Imagine two identical patients. Same age, same medical history, same cancer diagnosis. One of them will be granted access to cutting-edge proton therapy treatment and the other will not. Why? Because their coverage decisions are being made by different insurance companies.

"You could have one insurance product that approves a particular indication for proton therapy, but an identical patient with a different insurance product might not get proton therapy approved," said Dr. Minesh P. Mehta, deputy director and chief of radiation oncology at Miami Cancer Institute. "You can imagine the consternation and confusion that causes, and the time and effort and energy that's wasted in trying to get those approvals."

While many insurance companies are beginning to accept the recommendations of organizations like the American Society for Radiation Oncology (ASTRO) that outline cases where there is a clear benefit to the treatment, other insurance companies — typically smaller ones that lack the bandwidth to keep up with emerging evidence — still do not.

Another reason a payor might refuse to cover proton therapy is because the downstream benefits to the patient for a particular indication, (such as fewer long-term side effects compared to conventional radiotherapy) may not be felt for years to come. "The challenge for an insurance company is that 5, 10, 15 years later, they're not covering that patient," said Mehta. "That patient is somebody else's responsibility, so their perspective is very narrow."

For example, if a woman with breast cancer needs the lymph nodes under her breast bone treated, some of the heart will get irradiated with radiotherapy. That patient's risk of developing cardiac complications later on in life could be diminished with proton therapy, but demonstrating those comparative benefits in a trial study can be difficult.

To address the lack of financial incentive insurance companies have to cover proton therapy, (which is significantly more expensive than conventional radiotherapy), Mehta proposes offering some sort of tax benefit for covering the therapies that result in less long-term toxicity.

Following the evidence
As the body of evidence mounts, most insurance companies will cover proton therapy for cancers with a demonstrated reduction in acute side-effects. One such example is certain patients with head and neck cancer.

At this year's American Society of Clinical Oncology (ASCO) annual meeting, Dr. Steven Frank, professor of radiation oncology and executive director of the Particle Therapy Institute at the MD Anderson Cancer Center in Texas, presented a study showing that oropharyngeal cancer patients treated with intensity modulated proton therapy (IMPT) experienced a significant reduction in malnutrition and feeding-tube dependence compared to traditional intensity modulated radiation therapy (IMRT).

There are about 10,000 taste buds in the anterior oral cavity and if a patient receives just two weeks of radiation therapy, according to Frank, it can wipe out those taste buds. He believes that maintaining a patient's ability to taste food during treatment provides motivation to continue eating and maintaining nourishment.

Insurance companies providing coverage for this indication is a fairly new phenomenon. In 2008, MD Anderson was only able to treat about 3% of their head and neck cancer patients with proton therapy, but now roughly 35% of those patients are receiving it.

"Over the last 10 years, we've been able to advance and articulate the value of proton therapy, which has allowed for health policy to be advocated and advanced," said Frank. "This randomized trial is the first large phase-three level-one evidence to be able to demonstrate that clinical value with the reduction of these major toxicities."

Frank and his team have developed model policies within the National Association for Proton Therapy (NAPT) and also helped ASTRO update its policies to include proton therapy indications.

His next goal is to demonstrate its cost-effectiveness through a reduction in healthcare costs associated with emergency room visits, hospitalizations, and imaging procedures. Although proton therapy is more expensive to deliver than radiotherapy, he has found that reducing those downstream costs mitigates the expense of treatment.

He has also been able to illustrate work productivity outcomes in patients who receive proton therapy versus radiotherapy. “That translates into societal benefits, because these employees pay taxes, they get back to work, and they're productive, and that is also a value that we aim to demonstrate and show in these cost-effectiveness analyses,” he added.

Leading the way to better coverage
Frank stresses that although the indications for proton therapy are growing, not every cancer patient is a candidate for the treatment. He estimates that about 20% of his patients would see real benefits from it.

MD Anderson recently opened up a new center with four additional rooms that allows for real-time tumor tracking, three-dimensional imaging on a day-to-day basis, and surface imaging.

“We have advanced the technology to be able to deliver protons in a similar manner to that by which we deliver conventional X-rays,” said Frank. “It really has expanded the indication and the enthusiasm of the physicians and the multidisciplinary teams to use this lifesaving technology.”

However, the cost to build and sustain one of these facilities is a major hindrance to adoption, and helps explain why there are only about 40 centers in the U.S.

But as the technology advances and the size of the centers gets smaller, it will become more accessible.

“We're seeing this as not just a U.S. phenomenon,” Frank said. “This is a global phenomenon and it's going to continue to grow rapidly over the next two decades.”

Medicare patients and pediatric patients who have cancers with a demonstrated benefit from proton therapy typically receive coverage, but what about patients between 21 and 40 years of age that may have testicular or cervical cancer? That’s where Frank’s focus is now.

“We want to make sure that these groups in between get equal access,” he said. “This level-one evidence and this phase-three data is so critical, because this is the practice-changing type of data that helps move the policy and [provides] access for more patients going forward.”