Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation
作者： Eduardo Diogene , Patricia Vella Bonanno , Michael Ermisch , Brian Godman , Antony Martin
关键词:
摘要: Medicines receiving a conditional marketing authorisation through Adaptive Pathways to Patients (MAPPs) will be challenge for payers. The ‘introduction’ of MAPPs is already seen by the European Agency (EMA) as fait accompli, with payers not consulted or involved. However, once medicines are approved MAPPs, they evaluated funding different activities. These include Health Technology Assessment (HTA) often immature clinical data and high uncertainty, financial considerations, negotiations types agreements, which can require monitoring post launch. Payers have experience new approval, fact that present additional challenges concern from their perspective. There may some activities where collaborate. final decisions on whether reimburse medicine via more variation than licensed conventional processes. This due only increasing uncertainty associated authorised but also differences in legal frameworks between member states. Moreover, if side-effect burden period approval until granting full shifted post-authorisation phase, bear such burdens. Collection robust during routine use challenging along prices collection. paper presents concept possible challenges.Concerns potential ways forward discussed number recommendations presented perspective
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sci-hub.se 参考文章(74)
Jerry Avorn, The $2.6 Billion Pill — Methodologic and Policy Considerations New England Journal of Medicine. ,vol. 372, pp. 1877- 1879 ,(2015) , 10.1056/NEJMP1500848
Bonny Parkinson, Catherine Sermet, Fiona Clement, Steffan Crausaz, Brian Godman, Sarah Garner, Moni Choudhury, Sallie-Anne Pearson, Rosalie Viney, Ruth Lopert, Adam G. Elshaug, Disinvestment and value-based purchasing strategies for pharmaceuticals: an international review PharmacoEconomics. ,vol. 33, pp. 905- 924 ,(2015) , 10.1007/S40273-015-0293-8
W Lipworth, I Kerridge, N Ghinea, If we don’t talk about value, cancer drugs will become terminal for health systems The Conversation. ,(2015)
Ayalew Tefferi, Hagop Kantarjian, S Vincent Rajkumar, Lawrence H Baker, Jan L Abkowitz, John W Adamson, Ranjana Hira Advani, James Allison, Karen H Antman, Robert C Bast, John M Bennett, Edward J Benz, Nancy Berliner, Joseph Bertino, Ravi Bhatia, Smita Bhatia, Deepa Bhojwani, Charles D Blanke, Clara D Bloomfield, Linda Bosserman, Hal E Broxmeyer, John C Byrd, Fernando Cabanillas, George Peter Canellos, Bruce A Chabner, Asher Chanan-Khan, Bruce Cheson, Bayard Clarkson, Susan L Cohn, Gerardo Colon-Otero, Jorge Cortes, Steven Coutre, Massimo Cristofanilli, Walter J Curran, George Q Daley, Daniel J DeAngelo, H Joachim Deeg, Lawrence H Einhorn, Harry P Erba, Francisco J Esteva, Elihu Estey, Isaiah J Fidler, James Foran, Stephen Forman, Emil Freireich, Charles Fuchs, James N George, Morie A Gertz, Sergio Giralt, Harvey Golomb, Peter Greenberg, Jordan Gutterman, Robert I Handin, Samuel Hellman, Paulo Marcelo Hoff, Ronald Hoffman, Waun Ki Hong, Mary Horowitz, Gabriel N Hortobagyi, Clifford Hudis, Jean Pierre Issa, Bruce Evan Johnson, Philip W Kantoff, Kenneth Kaushansky, David Khayat, Fadlo R Khuri, Thomas J Kipps, Margaret Kripke, Robert A Kyle, Richard A Larson, Theodore S Lawrence, Ross Levine, Michael P Link, Scott M Lippman, Sagar Lonial, Gary H Lyman, Maurie Markman, John Mendelsohn, Neal J Meropol, Yoav Messinger, Therese M Mulvey, Susan O’Brien, Roman Perez-Soler, Raphael Pollock, Josef Prchal, Oliver Press, Jerald Radich, Kanti Rai, Saul A Rosenberg, Jacob M Rowe, Hope Rugo, Carolyn D Runowicz, Brenda M Sandmaier, Alan Saven, Andrew I Schafer, Charles Schiffer, Mikkael A Sekeres, Richard T Silver, Lillian L Siu, David P Steensma, F Marc Stewart, Wendy Stock, Richard Stone, Rainer Storb, Louise C Strong, Martin S Tallman, Michael Thompson, Naoto T Ueno, Richard A Van Etten, Julie M Vose, Peter H Wiernik, Eric P Winer, Anas Younes, Andrew D Zelenetz, Charles A LeMaistre, None, In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs Mayo Clinic proceedings. Mayo Clinic. ,vol. 90, pp. 996- 1000 ,(2015) , 10.1016/J.MAYOCP.2015.06.001
Steven Simoens, Eline Picavet, Marc Dooms, David Cassiman, Thomas Morel, Cost-effectiveness assessment of orphan drugs: a scientific and political conundrum. Applied Health Economics and Health Policy. ,vol. 11, pp. 1- 3 ,(2013) , 10.1007/S40258-012-0004-Y
Govin Permanand, Hanne Bak Pedersen, Managing new premium-priced medicines in Europe Journal of Pharmaceutical Policy and Practice. ,vol. 8, pp. 1- 3 ,(2015) , 10.1186/2052-3211-8-S1-K2
Rita Banzi, Chiara Gerardi, Vittorio Bertele', Silvio Garattini, Approvals of drugs with uncertain benefit-risk profiles in Europe. European Journal of Internal Medicine. ,vol. 26, pp. 572- 584 ,(2015) , 10.1016/J.EJIM.2015.08.008
H‐G Eichler, LG Baird, R Barker, B Bloechl‐Daum, F Børlum‐Kristensen, J Brown, R Chua, S Del Signore, U Dugan, J Ferguson, S Garner, W Goettsch, J Haigh, P Honig, A Hoos, P Huckle, T Kondo, Y Le Cam, H Leufkens, R Lim, C Longson, M Lumpkin, J Maraganore, B O'Rourke, K Oye, E Pezalla, F Pignatti, J Raine, G Rasi, T Salmonson, D Samaha, S Schneeweiss, PD Siviero, M Skinner, JR Teagarden, T Tominaga, MR Trusheim, S Tunis, TF Unger, S Vamvakas, G Hirsch, From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clinical Pharmacology & Therapeutics. ,vol. 97, pp. 234- 246 ,(2015) , 10.1002/CPT.59
Tomas Forslund, Pauline Raaschou, Paul Hjemdahl, Ingvar Krakau, Björn Wettermark, Usage, Risk, and Benefit of Weight-Loss Drugs in Primary Care Journal of Obesity. ,vol. 2011, pp. 459263- 459263 ,(2011) , 10.1155/2011/459263
Steven Simoens, How to assess the value of medicines Frontiers in Pharmacology. ,vol. 1, pp. 115- 115 ,(2010) , 10.3389/FPHAR.2010.00115