By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
From The Cutting Room Floor: December 2015 Issue
Read the full magazine article: What Nine Of Biopharma’s Biggest Trendsetters Expect For 2016?
When Life Science Leader was seeking executive-level participation for its 2016 Outlook issue published in December 2015, the response was overwhelming. One of the problems this type of situation creates for a print publication is that you are faced with a tremendous amount of insights, but not enough pages on which to publish them. As a result, we decided to create a series of online articles to supplement the December 2015 feature, What Nine Of Biopharma’s Biggest Trendsetters Expect For 2016? The first trendsetter of our four-part series is Paul Hastings, chairman and CEO of OncoMed Pharmaceuticals. A seasoned executive with experience spanning the likes of QLT, Axys Pharmaceuticals, Chiron BioPharmaceuticals, LXR Biotechnology, and Genzyme, the following are Hastings’ previously unpublished responses to trends from other industries that will be big for biopharma for 2016.
What trends from other industries do you anticipate leaking into and impacting the biopharma industry and why?
“There are three areas that could dramatically change how we treat patients — the continued evolution of personalized medicine, increased ability to collect and analyze large data sets, and the widespread support for incorporating patient input into drug development. As data capabilities improve, so too does our ability to use genetic and clinical data to identify which patients will respond best to which medicines or specific dosing regimens, enabling targeted clinical development programs. These same data capabilities could also enable innovators to incorporate patient preference information (e.g., patient and caregiver perspectives from experience with a device) into clinical programs in a manner acceptable to regulators, physicians, and patients. The reimbursement landscape, from Medicare to private insurers, can have an outsized effect on our industry. Should nonmarket forces dictate price and patient access? The most extreme examples of this happening can be found in Europe where some countries (e.g., the UK’s National Institute for Health and Care Excellence [NICE] and Germany’s Institute for Quality and Economic Efficiency in Health Care [IQWiC]) do not have mutually exclusive price and utility decisions. We need to make sure this concept does not reach our shores, as it is not in the best interest of the patient. Already in the U.S. we are facing the pervasive use of specialty-tier pricing systems by health insurance companies that shift the cost burden to those patients who require what are often more expensive life-saving or disease-stabilizing medications used to treat serious health conditions. This, in essence, penalizes them for their biology,” asserts Hastings.
What’s going to be big in biopharma in 2016?
“We have had a big couple of years in FDA approvals. I think we have the potential to see incredible breakthrough level data from late-stage trials for technologies that have never been approved. Gene therapy, immunotherapy, and RNAi trials that are ongoing could be game changing for patients,” he summarizes.
“Value and pricing will also be big for 2016. Given the increasingly critical environment towards the biopharmaceutical industry, promoting the value of innovation and the promise of biopharmaceutical products will remain a priority for the industry. What most people don’t realize is that prescription drugs represent and continue to represent only 10 percent of the total healthcare budget in the U.S. This number has been constant for many years. However, the innovator drugs occupy an increasingly smaller percent compared to generics. If drug prices are increasing so disproportionally to the rest of healthcare, why is the percentage the same? It’s time to start looking at payers and their relationship to hospitals and hospital systems and shed light on the entire ecosystem and its contribution to innovation and costs, NOT just our [biopharma] small proportion. The biopharmaceutical industry has been facing a sustained, targeted, and seemingly organized criticism across multiple theaters with respect to drug pricing. This criticism is likely to persist as presidential candidates and state and federal legislators continue to focus only on the costs of biopharmaceutical products. In response, the industry is continuing to proactively demonstrate product value, as well as develop and promote policies that improve patient access to innovation. If this discussion turns into short-sighted policy, there will be significant consequences for biopharma innovator, as well as the patients they serve. Misguided proposals miss the true foes in U.S. healthcare (e.g., diseases like Alzheimer’s, diabetes, heart disease, and cancer). There are incredible breakthroughs just around the corner that are actually being tested in real patients, today. Those therapies – cures – will be inaccessible to patients because of continued insurer limits, denials and discriminatory cost sharing, or because those breakthroughs never saw the light of day as innovator cash flow dries up,” concludes Hastings.
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