by David F. Kisor, Pharm.D., Professor and Chair, Pharmaceutical Sciences, Director, Master of Science in Pharmacogenomics Program, Manchester University

David F. Kisor, Pharm.D.

The uptake of pharmacogenomics (PGx) in clinical practice is lagging, being related to a number of barriers including, largely, a lack of health professions student and practitioner education. Recent data illustrate the scope of the challenge in the pharmaceutical field.

A survey of practicing pharmacists (n=737; n=728 responding to most questions), across all education types (i.e. B.S./M.S./Pharm.D.), ages and years in practice regarding the use of genetic testing to guide drug therapy was reported in 2012. The study showed that only 18 percent of pharmacists believed they had a good, very good or excellent understanding of pharmacogenetic testing. Forty-one percent of the pharmacists believed they had a fair understanding of pharmacogenetic testing. Of the 728 pharmacists, 47 percent stated they had no genetics education. The remainder had some genetics education through undergraduate work (26 percent) or another avenue (39 percent), with some of the individuals receiving education via multiple settings.

This information demonstrates a clear need for PGx education in pharmacy. Fortunately, the field is rising to the challenge.

A survey of U.S. pharmacy colleges/schools showed the percentage of institutions with PGx in their Doctor of Pharmacy (Pharm.D.) curricula increased from 39 percent in 2005 to more than 89 percent in 2010. The latter information was provided by 75 of the then 109 colleges/schools of pharmacy in the U.S. that belong to the American Association of Colleges of Pharmacy (AACP). In the 2010 pharmacy college/schools report, just over 65 percent of respondents rated their institution’s PGx instruction as adequate, good or very good.

The increased focus on PGx education is now happening largely by design. Formal pharmacy education is now mandated by the 2016 Accreditation Council for Pharmacy Education (ACPE) standards to include PGx in the curricula of all pharmacy colleges/schools to ensure pharmacists entering practice are knowledgeable in the subject. In addition, numerous pharmacy programs, including The Ohio State University, Temple University, Presbyterian College and Manchester University, among others, have offered individual exercises incorporating student “pharmacogenotyping,” which have shown to increase students’ PGx knowledge. A shared PGx curriculum was offered through the PharmGenEd^TM program out of the University of California San Diego. More recently, academic institutions have rolled out innovative ways to teach these concepts. These approaches include the University of Pittsburgh’s Test2Learn^TM approach in the Pharm.D. core curriculum. Pharmacy colleges/schools are embracing PGx and are preparing graduates to incorporate PGx as a component of precision medicine in pharmacy practice.

Relative to educating practicing pharmacists, it was noted that in 2015 there were 35 knowledge or application programs related to pharmacogenetics/PGx. These self-study or live programs were associated with ACPE continuing education credits. Examples of more extensive practitioner-based PGx education have also been offered.

In 2015, a group of pharmacists completed a 20-hour certificate-training program that included 13 hours of home study and 7 hours of live education, including interaction with seven simulated patients. This program, offered by the Manchester University Pharmacy Program and the Indiana Pharmacists Alliance, was pointed at pharmacy practice, incorporating the pharmacist competencies in PGx from the Genetics/Genomics Competency Center (G2C2) website published by the National Human Genome Research Institute. The program will be offered again in the fall of 2016.

These kinds of programs are increasing in number. In March of 2016, the University of Florida College of Pharmacy and the University of Florida Health Personalized Medicine Program offered a certificate program for pharmacists as part of their inaugural conference on precision medicine. This effort included 15 hours of ACPE continuing education. The inaugural University of Florida conference was extremely well attended, which speaks to the rapidly growing interest in the pharmacy practice aspects of PGx. Additionally, a collaborative study is underway between academia and private industry to educate community pharmacists on how to provide PGx services. One of the components of the study is an online certificate-training program.

A commentary published in Pharmacogenomics in March 2016 from the Center for Applied Genomics & Precision Medicine at the Duke University School of Medicine noted that certificate training programs for pharmacists, such as those noted above, “could ensure the appropriate and safe use of PGx testing and optimize the lifetime benefits to patients.”

Other institutions are also playing an important role in moving the field forward. The AACP PGx special interest group recently published The DNA of Pharmacy Education: CAPE Outcomes and PGx online. This paper discusses educational approaches in pharmacy, combining G2C2 pharmacist competencies with the Center for the Advancement of Pharmacy Education (CAPE) outcomes, while considering the 2016 ACPE standards.

Optimally, inter-professional education in PGx with pharmacists, physicians, physician assistants, nurse practitioners, genetic counselors and other health care professionals would help to identify the specific roles that are needed in the health care team environment to optimally apply PGx as a component of precision medicine. These inter-professional education approaches are currently ongoing at various academic institutions.

The PGx education of pharmacy students and practicing pharmacists is now well underway, and further expansion of academic and professional education programs, such as expanded conference offerings and online certificate training programs, is likely. It is clear that the promise of personalized medicine is being fulfilled and the PGx component is advancing toward being the standard of patient care.

by Amy M. Miller, Ph.D., PMC Executive Vice President

Amy M. Miller, Ph.D.

Over the last two months, the administration has solidified its commitment to personalized medicine by naming esteemed leaders to head Vice President Biden’s Cancer “Moonshot” Task Force and the President’s Precision Medicine Initiative.

These efforts to improve global health are exciting, and the world looks forward to the discoveries that come from them. However, we have a set of personalized medicines, related diagnostic tests and other innovations that can, right now, improve care for many, and in some cases, provide that moonshot for one.

Yet even in the face of such incredible advances in science and medicine, we also have one sector whose decisions put a damper on that enthusiasm.

As many of you know, the Centers for Medicare and Medicaid Services (CMS) have a history of making policy decisions that have the unintended consequence of deterring use of and investment in personalized medicine products and services, most notably personalized medicine tests. Cutting-edge treatments and services for breast cancer, for example, represent some of the most incredible innovations of the last decade. Yet, payment rates for innovative diagnostic tests used to treat the disease have been cut significantly in the past, and may stand to be cut again. Until these kinds of decisions are revisited, even the most extraordinary progress in research will have only a modest impact on patient care.

In fact, unless CMS is actively engaged in the PMI and “Moonshot” initiatives, we might have a situation where new tools for improving health, such as therapeutics targeted to a particular marker, are not covered and paid for at sustainable rates. For example, CMS’ Center for Medicare and Medicaid Innovation (CMMI) is thinking up some programs to improve health care at a lower cost.  One would hope that under such a mandate personalized medicines would be advantaged, not disadvantaged, since we know with greater certainty that these therapies will work for their target populations.

Yet, CMMI is proposing a plan to cut payments for drugs provided in a physician’s office or a hospital, and many targeted treatments for a subset of breast cancer patients whose tumors are HER2-positive might be disadvantaged by the plan. We encourage CMS to value personalized medicines and their related diagnostics and to recognize this improvement in patient care with appropriate coverage and payment policies.

Furthermore, we encourage the administration to see its commitment to personalized medicine holistically. PMC has long argued that personalized medicine does not fit into the existing system of how health care is regulated, delivered and paid for. Each aspect of the health care system, from discovery to regulation, delivery and payment policy, must be aligned with the field’s principles. Most notably, CMS must be engaged in the dialogue.

Only then can the hope for change be realized fully.

by Christopher Wells, PMC Communications Director

Christopher Wells

In a report recently published online in Clinical Cancer Research, representatives from the co-convening organizations of the Turning the Tide Against Cancer initiative say alternative payment models (APMs) should incentivize the adoption of innovative medicines and technologies like those associated with personalized medicine.

“Ultimately, APMs can be a powerful means of driving innovation in treatment and care delivery, facilitating research and promoting access for patients with cancer to proven, individualized, life-changing treatments,” the authors write in a piece titled “The Impact of Alternative Payment Models on Oncology Innovation and Patient Care.” The authors warn about unintended consequences of APMs that are put in place with consideration only to the cost of therapies.

The report was co-authored by Amy M. Miller, Ph.D., Executive Vice President, PMC; Gilbert Omenn, M.D., Ph.D., Director, Center for Computational Medicine and Bioinformatics, University of Michigan, Chair of the American Association for Cancer Research (AACR) Health Policy Committee; and Marcia Kean, Chairman, Feinstein Kean Healthcare. The authors used the results of a multidisciplinary round table on APMs to identify five critical considerations for the development of APMs. They include:

• APMs should keep pace with rapidly emerging science by incentivizing the adoption of innovative medicines and technologies that have the potential to improve patient outcomes and make health care more efficient
• APMs should include mechanisms to encourage patient participation as appropriate in clinical trials as well as ongoing post-market clinical research
• Clinical pathways should be transparent and evidence-based, and updated regularly to reflect current scientific evidence and clinical advances within the overall continuum of care
• When providers and patients are making treatment decisions, patients should be given a clear, comprehensive picture of their treatment options, including cost information that is tailored to the specific patient’s insurance coverage and treatment plan
• APMs should require that clinical data be aggregated and integrated into providers’ workflows via electronic health records in order to support learning health care systems

The recommendations were discussed during a panel session at AACR’s 2016 annual meeting on Sunday, April 17, which Omenn moderated.