At the 8th Annual Oncology Market Access & Pricing USA 2017 meeting hosted by eyeforpharma, pharmaceutical developers shared strategies on how a “value” culture can be infused right from the preclinical stage of oncology product development.
Provider organizations, health policy researchers, and patient advocacy groups have been working hard toward developing a well-rounded value framework, and the pharmaceutical industry is taking note and working to ensure these frameworks are fair on their product. At the 8th Annual Oncology Market Access & Pricing USA 2017 meeting hosted by eyeforpharma, pharmaceutical developers shared strategies on how a “value” culture can be infused right from the preclinical stage of product development.
“The current value frameworks do not do a perfect job of assessing value,” said Matthew Monberg, PhD, director, Outcomes Research Immuno-Oncology/PD-1 at Merck. Monberg noted that while value can be defined in several different ways, the existing frameworks should not be dismissed, “because they are not going away.” He also emphasized that everyone across a company that is involved in the drug development process should be aware of the existence of these frameworks.
Monberg noted that cost-effectiveness models are a complex undertaking and simplifying them could lead to important parts being missed within the assessment. He explained that framework designers would say that if there are issues then there are also possible solutions, “and in some cases, we should assume that framework designers mean the best.” Monberg said.
“In the United States, value frameworks are influential as far as they are credible,” Monberg said. Citing “utility” as a example of an outcome that is measured in a standardized way, Monberg said that drug developers should collaborate with and educate product assessors to help them make informed decisions.
The bottom line though is that patients are paramount and they should be at the forefront of all our decisions, Monberg emphasized. “Patients are not monolithic and it’s an important thing to consider with trial design and other research decisions.”
Keeping patients front and center was also at the core of the presentation by Amanda Bruno, PhD, senior director, value evidence leader, Cross Therapy Area, GlaxoSmithKline, who spoke about establishing a future-proof value creation model.
Value assessment, per Bruno, should,
This kind of an assessment necessitates asking the right questions to achieve the end goal, which Bruno noted, should be:
“To get there, we need to understand the value drivers for oncology medicines and lead your organization to consider all aspects of value in their decision making,” Bruno said, adding that while there are no “magic bullets” for generating the desired value evidence, the concept should be instilled early on in drug development.
Incorporating patient-reported outcomes measures is important, Bruno said, and patient input should be utilized to fill evidence-gap analysis, data collection tools, and randomized clinical trial design.
Monberg said that the P.I.C.O. model is important to address value in the clinical context:
A persuasive and decisive leader can help instill this value goal, Bruno said, including getting buy-in from stakeholders, ensuring business results are delivered, aligning everyone around value creation, and communicating effectively.