title: Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?
abstract: Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.
authors.affiliation: Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.
authors.forename: Brian
authors.initials: B
authors.lastname: Godman
authors.forename: Rickard E
authors.initials: RE
authors.lastname: Malmström
authors.forename: Eduardo
authors.initials: E
authors.lastname: Diogene
authors.forename: Andy
authors.initials: A
authors.lastname: Gray
authors.forename: Sisira
authors.initials: S
authors.lastname: Jayathissa
authors.forename: Angela
authors.initials: A
authors.lastname: Timoney
authors.forename: Francisco
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authors.lastname: Acurcio
authors.forename: Ali
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authors.lastname: Alkan
authors.forename: Anna
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authors.lastname: Brzezinska
authors.forename: Anna
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authors.lastname: Bucsics
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Campbell
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Czeczot
authors.forename: Winnie
authors.initials: W
authors.lastname: de Bruyn
authors.forename: Irene
authors.initials: I
authors.lastname: Eriksson
authors.forename: Faridah Aryani Md
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authors.lastname: Yusof
authors.forename: Alexander E
authors.initials: AE
authors.lastname: Finlayson
authors.forename: Jurij
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authors.lastname: Fürst
authors.forename: Kristina
authors.initials: K
authors.lastname: Garuoliene
authors.forename: Augusto
authors.initials: A
authors.lastname: Guerra Júnior
authors.forename: Jolanta
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authors.lastname: Gulbinovič
authors.forename: Saira
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authors.lastname: Jan
authors.forename: Roberta
authors.initials: R
authors.lastname: Joppi
authors.forename: Marija
authors.initials: M
authors.lastname: Kalaba
authors.forename: Einar
authors.initials: E
authors.lastname: Magnisson
authors.forename: Laura
authors.initials: L
authors.lastname: McCullagh
authors.forename: Kaisa
authors.initials: K
authors.lastname: Miikkulainen
authors.forename: Gabriela
authors.initials: G
authors.lastname: Ofierska-Sujkowska
authors.forename: Hanne Bak
authors.initials: HB
authors.lastname: Pedersen
authors.forename: Gisbert
authors.initials: G
authors.lastname: Selke
authors.forename: Catherine
authors.initials: C
authors.lastname: Sermet
authors.forename: Susan
authors.initials: S
authors.lastname: Spillane
authors.forename: Azuwana
authors.initials: A
authors.lastname: Supian
authors.forename: Ilse
authors.initials: I
authors.lastname: Truter
authors.forename: Vera
authors.initials: V
authors.lastname: Vlahović-Palčevski
authors.forename: Low Ee
authors.initials: LE
authors.lastname: Vien
authors.forename: Elif H
authors.initials: EH
authors.lastname: Vural
authors.forename: Janet
authors.initials: J
authors.lastname: Wale
authors.forename: Magdałene
authors.initials: M
authors.lastname: Władysiuk
authors.forename: Wenjie
authors.initials: W
authors.lastname: Zeng
authors.forename: Lars L
authors.initials: LL
authors.lastname: Gustafsson
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D003695:Delivery of Health Care / Q000379:methods*; D055808:Drug Discovery / Q000379:methods*; D004345:Drug Industry / Q000379:methods; D017723:Drug Utilization Review / Q000379:methods*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*
chemical_list: D004364:Pharmaceutical Preparations
keywords: clinical pharmacology; critical drug evaluation; dabigatran; differential pricing; ivacaftor; managed entry agreements; new models; rational use of medicines; sofosbuvir; trastuzumab emtansine