The cost-value argument for expanding proton therapy coverage

April 17, 2023
by John R. Fischer, Senior Reporter
It may sound counterintuitive, but evidence suggests proton therapy for some indications costs less in total than conventional radiotherapy. Although the treatment is more expensive, it pays for itself through better long-term outcomes. Radiation oncologists, researchers and cancer advocates point to proton therapy’s value as a reason for insurers to update their guidelines and expand coverage.

Payers continue to classify the treatment as “experimental” and “investigational” for the majority of cancers, saying that it is not “medically necessary.” This analysis may emphasize the cost of treatment over the clinical well-being of the patient and fail to account for costly side effects, particularly those that do not occur until years later.

Additionally, all radiotherapy procedures account for around 2.5% of all oncological spending in the U.S., and proton therapy spend is 1.3% of radiotherapy, making overall costs for it less expensive than those for other cancer treatments, according to Dr. Andrew Chang, a radiation oncologist and president of California Protons in San Diego, California.

“We spend 50-60 times more on systemic therapies such as immunotherapy that have a lot less impact, overall, on patients,” he told HCB News.

Chang and other experts say that providers and insurers must reach a consensus on the definition of medical necessity, one that accounts for the clinical care of the patient during initial treatment and the side effects that may occur right after and years in the future, as only then will they be able to effectively care for patients and in the process, save on costs.

Looking at the overall value
By only looking at initial treatment costs, which are more expensive for proton therapy than radiotherapy, insurers set themselves and patients up to potentially spend tens of thousands and in some cases, hundreds of thousands more on care should side effects occur. For example, when undergoing radiotherapy, throat cancer patients often suffer a severe sunburn from the irradiation that prevents them from eating and swallowing food, forcing them to rely on a feeding tube, as well as pain medication continually for relief and frequent visits to the ED.

These post-treatment needs fly in the face of value-based care clinically and financially, by forcing patients to have to dole out more money on medical expenses, many of which may require the insurer to contribute under the contracts they have with patients.

According to a 2014 study in Oncology Payers, when compared to one another, the price of care during throat cancer patients’ initial treatment was just 6% more with proton therapy than with intensity-modulated radiotherapy, with IMRT patients losing three times more body weight. When factoring in the cost of re-simulation due to the weight loss, along with those for a feeding tube, pain medication, hospitalizations and visits to the ED, overall costs for IMRT were 20% higher than those of proton therapy.

“The insurer who denied proton therapy thinking it would save money will have to pay for the increased cost of the member’s overall cancer care. For employer self-funded health plans, these insurers are unnecessarily passing that expense on to them, in addition to the added expense of having a valued employee out of work for a longer period of time,” said Rich Collins, a partner at Arnall Golden Gregory with 25 years in healthcare litigation.

In another three-year study published in 2020 in JCO Oncology Practice, MD Anderson Cancer Research Center found during one- to six-month follow-ups that total average charges for overall ancillary care use (internal medicine, pharmacy, laboratory, emergency room visits, and diagnostic imaging) was 4.7% lower for patients who underwent proton therapy versus photon radiotherapy. It also found that objective evidence-based treatment guidelines did not lead to overuse, ensured appropriate patient selection, and reduced administrative burdens for all parties.

The problem, according to Chang, is that side effects may not occur until five to ten years after treatment, dissuading insurers from considering the cost of care for them in their initial evaluation. Depending on where the cancer is, these side effects may include damage to nearby organs from radiotherapy such as the kidneys, strictures in the valves, scarring in the throat, and even the development of secondary cancers.

By then, many patients have often retired and enrolled in Medicare, placing the burden of the cost of addressing the unnecessary side effects on the shoulders of taxpayers.

“Coding systems don’t account for those things, only looking at individual treatments to determine if they will approve a treatment for a specific case,” said Chang.

In need of more objective guidelines
Insurers often classify proton therapy as experimental and investigational even for enrollment in clinical studies, limiting the number of recruits needed for thorough assessments.

“This slows down research and can lead to disparities in research recruitment and access to advanced treatments,” said Bill Thomas, associate vice president of the office of governmental relations at Hampton University, the only Historical Black College and University with its own proton therapy center, the Proton Therapy Institute.

A 2022 study published in JAMA showed that Black patients were less likely to receive proton therapy than White patients, especially for cancers that proton therapy is recommended for over photon-based radiation, including tumors with complex anatomies, surrounding by sensitive tissues, or in children, for which proton therapy is universally covered. Even when the number of proton therapy facilities rose, racial disparities increased, indicating that the problem lies with health insurance policies that do not account for the specific risks that people of color face and discriminatory factors that limit their access to care.

According to Dr. Eric Brooks, chief health value officer for the department of radiation oncology at the University of Florida Health Proton Therapy Institute, while many insurers act in good faith, an increasing number have been revealed in recent court cases to be using alternative approval policies or deploying "shadow" methods not specified in their contracts with patients to make coverage decisions. In addition, many payers now outsource their prior authorization reviews altogether to third-party vendors or administrators who may in fact apply different approval policies of their own. This misleads patients, who anticipate benefits based on the contract plan and criteria or methods for those decisions with their insurer, not third parties.

While initial denials, which are most common among young working adults, can be appealed, the process is often long, which risks the cancer spreading and progressing.

“Each week of delay in treatment start — due perhaps to long wait times for PA decisions — can lead to a 1.2% to 3.2% increase in cancer death, a non-negligible risk that could nullify the survival benefit of treatments like protons that are eventually approved,” said Brooks. “Recent research shows that simple PA submission can delay treatment start time by an average of three weeks, but those requiring an appeal can take up to four months. This has effects on our patients.”

Likewise, taking payors to court can take years, with even prelitigation appeals taking too long. As a result, many patients will opt to pay for the treatment out-of-pocket or undergo radiotherapy at the insurer’s expense and risk the potential side effects.

“The real issue is how do we develop a uniform set of standards and guidelines for proton therapy coverage,” said Collins. “Each insurer drafts its own guidelines, its own exclusions, its own definition of ‘medical necessity,’ typically only revising them when ordered by a court to do so.”

Addressing the problem together
Unlike Medicare, which covers proton therapy for a broad array of cancer patients, insurers are private companies that can determine coverage as each sees fit. Ensuring that they determine coverage quickly with fair and contractually appropriate reviews based on an agreed upon consensus of what is medically necessary can only be achieved through legislation that holds such reviews accountable and establishes penalties for when health insurance companies act in a way that is opposite of this consensus or fail to give patients a timely response to prevent harmful delays, says Brooks.

“Course-correcting the prior authorization dilemma requires a slate of new or modified laws or administrative agency rules to help curtail poor PA practices throughout the industry to better safeguard you, our families, and future generations from an arduous process that is becoming increasingly clear to impact outcomes on care,” he said.

As care continues to become more personalized and value-based, referring oncologists also need to have a bigger say in coverage decisions. In Virginia, Hampton University is currently advocating for legislation that will ensure patients receive the treatment their physicians prescribe for them. “These decisions should be made by oncologists trained to treat cancer,” said Thomas.

But providers and insurers must communicate and have agreed upon criteria for what is medically necessary. To do this, providers need to conduct and present more research that proves the long-term financial benefits of proton therapy, and insurers must be open to hearing and incorporating this feedback into their coverage policies.

Collins says that in addition to saving on side effect treatments, expanding coverage will help them save even more by avoiding lengthy and costly litigations and appeals over denials.

“If they do not, then insurers risk losing business with their members and their employers’ business by denying companies the return of healthy workers with no long-term disruptions brought on by avoidable radiotherapy side effects,” he said.

He suggests that they instead initiate programs that value membership longevity and reward plan renewals. “They can use their warehouses of claims data to identify providers for network inclusion, or to establish a center of excellence or blue ribbon panel of providers, to expand access while containing the cost of proton therapy.”

The continued use of inconsistent policies and guidelines in proton therapy coverage only seeks to further the burden of other obstacles, such as the limited number of centers available for treatment in the U.S. and worldwide. By opening up access, insurance companies can create more incentives to obtain funding to build these centers in more places. Chang says this approach should be region-based.

“Instead of having half a dozen centers in southern California, we should probably have one or two in Southern California and one in Northern California, one in Arizona, and one in Nevada. We should really make them a regional resource, rather than every healthcare system wanting to own one in order to have it as a competitive device to differentiate themselves from their crosstown rivals, which unfortunately is what’s happened, especially in the East Coast,” he said.

A recent string of court victories for patients and those who have brought cases on behalf of patients have sent a message to insurers that they must make some changes to their guidelines. While these situations are likely to help push insurers to expand their guidelines, greater cooperation between payers and providers and an agreed upon consensus of what constitutes as medically necessary are key to ensuring that patients are getting the best care for the long run.