yearly percentage increase of consumption was also performed based on data for 2007, but this was based on data from Pharmanet only. 2. The extrapolation of these results from the PS/EP to the whole population of Belgium is given by: N patients (≤ 65 years) X 40 + N patients (> 65 years) X 20 3. The setting of the first ChEl prescription: home, hospital or ROB/RVT-MR/MRS. Prescriptions handled by a hospital pharmacy are identified using the RIZIV/INAMI medication codes. Patients in ROB/RVT-MR/MRS are identified using the lump sum paid by the health insurance at three month intervals. 4. The routine use of new diagnostic markers. Recently a revision of the diagnostic criteria for clinical diagnosis has been proposed, 20 reflecting the increasing importance of new markers. We quantified the introduction of these new tests in routine practice in Belgium, using the specific codes of reimbursement as a proxy for the test. The following supportive features were studied (using reimbursement codes):
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