Shifting Landscape of Care Delivery Is Impacting Value-Based Cancer Care

Discussions of value in cancer care should also include the protection of community oncology, which allows patients to receive care where they live. The future of cancer therapy means not only people living with cancer as a chronic disease, but people living at home and being with their families because they are able to get care in their own community, explained Debra Patt, MD, PhD, MBA, executive vice president, policy and strategic initiatives, Texas Oncology.

Patt served as the chair of The American Journal of Managed Care®’s Institute for Value-Based Medicine event in Austin, Texas, held June 23, 2022, in partnership with Texas Oncology.

The event covered a range of topics related to value-based cancer care, including oral oncolytics, electronic patient-reported outcomes (ePROs), and state and federal policy.

The current shifting landscape of care delivery is also impacting value, Patt noted, with vertical integration of payers, pharmacy benefit managers (PBMs), and specialty pharmacies driving that shift. One consequence is the increased use of formulary exclusions and fail-first therapies, which provide challenges to physicians.

For example, in breast cancer, there are no data to make comparisons among the different cyclin dependent kinase (CDK) 4/6 inhibitors; however, insurance companies may select one CDK4/6 inhibitor over the others. “But as clinicians, there are toxicity reasons and compliance reasons why we might choose one over the others,” Patt explained. “So, this is a challenging environment for us to navigate for the patients we serve.”

Another shift is the growth of oral therapies. Currently, 30% of the therapies given to patients with cancer are oral therapies, but that share is expected to grow to 60% by 2024, Patt noted.

When looking at total US oncology drug sales, self-administered oral medications now account for more than half (53% in 2022) of the drug spend, said Gurjyot “Gury” Doshi, MD, medical director, oral oncolytics, Texas Oncology. “Orals are here as a prominent form of therapy for our cancer patients,” she said.

The increasing use of oral therapies is contributing to the paradigm shift happening in cancer care, because these agents represent more than just a different route of administration, Doshi noted. Oral oncolytics impact drug accessibility and financial burden, require additional safety monitoring, present adherence concerns, and shift the traditional provider roles and responsibilities to patients and caregivers. In a sense, patients are being their own provider when they are on oral oncolytics, she explained.

When the patient is taking that medication in the home, the patient’s behavior and their environment have an important impact, added Mark Alwardt, vice president, specialty pharmacy medically integrated dispensing (MID), McKesson. The patient’s ability to take their treatment may be affected by multiple factors, including their access to the pharmacy, whether their home is a safe place to which medications can be delivered, and whether they need to take a drug holiday while caring for children.

Texas Oncology has addressed oral oncolytics and the changes that are needed to ensure value-based care by utilizing a MID model. Since moving to this model, one medical team within Texas Oncology has seen increased access to therapy, decreased financial burden, and improved care coordination.

“No one is going to care for your patients as you do—not an outside pharmacy, and not anyone else outside of that absolutely intimate medical care delivery team,” Doshi said. “And so, this is how we have practiced our high-quality oncology care in Texas and delivered high-quality care in a value-based world.”

Understanding the MID Model
The MID model uses a single coordinated care team that is anchored by physicians, who work hand in hand with mid-level providers, patient assistance teams, social workers, nursing staff, and others. Care is documented in one record so adverse effects can be easily monitored and addressed. The result is increased patient satisfaction, adherence, and care plan compliance, Doshi said.

The key elements of the model are:

• treatment decisions guided by National Comprehensive Cancer Network (NCCN) guidelines and value pathways;
• a comprehensive drug order set that incorporates supportive care for a standardized approach;
• financial counseling that centralizes the prior authorization and patient assistance process;
• toxicity management through proactive outreach to patients and ePROs that allow for early intervention; and
• adherence and compliance that are improved through more touchpoints from the care team.

Alwardt noted that the challenge for medically integrated care is bridging the medical benefit and the pharmacy benefit. “That pharmacy world can be very complicated in how it’s operated and very different from the experience of many physicians,” he said.

The impact of financial burden on patients cannot be understated. Doshi highlighted research on the association of out-of-pocket (OOP) costs with prescription abandonment and delay in fills for oral cancer therapies.1 When the OOP cost is a relatively low $10 or less, there is still a 10% abandonment rate; this increases to 31.7% when the OOP cost is $100 to $500 and to 49.4% when the OOP cost tops $2000. Overall, the abandonment rate was 18%, affecting about 1 of every 5 patients.

While Texas Oncology is still reviewing the data, the prescription abandonment rate at Texas Oncology is so far less than 5% for all patients, Doshi noted.

Using Digital Health Solutions to Improve Care
Another tool that Texas Oncology has implemented to improve care is a collection of digital health solutions (DHS). While DHS comes with the promise of improving the patient and provider experience, improving outcomes, and reducing costs, DHS companies cannot do this on their own, said Amila Patel, PharmD, BCOP, chief clinical officer, Navigating Cancer. They must have a tight relationship with the organizations they work with, to understand those organizations’ needs.

Over the course of 3 years, Texas Oncology and Navigating Cancer partnered to move from manual documentation processes to patient-driven value-based care using technology solutions, Patel said. The Navigating Cancer DHS is composed of 4 main products; Texas Oncology implemented the first one in 2019, and the other 3 products had all been implemented by 2021.

The first product was the care management platform, which was set up to enable clinic staff to document, triage, and manage patient care activities. The platform also incorporates symptom management pathways so issues are addressed in a centralized fashion, Patel explained. Texas Oncology set out to implement this product because of prolonged callback times for symptoms that resulted in patients ending up in the emergency department (ED).

After incorporating the new product, Texas Oncology improved incident resolution times by 33%. More than 60% of symptom incidents were resolved in less than 1 hour.

The second product, implemented in July 2020, was a web-based application to remotely monitor symptoms and oral adherence. It utilizes a modified version of the National Cancer Institute’s PRO-CTCAE (Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events) Measurement System.

“By layering in this proactive solution, you can see that we’ve started to shift how patients are reporting how they’re feeling to their care team. [It’s moving] from less of that reactive nature to more of this proactive nature,” Patel said.

At Texas Oncology, 22% of all symptoms are now being recorded through remote monitoring. Nearly three-quarters (73%) of patients enrolled completed at least 1 ePRO assessment. According to Patel, an effectiveness analysis is planned to evaluate if the monitoring program has impacted ED visits, hospitalizations, and time on therapy.

An included feature of this product is the ability to “decline a call.” Due to the sheer volume of symptoms being uploaded, nurses were feeling overburdened and frustrated when they would call a patient about an uploaded symptom only for the patient to tell them that they were feeling just fine. The feature allows patients to upload symptoms but to also check a box at the end if they don’t want to receive a call from the care team.

Adding this feature reduced nurses’ workload, and Navigating Cancer found that 20% of symptom submissions were associated with a declined call. Implementing this feature reduced the average time to call by 36%, and it increased staff satisfaction, Patel explained.

Finally, in November 2021, the final 2 products were implemented: the patient portal and patient education. The patient portal allows patients to access their records, securely message the care team, and view educational content related to their cancer diagnosis and treatments.

Navigating Cancer and Texas Oncology found high rates of digital activity, including the following:

• 92% of the patients invited had registered for the patient portal;
  after 3 months, the average number of logins per patient was 12; and
• 64% of digital education items that were sent were read by patients.

Throughout the process of implementing these products, Navigating Cancer and Texas Oncology had the opportunity to better understand how the solutions were being used among different types of patient populations, Patel explained. She added that it was important to ensure while developing these tools and providing access to patients that “we [didn’t] create any type of digital divide.”

While they found high utilization among elderly patients and those in rural areas, remaining areas for improvement are among racial/ethnic minorities and patients who do not speak English.

“We envision that as patients are receiving more care in their home that our solution has to meet those patients where they are at as well,” Patel said.

Payer and Provider Collaboration
While collaboration with technology companies helps to improve care delivery, the increasing costs and incidence of cancer will require more payer and provider collaborations, said Lalan Wilfong, MD, vice president, payer relations and practice transformation, The US Oncology Network.

For both commercial and government payers, the per-member per-month costs for oncology are higher than for any other disease state, Wilfong noted. In addition, costs vary greatly, yet no proof exists that higher costs necessarily improve outcomes for patients.

Wilfong echoed Patt’s earlier point about the impact that vertical integration is having and highlighted that health insurers are not just insurers anymore: They are entire networks that also include provider services, PBMs, and specialty pharmacies.

When looking at value in health care, the entire landscape must be considered, Wilfong said. Furthermore, it is important to remember that different stakeholders view different cost-containment tools differently. For instance, physicians don’t like Centers of Excellence (COE) because they don’t necessarily feel they improve outcomes, but patients love the idea of them—and employers care that their employees like them, which means a payer can’t really sell a benefit design that excludes COE.

“We have to think about how [physicians and practices] fit in. How do we fit in with value-based care programs?” Wilfong noted.

Practices should consider engaging with payer partners, and part of that is being able to answer some crucial questions, such as:

• What are the needs for payers in your area and who are their stakeholders?
• Who are your competitors and what are they doing in this space?
  What do you have to offer? and
• How do you leverage what you are doing well into payer contracts?

Texas Oncology is participating in multiple value-based care agreements with commercial payers, including the Oncology Medical Home, total-cost-of-care models, pay-for-performance models, full capitation, and pathways, Wilfong explained.

“Payment reform is here, and it’s going to continue,” said Wilfong. “We need to position ourselves for ongoing success. We need to understand the rationale behind the payment policies to ensure our continued viability.”

Taking Steps to Bring Value Into the Equation
Susan M. Escudier, MD, vice president, value-based care and quality programs, Texas Oncology, highlighted Texas Oncology’s success in value-based care models, including the Oncology Care Model (OCM), which officially came to an end 1 week after the meeting. (At the time of the meeting, CMS had not yet announced the Enhancing Oncology Model, which will replace OCM starting in July 2023.²)

In order to participate in value-based care agreements and improve quality of care, Texas Oncology implemented a number of changes.

Treatment pathways were developed internally and then merged with the NCCN guidelines to ensure standard-of-care updates, which reduced errors, increased standardization, and provided patients with state-of-the-art care.
Enhanced services, such as care coordination, genetic counseling, social workers, and support groups, were offered.

Shared decision making was promoted using a physician-derived care plan given to the patient with their diagnosis, prognosis, the toxicity of treatment, and the cost of treatment.

Advanced care planning was provided so the patient’s values could determine the level of care they received.

Prognostic modeling was used to help predict which patients will do well on treatment and to pick treatment accurately.

Patient satisfaction was gauged using surveys to help identify areas of success and areas of improvement.

In the OCM, from June 2016 to June 2021, Texas Oncology decreased admissions from 24.7% to 16.2% and ED visits from 23.8% to 18.3%.

In addition, it realized total shared savings of $133.8 million. In a value-based care model with Cigna, Texas Oncology reduced ED visits 30%, from 789.5 to 556 visits per 1000 patients from October 2019 to September 2021.

Finally, in a model with Humana, inpatient claims per patient dropped 15%, from 7.9 to 6.69 claims per patient from April 2019 to September 2021.

The future of value-based care is likely to shift from being voluntary to mandatory, with physician practices assuming more risk, according to Escudier. In addition, more focus will likely be placed on outcome-based measures, ePROs, bundled or episode-based models, population health and health equity, real-time analytics, visibility into cost, and fewer to no upfront payments, such as the Monthly Enhanced Oncology Services payments in OCM.

Drug Pricing, White Bagging, and “Whack-a-Mole”
In the meeting’s second half, the focus shifted to federal and state policy, first with a presentation on federal policy by Ted Okon, MBA, executive director, Community Oncology Alliance (COA), followed by a panel on state policy.

Okon began with a brief rundown of what is happening in Washington, DC. At the time, Ukraine, guns, and inflation were dominating the landscape, and drug pricing reform had taken a backseat. He noted a few major health care issues to watch: drug pricing reform, 340B, and PBMs.

There is “lots of heat on Democrats to do something” on drug pricing reform before the election later this year. Senator Joe Manchin, D-West Virginia, is apparently coming around on the idea of a smaller-scale reconciliation bill that would include drug pricing, Okon said, and “if he can get behind it, the Senate will likely pass it and the House will definitely pass it.”

However, any drug pricing reform would not go into effect until 2025. Furthermore, it would start with Part D drugs outside oncology before getting to oncology Part B drugs, Okon added.

Frequently, Okon is quoted, mistakenly, as saying that the 340B program is terrible, but he firmly stated that he believes it is a critical program and a safety net for patients with cancer who are uninsured or underinsured.

However, the program has expanded beyond safety-net providers to more than half of the hospitals in the United States, and 340B is estimated to surpass both Medicare and Medicaid to become the largest federal program by 2026.³

“This is a program that has simply mutated,” Okon said.

A week before Okon’s talk, the Supreme Court had ruled on a case impacting 340B hospitals. In a unanimous decision, the court found that HHS’s decision to lower reimbursement rates to hospitals so that those in the 340B program received reduced rates because they received discounted drugs was unlawful.⁴ This ruling was not, Okon emphasized, in favor of the 340B hospitals. At the heart of the ruling was that HHS had reduced rates in 2018 and 2019 without using survey data. Over the last 2 years, HHS has surveyed hospitals and the results find that payment to 340B hospitals should be average sales price (ASP) minus 28.7%, not ASP minus 22.5%, which is what they had reduced the rate to.

“If [the HHS does] what they should, [340B] hospitals will see even lower reimbursement,” Okon said.

PBMs are now a big player in the 340B space, and they are making huge profits on the program, he said. The top 3 PBMs control 80% of the market and the top 6 PBMs control 96%. Per Okon, the PBMs want to control what the doctor prescribes and where and how the drug is delivered. “They want to become a doctor,” he said. “So, this is crazy.”

Another area where PBMs are making money is through direct and indirect remuneration (DIR) fees. “It’s a way that PBMs can do whatever they want,” Okon said.

CMS has ultimately moved to outlaw DIR fees in 2024, but COA expressed concerned that PBMs will simply take what they make on the back end and move the fees to the front end. Okon said that trying to rein in PBMs is like playing a game of “PBM whack-a-mole.”

On the state level, some states are trying to implement PBM legislation to take back money from the PBMs, Okon said during the panel discussion.

States haven’t gone after DIR fees because those are part of the Medicare program, but they are going after anti-clawback laws to curb clawback practices of PBMs.

At the regional level, said Wilfong, there is also pressure for the use of white bagging, in which selected pharmacies contract with the insurer to ship medications directly to the site of care. According to Patt, Texas Oncology has a policy that it does not white bag. In the past, the issue has arisen of prescriptions for oral medications being steered toward the PBM or insurer’s own pharmacy, but Patt is now also seeing this happen in the intravenous space.

Okon said there is more pressure to mandate that prescriptions are not filled in the practice and more pressure for white bagging. When the prescription goes to a contract pharmacy, the insurer or PBM is able to get the 340B discount and “make a ton of money.” He doesn’t see states necessarily doing anything in this area, because they see the money in the program and want to get in on the action.

“That’s why you see that some of the legislation percolating at the state level is actually more toward getting some of the 340B dollars, which is crazy, as opposed to literally taking 340B and curbing the program,” Okon said. 

References
1. Doshi JA, Li P, Huo H, Pettit AR, Armstrong KA. Association of patient out-of-pocket costs with prescription abandonment and delay in filles of novel oral anticancer agents. J Clin Oncol. 2018;36(5):476-482. doi:10.1200/JCO.2017.74.5091
2. Caffrey M. CMS announces OCM successor, but gap year remains for oncology practices. AJMC. June 27, 2022. Accessed July 14, 2022. https://www.ajmc.com/view/cms-announces-ocm-successor-but-gap-year-remains-for-oncology-practices
3. 340B program at a glance. Berkeley Research Group. December 2021. Accessed July 14, 2022. https://media.thinkbrg.com/wp-content/uploads/2021/12/09062840/340B_Forecast-Report-Infographic_2021.pdf
4. Joszt L. Supreme Court unanimously rules in favor of hospitals in 340B decision. AJMC. June 15, 2022. Accessed July 14, 2022. https://www.ajmc.com/view/supreme-court-unanimously-rules-in-favor-of-hospitals-in-340b-decision