Key Trends in European Market Access

  • ID: 3797444
  • Report
  • Region: Europe
  • 145 pages
  • Datamonitor Healthcare
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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.
- 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?
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EXECUTIVE SUMMARY

- Accelerating access to medicines
- Health technology assessment harmonization
- Key national developments in health technology assessment
- External reference pricing
- Managed entry agreements
- Price resistance: Sovaldi case study
- Postmarketing cost containment
- Off-label prescribing
- Outlook

ACCELERATING ACCESS TO MEDICINES

- Earlier access to medicines is a priority for the EU and its member states
- Creation of the Expert Group on Safe and Timely Access to Medicines for Patients
- Established approaches to accelerated assessment
- Adaptive pathways: a new initiative to expedite access to innovative medicines
- National initiatives to accelerate access to medicines
- Bibliography

HEALTH TECHNOLOGY ASSESSMENT HARMONIZATION

- European initiatives to harmonize health technology assessment, 17.Multi-HTA early dialogues
- Parallel scientific advice
- EUnetHTA’s HTA Core Model
- Rapid relative effectiveness assessment
- The HTA Network calls for closer cooperation in HTA
- Bibliography

KEY NATIONAL DEVELOPMENTS IN HEALTH TECHNOLOGY ASSESSMENT

- France: the increasing importance of health economic evaluation
- Germany: industry dissatisfaction with AMNOG continues
- Italy: national and regional governments re-affirm commitment to HTA
- Spain: therapeutic positioning reports have yet to streamline HTA processes
- UK: NICE advocates limited methodological change, but establishes a new Office for Market Access and will play a key role in the Cancer Drugs Fund
- Bibliography

PRICING AND REIMBURSEMENT DELAYS

- Pricing and reimbursement delays pose a persistent problem for drug manufacturers, patients, and politicians
- Bibliography

EXTERNAL REFERENCE PRICING

- External referencing pricing is common in Europe, but systems vary widely
- Manufacturers seek to minimize the impact of ERP by careful launch sequencing, offering discounts, or even withdrawing drugs in some circumstances
- Industry calls for more moderate use of ERP are likely to have limited success
- Has ERP had its day?
- Bibliography

MANAGED ENTRY AGREEMENTS

- Uncertainty around drug effectiveness drives the use of managed entry agreements
- The managed entry environment in leading European markets
- Patterns of managed entry in Europe
- Payer and manufacturer perspectives on MEAs
- The growth of electronic health records and EU collaboration on disease registries will boost MEAs
- Bibliography

PRICE RESISTANCE: SOVALDI CASE STUDY

- Will Sovaldi be a watershe d?
- International charities seek to challenge Sovaldi's intellectual property protection and expedite the launch of generics
- Proposals for international collaboration on pricing and procurement
- National policies on access to Sovaldi
- Sovaldi's legacy for pharmaceutical pricing
- Bibliography

POSTMARKETING COST CONTAINMENT

- Austerity hits southern European pharmaceutical markets hard
- Parallel trade - an increasingly complex pattern of imports and exports
- Generics - a tried and true method of cutting costs
- Biosimilars - a new front in the war on pharmaceutical expenditure
- Cost-containment pressures are set to intensify
- Bibliography

OFF-LABEL PRESCRIBING

- Off-label prescribing for economic reasons: Avastin in the spotlight
- France: new legislation allows off-label use for economic reasons
- Germany: a court upholds the legality of contracts for off-label prescribing
- Italy: the government has fined manufacturers and changed the law to allow off-label prescribing to cut costs
- Spain: autonomous communities contemplate off-label prescribing
- UK: the government resists stakeholder demands for off-label prescribing on economic grounds
- Bibliography

OUTLOOK

- Taking a (very) long-term perspective on the role of pharmaceuticals in changing healthcare Systems
- Bibliography

APPENDIX

- About the author
- Scope
- Methodology
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