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Evidence-Based Oncology June 2019
MIT Group Brings Together Stakeholders to Brainstorm How to Pay for Curative Therapies Over Time
Mary Caffrey
Two-Sided Risk in the Oncology Care Model
Kashyap Patel, MD, ABOIM, BCMAS; Maharshi Patel, MBA; Taylor Lavender, BS, PA; Dhwani Mehta, MS, RD; Asutosh Gor, MD, Sashi Naidu, MD; and Chuck Newton, BS
NCCN's Putnam Serving as Point of Contact for Payers, Employers to Keep Cancer Care "Accessible"
Mary Caffrey
From the Editor-in-Chief: New Ways to Pay for Cures
Joseph Alvarnas, MD
Addressing Oncologists' Gaps in the Use of Biosimilar Products
Chad Williamson, MBA, MS; Leanne Berger, BS, Thomas P. Sullivan, BS; Jeffrey Crawford, MD; and Gary H. Lyman, MD, MPH, FASCO, FRCP
NCATS: Getting Insights Through the Risky "Middle Zone" to Drug Development
Mary Caffrey
NCODA Patient Surveys Support the Need for Medically Integrated Pharmacies
Kirollos S. Hanna, PharmD, BCPS, BCOP
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Conference Coverage: FLASCO/ISPOR
Coverage by Allison Inserro, Samantha DiGrande, and Christina Mattina
Medical World News: Clinical Updates
Coverage by Jaime Rosenberg, Laura Joszt, and Mary Caffrey
Medical World News: Managed Care Updates
Coverage by Jaime Rosenberg, Laura Joszt, and Mary Caffrey
Medical World News: Regulatory Update
Coverage by Jaime Rosenberg, Laura Joszt, and Mary Caffrey
AJMCtv® Interviews, June 2019
Produced by Samantha DiGrande and Jaime Rosenberg

Conference Coverage: FLASCO/ISPOR

Coverage by Allison Inserro, Samantha DiGrande, and Christina Mattina
Conference coverage from the annual meeting's of the Florida Society of Clinical Oncology's annual meeting and ISPOR. 

Panelists Offer an Insider Perspective of the Unstable Future of Genetic Testing Reimbursement

To begin a session on the reimbursement of genetic testing during the Florida Society of Clinical Oncology’s annual meeting in Kissimmee, incoming president Luis E. Raez, MD, put things in perspective: “I’ve been practicing for more than 30 years, and it used to be that when you would explain a treatment plan to a patient, they would ask if they’re going to respond to it and you would have to say ‘I don’t know.’ Now, with genetic testing, hopefully you can say ‘Yes.’"

Specifically, Raez discussed the importance of repeat genetic testing for patients, especially those with an anaplastic lymphoma kinase (ALK) mutation. “We used to test [for] genetic aberrations 1 time. That is not the future of treatment. If you want to give your patients a specific drug, when patients have ALK, once they start treatment, they develop resistant mutations [to that therapy]. That’s why you need to test again, and based on which resistant mutation the patient has, that’s how you decide which drug to give.”

However, genetic testing is expensive, and especially with repeat testing, the question becomes, “How will this be paid for?"

James Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and previously a medical officer at CMS in the Coverage Analysis Group, explained that he was at CMS when Foundation Medicine submitted its request for a national coverage determination (NCD). As discussed in the June 2018 issue of Evidence-Based Oncology™,1 Foundation Medicine’s FoundationOne CDx was the second product to pursue FDA/CMS dual review, which paved the way for comprehensive genomic profiling in patients with advanced cancer. 

But now, Almas said, “The NCD that was ultimately issued has flaws in it. The NCD does not allow for the same test to be used more than once, with 1 exception, and CMS is going to announce soon that it is reopening the NCD for Foundation Medicine.”

The decision to reopen an NCD is not taken lightly. Michael Kolodziej, MD, vice president and chief innovation officer at ADVI Health, spoke out from the crowd during the panel to say that “When an NCD is reopened, it’s dangerous. In reality, it’s a threat to Foundation Medicine.”

Almas said that this decision was based primarily on the hesitance around the evidence of next-generation sequencing (NGS). “Most of these tests are FDA approved, but they have not gone through the equivalence of a phase 3 study done for drugs. Evidence, in some cases, is weak. You have to ask solid questions when you have a lab [that] you’re basing treatment decisions off of. You have to assess the lab and then face the challenge of reimbursement,” he said.

However, he also explained that he personally hopes CMS will reconsider its stance on hereditary testing reimbursement when they reopen the NCD. “NGS is used for tons of things. The CDC uses it every day. NGS is just a tool, but they didn’t understand that at CMS. We hope that there’s a change in testing frequency, [as there are] scientific reasons to conduct repeat testing,” said Almas.

Elizabeth Dragolovich, RN, associate director of reimbursement at Foundation Medicine, offered an insider’s perspective. She explained that Medicare coverage of the Foundation Medicine test is pretty broad and allows for reimbursement and coverage for people with a recurrence of cancer. “It’s great coverage for the 4.5 million beneficiaries in Florida who have traditional fee-for-service or Medicare Advantage plans, but what happens with government payers doesn’t always translate to private payers. And not only between Medicare and private payers, but also things don’t seem to translate from one private payer to another. Some are open to adopting broad testing, others are not.”

Though there is confusion about where the reimbursement decision for genetic testing will end up as it was reported April 30 that the NCD had been reopened, Dragolovich was clear in the convictions she shares with Foundation Medicine, “We feel very strongly that patients have a right to have a full understanding of the context of their disease,” she said.

REFERENCE:
  1. Ramamurthy L, Maxwell K, Sawchwyn B, Anhorn R. Perspective: FDA/CMS parallel review advances coverage for cancer comprehensive genomic profiling. Am J Manag Care. 2018;24(SP6):SP193-SP196



Collaboration to Ensure Access to Cancer Care Despite Increasing Cost Constraints

Making lifesaving but costly cancer therapies available to patients requires collaboration across the healthcare system, agreed a panel of stakeholders at the Business of Oncology Summit hosted by the Florida Society of Clinical Oncology. 

Logistically, collaborating in healthcare has always been a good idea, but it’s now necessary to survive, due to the happenings in the ecosystem over the past decade, said moderator Ira Klein, MD, senior director of healthcare quality strategy, Janssen. Payment methodologies are becoming increasingly based on outcomes, health systems and infrastructure are aggregating with mergers and acquisitions, and there is increased vertical and horizontal integration. These changes will affect patients, payers, delivery systems, and more, he said. 

“We have a lot of change, a little chaos, and some different business rules than we had 10 years ago,” Klein summarized. In light of these changes, he asked the panelists to explain how they collaborate with other stakeholders. 

Michael Diaz, MD, who is a practicing oncologist at Florida Cancer Specialists, said that he is often asked by local accountable care organizations how they can rein in the costs of cancer treatment, and he answers by explaining the clinical advantages of certain drugs for certain patients. For instance, sometimes a more expensive drug therapy can actually lower the total costs of care if it helps avoid complications and hospitalizations. He also discussed his efforts to introduce end-of-life care conversations earlier in the course of treatment. 

Vicki Trallo, RN, a patient navigator at Moffit Cancer Center, agreed that patients need to be better informed of their options. In her role, she has had to become knowledgeable on the basics of insurance because patients often are unaware of their coverage, benefits, and options. She mentioned that the patient education sheets from CancerCare and the American Society of Clinical Oncology (ASCO) provide information patients can digest. 

In addition to offering these patient-focused services, including educational modules on managing cancer and financial toxicity, ASCO is working to change the system, starting at the top, by issuing policy statements on proposed legislative changes, explained Stephen Grubbs, MD, vice president of clinical affairs, ASCO. For instance, ASCO recently took a position against Medicaid waivers to require enrollees to work, and it was active in the debate about repealing and replacing the Affordable Care Act without taking a political stance. For ASCO, collaboration extends beyond the federal healthcare system, Grubbs added, to encourage employers to invest in employee health. 

Another area in which collaboration is necessary for sustainability is in pharmaceutical development, said Al Wallace, field reimbursement manager, Bayer. The drug maker looked for a model for bringing a newly acquired drug to market that could benefit all stakeholders, even with the “difficult political climate” for putting a price tag on innovation. The company arrived at the idea of a money-back guarantee that would reimburse stakeholders—potentially including the patient, provider, payer, and pharmacy benefit manager—if a patient does not respond within 90 days. Although the idea is still in its infancy, it has sparked new conversations among stakeholders. 

“This type of model is going to be part of the equation, if not the solution, in the future as we look at access to expensive products,” Wallace predicted. 

Technology can also enable greater collaboration, said Diaz. Having integrated medical records and organized data can increase efficiency within an oncology practice, but it can also help evaluate which external components of the healthcare system add value to the patient and society. In this exciting time of growth in oncology, “Everybody has to make sure resources are being allocated efficiently,” said Diaz. 

As an example of collaboration on a national level, Grubbs discussed ASCO’s CancerLinQ initiative, which aims to aggregate real-world data from practices’ electronic health records to examine outcomes but has run into challenges in extracting that data. The holy grail of technology collaborations would be to consolidate complete clinical information and costs in one place, he said. 

Wallace noted that pharmaceutical companies that work with patient counselors and navigators are finding that having multiple sets of eyes on the patients allows them to assess which patients need the most assistance. He said, however, that the industry could still do a better job of making patients and providers aware of their programs to help patients afford drugs. 

In response to an audience question on how to manage the high costs of expensive drug combinations, Grubbs noted the importance of judging stakeholders by the factors they can control. For instance, clinicians and practices should be held accountable for utilizing treatments appropriately in accordance with tools like the ASCO pathways, not for the costs of drugs. 

Diaz agreed, and he added that he hopes to see more value-based reimbursement for medications as part of the future of cancer care. This seems likely with the introduction of such proposals in the Oncology Care Model 2.0, an alternative to CMS’ Oncology Care Model being developed by the Community Oncology Alliance,1 as well as support from groups like ASCO and pharmaceutical companies. 

“We are ethically obliged to make the best use of resources,” Diaz said. According to the experiences of the panelists, each stakeholder can start to meet that obligation by searching for areas of collaboration with other parts of the healthcare system. 

REFERENCE:
  1. Caffrey M. COA close to filing OCM 2.0 for federal review. The American Journal of Managed Care® website. ajmc.com/conferences/coa-2019/coa-close-to-filing-ocm-20-for-federal-review-. Published April 5, 2019. Accessed April 26, 2019. 



Cancer Survivors, Caregivers, Advocates Share Experiences With Financial Toxicity

In a panel discussion during the Business of Oncology Summit hosted by the Florida Society of Clinical Oncology, survivors and caregivers described how their cancer journeys were affected by financial toxicity. 

Fumiko Chino, MD, a cancer researcher at Duke Radiation Oncology, began the panel by giving a brief overview of financial toxicity, a side effect of cancer treatment that has garnered attention in published commentaries and the lay press. Then she shared a disclosure: As a young widow, she was burdened with exorbitant medical bills after her husband died of cancer, which led her to start medical school to study the issue. 

 
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