Precision Pharmacotherapy: Ready for Prime Time?
In general, there is a lack of adequate evidence from well-designed, controlled clinical trials demonstrating that the use of pharmacogenomic data to individualize drug therapy is directly related to improvements in clinical outcome in nononcology therapeutic areas.
In this issue, Robert Alesiani, PharmD, CGP, offers a brief overview of the potential benefits of clinical pharmacogenomics as an element of precision medicine and illustrates that potential with a case presentation in mental health care. Although the importance and value of genotypic and phenotypic data are increasingly well accepted and applied in oncology care, it is less true in the nononcology setting. I believe that we are on the verge of significant growth in the use of precision prescribing, or precision pharmacotherapy, in a number of nononcology therapeutic areas. But there are a few barriers that need to be considered and overcome to fully reach this potential. I propose that those barriers be categorized under 3 major headings: data, financial, and training.
In general, there is a lack of adequate evidence from well-designed, controlled clinical trials demonstrating that the use of pharmacogenomic data to individualize drug therapy is directly related to improvements in clinical outcome in nononcology therapeutic areas. When controlled trials have been completed (eg, warfarin), the results have been mixed. The good news is that several large multicenter studies are under way, and we should have a growing body of literature in the near future to better inform the use of precision pharmacotherapy in cardiovascular medicine, mental health, and other therapeutic areas. The other data gap that needs to be addressed is the availability of evidence from well-designed health economics research evaluating the cost-effectiveness of gathering and using pharmacogenomics data in routine clinical practice.
There are a number of unanswered questions relative to the financial support for clinical pharmacogenomics. Will employers, payers, and/or providers be willing to fund the testing and clinical services to permit sustainable and widespread growth of clinical pharmacogenomics? With the shifting sands of health care reimbursement and assignment of risk, how will incentives align to support the routine use of individualized drug therapy? In the emerging realm of population health management, will accountable care structures and provider networks realize the benefits of incorporating clinical pharmacogenomics into routine clinical care, where it is supported by the data, and therefore be incentivized to fund the necessary resources? As mentioned above, well-designed health economics research with an appropriate perspective will be needed to best answer these and other questions related to having sustainable pharmacogenomics services. It is unlikely, in this environment, that we can count on a traditional fee-for-service consult model to emerge as the long-term solution for resourcing a precision pharmacotherapy program. Creative business planning that is built upon clinical and financial outcomes data demonstrating the value of such a program will be needed.
There is a relative absence of adequately trained pharmacists, physicians, and other health care team members in the field of pharmacogenomics to permit immediate and safe widespread application of precision prescribing. Like in many areas, a little information can be a dangerous thing. Initially, we should anticipate that clinical pharmacogenomics consulting services will be the primary mechanism for delivering limited precision pharmacotherapeutic recommendations, similar to the early years of applied pharmacokinetics. However, the long-term goal needs to be widespread training of clinical pharmacists in the practical application of genotypic and phenotypic data in individualizing drug therapy, so that it becomes an expected and routine part of comprehensive medication management. As a profession, we must define education and training pathways to adequately prepare ourselves for meeting this anticipated clinical need.
In conclusion, we should anticipate that precision pharmacotherapy will be an important aspect of therapeutics, and we therefore need to prepare for how best to meet this need within organized systems of health care delivery. To best prepare, we need to work collectively to fill the gaps related to clinical and economic data, training, and viable business models to define successful models of care delivery in different practice environments.
Curtis E. Haas, PharmD, FCCP, is the director of pharmacy for the University of Rochester health care system in New York.