Quality Measures Are Key to Supporting Drug Value
Washington, DC—An opportunity for value enhancement from the drug manufacturer’s perspective includes the improved use of data to meet the needs of stakeholders, especially the patient. Data that are generated should support the value of the manufacturer’s therapies in light of newly established value-based models, which often rely on quality metrics, for example, that are not obvious from clinical trials. Finally, wraparound services can add to a drug’s value and help to distinguish it from a competitor’s drug.
These were the themes that a panel of experts discussed at the Sixth Annual Conference of the Association for Value-Based Cancer Care, moderated by Darin T. Rubin, Partner and Managing Director, The Dedham Group, New York, NY.
Bedrick Gadea, PhD, Partner, The Dedham Group, listed 4 trends in oncology that manufacturers must consider when positioning their medications:
- Using value-based models, such as oncology medical homes and episode-based payments, and engaging payers and providers within these models
- Understanding the value frameworks that will have the biggest impact going forward, and how a manufacturer’s drugs align with these frameworks
- Optimizing data collection and the use of data to better target providers and payers. “Some manufacturers are even building real-world evidence departments to be able to address some of these emerging needs with providers,” said Dr Gadea
- Understanding the impact of outcomes-based contracting in which payments may be linked to progression-free survival from clinical trials, for example.
The Right Measures Are Needed
Smart data are becoming more important for prompting intervention and getting the right patient to receive the right drug at the right time, said Mr Rubin. However, a vast amount of information needs to be considered in achieving this goal, he added.
“We’ve been trying to do [outcomes-based contracting] for a number of years in some other therapeutic areas, and it’s been very challenging for us,” said Dina Smith, Head of Specialty Pharmacy and Trade Strategy, Bayer Pharmaceuticals. “We do want to have skin in the game here.”
The current environment lacks outcomes measures, said Danielle Ziernicki, PharmD, Director, Oncology Healthcare Quality, Johnson & Johnson Healthcare Systems. Translating measures from a clinical trial into quality measures is challenging, as is incorporating these measures into the electronic medical record, she said.
Manufacturers are asking stakeholders how they reconcile quality metrics with end points, said Mr Rubin. “There’s a lot of room for interpretation. At the end of the day it’s evolving quickly, but we’re not quite there yet,” he said.
“A big shift, and a big challenge in industry, is that traditional research and development studies don’t necessarily look at the US quality measures or think about launching in the US value-based care environment,” said Dr Ziernicki.
Engaging stakeholders early in the process is important to understand the end points that the pharmaceutical industry should be considering.
“In today’s market in the models that we’re moving to, we need to get ahead of that as an industry,” said Ms Smith.
The Pharmaceutical Research and Manufacturers of America, which is able to capture data across different stakeholders, must evolve to be able to show the value proposition within the value-based models, said John Ryan, Director, Value and Quality, The Dedham Group.
Pharmaceutical manufacturers are increasingly investing in “nonproduct assets,” such as access programs and hub service models, as a way of differentiating themselves from other pharmaceutical manufacturers. More manufacturers are also coming to the table with best practices for the use of their drugs to satisfy alternative payment models, according to Mr Rubin.
In assembling the drug attributes that align with value-based models, Dr Gadea used the example of immunotherapy for lung cancer, in which drug manufacturers emphasize up-front PD-L1 testing to ensure appropriate use and optimization of the total cost.
The key to offering wraparound services is understanding the patient’s journey, and how to ensure continuous care that does not overburden the patient, said Ms Smith. Seeking financial assistance is a critical wraparound service “that we have to take head on, especially in today’s day and age, when there’s so much more prior authorization in this field,” she said.
Keeping the patient at the center of any framework, delivering drugs that meet the patients’ needs, and ensuring access to these drugs are all essential to improving the value of patient care, said Dr Ziernicki.