• Banzi R, Gerardi C, Bertele’ V, Garattini S. Approvals of drugs with uncertain benefit-risk profiles in Europe. Eur. 2015 Oct;J. INTERN. MED.. 26(8):572-84. PubMed: PM26342723
  • Barker RW, Garner S. Realising the potential of adaptive development of medicines. Rev Recent Clin Trials. 2015;10(1):19-24. PubMed: PM25925883
  • Boon W, Martins L, Koopmanschap M. Governance of conditional reimbursement practices in The Netherlands. Health Policy. 2015 Feb;119(2):180-5. PubMed: PM25467790
  • Brugger U, Horisberger B, Ruckstuhl A, Plessow R, Eichler K, Gratwohl A. Health technology assessment in Switzerland: a descriptive analysis of “Coverage with evidence Development” decisions from 1996 to 2013. BMJ Open. 2015;5(3):e007021, 2015. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4386218PubMed: PM25818273
  • Bubela T, McCabe C, Archibald P, Atkins H, Bradshaw S, Kefalas P, et al. Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regen Med. 2015 Oct;10(7):897-911. PubMed: PM26565607
  • Capkun G, Lahoz R, Verdun E, Song X, Chen W, Korn JR, et al. Expanding the use of administrative claims databases in conducting clinical real-world evidence studies in multiple sclerosis. Curr Med Res Opin. 2015 May;31(5):1029-39. PubMed: PM25661016
  • Clarke et al. Toward a Functional Definition of a “Rare Disease” for Regulatory Authorities and Funding Agencies. Value in Health. 2015; 17:757-761
  • Claxton K, Martin S, Soares M, Rice N, Spackman E, Hinde S, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015 Feb;19(14):1-503. PubMed: PM25692211
  • De Lusignan S, Crawford L, Munro N. Creating and using real-world evidence to answer questions about clinical effectiveness. J Innov Health Inform. 2015;22(3):368-73. PubMed: PM26577427
  • Drummond M. When do performance-based risk-sharing arrangements make sense? Eur J Health Econ. 2015 Jul;16(6):569-71. PubMed: PM25783211
  • Drummond M. Health technology assessment and its interface with regulation, policy and management. In: Llano-Searis JE, Campillo-Artero C, editors. Health technology assessment and health policy today: a multifaceted view of their unstable crossroads. New York: Springer; 2015. p. 3-14.
  • Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Borlum-Kristensen F, Brown J, et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. PubMed: PM25669457
  • Facey K, Henshall C, Sampietro-Colom L, Thomas S. IMPROVING THE EFFECTIVENESS AND EFFICIENCY OF EVIDENCE PRODUCTION FOR HEALTH TECHNOLOGY ASSESSMENT. Int J Technol Assess Health Care. 2015 Jan;31(4):201-6. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697336PubMed: PM26646858
  • Fernandez-Lopez S. FDA Draft Guidance on the Naming of Biosimilars. BioDrugs. 2015 Oct;29(5):323-5. PubMed: PM26481940
  • Ferrario A, Kanavos P. Dealing with uncertainty and high prices of new medicines: a comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Soc Sci Med. 2015 Jan;124:39-47PubMed: PM25461860
  • Gammie T, Lu CY, Babar ZU. Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries. PLoS One. 2015;10(10):e0140002, 2015. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4599885PubMed: PM26451948
  • Godman B, Malmstrom RE, Diogene E, Gray A, Jayathissa S, Timoney A, et al. Are new models needed to optimize the utilization of new medicines to sustain healthcare systems? Expert Rev Clin Pharmacol. 2015 Jan;8(1):77-94. PubMed: PM25487078
  • Halpin L, Savulescu J, Talbot K, Turner M, Talman P. Improving access to medicines: empowering patients in the quest to improve treatment for rare lethal diseases. J Med Ethics. 2015 Dec;41(12):987-9. PubMed: PM25889754
  • Hofer MP, Jakobsson C, Zafiropoulos N, Vamvakas S, Vetter T, Regnstrom J, et al. Regulatory watch: Impact of scientific advice from the European Medicines Agency. Nat Rev Drug Discov. 2015 May;14(5):302-3. PubMed: PM25881970
  • Hsu JC, Lu CY. The evolution of Taiwan’s National Health Insurance drug reimbursement scheme. Daru. 2015;23:15, 2015. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4333892PubMed: PM25889754
  • Hwang TJ and Ciolino JB. Retinal Implants and Medicare Reimbursement Policies for Breakthrough Treatments in Ophthalmology. JAMA Ophthalmology. 2015; 133: 373-374
  • Hwang TJ, Lehmann LS & Kesselheim AS. Precision medicine and the FDA’s draft guidance on laboratory-developed tests. Nature Biotechnology. 2015; 33 449-451
  • Jonsson B. Bringing in health technology assessment and cost-effectiveness considerations at an early stage of drug development. Mol Oncol. 2015 May;9(5):1025-33. PubMed: PM25454346
  • Kaiser T, Vervlgyi V & Wieseler B. Nutzenbewertung von Arzneimitteln, Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 2015;58: 232-239 [Note: Publication in German, title ‘Benefit assessment of drugs’, comments on joint HTA-Regulatory scientific advice]
  • Keane M. It’s time for change; commentary in response to feature article by Halpin et al. J Med Ethics. 2015 Dec;41(12):954-5. PubMed: PM24586023
  • Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015;351:h4633, 2015. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4580726PubMed: PM26400751
  • Levin L. EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES. Int J Technol Assess Health Care. 2015 Jan;31(4):207-9. PubMed: PM26560412
  • Lewis JR, Kerridge I, Lipworth W. Coverage with evidence Development and Managed Entry in the Funding of Personalized Medicine: Practical and Ethical Challenges for Oncology. J Clin Oncol. 2015 Dec 1;33(34):4112-7. PubMed: PM26460298
  • Leyens L, Richer E, Melien O, Ballensiefen W, Brand A. Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine. Public Health Genomics. 2015;18(5):249-59. PubMed: PM26316202
  • Liberti L, Stolk P, McAuslane N, Somauroo A, Breckenridge AM, Leufkens HG. Adaptive licensing and facilitated regulatory pathways: A survey of stakeholder perceptions. Clin Pharmacol Ther. 2015 Nov;98(5):477-9. PubMed: PM25877216
  • Lipska I, Hoekman J, McAuslane N, Leufkens HG, Hovels AM. Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions? Clin Pharmacol Ther. 2015 Nov;98(5):489-91. PubMed: PM26250656
  • Lu CY, Lupton C, Rakowsky S, Babar ZU, Ross-Degnan D, Wagner AK. Patient access schemes in Asia-pacific markets: current experience and future potential. J. 2015;pharm. policy pract.. 8(1):6, 2015. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359387PubMed: PM25815200
  • McCauley JL. Guidelines and Value-Based Decision Making: An Evolving Role for Payers. N c med j. 2015 Sep;76(4):243-6. PubMed: PM26509518
  • Menon D, Stafinski T, Nardelli A, Edwards A. Introduction of a new health technology into a provincial health system: A case study of insulin pump therapy. Healthc Manage Forum. 2015 Sep;28(5):210-4. PubMed: PM26227318
  • Messner DA, Towse A, Mohr P, Garau M. The future of comparative effectiveness and relative efficacy of drugs: an international perspective. J Comp Eff Res. 2015 4(4):419-27. PubMed: PM25730094
  • Milne CP, Cohen JP, Felix A, Chakravarthy R. Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry. Clin Ther. 2015 Aug;37(8):1852-8. PubMed: PM26143223
  • Moloney R, Mohr P, Hawe E, Shah K, Garau M, Towse A. PAYER PERSPECTIVES ON FUTURE ACCEPTABILITY OF COMPARATIVE EFFECTIVENESS AND RELATIVE EFFECTIVENESS RESEARCH. Int J Technol Assess Health Care. 2015 Jan;31(1-2):90-8. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4505735PubMed: PM26168804
  • Montilla S, Xoxi E, Russo P, Cicchetti A, Pani L. MONITORING REGISTRIES AT ITALIAN MEDICINES AGENCY: FOSTERING ACCESS, GUARANTEEING SUSTAINABILITY. Int J Technol Assess Health Care. 2015 Jan;31(4):210-3. PubMed: PM26646859
  • Parkinson B, Sermet C, Clement F, Crausaz S, Godman B, Garner S, et al. Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review. Pharmacoeconomics. 2015 Sep;33(9):905-24. PubMed: PM26048353
  • Rasi G, Bonini S. Innovative medicines: new regulatory procedures for the third millennium. Expert Opin Biol Ther. 2015;15 Suppl 1:S5-8. PubMed: PM25777774
  • Rawlins MD. National Institute for Clinical Excellence: NICE works. J R Soc Med. 2015 Jun;108(6):211-9. PubMed: PM26085559
  • Ridge JR, Statz S. Exact Sciences’ experience with the FDA and CMS parallel review program. Expert Rev Mol Diagn. 2015;15(9):1117-24. PubMed: PM26211481
  • Rosano GM, Anker SD, Marrocco W, Coats AJ. Adaptive licensing – A way forward in the approval process of new therapeutic agents in Europe. Int J Cardiol. 2015 Apr 1;184:568-9, PubMed: PM25767018
  • Rothenbacher D, Capkun G, Uenal H, Tumani H, Geissbuhler Y, Tilson H. New opportunities of real-world data from clinical routine settings in life-cycle management of drugs: example of an integrative approach in multiple sclerosis. Curr Med Res Opin. 2015 May;31(5):953-65. PubMed: PM25758179
  • Salmikangas P, Schuessler-Lenz M, Ruiz S, Celis P, Reischl I, Menezes-Ferreira M, et al. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective. Adv Exp Med Biol. 2015;871:103-30. PubMed: PM26374215
  • Scannell JW, Hinds S, Evans R. Financial returns on R&D: looking back at history, looking forward to adaptive licensing. Rev Recent Clin Trials. 2015;10(1):28-43. PubMed: PM25925881
  • Short H, Stafinski T, Menon D. A National Approach to Reimbursement Decision-Making on Drugs for Rare Diseases in Canada? Insights from Across the Ponds. Healthc Policy. 2015 May;10(4):24-46. PubMed: PM26142357
  • Simon R, Blumenthal GM, Rothenberg ML, Sommer J, Roberts SA, Armstrong DK, et al. The role of nonrandomized trials in the evaluation of oncology drugs. Clin Pharmacol Ther. 2015 May;97(5):502-7. PubMed: PM25676488
  • Sipp D. Conditional approval: Japan lowers the bar for regenerative medicine products. Cell Stem Cell. 2015 Apr 2;16(4):353-6. PubMed: PM25842975
  • Towse A, Garau M, Mohr P, Messner DA. Futurescapes: expectations in Europe for relative effectiveness evidence for drugs in 2020. J. 2015;comp. eff. res.. 4(4):401-18. PubMed: PM25740283
  • Tsoi B, O’Reilly D, Masucci L, Drummond M, Goeree R. Harmonization of HTA–based reimbursement and regulatory approval activities: a qualitative study. J Popul Ther Clin Pharmacol. 2015;22(1):e78-e89. PubMed: PM25715384
  • Vitry A, Nguyen T, Entwistle V, Roughead E. Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study. J. 2015;pharm. policy pract.. 8:25, 2015. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4610052PubMed: PM26483954