Innovation in European healthcare – what can Sweden learn? - LIF

Implementation and use of innovative
drugs in the outpatient sector: AMNOG
• Federal Joint Committee assesses within three
months after a new pharmaceutical accessed
the market if claimed additional benefit in
relation to the appropriate comparator is proven
• The companies submit a dossier to the FJC
based on the authorisation documents and all
studies carried out on these pharmaceuticals
• They have to prove the pharmaceutical´s
additional benefit in comparison to a specific
appropriate comparator set forth by the FJC
• The FJC can commission the Institute for Quality
and Efficiency in Health Care or third parties to
assess the benefits
• The findings of the assessment our published
and pharmaceutical companies, associations
and experts are given the opportunity to
comment on the findings
• After another three months, the FJC passes a
resolution based on the benefit assessment and
the round of consultation, the extent of the
additional benefit and the costs of the therapy
• After publication the FJC takes a decision on the
further procedure for establishing a price for the
pharmaceutical
• The GKV-Spitzenverband and the specific
pharmaceutical company then negotiates the
reimbursement price for pharmaceuticals that
have proven additional benefit as a discount on
the original selling price within six months
• If negotiations do not achieve an agreement, an
arbitration commission defines the
reimbursement price using the European price
level as a standard
• If the new pharmaceutical does not have any
additional benefit compared to the appropriate
comparator, it will be included in the reference
price system six months after market launch
• If a pharmaceutical without additional benefit
cannot be assigned to any reference price
group, a reimbursement price will also be agreed
where the annual therapeutic expenses are not
any higher than of the appropriate comparator.
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