Conference Coverage: FLASCO/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.

Financial toxicity has measurable impacts on quality of life and satisfaction with care, Chino said, as data show an increased risk of medication nonadherence due to financial toxicity, a 2.65 times higher risk of bankruptcy with a cancer diagnosis, and a 79% higher risk of mortality with a cancer-related bankruptcy. Aside from these measurable effects, there’s also an intangible burden.

“The stress and overwhelming crushing defeat of these bills that would come in every week—it had an effect on our quality of life,” Chino said. “It forced us to make difficult decisions about his care.”

Panelist Beth Fisher, who calls herself a “cancer warrior,” shared her harrowing tale of receiving a multiple myeloma diagnosis while uninsured, her struggle to find a cancer center that would accept an uninsured patient, and her “extremely frustrating” experience of being rejected twice by Medicaid before applying in person. More than 6 years later, her medical bills—for radiation, 21 days of chemotherapy per month, quarterly infusion treatments, and any complications—cost her about $2000 out of pocket per month despite her Medicaid coverage.

Fisher offered her personal example of making difficult decisions about her care: Although she routinely takes the medications she needs to stay alive, she does not fill prescriptions that would improve her comfort and quality of life, such as pain or sleep medications, which she called “luxury items.”

Another panelist, April Thompson, shared her experience as a caregiver for her husband, who has neck and mouth cancer. On top of the shock of the cancer diagnosis and the pain of seeing him unable to eat normally, their insurance does not pay for the liquid diet he now needs, and they have to pay for it out of pocket. Thompson had to quit her job to care for her husband, which made their financial situation worse. She credits the strong support system of her church, family, and friends for helping the couple pull through, but she still gets frustrated by medical costs she sees as too high—for instance, the $7 roll of tape used to secure her husband’s stomach tube.

The experience of panelist Cat Somerville provided a sharp contrast illustrating the role of circumstance in determining one’s level of financial burden. When Somerville received a breast cancer diagnosis in 2006 and again in 2012, her large employer’s generous insurance plan and leave policy covered her treatment and paid her full salary plus commission for months, allowing her to focus on her recovery without worrying about money. By 2016, when doctors found 2 small lesions they treated with radiation, she was in the process of retiring and switching to Medicare. She was shocked to find out that Medicare would not cover the palbociclib (Vibrance) she had been taking, but charities ended up paying for the drug, so the cancer did not significantly impact her finances.

Somerville said she was lucky that her employer provided a good healthcare plan, but she recognized that not everyone is so fortunate. “I just think it’s unfair,” she said. “Really, you’re at the mercy of your employer’s person who picks your healthcare.”

Providing a different perspective on the problem was Christy Banach, director of patient financial services at Florida Cancer Specialists, who leads a team of financial counselors who educate patients on their benefits and prepare them for the costs of their treatment. Although that message is not always received well by individuals going through the trauma of illness, Banach said it would “disservice our patients if we did not educate them.” The counselors can help patients explore solutions like copay cards, charitable foundations, or payment plans.

It can be hard for clinics to allocate the time and resources to help patients understand their financial options, but Banach sees it as essential for allowing patients to focus more on their care and getting well instead of the financial burden of their illness.

To wrap up, Chino asked the panelists to name 1 thing they would improve to make a difference in the patient experience.

Fisher suggested reducing turnover in treatment centers so that patients can have the consistency and comfort of seeing the same face at their appointments. “Of all the millions of doctors I’ve been to through this, it would be nice to see the same people occasionally,” she said.

Somerville highlighted the importance of education and the need for oncologists to encourage patients to seek out support groups and resources. In her circle of fellow breast cancer survivors, each woman has positive and negative stories on navigating the healthcare system and wants to share their knowledge to help others.

According to Thompson, employers should be willing to sit down and discuss healthcare with their employees to help them decide what kind of insurance is best for their situation.

Banach suggested making sure everyone in the clinic office—including nurses, medical assistants, and front-desk staff—knows which resources are available for patients when the costs of care comes up in a conversation, since patients may have more trust in them than in the financial counselor.

New Therapies Offer Possible Cures but Pose Affordability Challenges

Chino agreed with the importance of making everyone on the care team familiar with the concept of financial toxicity. “As a provider, I feel uncomfortable talking about cost, but I also know that if we don’t talk about cost that it can be catastrophic for our patients,” she said. There are more drugs on the market today revolutionizing diseases that were once thought to be death sentences, like chimeric antigen receptor T-cell therapy for cancer. But their upfront prices are terrifying commercial payers and government payers alike. A panel on the last day of ISPOR 2019 discussed these issues in a session called, “Is Affordability Driving a Need to Revolutionize Drug Pricing?”

“I think we could probably spend all day on this topic,” said moderator Colleen M. Flood, FRSC, a health law and policy professor at the University of Ottawa. Small patient populations with challenging, rare, and life-threatening diseases may have the option of using targeted drugs, which may be more cost-effective in the long run but are raising affordability challenges, she said.

She asked Lou Garrison, PhD, the assistant director of the Pharmaceutical Outcomes Research and Policy Program at the University of Washington, to discuss some of the pricing approaches that are being tried to address the challenge.

Most economists would settle on differential pricing across countries, he said, but how to do that in a way that makes sense is a challenge. Innovative medicines are a “different commodity” than other traditional healthcare services, and Garrison said they have “properties of global public goods.” On the other hand, there has to be incentives for innovation, he said.

Mark Trusheim, MS, BS, a strategic director at Massachusetts Institute of Technology (MIT), the NEW Drug Development ParadIGmS (NEWDIGS), discussed some of the innovative approaches to pricing that are being tried to address 3 challenges related to life-changing therapies: the timing of payments; uncertainty about performance, or how long therapies will work; and the volatility that may occur, especially when taking into account small patient populations and small health plans.

Some approaches are milestone-based contracts, but he said NEWDIG prefers multiyear annuity payments. Another approach are carve-outs, or what Trusheim called “an old idea in a new context.”

In this model, a disease carve-out might include a portfolio of gene therapies for rare diseases and add medical management into it.

One panelist, Mina Bhanji, a senior vice president for Global Market Access at Merck, said the pharmaceutical industry represents a smaller part of healthcare spending than hospital and physician services, and warned about “unintended consequences” if pricing approaches curtailed innovation.

“We are the only part of the system that has cost containment built into it,” she said, referring to the patent system. She added that if misaligned incentives and inefficiencies could be reduced, that alone would help provide more access for patients.

Meindert Boysen, PharmD, MSc, the director for the technology appraisal and the highly specialized technologies programs at the United Kingdom’s National Institute for Health and Care Excellence, described how he has to translate innovation to both his committee members as well as payers.

“We place ourselves in England on the value side,” he said, and payers want to know how therapies will be implemented.