How to solve financing gap to ensure patient access to patented pharmaceuticals in CEE countries? – the good, the bad, and the ugly ways

ABSTRACT

Introduction: There is significant difference in utilization of patented medicines in the EU, as pharmaceuticals at Western European price levels are usually not cost-effective in Central and Eastern European (CEE) countries. The article reviews options to solve the ‘financing gap’ posed by the challenge of covering patented medicines from more restricted resources in countries with greater unmet medical need.

Areas covered: Hidden volume restrictions to patented pharmaceuticals implemented by payers to facilitate financial sustainability may increase European inequity in patient access. Confidential price discounts and financial risk-sharing agreements improve cost-effectiveness of pharmaceuticals with limited impact on the European floor price. Narrowing the eligible group of patients on the positive drug list can help to target the medicines to patients with potentially greater health benefit whilst reducing the budget impact. Pay-for-performance schemes can improve cost-effectiveness of pharmaceuticals with significant uncertainty or heterogeneity in the magnitude of added therapeutic value. Increased utilization of off-patent pharmaceuticals can increase patient access through re-investing the savings from generic or biosimilar price erosion.

Expert opinion: Transparent and sustainable pharmaceutical policies aiming to improve the allocative efficiency of scarce resources should be implemented in CEE to reduce financing gap and improve patient access to high-cost medicines.

KEYWORDS:

• Central and Eastern Europe
• pharmaceutical policy
• off-patent medicines
• patient access
• inequity

Article highlights

• There is significant difference in utilization of patented medicines within the EU countries.

• Patented medicines at price levels of higher income countries are usually not cost-effective in lower income EU countries.

• CEE countries need to develop policy solutions to manage the challenge of financing patented medicines proposed at international price levels in order to improve the patient access to high-cost pharmaceuticals with significant added value.

• Confidential price discounts and risk-sharing agreements may ensure that coverage decisions of patented pharmaceuticals are based on cost-effectiveness and budget impact criteria without the domino effect of price reduction through external price referencing.

• Although the implementation of volume restrictions can ensure the sustainability of health care financing, it may prevent eligible patients from accessing to effective medicines and may increase inequity within- and between countries.

• Enforced utilization of off-patent pharmaceuticals can improve patient access by re-investing savings from the generic and biosimilar price erosion in case of access barriers implemented prior the patent expiry.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.