ASCO released a conceptual framework to measure the value of cancer treatment options.
The framework is in the form of a scale that measures the clinical benefit and toxicity of a certain regimen to calculate a “net health benefit” score, according to information presented during a press conference. Doctors and patients can compare this score with the cost of cancer treatment to determine the best course of action for a patient once presented with all options.
“This is not meant to be a ranking or a calculator for individual drugs,” Lowell E. Schnipper, MD, FASCO, co-chair of the ASCO Value in Cancer Care Task Force, chief of hematology and oncology at Beth Israel Deaconess Medical Center, professor of medicine at Harvard Medical School and a HemOnc Today Editorial Board member, said during the press conference. “It is a way to provide information in a standardized and objective way to both physicians and patients about the value of new treatment options that emerge from clinical trials that compare a standard of care to a new treatment option.”
Lowell E. Schnipper
The scale provides a maximum of 100 points for curative treatments and 130 points for advanced or metastatic disease treatments. Points are earned (or subtracted) based on OS or PFS as well as toxicity data when compared to a control regimen — or the current standard of care — against which the drug or drug combination is being measured in a randomized clinical trial.
Bonus points can be earned in the metastatic setting if the agents provide palliation or lead to significantly prolonged periods of treatment-free care vs. the comparator.
ASCO’s Value in Cancer Care Task Force — also co-chaired by Nancy E. Davidson, MD, director of the University of Pittsburgh Cancer Institute and UPMC Cancer Center — had been working on developing this framework for more than a year and will now solicit public comment on this proposal through August 21.
ASCO would like to ultimately rate many drugs via the “net health benefit” and to create user-friendly software for patients and their doctors to access the information.
Application of the framework
The task force applied the framework to four clinical scenarios: first-line treatment of non–small cell lung cancer, treatment of advanced multiple myeloma, treatment of metastatic castration-resistant prostate cancer, and adjuvant therapy for women with HER-2–positive breast cancer.
The best score presented was a 48 (out of 100) for early-stage, HER-2–positive breast cancer treatment that includes trastuzumab (Herceptin, Genentech) and doxorubicin, cyclophosphamide and paclitaxel chemotherapy vs. chemotherapy alone. Treatment with the trastuzumab combination confers a 39% reduction in the risk for death compared with chemotherapy alone, and both regimens are associated with three grade 3 to grade 5 toxicities.
The trastuzumab combination has a reported monthly cost of approximately $65,700, whereas the standard treatment costs approximately $7,000 per month.
Bortezomib (Velcade, Millennium) scored a 47 out of 130 in the treatment of advanced multiple myeloma when combined with the control arm of melphalan plus prednisone. The addition of bortezomib to the standard of care improves median OS (56.4 months vs. 43.1 months) but is associated with more grade 3 to grade 5 toxicities (42 vs. 34).The bortezomib treatment costs approximately $7,000 per month, whereas the standard treatment costs approximately $280 per month.
Front-line treatment for metastatic castration-resistant prostate cancer with cabazitaxel (Jevtana, Sanofi) and prednisone resulted in a net health benefit of 16 out of 130 when compared with mitoxantrone plus prednisone. The cabazitaxel regimen costs approximately $10,700 monthly compared to the control treatment at approximately $245 per month.
Other metastatic prostate cancer treatments had somewhat higher scores including abiraterone (Zytiga, Janssen) plus prednisone vs. placebo at 42 out of 130 and enzalutamide (Xtandi, Astellas) vs. placebo at 32 out of 130.
For EGFR-mutated advanced NSCLC, a treatment regimen composed of bevacizumab (Avastin, Genentech) plus standard carboplatin and paclitaxel yielded a net health benefit score of 16 out of 130 due to small survival benefits (median OS, 12.3 months vs. 10.3 months). The cost of the bevacizumab combination is approximately $11,900 per month, whereas the control treatment of carboplatin plus paclitaxel alone costs approximately $182 monthly.
Also for NSCLC, pemetrexed (Alimta, Eli Lilly) plus cisplatin demonstrated a net health benefit score of 0 out of 130 and costs approximately $9,200 monthly compared with approximately $812 per month for cisplatin plus gemcitabine.
Interpretation of results
Schnipper warned though that the scores are based on their value as compared to the standard of care they were tested against and should not be used to compare with each other.
“These are examples of how … the net health benefit is derived from these clinical trials, how the net health benefit differs, and how those differences are juxtaposed against cost,” Schnipper said. “Ultimately, we hope this will be the fulcrum and catalyst for conversation between the doctor and the patient. There is no such thing as a great score between different clinical trial regimens. In one comparison, yes, the higher the net health benefit score the better. But, that is only restricted to the clinical trial at issue — the test treatment against the control.”
Further, changes to the control can greatly impact the health benefit, Schnipper said.
“If I took a treatable disease for which there were already drugs out there but chose to test my new drug against something with no clinical activity, it’s probable that the health benefit would be quite high, but that would be unfortunate because it’s not the best control,” he said. “The best control is the best treatment against which the new treatment is being compared, and that score might not be as great. So, the subtlety of this really lies with the doctor and the patient in discussion.”
The task force didn’t include cost in its scoring system to determine the net health benefit because of concerns that it could be too complicated for patients to understand, according to information presented during the press conference.
Richard L. Schilsky
“We never set out to develop a rating scale and we don’t have one now and we don’t intend to have one in the future,” Richard L. Schilsky, MD, FACP, FASCO, chief medical officer for ASCO, said during the press conference. “We set out to create a framework to facilitate the discussion between doctors and patients. Lumping all these complex variables … into a single number, we were concerned would actually obscure the transfer of information to patients rather than simplify it.
“Therefore we … focused on the clinically important outcomes and rolled that into a net health benefit score simply to provide a resultant assessment of what a new treatment has to offer and describe the cost separately,” Schilsky added. “The cost to an individual person is unique depending upon their insurance coverage. We will be test driving this now that it is released and see if people find it as useful as we hope it will be.” – by Anthony SanFilippo
Disclosure: Schnipper reports a consultant/advisory role with Merck and a leadership position with Eviti. Davidson and Schilsky report no relevant financial disclosures. See the full study for a complete list of relevant financial disclosures for the other members of the ASCO Value in Cancer Care Task Force.