Multidisciplinary Care as the Catalyst for Innovation in Oncology

Promoting safe and effective cancer care delivery warrants consideration of factors beyond the care provided in the clinic. Disparities, cost, and social determinants of health (SDOH) are among the issues affecting patient outcomes in oncology, and addressing these unmet needs requires a multidisciplinary care team approach that focuses on the value and quality of care each patient receives, noted Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services, Emory Healthcare and Emory Winship Cancer Institute, in Atlanta, Georgia.

Haumschild served as the chair of a meeting of the Institute for Value-Based Medicine, presented by The American Journal of Managed Care® (AJMC®) in Atlanta on July 28, 2022. The event was held in partnership with Emory Winship Cancer Institute.

Event speakers covered topics driving innovation in multidisciplinary cancer care, including the use of biosimilars, comprehensive genomic profiling (CGP), and precision medicine. Disparities in prostate cancer care treatment and preventive strategies to address the rising threat of human papillomavirus (HPV)-related oropharynx cancer were also addressed.

As physicians of different specialties work together in the shared decision-making of a patient’s treatment plan, Haumschild said that one of the major challenges they all face in managing cancer care today is the rising drug spend associated with novel therapies coming to market.

Whether one examines the commercial, Medicare, or Medicaid population, oncology is the top spend category.¹ And spending continues to increase, with cancer treatment costs expected to reach $250 billion worldwide by 2024.²

“We know that oncology drug spend continues to grow year over year, and while [on one hand] this is great—it’s offering great efficacy for patients and offering further lines of therapy—at the same time, it is creating a higher cost of care. As I talk to payers and oncology benefit managers, [I find] this is something that they’re trying to wrestle with,” Haumschild said. “Where do we draw the line?”

Exploring the Pharmacoeconomic Benefits of Biosimilars
To reduce spending while offering the same quality of care, oncologists have turned to biosimilars as a cost-effective option. Biosimilars share a highly similar clinical molecular structure as their more expensive reference products. A recent AJMC® study indicated that the projected savings from biosimilars from 2021 to 2025 will be $38.4 billion, but also that barriers remain to increasing both supply and uptake.³

In looking at the approval process for both reference and biosimilar drugs, Haumschild explained that approval of a biologics license application can take 11 to 13 years and cost more than $1 billion. To license a therapy, sponsors must have 2 adequate control studies vs placebo or standard of care.

The application process for biosimilars is more expedited and less expensive, with a time frame of 6 to 8 years and costs in the $100-million to $200-million range. Analytical pharmacokinetics and pharmacodynamics data are also used more for reference in the approval process, rather than clinical data. “That’s why biosimilars are able to mature into our health system at a lower cost of care, because development costs are less,” Haumschild said.

These incentives are gaining traction among industry partners who are recognizing the value of biosimilars, he said; a 65% increase in approved biosimilars and a 157% increase in biosimilars availability within the United States were reported in 2020.⁴

“We’re seeing more competition within the states, more discovery, and more innovation in creating pathways for biosimilar use, not only on the health care side, but also within our payers,” noted Haumschild. “They’re making sure they have access to these agents at an affordable price to create access and reduce financial toxicity to their covered lives.”

However, utilization continues to prove a significant issue in oncology, even as more biosimilars become approved and enter the market. Along with patent litigation and lack of education among physicians and patients, reimbursement is one of the notable challenges to uptake.

As a strategy to incentivize providers to use biosimilars when appropriate, CMS in 2018 created a pass-through status on new-to-market biosimilars that allows for improved reimbursement. Particularly for Disproportionate Share Hospitals that are part of the 340B program, regulatory changes from CMS create major incentives to use biosimilars: These products are reimbursed at average sales price (ASP) plus 6%, while certain on-patent drugs are reimbursed at a rate of ASP minus 22.5%. Attempts to override this provision were rejected in the Balanced Budget Act of 2018.⁵

“Our goal is to expand our scarce resources to impact more and more patients. And so, if we can leverage something like biosimilars that provide great efficacy, I think it’s a great way of providing care, and also creating savings for the health system to make more of a sustainable care model that extends to new clinics and new areas of practice,” Haumschild added.
As a National Cancer Institute–designated Comprehensive Cancer Center, Emory Winship Cancer Institute considers several pharmacoeconomic and implementation factors in determining strategies to improve biosimilar uptake, said Haumschild. These include:

• Costs to the health system
• Out-of-pocket costs for patients and how the medication falls into their coinsurance or tiered co-pay expenses
• How the drug leads to precertification and delays for the patient
• Reimbursement
• Immunogenicity
• Electronic medical record implementation
• Key opinion leader hesitation on the medical, pharmacy, and payer sides
• Patient education
• Inventory management
  

Promoting financial management in cancer care demands recognition of 2 crucial points, Haumschild said: that total cost of care is more indicative of drug spend than acquisition cost, and that it is imperative to understand how patient liability relates to decreases in overall expense. Ultimately, creating alignment between clinical and financial benefits requires multidisciplinary care teams who can individually and collectively account for the implementation of consistently effective care to patients.

Evidence-based care—meaning the combination of utilization management, shared decision-making, and financial stewardship—that is consistent across all locations provides patients with improved outcomes while giving organizations predictability regarding drug spend, Haumschild said.

“If we’re going to preserve our health care dollars, and reduce the US health care spend, these are the types of strategies we need to make sure we’re adopting. The one nice thing about biosimilars is that we’re really leveraging lower-cost therapies with great efficacy, and…[they fit] in this equation a lot better than most other therapies we’re thinking about.”

Reducing Risks of HPV-Related Oropharynx Cancer Incidence and Unnecessary Treatment
Similar in cost-effectiveness with biosimilars is HPV vaccination, according to Nabil Saba, MD, director of head and neck oncology at Winship Cancer Institute, who described the latter as a cost-saving and potentially lifesaving opportunity that is undermined by a lack of uptake among patients and varied recommendation practices by physicians.

Among the virally mediated cancers caused by HPV, head and neck squamous cell carcinomas (HNSCC) of the oropharynx are among the most prevalent in the United States (18,225 cases per year), with a lower 5-year overall survival (OS) rate (51.2%) compared with HPV-related cervical (64.2%), anal (65.9%), and vulvar (66.0%) cancers.⁶

Saba, who leads management and prevention efforts against HPV-related HNSCC, said that while vaccines are highly effective in preventing disease, adherence rates in the United States have lagged far behind those of other nations such as the United Kingdom, where cervical cancer has been nearly eradicated in young women.⁷

Specific to HNSCC, he said that head and neck cancer is a very heterogeneous disease and that some variants are related to tobacco use. Disease related to tobacco use, even if the patient is HPV negative, usually has worse disease prognosis compared with disease related to HPV positivity.

“Prior to our understanding of this disease, our approach to head and neck cancer has been mostly focused on [tobacco-related] HPV-negative disease, which has been managed mostly by multimodal therapy, and [such management] is still the case….We give patients very high doses of radiation and chemotherapy,” noted Saba.

Incidence of HPV-related oropharynx cancer continues to rise while that of tobacco-mediated disease decreases, due to lower prevalence of smoking, he said. Providers are tasked with reducing the toxicity of treatment for patients with less severe prognoses while also preserving survival.
The demographics of patients are also noteworthy. In the United States, women aged between 20 and 24 years contract 1 or more of the 14 high-risk HPV types at higher rates than men of the same age, while in older age groups, men have higher frequency of infection. Moreover, incidence of HPV-related oropharynx cancer appears to be much higher in men—particularly White male patients older than 65 years—than in women, said Saba.

“Remember, people who are currently in their 40s and 50s are not getting vaccinated against HPV. This is why the projection over the next 10 years for this group of people, who will reach their 60s, shows a much higher incidence of HPV-related oropharynx cancer,” he added.

Despite the notable risk posed by HPV-related oropharynx cancer in older men, Saba highlighted findings of a 2017 National Health Interview Survey indicating that only 3% of men aged between 27 and 45 years have received 1 or more doses of HPV vaccine, compared with 16% of women (N = 7222).8 Vaccination rates were also lower among men aged 19 to 26 years (21%) compared with women (52%) of the same age (N = 2522).

“There’s no evidence biologically that the vaccine works for younger patients more than older patients,” said Saba. “It is basically a question of how many cancers are we trying to prevent when age enters the equation.”
The lack of a screening tool for HPV-related oropharynx cancer is also an issue. As there is no precursor lesion, patients are more likely to appear with more advanced disease and therefore require radiation and chemotherapy or surgery. The FDA has also approved the immunotherapies pembrolizumab and nivolumab to treat advanced HPV-related oropharynx cancer, said Saba.

CDC recommendations currently indicate that for patients who are inadequately vaccinated by age 27 years, shared clinical decision-making should be conducted by providers until age 45 years. Saba noted several recommendations for clinicians managing patients, with the ultimate goal of reducing and potentially eradicating HPV-related cancers over the next 2 decades. It includes:

• a multidisciplinary approach to care management, including consultation from radiation oncology, medical oncology, surgery, and neuroradiology clinicians;
• a comprehensive pediatric prophylactic series, with a coordinated catch-up adult vaccine as needed;
• collaborating with the cancer research field to treat patients who already have the disease; and
• working with policy makers to improve the rate of vaccinations and educate the population.

“Any one of you who looks at what happens to these patients in our clinic should understand that it’s much, much better to take the vaccine and avoid this cancer from happening rather than having to treat it,” said Saba.

Exploring Utility of Genomic Profiling and Precision Medicine in Oncology
In advancing diagnostic capabilities and promoting use of personalized medicine, genomic profiling has emerged as a cost-effective option that can avoid unnecessary treatment costs and eliminate waste.

Following Saba’s presentation, Ajay Nooka, MD, MPH, discussed CGP’s potential in multiple myeloma (MM), a disease that affects approximately 150,000 Americans and is expected to be diagnosed in 35,000 new patients this year.9 Nooka is a professor and director of the myeloma program in the Department of Hematology and Medical Oncology at Emory University School of Medicine, and scientific director, Data and Technology Applications Shared Resource, Winship Cancer Institute.

“If people are living longer and the incidence is remaining stable, it’s a huge health care burden on society when you’re talking about continuous treatment,” Nooka said. “There’s a time where we all need to stop and think, is treatment necessary? Are all patients exactly the same and should they be treated the same?”

In aiming to help patients with MM achieve minimal residual disease (MRD) negativity and sustain progression-free survival (PFS), Nooka’s practice developed a MRD Decision Protocol that leverages Clonoseq’s next-generation sequencing (NGS-MRD) tool. By immunosequencing T cells and B cells, he said, it enables precise and sensitive measurement of the dominant receptor sequences present in the cancer cells that can be modified to achieve MRD negativity in MM.

“Once this dominant sequence is identified, it can be quantified and tracked over time,” he said. “Achieving MRD-negative status is the key and it has been shown to be prognostic.”

Nooka added that findings of a recent study examining the prognostic value of MRD showed that patients with relapsed/refractory MM with MRD negativity were associated with a nearly 70% improvement in PFS compared with MRD-positive individuals (HR, 0.34; 95% CI, 0.24-0.47; P < .001), as well as significantly improved OS (HR, 0.28; 95% CI, 0.18-0.45; P < .001).¹⁰

The cost-effectiveness of NGS-MRD testing also cannot be understated. An analysis by Nooka and colleagues investigating the use of Emory’s MRD Decision Protocol indicated that 21% of patients with MM with sustained MRD negativity would be eligible to discontinue treatment, with only continued monitoring required.¹¹

Compared with projected costs associated with no MRD testing ($2,467,198), the incremental cost benefits totaled to $915,630 when implementing the test ($1,551,567) among the cohort of patients initiating maintenance therapy at Emory.

Over time, the cost savings over 5 years, 10 years, and across the lifetime were estimated to be $47,485,365, $105,535,069, and $181,294,838, respectively.

“Payers have to come up with a solution,” said Nooka. “Not all patients need maintenance therapy for life, and if you can identify those patients, those are huge savings.”

In addition to guiding clinicians on when treatment is necessary, genomic profiling also shows utility in deciding which therapy would lead to the best clinical outcomes for patients.

Highlighting lung cancer as the “poster child” for demonstrating the benefits of precision medicine, Ticiana Leal, MD, director of thoracic medical oncology at Winship Cancer Institute, said that substantial improvements in survival for non–small cell lung cancer (NSCLC) have been found to correspond with timing of approved targeted therapy.¹²

Taken as separate cohorts, some men, women, and individuals of various race/ethnicity groups have all been found to benefit from the introduction of targeted therapy in NSCLC, Leal said. Better understanding of the genomic complexity of the disease, advances in diagnostic testing, and a growing number of targetable mutations allow for greater flexibility in determining each patient’s optimal treatment pathway.

“The National Comprehensive Cancer Network [NCCN] has continuously updated its guidelines in real time to reflect changes that we’re seeing in clinical practice with these new FDA approvals, and in these guidelines, we also have emerging targets,” noted Leal.

“We’ve learned through multiple clinical trials and real-world data that clinical factors are not enough to advise against tissue genotyping in advanced NSCLC. You’re going to miss out on people who actually have mutations if it is not implemented.”

With the NGS testing paradigm shifting toward patients with earlier-stage NSCLC, given recent targeted therapy approvals, the decision between tissue or liquid biopsy has been the focus of debate: Which approach can best identify actionable mutations and accelerate initiation of personalized medicine?

Advantages and disadvantages have been cited for both approaches, said Leal, but evidence suggests that liquid biopsy, via cell-free DNA testing, improved detection of the 8 NCCN guideline-recommended biomarkers, as well as provided faster result turnaround time.¹³ Moreover, when tissue and plasma testing is done concurrently, a prospective single institution study of 323 patients with metastatic NSCLC showed that it increased targetable mutation detection vs tissue and plasma alone.¹⁴

Leal utilizes this concurrent approach at her clinical practice, and she spoke further on the cost-effectiveness of NGS-based testing vs single-marker testing. Although initial costs for single-marker testing may be lower, this approach is more likely to require repeat testing or a second attempt to collect tissue that can prove harmful to the patient and be more costly in the long term.

In an analysis that investigated patients with NSCLC who were matched to targeted therapy based on actionable mutations—identified via either NGS-based testing or single-marker testing—results showed that the incremental cost-effectiveness ratio improved from $148,478 to $110,000 per life-year gained for those who underwent NGS.¹⁵

“All of the clinicians trying to interpret NGS results need to have more assistance so they can make the decision on what’s the right therapy,” exclaimed Leal.

Emory has formed a molecular tumor board consisting of molecular pathologists, clinicians, and data interpreters to optimize the identification of actionable mutations and suitable targeted therapies, Leal described.
“Bridging the gap in terms of disparities in care is very important for us to address,” she said. “We’ve seen nationwide that biomarker testing is still suboptimal. A lot of work remains to be done not only in maximizing uptake of genetic testing, but also in maximizing our approach in getting the right patient onto the right therapy at the right time.”

Addressing Disparities in Prostate Cancer Care Treatment
Along with disparities in care provided in the clinic, systemic health and social factors separate from the hospital setting have a significant impact on equitable health care quality and access in the United States, noted Bradley Carthon, MD, PhD, a medical oncologist at Winship Cancer Institute.

Carthon opened his discussion with a case study of a patient with prostate cancer, the most common cancer among men in the United States (other than skin cancers) and the second leading cause of male cancer-related death. Carthon described how transportation barriers that caused the patient to be a “no-show” for scheduled radiation appointments led to a 1-month hospital stay, during which the patient was diagnosed with metastatic disease. In managing care for patients with prostate cancer, Carthon highlighted several points that clinicians should consider:

• Definitive therapy: “Can we cure or stop disease progression in the very beginning?”
• Medical mistrust: “Was there something in this patient’s history, background, or family that really did not lend itself to that particular care situation?”
• Navigation: “Could this outcome have been improved with the addition of someone to help folks navigate a very complex scenario?”
• Current treatment options and genomics: “What things do we have to think about doing in dealing with this scenario?”

The metropolitan area of Atlanta is a case in point in the stark differences among life expectancy by neighborhood. The estimate, for instance, for the Bankhead neighborhood, where the median household income is $42,762, is 63.6 years, whereas it is 87.6 years in the Vinings neighborhood, where the median household income is $85,635.

Although the influence of race on health outcomes in prostate cancer is considered to be primarily associated with socioeconomic factors as opposed to an inherent biological risk, Carthon noted that findings of a recent study examining cancer mortality rates in poor vs affluent counties showed that Black men of both social statuses were at significantly greater mortality risk than White counterparts, regardless of income.

“I’m not here to say that economic [status] doesn’t play a role, because we know that it does. But there is some [combination of] factors driving this—it may not be biological [only], it may not be economics [only]. It’s a very complex situation,” he said.

Disparities in the lifetime probability of developing and dying from prostate cancer have narrowed for Black vs White men over time, but Black men remain at significantly greater risk for both outcomes.

Nonetheless, Black men are less likely to be offered prostate specific antigen (PSA) screening in the United States. And for those who arrive at the clinic with localized disease, information from the Surveillance, Epidemiology, and End Results database from between 1992 and 2009 show that Black men, vs their White counterparts, were much less likely to be offered surgery via radical prostatectomy.¹⁶

Carthon added that disparities can also be observed regarding the use of dose-escalated radiation, image-guided radiation, and treatment of the prostate only (without lymph node radiation for low-risk disease): Black Americans are less likely to receive all of these therapies.

Further, the results of clinical trials that include IMPACT, TITAN, Radium-223, and TAX 327 have all shown that systemic therapies have notably engendered greater responses among Black vs White patients.

“But when we look at the way in which we provide these medicines, that’s the difference. If someone has to drive, take 2 buses, or a train from Waycross, Georgia, all the way to Emory to receive sipuleucel-T, or if they’re trying to check for appointment slots and don’t have internet, all of those things become a challenge,” said Carthon.

In learning from the care management of other cancer types, Carthon noted strategies that can prove helpful in decreasing time to diagnosis, improving engagement among patients, and reducing SDOH issues. These include same-day biopsy, coordinated reminders via mailed letters and phone calls, and counseling and educational programs.

A multidisciplinary approach should be taken to optimally integrate these initiatives, said Carthon, with care navigation the first priority.

Also, added Carthon, “the elephant in the room is that during COVID-19, people just didn’t make it out to do the screening or appointments, not only for prostate cancer, but for a number of cancers.”

“The difference in resolving an abnormal PSA, just like for the same-day biopsy program, has been someone to help guide patients through this concept. This is something we should really bring into that multidisciplinary approach in a more formalized manner—not just to help patients get from appointment to appointment, but really to help people work through these complex times.”

Underscoring the Impact of Multidisciplinary Care
After presenting individually, the speakers concluded the event with a panel discussion aimed at addressing the impact of multidisciplinary teams on their respective fields of expertise.

Acknowledging the siloed nature of oncology care delivery, Saba said that the complexity involved with each individual cancer case necessitates a patient-centered approach involving multidisciplinary care teams that are built around the individual. Leal added that the patients themselves and other community oncology practices who may comanage their care should be involved in this shared decision-making process, with the ultimate goal of improving quality of care.

“Initially, it’s not easy to implement [multidisciplinary teams] because we come from different backgrounds,” said Saba. “It takes a lot of courage, I think, for each one of us to basically say that we’re going to give something and basically sacrifice the older patterns of how we used to do things and be open-minded to adventure. Because I think without being able to basically throw yourself into a little bit of the unknown, nothing gets done.”

He added that while the multidisciplinary approach is most often associated with improved outcomes, the number of specialists seeing a patient during these appointments, ranging from nutritionists and social services to radiologists and surgeons, can sometimes be overwhelming to the patient. So, clinicians must also weigh these aspects in deciding how to optimally approach a given patient’s care.

Keeping the value-based aspect of care in mind is important, too. In strategizing different ways to deliver care, Haumschild asked the panel how they approach cost-effectiveness and preventive screening in their respective multidisciplinary teams.

Leal noted that a lot of work is needed to address poor lung cancer screening rates. In the United States, study findings have shown that lung cancer screening rates remained stable between 2019 and 2020, with just under 1 in 15 eligible persons screened.¹⁷ In other countries, such as Brazil, screening is almost nonexistent.

A major effort is required to coordinate these preventive services, including screening, smoking cessation programs, and follow-up care, Leal said, especially among frontline primary care physicians who may not be adequately educated to assess the signs and symptoms of complex cancers.
“Hopefully, evolving science will help us tease out higher-risk patients based on genetics and on blood-based biomarkers,” she said. “In lung cancer, though, we’ve got a long way to go before we actually [are using] screening to make a real dent in survival and in preventing late-stage disease for patients.”

Community involvement is also a strategy to promote early screening. Carthon noted that partnerships with trusted organizations, including churches and barbershops, can decrease medical mistrust and engage patients before cancers progress to metastatic or advanced disease.

“It’s a practical challenge,” he said. “There’s a role for an approach in that earlier scenario before they would have to see me, but it may not be that way for other cancers.”

Nooka agreed that this would often hold true in the hematological space, because a disease such as MM is not preceded by a precursor lesion; the benefits of universal screening would not be as helpful. Risk stratification could be more effective to identify and track certain populations for hematologic diseases, he said.

Ultimately, knowing about the biology and behavior of each particular disease is essential in managing care, said Saba, to avoid overdiagnosis and overtreatment and to eliminate waste.

“Think about how much stress we’re putting these patients under, [potentially with] many unnecessary procedures and treatments. [In terms of] screening, of course, lung cancer is different compared with, [say], thyroid or prostate cancer. It is very important [to ensure] that the [health care provider] who is making the decisions knows about the [specific] disease.”

“If everyone is there to keep each other honest, I think [multidisciplinary consultation] really does help determine what is best for each patient,” concluded Carthon. 

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