ASCO President Dr Daniel F. Hayes Applauds Recommendations for Cancer Moonshot

The Blue Ribbon Panel (BRP)—a committee of scientific experts, patient advocates, and representatives from the phar­maceutical industry, appointed by the National Cancer Institute (NCI) to lead the White House Cancer Moonshot initiative—re­leased a preliminary report¹ with important recommendations that can support faster, more precise treatments for patients diagnosed with cancer, with potential for much improved outcomes. The American Journal of Managed Care® reached out to Daniel F. Hayes, MD, FASCO, 2016-2017 president of the American Society of Clinical Oncology (ASCO), to understand his perception of how these recommendations would impact cancer care in the United States.

AJMC:

One of the suggestions of the BRP is to better link databases to assimilate patient information across systems, with the potential to recruit patients to participate on trials. Since interoperability remains a significant challenge for our healthcare system, do you foresee this as a more long-term recommendation?

HAYES:

Widespread interoperability for sharing electronic health information is critical for optimal cancer care. It’s incredible that we have a standardized method for streaming TV shows, but not for taking care of sick patients. I’m pleased that the Panel included this recommendation in the report. Frankly, this is the kind of innovation that we cannot put on the long-term track. The cancer community—the entire medical community, actually—needs to put our full support behind interoperability so that it is achieved more quickly. The American public does not suffer lack of access and interoperability when it comes to other potentially sensitive information (eg, financial informa­tion). We should expect no less when it comes to the medical information needed to stay healthy and treat illness, especially a serious diagnosis like cancer. This is the kind of innovation that the Moonshot requires. ASCO is fully supportive of this transformative idea.

AJMC:

How are individual clinics and smaller practices adopt­ing interoperability?

HAYES:

There are 2 issues embedded in this question: 1) the adoption of electronic health records (EHRs) and 2) interopera­bility among them. Individual clinics and smaller practices are having a very difficult time, especially with the first. The problem isn’t isolated to just small practices, however. Even large, inter­nationally recognized cancer institutions may be in a situation where they’re using multiple electronic records systems that do not talk across clinics and departments—whether they are across town, in different states, or right next door to one another. This is a major concern in oncology, where we routinely work with pa­tients going to multiple medical providers across the continuum of care, eg, radiation therapy, surgery, chemotherapy, imaging, pathology, etc. Gaining access to medical information and seam­lessly integrating and analyzing it for patients across multiple providers takes more effort than it should.

Because of this, ASCO has called on Congress to address this issue directly. ASCO issued the following 4 recommendations, which should be part of the Moonshot initiative:

• Congress should enact legislation as quickly as possible to ensure widespread interoperability is achieved.
• Congress should pass legislation to remove barriers to interop­erability, especially information blocking.
• Policy makers should ensure that cancer patients, oncologists, and other oncology providers do not bear the costs of achieving interoperable EHRs and of companies refraining from informa­tion blocking.
• Federal officials should work with ASCO and other stakeholders to ensure that healthcare providers have the information nec­essary to be prudent purchasers and users of health informa­tion technology systems.

We are pleased that the BRP included the idea of a National Can­cer Data Ecosystem. ASCO is building this with CancerLinQ and working with patient organizations and our colleagues across the medical professions to integrate data.

AJMC:

Although pediatric cancers have received specific recommendations from the panel to improve clinical outcomes, geriatric cancers have not. Your thoughts on that?

HAYES:

You raise a very important point. It is admirable that the BRP recognized unique issues facing children with cancer, which ASCO supports. We also need to put focus on older adults with cancer because oncology clinicians face tremendous challenges in meeting their cancer care needs.

Patients over 65 make up 60% of those diagnosed with cancer and 70% of cancer deaths. ASCO issued a statement in October 2015 that includes recommendations on improving the evidence base for treating older adults with cancer.² ASCO’s Moonshot recom­mendations to the NCI BRP included many items from the state­ment, including broadening eligibility criteria to facilitate greater participation of older adults in research, conducting pragmatic trials that focus on broader patient populations, and conducting research with real-world data.

Many of the Moonshot initiative’s recommendations are likely to improve care for older patients, even if the specific recommenda­tions are much broader. As efforts are made to implement these recommendations, however, it will be important to ensure that they consider the needs of geriatric patients.

Examples of the Panel’s recommendations that have the potential to improve care for older adults:

• The network for patient engagement has the potential to in­crease older adults’ participation in clinical trials by matching patients based on the tumor profile to appropriate trials.
• The National Cancer Data Ecosystem for Sharing and Analysis could provide data on older adults from real-world settings, which would complement research from randomized clinical trials that often exclude older adults.
• The focus on research into symptom management is particular­ly relevant to older adults because this population often places great value on endpoints other than overall survival (eg, func­tional independence).

AJMC:

With the rapid rise in the number of oral anticancer agents, monitoring patient adherence can prove to be a significant challenge that ultimately impacts patient outcomes. Do you think the panel should have proposed ways to improve patient adherence to treatment? How can we address this issue in cancer patients?

HAYES:

Orally administered anticancer agents allow many pa­tients to undergo treatment outside of a hospital or doctor’s office and go about their daily lives with minimal disruption, providing significant advantages over more traditional intravenous (IV) or injected medications.

Patient adherence to oral anticancer agents can pose a signifi­cant challenge, because obviously, medicines don’t work in the bottle—they only work in the patient! Poor adherence leads to reduced rates of response, more complications from the cancer, and increased medical costs. Among the many barriers to oral cancer therapy adherence, cost is a significant barrier. Some health plans impose significantly higher cost-sharing require­ments on patients who receive oral anticancer medications. (Cancer medications delivered by IV are covered under the med­ical benefit provision, while cancer drugs taken orally are often covered under the outpatient prescription drug benefit.)

To address this issue, ASCO has continued to advocate for states and the federal government to pass legislation that ensures patients can access oral cancer drugs under the same general cost-sharing rules as other cancer drugs.

In addition to cost, side effects and forgetfulness in every­day life can lead to poor adherence and persistence with oral medications. In this regard, ASCO’s recommendations to the NCI highlighted the need to enhance our patient-reported outcomes (PRO) measurement tools so that we can determine what toxicities patients are actually experiencing—financial, physical, or psychosocial. NCI and the oncology community have made a huge investment in developing a PRO tool that measures the common toxicity criteria in cancer clinical trials (PRO-CTCAE). We are pleased that the BRP recognized the val­ue of the PRO-CTCAE. However, ASCO further strongly recom­mends that the NCI invest in:

1. Implementing the PRO-CTCAE, which will require invest­ment in enhancing the way we conduct trials to regularly capture toxicity information from trial participants.
2. Enhancement of the PRO-CTCAE to incorporate additional factors that patients may consider when making a treat­ment decision, in addition to the “important medical and clinical conditions” already included in the PRO-CTCAE.

Although various methods for measuring and improving ad­herence are available, additional research is needed to identify optimal methods that will work across diverse practice settings. Indeed, ASCO has supported such trials through our Conquer Cancer Foundation grants system. Other organizations, includ­ing NCI, are doing so as well, but we need more resources to address this critical issue.

AJMC:

As we transition toward precision healthcare, there is no dearth of diagnostic tests or molecular data on tumors. However, interpretation of this data seems to be a significant hurdle. Does the report address this issue?

HAYES:

Several sections of the report include provisions that would help advance our understanding of diagnostic testing and molecu­lar profiling data:

• Network for direct patient engagement: making testing accessi­ble and enabling data sharing and participation in molecularly driven clinical trials
• Fusion oncoproteins in pediatric cancer: improving under­standing of the role of oncoproteins in pediatric cancers and identifying therapeutic targets
• Retrospective analysis of biospecimens from patients treated with standard of care: we may discover molecular biomarkers for response or resistance
• Generation of human tumor atlases: documenting genetic lesions and cellular interactions that guide the development of each tumor as it evolves from a precancerous lesion to advanced cancer

Many of these recommendations build on important work that the NCI is already engaged in, such as genomic testing and inves­tigation of molecularly driven therapies in the adult and pediatric MATCH trials and Lung-MAP trial, biospecimen banking and analysis through the National Clinical Trials Network and the Co­operative Groups before it, the Exceptional Responders Programs, and The Cancer Genome Atlas (TCGA) that advanced basic science understanding of common tumors.

ASCO has, over the last 3 decades, provided evidence-based guide­lines for using tumor biomarker tests to direct patient care, and we have helped establish criteria for doing so. Because we believe that “a bad tumor biomarker test is as bad as a bad drug,” we have recently supported an analysis of increasing the value of tumor biomarker tests performed by the National Academy of Medicine (formerly the Institute of Medicine).

In our recommendations to the BRP, ASCO also discussed the need to better understand molecular testing through the Coverage with Data Development mechanism, as well as leveraging clinical trials, like ASCO’s TAPUR study,³ to test whether drugs used for a molec­ular target in one cancer are effective for the same target in other cancers, and using learning healthcare systems like CancerLinQ to accumulate and analyze data on testing and associated therapies.

The question you raise also points to the importance of a strong, definitive role for the FDA in premarket regulation of testing that is used to indicate precision therapies. In an era when we are using targeted drugs (especially drugs that may work only if the target is present), it is vital that we understand the safety and efficacy of the test that indicates whether a tumor has the target.

AJMC:

Do you think we need greater emphasis on cancer prevention research?

HAYES:

Yes, absolutely. We were really pleased to see the BRP’s fo­cus on improving prevention research within its report to the NCI. The panel specifically highlighted people at higher risk for cancer, because of their family history, and the need to implement screen­ing. ASCO also believes it is important to advance research related to behavioral changes and socioeconomic factors that influence population health behaviors that prevent people from doing what we know works to prevent cancer, such as energy balance and obesity prevention and treatment.

AJMC:

While on one hand imaging technologies accelerate cancer diagnosis, unnecessary imaging can result in overdiagnosis. Do you think integrating information across multiple testing platforms is the way forward, rather than interpreting individual tests that may present just a part of the picture? Who should be responsible to assimilate this data, which may exist in silos: the oncologist or the primary care physician?

HAYES:

There are multiple answers to this question. The first component regards ordering of diagnostic tests. We support de­velopment of evidence-based oncologic pathways and guidelines to help physicians make good decisions for their patients. Indeed, we have a very active guidelines program that is widely respected, and we have recently published criteria for determining the quality of clinical pathways. Although we support physician autonomy in caring for his/her patient, we are convinced that these guidelines and pathways can help guide appropriate diagnostic test ordering and reduce unnecessary imaging.

We agree that multiple physicians caring for 1 patient can result in inconsistent care. As cancer has become increasingly complex and multimodal in its treatment, having multiple providers, each with specialized expertise, is often necessary and important. That said, multiple physicians caring for 1 patient can result in incon­sistent care if such care is not coordinated. As we’ve noted, ASCO has been advocating for action by policy makers to promote the interoperability of electronic health data across multiple informa­tion technology systems. At this time, the patient plays an import­ant role in helping to assemble data, but the healthcare system has an obligation to meet this demand.

AJMC:

What is your realistic estimate of the impact the recommendations will have on improving cancer outcomes? Where in cancer care do you expect to see the biggest strides?

HAYES:

The panel’s thoughtful work makes an important con­tribution to the Cancer Moonshot initiative. We will be eager to see how the Cancer Moonshot Task Force and Vice President Joe Biden move ahead with their reports. The recommendations could significantly expedite our nation’s progress against cancer, if Con­gress provides the crucial additional funding to support the Cancer Moonshot initiative. ASCO is heavily engaged in the discussion as the work proceeds.

We are pleased the panel also sent recommendations to the Task Force for policy changes related to cancer research and care de­livery. ASCO is working closely with the Vice President’s office to advance policy and regulatory changes that will help streamline research, standardize regulatory requirements, and enable public— private partnerships to extend the Moonshot initiative. Some­times being innovative requires finding the straight line through a process that can get lost in the endless loops of bureaucracy. We are optimistic that the Moonshot initiative will provide a shot in the arm to move our already impressive anticancer efforts forward, and we advocate for a sustained program to support the research and care delivery that is needed to maintain them.

References

1. Dangi-Garimella, S. Panel delivers recommendations for the Cancer Moonshot. The Amer­ican Journal of Managed Care® website. http://www.ajmc.com/newsroom/cancer-moon­shots-blue-ribbon-panel-delivers-consequential-recommendations-to-the-white-house. Published September 7, 2016. Accessed September 19, 2016.

2. Hurria A, Levit LA, Dale W, et al; American Society of Clinical Oncology. Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology Statement. J Clin Oncol. 2015;33(32):3826-3833. doi: 10.1200/JCO.2015.63.0319.

3. TAPUR: American Society of Clinical Oncology. TAPUR website. http://www.tapur.org/. Accessed September 19, 2016.

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