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5EU: Pricing, Reimbursment and Regulatory Update
Datamonitor, October 2011, Pages: 35
Governments across the five major EU markets (France, Germany, Italy, Spain, and the UK) have been busy implementing regulatory, pricing, and reimbursement reforms in 2011. Price cuts have impacted brands, while pro-generic measures and new market access and reimbursement requirements could negatively impact pharma. However, there are moves to improve patient access to certain novel drugs.
Features and benefits
- Insight into regulatory and pricing and reimbursement issues in France, Germany, Italy, Spain, and the UK.
- Overview of regulatory reform issues in France, Germany, Italy, Spain and the UK.
- Driven by their high budget deficits post-recession, both Italy and Spain pushed through their austerity packages in 2011, which has led to substantial drug price cuts in both countries. Furthermore, pro-generic measures are being introduced to help reduce overall drug expenditures.
- Pharmaceutical companies will also need to be mindful of new market access and reimbursement requirements which could make it harder to secure reimbursement, with new drugs needing to prove their cost effectiveness against active comparators in both France and Germany.
- Several countries are working on improving access for patients to certain innovative and expensive drugs. As well as benefiting patients by giving them access to drugs they would not otherwise have been able to obtain, these measures will have a positive impact on pharma by securing higher revenue streams for companies that manufacture them.
Your key questions answered
- Evaluate the key pricing, reimbursement, and regulatory issues in the 5EU markets and their impact on branded pharmaceutical market access and uptake
- Gain insight into the strategies employed by pharmaceutical companies in response to changes in the regulatory environment.
Strategic scoping and focus
Datamonitor key findings
Price cuts have been brought in under austerity measures
Pro-generic measures are threatening pharmaceutical companies' profit margins
Market access and reimbursement negotiation for novel drugs
Improved novel drug access will have a positive effect on pharma
FRANCE – PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
The failings of AFSSAPS are brought into the spotlight in
Clinical trials for new drugs must be conducted against active comparators
Pharmacovigilance is to be improved
Pharmaceutical companies will be required to pay a new industry tax
Sales representative visits to hospitals could be replaced by team visits
Other measures addressed by the reform bill
GERMANY – PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
Further clarity on Germany’s upcoming price negotiation agreement revealed
Companies may be required to submit a dossier without being requested to do so
Companies will need to negotiate with the G-BA on issues concerning the comparator
ITALY – PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
Italy’s new austerity measures will see re-introduction of patient co-pay
Italy sets new reference price reductions
AIFA makes it mandatory for regions to supply drugs from a centralized list
The number of counterfeit drugs is rising in Italy
SPAIN – PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
A new committee will take responsibility for examining cost-effectiveness
15% price cuts announced set to further impact pharmaceutical sales
Doctors must now prescribe by international non-proprietary name in Spain
New reference pricing groups are to be created
UK – PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
MHRA scheme to improve access to drugs is dropped
Disparities are appearing in cancer drug access
NHS reform plan continues to attract criticism
NHS reform plans continue to evolve in
Greater clarity on value-based pricing, but there is still some way to go
Off-label prescribing proposal is criticized by UK pharma
Department of Health ends price adjustment deal under PPRS
GPs given powers to make risk-sharing agreements directly with pharma
Publications and online articles
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