Value framework research explains why we need it

Korean Cancer Study Group emphasizes necessity of Korean model based on ASCO and ESMO

Experts claim value framework criteria and evidence fitting to Korean circumstances are needed to justify limited National Health Insurance (NHI) finance granting reimbursement on high-cost anticancer treatment with clinical uncertainty.

 

The argument is that new value framework scales are needed for a new high-cost anticancer treatment with weak evidence of improving survival time and progression-free survival (PFS), because they raise an issue of uncertain efficacy when evaluating cost-effectiveness.

 

Korean Cancer Study Group recently unveiled a final report on a study of pharmaceutical value framework, cosigned by Health Insurance Review and Assessment Service (HIRA).

 

The research team evaluated six drugs—non-small cell lung cancer (SNCLC) targeted therapy Tagrisso (osimertinib), immunotherapies Tecentriq (atezolizumab), Keytruda (pembrolizumab), nivolumab, and multiple myeloma treatments Kyprolis (carfilzomib) and Pomalyst (pomalidomide)—with two tools applicable for Korean environment, American Society of Clinical Oncology’s (ASCO) Value Framework (VF) and European Society for Medical Oncology’s (ESMO) Magnitude of Clinical Benefit Scale (MCBS) ASCO VF and ESMO-MCBS assessed clinical efficacy, toxicity and quality of life, but had a gap in evaluation methods used with unclear aspects in each, which resulted in different assessment outcomes depending on investigator and drug.

 

ASCO VF had an issue with clinical benefit indicators.

 

Among three indicators including overall survival (OS), PFS, objective response rate (ORR), OR is meaningful as an ultimate target endpoint.

 

So it may seem reasonable to set weighted value of OR lower than PFS or ORR, but weighted value or preference from the perspective of patient has not been reflected.

 

The research team pointed out “Applying ASCO VF in Korea could result in a significant discrepancy in scores when respective evaluators assess randomized clinical studies of a drug.

 

If a clarified guidance is not given on the scale of value framework, a tool originally designed to help the bilateral decision-making between a doctor and patient could actually cause confusion instead.” Meanwhile, the team found an issue of insufficient amount of ESMO-MCBS-based literature on anticancer treating blood cancer.

 

When developing ESMO-MCBS, various drugs treating a variety of cancers were reviewed but drug for blood cancer was not included.

 

“The tools have limitations in clearly answering the questions of how to define ‘clinical benefit;’ how would ASCO VF specify items evaluated for toxicity; what indicators could be used to assess quality of life; or what criteria could measure improved toxicity in ESMO-MCBS,“ nevertheless, “the value frameworks support the argument of rising medical expenditure, due to increased number of cancer patients and high-cost anticancer treatments, should develop ‘value-based’ scale evaluating ‘value’ more objectively,” the team assessed.

 

The related expert survey and focused group interview drew a conclusion that the majority of the experts agreed value framework for anticancer treatment should be adopted in Korea, and they answered both of the external tools should be considered instead of preferring either of them.

 

The weighted values from analytic hierarchy process (AHP) showed oncologists considering efficacy of an anticancer treatment more when prescribing than how much ASCO VF considers of relative importance of efficacy.

 

The researchers stated, “This should be clarified when adopting ASCO VF as a Korean value framework.

 

When applying clinical value framework for anticancer treatment, this part should be consulted with experts to better define and reflect it.” The report also recommended conducting follow-up studies to specify criteria to assess toxicity, alleviated symptoms, and improved quality of life.

 

“Developing a unique value framework for Korea would require a series of discussions and studies in the future, and continuous efforts should be made to explore and generate value-based endpoint fully reflecting the Korean landscape and various stakeholders,” the researchers concluded.