Ask The Board

Q: What innovations are needed to create better diagnostics for personalized medicine, and how can payors support them?

A: Next generation sequencing (i.e., high throughput sequencing of genes via a panel) may enable more genetic information to be efficiently generated to best determine a course of treatment. Although this technology offers significant benefits, improvements in it are still needed for faster turnaround time, decreased cost of testing, and standardization of analytical methodologies. Liquid biopsy is another emerging technology creating the means for less-invasive sampling for patients. Rather than extracting tumor tissue via biopsy to test the tumor for molecular targets, sampling of blood may enable testing of tumor cells. Payors can ensure reimbursement for companion diagnostics, including those derived from novel technologies, to enable access to corresponding drug treatments. New business models should be created which view the companion diagnostic and drug as a single entity. They create value for the healthcare system when used together.

TIM GARNETT
Dr. Tim Garnett is the chief medical officer and senior VP of Medicines Development Unit (MDU) for Lilly and is responsible for medical, regulatory, global product safety, and global health outcomes.

Q: From your perspective, what is the top trend/topic/ issue in our industry? Why?

A: The ebola scare served as an overdue wake-up call about the potential spread of infectious diseases, including drug-resistant bacteria. Each year, more than five million people in the U.S. and Europe become infected with serious, resistant bacterial infections, and at least 48,000 die as a direct result of these infections. More than two million children, mostly in the undeveloped world, die each year of bacterial pneumonia alone. Without increased action, a nightmare scenario will continue to emerge. While the worldwide chorus advocating reforms has gotten louder, more needs to be done. We should enforce better surveillance and infection control in hospitals, use antibiotics only when necessary, and reform reimbursement policies to accelerate innovation. Additionally, we should develop new, targeted antibiotics through clear regulatory pathways and rapid diagnostics, which will promote antibiotic stewardship and appropriate use of these assets. Above all, we should remove barriers that prevent millions of people annually from getting the right medicine at the right time.

BARRY EISENSTEIN
Barry Eisenstein, MD, FACP, FIDSA, FAAM, is senior VP of scientific affairs at Cubist Pharmaceuticals

Q: What is the top trend, topic, or issue in our industry, and why?

A: Drug Pricing. More drugs for cancer and rare diseases will be approved by the FDA. These will come with high price tags. While most of these drugs are priced responsibly, insurance companies will still howl when they come to market, as they did with Gilead’s Sovaldi. Because many new drugs are priced extremely high, people are challenging the basis of these costs. Certainly, these prices aren’t justified by the amount of R&D spent. Nor are they justified on the amount of money sunk into previous R&D failures. Drugs should be priced based on value. For example, if a patient with a rare disease costs the healthcare system $600,000 per year (i.e., hospitalizations, doctor care, home care), the introduction of a new drug that enables a patient to have a normal life, even if priced at $300,000 per year, still represents a win for all.

JOHN LAMATTINA
John LaMattina, Ph.D., is the former senior VP at Pfizer, Inc. and president of Pfizer Global Research and Development. In this role, he oversaw the drug discovery and development efforts of more than 12,000 colleagues in the United States, Europe, and Asia.