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Curs preconferinta

How can good pharmaceutical policy practices improve patient access in lower income countries?

Precongress training course

Poiana Brașov, Thursday, 12 October 2017, 8.00-13.00.

Presented by: András Inotai, PhD, Department of Health Policy and Health Economics, Eötvös Loránd University (ELTE) / Syreon Research Institute / ISPOR Hungary, Former President

Brief description:

This precongress training course gives an overview of key pharmaceutical policy principles related to pricing, reimbursement and patient access of patented and off-patent pharmaceuticals in lower income countries. External price referencing (i.e. payers refer to list prices of pharmaceuticals in other countries as a benchmark) may result in higher prices and therefore limited patient access in lower income countries. Value based pricing is used to establish pharmaceutical price according to the price level what is cost-effective in any given country. As implementation of cost-effectiveness criterion is not strong in our region, the prices of innovative pharmaceuticals are generally not value based in Central and Eastern Europe.

The module discusses key principles of EPR to minimise its negative consequences. Confidential discounts through managed entry agreements (MEAs) may improve the cost-effectiveness of innovative pharmaceuticals in lower income countries. The course introduce the taxonomy of these techniques and discuss key criteria of their implementation in lower incomes countries. Payers in our region, however, might follow different approaches to maintain financial sustainability, e.g.

1) for high-priced medicines waiting lists are introduced;

2) the medicine may only be available in restricted indication or for limited duration,

3) prescription is restricted only in selected central institutions;

4) volume limits are introduced either at the physician’s level or at institutional level. The consequence of these restrictions is that not all eligible patients have access to high-priced medicines. Therefore the objective of off-patent pharmaceuticals (including biosimilars) in our region is not only to generate cost savings, but to improve patient access to modern medicines. On the other hand, facilitating price erosion by changing the reference products according to the actually lowest price medicine may result in adverse outcomes, such as unreliable drug supply, compromised bioequivalence, poor patient adherence or increased hospitalisation. Consequently the success criteria of generic and biosimilar drug policies have to be based on multiple factors.

Areas covered:

Module I (90’) Implication of external price referencing on lower income countries

  • external price referencing – methodological questions
  • implications of lower income countries
  • key principles of external price referencing

Coffee break I (15’)

Module II (90’) Rationale and taxonomy of Managed Entry Agreements

  • uncertainties related to policy decisions of pharmaceutical technologies
  • management of uncertainties: concept of risk-sharing
  • risk-sharing -> managed entry agreements (MEAs)
  • relevance of MEAs in lower income countries
  • key criteria to implement MEAs in lower income countries

Coffee break II (15’)

Module III (90’) Role of off-patent pharmaceuticals: cost-savings or improved patient access?

  • internal price referencing: caveats of the lowest price policy objective
  • evaluation of social benefit and risks for off-patent pharmaceuticals
  • success criteria of generic and biosimilar drug policies