Key Trends in European Market Access to Pharmaceuticals 2016 - Research and Markets

Recent months have seen a remarkable convergence of initiatives to foster greater European cooperation in market access. On the one hand, the EU has been promoting measures to expedite the launch of new medicines (eg adaptive pathways) and facilitate joint activity in health technology assessment. On the other hand, concerns over the pricing of some new drugs - most notably Gilead's Sovaldi (sofosbuvir) - have prompted national governments to seek new alliances in order to help control the cost of innovative medicines.

International collaboration in market access has undeniable attractions, but it is likely to present significant challenges in practice. It remains to be seen how much authority national agencies will be willing to relinquish, and national governments will continue to make final pricing and reimbursement decisions. Healthcare stakeholders will also have to contend with the pressures of increasing tensions between the demands of the EU, national governments, and regional authorities.

Scope

- Detailed analysis of most important events in Europe impacting market access for pharmaceuticals

- An overview of the routes for expedited market access

- A discussion of the likely impact of growing harmonization of the European health technology assessment and the experience with pilots conducted so far

- Overview of recent or ongoing pricing and reimbursement reforms in Germany, France, Italy, Spain and the UK

- Analysis of evolution of cost containment tools such as internal or international reference pricing, generics and biosimilars use, and off-label use of medicines

This report addresses the following questions:

- What countries have passed reforms that are impacting pricing and reimbursement and how will they shape market access going forward?

- What are the key takeaways and strategic implications from experience with HTA scientific advice?

- How will health technology assessment harmonization impact market access going forward?

- How has Sovaldi changed the way in which European countries collaborate on pricing and what will be the impact going forward?

- How are cost containment tools such as internal or international reference pricing, generics and biosimilars use, and off-label use of medicines, impacting market access in Europe?

Key Topics Covered:

1. Executive Summary
2. Accelerating Access To Medicines
3. Health Technology Assessment Harmonization
4. Key National Developments In Health Technology Assessment
5. Pricing And Reimbursement Delays
6. External Reference Pricing
7. Managed Entry Agreements
8. Price Resistance: Sovaldi Case Study
9. Postmarketing Cost Containment
10. Off-Label Prescribing
11. Outlook
12. Appendix