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

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72 Special Solidarity Fund <strong>KCE</strong> Reports 133<br />

System of<br />

reimbursement<br />

Who <strong>de</strong>ci<strong>de</strong>s on<br />

reimbursement of<br />

medicines? / Parties<br />

involved?<br />

Table 11: Overview of extramural and intramural reimbursement<br />

Intra muros<br />

Extramural Intramural<br />

Reimbursed to the patient un<strong>de</strong>r the<br />

Drug reimbursement system (GVS–<br />

Geneesmid-<strong>de</strong>lenvergoedingssysteem)<br />

GVS has 3 annexes:<br />

- Schedule 1A: medicines for which an<br />

alternative exist that is 100 %<br />

reimbursable. Maximum limit of<br />

reimbursement/patients has to pay<br />

an absolute amount.<br />

- Schedule 1B: medicines that are<br />

100% reimbursable.<br />

- Schedule 2: medicines which require<br />

an authorisation for (partial of full)<br />

reimbursement<br />

College of Health Insurers (CVZ-<br />

College <strong>van</strong> Zorgverzekeraars) advises the<br />

Government on therapeutic value and cost<br />

of medicines<br />

Dutch Government- Minister of Health<br />

finally <strong>de</strong>ci<strong>de</strong>s on the adoption of<br />

medicines on the list of Drug<br />

Reimbursement System<br />

Costs are charged on the hospital general budget,<br />

not to the patient.<br />

Compensation arrangements: hospitals are extra<br />

compensated by health insurers for specific<br />

medicines and un<strong>de</strong>r specific conditions un<strong>de</strong>r:<br />

- Policy Regulation on ‘Expensive Drugs’<br />

- Policy Regulation on ‘Orphan Drugs’ (only<br />

aca<strong>de</strong>mic hospitals)<br />

Step 1: Framework set by the supervising,<br />

in<strong>de</strong>pen<strong>de</strong>nt Dutch Healthcare Authority<br />

(Ne<strong>de</strong>rlandse Zorgautoriteit):<br />

- Members of Health Insurers<br />

- Members of Healthcare Provi<strong>de</strong>rs<br />

Step 2: Bilateral negotiations between:<br />

- Health Insurers<br />

- Healthcare provi<strong>de</strong>rs<br />

Exception: College of Health Insurers also advises<br />

the Dutch Healthcare Authority on the adoption of<br />

medicines within the policy regulations ‘Orphan<br />

Drugs’ and ‘Expensive Drugs’<br />

The costs for (orphan) Drugs that are given to patients intra muros, are charged on<br />

the hospital budget. Hospitals are compensated by the health insurers for the medicines<br />

they are prescribing, based on negotiations between both parties. The framework, in<br />

which negotiations on compensations and budget between hospitals and health insurers<br />

take place, is <strong>de</strong>signed and supervised by the Dutch Care Authority (Ne<strong>de</strong>rlandse<br />

Zorgautoriteit), a non-governmental, in<strong>de</strong>pen<strong>de</strong>nt board that takes up the role of<br />

supervisor and regulator of the healthcare market in the Netherlands.<br />

Because the expensive (orphan) drugs, prescribed intra muros, laid a heavy bur<strong>de</strong>n on<br />

the budget of hospitals in the past, compensation arrangements (beleidsregels) have<br />

been conclu<strong>de</strong>d between the health insurers and healthcare provi<strong>de</strong>rs, applying for<br />

specific medicines and un<strong>de</strong>r specific conditions. The (partial) compensation of hospitals<br />

by the health insurer is based on an ex-post calculation. Two compensation<br />

arrangements are rele<strong>van</strong>t from the perspective of rare disease:<br />

• Policy Regulation on Expensive Drugs CI-1087, 1st of January 2009: un<strong>de</strong>r<br />

this policy regulation, hospitals will be compensated for a registered drug<br />

by the health insurer, if the estimated total costs correspond to 0.5% or<br />

more of the total medicines expenditure of hospitals at macro-level. If this<br />

condition is being met, a hospital will be reimbursed 80% of the costs,<br />

based on a ex-post calculation.<br />

• Policy Regulation on Orphan Drugs CI-1043: only applying to aca<strong>de</strong>mic<br />

hospitals: aca<strong>de</strong>mic hospitals are eligible for compensation, if the total<br />

costs of an orphan drug are estimated to exceed 5% or more of average<br />

total medicines expenditure of aca<strong>de</strong>mic hospitals. If this condition is<br />

being met, the health insurer will fully (100%) reimburse the costs of the<br />

orphan drugs on top of the regular budget

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