At the 8th Annual Oncology Market Access & Pricing USA 2017 meeting hosted by eyeforpharma, the discussion ranged from raw material short-supplies to pragmatic trials to risk-sharing, and understanding these challenges to meet stakeholder goals.
Moderator Ann Collins, senior vice president of strategy, Cota Healthcare, described the struggles of the FDA and the European Medicines Agency to gain relevant information.
“Biopharma is struggling to provide [them] the right data,” Collins said. “Currently there are several commercial and non-commercial efforts to do just that. But what does it mean to drive results?” Collins explained that results can be measured in terms of patient outcomes or in terms of market access—the outcome here being defined from each stakeholders’ vantage point.
“Sandoz is looking at this with respect to both biosimilars and regular drugs,” said Seth Coombs, vice president, Oncology and Injectable Products for the company. He explained that for a pharmaceutical developer, ensuring a quality supply of the necessary raw material to ensure we get consistent products in the hands of patients, is vital.
“Limiting shortages, which is an issue, is important to us. Market access means that if Dana-Farber [Cancer Institute] calls me to say they don’t have a particular drug, I make sure that they have it the next day,” Coombs added.
Kevin Fitzpatrick, CEO, CancerLinQ LLC, highlighted the data silos within healthcare and the challenge of coalescing the information to provide a big-picture view that can provide guidance to improving the quality of care in oncology—a goal that CancerLinQ
plans to achieve. “The question remains: quality and value for whom?” said Fitzpatrick.
Stressing the importance of the unique perspective presented by each stakeholder, Fitzpatrick said that patient advocates have measures to quantify patient values; hospital administrators are documenting and quantifying throughput; physicians want to achieve compliance and implement best practices; and the pharmaceutical industry is looking at real-world evidence and market access. CancerLinQ is trying to bring this information together, Fitzpatrick added.
“If a patient does not get access to an FDA-approved product, then that is a problem,” said Bryon Wornson, vice president, Global Health & Value Oncology Lead, Pfizer. “We spend a lot of time pulling the product through to the last mile, which is when it reaches patient hands.”
Speaking specifically with respect to access issues with the new immuno-oncology (IO) agents
, Wornson said that the major driving forces for access in this case are competition and government regulation. “The oncology landscape has changed—with IO, if you are late to market, what is the value proposition and is there still an unmet need?” Wornson also highlighted the continued shift of risk away from payers to providers and to manufacturers, which he said is also seeing a lot of activity.
“Government policies have a significant impact and we are working with insurers to understand the limitations of these policies,” he added. “There’s more value in pragmatic data but we are limited by our labeling indications. So, these are the 2 mega forces driving innovation.”
Steering the conversation to address real-world evidence Wornson said that while positive risk-benefit analyses are important, real-world evidence should ideally penetrate the drug-development conversation very early. “If you wait for after product launch, it might take a while before you get outcomes data back,” for analysis and intervention.