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BIOSIMILAR MEDICINES in FINNISH HOSPITALS Introduction of Biosimilar Infliximab

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BIOSIMILAR MEDICINES in FINNISH HOSPITALS Introduction of Biosimilar Infliximab Maarit Simi BIOSIMILAR MEDICINES IN FINNISH HOSPITALS Introduction of Biosimilar Infliximab Biosimilar Medicines in Finnish Hospitals Introduction of Biosimilar Infliximab Maarit Simi Master’s Thesis Spring 2017 Technology business Oulu University of Applied Sciences TIIVISTELMÄ Oulun ammattikorkeakoulu Teknologialiiketoiminta, YAMK Tekijä: Maarit Simi Opinnäytetyön nimi: Biosimilaarit lääkevalmisteet Suomen sairaaloissa Työn ohjaaja: Hannu Päätalo Työn valmistumislukukausi- ja vuosi: Kevät 2017 Sivumäärä: 194 + 13 Biologisten lääkkeiden hintakilpailu on ollut vaatimatonta ennen biosimilaarien tuloa markkinoille. Ensimmäinen biosimilaari, somatropin, sai EU:ssa myyntilupansa 2006 ja vuonna 2013 sai myyn- tiluvan ensimmäinen biosimilaari monoklonaalinen vasta-aine, infliximab. Suomi oli yksi ensimmäi- sistä maista, johon tuote Euroopassa 2013 lanseerattiin. Esimerkiksi, Pohjoismaista Ruotsi ja Tanska lanseerasivat myöhemmin, 2015 helmikuussa. Infliximabin alkuperäisvalmiste, Remicade, oli Suomessa tukkuohjehinnoin vuoden 2014 ja 2015 tilastoissa suomen viiden myydyimmän lää- kevalmisteen joukossa. Infliximab on sairaalavalmiste ja biosimilaarin infliximabin tultua markkinoille, oletettiin sen aiheut- tavan hintakilpailua ja tuovan sairaaloille säästöjä. Opinnäytetyön tarkoituksena oli selvittää biosi- milaarien käyttöönottoa Suomen sairaaloissa, selvittää toteutuiko hintakilpailu, saavutettiinko sääs- töjä ottamalla biosimilaari käyttöön, sekä mihin säästetyt rahat käytettiin. Tutkimus toteutettiin Word-pohjaisella kyselyllä, ja lähetettiin sähköpostitse ryhmille, joilla on käyttökokemusta biosimi- laarista infliximabista, tai jotka ovat vastuussa lääkehankinnoista tai budjeteista. Teoriaosuudessa on selvitetty mitä biologisilla ja biosimilaareilla lääkkeillä tarkoitetaan, kartoitettiin biosimilaarien asemaa muissa Euroopan maissa sekä selvitettiin biologisten lääkkeiden käyttöä ja kustannuksia Suomessa. Tiedon lähteinä käytettiin mm. IMS-tilastoja, Fimean ja EMA:n julkaisuja, sekä alan lehtiä. Tietoja etsittiin myös PubMedin kautta. Mielenkiinto tehdä opinnäytetyö aiheesta lähti kirjoit- tajasta itsestään. Tutkimuksista saatujen tulosten mukaan, infliximab oli vuonna 2015 sairaaloiden kolmanneksi kal- leimpien biologisten lääkkeiden joukossa (ostohinnoin laskettuna) ja biosimilaarin infliximabin ai- heuttaman hintakilpailun avulla sairaaloissa saavutettiin lääkekustannussäästöjä, jotka useimmiten käytettiin lääkekustannusten hallintaa. Toisaalta biosimilaarin infliximabin käyttöönotto mahdollisti myös uusien lääkkeiden käyttöönoton sairaalan valikoimassa sekä useamman potilaan hoidon in- fliximab-valmisteella. Myös yritys, joka markkinoi infliximabin alkuperäisvalmistetta, Remicadea, lähti hintakilpailuun mukaan laskemalla hintaansa ainakin osissa sairaaloissa jo ennen kuin biosi- milaari infliximabi osallistui ensimmäisen kerran tarjouskilpailuun. Apteekkareilta saatujen arvioiden mukaan markkinoille tulevien uusien biosimilaarien odotetaan mahdollistavan kustannussäästöjä seuraavan viiden vuoden aikana yksittäiselle sairaalalle enimmillään jopa 5 miljoonaa euroa. 3 Uusia biosimilaareja on tulossa markkinoille lähitulevaisuudessa ja olisikin mielenkiintoista selvittää myös näiden valmisteiden osalta millaiseksi hintakilpailu sairaaloissa muodostuu. Lähtevätkö käy- tettävät alkuperäisvalmisteet hintakilpailuun mukaan ja millainen hintaero on biosimilaariin. Toi- saalta markkinatilanne on myös muuttumassa biosimilaarien osalta, kun biosimilaareja, jolla on sama vaikuttava aine, tulee markkinoille ja tuotteet alkavat kilpailla keskenään. Olisi mielenkiin- toista tietää, miten tämä tulee vaikuttamaan lääkkeiden hinnoitteluun. Asiasanat: Biosimilaari, biologinen lääke, kustannussäästöt, kustannuspaineet, lääkekustannukset 4 ABSTRACT Oulu University of Applied Sciences Technology Business Author: Maarit Simi Title of Master thesis: Biosimilar medicines in Finnish hospitals Supervisor: Hannu Päätalo Term and year when the thesis was submitted: Spring 2017 Number of pages: 194 + 13 appendices Price competition for biological medicines has been modest before the arrival of biosimilars on the market. In Europe, the first biosimilar, somatropin, was approved in 2006 and the first biosimilar monoclonal antibody, infliximab, more complex biological medicinal product, was approved in 2013. Finland was one of the first European countries to able to launch the biosimilar infliximab in the autumn of 2013. Several other countries, such as Denmark and Sweden, launched the product in February 2015. The originator infliximab, Remicade, was one of the ten best-selling pharmaceuti- cals in wholesale prices in Finland in 2014 and 2015. Infliximab is a hospital product and after biosimilar infliximab entered the markets, it was assumed to cause price competition and to generate savings for hospitals. The purpose of the thesis was to find out about the introduction of biosimilars in Finnish hospitals, to determine whether price com- petition was achieved, whether savings were achieved by using the biosimilar and how the savings were used. The study was carried out using a Word-based questionnaire which was emailed to groups with clinical experience of biosimilar infliximab or who are responsible for budgets or drug purchasing. In the theoretical part, what is meant by biological and biosimilar medicines, the situation of biosimilars in other European countries, and the use and cost of biological medi- cines in Finland were investigated. The sources of information were, IMS statistics, Fimea and EMA publications, and professional magazines. Information was also searched through PubMed. The author's own interest in and familiarity with the topic were the reasons for the choice of subject. According to the results of the studies, in 2015, infliximab was among the third most expensive biological medicines in the hospitals (at purchasing prices). Hospitals were able to achieve cost savings by using biosimilar infliximab and in most cases savings were used to manage medication costs. In addition, the cost savings did enable commissioning of new medicinal products to the pharmaceutical formulary and made also possible to treat more patients with the infliximab. Also, a company that markets the infliximab originator product, Remicade, participate in the price com- petition by lowering its price (at least in some hospitals) already before the biosimilar infliximab took part in the tendering for the first time. According to estimates from pharmacists, new biosimilars entering the market are expected to provide cost savings of up to EUR 3 - 5 million for a single hospital over the next five years. More biosimilars are coming into the market in the near future, and it would be interesting to follow, how biological medicines price competition in hospitals evolves. Will the originator products partic- ipate in the price competition and what will be the price difference between the biosimilar and orig- inator? On the other hand, the market situation is also changing with regards to biosimilars because 5 more biosimilars with the same active substance enter the market and the biosimilars start to com- pete against each other. It would be interesting to know how this will affect the pricing of biological medicines. Keywords: Biosimilar, biological medicines, cost savings, cost pressure, cost of medicines 6 CONTENTS ABBREVIATIONS ....................................................................................................................... 14 LIST OF APPENDICES .............................................................................................................. 16 1 INTRODUCTION ................................................................................................................ 17 2 RESEARCH PROBLEM AND THE OBJECTIVES OF THE STUDY ................................... 18 3 STUDY DESIGN ................................................................................................................. 20 4 STUDY METHOD ............................................................................................................... 21 4.1 Research method .................................................................................................... 21 4.2 Informers ................................................................................................................. 22 4.3 Collection of material ............................................................................................... 22 4.4 Handling and analysis of material ............................................................................ 22 5 REVIEW OF LITERATURE................................................................................................. 23 5.1 What is biological medicinal product? ...................................................................... 23 5.1.1 Definition of European Medicines Agency ................................................. 25 5.1.2 How are biological medicinal products produced? ..................................... 26 5.1.2.1 Manufacturing changes of biological medicinal products ........................... 27 5.2 Biological medicines versus small molecules ........................................................... 29 5.3 Legal instruments for intellectual property rights protection ...................................... 31 5.3.1 Patent system of the EU Pharmaceutical medicinal products .................... 32 5.3.2 Supplementary Protection Certificate (SPC) .............................................. 33
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