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

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202 Special Solidarity Fund KCE Reports 133 9.17 SSF CASES FOR INTERNATIONAL BENCHMARKING 9.17.1 The Netherlands Name Active substance Indication Reimbursement Source Citation of the expert / Rekevant remark Adagen Pegademase bovine A type of SCID (severe combined immunodeficiency syndrome) caused by the chronic deficiency of the adenosine deaminase (ADA) enzyme Vidaza Azacitidine Myelodysplastic syndrome Kuvan sapropterin dihydrochloride Cellcept Mycophenolate mofetil Mabthera Rituximab Avastin Bevacizumab Bi-myconase and/or sucraid Ointmenst, disinfectants, painkillers, tape, food supplements Implantable cardiac valves (aortic valves) Implantable pulmonary valves Brainstem implant Neuro stimulator of the stomach Glucamylase & invertase (saccharase) Phenylketonuria (PKU) - tetrahydrobiopterin defiency Auto immunology diseases - neophrotic syndrome US-registered orphan drugs (non-EU): not reimbursed intra muros, nor extra muros. Today, adagen could possibly be paid by pharmacist's, pharma company or the hospital through ad hoc-reimbursement systems (however not by the health insurers) GREY ZONE. Received recently a positive advice to be recognized as 'Expensive Drugs' (intra muros) - 80% reimbursable - prescribed by specialists in all hospitals Received recently a positive advice to be adopted in the Drug Reimbursement System (GVS-extra muros) - 100% reimbursable Reimbursed under GVS - Schedule 2 (advies CVZ, 2007) Recognized as 'Expensive Drugs' (intra Heamatologic oncology (leukemia - muros) - 80% compensated - prescribed lymphoma) by specialists in all hospitals Brain tumors (glioblastoma) - eye disorders-cancer colon métatasé 2ième intention-tumeur de l'ovaire Enzyme deficiency sucrose isomaltase Recognized as 'Expensive Drugs' (intra muros) - 80% reimbursable - prescribed by specialists in all hospitals Not reimbursable by the Health Insurer (high probability) J.Huizer, Dutch Steering Committee on Orphan Drugs J.Huizer, Dutch Steering Committee on Orphan Drugs J.Huizer, Dutch Steering Committee on Orphan Drugs With respect to reimbursement registered drugs are granted priority over nonregistered (in NL). In the NL there is no special legislation for the reimbursement of non-registered drugs. A request for advice for the treatment and reimbursement can be submitted at the Federation of Health Insurers (College voor Zorgverzekeringen). The Health insurer will then take care of the reimbursement. However, the health insurer can also decide not to accept the advice of the CVZ. If In case of intramural treatment, drugs that are listed under the policy regulation 'Expensive drugs' are being compensated by the state to hospitals for 80%. The other 20% share is charged on the hospital budget. Drugs that are listed under the policy regulation 'orphan drugs' are fully (100%) compensated to the hospital (however, only academic hospitals). No information available. A. Prenger, A positive advice has been given for the reimbursement, in case of treatment Zorgverzekeraars of neophrotic syndrome. Nederland+literature review A. Prenger, Listed under the policy regulation 'Expensive drugs': 80% compensation for Zorgverzekeraars hospitals Nederland+literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs Epidermolysis bullosa - ichthyosis No information. Degenerative valve disease (aged persons) Congenital cardiac malformations (children) Patients who have no remaining auditory nerves (ex. Bilateral vestibular schwannomas tumors on both balance nerves) Severe gastro paresis Probably not reimbursed under GVS - Advies CVZ Hospitals are probably compensated to a specific limit ( (only for academic hospitals), as the Neurostimulator is listed under a policy regulation J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review Listed under the policy regulation 'expensive drugs for a number of indications. However, no information could be found concerning the reimbursement in case of brain tumor or eye cancer. Hospitals are probably compensated for 80%. 20% is charged on the hospital budget. Since 1995, glucoamylase is excluded from the treatment for acute diarrhoea. Enzym deficientie sucrose isomaltase is not on the list of the patient organisation for metabolic indications. Probably not reimbursed by the health insurer. No information. No information. Neurostimulator: no information on current status. However, it seems that hospitals are partly compensated for the costs (up to a specific maximum), as the neurostimulator has been the subject of a policy regulation that only applies to academic hospitals.
KCE Reports 133 Special Solidarity Fund 203 Name Active substance Indication Reimbursement Source Citation of the expert / Rekevant remark Remodulin tréprostinil pulmonary hypertension Viagra/revatio pulmonary hypertension Ilomedine iloprost pulmonary hypertension Elvorine cerebral folate deficiency Calcort déflazacort duchenne muscular dystrophy- syndrome néphrotique Myozine alglucosidase alfa Pompe disease Sovrima idebenone Friedreic's ataxia Reimbursed under GVS - listed under Schedule 2 + Paid on the hospital budget (intra muros) Reimbursed under GVS - listed under Schedule 2 + Paid on the hospital budget (intra muros) Reimbursed under GVS - listed under Schedule 2 + Paid on the hospital budget (intra muros) Not registered in NL - no request for marketing authorisation could be found Not registered in NL - not reimbursed. Patients/parents are paying it out-ofpocket. Paid on the hospital budget (intra muros): adopted on the list of 'Orphan Drugs' - 80 % reimbursed - only prescribed by specialists in the 8 academic hospitals Not reimbursed under GVS - Still in clinical trial process - Patients/parents are paying it out-of-pocket J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review No information. No information. Not registered in the NL and no request for reimbursement has been submitted. No further information available. Not registered in the NL and not reimbursable. Costs are charged on the patients. No information. Ditropan for intravesical application oxybutynin chloride incontinency neurogenic bladder No information. Cochlear, contraleteral implant Sensori-neural hearing loss "lack" of bones of the skull (after No information. Customised cranial implant accident, operation, malformation,,,) mise au point en vue d'envisager No information. Cortical electrodes une intervention au niveau de l'encéphale en cas d'épilepsie réfractaire in case of skin graft as a No information. Intégra consequence of a fire, suite à des brûlres, diverse impairments (accidents…) No information. Middle ear implant Sensori-neural hearing loss No information. Diafragmatic pacemaker diafragmatic paralysis Contrathion Cystadane homocystinuria No information could be found. Possibly it is paid by the hospital budget. No information could be found. Possibly it is paid by the hospital budget. Reimbursed under GVS - listed under Schedule 1B - 100% reimbursable J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review J.Huizer, Dutch Steering Committee on Orphan Drugs + Literature review Not registered yet (procedure is ongoing at EMEA level) - not reimbursable. Costs are charged on the patients. No information. Possibly charged on the hospital budget. No information.
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Optimalisatie van de werkingsprocessen van het Bijzonder ... - KCE

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