title: Novel methodology for pharmaceutical expenditure forecast.
abstract: OBJECTIVE
  The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the 'EU Pharmaceutical expenditure forecast'; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm).
  
  
  METHODS
  1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis.
  
  
  RESULTS
  This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and discount price, distribution chains, and the time to reach peak sales for new drugs; 2) estimating the statistical distribution of the budget impact; and 3) testing different pricing and reimbursement policy decisions on health expenditures.
  
  
  CONCLUSIONS
  This methodology was independent of historical data and appeared to be highly flexible and adapted to test robustness and provide probabilistic analysis to support policy decision making.
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Anne-Lise
authors.initials: AL
authors.lastname: Vataire
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Cetinsoy
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Samuel
authors.initials: S
authors.lastname: Aballéa
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Rémuzat
authors.affiliation: Creativ-Ceutical, Milano, Italy.
authors.forename: Duccio
authors.initials: D
authors.lastname: Urbinati
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Åsa
authors.initials: Å
authors.lastname: Kornfeld
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Olfa
authors.initials: O
authors.lastname: Mzoughi
authors.affiliation: University of Marseille, Marseille, France.
authors.forename: Mondher
authors.initials: M
authors.lastname: Toumi
keywords: biosimilar; forecast model; generic; health policy; innovative medicine; pharmaceutical expenditure