Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS RESOURCES PUBLICATIONS ADVANCED THERAPIES IN THE EU: CHALLENGES WITH HTA AND REAL-WORLD EVIDENCE Publication Market Access ADVANCED THERAPIES IN THE EU: CHALLENGES WITH HTA AND REAL-WORLD EVIDENCE Market access aims to make a health technology not only available and affordable for every patient, but also profitable for the company placing it on the market. Indeed, where a health technology is unprofitable, it does not stay long on the market and becomes unavailable to patients. With advanced therapy medicinal products (ATMPs, or advanced therapies) this is unfortunately common. As of November 2020, five of the 15 ATMPs approved by the European Commission (ChondroCelect®, Glybera®, MACI®, Provenge®, Zalmoxis®) have been withdrawn from the European market, primarily because reimbursement was denied. ATMPs create a lot of hope for patients and a lot of worries for public budget holders. Due to their characteristics, they are expensive to develop, produce and to follow up after administration. Their expedited development plans and limited evidence packages at marketing authorisation can make value assessment challenging for health technology assessment (HTA) bodies. This article aims to shed light on the success factors to obtain – in the best timelines – and maintain positive HTA recommendations in Europe. It focuses on some of the larger European economies, namely England, Germany, and France, and refers to Italy’s pay-by-result expertise when dealing with post-launch evidence generation. Published on: Jun 01, 2021 DOWNLOAD THE FULL PUBLICATION NOW Fill in the form to download the content --- Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d'Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Islands Poland Portugal Puerto Rico Qatar Rennes st Gregoire Romania Russian Federation Rwanda Réunion Saint Barthélémy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Sri Lanka State of Palestine Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria São Tomé and Príncipe Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu USA Minor Outlying Islands Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (USA) Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Select your country...* *I have read and agreed to the Terms of Use and the Privacy Policy. Yes, I would like to receive communications regarding VCLS services and events UNLOCK DOWNLOAD PUBLICATION BY Gabrielle Nayroles, M.Sc. Director, Market Access As a Director in the Market Access team, Gabrielle is responsible for conducting market access analyses and providing recommendations and… View profile Henrike Granzow, M.Sc. Director, Market Access As a Director in the Market Access Team, Henrike is responsible for developing successful market access and reimbursement strategies, on… View profile Chris Wilson, M.Sc., MTOPRA Senior Director, Drugs & Biologics As Senior Director Regulatory Science, Drugs, and Biologics Chris provides leadership and support across Market Access, Regulatory, and Medical / Regulatory Writing functions. In… View profile ALL OUR RESOURCES Blog Glossary Presentations Publications Webinars Whitepapers Case Studies ALL OUR RESOURCES MORE RESOURCES Brexit Cell & Gene Therapy Clinical Trials Digital health EMA FDA IVD IVD Market Access Medical Device Microbiome Orphan & Rare Disease Paediatric BROWSE BY TOPIC... WEBINAR IVD Ask the experts: Will you be ready for the new IVD regulation? The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies… PUBLICATION IVD IVDR Readiness Checklist In the blog post “IVD Directive to IVD Regulation Transition – 8 months remaining”, my colleague outlined some key focus… BLOG Market Access Social Security Finance Bill 2021 in France: Reform on early access to health technologies What… The PLFSS 2021 law was voted but all decrees are not yet published. Ongoing discussions with the CEPS (Pricing Committee)… WEBINAR Cell & Gene Therapy Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its… GET IN TOUCH --- Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d'Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Islands Poland Portugal Puerto Rico Qatar Rennes st Gregoire Romania Russian Federation Rwanda Réunion Saint Barthélémy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Sri Lanka State of Palestine Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria São Tomé and Príncipe Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu USA Minor Outlying Islands Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (USA) Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Select your country...* --- Search Engine Conference Referral Social Media (LinkedIn, Twitter) Webinar Neighborhood Event Neighborhood Website How did you hear about us ?* --- Biologic Drugs Cell, Gene and Tissue Therapy Chemical Drugs Classical Medical Device Combination Product Digital Medical Device E-Health/M-Health IVDs & CDx Microbiome-based Products Vaccines Other Product type...* *I have read and agreed to the Terms of Use and the Privacy Policy. Yes, I would like to receive communications regarding VCLS services and events SEND VCLS INSIGHTS Blog Events Presentations Publications Whitepapers Webinars ABOUT Who We Are What We Do Team Jobs Life at VCLS Neighborhood VCLS © 1997 - 2021 - ALL RIGHTS RESERVED SITE MAP PRIVACY POLICY TERMS OF USE FOLLOW US ON SOCIAL MEDIA