aspect of our society. The discovery
of new targeted therapies, the
development of better drug delivery systems,
facilitating patient access to therapy,
and innovative approaches to hold
Cancer care has influenced every down treatment costs are just a few of the strategies that can contribute to improved patient care, especially from a drug developer’s perspective. However, innovation can prove challenging for the pharmaceutical industry, especially with respect to reimbursement.
fall of 2014. Participants included Irwin
W. Tischler, DO, national medical director,
oncology, for Cigna, and Bryan Loy,
Revolutionizing patient care, however, needs much more, as was revealed during conversations with payer representatives from leading managed care enterprises during the Oncology Stakeholders Summit: Insights discussion organized by The American Journal of Managed Care in the MD, physician lead—cancer, Humana. Peter Salgo, MD, professor of medicine and anesthesiolog at Columbia University and associate director of surgical intensive care at NewYork-Presbyterian Hospital, interviewed the experts.
Salgo began by asking the experts what were the most influential innovations in oncology over the previous decade. Tishcler considered personalized treatment and molecular diagnostics to individualize treatment as most important; he regarded these developments as a means to reduce side effects and provide care tailored to treat a specific genetic abnormality, and only sees the role of personalized therapy evolving and getting even more specific over time. Loy recognized the increasing openness among various groups about their cancer experiences. He thinks we have come a long way, with all stakeholders involved—patients, payers, providers, and policy experts—grabbing on to a common platform to discuss cost-effective ways of utilizing technology to improve patient care. “We wouldn’t have heard that 10 to 12 years ago,” he said.
Loy acknowledged that molecular testing has had a huge impact on cancer treatment options. He sees even more opportunity in gathering stakeholders to make best of this tremendous scientific achievement. Citing Kentucky, his home state, as an example, Loy said that contextualizing risk is difficult for some patients. With the biomarker tests, however, results and disease risk can be assigned a definitive value to help bring things into perspective for the patient. The dialogue also highlights shared accountability among all involved.
Rep Fred Upton (R-Michigan) and Rep Diana DeGette (D-Colorado) have launched the 21st Century Cures initiative to “bridge the gap between the science of cures and the way the therapies are regulated.” A dialogue has already begun between the committee and various stakeholders from the healthcare world.1 “Do you see this initiative impacting some of the regulatory barriers that currently impact the industry?” asked Salgo. Tischler said he expects this initiative, coupled with the influence of the current digital revolution, to improve patient access to novel therapies. He said the initiative is looking for suggestions and solutions to move the process without the oversight and regulation that have been a barrier to drug development thus far. Loy, too, acknowledged that the initiative is a healthy first step to hasten the drug development process so patients gain access to novel treatment options. Whether and how they exploit available treatments will vary, he said.
Both Loy and Tischler agreed that the pharmaceutical industry faces tremendous risks during product development, but Tischler believes the initiative is working to overcome some of these barriers. “If we can adopt something along these lines that this bill is purporting to do, it may lower some of the costs and enable us to use some of the technologies that are available. And I think that if there is still a return on their investment dollar and their research dollars, they won’t be as adverse to it,” he said. Loy also believes in the potential of an adaptive clinical trial design, especially in the search for breakthrough therapies. According to Loy, the existence of guidelines alone would bring tremendous clarity to the drug development process, even if it does not have a direct influence on the pace of innovation.
PERSONALIZED MEDICINE AND THE CHALLENGE OF PHARMACOGENOMICS
While personalized medicine presents a tremendous opportunity to improve treatment outcomes, the challenge lies in its high cost, analyzing the vast amount of data generated from the genomic tools, and making sense out of those tools. Tischler stated that pharmacogenomics applications are in preliminary stages and currently do not have any clinical utility, but that payers end up covering their expenses anyway. Loy agreed, saying that payers need to be convinced about the value of spending money on personalized treatment options while distinguishing between the clinical utility of a genomic test versus patient eligibility for a future trial.
An important consideration that needs improvement is the lack of communication between all those involved in personalized testing, said Loy. This results in tests being conducted but results not being shared to allow for more-informed treatment decisions. This is especially important when decisions to not treat a patient are made based on a test. “You really need to make sure that if you are deciding not to treat, that you’re not living with regret later on because of your unknown risk tolerance and unknown understanding of probability,” Loy said.
MEDICARE REIMBURSEMENT POLICIES AND PHARMACEUTICAL INNOVATION
Both Loy and Tischler pointed to several issues associated with Medicare, especially sequestration, which primarily harmed reimbursement rates for oncologists. And patients who stand to gain from the treatment have high cost sharing or high deductibles, which, in cancer care, has resulted in bankruptcies, said Loy. To help ease difficult decisions of choosing between treatment and affording a normal life, Loy’s solution is to hold multistakeholder conversations now, rather than later, and to center them around cost issues. He thinks these decisions must
be made early on in the treatment process to help patients “fight their battle by making reasonable choices, rather than wait until a catastrophic situation arises.”
One of the solutions that Tischler suggested was having 1 deductible and 1 co-payment that would cover the entire treatment, rather than individual co-pays per visit or per prescription. “We’re talking about it with some employer groups, with our national teams to see if by one deductible, one co-pay, it covers their entire treatment,” he said.