Spain’s (and Portugal’s) Market Access – update Oct16

  • About 60.000 patients treated from HCV infection. Read more.
    • MOH released data on drug access. 59.000 patients treated this year (52.000 F2-F4). Curation rete is at 97%
    • Targeted patients account for 95.000 patients in Spain.
  • The EU Socialist party presents a proposal on innovation at the EU Parliament, and then presents it to the Spanish parliament, where they get support. Read more.
    • ‘…harmonizing the criteria for pricing and reimbursement to take into account the level of innovation and analysis of economic and social profitability, and establish a European classification of the added value of medicines.’
  • Spanish AEMPS accepts biosimilar indication extrapolation. Read more.
    • Sol Ruiz, Officer from the AEMPS stated last week after the Spanish Rheumatoid Association meeting that “It is possible to extrapolate indications” and referred to the same arguments used to pass the extrapolation of indications of biosimilars”
  • Portuguese Hospitals to be imposed Biosimilar quotas. Read more.
    • Hospitals Portuguese National Health Service (NHS) will have to reach a minimum quota of 20 percent for biosimilars in 2017, as reported by the National Authority of Medicines and Portuguese Health Products (Infarmed) through a statement .
    • In the policy note issued by the Portuguese news agency, ensure that the objective of this measure is to “increase the savings potential of these drugs, optimizing available resources to facilitate the financing of new innovations.”