1500 Table 1. List of Antimicrobial Agents Approved Before and After the GAIN Act
Year 2006
2007 2008 2009 2010 2011 2012 2013 2014
2015
2016 2017
2018b
No. of Antimicrobials Approved
2
0 0 1 2 1
2a
2 7
2
2 4 1
Antibiotics Approved None
None None
Telavancin
Ceftaroline, gatifloxacin ophthalmic solution Fidaxomicin Bedaquilinea Telavancin
Dalbavancin, oritavancin, tedizolid, ceftolozane-tazobactam, finafloxacin otic suspension
Ceftazidime-avibactam, None
Antifungals Approved
Anidulafungin, posaconazole
None None None None None None
Luliconazole
Efinaconazole, tavaborole
Isavuconazonium sulfate
None
Delafloxacin, meropenem-vaborbactam, ozenoxacin, secnidazole None Plazomycin
aBedaquiline and raxibacumab were both FDA approved after July 9, 2012. bAs of May 8, 2018.
the drugs provide value for money. Value-based pricing is a method that could be used to determine a price for new anti- bacterial agents at which these drugs provide value to the patient and health system rather than per the cost of the drug or his- torical prices.8,9 This VBP reflects an assessment of the com- parative effectiveness of the drug compared to other available treatments. An important factor will be the definition of “value,” which might also include other factors than the impact of the drug on patient health, that is, wider social impact and the health impact of disease.8 In conclusion, although the GAIN Act has been a laudable
initiative aiming to reduce the devastating burden of anti- microbial resistance, substantial barriers remain. Accordingly, there is a need for new policies that incorporate the CIP to incentivize antibiotics innovation and create better solutions for the devastating burden of antimicrobial resistance. Equally important, VBP of the new antibiotics is essential throughout the innovative process.
Acknowledgments. None to disclose. Financial support. No financial support was provided relevant to this article.
Conflicts of interest. The author reports no conflicts of interest relevant to this article.
References
1. WHO.WHO publishes list of bacteria for which new antibiotics are urgently needed. World Health Organization 2017;27 February 2017 News Release GENEVA. (
http://www.who.int/en/news-room/detail/27-02-2017-who-pub lishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed).
2. CDC fact sheet: antibiotic/antimicrobial resistance. Centers for Disease Control and Prevention website.
https://www.cdc.gov/drugresistance/index. html. Published 2017. Accessed September 17, 2018.
3. Generating antibiotic incentives now. Food and Drug Administration Safety and Innovation Act Public Law 112-144, Department of Health and Human Services. Food and Drug Administration website.
https://www.fda.gov/down loads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDER/UCM595188.pdf. Published 2012. Accessed September 17, 2018.
4. Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis 1995;1:7–15.
5. Weiss RA, McMichael AJ. Social and environmental risk factors in the emergence of infectious diseases. Nat Med 2004;10:S70–S76.
6. Simpkin VL, Renwick MJ, Kelly R, Mossialos E. Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot 2017;70:1087–1096.
7. Mueller-Langer F. Neglected infectious diseases: are push and pull incentive mechanisms suitable for promoting drug development research? Health Econ Policy Law 2013;8:185–208.
8. Verhoef TI, Morris S. Cost-effectiveness and pricing of antibacterial drugs. Chem Biol Drug Des 2015;85:4–13.
9. Robinson JC, Howell S, Pearson SD. Value-based pricing and patient access for specialty drugs. JAMA 2018;319:2169–2170.
None
Monoclonal Antibodies Targeting Pathogenic Bacterial or Fungal Agents
None
None None None None None
Raxibacumaba None None
None
Bezlotoxumab, Obiltoxaximab None None
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