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Impact of Pharmacogenomics on Public Healthcare Policy: Educating Patients, Payors and Healthcare Providers
Business Insights, March 2008, Pages: 171
Immense advances in genetic code decipherment over the last decade have recently led to personalized medicine, or ‘the right drug for the right person’, becoming an achievable concept. Pharmacogenomics (PGx) embodies the principles of personalized medicine by combining pharmacology with genetic information to improve drug safety and efficiency.
The pharma industry is currently applying PGx throughout its R&D processes to enhance decision making, streamline clinical trial design and reduce drug failures and product withdrawals. Companies are also attempting to increase the impact of PGx by engaging in strategic alliances and collaborations. However, it is crucial that governments and regulators provide sufficient rewards for developers if innovation in this field to continue. This can be achieved by establishing suitable incentives, regulatory frameworks and reimbursement environments.
Impact of Pharmacogenomics on Public Healthcare Policy: Educating patients, payers and regulators is a new report published by Business Insights that examines how PGx implementations can help to improve efficiency and productivity within the industry, across the fields of pharma, biotech and diagnostics. The PGx strategies of major companies are profiled and recent alliances and licensing opportunities are highlighted.
This report discusses how reimbursement issues may influence the uptake of PGx and assesses major regulatory issues in Europe, Japan and the US. The current market trends, future challenges and opportunities facing PGx are also investigated.
Discover the potential value of pharmacogenomic tests and products to your R&D program, identify the latest regulatory and reimbursement issues and benchmark PGx implementation strategies with this report.
Top five reasons to order your copy today
- Identify how companies are implementing PGx technologies with this report’s analysis of key strategies, alliances and licensing opportunities for major pharma, biotech and diagnostics companies.
- Discover how PGx can create cost-savings through improved decision-making and reduced development times by examining the challenges and opportunities facing this technology and assessing the realistically attainable benefits.
- Understand the latest reimbursement issues influencing coverage, coding and payment in the PGx field by using this report’s profile of key reimbursement drivers and analysis of the cost-effectiveness and commercial viability of PGx tests and technologies.
- Assess the extent to which changes in the regulatory landscape may influence future applications of PGx with this report’s analysis of influential white papers currently under review and major developments in the regulatory environments of Europe, Japan and the US.
- Evaluate stakeholder importance in the uptake of PGx products and tests and understand how education and patient consent will affect PGx utilization in the drive towards personalized medicine.
Some key findings from this report...
- Pharmacogenomics (PGx) can improve drug safety and efficiency to increase success rates in pharma R&D. Although the biotech and diagnostic industries have been quick to adopt this technology, the pharma industry has been the slowest to realize the potential benefits.
- Regulators in the US, Europe and Japan are beginning to engage in the collection, submission and analysis of PGx data through a newly established regulatory framework. However, there are concerns that regulations that may stifle innovation in this rapidly evolving field.
- Pharma, biotech and diagnostics companies have adopted a variety of PGx strategies in their R&D programs, and in some cases have active companion diagnostic programs that run in parallel.
- The pharma industry continues to fight for cost-effectiveness and fair reimbursement in PGx tests and products. PGx testing is generally not mandatory prior to drug prescription and approval does not currently guarantee reimbursement.
- The patent landscape will become more complex as companies seek to develop personalized medicines in an effort to improve the proprietary status of approved and novel drugs.
Key issues examined in this report...
- Productivity improvements. PGx technologies aim to alleviate the current productivity crisis in the bio-pharma industry, specifically in terms of regulatory approvals, reimbursement, containment of R&D costs and accurate stratification of patient populations.
- Industrial consolidation. Reductions in productivity have been one of the key factors driving consolidation within the pharma industry. The application of new technologies such as PGX testing and patient stratification is helping to address this issue.
- Go/no-go decision-making. The additional information and resources associated with PGx applications can be used to make go/no-go decisions earlier in the drug development process, reducing the financial liability of potential drug failures.
- Toxicology and safety. Effective PGx implementations can result in the earlier identification of toxicology and safety issues in late-stage R&D. Clinical trials can then be adapted to reposition the drug candidate, significantly reducing the prospect of negative publicity.
Your questions answered...
- What is PGx and how is it being applied in the industry?
- Which of the leading companies adopting PGx and how are they applying it to their development programs?
- What are the opportunities and challenges facing PGx?
- Which strategies are diagnostic companies using to develop PGx tests?
- What reimbursement hurdles do PGx tests and products have to overcome in order to reach the market?
- How is the r evolution of PGx changing the reimbursement environment?
- How will regulatory frameworks provide incentives for the adoption of PGx technologies in the future?
- What is the current IP landscape within the PGx field?
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