For too long, lung cancer has had one of the worst prognoses of any cancer. It is the leading cause of cancer-related deaths worldwide (

); only 1 in 5 people with lung cancer will be alive 5 years after diagnosis.

New advances are creating the opportunity to transform the diagnosis, treatment, and management of lung cancer. However, survival rates have improved only modestly and are lagging behind those of other common cancers (

 The time for us to act is now: to come together as a community, to bend the lung cancer survival curve faster, and to significantly improve patient outcomes in this devastating disease. For more than 45 years, the International Association for the Study of Lung Cancer (IASLC), with our membership of nearly 6500 lung cancer experts worldwide,

 has been working tirelessly toward a world without lung and other thoracic cancers. The task is immense as lung cancer is, and to add strength to our efforts we recently joined with other leading organizations in the lung cancer space to create a powerful force for change: The Lung Ambition Alliance (“The Alliance”).

The Alliance unites the IASLC, the Global Lung Cancer Coalition, AstraZeneca, and Guardant Health with a common goal: to one day eliminate lung cancer as a cause of death. To achieve this bold goal, we will start by doubling the 5-year survival in lung cancer by 2025. Improving survival rates in lung cancer is both complicated and multifactorial; thus, our plans must be varied and dynamic to address each barrier to ensure optimal outcomes. We need to move beyond existing prevention efforts to target every point in the patient journey with innovative and effective strategies. This includes establishing early diagnosis through broader screening guidelines, developing more innovative medicines, and ensuring the best quality of care and support for patients and families. The Alliance has identified 3 priority areas that align with critical points in the patient journey, and we are already undertaking several flagship projects, focused on these priority areas, to create positive change in the lung cancer landscape.

Increasing Lung Cancer Screening and Early Diagnosis

Late diagnosis is a key reason that survival rates for lung cancer are so poor.

 Forty percent of patients are diagnosed after cancer has already spread beyond the lung.

 To significantly shift the survival curve, we must diagnose and treat patients at earlier stages of disease. Because early-stage disease is often asymptomatic, this can be done only by improving lung cancer screening.

The IASLC has focused on improving lung cancer screening for some time. In October 2018, we issued a statement supporting the findings of the Dutch—Belgian NELSON (Nederlands-Leuven Longkanker Screenings Network) Randomized Lung Cancer Screening Trial

 and the National Lung Screening Trial (NLST).

The landmark 2011 NLST was the first large-scale trial to show that lung cancer screening with low-dose computed tomography (LDCT) can significantly reduce mortality. The NLST enrolled more than 50,000 patients, aged 55 to 74 years,

 who were current smokers with >30 pack-years of cigarette smoking history or who had quit smoking in the past 15 years.

 Results showed that participants who received LDCT scans had a 20% lower risk of dying from lung cancer than participants who received standard chest x-rays, and 50% of lung cancers detected by LDCT were stage I disease.

However, in addition to highlighting the obvious advantages of screening, the NLST also revealed flaws in real-world national screening programs.

 First, CT scanning is associated with a high rate of false-positive results. In the NLST, 24.2% of the results from the CT scans performed were positive, and more than 96% of nodules uncovered were later deemed to be false positives,

causing unnecessary stress and concern to thousands of patients.

In addition, for those patients who did test positive, further procedures were required to confirm the diagnosis, including additional scanning or a biopsy, which can be invasive and carry serious risks. Finally, perhaps the biggest barrier to large-scale screening programs is the limit that national insurance coverage and reimbursement policies place on which patients are eligible to receive screening.

For example, in the United States, guidelines were adopted by the US Preventive Services Task Force based on data from NLST, and lung cancer screening has been recommended since 2014. However, these guidelines have been enforced only in high-risk individuals (

), which means that they are utilized by only about 8% of those dying from this disease annually.

Outside the United States, few countries have screening policies. After reviewing the NLST results, many countries continued to wait for data from a study outside of the United States to confirm the findings before they considered implementing screening. Confirmation finally became available in 2018, when results from the 10-year follow-up of NELSON were presented at the IASLC 19th World Conference on Lung Cancer. With 15,822 participants, the NELSON trial was the largest-ever European lung cancer CT screening trial. The study was designed to determine the effect of stringent referral criteria and increasing screening intervals on the characteristics of screen-detected lung cancers. The study confirmed the findings of the NLST and helped to address key questions, including how to minimize false positives.

In NELSON, LDCT screening led to a 26% reduction (P = .0003) in lung cancer deaths in men and a 39% reduction (P = .0054) in women after 10 years, and it confirmed that we can increase the number of patients diagnosed with early-stage lung cancer. Compared with other trials, the screen-detected lung cancers of the NELSON trial were relatively more often diagnosed at stage I, when there is curative possibility, and less often at stage IIIB-IV, when the prognosis has significantly worsened. Findings from NELSON are summarized in 

We now have the data and insights we need to act and implement national-level LDCT screening programs for people at high risk for lung cancer. However, despite growing evidence from lung cancer CT screening studies, few countries, districts, or regions have implemented LDCT screening for lung cancer. In countries where they do exist, policies vary from region to region, and too few sites are set up to implement screening effectively, too few patients are offered screenings, and there is low uptake.

The Lung Ambition Alliance will focus its efforts and programs on addressing the potential barriers to the uptake of screening. We will promote greater understanding and awareness of the strong evidence of the benefits of implementing screening of high-risk populations with LDCT, as supported by findings from the NLST and NELSON studies.

 By doing so, we hope to encourage the adoption of national screening guidelines and policies. We will also continue to explore methods beyond CT scans to improve diagnosis rates of the diseases and to reduce false positives.

One of the foundational programs of The Alliance is advancing screening with the Early Lung Imaging Confederation (ELIC), a potentially practice-changing global resource for lung cancer researchers and care teams. ELIC is a new cloud-based screening registry that is designed to accelerate improvements in the multidisciplinary

detection and management of early-stage lung cancer.

 It uses new and emerging artificial intelligence and deep learning techniques to facilitate detailed analysis of gathered CT data to improve the reliability of clinical decision support with CT screening, and to assist in the development of precise quantitative disease biomarkers.

ELIC was developed in 2018 by the IASLC with the intention of creating a large, globally accessible, privacy-secured network of shared CT lung cancer images and associated biomedical data.

In December 2018, the IASLC announced the completion of a 4-month pilot project which showed ELIC’s potential to bring significant improvements to lung cancer screening by creating a viable environment for the analysis of large collections of quality-controlled CT lung cancer images.

 Phase 2 of the project is currently underway, in which additional “data spokes” are being added to make the registry of images more robust and powerful, and quantitative algorithm experiments are being run on data from 6 sites. Once this is complete, ELIC will expand out to a fully operational system and conduct numerous experiments of the internationally curated data.

We are at a critical moment in the fight against lung cancer. Medical innovations and an increased understanding of the underlying biology of lung cancer are already shifting what is possible in treatment. The key challenge now is to accelerate treatment advances for people with lung cancer today, and for the millions who will be diagnosed in the future. However, several barriers remain to be overcome.

First, it is important that patients receive a timely and accurate diagnosis. Barriers to accurate and timely lung cancer staging represent a lost opportunity to guide patients on the appropriate treatment path. The IASLC has led in the creation of lung cancer staging standards for years. With the support of The Alliance, the IASLC is working to standardize international lung cancer staging guidelines and deepen insights into disease progression. Insights from this effort will inform the 9th edition of the Tumor, Node and Metastasis staging system, the most common method for staging lung cancer, and will guide physicians in identifying the right treatment

Secondly, testing for biomarkers plays an important role in guiding selection of patients for precision medicine therapies. However, currently, many patients who may be eligible for precision medicines, and the improved outcomes they may offer, are not being tested for biomarkers at diagnosis.

The Alliance will champion initiatives focused on biomarker discovery and on improving access to high-quality diagnostic approaches like liquid biopsy, as well as the increased uptake of precision medicine approaches in earlier settings where there is greater potential for cure. We are currently exploring several projects in this area, including those that will investigate the validation of surrogate endpoints and identification of predictive biomarkers to accelerate the development of new treatments.

Third, the emergence of precision medicine is making prolonged clinical response a realistic goal of lung cancer therapy. To further improve lung cancer survival outcomes, however, we must explore the potential for precision medicines in earlier stages (stages I-III) where there is a greater chance of cure.

 As part of its Major Pathologic Response Project, The Alliance is working to validate surrogate endpoints and identify predictive biomarkers to accelerate the delivery of innovative medicines.

Lastly, poor survival outcomes in lung cancer may also be tied to the disparity in lung cancer research funding compared with other cancer types (

 Lung cancer is consistently underfunded relative to societal health cost and economic costs.

In the United States, funding for lung cancer research in 2016 was only about half that of breast cancer research.

 The National Cancer Institute’s funding for lung cancer research was $321 million in 2016, compared with $545 million and $208 million for breast cancer research and colorectal cancer research, respectively.

The Alliance will work to improve awareness and understanding of lung cancer, to reduce stigma in the hope that this correlates to a level of public funding for lung cancer research that matches the urgency of the disease and the current promise of medical innovations.

At the IASLC 2019 World Conference on Lung Cancer in Barcelona in September 2019, The Alliance announced the official launch of an international survey, conducted by Ipsos MORI, which will invite general practitioners, lung cancer specialists, and the public from 7 countries across 3 continents to share their perceptions around lung cancer. The survey will help generate insights and aid The Alliance in developing tailored patient solutions as well as advocacy initiatives. The survey will also establish a barometer by acting as a benchmark to help track the impact of Alliance programs over time. The results of this survey are expected in 2020.

The Alliance’s final priority area recognizes that people with lung cancer need support on their journey of care. We, as a lung cancer community, need to work with advocates and policymakers to deliver projects to address the healthcare challenges most urgent to patients. Patients need access to the multidisciplinary team they require to manage their condition; health systems and insurers need to have an urgency to act instilled in them to provide patients with access to the best possible treatment. 

To this end, The Alliance is committed to implementing benchmarking and quality improvement processes in the management of lung cancer. We will identify projects to ensure that patients have a better experience in their journey and achieve better outcomes. The Alliance has launched a new grants program, the Initiatives in Lung Cancer Care (ILC

), to engage with the global community and encourage ambitious in-country solutions that can potentially transform patient care and improve survival rates in lung cancer. The ILC

 program is an open call, inviting registered patient organizations around the world to submit proposals for projects that can potentially transform patient care and improve survival within their home countries.

The program recognizes the high variation in lung cancer management around the world as well as the specific, localized barriers to quality care that must be considered when developing patient-centric solutions to address them.

The Alliance began accepting grant applications in November 2019 and will evaluate and select submissions that meet the criteria for funding. 

The Alliance is only a few months old, but the efforts of each individual partner go back decades. This is just the start of an essential process of change that must be taken together by the lung cancer community to ensure that we succeed in transforming lung cancer from a disease with poor patient outcomes to a disease that can be treated successfully, offering new hope to families and communities around the world.

This is a movement designed to grow, welcoming all those who believe that by breaking siloes, facilitating dialogue, and collaboratively searching for new solutions we can accelerate the extraordinary potential of today’s science and technology. We will bend the survival curve in lung cancer, together.

Giorgio Scagliotti, MD, PhD, is professor of oncology at University of Torino and head of the Department of Oncology and chief of the Division of Medical Oncology at the San Luigi Hospital in Torino, Italy. He is the past president of the International Association for the Study of Lung Cancer (2018-2019) and a current board member of the organization. He is also a member of several other scientific societies, including the Italian Society of Respiratory Medicine, the Italian Association of Medical Oncology, the European Respiratory Society, and the American Society of Clinical Oncology. Dr Scagliotti was the 2016 Addario Lectureship Award recipient.

1. World Health Organization. Latest global cancer data: Cancer burden rises to 18.1 million new cases and 9.6 million cancer deaths in 2018. who.int/cancer/PRGlobocanFinal.pdf. Accessed November 22, 2019.

2. Lung [cancer fact sheet]. World Health Organization/International Agency for Research on Cancer website. gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Updated March 2018. Accessed November 22, 2019.

3. National Cancer Institute: Surveillance, Epidemiology, and End Results Database. Cancer stat facts: lung and bronchus cancer. seer.cancer.gov/statfacts/html/lungb.html. Accessed November 22, 2019.

4. International Association for the Study of Lung Cancer. iaslc.org/About-IASLC/Who-We-Are. Accessed November 22, 2019.

5. Cancer.net editorial board. Lung cancer—non-small cell: statistics. Cancer.net website. cancer.net/cancer-types/lung-cancer-non-smallcell/statistics. Updated January 20, 2019. Accessed November 22, 2019.

6. EpiCast report: non—small cell lung cancer (NSCLC)–epidemiology forecast to 2025. GlobalData website. globaldata.com/store/report/gdhcer132-16--epicast-report-non-small-cell-lung-cancer-nsclcepidemiology-forecast-to-2025/. Published November 2016. Accessed October 27, 2019.

7. ASCO Post staff. IASLC issues statement on lung cancer screening with low-dose computed tomography. The ASCO Post website. ascopost.

com/issues/november-10-2018/iaslc-issues-statement-on-lung-cancerscreening/. Published November 10, 2018. Accessed November 22, 2019.

8. National Lung Cancer Screening Trial. National Cancer Institute website. cancer.gov/types/lung/research/nlst. Updated September 8, 2014. Accessed November 22, 2019.

9. National Lung Screening Trial. clinicaltrials.gov/ct2/show/NCT00047385. Updated May 20, 2014. Accessed November 22, 2019.

10. Hoffman RM, Sanchez R. Lung cancer screening. Med Clin North Am. 2017;101(4):769-785. doi: 10.1016/j.mcna.2017.03.008.

11. Van der Aalst CM, ten Haaf K, de Koning HJ, et al. Lung cancer screening: latest developments and unanswered questions. Lancet Respir Med. 2016;4(9):P749-P761. doi: 10.1016/S2213-2600(16)30200-4.

12. National Lung Screen Trial Research Team; Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409. doi: 10.1056/NEJMoa1102873.

13. Chassagnon G, Revel MP. Lung cancer screening: current status and perspective. Diagn Interv Imaging. 2016;97(10):949-953. doi: 10.1016/j.diii.2016.06.018.

14. Ma J, Ward EM, Smith R, Jemal A. Annual number of lung cancer deaths potentially avertable by screening in the United States. Cancer. 2013;119(7):1381-1385. doi: 10.1002/cncr.27813.

15. US Preventive Services Task Force. Lung cancer: screening. www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/lung-cancer-screening. Accessed November 22, 2019. 

16. Yousaf-Khan U, van der Aalst C, de Jong PA, et al. Final screening round of the NELSON lung cancer screening trial: the effect of a 2.5-year screening interval. Thorax. 2017;72(1):48-56. doi: 10.1136/thoraxjnl-2016-208655.

17. Ebell M, Thai TN, Royalty KJ Cancer screening recommendations: an international comparison of high-income countries. Public Health Rev. 2018;39:7. doi: 10.1186/s40985-018-0080-0.

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Articles

Evidence-Based Oncology

For more than 45 years, the International Association for the Study of Lung Cancer has been working tirelessly toward a world without lung and other thoracic cancers. To add strength to our efforts we recently joined with other leading organizations in the lung cancer space to create a powerful force for change: The Lung Ambition Alliance

Improving Survival in Lung Cancer: Commitment of The Lung Ambition Alliance

As CMS prepares to move forward with new models of value-based cancer care, a radiation oncologist, speaking at the Institute for Value-Based Medicine®, an initiative of 

, discussed her findings regarding whether accountable care models had an effect on cancer care spending.

Miranda Lam, MD, MBA, presented a 2018 study

 looking at Medicare accountable care organizations (ACOs) for patients with cancer; Lam, of  Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, said the results, which found an $11 difference per beneficiary, indicate models created for primary care may not be applicable for oncology purposes.

Lam examined national Medicare claims from 2011 to 2015; practices that became part of ACOs were identified and matched to non-ACO practices within the same region. She and her coauthors looked at whether the introduction of ACOs led to lower overall spending, lower spending by service type, and spending on cancer-specific services (radiation therapy, chemotherapy, hospitalizations, emergency departments, and hospice).

A difference-in-difference analysis showed that the introduction of ACOs had no meaningful impact on overall spending (-$308 per beneficiary in ACOs vs -$319 in non-ACOs; difference, $11; 95% CI, -$275 to $297; 

Within the 11 different cancer types examined, there was no change in total spending. And changes in spending and utilization did not meaningfully differ between ACO and non-ACO patients within cancer-specific categories. 

Lam used the study as a prelude to her thoughts about CMS’ Radiation Oncology (RO) Model, which CMS proposed in July. Unlike the ACOs she studied, participation in the 2-sided risk model will be mandatory and, as of this writing, is slated to begin January 1, 2020.

 Currently, the plan proposes to randomize 40% of radiation providers and hospitals into the mandatory model, based on zip code. 

There are some other differences between this model and previous bundle-type models as well. For instance, the  payments will be site neutral between freestanding and hospital outpatient departments, and payments will be prospective (payment will be up front once an episode begins, for 90-day episodes of care) rather than retrospective. 

The 2-sided risk model will be risk-adjusted and differ by geographic location, for 17 types of cancer. Three percent of the payments will be earned based on patient satisfaction and quality measures, which will include a care plan for pain, depression screening and a follow-up plan, an advanced care plan, and a treatment summary communication.

Lam acknowledged why CMS was taking the road of mandatory participation, saying “we might even benefit from having an initial sort of voluntary pilot phase to work out the some of the kinks.” But, Lam said, she knew that so few providers and practices join voluntary models.

In addition, CMS wants quality metrics, which some radiation oncologists might hesitate to supply. But Lam said this is not only CMS’ fault, “This is also on us as a field, in that we don’t have great quality metrics.” 

“I think quality metrics in oncology are difficult—and definitely in radiation oncology, we often don't have [them]. We use process measures or structural measures [as] their surrogates for actual quality measures. The things that probably people care about are really hard to measure&mdash;local control, overall survival, those take time,” Lam said, adding that “they don't fit into that bundle as well.”

In addition, she said she “worries a little bit about potential skimping on care, certain areas where you may not get paid more for something that’s much more resource intensive, but maybe better for the patient.”

Another area of concern: innovation and clinical trials, which are not included in bundling, with the exception of  trials funded by the National Institutes of Health. And, she noted, “Our field is really based in technology,” saying that during the past “decade or two radiation oncology has really made great strides in changing the way we deliver care that I think is really good for patients.”

There are other worries as well: the risk that without adjustments, that the bundles might widen disparities, which are already known to affect cancer care and outcomes more broadly. The other is that bundled payment would not work in palliative care, where the 90-day timeframe might disincentivize a provider from treating some patients. 

Lastly, she said, not all cancers are the same, even if they seem to be. Yet as she understood the model as proposed, CMS would pay one price for treating lung cancer.  “What does it mean to treat lung cancer? Does that mean stage I lung cancer, or someone who is stage III or IV, or someone whose lung cancer has metastasized to the bone?”

However, she said, “I think many of us agree that the way we pay for healthcare is not sustainable,” adding that she hopes CMS listens to stakeholders who have provided feedback about the RO model.

Lam MB, Figueroa JF, Zheng J, Orav EJ, Jha AK. Spending among patients with cancer in the first 2 years of accountable care organization participation. 

. 2018;36(29):2955-2960. doi: 10.1200/JCO.18.00270. 

Innovation Center. Radiation Oncology Model. CMS website. innovation.cms.gov/initiatives/radiation-oncology-model/

. Updated August 7, 2019. Accessed November 20, 2019.

As CMS prepares to move forward with new models of value-based cancer care, a radiation oncologist, speaking at the Institute for Value-Based Medicine®, discussed her findings regarding whether accountable care models had an effect on cancer care spending.

Radiation Oncologist Discusses Concerns With Incoming CMS Payment Model

Just over a week before CMS revealed some of its thinking on the future of oncology value-based care,1 oncologists and others who crowded into a Nashville, Tennessee, ballroom at the end of October shared their thoughts, successes, and frustrations regarding the current Oncology Care Model (OCM).

At certain points during the latest installment of the Institute for Value-Based Medicine®, an initiative of 

, it was hard to tell if the physicians and healthcare executives were thinking about January 2020 or January 2021. Next month, oncology practices participating in the OCM must

decide whether to accept 2-sided risk. Come January 2021, CMS plans to start Oncology Care First (OCF), the successor to OCM; on November 1, it released a request for information (see 

“It sounds scary, but I hope you leave tonight inspired, because I think we’re ahead of the game on this,” said Stephen M. Schleicher, MD, MBA, cochair of the meeting, an oncologist at Tennessee Oncology, and chair of the Quality and Value Committee of OneOncology, a network of community oncology practices. According to Schleicher, the oncology community should focus on 3 steps:

• Understanding the models in-depth because value-based care (VBC) is here to stay.

• Educating payers on how to improve their models to make sure that cost control does not come at the expense of patients.

• Optimizing care coordination to prevent avoidable emergency department (ED) visits and hospitalizations, facilitate end-of-life care planning, and avoid unnecessary tests and pharmaceutical use.

“Think before that PET [positron emission tomography] scan if you need it, think before that expensive drug, if we have a biosimilar instead,” he said, offering up  examples.

Darin Gordon, who is widely credited with turning around TennCare, the state’s $10.5 billion Medicaid managed care program, described how it took him a few years to “lean into” the idea of VBC and value-based purchasing (VBP).

As part of his presentation, he reviewed a VBP framework, created by the Health Care Payment Learning & Action Network, which created a pathway for describing alternative payment models. The 4 classifications include category 1, fee for service (FFS); 2, FFS and a link to quality and value; 3, alternative payment models built on an FFS architecture; and 4, population-based payment.

Gordon said that even after he “fully embraced” VBP, he had to again change his thinking. “I’ll just say this: As a self-diagnosed value-based purchasing zealot…where I literally thought we should buy light bulbs on a value-based purchasing agreement, after going through it, you discover there is a lot of stuff that valuebased

At the same time, he said, “there’s a big belief in the industry that we don’t arrive [to VBP] until we get everyone to category 4. I don’t think that’s right, either.”

Although the categories may seem like a continuum, with some organizations falling into category 2 or 3 because it works best for them, the only thing you won’t find, he said, is anyone defending FFS. There is plenty of evidence that FFS does not work, even if the evidence on VBP is not yet conclusive.

Instead, fueled by rising healthcare costs, there is an overwhelming sense from payers that “we have to try something different,” he said. Oncology is spread among all 4 categories—commercial, Medicare, Medicaid, and the exchanges.

In Tennessee, Gordon said he saw wide variability in cost from provider to provider, a diff erence of as much as 3 to 6 times that couldn’t be explained.

“We needed more tools to incentivize quality improvement,” he said. However, he said, he didn’t want to tell doctors what to do or how to do it: “I wanted to…create a dynamic [in which] the provider could start asking diff erent questions, should be asking diff erent questions.”

At the time, Vanderbilt University had a tool to connect patients to doctors via text. Although they didn’t get reimbursed for it, the institution was large enough to absorb the cost, according to Gordon. At that point, he said, he realized he could use the state’s Medicaid program to change reimbursement for physicians who had already told him, “We know what we need to do for patients, and we also know we won’t get paid for doing those things.” 

“That was a big driving force for this,” he said.

Gordon addressed some advocacy groups’ concern that VBP agreements can be used to restrict access to certain treatments: “Actually, it’s just creating diff erent questions that the providers themselves—that clinician&mdash;[will] ask themselves in ensuring that they have the best possible outcome for that member.”

When VBP functions at its highest level—when payers, providers, and patients work together to improve health&mdash;he said, “quite frankly, a lot of discussions about prior authorizations are meaningless.” He added, “I don’t care as much, because you’re fully at risk.”

Although Gordon said he believes that VBP will remain firmly on landscape, Michael Kolodziej, MD, FACP, vice president and chief innovation offi cer at ADVI Health, was decidedly less upbeat. “I’m going to disagree with just about everything you just said,”he told Gordon, then said commercial payers look at oncology practices the same way Willie Sutton looked at banks: “That is where the money is.”

“How did we get into this mess?” Kolodziej asked. “The cost of taking care of cancer patients in the [United States] has exploded largely as a consequence of the cost of drugs that have brought great value for our patients but at a signifi cant price, and the rate of the trend so far exceeds the average person’s income that nearly everybody says [it is] unsustainable,” he said, launching into a review of the first alternative payment models in oncology. 

When Kolodziej was in charge of oncology strategies at Aetna, he participated in the OCM when it launched. “As a care delivery model, the OCM is awesome, but Medicare did not go into this to improve the quality of cancer care. They went into this to save money,” he said. “The payment is based on this goofy methodology that they developed, and I think anybody who spent time thinking about this recognizes that the model is way too complicated, just way too complicated.”

So, after 4 performance periods, what have oncologists learned? There are problems with various parts of the model, Kolodziej said, which has been adjusted several times. Yet, even as savings increased, in his view, 90% of the participating oncology practices have no idea why they generated savings. “This model does not fix their pain,” he said, because it does not address the cost of drugs.

When he was at Aetna in a partnership with Texas Oncology, using the ClearPlus pathway saved 20% of the cost of care. He attributed that to the use of pathways, not Aetna’s medical home. He also challenged the notion that payers consist only of health insurance plans. The employers are the payers, he said, and they are complaining loudly to health plans.

“We have a long history [over the past] 20 years of paying too much for stuff that doesn’t work. We got some stuff now that works. That makes it really challenging,” he said, citing study findings that showed no link between the marginal added benefit of new drugs and the launch price.

Referring back to the next iteration of the next oncology care model to come out of the Center for Medicare and Medicaid Innovation, Kolodziej was pessimistic: “I think that they cannot have a care model in which 85% of oncologists in the [United States] cannot participate, and that’s what OCM is right now.” Alternative payment models are not cutting it, he said.

Hearkening back to the idea of using new tools to drive improvement, Robert Daly, MD, MBA, of Memorial Sloan Kettering Cancer Center (MSKCC), explained how the center uses predictive data analytics to improve care for patients by meeting CMS quality measures for avoiding preventable hospitalization due to 9 conditions: neutropenia, fever, pain, dehydration, anemia, pneumonia, sepsis, nausea, and diarrhea.

With proactive care and increased communication, these can be managed in outpatients, he said. 

Why is this an issue? Patients on active treatment have 1 hospital admission and 2 ED visits per year; about 50% of those ED visits and 40% of the admissions

are related to treatment toxicities, for 3 main reasons, Daly said:

• Patients are not being equipped to manage adverse eff ects at home.

• Patients assume little can be done to help them and don’t seek care until symptoms worsen.

• Communication varies between the patient and the clinician.

“As anyone who has treated cancer patients knows, they’re not just coming in with 1 symptom—they’re coming in with clusters of symptoms, “ Daly said.

Daly said the MSKCC pilot study was inspired by the work of Ethan Basch, MD, MSc, on the effect of patient-reported outcomes (PROs) on survival and quality of life. The 2017 study found that proactive self-management resulted in better outcomes for patients compared with standard of care, including a 30% improvement in quality of life, 7% fewer ED visits, and 5 months’ longer survival.

The pilot project, called InSight Care, combines PROs with data and proactive care and case management to prevent hospitalizations and ED visits, keeping the patient “in sight” of the provider 24/7 through the use of digital technologies. Data analytics identifi es the highest-risk patients—the 25% of new antineoplastic patients

most at risk of arriving at MSKCC’s urgent care center. The risk model helps providers stratify patients to identify who is at high risk of a potentially preventable visit within the fi rst 6 months.

The model combines data from the electronic health record, including laboratory tests, home medications, comorbidities, and psychosocial data, to create a risk score. Doctors can add patients to the high-risk group using an override feature. In addition, Daly said, the interface that the patient sees is designed to lower barriers to patients’ completion of assessments. The questions have binary answers (yes or no), and the patient can give more details and use an avatar to provide a visual description of symptom location. The MSKCC staff can tell instantly tell if the alerts are mild, moderate, or severe. If necessary, the team can see the patient through a specialized video portal, instead of making the person drive into New York City from the suburbs.

As the pilot nears the 1-year mark, Daly said, the results show an eff ect, with a 59% reduction of high-risk patients visiting the urgent care center. Within the program’s first 30 days, there was a 60% adherence rate of completing assessments; for patients being treated for more than 3 months, a 50% adherence rate.

“That means we’re getting the symptom data from patients every other day on active treatment. That really helps to take better care of them,” Daly said.

Patients love the system, he said, because they know a member of the care team will get back to them within minutes. “They feel that they’re never alone, that there’s this team that is responding to them and helping to get them through their treatment. And they like the remote consultation,” Daly said. Oncologists like the system because they know that their patients are being taken care of while they are busy in the clinic, he added.

Some of the issues that have arisen include trust, Daly said. “This is an extension of the primary team working with the primary oncology teams to manage those symptoms,” he said. “How do we build trust with the primary oncology teams so that they feel those symptoms are being managed in a way that they would want them

In addition, MSKCC initially hired clinicians with experience in palliative, supportive, and symptom care for the project, but as time went, it became clear that patients prefer someone with disease-specific experience.

Of note, when CMS held a listening session November 4 about the OCF model, officials announced that electronic PROs will be required to participate.

1. Innovation Center. Public listening session: informal RFI on Oncology Care First model. CMS website. innovation.cms.gov/resources/oncology-listening-session.html. Updated November 14, 2019. Accessed November 20, 2019.

2. What is the Health Care Payment Learning & Action Network? Health Care Payment Learning and Action Network website. hcp-lan.org/.Accessed November 21, 2019.

3. Prasad V. Do cancer drugs improve survival or quality of life? BMJ. 2017;359:j4528. doi:10.1136/bmj.j4528.

4. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318(2):187-198. doi: 10.1001/jama.2017.7156.

Coverage from the Institute for Value-Based Medicine® session held in Nashville, Tennessee.

Hope and Some Skepticism Whether Oncology Payment Models Will Work

In 2018, The FDA approved 19 drugs, 4 biosimilars, and added 38 indications for therapies that fight cancer.

The pace continued in 2019: of the 41 new agents approved through November, 15 are used in cancer  or blood disorders.

This period of innovation is likely to continue, and even accelerate, due to the FDA’s willingness to examine real world data and alternative approval endpoints, 1 off ering evidence that research focused on rare cancers, or improving outcomes and reducing toxicities, is having an impact.

However, innovation has come at a price. In 2018 spending on cancer medicines rose by 12.9%,

while the overall US infl ation rate was only 1.9%.

Controlling healthcare costs dominates nearly all other considerations in the political debate over healthcare reform. For federal policymakers, ensuring the sustainability of the Medicare Trust Fund is central to all considerations for future CMS care and reimbursement models.

 These concerns have delayed CMS’ development of reimbursement models for emerging cancer treatment technologies, such as chimeric antigen receptor (CAR) T-cells. 

Fears about the Medicare Trust Fund and healthcare related infl ation have propelled CMS leadership to increase the level of risk that clinicians and healthcare systems bear in care delivery. The inclusion of advanced alternative payment models (APMs) within the Medicare Access and CHIP Reauthorization Act of 2015 show the importance of bringing greater cost accountability and transparency to physicians and healthcare systems.

Unfortunately, this adds administrative burdens and ironically hold physicians accountable not only for the costs that they can control, but also for those they cannot control, such as the proper use of high-cost pharmaceuticals.. Thus, physicians and healthcare systems are disempowered from leading meaning, sustainable innovation efforts and have at best highly imperfect models through which they can follow the lead of the agency.

™ we examine this issue from multiple perspectives. Kathy Oubre, MS, provides perspective on biosimilars that may provide an innovative paradigm for blunting the cancer pharmaceutical rate of inflation. Keely Macmillan, MPH, provides an overview of the proposed Oncology Care First (OCF) model and how it may or may not lead to better incentives for physicians to practice value-based cancer care. Finally, Associate Editor Kashyap Patel, MD, provides one of 2 physician perspectives on the OCF model.

We must not forget that physicians and healthcare systems that actually provide care to patients are essential incubators for transformational ideas that bring us closer to realizing the full potential of the value-based cancer care paradigm. For physicians and cancer care systems to lead this transformation, they need to be allowed to lead and innovate in an unfettered way. Alternative APMs must give physicians fl exibility to succeed in the pursuit of economically sustainable care excellence.

Physicians should never be penalized for delivering the most appropriate care to their patients, even if it is more expensive. The future of increasing eff ective cancer care that better serves patients and their families is dependent upon ensuring that physician and healthcare system leaders are allowed to move forward, at speed and empowered to succeed in making this future a reality. 

1. Dietz C, Bin Han Ong M. FDA approves 19 new cancer drugs and biologics in 2018—and don’t forget two new endpoints and “real-time” review. The Cancer Letter. cancerletter.com/articles/20190125_2/. Published January 25, 2019. Accessed November 30, 2019.

2. US Food and Drug Administration. Novel drug approvals for 2019. www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019. Accessed November 30, 2019.

3. IQVIA Institute for Human Data Science. Global Trends 2019. iqvia.com/-/media/iqvia/pdfs/institute-reports/global-oncology-trends-2019.pdf?_=1575154005513. Published May 2019. Accessed November 30, 2019.

4. US Inflation Calculator. Current US inflation rates: 2009-2019. usinflationcalculator.com/inflation/current-inflation-rates/. Accessed November 30, 2019.

5. Cubanski J, Neuman T, Freed M. The facts on Medicare spending and financing. Kaiser Family Foundation.. kff.org/medicare/issue-brief/the-facts-on-medicare-spending-and-financing/. Published August 20, 2019. Accessed November 30, 2019.

6. Medicare Access and CHIP Reauthorization Act of 2015, HR 2, 114th Cong, 1st Sess, (2015).

Dr Alvarnas is editor-in-chief of Evidence-Based Oncology.™ He is vice president of Government Affairs, senior medical director for Employer Strategy, and associate clinical professor, Hematology & Hematologic Cell Transplantation, City of Hope, Duarte, Califonia.

From the Editor-in-Chief: Lead, Follow, or Get Out of the Way

The interview is edited slightly for clarity.

On October 31, 2019, authors from Tennessee Oncology, OneOncology, and Tuple Health published an article in JAMA Oncology that offered a stunning conclusion: Even if a practice in the Oncology Care Model (OCM) complied precisely with current guidelines from the National Comprehensive Cancer Network (NCCN) for metastatic non—small cell lung cancer and did everything right, drug costs would make it impossible to meet the financial targets spelled out in the model.

 The authors offered a solution: Instead of being judged against unattainable benchmarks, OCM practices should be measured based on their adherence to

clinical pathways or ability to document why a pathway didn’t make sense for a particular patient.

Almost on cue, the next day, the Center for Medicare & Medicaid Innovation (CMMI) released its proposal for Oncology Care First (OCF), the would-be successor to the OCM.

 One of the paper’s authors, Tennessee Oncology’s Stephen M. Schleicher, MD, MBA, was pleased to see that OCF reflected some of the issues he had his colleagues had discussed. Schleicher, who also serves as medical director for value-based care for OneOncology, a network that includes 242 providers, discussed the findings and CMMI’s proposal with E

 Please describe your practice’s overall experience with the OCM. What changes have had the biggest impact on clinical outcomes?

: I’m a medical oncologist at Tennessee Oncology; we are part of OneOncology, where I am chair of the Quality and Value Committee. I’ve been very passionate about value-based payment for the past 5 to 6 years since the Affordable Care Act came out and, specifically, as an oncologist, when the OCM came to fruition. Our experience with the OCM, most importantly, has been a learning experience. I think that’s one of the biggest benefits of the model and why it has been a voluntary pilot. We’re getting lots of information about how we’re doing in keeping patients out of the emergency room when we can and how we’re using hospice.

We’ve had the opportunity to get rewarded through the care-management fees to provide nurse navigators, to help be the bridge between when the patient is in clinic and when the patient is at home. We’ve learned how to continue that communication and help direct patients to the clinic for fluids instead of to the emergency [department], to help assess a patient’s pain and act quickly before the pain gets out of control—similarly with nausea and constipation. So, we’ve been able to, through the resources provided from Medicare as part of the OCM, hire some additional staff to help with that. Staff is one thing; secondly, with the analytic capabilities we’ve been encouraged to develop through our partners with Flatiron Health and now with OneOncology, as I mentioned, an understanding of our utilization patterns and how they compare with our peers’, both within the Oncology Care Model and without. Those are some huge benefits of the model, and one of the most exciting aspects of the model involves all we have learned to improve the care we’re delivering to our patients.

,1 one of the central points you and your co-authors make is that practices should be held accountable for adhering to clinical pathways or documenting good reasons the pathway does not make sense. How did you arrive at that conclusion?

So, it’s a great question. The impetus for putting this paper together was the whole issue of accountability versus control. As oncologists, we want to be accountable for things we do incorrectly, of course—even if that’s not on purpose. But delivering a more expensive chemotherapy to a patient when there’s a better option, using an emergency room instead of a clinic for things that could be handled outpatient&mdash;those are things we can be accountable for, that we can control, and we should be accountable for. But there also are aspects of cancer care that we have no control over, and the main thing there&mdash;the elephant in the room&mdash;is the price of drugs.

New drugs have tremendous benefit for patients. We want to be able to give new drugs to our patients. Immunotherapy is really the big thing that has boomed since the start of the OCM. But those drugs that have good benefits also have high price tags, and we want to make sure we can give those drugs to patients without being penalized, because in the current OCM, the total cost of drug use is something we are accountable for and could be penalized for. What we wanted to do with the paper and this research is understand how well the OCM is incorporating the new prices of drugs into their expected costs of treating cancer patients. We looked at lung cancer.…The field has [advanced] even since the time of the data that we looked at for this paper. But since the start of the OCM, immunotherapy made its way into the second-line treatment of metastatic non—small cell lung cancer with both Keytruda [pembrolizumab] and Opdivo [nivolumab], which both have survival benefits. We thought that was a good opportunity to look and see if, when we used these drugs correctly—which we can control&mdash;we are still over target on what we should be spending, and if it’s due to the price alone, we cannot control that. And that’s a problem with a value-based care model&mdash;trying to improve the quality of care and the cost of care if we can’t control that.

So, that’s why we looked at lung cancer. We looked at all our cases where Medicare told us we had spent more than expected, and within that, where we had prevented everything that was the goal of the OCM. [We looked at cases where] we prevented emergency [department] visits, we prevented hospitalizations, postacute care, inappropriate chemotherapy at end of life—all these aspects that we can control and one should be able to prevent. We saw that in many of our cases&mdash;over half&mdash;we had done all that, but we were still over target because we had used either Keytruda or Opdivo in the second-line setting for metastatic non—small cell lung cancer. That was NCCN compliant at the time and is still standard of care, although we now often use immunotherapy first line. We found in that group of patients that we were over target for using the right drug at the right time for patients that deserved to have that drug, yet the model, despite Medicare’s best attempts, couldn’t account for that, and that is what we are trying to communicate with the paper. Our conclusion was that we were pathway or guideline concordant, which is what we can control and that’s what we should be doing; the cost was higher because of the price, which we can’t control. So maybe the pathway concordance&mdash;following pathways we can all agree on&mdash;is a better measure of us using the right drug than the cost of care itself, from a drug perspective.

 And the data you present were consistent across the practices that you surveyed?

Exactly. We have 30 clinics in Tennessee Oncology right now—OneOncology has over 100&mdash;but we were looking at Tennessee Oncology, and this was not clinic specific; this was across all our providers at the different clinical sites.

The day after your paper appeared, CMMI released a request for information on a model that is being called Oncology Care First, or OCF, which will be the successor to OCM when it expires in 2021. What are your observations so far about OCF?

OCF, I think, is an example of Medicare being very thoughtful—of recognizing that we need to change the way care is delivered but also recognizing that cancer is a very difficult disease because it is very heterogeneous&mdash;every patient with cancer is different, every cancer is different. We have high costs of care both from utilization and drugs. So, I think they tried to come up with a thoughtful model to do this.

There were 2 components of the OCF model that I thought are definite improvements from OCM that relate to our paper in terms of the accountability versus control. The first is how they calculate the expected cost of treating cancer care and how drug costs are incorporated into that; there are 2 mechanisms for that through the trend factor that accounts for overall implementation of healthcare costs, and the novel therapy adjustment, which is how a practice is using new drugs that have been FDA approved compared with their peers.

In the OCM, they applied this across all cancer types and all patients in conglomerate; OCF, they will look at the specific cancer itself. When a new drug or a new indication comes to that disease, they will try to account for that change at the [level of the] disease itself—which, hopefully, improves the accuracy of predicting the cost of care as healthcare standards of care change in oncology. That’s a benefit and shows that Medicare was listening to us as we all provided feedback during the OCM, and it is clearly very relevant to the paper we just published in 

A second improvement is how providers should be accountable for some of the low-risk cancers, such as low-risk breast, low-risk bladder, and low-risk prostate. Let’s take low-risk breast cancer—that could be a patient who had surgery, chemotherapy, and radiation therapy 4 to 5 years ago but still requires antiestrogen therapy&mdash;a hormonal pill. In that case, the provider might be seeing the woman every 6 months to prescribe that pill; standard of care might be a mammogram once a year for a patient who still has her breasts intact, with an exam. In the current setting, if we are treating a patient like that but they go to the emergency room because they have a stroke or because they need a hip replacement or they have a heart attack&mdash;something completely unrelated to their disease&mdash;we are still accountable for that care under the current OCM. They have corrected this in the current OCF by removing these patients from the accountability portion of the total cost of care, such that we are more accountable for patients for whom we are providing intense chemotherapy, seeing them regularly and really are responsible for their care, versus patients we are seeing every 6 months who have other unrelated health problems that could throw off our ability to succeed in the value-based care model.

: That would seem to make sense. Do you have any other observations as you move forward with alternative payment models?

 It’s important for groups to be in these models, even if they are voluntary, just to learn about how they are doing compared with their peers and find opportunities for improvement. And as long as groups can publish on these matters and make it known to their other colleagues across the country interested in improving the value of care of cancer—if we can communicate that through publications such as ours [in 

], through conferences, through Medicare, to help these models get better over time, that’s really how we succeed: all of us coming together versus working independently. REFERENCES

1. Lyss AJ, Supalla SN, Schleicher SM. The Oncology Care Model-why it

works and why it could work better: accounting for novel therapies in

value-based payment [published online October 31, 2019]. JAMA Oncol.

2. Oncology Care Model. CMS website. innovation.cms.gov/initiatives/

oncology-care/. Updated November 13, 2019. Accessed November 13, 2019.

An article Schleicher co-wrote in JAMA Oncology, which appeared the day before the announcement of Oncology Care First, offered insights into the need for changes to the original OCM.

December 2019

Improving Survival in Lung Cancer: Commitment of The Lung Ambition Alliance

Radiation Oncologist Discusses Concerns With Incoming CMS Payment Model

Hope and Some Skepticism Whether Oncology Payment Models Will Work

From the Editor-in-Chief: Lead, Follow, or Get Out of the Way

Provider Perspective: Stephen M. Schleicher, MD, MBA, Addresses Accountability Versus Control in Oncology Care First

Provider Perspective: Kashyap Patel, MD, Sees Collaboration Going Into Oncology Care First

Empower Physicians to Fight Financial Toxicity With Biosimilars

Can Cancer Care Lead the Way Toward a Value-Based Future?