Allen Analyzes Initiatives and Challenges for Policies Shaping Cancer Care

Jeff Allen, PhD

President and CEO

Friends of Cancer Research

Washington, DC

Targeted Oncology: Please describe how Friends of Cancer Research fits into the wider oncology space.

ALLEN: We are highly interested in doing what we can to support the advancement of innovative research [in oncology]. We do that through a number of different scientific partnerships where we manage collaborative projects that bring together various stakeholders across the public and private sector to advance strategies for optimizing the development new medicines. We aim to identify ways that technological advancements can continue to support novel approaches to developing new treatments and identify policies needed to support that. We largely focus on federal policy, specifically related to the FDA, and that [has] grown over the last several years because of the diversity of different technologies that are involved in cancer research and care. Our projects extend beyond the development of new drugs and include policy initiatives to support technologies to improve diagnosis, or even cell and gene therapies that are becoming additional components to treatment [for patients with cancer].

What is the impact of new policy you have worked on for the day-to-day practice of a community oncologist?

Hopefully, it will add to a more rapid transition from early-stage research into available new therapies. It’s a long process; people have estimated that it is very resource-intensive, it is time-consuming, and it takes nearly a decade to transition from a new scientific discovery into an actual drug that can be available for a patient. Our hope is to try and condense that [process] to speed those discoveries up and transition them [more quickly] into actual available therapies. There are differences in terms of how rapidly some of the new discoveries [become] available [to physicians and patients], with a lot of trials being conducted in academic centers. Oftentimes there may be greater opportunities or awareness of ways to obtain new treatment earlier, but I think that policy plays an important role in trying to accelerate the development and availability of [new treatments] for patients with cancer no matter where they’re treated.

What is one of the most important ongoing policy initiatives for oncologists to know about?

There are significant efforts, both at the federal and state level, to try and ensure access to comprehensive genomic profiling. As this becomes increasingly important, in order to determine the most appropriate treatment for patients with cancer, I think it’s critical that we make sure that policies are in place so that there is ample knowledge of how to obtain comprehensive genomic sequencing, that patients are aware that this should be part of their care in most cases, and that these testing platforms are well validated and quality control measures are put into place to ensure the accuracy of the test results. Ultimately, [we also need to make sure] that payment is there to follow [the use of genomic profiling], so that it’s accessible and reimbursable and all patients can have the greatest understanding about what’s available for them and what the most appropriate treatment is.

How do challenges to implementing these policy initiatives differ between the federal and state levels?

[When we look at policy] with regard to things related to the FDA, that agency functions as a federal entity that can cover all states, in most cases, but I think where we see a more patchwork approach is on the insurance side of things and for coverage [of treatment for cancer]. A recent example where we saw that play out was in access to clinical trials, where in certain states reimbursement of routine costs that were associated with clinical trials was not being covered. This was preventing patients from being able to participate in clinical trials or…physicians [from referring] them into clinical trials, because of the additional costs that they would incur. Now, by not participating in the clinical trial they would have these routine costs covered, and that sort of misalignment was a huge barrier to access. These were things that could be resolved at the federal level in order to make sure that all states had programs in place that were covering routine costs associated with clinical trials to alleviate that barrier [to care].... That’s one example where there was a lot of unevenness across various state programs, given that oftentimes there may not be total coordination around payment policy and Medicaid and Medicare policies as implemented by different states.

Where does policy currently stand regarding clinical trials and what are you hoping can change through policy implementation?

In terms of some of these additional coverage provisions to help allow for greater participation, some of those have been remedied, but I think where it continues to be a challenge is in how policies [can] be implemented to continue to help support sites that are interested in participating in clinical trials. Also, how can clinical trials be designed in a way that is a minimal burden to the practice sites as well? I think that needs to be consciously examined, and there are efforts underway to try and minimize data collection where it may be unnecessary, [such as] whether there are certain questions [that can be answered] and clinical trials [developed] with a more pragmatic type of design, which would minimize the burden on sites for participation as well as patients. We recognize that any additional data collection that is added into a clinical practice setting is going to require additional resources and additional time, and oftentimes, there’s not a lot of wiggle room in different practices. [This cumbersome data collection] could preclude them from being able to offer different clinical trials in a resource-constrained environment. Hopefully federal policy can continue to examine ways to support sites and support practices to allow them to participate in research and offer that as a part of cancer care.

What would you want patients and physicians to know more about regarding clinical trials?

With clinical trials, [it would be] trying to improve the understanding that participating in a clinical trial can offer optimal care. It can provide access to perhaps some of the most cutting-edge medicines, but it also comes with very high-quality care…associated with it. I think there can sometimes be a [misunderstanding] that clinical trials are only available to patients who have exhausted all other options, and they are simply experimental. Of course, there is an experimental element to answer questions about optimizing care or potentially new agents, but clinical trials can play a role in care at various stages of cancer diagnosis and treatment. It doesn’t need to be a last resort to participate [in one], and I think trying to raise the awareness that clinical trials can be part of optimizing care could be very important in providing timely access [to potentially lifesaving care].

Which new technologies on the horizon have policy initiatives that are being worked on?

On the diagnosis and genomics front, ensuring that there is availability of comprehensive genomic profiling [is so important] because it can help identify the most appropriate options [for treatment]. This is becoming perhaps more feasible than it had been decades ago, just by the availability of different testing platforms offered to more patients, particularly in geographically diverse locations. There isn’t necessarily the need to have advanced genomic profiling at every institution, as there are now centralized labs that are able to take patient samples remotely, evaluate the genomic profile, and provide those results to the physicians and the patients for them to determine what the best course of action is.

With this being more widely accessible now, I think it’s important to ensure that the policy arena is supporting that technological accessibility and make sure that payment programs are in place for appropriate reimbursement to be provided. There’s been a continued growth in the number of targeted therapies [and] continued advancement in understanding the genomic markers that inform the use of immunotherapies, even…cell and gene therapies can be deployed to specific molecular mechanisms that are personally tailored for different patients. It’s [a matter] of starting at that molecular basis in order to design the best course of treatment, but in order for that to be successful, we have to ensure that it is as widely accessible as possible.

How can community oncologists keep up with policy changes?

I imagine it’s a challenge [to keep up], and hopefully that’s a good problem to have, because a reason that it can be as complicated is, hopefully, because of the successes and the rapidity [with] which advancements are being made…. It is important for those organizations that offer critical tools such as clinical guidelines, like ASCO [American Society of Clinical Oncology] or the NCCN [National Comprehensive Cancer Network], to be able to help make sure that that information is widely accessible. It can often be lost that there are differences between community-based care and that [of] an academic setting, where just based on the specialization that occurs in an academic setting…there may be more opportunities close at hand to interact with colleagues or ask questions. But the technology is available for that, so I think we’ve seen great success in things like remote tumor boards to provide additional information and share expertise across the field and be a real resource to providing optimal care.

What other policy initiatives are important for physicians to know about?

We’ve seen...the challenges that are faced in instances of drug shortages, and that is an example of a policy situation that truly needs to be addressed. The market situation for some of these older drugs is such that it doesn’t take a lot to destabilize the market, and it can deplete the supply of drugs that have been shown to be quite effective for several different cancers or at least involved in their successful treatment. That’s really a shame that that hasn’t been able to be addressed sufficiently, and that we find ourselves in a scenario where federal policy has been put into place to be able to identify the potential of the onset of a drug shortage. That has improved being able to identify when a drug might be going into shortage, but what hasn’t followed is the actual solution to be able to address that shortage or prevent it in the first place.

At a federal level we need to start examining ways that shortages can be alleviated much faster. There [have] been bills that we’ve been working on to provide mechanisms for manufacturing contract stability, to address situations of shortages, and incentivize manufacturers to be able to develop some of these sterile injectable drugs that are at high risk for shortage and are a critical part of cancer care.... Awareness is also important to be able to notify the appropriate government agencies when a shortage is encountered, and even more critical, [knowing if] there are ways to address that at the practice level to make sure that, hopefully, those shortages can be alleviated, and additional supply can be identified.

How does Friends of Cancer Research work with the community to create policy initiatives?

We work with our colleagues in the research community, and [those who are] involved in providing cancer treatment and care, identifying some of the challenges that they’re facing that could be addressed through modified policy. Oftentimes, given where we typically work in Washington, DC, we’re working closely with the variety of federal agencies that [typically] implement these types of programs. So [we work on] understanding what their limitations are and where additional policy or resources can help develop programs to try and address some of these challenges on the ground. It is…a long continuum because identifying the challenge and designing the potential solutions at a federal level, and working toward consensus among various stakeholders can take time.

Then if you’re working with Congress to implement some of these potential solutions, they may not have the same vantage point regarding what’s happening in cancer research and care because of the number of issues they may be dealing with [at any given time]. It requires working closely with their offices and with members of Congress to help identify the problem and explore what things they might be able to do to remedy some of these challenges.