The good news is that if a company has been proactively addressing the other pitfalls we’ve described, then it will already be on track to successfully generate and communicate data supporting each country’s reimbursement decision. These can include the collection of patient reported outcomes and / or planning for real word data generation post-approval to close existing data gaps.
#Ema meaning trial#
Other requirements that can be crucial to patient access in Europe are often neglected during pivotal trial design. Such errors can cause a therapy to be less favorably assessed during HTAs, with decision-makers seeing the therapy as representing “no clinical improvement.” In these cases, subsequent pricing negotiations will be negatively impacted (or perhaps fail altogether), and products can ultimately be pulled from otherwise lucrative markets. Or, they failed to look ahead and by the date of launch, the original comparator was not appropriate because the standard of care had changed. For example, there have been cases when pharma companies have designed late-stage clinical trials that used comparators that were not relevant for key European markets. Next to the requirements outlined in pitfall #2 related to meeting efficacy and safety requirements, manufacturers need to think carefully about the endpoints and evidence that will be relevant to payers. If the submitted data package does not support a positive decision from each country’s HTA, then a product is at risk of partial reimbursement or even no reimbursement at all. However, a marketing authorization does not grant a product reimbursed access to patients.Įach country has individual requirements for reimbursement, with independent Health Technology Assessments (HTAs) being used to support decision-making. CHMP makes a recommendation and then passes it on to the European Commission (EC), which makes the final decision on whether a product can be marketed. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is specifically responsible for pharmaceuticals. The EU equivalent of the FDA, the European Medicines Agency (EMA), is responsible for evaluating the efficacy and safety of medicinal products. In the EU, regulatory approval and reimbursement are more stepwise and decoupled. If a product is FDA approved, then Medicare / Medicaid and private insurance coverage will naturally follow. In the US, FDA approval is essentially interchangeable with broad reimbursement.
Pitfall #4 – Believing EMA marketing authorization = patient access Why It’s Important In this installment, we address pitfall #4. Caring too late about your infrastructure.Using individual preferences vs analysis to select HQ location.Building like big pharma when you’re not.Failing to realize that EAPs can boost…or bite.Not making the right European connections.Missing the mark with local health technology assessment (HTA).Thinking your list price won’t cross borders.Believing EMA marketing authorization = patient access.Missing the opportunity of conditional marketing authorization.Not realizing Europe may have its own clinical endpoints in mind.
Not knowing what it takes to “go it alone” across Europe.
#Ema meaning series#
In this ongoing series of articles, we are outlining the 12 most common pitfalls that biopharma companies experience as they enter European markets: The stakes are high, and there are many pitfalls to avoid.
#Ema meaning how to#
Europe is attractive for various reasons, including its large population, high per-capita spend on healthcare, and vast market potential.īut successfully entering Europe is a complex undertaking, and biopharma companies need to know how to safely navigate the process. on November 4th, 2021.Īt some point in its development, any growth-minded non-European biopharma company will look to Europe as a possible source of new opportunity. Posted by Suzanna van Straaten and Theofanis Manolikas, Dr.
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