Barriers for access to new medicines: Searching for the balance between rising costs and limited budgets

Frontiers in Public Health

Volumn 6, Issue DEC, 2018, Pages

  Godman, Brian ^a,b,c,d   Bucsics, Anna ^e   Bonanno, Patricia Vella ^a   Oortwijn, Wija ^f,g   Rothe, Celia C ^h   Ferrario, Alessandra ⁱ   Bosselli, Simone ^j   Hill, Andrew ^k   Martin, Antony P ^b,l   Simoens, Steven ^m   Kurdi, Amanj ^a,n   Gad, Mohamed ^o   Gulbinovič, Jolanta ^p   Timoney, Angela ^a,q   Bochenek, Tomasz ^h   Salem, Ahmed ^r   Hoxha, Iris ^s   Sauermann, Robert ^t   Massele, Amos ^u   Guerra, Augusto Alfonso ^v   Petrova, Guenka ^w   Mitkova, Zornitsa ^w   Achniotou, Gnosia ^x   Laius, Ott ^y   Sermet, Catherine ^z   Selke, Gisbert ^aa   Kourafalos, Vasileios ^ab   Yfantopoulos, John ^ac   Magnusson, Einar ^ad   Joppi, Roberta ^ae   Oluka, Margaret ^af   Kwon, Hye Young ^ag   Jakupi, Arianit ^ah   Kalemeera, Francis ^ai   Fadare, Joseph O ^aj   Melien, Oyvind ^ak   Pomorski, Maciej ^al   Wladysiuk, Magdalene ^am   Markovic Pekovic, Vanda ^an,ao   Mardare, Ileana ^ap   Meshkov, Dmitry ^aq   Novakovic, Tanja ^ar   Fürst, Jurij ^as   Tomek, Dominik ^at   Zara, Corrine ^au   Diogene, Eduardo ^av   Meyer, Johanna C ^d   Malmström, Rickard ^c   Wettermark, Björn ^c,aw   Matsebula, Zinhle ^ax   Campbell, Stephen ^ay   Haycox, Alan ^b   more..

^a UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^b UNIVERSITY OF LIVERPOOL MANAGEMENT SCHOOL   (United Kingdom)

^c KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^d SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY   (South Africa)

^e Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA)   (Belgium)

^f ECORYS Netherlands   (Netherlands)

^g RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^h JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

ⁱ HARVARD MEDICAL SCHOOL   (United States)

^j Plateforme Maladies Rares   (France)

^k UNIVERSITY OF LIVERPOOL   (United Kingdom)

^l The Innovation Centre   (United Kingdom)

^m UNIVERSITY OF LEUVEN   (Belgium)

ⁿ HAWLER MEDICAL UNIVERSITY   (Iraq)

^o IMPERIAL COLLEGE LONDON   (United Kingdom)

^p VILNIUS UNIVERSITY   (Lithuania)

^q NHS LOTHIAN   (United Kingdom)

^r IQVIA   (United States)

^s University of Tirana Faculty of Medicine   (Albania)

^t Hauptverband der Osterreichischen Sozialversicherungstrager   (Austria)

^u UNIVERSITY OF BOTSWANA   (Botswana)

^v FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

^w MEDICAL UNIVERSITY OF SOFIA   (Bulgaria)

^x Health Insurance Organisation   (Cyprus)

^y State Agency of Medicines   (Estonia)

^z Institute for Research and Information in Health Economics   (France)

^aa Wissenschaftliches Institut der AOK WIdO   (Germany)

^ab Medicines Division   (Greece)

^ac UNIVERSITY OF ATHENS   (Greece)

^ad Ministry of Health   (Iceland)

^ae Pharmaceutical Drug Department   (Italy)

^af UNIVERSITY OF NAIROBI   (Kenya)

^ag Mokwon University   (South Korea)

^ah UNIVERSITY FOR BUSINESS AND TECHNOLOGY   (Serbia)

^ai UNIVERSITY OF NAMIBIA   (Namibia)

^aj EKITI STATE UNIVERSITY   (Nigeria)

^ak NORWEGIAN INSTITUTE OF PUBLIC HEALTH   (Norway)

^al Agency for Health Technology Assessment in Poland   (Poland)

^am HTA CONSULTING   (Poland)

^an MINISTRY OF HEALTH AND SOCIAL WELFARE   (Bosnia and Herzegovina)

^ao UNIVERSITY OF BANJA LUKA   (Bosnia and Herzegovina)

^ap CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^aq N A SEMASHKO NATIONAL RESEARCH INSTITUTE OF PUBLIC HEALTH   (Russian Federation)

^ar ZEM Solutions ^*  (Serbia)

^as Health Insurance Institute   (Slovenia)

^at SLOVAK MEDICAL UNIVERSITY   (Slovakia)

^au C Agy Hlth Technol Assess Res   (Spain)

^av HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^aw STOCKHOLM COUNTY COUNCIL   (Sweden)

^ax Raleigh Fitkin Memorial Hospital   (Swaziland)

^ay UNIVERSITY OF MANCHESTER   (United Kingdom)

more..

Author keywords

Cancer; Financing; Health policy; Managed entry; New models; Orphan diseases; Pharmaceuticals

Indexed keywords

EID: 85059234435     PISSN: None     EISSN: 22962565     Source Type: Journal    
DOI: 10.3389/fpubh.2018.00328     Document Type: Review

References (283)

1. Garattini S, Bertele V, Godman B, Haycox A, Wettermark B, Gustafsson LL. Enhancing the rational use of new medicines across European health care systems. Eur J Clin Pharmacol. (2008) 64:1137-8. doi: 10.1007/s00228-008-0537-z
2. 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) 8:77-94. doi: 10.1586/17512433.2015.990380
3. Malmstrom RE, Godman BB, Diogene E, Baumgartel C, Bennie M, Bishop I, et al. Dabigatran-a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Front Pharmacol. (2013) 4:39. doi: 10.3389/fphar.2013.00039
4. Kaplan W, Wirtz V, Mantel-Teeuwisse A, Stolk P, Duthey P, Laing R. Priority Medicines for Europe and the World. 2013 Update. Available online at: http://www.who.int/medicines/areas/priority_medicines/MasterDocJune28_FINAL_Web.pdf
5. Irazola VE, Gutierrez L, Bloomfield G, Carrillo-Larco RM, Dorairaj P, Gaziano T, et al. Hypertension prevalence, awareness, treatment, and control in selected LMIC communities: results from the NHLBI/UHG Network of Centers of Excellence for Chronic Diseases. Global Heart (2016) 11:47-59. doi: 10.1016/j.gheart.2015.12.008
6. International Diabetes Federation. IDF Diabetes Atlas. 8th ed. (2017). Available online at: http://www.diabetesatlas.org
7. Cameron A, Ewen M, Ross-Degnan D, Ball D, Laing R. Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet (2009) 373:240-9. doi: 10.1016/S0140-6736(08)61762-6
8. Ofori-Asenso R, Agyeman AA. Irrational use of medicines-A summary of key concepts. Pharmacy (2016) 4:35. doi: 10.3390/pharmacy4040035
9. Mbui JM, Oluka MN, Guantai EM, Sinei KA, Achieng L, Baker A, et al. Prescription patterns and adequacy of blood pressure control among adult hypertensive patients in Kenya; findings and implications. Expert Rev Clin Pharmacol. (2017) 10:1263-71. doi: 10.1080/17512433.2017.1371590
10. Atieno OM, Opanga S, Martin A, Kurdi A, Godman B. Pilot study assessing the direct medical cost of treating patients with cancer in Kenya; findings and implications for the future. J Med Econ. (2018) 21:878-87. doi: 10.1080/13696998.2018.1484372
11. Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. (2014) 73:198-206. doi: 10.1136/annrheumdis-2012-202603
12. Kostic M, Djakovic L, Sujic R, Godman B, Jankovic SM. Inflammatory Bowel Diseases (Crohn s Disease and Ulcerative Colitis): Cost of Treatment in Serbia and the Implications. Appl Health Econ Health Policy (2017) 15:85-93. doi: 10.1007/s40258-016-0272-z
13. Goldstein DA, Clark J, Tu Y, Zhang J, Fang F, Goldstein R, et al. A global comparison of the cost of patented cancer drugs in relation to global differences in wealth. Oncotarget (2017) 8:71548-55. doi: 10.18632/oncotarget.17742
14. Kwon H-Y, Kim H, Godman B. Availability and affordability of drugs with a conditional approval by the European Medicines Agency; Comparison of Korea With Other Countries and the implications. Front Pharmacol. (2018) 9:938. doi: 10.3389/fphar.2018.00938
15. OECD. Health at a Glance 2017-OECD Indicators. Available online at: https://read.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2017_health_glance-2017-en#page1
16. Brennan T, Shrank W. New expensive treatments for hepatitis C infection. JAMA (2014) 312:593-4. doi: 10.1001/jama.2014.8897
17. de Bruijn W, Ibanez C, Frisk P, Bak Pedersen H, Alkan A, Vella Bonanno P, et al. Introduction and utilization of high priced HCV medicines across Europe; implications for the future. Front Pharmacol. (2016) 7:197. doi: 10.3389/fphar.2016.00197
18. Ma CKK, Danta M, Day R, Ma DDF. Dealing with the spiralling price of medicines: issues and solutions. Intern Med J. (2018) 48:16-24. doi: 10.1111/imj.13652
19. Husereau D, Henshall C, Sampietro-Colom L, Thomas S. Changing health technology assessment paradigms? Int J Technol Assess Health Care (2016) 32:191-9. doi: 10.1017/S0266462316000386
20. Phelan M, Cook C. A treatment revolution for those who can afford it? Hepatitis C treatment: new medications, profits and patients. BMC Infect Dis. (2014) 14(Suppl. 6):S5. doi: 10.1186/1471-2334-14-S6-S5
21. Andrieux-Meyer I, Cohn J, de Araujo ES, Hamid SS. Disparity in market prices for hepatitis C virus direct-acting drugs. Lancet Global Health (2015) 3:e676-7. doi: 10.1016/S2214-109X(15)00156-4
22. Kelly RJ, Smith TJ. Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care. Lancet Oncol. (2014) 15:e112-8. doi: 10.1016/S1470-2045(13)70578-3
23. Prasad V, Wang R, Afifi SH, Mailankody S. The rising price of cancer drugs-A new old problem? JAMA Oncol. (2017) 3:277-78. doi: 10.1001/jamaoncol.2016.4275
24. ACS Chemical-Neurosciences. New 2016 Data and Statistics for Global Pharmaceutical Products and Projections through 2017. Available online at: https://pubs.acs.org/doi/pdfplus/10.1021/acschemneuro.7b00253
25. Kantarjian HM, Fojo T, Mathisen M, Zwelling LA. Cancer drugs in the United States: Justum Pretium-the just price. J Clin Oncol. (2013) 31:3600-4. doi: 10.1200/JCO.2013.49.1845
26. Dusetzina SB. drug pricing trends for orally administered anticancer medications reimbursed by commercial health plans, 2000-2014. JAMA Oncol. (2016) 2:960-1. doi: 10.1001/jamaoncol.2016.0648
27. Gordon N, Stemmer SM, Greenberg D, Goldstein DA. Trajectories of Injectable Cancer Drug Costs After Launch in the United States. J Clin Oncol. (2018) 36:319-5. doi: 10.1200/JCO.2016.72.2124
28. Gyawali B, Sullivan R. Economics of cancer medicines: for whose benefit? New Bioeth (2017) 23:95-104. doi: 10.1080/20502877.2017.1314885
29. IMS Institute for Healthcare Informatics. Global Oncology Trend Report. A Review of 2015 and Outlook to 2020. (2016). Available online at: https://morningconsult.com/wp-content/uploads/2016/06/IMS-Institute-Global-Oncology-Report-05.31.16.pdf
30. Chalkidou K, Marquez P, Dhillon PK, Teerawattananon Y, Anothaisintawee T, Gadelha CA, et al. Evidence-informed frameworks for cost-effective cancer care and prevention in low, middle, and high-income countries. Lancet Oncol. (2014) 15:e119-31. doi: 10.1016/S1470-2045(13)70547-3
31. New drugs and indications in 2011. France is better focused on patients' interests after Mediator° scandal, but stagnation elsewhere. Prescrire Int. (2012) 21:106-7
32. Editorial. New drugs, new indications in 2015: little progress, and threats to access to quality healthcare for all. Rev Prescrire (2016) 36:132-7
33. Godman B, Oortwijn W, de Waure C, Mosca I, Puggina A, Specchia ML, et al. Links between Pharmaceutical R&D Models and Access to Affordable Medicines. A Study for the ENVI COMMITTEE. Available online at: http://www.europarl.europa.eu/RegData/etudes/STUD/2016/587321/IPOL_STU(2016)587321_EN.pdf
34. WHO. Access to New Medicines in Europe: Technical Review of Policy Initiatives and Opportunities for Collaboration and Research. Available online at: http://www.euro.who.int/__data/assets/pdf_file/0008/306179/Access-new-medicines-TR-PIO-collaboration-research.pdf?ua=1
35. Editorial. New products and new indications in 2016: a system that favours imitation over the pursuit of real progres. Rev Prescrire (2017) 37:132-6
36. Haycox A. Why Cancer? Pharmacoeconomics (2016) 34:625-7. doi: 10.1007/s40273-016-0413-0
37. Simoens S, Picavet E, Dooms M, Cassiman D, Morel T. Cost-effectiveness assessment of orphan drugs: a scientific and political conundrum. Appl Health Econ Health Policy (2013) 11:1-3. doi: 10.1007/s40258-012-0004-y
38. Prasad V. Do cancer drugs improve survival or quality of life? BMJ (2017) 359:j4528. doi: 10.1136/bmj.j4528
39. Cohen D. Cancer drugs: high price, uncertain value. BMJ (2017) 359:j4543. doi: 10.1136/bmj.j4543
40. Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ (2017) 359:j4530. doi: 10.1136/bmj.j4530
41. Grössmann N, Wild C. Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval? ESMO Open (2017) 1:e000125. doi: 10.1136/esmoopen-2016-000125
42. Del Paggio JC, Azariah B, Sullivan R, Hopman WM, James FV, Roshni S, et al. Do contemporary randomized controlled trials Meet ESMO thresholds for meaningful clinical benefit? Ann Oncol. (2017) 28:157-62. doi: 10.1093/annonc/mdw538
43. Hill A, Gotham D, Fortunak J, Meldrum J, Erbacher I, Martin M, et al. Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment. BMJ Open (2016) 6:e009586. doi: 10.1136/bmjopen-2015-009586
44. Hill A, Redd C, Gotham D, Erbacher I, Meldrum J, Harada R. Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis. BMJ Open (2017) 7:e011965. doi: 10.1136/bmjopen-2016-011965
45. Pauwels K, Huys I, Casteels M, Larsson K, Voltz C, Penttila K, et al. Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012. Orphanet J Rare Dis. (2017) 12:36. doi: 10.1186/s13023-017-0578-4
46. Henrard S, Arickx F. Negotiating prices of drugs for rare diseases. Bull World Health Organ. (2016) 94:779-81. doi: 10.2471/BLT.15.163519
47. Brau R, Tzeng I. Orphan Drug Commercial Models. Available online at: https://www.lifescienceleader.com/doc/orphan-drug-commercial-models-0001
48. Simoens S, Huys I. Market access of Spinraza (Nusinersen) for spinal muscular atrophy: intellectual property rights, pricing, value and coverage considerations. Gene Ther. (2017) 24:539-41. doi: 10.1038/gt.2017.79
49. Luzzatto L, Hyry HI, Schieppati A, Costa E, Simoens S, Schaefer F, et al. Outrageous prices of orphan drugs: a call for collaboration. Lancet (2018) 392:791-4. doi: 10.1016/S0140-6736(18)31069-9
50. EURODIS. Breaking the Access Deadlock to Leave No One Behind. A Contribution by EURORDIS and Its Members on Possibilities for Patients' Full and Equitable Access to Rare Disease Therapies in Europe. (2018). Available online at: https://www.eurordis.org/sites/default/files/reflexion-paper.pdf
51. Heon-Klin V. European Reference networks for rare diseases: what is the conceptual framework? Orphanet J Rare Dis. (2017) 12:137. doi: 10.1186/s13023-017-0676-3
52. European Commission. European Reference Networks. Available online at: https://ec.europa.eu/health/sites/health/files/ern/docs/2017_brochure_en.pdf
53. Ermisch M, Bucsics A, Vella Bonanno P, Arickx F, Bybau A, Bochenek T, et al. Payers' views of the changes arising through the possible adoption of adaptive pathways. Front Pharmacol. (2016) 7:305. doi: 10.3389/fphar.2016.00305
54. Vella Bonanno P, Ermisch M, Godman B, Martin AP, Van Den Bergh J, Bezmelnitsyna L, et al. Adaptive pathways: possible next steps for payers in preparation for their potential implementation. Front Pharmacol. (2017) 8:497. doi: 10.3389/fphar.2017.00497
55. Godman B, Finlayson AE, Cheema PK, Zebedin-Brandl E, Gutierrez-Ibarluzea I, Jones J, et al. Personalizing health care: feasibility and future implications. BMC Med. (2013) 11:179. doi: 10.1186/1741-7015-11-179
56. Rosenthal ET, Evans B, Kidd J, Brown K, Gorringe H, van Orman M, et al. Increased identification of candidates for high-risk breast cancer screening through expanded genetic testing. J Am Coll Radiol. (2017) 14:561-8. doi: 10.1016/j.jacr.2016.10.003
57. George A, Riddell D, Seal S, Talukdar S, Mahamdallie S, Ruark E, et al. Implementing rapid, robust, cost-effective, patient-centred, routine genetic testing in ovarian cancer patients. Sci Rep. (2016) 6:29506. doi: 10.1038/srep29506
58. Leopold C, Vogler S, Habl C, Mantel-Teeuwisse AK, Espin J. Personalised medicine as a challenge for public pricing and reimbursement authorities-A survey among 27 European countries on the example of trastuzumab. Health Policy (2013) 113:313-22
59. Godman B, Malmstrom RE, Diogene E, Jayathissa S, McTaggart S, Cars T, et al. Dabigatran-a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs. Front Pharmacol. (2014) 5:109. doi: 10.3389/fphar.2014.00109
60. Cohen D. Dabigatran: how the drug company withheld important analyses. BMJ (2014) 349:g4670. doi: 10.1136/bmj.g4670
61. Sinigoj P, Malmstrom RE, Vene N, Ronquist-Nii Y, Bozic-Mijovski M, Pohanka A, et al. Dabigatran concentration: variability and potential bleeding prediction in 'real-life' patients with atrial fibrillation. Basic Clin Pharmacol Toxicol. (2015) 117:323-9. doi: 10.1111/bcpt.12417
62. Pauwels K, Huys I, Vogler S, Casteels M, Simoens S. Managed entry agreements for oncology drugs: lessons from the european experience to inform the future. Front Pharmacol. (2017) 8:171. doi: 10.3389/fphar.2017.00171
63. Ferrario A, Araja D, Bochenek T, Catic T, Dankó D, Dimitrova M, et al. The implementation of managed entry agreements in Central and Eastern Europe: findings and implications. Pharmacoeconomics (2017) 35:1271-85. doi: 10.1007/s40273-017-0559-4
64. 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) 124:39-47. doi: 10.1016/j.socscimed.2014.11.003
65. Ferrario A, Kanavos P. Managed Entry Agreements for Pharmaceuticals: The European Experience. EMiNet, Brussels (2013). Available online at: http://eprints.lse.ac.uk/50513/
66. Annemans L, Panie L. Dynamic Outcomes Based Approaches to Pricing and Reimbursement of Innovative Medicines (2017). Available online at: https://www.eurordis.org/sites/default/files/FIPRA.pdf
67. Schey C, Krabbe PF, Postma MJ, Connolly MP. Multi-criteria decision analysis (MCDA): testing a proposed MCDA framework for orphan drugs. Orphanet J Rare Dis. (2017) 12:10. doi: 10.1186/s13023-016-0555-3
68. Hughes-Wilson W, Palma A, Schuurman A, Simoens S. Paying for the Orphan Drug System: break or bend? Is it time for a new evaluation system for payers in Europe to take account of new rare disease treatments? Orphanet J Rare Dis. (2012) 7:74. doi: 10.1186/1750-1172-7-74
69. Angelis A, Kanavos P. Multiple Criteria Decision Analysis (MCDA) for evaluating new medicines in Health Technology Assessment and beyond: the advance value framework. Soc Sci Med. (2017) 188:137-56. doi: 10.1016/j.socscimed.2017.06.024
70. Angelis A, Montibeller G, Hochhauser D, Kanavos P. Multiple criteria decision analysis in the context of health technology assessment: a simulation exercise on metastatic colorectal cancer with multiple stakeholders in the English setting. BMC Med Inform Decis Mak. (2017) 17:149. doi: 10.1186/s12911-017-0524-3
71. Marsh K, IJzerman M, Thokala P, Baltussen R, Boysen M, Kalo Z, et al. Multiple criteria decision analysis for health care decision making-emerging good practices: Report 2 of the ISPOR MCDA emerging good practices task force. Value Health (2016) 19:125-37. doi: 10.1016/j.jval.2015.12.016
72. Zelei T, Molnár MJ, Szegedi M, Kaló Z. Systematic review on the evaluation criteria of orphan medicines in Central and Eastern European countries. Orphanet J Rare Dis. (2016) 11:72. doi: 10.1186/s13023-016-0455-6
73. Gustafsson LL, Wettermark B, Godman B, Andersen-Karlsson E, Bergman U, Hasselstrom J, et al. The 'wise list'-a comprehensive concept to select, communicate and achieve adherence to recommendations of essential drugs in ambulatory care in Stockholm. Basic Clin Pharmacol Toxicol. (2011) 108:224-33. doi: 10.1111/j.1742-7843.2011.00682.x
74. Eriksen J, Gustafsson LL, Ateva K, Bastholm-Rahmner P, Ovesjo ML, Jirlow M, et al. High adherence to the 'Wise List' treatment recommendations in Stockholm: a 15-year retrospective review of a multifaceted approach promoting rational use of medicines. BMJ Open (2017) 7:e014345. doi: 10.1136/bmjopen-2016-014345
75. Godman B, Wettermark B, van Woerkom M, Fraeyman J, Alvarez-Madrazo S, Berg C, et al. Multiple policies to enhance prescribing efficiency for established medicines in Europe with a particular focus on demand-side measures: findings and future implications. Front Pharmacol. (2014) 5:106. doi: 10.3389/fphar.2014.00106
76. Moorkens E, Vulto AG, Huys I, Dylst P, Godman B, Keuerleber S, et al. Policies for biosimilar uptake in Europe: an overview. PLoS ONE (2017) 12:e0190147. doi: 10.1371/journal.pone.0190147
77. Lemos LLP, Guerra Junior AA, Santos M, Magliano C, Diniz I, Souza K, et al. The assessment for disinvestment of intramuscular interferon beta for relapsing-remitting multiple sclerosis in Brazil. Pharmacoeconomics (2018) 36:161-73. doi: 10.1007/s40273-017-0579-0
78. 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) 33:905-24. doi: 10.1007/s40273-015-0293-8
79. Guerra-Junior AA, Pires de Lemos LL, Godman B, Bennie M, Osorio-de-Castro CGS, Alvares J, et al. Health technology performance assessment: real-world evidence for public healthcare sustainability. Int J Technol Assess Health Care (2017) 33:279-87. doi: 10.1017/S0266462317000423
80. Nguyen TA, Knight R, Roughead EE, Brooks G, Mant A. Policy options for pharmaceutical pricing and purchasing: issues for low-and middle-income countries. Health Policy Plan. (2015) 30:267-80. doi: 10.1093/heapol/czt105
81. Vian T, Kohler JC, Forte G, Dimancesco D. Promoting transparency, accountability, and access through a multi-stakeholder initiative: lessons from the medicines transparency alliance. J Pharm Policy Pract. (2017) 10:18. doi: 10.1186/s40545-017-0106-x
82. Woerkom M, Piepenbrink H, Godman B, Metz J, Campbell S, Bennie M, et al. Ongoing measures to enhance the efficiency of prescribing of proton pump inhibitors and statins in The Netherlands: influence and future implications. J Comp Effect Res. (2012) 1:527-38. doi: 10.2217/cer.12.52
83. Cameron A, Mantel-Teeuwisse AK, Leufkens HG, Laing RO. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health (2012) 15:664-73. doi: 10.1016/j.jval.2012.04.004
84. Godman B, Baker A, Leporowski A, Morton A, Baumgärtel C, Bochenek T, et al. Initiatives to increase the prescribing of low cost generics; the case of Scotland in the international context. Med Res Arch. (2017) 5:1-34
85. Kaplan WA, Ritz LS, Vitello M, Wirtz VJ. Policies to promote use of generic medicines in low and middle income countries: a review of published literature, 2000-2010. Health Policy (2012) 106:211-24. doi: 10.1016/j.healthpol.2012.04.015
86. Fadare JO, Adeoti AO, Desalu OO, Enwere OO, Makusidi AM, Ogunleye O, et al. The prescribing of generic medicines in Nigeria: knowledge, perceptions and attitudes of physicians. Expert Rev Pharmacoecono Outcomes Res. (2016) 16:639-50. doi: 10.1586/14737167.2016.1120673
87. Khan B, Godman B, Babar A, Hussain S, Mahmood S, Aqeel T. Assessment of active pharmaceutical ingredients in the registration procedures in Pakistan: implications for the future. GaBI J. (2016) 5:154-63. doi: 10.5639/gabij.2016.0504.041
88. Godman B, Abuelkhair M, Vitry A, Abdu S, Bennie M, Bishop I, et al. Payers endorse generics to enhance prescribing efficiency: impact and future implications, a case history approach. GABI J. (2012) 1:69-83. doi: 10.5639/gabij.2012.0102.017
89. Godman B, Wettermark B, Bishop I, Burkhardt T, Fürst J, Garuoliene K, et al. European payer initiatives to reduce prescribing costs through use of generics. GABI J. (2012) 1:22-7. doi: 10.5639/gabij.2012.0101.007
90. Dylst P, Vulto A, Godman B, Simoens S. Generic medicines: solutions for a sustainable drug market? Appl Health Econ Health Policy (2013) 11:437-43. doi: 10.1007/s40258-013-0043-z
91. Adamski J, Godman B, Ofierska-Sujkowska G, Osinska B, Herholz H, Wendykowska K, et al. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. (2010) 10:153. doi: 10.1186/1472-6963-10-153
92. Paris V. Belloni A. Value in Pharmaceutical Pricing. Available online at: http://www.oecd-ilibrary.org/social-issues-migration-health/value-in-pharmaceutical-pricing_5k43jc9v6knx-en
93. WHO. WHO Guideline on Country Pharmaceutical Pricing Policies. Available online at: http://apps.who.int/medicinedocs/documents/s21016en/s21016en.pdf
94. WHO Europe. Medicines Reimbursement Policies in Europe. Available online at: http://www.euro.who.int/__data/assets/pdf_file/0011/376625/pharmaceutical-reimbursement-eng.pdf?ua=1
95. Godman B, Shrank W, Andersen M, Berg C, Bishop I, Burkhardt T, et al. Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications. Expert Rev Pharmacoecon Outcomes Res. (2010) 10:707-22. doi: 10.1586/erp.10.72
96. Moon JC, Godman B, Petzold M, Alvarez-Madrazo S, Bennett K, Bishop I, et al. Different initiatives across Europe to enhance losartan utilization post generics: impact and implications. Front Pharmacol. (2014) 5:219. doi: 10.3389/fphar.2014.00219
97. Brett J, Elshaug AG, Bhatia RS, Chalmers K, Badgery-Parker T, Pearson S-A. A methodological protocol for selecting and quantifying low-value prescribing practices in routinely collected data: an Australian case study. Implement Sci. (2017) 12:58. doi: 10.1186/s13012-017-0585-9
98. Mestre-Ferrandiz J, Towse A, Berdud M. Biosimilars: How can payers get long-term savings? Pharmacoeconomics (2016) 34:609-16. doi: 10.1007/s40273-015-0380-x
99. Simoens S, Sinnaeve PR. Patient co-payment and adherence to statins: a review and case studies. Cardiovasc Drugs Ther. (2014) 28:99-109. doi: 10.1007/s10557-013-6497-2
100. Vrijens B, Antoniou S, Burnier M, de la Sierra A, Volpe M. Current situation of medication adherence in hypertension. Front Pharmacol. (2017) 8:100. doi: 10.3389/fphar.2017.00100
101. Nielsen JO, Shrestha AD, Neupane D, Kallestrup P. Non-adherence to anti-hypertensive medication in low-and middle-income countries: a systematic review and meta-analysis of 92443 subjects. J Hum Hypertens. (2017) 31:14-21. doi: 10.1038/jhh.2016.31
102. Cramer JA, Benedict A, Muszbek N, Keskinaslan A, Khan ZM. The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: a review. Int J Clin Pract. (2008) 62:76-87. doi: 10.1111/j.1742-1241.2007.01630.x
103. Nashilongo MM, Singu B, Kalemeera F, Mubita M, Naikaku E, Baker A, et al. Assessing adherence to antihypertensive therapy in primary health care in Namibia: findings and implications. Cardiovasc Drugs Ther. (2017) 31:565-78. doi: 10.1007/s10557-017-6756-8
104. Rampamba EM, Meyer JC, Godman B, Kurdi A, Helberg E. Evaluation of antihypertensive adherence and its determinants at primary healthcare facilities in rural South Africa. J Comp Effect Res. (2018) 7:661-72. doi: 10.2217/cer-2018-0004
105. Sandoz. Kenya is first country to launch 'Novartis Access', expanding affordable treatment options against chronic diseases (2015) Available online at: https://www.sandoz.com/news/media-releases/kenya-first-country-launch-novartis-access-expanding-affordable-treatment
106. Medical Brief. SA Signs Deal With Janssen to Lower Price of TB Medicine (2018). Available at URL: https://www.medicalbrief.co.za/archives/sa-signs-deal-janssen-lower-price-tb-medicine/
107. La Mola F, Liu C, de Salaberry J. Paying for the Cure-Transforming the Financing of Novel Therapies. Available online at: https://www.lek.com/sites/default/files/insights/pdf-attachments/Paying-for-the-cure_3.pdf
108. European Commission. Innovative Payment Models For High-Cost Innovative Medicines. Available onlone at: https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/docsdir/opinion_innovative_medicines_en.pdf
109. Jorgensen J, Kefalas P. Annuity payments can increase patient access to innovative cell and gene therapies under England's net budget impact test. J Mark Access Health Policy (2017) 5:1355203. doi: 10.1080/20016689.2017.1355203
110. KCE. How to Improve the Belgian Process for Managed Entry Agreements? (2017). Available online at: https://kce.fgov.be/sites/default/files/atoms/files/Download%20the%20synthesis%20in%20English%20%2840%20p.%29.pdf
111. WHO. Informal Advisory Group on the Availability and Affordability of Cancer Medicines (2018). Available online at: http://apps.who.int/iris/bitstream/handle/10665/272961/WHO-EMP-IAU-2018.04-eng.pdf
112. Godman B, Wettermark B, Hoffmann M, Andersson K, Haycox A, Gustafsson LL. Multifaceted national and regional drug reforms and initiatives in ambulatory care in Sweden: global relevance. Expert Rev Pharmacoecon Outcomes Res. (2009) 9:65-83. doi: 10.1586/14737167.9.1.65
113. Wettermark B, Godman B, Eriksson C, van Ganse E, Garattini S, Joppi R, et al. Einführung neuer Arzneimittel in europäische Gesundheitssysteme (Introduction of new medicines into European healthcare systems). GGW (2010) 10:24-34
114. Godman B, Acurcio F, Guerra Junior AA, Alvarez-Madrazo S, Faridah Aryani MY, et al. Initiatives among authorities to improve the quality and efficiency of prescribing and the implications. J Pharma Care Health Syst. (2014) 1:1-15. doi: 10.4172/jpchs.1000113
115. Godman B, Paterson K, Malmstrom RE, Selke G, Fagot JP, Mrak J. Improving the managed entry of new medicines: sharing experiences across Europe. Expert Rev Pharmacoecon Outcomes Res. (2012) 12:439-41. doi: 10.1586/erp.12.44
116. Godman B, Joppi R, Bennie M, Jan S, Wettermark B. Managed introduction of new drugs. In Elseviers M, Wettermark B, Almarsdottir AB, Andersen M, Benko R, Bennie M, Eriksson I, Godman B, Krska J, Poluzzi E, Taxis K, Vlahovic-Palcevski V, Stichele RV editors. Drug Utilization Research: Methods and Applications. Chichester: John Wiley & Sons (2016). p. 210-21
117. Lubloy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. (2014) 14:469. doi: 10.1186/1472-6963-14-469
118. Griffin JP, Griffin TD. The economic implications of therapeutic conservatism. J R Coll Physicians Lond. (1993) 27:121-6
119. Richards PSM. Extent and Causes of International Variations in Drug Usage. A Report for the Secretary of State for Health. Available online at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216249/dh_117977.pdf; 2012
120. Packer C, Simpson S, Stevens A. International diffusion of new health technologies: a ten-country analysis of six health technologies. Int J Technol Assess Health Care (2006) 22:419-28. doi: 10.1017/S0266462306051336
121. Mason A. New medicines in primary care: a review of influences on general practitioner prescribing. J Clin Pharm Ther. (2008) 33:1-10. doi: 10.1111/j.1365-2710.2008.00875.x
122. Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLoS Med. (2010) 7:e1000352. doi: 10.1371/journal.pmed.1000352
123. Dunn AG, Braithwaite J, Gallego B, Day RO, Runciman W, Coiera E. Nation-scale adoption of new medicines by doctors: an application of the Bass diffusion model. BMC Health Serv Res. (2012) 12:248. doi: 10.1186/1472-6963-12-248
124. Chauhan D, Mason A. Factors affecting the uptake of new medicines in secondary care-a literature review. J Clin Pharm Ther. (2008) 33:339-48. doi: 10.1111/j.1365-2710.2008.00925.x
125. Bjorkhem-Bergman L, Andersen-Karlsson E, Laing R, Diogene E, Melien O, Jirlow M, et al. Interface management of pharmacotherapy. Joint hospital and primary care drug recommendations. Eur J Clin Pharmacol. (2013) 69(Suppl. 1):73-8. doi: 10.1007/s00228-013-1497-5
126. Lima-Dellamora Eda C, Caetano R, Gustafsson LL, Godman BB, Patterson K, Osorio-de-Castro CG. An analytical framework for assessing drug and therapeutics committee structure and work processes in tertiary Brazilian hospitals. Basic Clin Pharmacol Toxicol. (2014) 115:268-76. doi: 10.1111/bcpt.12215
127. Vogler S, Zimmermann N, Habl C, Mazag J. The role of discounts and loss leaders in medicine procurement in Austrian hospitals-a primary survey of official and actual medicine prices. Cost Effect Resour Alloc. (2013) 11:15. doi: 10.1186/1478-7547-11-15
128. Barrett A, Roques T, Small M, Smith RD. How much will Herceptin really cost? BMJ (2006) 333:1118-20. doi: 10.1136/bmj.39008.624051.BE
129. Vogler S, Zimmermann N. In Coordination with the Pharmaceutical Pricing and Reimbursement Information (PPRI) network and the World Health Organization (WHO). Glossary of Pharmaceutical Terms (2016). Available online at: http://whocc.goeg.at/Literaturliste/Dokumente/MethodologyTemplate/Glossary_Update2016_final.pdf
130. Wild C, Langer T. Emerging health technologies: informing and supporting health policy early. Health Policy (2008) 87:160-71. doi: 10.1016/j.healthpol.2008.01.002
131. Wild C, Simpson S, Douw K, Geiger-Gritsch S, Mathis S, Langer T. Information service on new and emerging health technologies: identification and prioritization processes for a European union-wide newsletter. Int J Technol Assess Health Care (2009) 25(Suppl. 2):48-55. doi: 10.1017/S0266462309990687
132. Packer C, Fung M, Stevens A. Analyzing 10 years of early awareness and alert activity in the United kingdom. Int J Technol Assess Health Care (2012) 28:308-14. doi: 10.1017/S026646231200030X
133. Joppi R, Dematte L, Menti AM, Pase D, Poggiani C, Mezzalira L. The Italian Horizon Scanning Project. Eur J Clin Pharmacol. (2009) 65:775-81. doi: 10.1007/s00228-009-0666-z
134. Nachtnebel A, Breuer J, Willenbacher W, Bucsics A, Krippl P, Wild C. Looking back on 5 years of horizon scanning in oncology. Int J Technol Assess Health Care (2016) 32:54-60. doi: 10.1017/S0266462316000052
135. Simpson S, Hillier J, Gutierrez-Ibarluzea I, Kearney B, Norderhaug I, Fay AF, et al. A Toolkit for the Identification and Assessment of New and Emerging Health Technologies. Birmingham: EuroScan
136. Eriksson I, Wettermark B, Persson M, Edstrom M, Godman B, Lindhe A, et al. The early awareness and alert system in Sweden: history and current status. Front Pharmacol. (2017) 8:674. doi: 10.3389/fphar.2017.00674
137. KCE REPORT 283. horizon Scanning for Pharmaceuticals: Proposal for the Beneluxa Collaboration. Available online at: http://www.beneluxa.org/sites/beneluxa.org/files/2017-07/Horizon%20scanning_ScientificReport_full.pdf
138. Eriksson I, von Euler M, Malmström RE, Godman B, Wettermark B. Did we see it coming? An evaluation of the Swedish early awareness and alert system. Appl Health Econ Health Policy (2018). doi: 10.1007/s40258-018-0434-2
139. Wettermark B, Persson ME, Wilking N, Kalin M, Korkmaz S, Hjemdahl P, et al. Forecasting drug utilization and expenditure in a metropolitan health region. BMC Health Serv Res. (2010) 10:128. doi: 10.1186/1472-6963-10-128
140. Nachtnebel A, Geiger-Gritsch S, Hintringer K, Wild C. Scanning the horizon: development and implementation of an early awareness system for anticancer drugs in Austria. Health Policy (2012) 104:1-11. doi: 10.1016/j.healthpol.2011.11.003
141. Kahveci R, Oortwijn W, Godman B, Koç EM, Tibet B. Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries in Pharmaceutical Market Access in Developed Countries. Koçkaya G, Wertheimer A editors (2018). Available online at: http://books.seedmedicalpublishers.com/index.php/seed/catalog/view/Pharmaceutical_MA_developed/PDF/747.ch15
142. Oortwijn W, Sampietro-Colom L, Habens F, Trowman R. How can health systems prepare for new and emerging health technologies? The role of horizon scanning revisited. Int J Technol Assess Health Care (2018) 34:254-9. doi: 10.1017/S0266462318000363
143. Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health (2014) 17:5-14. doi: 10.1016/j.jval.2013.08.2291
144. van de Vooren K, Duranti S, Curto A, Garattini L. A critical systematic review of budget impact analyses on drugs in the EU countries. Appl Health Econ Health Policy (2014) 12:33-40. doi: 10.1007/s40258-013-0064-7
145. Barbosa WB, Costa JO, de Lemos LLP, Gomes RM, de Oliveira HN, Ruas CM, et al. Costs in the treatment of schizophrenia in adults receiving atypical antipsychotics: an 11-year cohort in Brazil. Appl Health Econ Health Policy (2018) 16:697-709. doi: 10.1007/s40258-018-0408-4
146. Godoi IP, Santos AS, Reis EA, Lemos LL, Brandao CM, Alvares J, et al. Consumer Willingness to Pay for Dengue Vaccine (CYD-TDV, Dengvaxia(R)) in Brazil; implications for future pricing considerations. Front Pharmacol. (2017) 8:41. doi: 10.3389/fphar.2017.00041
147. Weernink MGM, Janus SIM, van Til JA, Raisch DW, van Manen JG, Ijzerman MJ. A systematic review to identify the use of preference elicitation methods in healthcare decision making. Pharm Med. (2014) 28:175-85. doi: 10.1007/s40290-014-0059-1
148. Campbell SM, Godman B, Diogene E, Furst J, Gustafsson LL, MacBride-Stewart S, et al. Quality indicators as a tool in improving the introduction of new medicines. Basic Clin Pharmacol Toxicol. (2015) 116:146-57. doi: 10.1111/bcpt.12295
149. Godman B, Campbell S, Suh HS, Finlayson AE, Bennie M, Gustafsson LL. Ongoing measures to enhance prescribing efficiency across Europe: implications for other countries. J Health Tech Assess. (2013) 1:27-42
150. Vogler S, Paris V, Ferrario A, Wirtz VJ, de Joncheere K, Schneider P, et al. How can pricing and reimbursement policies improve affordable access to medicines? Lessons learned from European countries. Appl Health Econom Health Policy (2017) 15:307-21. doi: 10.1007/s40258-016-0300-z
151. Sermet C, Andrieu V, Godman B, Van Ganse E, Haycox A, Reynier JP. Ongoing pharmaceutical reforms in France: implications for key stakeholder groups. Appl Health Econom Health Pol. (2010) 8:7-24. doi: 10.2165/11313900-000000000-00000
152. Godman B, Bucsics A, Burkhardt T, Haycox A, Seyfried H, Wieninger P. Insight into recent reforms and initiatives in Austria: implications for key stakeholders. Expert Rev Pharmacoeconom Outcomes Res. (2008) 8:357-71. doi: 10.1586/14737167.8.4.357
153. Hollis A. Sustainable financing of innovative therapies: a review of approaches. Pharmacoeconomics (2016) 34:971-80. doi: 10.1007/s40273-016-0416-x
154. Svensson M, Nilsson FO, Arnberg K. Reimbursement decisions for pharmaceuticals in Sweden: the impact of disease severity and cost effectiveness. Pharmacoeconomics (2015) 33:1229-36. doi: 10.1007/s40273-015-0307-6
155. Kwon HY, Godman B. Drug pricing in South Korea. Appl Health Econ Health Policy (2017) 15:447-53. doi: 10.1007/s40258-017-0307-0
156. Griffiths EA, Hendrich JK, Stoddart SD, Walsh SC. Acceptance of health technology assessment submissions with incremental cost-effectiveness ratios above the cost-effectiveness threshold. ClinicoEconom Outcomes Res. (2015) 7:463-76. doi: 10.2147/CEOR.S87462
157. Raftery JP. NICE's cost-effectiveness range: should it be lowered? Pharmacoeconomics (2014) 32:613-5. doi: 10.1007/s40273-014-0158-6
158. Garner S, Rintoul A, Hill SR. Value-based pricing: l'enfant terrible? Pharmacoeconomics (2018) 36:5-6. doi: 10.1007/s40273-017-0567-4
159. Santos AS, Guerra-Junior AA, Godman B, Morton A, Ruas CM. Cost-effectiveness thresholds: methods for setting and examples from around the world. Expert Rev Pharmacoeconom Outcomes Res. (2018) 18:277-88. doi: 10.1080/14737167.2018.1443810
160. Kawalec P, Tesar T, Vostalova L, Draganic P, Manova M, Savova A, et al. Pharmaceutical regulation in central and Eastern European countries: a current review. Front Pharmacol. (2017) 8:892. doi: 10.3389/fphar.2017.00892
161. Garrison LP, Towse A. Value-based pricing and reimbursement in personalised healthcare: introduction to the basic health economics. J Personal Med. (2017) 7:10. doi: 10.3390/jpm7030010
162. Pharmaceutical Executive. UK: Is Value Based Assessment the New Value Based Pricing? (2014). Available online at: http://www.pharmexec.com/uk-value-based-assessment-new-value-based-pricing
163. Towse A, Barnsley P. Approaches to identifying, measuring, and aggregating elements of value. Int J Technol Assess Health Care (2013) 29:360-4. doi: 10.1017/S0266462313000524
164. Marseille E, Larson B, Kazi DS, Kahn JG, Rosen S. Thresholds for the cost-effectiveness of interventions: alternative approaches. Bull World Health Organ. (2015) 93:118-24. doi: 10.2471/BLT.14.138206
165. Faleiros DR, Alvares J, Almeida AM, de Araujo VE, Andrade EI, Godman BB, et al. Budget impact analysis of medicines: updated systematic review and implications. Expert Rev Pharmacoeconom Outcomes Res. (2016) 16:257-66. doi: 10.1586/14737167.2016.1159958
166. Antonanzas F, Rodriguez-Ibeas R, Juarez-Castello CA. Personalized medicine and pay for performance: should pharmaceutical firms be fully penalized when treatment fails? Pharmacoeconomics (2018) 36:733-43. doi: 10.1007/s40273-018-0619-4
167. Vogler S, Paterson KR. Can price transparency contribute to more affordable patient access to medicines? Pharmacoeconomics (2017) 1:145-7. doi: 10.1007/s41669-017-0028-1
168. Press Release. Ireland to Open Negotiations With Belgium, the Netherlands, Luxembourg and Austria on Drug Pricing and Supply-Minister Harris. Available online at: http://health.gov.ie/blog/press-release/ireland-to-open-negotiations-with-belgium-the-netherlands-luxembourg-and-austria-on-drug-pricing-and-supply-minister-harris/
169. European Observatory. How Can Voluntary Cross-Border Collaboration in Public Procurement Improve Access to Health Technologies in Europe? Available online at: http://www.euro.who.int/__data/assets/pdf_file/0009/331992/PB21.pdf?ua=1
170. Ferrario A, Humbert T, Kanavos P, Pedersen HB. Strategic procurement and international collaboration to improve access to medicines. Bull World Health Organ. (2017) 95:720-2. doi: 10.2471/BLT.16.187344
171. ESIP. Regulation on Health Technology Assessment Position Paper of the European Social Insurance Platform (ESIP). (2018). Available online at: https://www.esip.eu/publications-intranet?idf=137&preview=332
172. European Commission. Strengthening of the EU cooperation on Health Technology Assessment (HTA), Inception Impact Assessment. (2016). Available online at: http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdf
173. European Commission. Proposal for a Regulation of the European Parliament of the Council on Health Technology Assessment Amending Directive 2011/24/EU (2018/0018(COD). (2018). Available online at: file:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52018PC0051
174. Kanavos P, Wouters O. Competition Issues in the Distribution of Pharmaceuticals, Session III of the OECD Global Forum on Competition, Paris. (2014). Available online at: http://eprints.lse.ac.uk/56006/1/__lse.ac.uk_storage_LIBRARY_Secondary_libfile_shared_repository_Content_Wouters, %20O_Competition%20issues_Wouters_Competition%20issues_2014.pdf
175. Vandoros S, Stargardt T. Reforms in the Greek pharmaceutical market during the financial crisis. Health Policy (2013) 109:1-6. doi: 10.1016/j.healthpol.2012.08.016
176. Vogler S, Habl C, Bogut M, Voncina L. Comparing pharmaceutical pricing and reimbursement policies in Croatia to the European Union Member States. Croatian Med J. (2011) 52:183-97. doi: 10.3325/cmj.2011.52.183
177. Rotar AM, Preda A, Loblova O, Benkovic V, Zawodnik S, Gulacsi L, et al. Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries. Health Policy (2018) 122:230-6. doi: 10.1016/j.healthpol.2018.01.006
178. Toumi M, Jaroslawski S, Sawada T, Kornfeld A. The use of surrogate and patient-relevant endpoints in outcomes-based market access agreements: current debate. Appl Health Econom Health Policy (2017) 15:5-11. doi: 10.1007/s40258-016-0274-x
179. Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet (2014) 384:164-72. doi: 10.1016/S0140-6736(13)62422-8
180. Prasad V, Kim C, Burotto M, Vandross A. The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses. JAMA Intern Med. (2015) 175:1389-98. doi: 10.1001/jamainternmed.2015.2829
181. Carlson JJ, Chen S, Garrison LP Jr. Performance-based risk-sharing arrangements: an updated international review. PharmacoEconomics (2017) 35:1063-72. doi: 10.1007/s40273-017-0535-z
182. Clopes A, Gasol M, Cajal R, Segu L, Crespo R, Mora R, et al. Financial consequences of a payment-by-results scheme in Catalonia: gefitinib in advanced EGFR-mutation positive non-small-cell lung cancer. J Med Econom. (2017) 20:1-7. doi: 10.1080/13696998.2016.1215991
183. Annemans L. The Use of Real World Data Throughout an Innovative Medicine's Lifecycle. (2017). Available online at: https://www.inami.fgov.be/SiteCollectionDocuments/real_world_data.docx
184. IMI GetReal. New Methods for RWE Collection Synthesis. (2018). Available online at: http://www.imi-getreal.eu/
185. Yeung K, Li M, Carlson JJ. Using performance-based risk-sharing arrangements to address uncertainty in indication-based pricing. J Manag Care Special Pharm. (2017) 23:1010-5. doi: 10.18553/jmcp.2017.23.10.1010
186. Nayroles G, Frybourg S, Gabriel S, Kornfeld A, Antonanzas-Villar F, Espin J, et al. Unlocking the potential of established products: toward new incentives rewarding innovation in Europe. J Mark Access Health Pol. (2017) 5:1298190. doi: 10.1080/20016689.2017.1298190
187. Chandra A, Garthwaite C. The economics of indication-based drug pricing. N Engl J Med. (2017) 377:103-6. doi: 10.1056/NEJMp1705035
188. Persson U, Norlin JM. Multi-indication and combination pricing and reimbursement of pharmaceuticals: opportunities for improved health care through faster uptake of new innovations. Applied Health Econom Health Pol. (2018) 16:157-65. doi: 10.1007/s40258-018-0377-7
189. Newman M. Bitter pills for drug companies. BMJ (2010) 341:632-3. doi: 10.1136/bmj.c5095
190. Godman B, Wilcock M, Martin A, Bryson S, Baumgärtel C, Bochenek T, et al. Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future. GaBI J. (2015) 4:125-35. doi: 10.5639/gabij.2015.0403.028
191. Staton T. Pfizer adds another $325M to Neurontin settlement tally. Total? $945M. Available online at: http://www.fiercepharma.com/story/pfizer-adds-another-325m-neurontin-settlement-tally-total-945m/2014-06-02
192. European Commission. Study on the Economic Impact of Supplementary Protection Certificates, Pharmaceutical Incentives and Rewards in Europe. Available online at: https://www.copenhageneconomics.com/dyn/resources/Publication/publicationPDF/5/445/1527517171/copenhagen-economics-2018-study-on-the-economic-impact-of-spcs-pharmaceutical-incentives-and-rewards-in-europe.pdf
193. Leporowski A, Godman B, Kurdi A, MacBride-Stewart S, Ryan M, Hurding S, et al. Ongoing activities to optimize the quality and efficiency of lipid-lowering agents in the Scottish national health service: influence and implications. Expert Rev Pharmacoeconom Outcomes Res. (2018) 2018:1-12. doi: 10.1080/14737167.2018.1501558
194. Godman B, Bishop I, Finlayson AE, Campbell S, Kwon HY, Bennie M. Reforms and initiatives in Scotland in recent years to encourage the prescribing of generic drugs, their influence and implications for other countries. Expert Rev Pharmacoeconom Outcomes Res. (2013) 13:469-82. doi: 10.1586/14737167.2013.820956
195. Moon S, Jambert E, Childs M, von Schoen-Angerer T. A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries. Global Health (2011) 7:39. doi: 10.1186/1744-8603-7-39
196. Rémuzat C, Tavella F, Toumi M. Differential Pricing for Pharmaceuticals: Overview of a Widely Debated Pricing Concept and Key Challenges. ISPOR. (2015). Available online at: file:///C:/Users/mail/Desktop/My%20documents/Ongoing%20papers/Frontiers%20PH%20New%20Medicines/Remuzat%20et%20al%202015.pdf
197. Leopold C, Vogler S, Mantel-Teeuwisse AK, de Joncheere K, Leufkens HG, Laing R. Differences in external price referencing in Europe: a descriptive overview. Health Policy (2012) 104:50-60. doi: 10.1016/j.healthpol.2011.09.008
198. Carone G, Schwierz C, Xavier A. Cost-Containment Policies in Public Pharmaceutical Spending in the EU. Available online at: http://ec.europa.eu/economy_finance/publications/economic_paper/2012/pdf/ecp_461_en.pdf
199. Persson U, Jonsson B. The End of the International Reference Pricing System? Appl Health Econom Health Pol. (2016) 14:1-8. doi: 10.1007/s40258-015-0182-5
200. KE International. Resurrecting the Ghost of Høsbjør Past: Global Fund Seeks to Establish Global Framework on Tiered Pricing Enforced by WTO Rules. Available online at: http://keionline.org/node/19792014
201. Baker B. Industry-Led Tiered-Pricing or Country-Led, Real Equitable Access-the Global Fund's Task Force Proposal Get Worse Instead of Better. (2014). Available online at: http://infojustice.org/wp-content/uploads/2014/03/Baker-Global-Fund-Tiered-Pricing-03282014.pdf
202. Medical Brief. SA Takes First Step Towards Producing its Own Vaccines Again. (2018). Available online at: https://www.medicalbrief.co.za/archives/sa-takes-first-step-towards-producing-vaccines/
203. Walwyn DR. Why Manufacturing a Key Vaccine in South Africa is so Important. (2018). Available online at: https://theconversation.com/why-manufacturing-a-key-vaccine-in-south-africa-is-so-important-94380
204. Kershaw A. Transforming the Brazilian Domestic Pharma Industry Through PDPs. (2015). Available online at: https://ihsmarkit.com/research-analysis/transforming-the-brazilian-domestic-pharma-industry-through-pdps.html
205. GSK. GSK and Brazil's Fiocruz Form Partnership for New R&D Effort and Increased Vaccine Access. (2009). Available online at: https://www.gsk.com/en-gb/media/press-releases/gsk-and-brazil-s-fiocruz-form-partnership-for-new-rd-effort-and-increased-vaccine-access/
206. Novartis. Novartis Access. Available online at: https://www.novartis.com/about-us/corporate-responsibility/expanding-access-healthcare/novartis-access
207. Mihajlovic J, Dolk C, Tolley K, Simoens S, Postma MJ. Reimbursement of targeted cancer therapies within 3 different European health care systems. Clin Ther. (2015) 37:474-80. doi: 10.1016/j.clinthera.2014.12.005
208. Bentley TGK, Cohen JT, Elkin EB, Huynh J, Mukherjea A, Neville TH, et al. Validity and Reliability of Value Assessment Frameworks for New Cancer Drugs. Value Health (2017) 20:200-5. doi: 10.1016/j.jval.2016.12.011
209. Cherny NI, Sullivan R, Dafni U, Kerst JM, Sobrero A, Zielinski C, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol. (2015) 26:1547-73. doi: 10.1093/annonc/mdv249
210. Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, et al. American society of clinical oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. (2014) 32:1277-80. doi: 10.1200/JCO.2013.53.8009
211. Schnipper LE, Davidson NE, Wollins DS, Tyne C, Blayney DW, Blum D, et al. American society of clinical oncology statement: a conceptual framework to assess the value of cancer treatment options. J Clin Oncol. (2015) 33:2563-77. doi: 10.1200/JCO.2015.61.6706
212. Godman B, Wild C, Haycox A. Patent expiry and costs for anti-cancer medicines for clinical use. Gener Biosimilars Initiat J. (2017) 6:1-2. doi: 10.5639/gabij.2017.0603.021
213. Wild C, Grossmann N, Bonanno PV, Bucsics A, Furst J, Garuoliene K, et al. Utilisation of the ESMO-MCBS in practice of HTA. Ann Oncol. (2016) 27:2134-6. doi: 10.1093/annonc/mdw297
214. Henshall C, Sampson L, Eichler H-G, Lemgruber A, Longson C, O'Rourke B, et al. Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies: what are they looking for, and how and why does this differ from what regulators require? Ther Innovat Regul Sci. (2013) 48:341-6. doi: 10.1177/2168479013512488
215. Ferguson JS, Summerhayes M, Masters S, Schey S, Smith IE. New treatments for advanced cancer: an approach to prioritization. Br J Cancer (2000) 83:1268-73. doi: 10.1054/bjoc.2000.1406
216. Wilking N, Lopes G, Meier K, Simoens S, van Harten W, Vulto A. Can we continue to afford access to cancer treatment? Eur Oncol Haematol. (2017) 13:114-9
217. Dreicer JJ, Mailankody S, Fahkrejahani F, Prasad V. Clinically meaningful benefit: real world use compared against the American and European guidelines. Blood Cancer J. (2017) 7:645. doi: 10.1038/s41408-017-0009-8
218. EUnetHTA. Endpoints used in Relative Effectiveness Assessment: Surrogate Endpoints. (2015). Available online at: https://www.eunethta.eu/wp-content/uploads/2018/03/surrogate_endpoints.pdf
219. Tefferi A, Kantarjian H, Rajkumar SV, Baker LH, Abkowitz JL, Adamson JW, et al. In support of a patient-driven initiative and petition to lower the high price of cancer drugs. Mayo Clin Proc. (2015) 90:996-1000. doi: 10.1016/j.mayocp.2015.06.001
220. Editorial. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood (2013) 121:4439-42. doi: 10.1182/blood-2013-03-490003
221. Ghinea H, Kerridge I, Lipworth W. If We Don't Talk About Value, Cancer Drugs Will Become Terminal for Health Systems. Available online at: http://theconversation.com/if-we-dont-talk-about-value-cancer-drugs-will-become-terminal-for-health-systems-44072
222. Uyl-de Groot CA dVE, Verweij J, Sullivan R. Dispelling the myths around cancer care delivery: It's not all about costs. J Cancer Policy (2014) 2:22-9. doi: 10.1016/j.jcpo.2014.01.001
223. Kanavos P, Schurer W. The dynamics of colorectal cancer management in 17 countries. Eur J Health Econom. (2010) 10(Suppl 1):S115-29. doi: 10.1007/s10198-009-0201-2
224. Hoen E't. Access To Cancer Treatment. A Study of Medicine Pricing Issues With Recommendations for Improving Access to Cancer Medication. Available online at: https://www.oxfam.org/sites/www.oxfam.org/files/file_attachments/rr-access-cancer-treatment-inequality-040215-en.pdf
225. Jakupi A, Godman B, Martin A, Haycox A, Baholli I. Utilization and expenditure of anti-cancer medicines in Kosovo: findings and implications. Pharmacoeconomics (2018). doi: 10.1007/s41669-017-0066-8
226. Larock AS, Mullier F, Sennesael AL, Douxfils J, Devalet B, Chatelain C, et al. Appropriateness of prescribing dabigatran etexilate and rivaroxaban in patients with nonvalvular atrial fibrillation: a prospective study. Ann Pharmacother. (2014) 48:1258-68. doi: 10.1177/1060028014540868
227. Troncoso A, Diogene E. Dabigatran and rivaroxaban prescription for atrial fibrillation in Catalonia, Spain: the need to manage the introduction of new drugs. Eur J Clin Pharmacol. (2014) 70:249-50. doi: 10.1007/s00228-013-1593-6
228. Piccinni C, Raschi E, Poluzzi E, Puccini A, Cars T, Wettermark B, et al. Trends in antiarrhythmic drug use after marketing authorization of dronedarone: comparison between Emilia Romagna (Italy) and Sweden. Eur J Clin Pharmacol. (2013) 69:715-20. doi: 10.1007/s00228-012-1377-4
229. Cars T, Lindhagen L, Malmstrom RE, Neovius M, Schwieler J, Wettermark B, et al. Effectiveness of drugs in routine care: a model for sequential monitoring of new medicines using dronedarone as example. Clin Pharmacol Ther. (2018) 103:493-501. doi: 10.1002/cpt.751
230. van Vollenhoven RF, Askling J. Rheumatoid arthritis registries in Sweden. Clin Exp Rheumatol. (2005) 23(5 Suppl 39):S195-200
231. Raaschou P, Simard JF, Holmqvist M, Askling J. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma: nationwide population based prospective cohort study from Sweden. BMJ (2013) 346:f1939. doi: 10.1136/bmj.f1939
232. Iannone F, Gremese E, Atzeni F, Biasi D, Botsios C, Cipriani P, et al. Longterm retention of tumor necrosis factor-alpha inhibitor therapy in a large italian cohort of patients with rheumatoid arthritis from the GISEA registry: an appraisal of predictors. J Rheumatol. (2012) 39:1179-84. doi: 10.3899/jrheum.111125
233. Dos Santos JB, Almeida AM, Acurcio FA, de Oliveira Junior HA, Kakehasi AM, Guerra Junior AA, et al. Comparative effectiveness of adalimumab and etanercept for rheumatoid arthritis in the Brazilian public health system. J Compar Effect Res. (2016) 5:539-49. doi: 10.2217/cer-2016-0027
234. Garcia-Doval I, Cohen AD, Cazzaniga S, Feldhamer I, Addis A, Carretero G, et al. Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti-tumor necrosis factor agents versus classic therapies: prospective meta-analysis of Psonet registries. J Am Acad Dermatol. (2017) 76:299-308.e16. doi: 10.1016/j.jaad.2016.07.039
235. Marra LP, Araujo VE, Oliveira GC, Diniz LM, Guerra Junior AA, Acurcio FA, et al. The clinical effectiveness of insulin glargine in patients with Type I diabetes in Brazil: findings and implications. J Compar Effect Res. (2017) 6:519-27. doi: 10.2217/cer-2016-0099
236. Forslund T, Raaschou P, Hjemdahl P, Krakau I, Wettermark B. Usage, risk, and benefit of weight-loss drugs in primary care. J Obesity (2011) 2011:459263. doi: 10.1155/2011/459263
237. Gomes RM, Guerra Junior AA, Lemos LL, Costa Jde O, Almeida AM, Alvares J, et al. Ten-year kidney transplant survival of cyclosporine-or tacrolimus-treated patients in Brazil. Expert Rev Clin Pharmacol. (2016) 9:991-9. doi: 10.1080/17512433.2016.1190270
238. Frisk P, Aggefors K, Cars T, Feltelius N, Loov SA, Wettermark B, et al. Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden. Eur J Clin Pharmacol. (2018) 74:971-8. doi: 10.1007/s00228-018-2456-y
239. Nakwatumbah S, Kibuule D, Godman B, Haakuria V, Kalemeera F, Baker A, et al. Compliance to guidelines for the prescribing of antibiotics in acute infections at Namibia's national referral hospital: a pilot study and the implications. Expert Rev Anti-Infect Ther. (2017) 15:713-21. doi: 10.1080/14787210.2017.1320220
240. Matlala M, Gous AG, Godman B, Meyer JC. Structure and activities of pharmacy and therapeutics committees among public hospitals in South Africa; findings and implications. Expert Rev Clin Pharmacol. (2017) 10:1273-80. doi: 10.1080/17512433.2017.1364625
241. Tiroyakgosi C, Matome M, Summers E, Mashalla Y, Paramadhas BA, Souda S, et al. Ongoing initiatives to improve the use of antibiotics in Botswana: University of Botswana symposium meeting report. Expert Rev Anti-Infect Ther. (2018) 16:381-4. doi: 10.1080/14787210.2018.1467756
242. Meyer JC, Schellack N, Stokes J, Lancaster R, Zeeman H, Defty D, et al. Ongoing initiatives to improve the quality and efficiency of medicine use within the public healthcare system in South Africa; a preliminary study. Front Pharmacol. (2017) 8:751. doi: 10.3389/fphar.2017.00751
243. Matusewicz W, Godman B, Pedersen HB, Furst J, Gulbinovic J, Mack A, et al. Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe. Expert Rev Pharmacoeconom Outcomes Res. (2015) 15:755-8. doi: 10.1586/14737167.2015.1085803
244. Kwon HY, Kim H, Godman B, Reich MR. The impact of South Korea's new drug-pricing policy on market competition among off-patent drugs. Expert Rev Pharmacoeconom Outcomes Res. (2015) 15:1007-14. doi: 10.1586/14737167.2015.1083425
245. Abuelkhair M, Abdu S, Godman B, Fahmy S, Malmstrom RE, Gustafsson LL. Imperative to consider multiple initiatives to maximize prescribing efficiency from generic availability: case history from Abu Dhabi. Expert Rev Pharmacoeconom Outcomes Res. (2012) 12:115-24. doi: 10.1586/erp.11.90
246. Thokala P, Devlin N, Marsh K, Baltussen R, Boysen M, Kalo Z, et al. Multiple criteria decision analysis for health care decision making-an introduction: report 1 of the ISPOR MCDA emerging good practices task force. Value Health. (2016) 19:1-13. doi: 10.1016/j.jval.2015.12.003
247. Adunlin G, Diaby V, Xiao H. Application of multicriteria decision analysis in health care: a systematic review and bibliometric analysis. Health Expect (2015) 18:1894-905. doi: 10.1111/hex.12287
248. Inotai A, Nguyen HT, Hidayat B, Nurgozhin T, Kiet PHT, Campbell JD, et al. Guidance toward the implementation of multicriteria decision analysis framework in developing countries. Expert Rev Pharmacoeconom Outcomes Res. (2018) 18:585-92. doi: 10.1080/14737167.2018.1508345
249. Broekhuizen H, Groothuis-Oudshoorn CG, van Til JA, Hummel JM, IJzerman MJ. A review and classification of approaches for dealing with uncertainty in multi-criteria decision analysis for healthcare decisions. Pharmacoeconomics (2015) 33:445-55. doi: 10.1007/s40273-014-0251-x
250. Husereau D, Boucher M, Noorani H. Priority setting for health technology assessment at CADTH. Int J Technol Assess Health Care (2010) 26:341-7. doi: 10.1017/S0266462310000383
251. Marsh K, Dolan P, Kempster J, Lugon M. Prioritizing investments in public health: a multi-criteria decision analysis. J Public Health (2013) 35:460-6. doi: 10.1093/pubmed/fds099
252. Reddy BP, Kelly MP, Thokala P, Walters SJ, Duenas A. Prioritising public health guidance topics in the National Institute for Health and Care Excellence using the Analytic Hierarchy Process. Public Health. (2014) 128:896-903. doi: 10.1016/j.puhe.2014.07.003
253. Youngkong S, Baltussen R, Tantivess S, Mohara A, Teerawattananon Y. Multicriteria decision analysis for including health interventions in the universal health coverage benefit package in Thailand. Value Health (2012) 15:961-70. doi: 10.1016/j.jval.2012.06.006
254. Wahlster P, Goetghebeur M, Kriza C, Niederlander C, Kolominsky-Rabas P. Balancing costs and benefits at different stages of medical innovation: a systematic review of Multi-criteria decision analysis (MCDA). BMC Health Serv Res. (2015) 15:262. doi: 10.1186/s12913-015-0930-0
255. Tanios N, Wagner M, Tony M, Baltussen R, van Til J, Rindress D, et al. Which criteria are considered in healthcare decisions? Insights from an international survey of policy and clinical decision makers. Int J Technol Assess Health Care (2013) 29:456-65. doi: 10.1017/S0266462313000573
256. Morton A. Treacle and smallpox: two tests for multicriteria decision analysis models in health technology assessment. Value Health (2017) 20:512-5. doi: 10.1016/j.jval.2016.10.005
257. Picavet E, Morel T, Cassiman D, Simoens S. Shining a light in the black box of orphan drug pricing. Orphan J Rare Dis. (2014) 9:62. doi: 10.1186/1750-1172-9-62
258. DeRidder R, Adriaens C, Kleinermans D, Mortier M, Quanten A, Arickx F. Mechanism of coordinated access to orphan drugs. Orphan J Rare Dis. (2012) 7(Suppl 2):A24. doi: 10.1186/1750-1172-7-S2-A24
259. EURODIS. Mechanism of Coordinated Access to orphan medicinal products (MoCA). Available at URL: https://www.eurordis.org/content/moca
260. MOCA. Process on Corporate Social Responsibility in the Field of Pharmaceuticals Platform on Access to Medicines in Europe Working Group on Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA-OMP). Available online at: http://download2.eurordis.org.s3.amazonaws.com/moca/history/WG%20MoCA-OMP%20Transparent%20Value%20Framework.pdf
261. Bucsics A. Payer Experience in MoCA. Available online at: http://download2.eurordis.org.s3.amazonaws.com/moca/presentations/PRES-2016-05%20Payer%20Experience%20in%20MoCA%20%28Bucsics%29.pdf
262. Deticek A, Locatelli I, Kos M. Patient access to medicines for rare diseases in European countries. Value Health (2018) 21:553-60. doi: 10.1016/j.jval.2018.01.007
263. Joppi R, Bertele V, Garattini S. Orphan drugs, orphan diseases. the first decade of orphan drug legislation in the EU. Eur J Clin Pharmacol. (2013) 69:1009-24. doi: 10.1007/s00228-012-1423-2
264. Joppi R, Gerardi C, Bertele V, Garattini S. Letting post-marketing bridge the evidence gap: the case of orphan drugs. BMJ (2016) 353:i2978. doi: 10.1136/bmj.i2978
265. Prata WM, Silvestre RG, Godman B, Martin A, Dias CZ, Dias EM, et al. A critical look at innovation profile and its relationship with pharmaceutical industry. Int J Sci Res Manag (IJSRM). (2017) 5:934-5948. doi: 10.18535/ijsrm/v5i7.20
266. Light DW, Kantarjian H. Market spiral pricing of cancer drugs. Cancer (2013) 119:3900-2. doi: 10.1002/cncr.28321
267. Workman P, Draetta GF, Schellens JH, Bernards R. How much longer will we put up with $100, 000 cancer drugs? Cell (2017) 168:579-83. doi: 10.1016/j.cell.2017.01.034
268. KEI. Delinkage. Available online at: http://delinkage.org/overview/
269. Outterson K, Gopinathan U, Clift C, So AD, Morel CM, Rottingen JA. Delinking investment in antibiotic research and development from sales revenues: the challenges of transforming a promising idea into reality. PLoS Med. (2016) 13:e1002043. doi: 10.1371/journal.pmed.1002043
270. O'Neill J. Securing New Drugs for Future Generations: The Pipeline of Antibiotics. The Review of Antimicrobial Resistance. Available online at: https://amr-review.org/sites/default/files/SECURING%20NEW%20DRUGS%20FOR%20FUTURE%20GENERATIONS%20FINAL%20WEB_0.pdf
271. Ranga M, Etzkowitz H. Triple helix systems: an analytical framework for innovation policy and practice in the knowledge society. Indus Higher Educ. (2013) 27:237-62
272. Batson A, Meheus F, Brooke S. Chapter 26: innovative financing mechanisms to accelerate the introduction of HPV vaccines in developing countries. Vaccine (2006) 24(Suppl 3):S3/219-25. doi: 10.1016/j.vaccine.2006.05.042
273. Mueller-Langer F. Neglected infectious diseases: are push and pull incentive mechanisms suitable for promoting drug development research? Health Econom Policy Law (2013) 8:185-208. doi: 10.1017/S1744133112000321
274. Rowe R, Stephenson N. Speculating on health: public health meets finance in 'health impact bonds'. Sociol Health Ill. (2016) 38:1203-16. doi: 10.1111/1467-9566.12450
275. Fernandez JM, Stein RM, Lo AW. Commercializing biomedical research through securitization techniques. Nat Biotechnol. (2012) 30:964-75. doi: 10.1038/nbt.2374
276. Lo AW. Can Financial Engineering Engineering Help Cure Cancer? (2016). Available online at: https://bfi.uchicago.edu/sites/default/files/file_uploads/Lo-can-financial-engineering-cure-cancer.pdf
277. Fagnan DE, Gromatzky AA, Stein RM, Fernandez JM, Lo AW. Financing drug discovery for orphan diseases. Drug Discov Today (2014) 19:533-8. doi: 10.1016/j.drudis.2013.11.009
278. Marsden G, Towse A, Pearson SD, Dreitlein W, Henshall C. GENE THERAPY: Understanding the Science, Assessing the Evidence, and Paying for Value. (2018). Available online at: https://www.ohe.org/news/new-publication-gene-therapy-understanding-science-assessing-evidence-and-paying-value
279. Espin J, Schlander M, Godman B, Anderson P, Mestre-Ferrandiz J, Borget I, et al. Projecting pharmaceutical expenditure in EU5 to 2021: adjusting for the impact of discounts and rebates. Appl Health Econom Health Policy (2018). 16:803-17. doi: 10.1007/s40258-018-0419-1
280. Siegfried N, Wilkinson T, Hofman K. Where From and Where to for Health Technology Assessment in South Africa. Chapter 4 South African Health Review. (2017). Available online at: http://www.hst.org.za/publications/South%20African%20Health%20Reviews/4_Where%20from%20and%20where%20to%20for%20health%20technology%20assessment%20in%20South%20Africa.pdf
281. Fadare JO, Oshikoya KA, Ogunleye OO, Desalu OO, Ferrario A, Enwere OO, et al. Drug promotional activities in Nigeria: impact on the prescribing patterns and practices of medical practitioners and the implications. Hospital Pract. (2018) 46:77-87. doi: 10.1080/21548331.2018.1437319
282. Massele A, Burger J, Katende-Kyenda NL, Kalemeera F, Kenaope T, Kibuule D, et al. Outcome of the first Medicines Utilization Research in Africa group meeting to promote sustainable and rational medicine use in Africa. Expert Rev Pharmacoeconom Outcomes Res. (2015) 15:885-8. doi: 10.1586/14737167.2015.1088386
283. Niaz Q, Godman B, Massele A, Campbell S, Kurdi A, Kagoya HR, et al. Validity of World Health Organisation prescribing indicators in Namibia's primary healthcare: findings and implications. Int J Qual Health Care (2018). doi: 10.1093/intqhc/mzy172