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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results-and costs-of popular cancer medications.
A new tool proposed by the American Society of Clinical Oncologists (ASCO) seeks to help oncologists better evaluate the efficacy and cost of cancer medications on the market. The tool is expected to help patients make difficult decisions regarding their choice of medication and the cost-effectiveness and financial toxicity of the treatments that are prescribed to them. The framework was developed by a team of invetigators led by Lowell E. Schnipper, MD, a Theodore and Evelyn Berenson Professor of Medicine at Harvard Medical School and the clinical director of the cancer center and chief of the hematology/oncology division at Beth Israel Deaconess Medical Center.
The tool works by assigning a score (0–130) to drugs to assess their benefit in clinical trials. This score, called the net health benefit (NHB), does not include drug cost information in its calculations, although drug cost information is presented alongside a drug’s score. Points are assigned or subtracted based on clinical benefit and toxicity of each medication. Survival benefit accounts for 80 of the possible 100 points that can be attributed to improvements in survival, and 20 points are added or subtracted for toxicity. Bonus points are awarded when a "statistically significant improvement in any cancer-related symptom is reported in a randomized trial of the new treatment; treatment-free interval bonus points should be awarded if a statistically significant improvement in treatment-free interval is reported in a randomized trial of the new treatment versus the comparator," according to the study.
There are actually two frameworks proposed by the study authors: one for advanced cancer and another for potentially curative treatment (adjuvant or neoadjuvant therapy), “recognizing the unique clinical concerns associated with these diverse treatment settings," the authors wrote. The maximum NHB score is 130 for the advanced disease framework and 100 for the curative framework. Treatment alternatives such as biosimilars will eventually be added within the tool, said Schnipper, who noted that the framework can be adapted for any cancer therapy that is the subject of a comparative clinical trial.
Although Schnipper told the New York Times that the tool is “not a way of ranking drugs,” but instead is “simply a way of understanding the outcome of a clinical trial,” many oncologists may use the tool in practice to weigh the cost effectiveness of a drug against its survival statistics to recommend a medication for a patient. In case studies, Schnipper et al. concluded that Roche’s Avastin had a score of 16 (bevacizumab, carboplatin, and paclitaxel), while Eli Lilly’s Alimta (cisplatin plus pemetrexed) for patients with EGFR mutation–positive advanced non-small cell lung cancer (NSCLC) scored a zero. Sanofi's Taxotere regimen (docetaxel and gemcitabine) also scored a zero, while Genentech and Astellas’ Tarceva (erlotinib) garnered a score of 44.
Importantly, the tool serves as a “catalyst for discussion,” and will allow patients’ voices to be heard in terms of preferences for clinical benefit, tolerance for toxicity (drug-associated side effects), and cost, Schnipper told BioPharm International in an email. The patient perspective is a big part of the value proposition, asserts Schnipper, and patients need tools such as these to make informed treatment decisions. “… if the patient cares more about physical comfort than length of survival in the treatment of an advanced form of cancer, the framework can be adjusted to award more points (a higher score) for those treatments that offer lower side effects. Conversely, if length of life is most important, then the scoring can be adjusted accordingly,” Schnipper added.
Schnipper said that the paper should serve as a “first draft” or prototype for what he hopes will eventually be an easy-to-use electronic tool for physicians. “Ultimately when we have incorporated the [stakeholder] inputs we receive, we will come out with an updated version and collaborate with software developers who will be asked to develop a user-friendly tool that will be populated with the data from clinical trials on clinical benefit, toxicity, and cost (out-of-pocket and total costs of drugs in the test regimen as compared with the standard of care against which the test regimen(s) were/was compared in the clinical trial). We envision that if there are three regimen options, the tool will demonstrate the net health benefit of each of the three options when compared with the standard of care treatments with which they were compared, and their cost,” Schnipper said. “That way the doctor can explain very clearly what the patient can expect and what the financial impact of a treatment selection will be.”
Although a member of the report’s task force is from an insurance company-Lee N. Newcomer, MD, senior vice-president for oncology at UnitedHealthcare-Schnipper declined to comment on the affect prior authorization may have on a physician’s autonomy to choose the proper treatment for his or her patient, saying only that the topic is “complex.”
When asked how the tool would influence prescribing behavior of physicians who make a portion of their income from the reimbursement of physician-administered injectables, Schnipper said that healthcare is changing and the “buy-and-bill” model may not have sticking power. “ASCO has proposed a bundled payment for oncologists' services that would be independent of the so-called 'buy-and-bill' mechanism that has been extant. So, [buy and bill] is going to fade away, whether ASCO’s [bundled payment model] or some variant thereof is adopted as compensation for cancer care services rendered by oncologists.” Schnipper continued, “Furthermore, even in the current situation, most oncologists want the best treatment for the patient’s cancer, and through ASCO’s work, are increasingly aware of the financial consequences the patients face when confronted with enormous copays for medical therapy that is superimposed on lost wages, etc.”
Memorial Sloan Kettering also recently released a similar drug pricing tool, called the DrugAbacus, that allows people to interactively explore the value of drugs and compare retail prices to “Abacus prices,” which are calculated based on parameters of cost of drug discovery and/or development, patient benefit, disease prevalence, side effects, and degree of public health benefit.