The ASCO Scorecard: What's In Store For Pharma?
By Ralf Huss, MD, Chief Medical Officer, Definiens
The American Society of Clinical Oncology (ASCO) recently announced a cancer drug scorecard, which rates drugs based on effectiveness, side effects, and cost. There's no doubt that doctors and patients today are seeking more effective ways to determine the best treatment regimens, and while industry feedback to the rating method has varied greatly, the scorecard is one approach to address this need. Other developing solutions that might impact the decision-making and treatment process, as well as patient recruitment efforts for clinical trials, are big data, companion diagnostics, and the creation of universal databases.
Why A Scorecard?
The industry is constantly searching for better ways to evaluate treatments for patients and improve patient recruitment efforts for clinical trials in the era of precision medicine. In particular, the trend toward combination therapies has amplified this need on the clinical side, leading to questions of how to effectively stratify patients to determine the most effective combinations. While many drugs now have some kind of diagnostic, they are not necessarily predictive. Detecting predictive biomarkers is a strong focus and goal, but it is also a challenging process and, thus, is still a work in progress for many pharmaceutical companies. For clinicians, determining what kind of drug to provide a patient and how to ensure reimbursement are ongoing challenges as well.
All of these factors have led to proposed solutions like the ASCO Scorecard, which takes into account all the knowledge the industry has collected in terms of drug performance, safety, and cost value for patients to enable a clinician to make a treatment decision more easily. While in theory this will be a helpful tool, it raises some concerns as well.
What’s The Impact?
While a scorecard method has great potential upsides, there is also the potential that it could actually impede the advancement of personalized medicine. Clinicians have the responsibility to make the best decision they can with the information they have at hand, which generally includes applying their own knowledge of the benefit of a particular therapy or combination and trying to personalize that therapy to his or her patients. Thus, using a scorecard to determine the best course of action may take away some of the decision-making for clinicians; for example, they may hesitate to run more “biomarker” tests to determine if a CDx drug, which may be more costly, might be of benefit to the individual patient, or may not suggest a clinical trial to a patient, if the scorecard recommends a different treatment option. While a scorecard will make the decision-making process easier, it may also take away the impetus for clinicians to advance personalized medicine in their daily practices.
Given that clinicians will now be using a scorecard method to determine the most appropriate treatment options, pharmaceutical companies may adjust their approaches to drug development as well. For example, some companies may seek to make sure their drugs are even more superior to competitors’ to ensure a spot on the card first. To do so, this may mean demonstrating benefit to a larger number of patients rather than smaller, more specific patient populations, for which personalized medicine is geared.
The third area that may be impacted by the scorecard is patient recruitment for clinical trials. In the digital age, patients are becoming more and more informed about the healthcare landscape and their treatment options. If patients have access to a scorecard, or are working with an oncologist who does, they will understandably try to obtain the best treatment for themselves based on what the scorecard says. While this is a normal reaction, it may unfortunately make it more difficult to recruit patients into a clinical trial if the scorecard recommends a treatment option that’s already approved and on the market. On the other hand, if the scorecard indicates the patient has a low probability of success with any of the approved treatments, he or she may be more willing to enroll in a clinical trial. In any case, this new approach to treatment decisions may ultimately change the way the industry conducts research and applies therapies.
While the scorecard approach does raise some challenges, drug companies do actually have an opportunity to leverage it to improve personalized medicine. In an effort to ensure a spot on the scorecard, for example, pharma companies may seek to develop more companion diagnostics to demonstrate the effectiveness of their drug in a certain population. This will require a more deliberate and upfront commitment to CDx at the early stages of drug development to ensure the right populations for the drugs are identified in order to maximize drug success and limit negative side effects – all of which will be important factors for a scorecard decision. Additionally, the scorecard approach has the potential to encourage pharmaceutical companies, whose drugs are already included on the card but being compared to a competing drug, to take a proactive approach to combining their therapies so both drugs score high as a combination. This will be helpful to personalized medicine development, as, currently, many physicians already need to consider multiple treatments for a patient given at unique times and in specific doses. Therefore, if pharma companies are proactive in combination therapy development, it will ultimately help physicians provide the right treatment for their individual patients.
Other Approaches
The ASCO Scorecard is just one method being discussed to better connect patients with treatments. Other advancements include Big Data and novel diagnostics, strategies for more effective patient stratification, tissue databases for drug discovery and research, and comprehensive patient databases to enable clinicians to treat their own patients based on how other similar patients have responded to a particular therapy.
Take Google, which is now entering the market with technology that evaluates a patient’s biological makeup and how he or she will respond to a specific treatment. There’s also Apple, which is helping connect patients with clinical trials through wearable devices. The industry is headed toward a big data approach where patients will be able to “Google” themselves to see what kind of therapy or trial they should try, and take a companion diagnostic test to determine more effectively what treatment(s) will work for them.
The scorecard method is a good start, but it cannot be the only approach to identifying the best treatment for a patient. There are kinks to be worked out with every new innovation, but knowing the industry can’t go back to the “one drug fits all” mentality, it’s important to start with the scorecard and add more empirical data. There is much buzz around the ASCO Scorecard now and the pros and cons of using it, but eventually the dust will settle and a more reasonable approach will take root: a scorecard being used as one tool, combined with a continued focus on drugs in development, companion diagnostics, and a big data view of patient biology and experiences.
About The Author
Dr. Huss is Chief Medical Officer of Definiens and has more than 20 years of training and experience in histopathology and cancer research. Prior to joining Definiens, he served as Global Head of Histopathology and Tissue Biomarkers at Roche Diagnostics.