{"id":2526,"date":"2017-12-07T10:00:39","date_gmt":"2017-12-07T09:00:39","guid":{"rendered":"http:\/\/ceptonstrategies.com\/en\/?p=2526"},"modified":"2019-08-07T16:00:34","modified_gmt":"2019-08-07T15:00:34","slug":"11-things-innovative-healthcare-firms-must-know-planning-launch-europe","status":"publish","type":"post","link":"https:\/\/ceptonstrategies.com\/en\/11-things-innovative-healthcare-firms-must-know-planning-launch-europe\/","title":{"rendered":"11 things innovative healthcare firms must know when planning to launch in Europe"},"content":{"rendered":"

1.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0EMA and FDA do not have the same requirements when evaluating a registration file. Anticipate the design of your phase 2 and 3 clinical trials to account of these differences.<\/p>\n

2.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Every European country has a specific healthcare system, with variations of reimbursement procedures and requirements (timing, dossier, price). Reimbursement decisions will be made by a combination of regional and national committees: national has precedence in some countries like France but regions can be the main decision-makers in other countries like Germany or Italy, despite using guidelines issued by national committees.<\/p>\n

3.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Medical practices are rather homogeneous across Europe. There is generally a European Expert Society for each therapeutic area, gathering members of national societies. Therefore, practitioners usually follow the same guidelines, published by these European Expert Societies.<\/p>\n

4.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0There are numerous patient advocacy groups and associations, organized at the regional, national, and pan-national level. In some disease areas, such as AIDS, these groups can be quite influential. This is true both in the US and the EU, and it is normal for groups focused on the same areas to exist on both continents.<\/p>\n

5.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0The registration procedure (CE mark) for medical devices and diagnostics is more simple and straightforward than in the US, but reimbursement is country-dependent and may be quite slow (up to several years). However, regulations are changing, and the registration process will become more demanding for Class 2b and 3 devices. Read more here. <\/a><\/p>\n

6.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0For diagnostics, there is no such thing in Europe as the LDT status allowing quick commercialization on a limited scope through CLIA labs.<\/p>\n

7.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Depending on disease areas, your commercial model will be different across countries. You will generally have to be more payor-centered in Northern Europe and more physician-centered in Southern Europe, with several countries such as Germany standing in-between.<\/p>\n

8.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0All European payors will demand comparative trial data with the standard of care. This will have tremendous implications on your trial design and must be anticipated.<\/p>\n

9.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0HEOR studies may be quite useful in some countries but not relevant in others due to different funding processes and stakeholders, or different evaluation methodologies at national level. For example, France’s HAS does not fully recognize QUALYs as a valid outcome measure.<\/p>\n

10.\u00a0\u00a0\u00a0Private health insurance companies have little influence over the reimbursement process of most drugs and devices. They usually follow the decisions of the National Healthcare System.<\/p>\n

11.\u00a0\u00a0\u00a0For most drugs, a certain launch sequence has to be followed in order to maximize reimbursement prices. You must start with countries with fast processes and high historical prices, and end with low-price and\/or slow countries such as Italy, Spain or Eastern European countries.<\/p>\n

<\/p>","protected":false},"excerpt":{"rendered":"

1.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0EMA and FDA do not have the same requirements when evaluating a registration file. Anticipate the design of your phase 2 and 3 clinical trials to account of these differences. 2.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Every European country has a specific healthcare system, with variations of reimbursement procedures and requirements (timing, dossier, price). Reimbursement decisions will be made by a […]<\/p>\n","protected":false},"author":4,"featured_media":2528,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[70],"tags":[],"yoast_head":"\n11 things innovative healthcare firms must know when planning to launch in Europe – Consulting Firm in Pharmaceutical, MedTech & Healthcare<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ceptonstrategies.com\/en\/11-things-innovative-healthcare-firms-must-know-planning-launch-europe\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"11 things innovative healthcare firms must know when planning to launch in Europe – Consulting Firm in Pharmaceutical, MedTech & Healthcare\" \/>\n<meta property=\"og:description\" content=\"1.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0EMA and FDA do not have the same requirements when evaluating a registration file. Anticipate the design of your phase 2 and 3 clinical trials to account of these differences. 2.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Every European country has a specific healthcare system, with variations of reimbursement procedures and requirements (timing, dossier, price). 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