Impact of Pharmacogenomics on Public Healthcare Policy.pdf
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1、H E A L T H C A R E Impact of Pharmacogenomics on Public Healthcare Policy Educating patients, payors and healthcare providers By Dr Cheryl L Barton ii Dr Cheryl L Barton Dr CL Barton has over ten years practical pharmaceutical research experience with a leading pharmaceutical company as well as a n
2、umber of years working as a lead analyst in a major Pan-European Bank. In 2002 Dr C L Barton Ltd (PharmaVision) was created to provide independent, tailor- made, pharmaceutical thematic research to investment houses. Where applicable the research reports combine independent scientific analysis with
3、patients- and prescription-based models to forecast the potential sales growth of key developmental drugs and isolate the key drivers within the pharmaceutical sector. For more details visit www.pharmavision.co.uk. Copyright 2008 Business Insights Ltd This Management Report is published by Business
4、Insights Ltd. All rights reserved. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Busi
5、ness Insights Ltd accepts no liability for the accuracy or completeness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibilit
6、y can be accepted by Business Insights Ltd for its completeness or accuracy. Copyright 2008 Business Insights Ltd This Management Report is published by Business Insights Ltd. All rights reserved. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohi
7、bited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Business Insights Ltd accepts no liability for the accuracy or completeness of the information, advice or comment contained in this Management
8、 Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by Business Insights Ltd for its completeness or accuracy. iii Table of Contents Impact of Pharmacogenomics on Public He
9、althcare Policy Executive Summary 10 Pharmacogenomics defined 10 Application regulatory framework and financial incentives are in place to ensure PGx innovation and implementation by the industry. ? Pharmaceutical, biotechnology and diagnostic companies must work together to educate payors, physicia
10、ns and providers regarding the benefits of PGx products and tests; and to apply it where appropriate to ensure a good ROI for investors. ? Despite these hurdles, significant opportunities exist including the provision of safer and more effective medicines particularly in areas of high unmet clinical
11、 need. PGx has the potential to revive abandoned projects or endorsing the use of “higher risk” medicine in conjunction with the appropriate companion diagnostics. 15 ? The majority of stakeholders now recognize the promise of PGx and numerous strategic alliances and collaboration are now in place t
12、o apply this technology within the R these differences can determine how a person responds to a specific drug or develops a specific disease. Conversely, pharmacogenetics (PGt) predicts a patients drug response by analyzing the genetic variations in the DNA (Figure 1.2). It is often used interchange
13、ably with the term PGx. Figure 1.2: The concept of pharmacogenetics Smaller Effect: Multiple Variants Larger Single- Varian Effect Single Gene Small No. Of Genes Whole Genome Complex Biological Pathway Pharmacogenetics Pharmacogenomics Source: Modified from Roden et al. 2006 Business Insights Ltd In
14、deed, there are some leaders in the field that believe that the term pharmacogenomics should be superseded by the term pharmacodiagnostics (PDx). PDx is also a term that may be referred to as a companion diagnostic, theranostic or even a therapeutic diagnostic which can be used to guide the prescrip
15、tion (Rx) of a pharma product in 21 conjunction with its respective diagnostic (Dx), thus denoted as RxDx As pharma and diagnostic companies continue to incorporate PGx along with a wide range of technologies to develop a new generation of diagnostic tests. These genetic tests exploit information ab
16、out a biomarker (genetic, proteomic, metabolic etc) which can be associated with a certain disease state and which when tested may influence the direction of treatment management. Why is pharmacogenomics important? PGx has the potential to help address some of the pharma industrys macroeconomic issu
17、es which impact productivity and return on investment (Figure 1.3). Figure 1.3: Costs, time and success rates associated with drug development Source: Kola we must apply. Willing is not enough; we must do.” Goethe The pharma industry exhibits high attrition rates with 70%-80% failure rate during cli
18、nical development resulting in only 1 drug approved for every 5,000-10,000 compounds tested. Even following approval, drugs are at risk from market withdrawal due to post-marketing adverse drug reactions (ADRs). This can have a drastic impact on pharma revenues and has far reaching consequences on t
19、he costs associated with treating ADRs, some of which may be life threatening. According to a study published by Gurwitz et al in 2003, the problem of ADRs is a significant and troubling issue, exhibiting an incidence of 50.1 ADRs per 1,000 person- years of treatment. Of these, 38.0% were life-threa
20、tening or fatal.1 According to recent report ADRs from “properly prescribed medication” is the fourth leading cause of death in the US and when combined with “improperly prescribed medication” is the third leading cause of death.2 Experts in the field suggest that up to a third of these ADRs could b
21、e identified and potentially avoid by developing and screening with PGx tests. Therefore, PGx testing may have considerable potential in: ? the selection of a compound with greater efficacy or lower ADRs; ? to identify a patient most likely to response to therapy; ? to identify the most appropriate
22、dose to avoid ADRs; or 1 http:/books.nap.edu/openbook.php?record_id=11897 ? identify drug response markers; ? enhance efficacy; ? reduce the incidence of toxicity; ? reduce the size of clinical trials; ? provide additional data to help address regulatory issues. The pharma industry is utilizing PGx
23、technologies to some degree throughout the R ? Pre-clinical drug development; ? Phase 1-3 studies; ? Phase 4 studies The following section provides examples of how this technology has been utilized to guide drug development programs. Efficacy studies According to industry experts the response rate t
24、o current medicines is unacceptably low (Figure 2.8). For many therapy areas, less than 50% of the addressable patient population responds to therapy, raising the question of whether or not the right drug is being prescribed to the wrong patient. Therefore, the industry needs to identify predictive
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