NEW YORK (GenomeWeb) – Intermountain Healthcare, a nonprofit healthcare system based in Salt Lake City, released two abstracts at the American Society of Clinical Oncology meeting this week demonstrating that using a next-generation sequencing tumor profiling test to choose a targeted therapy for cancer patients with metastatic disease is both cost-effective and results in better outcomes.
In one abstract, the group found that patients who are put on a "precision medicine" track have lower costs per week and longer progression-free survival. In a second abstract, the researchers found that an NGS-based tumor profiling test identified a targeted treatment in 82 percent of patients. The studies will be published this year in the Journal of Clinical Oncology.
The studies "lend credibility" to precision medicine, Derrick Haslem, director of medical oncology at Intermountain Precision Genomics, told GenomeWeb. The "outcome data suggests that precision medicine using a molecular-based approach with targeted therapies is perhaps better than standard chemotherapy in late-stage cancer patients."
Intermountain has been offering a 100-gene cancer panel since July 2013 for Stage IV metastatic patients. Initially, it outsourced the sequencing, but since October 2014 has been running the test, called ICG100, on the Illumina MiSeq out of its CLIA-certified laboratory and so far has tested around 400 patients. Average turnaround time is 17 days. The cost of the test varies, depending on how the sample is submitted, whether or not resubmission is needed, the number and type of variants identified, and other factors, but, on average, runs around $6,000.
"We haven't had any trouble really with payors paying for the testing," Haslem said.
In the cost-effectiveness study, the Intermountain Healthcare team ran a retrospective matched cohort study on 72 patients seen between July 2013 and December 2014 with metastatic cancer of diverse subtypes. Outcomes were compared between the 36 patients treated with a precision medicine approach compared to 36 patients that received standard chemotherapy. The two groups were matched according to age, gender, diagnosis, and the number of previous treatments.
The precision medicine arm received the ICG100 test, followed by a matched targeted agent.
The precision medicine arm survived longer and for a slightly lower cost. Progression-free survival was 22.9 weeks for the precision medicine arm compared to 12 weeks for the standard of care group. Costs per week were $3,204 for the precision medicine group and $3,501 in the chemotherapy group.
Haslem said that the study should help to discredit the idea that precision medicine approaches are too expensive. "This clearly showed that there was not an increase in cost," he said, and that there is "perhaps even a trend for improved costs."
The main contributors to increased cost in the chemotherapy arm, he added, were more and longer hospital stays and emergency room visits. So, not only were costs in that arm lower, but "those patients had a better quality of life," he said. "They weren't spending their time in ERs and hospitals."
They were also living longer, with progression-free survival, on average, about 11 weeks longer in the precision medicine arm.
In addition, Haslem said, targeted therapies offer other benefits. Many of the targeted drugs are oral agents, which allow patients to take them at home or work, while continuing to be productive at work and go about their daily life. They don't have to take time off work to go into the hospital for chemotherapy treatment. Also, the "side effects are much different, so they are spending less time in the hospital and have fewer complications," he said.
Meantime, Haslem predicted that costs on the precision medicine side will continue to go down. As NGS technology improves, those costs will drop, he said, and as more targeted agents are developed, drug costs may also decline, he said.
In the second study, the Intermountain team demonstrated the effectiveness of its ICG100 test in identifying targeted agents. Patients with metastatic disease that failed standard treatment and consented received the ICG100 test, the results of which were presented at the molecular tumor board.
Of 243 patients that went down this route, 188, or 77 percent, had actionable mutations, resulting in a treatment change in 117, or 62 percent, of patients. The test identified a targeted agent for an additional 38 patients, 20 percent, who have not yet progressed on their current treatment plan.
One challenge that has plagued a number of groups offering NGS-based tests to guide treatment is that often the testing identifies a potential drug that is not approved for the patient's specific indication, or indicates eligibility for a clinical trial that a patient will not be able to enroll in for logistical reasons like location.
Haslem said that Intermountain tries to get around these issues through its drug procurement process. The center has a "drug navigation specialist" that works with payors and the treating physician to obtain drugs for the patient. Haslem said that all 155, or 82 percent, of the patients for whom a targeted agent was identified, would have access to the targeted therapy.
Haslem said that the center employs a number of strategies to ensure patients have access to the drugs they need. First, he said, Intermountain has opened some clinical trials — basket trials that first identify a molecular alteration, which automatically makes the patient eligible for a clinical trial.
He said that it also has been working with the US Food and Drug Administration to gain access to approved drugs for off-label use. A drug navigator acts as an intermediary between the payor and the provider to help navigate the approval process, Haslem said.
Initially, "we met with more resistance up front with regards to getting the drug," Haslem said, "but as time has gone on and more evidence comes out … it's easier to use these drugs off label."
In the future, Haslem predicts that these types of precision medicine protocols will be used for earlier-stage patients. He thinks the next step for molecularly guided treatment strategies will be to demonstrate improved outcomes and cost effectiveness in patients with curable disease, but who for whatever reason do not tolerate chemotherapy. "Once we see evidence there, then it will likely be applied more broadly across the population," he said.
One goal at Intermountain, Haslem said, is to build out its database. He said the group is looking to put together a consortium of academics, the hospitals within the Intermountain system, and others that use Intermountain's genomic testing platform to "share the outcomes of patients and be able to learn more about what mutations are more prevalent and what drugs seem to work in particular situations, to make it a learning database."