As we enter 2015, Health Decisions’ mission – continuous innovation to reduce risk and time to market, fail unsuccessful products faster, enable cost-effective development of precision medicines and provide earlier and more affordable access to novel therapeutics and medical devices – is more important than ever. The biopharma and medical-device industries face numerous challenges. Foremost is the accelerating transition from developing products for the masses to an age of precision medicines.
Precision medicines offer high efficacy in high percentages of patients in relatively small populations. Unfortunately, development costs for precision medicines are not shrinking in proportion to population size. Neither are healthcare payer resources increasing in proportion to therapeutic benefit. Something’s gotta give.
Economic Strains of Precision Medicine Create a Volatile Situation
There are many reasons for high development costs, including needs to ensure the safety of novel biologics and develop companion diagnostics to identify responsive patients for each precision medicine. Naturally, high development costs leave the industry seeking to recover R&D investments and maintain traditional profits through high per-patient prices. On the other hand, healthcare payers are balking at per-patient costs that seem excessive by comparison with historical per-patient rates for mass-market, small-molecule drugs. Sometimes physicians balk as well. When physicians and patients struggle to get access to precision medicines, they may blame biopharma, health insurers or both. The resulting situation has been described as toxic. It is certainly volatile.
Everybody acknowledges that prices of precision medicines are high in absolute terms regardless of how great the therapeutic benefit. The debate is first about whether therapeutic benefit is great enough to justify the asking prices and, even when the benefit is clearly enormous, whether healthcare systems can bear the absolute cost of treatments.
Multiple Perspectives on the Challenges of Precision Medicine
I have substantial experience in multiple roles on both sides of this debate. While my role in the industry gives me a good understanding of development costs from the sponsor and CRO perspectives, I am still a practicing endocrinologist concerned about patient access to new treatments. As a former PI in > 100 clinical trials, I understand issues and costs from a site perspective. As a former executive of one of the largest hospital systems in the United States, I understand institutional perspectives on the cost of access to new diagnostics and therapeutics for patients with equally great medical needs and unequal financial resources. Finally, I teach a course on pharmaceutical economics at the Kenan-Flagler Business School at the University of North Carolina and understand the overall economic climate for industry and healthcare payers.
My hope is that such a diverse background will enable me to guide Health Decisions toward a clinical development approach that eases the transition to precision medicine for everybody – industry, investigational sites, healthcare payers, physicians and patients. Thus, while continuing to provide hiqh-quality, high-efficiency services to sponsors of clinical trials of all types of medicines and diagnostics, Health Decisions will focus in 2015 on finding more efficient ways to develop precision medicines. This blog will reflect such a focus. Look for future posts on topics including:
- A changing development routine for a world of precision medicine
- Food as pharmacoRx
- Efficacy vs. effectiveness
From Scientific Progress to Sustainable Advancements in Patient Care
Nothing can hold back the tide of scientific progress that is driving the transition to precision medicine. As an industry, we must find ways to keep up. That requires translating rapid scientific advancement into rapid, sustainable advancements in patient care. We have our work cut out for us, but at Health Decisions, the watchword for 2015 is simple: “Onward!”
Stephen DeCherney, MD, MPH, is CEO of Health Decisions. He is also a practicing endocrinologist, a Clinical Professor of Medicine, an Adjunct Professor of Business, Trustee of William Harvey Research Institute of Queen Mary Medical College, St Barts, London, Chair of the University of Delaware Research Foundation and a Trustee of the Christiana Care Health System, Delaware.