BRUSSELS, Jan 28 (APM) - A potential bridge across the "nightmare" gap between marketing authorisation and pricing in Europe was proposed in the European Parliament on Tuesday, during a conference on improving access to cancer treatments.
Francesco Perrone of the Italian National Cancer Institute, and one of the advisors to the Italian medicines agency on its reimbursement -by-results strategy for new drugs, highlighted the chaotic condition of Europe's drug market.
He directed his criticisms at the increasingly evident inconsistency between the transparency of Europe-wide authorisations via the European Medicines Agency, and the relative opacity and idiosyncracy of national drug-payment systems.
He said it was time for the EMA to become involved in pricing decisions too - for the sake of healthcare funding and for the sake of companies too.
"When the European Commission grants an authorisation via the European Medicines Agency, it is a statement that is valid right across the EU that the new drug is effective and safe", said Perrone, "but as soon as the company seeks reimbursement, Europe explodes into 28 different countries".
Only a few countries arrive rapidly at a decision regarding reimbursement, he pointed out. Some allow the use of the drug straight away, but without any reimbursement, some have special funds for innovative drugs ("but they are never enough - as the Cancer Drugs Fund in the UK demonstrates"), and "many countries spend a long time to define their policy", said Perrone.
Companies consequently face the "nightmare" of multiple national commissions and expert committees, mostly conducting lower-quality repeats of the assessment already done by the EMA, supported by "a few health technology assessment bodies working on limited and weak data with little consultative value".
"Fruitless sessions of negotiation" confer "little transparency (if any) in the way the price is decided", and the result is that the reimbursement allowed for similar products can vary by wide margins - often presenting healthcare funds with heavy burdens from exorbitant prices.
If healthcare authorities do not exercise greater care, there is a risk that funds will be exhausted, even in richer countries. But the standard defensive cost-saving measures such as deferring decisions, or refusing reimbursement for new drugs that offer only incremental benefits, are not the right answer, according to Perrone.
That way, patients lose out in access, physicians face restricted prescribing options, health authorities risk unpopularity and the pharmaceutical industry suffers uncertainty and delays in obtaining returns on investment, he said.
Instead, said Perrone, the price of a product should be discussed by the EMA at the earliest stages of assessment. This would make it possible to fix a value correlated - through a technical discussion - with the added benefit of the drug.
That EMA evaluation would then serve as a reference for the price in each member state, which would be automatically adjusted on the basis of agreed criteria such as national GDP. The system would be underpinned by an EU regulation, permitting immediate EU-wide release of the medicine.
The outcome would be faster access, fairer prices, and - in the long run - lower costs, since the higher volumes resulting from wider access to the medicine would translate into lower unit prices.
Perrone's suggestions come at a critical moment in EU thinking on drug access and pricing, with the EMA's pilot on adaptive pathways prompting renewed reflections on the need for closer coordination between marketing authorisation procedures and reimbursement.
As Perrone himself concluded, "changing times can make feasible what has not seemed possible before".
pod/rs
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
