DIA: Driving Insights to Action

The Gaps In Drug Pricing

Does a drug’s price reflect what the drug costs, what the drug is worth, some combination of the two, or something completely different? “The work that’s being done in the space of drug pricing, particularly some of the value-based pricing, indication-specific pricing, some of the novel ideas that are now being considered, are really important steps forward,” suggests Dr. Sean Tunis, Founder and Chief Executive Officer of the Center for Medical Technology Policy, former Chief Medical Officer at the US Centers for Medicare and Medicaid Services, and DIA Global Forum Value & Access Content Editor. “To what degree is that value-based price in any way supposed to be close to or related to what is an economically-viable price from a drug developer perspective, or from an industry perspective? There’s a big gap between, ‘What’s the value-based price’ and what the healthcare system ought to actually pay for something.”

Biosimilars’ Good News for Patients

Because they require no R&D investment, biosimilars – nearly identical copies of a biologic therapy that can be marketed when the original’s patent expires – can make these therapies available at reduced costs. This makes biosimilars very attractive to financially overburdened health care systems (and to patients). Dr. Cecil Nick has worked for more three decades in global clinical development and regulatory affairs, and will chair DIA’s Biosimilars 2017 Conference. “I think this is going to be the most exciting biosimilars event ever,” he explains in this Global Forum conference preview. “It’s not just a question of tracking through issues that the audience has heard many, many times before, but really delving into the really critical issues that are evolving as biosimilars are developing, as we’re gaining more experience, and as the regulations are evolving.”

Pace of Innovation vs. Regulation: Combination Challenge

In 2002, the FDA established the Office of Combination Products (OCP) to help manage complicated jurisdictional issues in the regulatory review and approval of drug delivery devices and diagnostics growing in both number and complexity. “I can only imagine what the possibilities will be with respect to the use of things like artificial intelligence and smart devices as they pertain to the delivery of medical products going forward. I feel it’s going to go far beyond where we could have ever foreseen,” suggests Kim Quaintance-Lunn, Vice President and Head of US Regulatory Policy for Bayer, and a member of the program committee for DIA's Combination Products 2017 Conference, in this Global Forum podcast. “The challenge that comes with that is, of course, from a regulatory perspective, how do you regulate that? How do you get in front of an area that moves so quickly as to be hard to even predict?”