Company: Merck & Co.
Title: SVP and head of the Center for Observational and Real-World Evidence
When Susan Shiff joined Merck in 2014, she took on the tough task of heading up a brand-new unit devoted to figuring out how the company could prove the value of its medicines.
“We needed to help the entire healthcare system really understand how our medicines and vaccines work in the real world--how physicians prescribe them, how patients take them,” she told Fierce in an interview. “We needed to show the value they bring to society.”
Indeed, Big Pharma is under pressure from all sides to provide data proving that the benefits of new and often expensive drugs outweigh their costs. Some of that mandate stems from the implementation of the Affordable Care Act and other legislation that has placed pressure on health payers and providers to hold down costs. Some comes from payers themselves pushing drugmakers to offer big discounts in return for formulary spots.
And Merck is feeling the heat: In August 2016, for example, pharmacy benefit giant Express Scripts excluded Merck’s new hepatitis C drug, Zepatier (elbasvir and grazoprevir), from its 2017 formulary.
Shiff’s job is to unite different research groups within Merck that collect data on real-world drug use, as well as to partner with insurers and other stakeholders who want to answer questions about drug value and efficacy. She brings to the task more than a decade of experience in health outcomes research, including 7 years at Pfizer, where she helped determine the best use of the reams of “big data” emerging from health providers.
“When I started my career, we had access to information about when patients filled their prescriptions, and that seemed great,” she said. “Now with electronic medical records there’s been an explosion of secondary data we can use.”
Shiff’s unit is making significant strides toward churning out real-world data. In June of this year, the company released results from a review of 58 studies of its HPV vaccine, Gardasil (recombinant human papillomavirus), which is widely underused despite its potential to reduce rates of cervical cancer. The review showed a significant reduction in genital warts and cervical pre-cancers in all 9 countries studied, with some benefits arising as early as one year after the vaccine launched onto the market.
The same month, at the American Diabetes Association Scientific Sessions, Merck presented several real-world studies of its DPP-4 diabetes drug Januvia (sitagliptin), including two showing that patients taking the product have no greater risk of long-term complications such as neuropathy, renal failure or bone fractures as those on a placebo. A separate analysis of more than 3,400 diabetes patients found that those on Januvia suffered fewer incidences of hypoglycemia than those taking more commonly used sulfonylurea drugs.
One of Shiff’s biggest challenges going forward will be to change the mindset at Merck so that everyone is thinking about proving the value of new medications earlier in the development process. It’s not just Zepatier that’s under pressure but several other Merck drugs, including its cancer immunotherapy Keytruda (pembrolizumab). In May, the FDA said it would launch its own real-world study to pit Keytruda against its chief rival, Bristol-Myers Squibb’s Opdivo (nivolumab), in a head-to-head study in lung cancer.
The demand for real-world evidence from regulators proves the value of Merck’s new approach to gathering, managing and reporting information about how its products are being used, Shiff said.
“We’re moving this earlier in the drug development process, doing epidemiologic studies to understand incidence and prevalence of disease, treatment patterns and pathways,” she said.
And Merck is out looking for healthcare providers who want to partner with the drugmaker in the search for evidence on drug safety and effectiveness. “They have the data, and together we can decide the legitimate scientific questions we want to answer together,” Shiff said. “That’s the best way to move forward.”