Challenges and opportunities for pharmaceutical pricing and reimbursement policies

In the field of pricing, common policies are increasingly being questioned because
they appear to be no longer able to deal with new challenges such as high-priced medicines.
In the Council conclusions on ‘Innovation for the benefit of patients’ as of 6 December
2014 European policy-makers noted with concern that, due to the very high prices of
some innovative medicines, patients do not always have access to innovative treatments
7]. Concerns have been voiced that medicine shortages that have increasingly been observed
also in higher-income countries, are, among other factors, attributable to existing
pricing policies 8]. External price referencing (i.e. international price comparison) is the commonly
applied pricing policy in European countries 9] and, increasingly, in several countries over the world 10]. This policy tends to incentivize marketing authorization holders to first launch
medicines in countries with higher price levels, and delay, and even refrain from,
launching in low-price countries 11]. While this has been long known, EPR’s possibly limiting impact access has been recently
observed particularly in countries that were hit hard by the crisis and related to
new high-priced medicines – the two main recent challenges mentioned above.

As a result, alternative pricing and funding models have been implemented or are under
discussion. In recent years, managed-entry agreements were introduced in several countries.
However, while they are instruments to manage uncertainty and to allow faster patient
access to new medicines, with possibly limited data on their effectiveness, they tend
to contribute to intransparency due to their confidential contents 12,13]. Although value-based pricing as an integrative pricing and reimbursement policy
is only in place in few countries (e.g. Sweden), tools (e.g. health technology assessments)
aiming to assess value are applied in several countries 14]. Discussions have started whether, and how, the economic situation of a country could
be considered into pricing policies 15].

At the same time, new opportunities could be seized. The recent and future patent
expiries of high-cost, frequently biotechnological, medicines is very likely to allow
patient access to highly effective medicines at lower prices and to offer potential
savings to public payers. However, it has not been fully explored yet how to make
best use of biosimilar medicines, and even generics.

The 2015 Vienna PPRI Conference provides a forum to discuss these issues with leading
experts including Suzanne Hill (WHO, K1) and Andy Gray (University of KwaZulu-Natal,
K3) and different stakeholders. Strand 1 of the PPRI Conference is particularly dedicated
to current and recurrent challenges in pharmaceutical pricing and reimbursement and
possible opportunities, with key-notes of Veronika Wirtz (Boston University, K4) and
Arnold Vulto (Erasmus University Hospital) as well as presentations about policies
to deal with high-cost medicines (e.g., O1, O2, O9, O14) and experiences with generic
policies (O6).