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Economic Evaluation in Drug Development
Which form of economic evaluation might be appropriate to assess whether a new me-too drug is cost-effective
Me-too drugs are drugs that are anatomically and physically very comparable to drugs that are already known in the market, with minimal dissimilarities. It is quite costly to produce a completely new and innovative drug. Therefore, in recent periods, companies more often than not take a less expensive direction to generate a new product (LaMattina, 2015). This is where me-too drugs come in. However, there is a great need to assess whether these new drugs are cost effective. The FDA is lawfully duty-bound to assess all drugs yielded for approval, together with all me-too products, irrespective of the number of in-class brand or standard replacements (Gagne and Choudhry, 2011). The best form of economic evaluation would be to review me-too drugs by use of routine mechanisms, for instance, by necessitating that they offer proof and substantiation of superiority over palliative or non-inferiority to another drug already known (Gagne and Choudhry, 2011). More so, this is to be done up until an all-purpose of a drug in the class is given approval. Subsequent to undertaking this, the manufacturers of such me-too drugs ought to...
In particular, superiority could be centered on clear enhancements in effectiveness or well-being. In addition, what ought to be undertaken is that signs could be sought for populations except those for which prevailing drugs in the class are sanctioned, for instance, elderly individuals or children, where fitting. One more option would be to try and find a new sign all in all (Gagne and Choudhry, 2011).
Impact of utilizing economic evaluation on the drug development process
Considering all aspects, there would be positive impact on utilizing economic evaluation on the drug development process. To begin with, in general, the impact of using economic evaluations on the development of drugs is that, first of all, it would be beneficial in price negotiations and concessions. In addition, it would assist agencies to be able to target drugs at the specific patients who are most likely to benefit from them. This will be all the more constructively impactful as the increasingly high prices of several new drugs, especially for diseases such as cancer, and the incremental instead of considerable enhancements…
References
Gagne, J. J., Choudhry, N. K. (2011). How Many "Me-Too" Drugs Is Too Many? JAMA, February 16, 2011 -- Vol 305, No. 7
Jacobs, P. (2011). Are economic evaluations an important tool in vaccine policy decisions? Expert review of pharmacoeconomics & outcomes research, 11(5), 507-511.
LaMattina, J. (2015). Impact Of 'Me-Too' Drugs On Health Care Costs. Forbes. Retrieved 30 March 2016 from: http://www.forbes.com/sites/johnlamattina/2015/01/19/impact-of-me-too-drugs-on-health-care-costs/#4d6a24482610
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