Overview
Europe’s payers face a thorny problem. As regulators strive to expedite the approval of innovative medicines, they are being asked to fund a steady stream of new drugs targeting serious, intractable, and often life-threatening diseases. Demand for access to these products is strong, but healthcare finances across the region are under intense pressure, prompting changes to the national health technology assessment (HTA) and pricing and reimbursement (P&R) processes.
Highlights
The European Commission has tabled proposals that would mandate member state compliance with harmonized clinical assessments. They have been the subject of fierce criticism by some powerful stakeholders, and prospects for meaningful HTA harmonization are clearly limited.
Most new drugs are still being reimbursed in 5EU countries, but pressure on healthcare budgets has seen haggling over issues such as cost and cost-effectiveness emerge as an increasingly frequent cause of delays in the completion of P&R procedures.
New drug prices are under growing pressure. Negotiations with payers and regulators are increasingly tough, while recent developments in the UK and France have narrowed negotiation-free pricing avenues.
Italy has spearheaded the use of registries to monitor the real-world use of innovative medicines, but regulators in other 5EU countries have also begun to impose post-launch data-collection requirements. In the UK, real-world evidence now effectively determines the long-term fate of products commissioned through the Cancer Drugs Fund (CDF), while registries will play an integral role in Spain’s new ultra-orphan drug funding initiative.
A shift towards centralized procurement has already been witnessed in several countries, while multilateral initiatives designed to limit procurement c.have begun to emerge. Spain has been the most active in the 5EU.
Key Questions Answered
Europe’s payers face a thorny problem. As regulators strive to expedite the approval of innovative medicines, they are being asked to fund a steady stream of new drugs targeting serious, intractable, and often life-threatening diseases. Demand for access to these products is strong, but healthcare finances across the region are under intense pressure, prompting changes to the national health technology assessment (HTA) and pricing and reimbursement (P&R) processes.
Highlights
The European Commission has tabled proposals that would mandate member state compliance with harmonized clinical assessments. They have been the subject of fierce criticism by some powerful stakeholders, and prospects for meaningful HTA harmonization are clearly limited.
Most new drugs are still being reimbursed in 5EU countries, but pressure on healthcare budgets has seen haggling over issues such as cost and cost-effectiveness emerge as an increasingly frequent cause of delays in the completion of P&R procedures.
New drug prices are under growing pressure. Negotiations with payers and regulators are increasingly tough, while recent developments in the UK and France have narrowed negotiation-free pricing avenues.
Italy has spearheaded the use of registries to monitor the real-world use of innovative medicines, but regulators in other 5EU countries have also begun to impose post-launch data-collection requirements. In the UK, real-world evidence now effectively determines the long-term fate of products commissioned through the Cancer Drugs Fund (CDF), while registries will play an integral role in Spain’s new ultra-orphan drug funding initiative.
A shift towards centralized procurement has already been witnessed in several countries, while multilateral initiatives designed to limit procurement c.have begun to emerge. Spain has been the most active in the 5EU.
Key Questions Answered
- What are the latest changes in HTA systems in the major European markets and what are the implications for drugs’ access prospects and evidence requirements?
- What mechanisms are used most commonly by payers to moderate the impact of new drug approvals on healthcare budgets and how do they vary between countries?
- What changes in the pricing policies will have the greatest impact on commercial prospects for new product launches?
- Which countries have seen the most restrictive reimbursement policies and why?
- How are managed entry agreements and real-world evidence utilized across key markets?
- What are the key post-launch drug access barriers?
