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Hur sker prioriteringar av resurser för att bekosta särläkemedel?: Cerezyme® – en fallstudie
Linnaeus University, Faculty of Health and Life Sciences, Department of Chemistry and Biomedical Sciences.
2013 (Swedish)Independent thesis Basic level (professional degree), 10 credits / 15 HE creditsStudent thesis
Abstract [sv]

Bakgrund: Strategier för att upprätta ett system för finansiering av särläkemedel, d.v.s. läkemedel för behandling av sällsynta sjukdomar, pågår. Målet är att individer med störst behov ska prioriteras utan att resurser till större individgrupper minskas. Problem föreligger dock vid fördelning av resurserna, då dessa redan är begränsade, och att särläkemedel medför mycket höga kostnader. Syfte: Syftet med detta examensarbete är att redovisa hur olika intressenter i Sverige bedömer i vilken omfattning särläkemedel skall användas, vem som skall bära kostnaderna, och hur prioriteringar bör göras för att skapa ett ekonomiskt utrymme för deras användning. Som modelläkemedel har Cerezyme® (ett läkemedel mot Gaucher’s sjukdom) använts. Metod: För att finna svar på min frågeställning gjordes datainsamling genom sökningar i följande databaser: Tandvård- och läkemedelsverket, Fass, Google och PubMed. För att studera prioritering exemplifierades arbetet genom en fallstudie av Cerezyme®. Resultat: Undersökningarna visade att prioriteringar sker genom kostnadsberäkningar av QALY (quality-adjusted life year) tillsammans med människovärdesprincipen, kostnadseffektivitetsprincipen, samt behovs- och solidaritetsprincipen. Utifrån dessa grunder handlägger TLV (Tandvård- och läkemedelsförmånsverket) för innefattande av läkemedelsförmån. TLV valde den 8 mars, 2012, att utesluta Cerezyme® ur läkemedelsförmånen på grund av för höga kostnader per patient och år. Detta överklagades av tillverkaren, Genzyme, men förvaltningsrätten avslog överklagandet den 30 april, 2012. Genzyme valde att överklaga domen, vilket kammarrätten sedan beviljade genom inhibering av TLV:s beslut tills en slutgiltig dom för Cerezyme® fastslagits. TLV överklagade återigen, vilket också avslogs. Cerezyme® finns inom förmån tills vidare. Slutsats: Det råder idag stora olikheter kring rätten att få behandling gällande särläkemedel beroende på patientens geografiska lokalisering, är det synnerligen viktigt att se över finansiering och prioritering av dessa behandlingar.

Abstract [en]

The choice of my thesis is based on orphan drugs, which individuals with rare diseases use as treatment, diagnostics or to prevent the progress of the disease. In order to get a classification as an orphan drug, the drug must be used for a condition that affects 5 or less of 10 000 individuals, based on the European classification. The clinical trials for this type of medicines are as every medical trial, expensive and orphan drugs have the smallest patient groups. Therefore there is no justification to the pharmaceutical companies in development in orphan drugs. This project is made by a case study and answer survey, and the literature research was based on articles written in English or Swedish, and articles older than 2000 were excluded.The purpose of this thesis is to evaluate how priorities of resources are made, to fund expensive drugs, in Sweden. Tandvårds- och läkemedelsförmånsverket (TLV) has the authority to decide whether different kind of medicines are subjects to the Swedish pharmaceutical benefits, which are funding a great amount of medicines. The thesis is based on evaluations from various stakeholder, Swedish laws and previous research in priority.Sweden is financing the orphan drugs in three ways. Orphan drugs included in Swedish pharmaceutical benefits are funded by customs fee to 2200 SEK, and the rest of the costs are financed by the state through the council counties. Orphan drugs in hospitalization are financed by the hospital, clinic or the county where the patient is registered. The orphan drugs which are prescribed but still excluded from the benefits are financed either by the patient, county or the hospital. The investigation of pricing and financial proposition of orphan drugs in Sweden is delayed but still in progress, and are expected to be presented in April, 2014.TLV make the decisions regarding pharmaceutical benefits through calculations of QALY’s and by three ethical grounds or principles. The principles stand for human dignity, cost-effectiveness, solidarity and needs. TLV could either approve the drug, which makes the drug included to pharmaceutical benefits, or disapprove the drug and makes it unavailable through state funding. TLV decided to exclude Cerezyme® from the Swedish pharmaceutical benefits. The decisions were made of calculations of QALY’s, which was calculated much higher costs than previously approved by TLV. The manufacturers of Cerezyme® did not agree with TLV’s decision, and went to higher courts. The recent decision of higher courts was to re-include Cerezyme® from pharmaceutical benefits, which makes the drug available to patients in desperate need again.Processes of different kinds of orphan drugs to include these to pharmaceutical benefits are not treated equally. Depending of the state of the disease, prevalence and geographic location, are patients treated variously. This is a major problem in management of orphan drugs, and should be prevented as soon as possible. All citizens should on equal terms, have access to same health care, this through Swedish Health Care laws.

Place, publisher, year, edition, pages
2013. , 33 p.
Keyword [en]
Orphan Drugs
Keyword [sv]
Särläkemedel, Vårdprioriteringar, Cerezyme, Särläkemedelsstatus
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-31360OAI: oai:DiVA.org:lnu-31360DiVA: diva2:682984
Subject / course
Pharmacy
Educational program
Bachelor of Science Programme in Pharmacy, 180 credits
Presentation
(Swedish)
Supervisors
Examiners
Available from: 2014-01-14 Created: 2014-01-01 Last updated: 2014-01-14Bibliographically approved

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