This week, around 2000 high-level executives from biopharmaceutical and biotech companies, venture capital firms and service companies are gathered in Turin, Italy, for the eighth annual BIO-Europe Spring conference. The programme included Lilly’s Richard Ascroft, Senior Director, Corporate Affairs and Market Access Australia, Canada, Europe. During a session focusing on the pricing and reimbursement environment in Europe, he spoke about the trends we can observe in European markets:
- The bar is raising
- Systems are converging
- Real World Evidence becomes increasingly important
He also highlighted the opportunities that we are presented with in the Transatlantic Trade and Investment Partnership (TTIP), currently being negotiated by the EU and the US, and the current European developments around Health Technology Assessment (HTA).
The Transatlantic Trade and Investment Partnership (TTIP)
If you’re a regular reader of this, you know our priority areas for TTIP centre around regulatory harmonisation, IP rights, and Market Access. On the latter specifically, TTIP should ensure that government pricing and reimbursement policies do not create obstacles to pharmaceutical trade between the EU and the US. The agreement should include a Pharmaceutical Annex on government pricing and reimbursement policies that:
- Promotes transparency principles in pricing & reimbursement processes
- Adequately recognises the value of pharmaceuticals and rewards innovation
- Aligned with EU “Transparency Directive” (Directive 89/105/EEC)
- Builds on recently agreed trade agreements eg EU-Korea FTA, US-Korea FTA, EU-Singapore
The systems looking at reimbursement across Europe continue to evolve. A greater use of health technology assessment is an important part of this in some countries. HTAs play an increasingly important role in guiding the therapy choices of both healthcare professionals and policy makers. Lilly believes that HTA systems and processes need to be transparent, objective and involve a range of stakeholders to ensure that the needs of patients and the invaluable insights of the companies developing medicines are adequately reflected. In Europe, actors involved in HTA have been looking at ways to harmonise HTA. This makes sense in certain areas, to avoid duplication of efforts, to improve and speed up patient access, and to tackle the ‘location lottery’ in Europe. The EU network EUnetHTA is working on precisely that, closer harmonisation of HTA efforts. You can read more about this in our previous blogs.
Here at Lilly we support some harmonisation of the "clinical data package" in European HTA processes to improve quality and establish clear guidelines for the assessment of clinical effectiveness and to safeguard a clear and common definition and understanding of "clinical value". We do, however, recognise that the final assessment and decision making must still be undertaken by individual member states so as to accommodate their local standards of care, societal values and health care budgets.