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Do patients have the “right” to proton beam therapy?

No one likes being rejected — especially when it’s your health insurance company rejecting a claim. Both doctors and patients use up a massive amount of time, effort, and mental energy just to get approval from insurance companies for medical care that patients need. 

But what happens when the insurance company denies payment for a treatment that hasn’t proven to be more effective than existing treatments, and is twice as expensive? In the case of proton beam therapy, you have a battle of wills, with an industry-backed patient advocacy group fighting against insurers for coverage of dubious treatment, to fund a medical arms race. 

The proton beam explosion

Proton beam therapy (PBT) is a relatively new cancer treatment that uses protons instead of photons to target cancerous tumors, avoiding radiation of surrounding tissue. The popularity of PBT to treat certain cancers has grown substantially in the past decade, as more and more health systems are building proton beam machines and centers for treatment. In 2009 there were six proton beam units; now there are 27, with at least 20 more in the works. 

With the explosion in proton beam centers — which cost at least $200 million to build — this therapy must be revolutionary! Well, not exactly. Proton beam therapy is useful for treating cancers in sensitive areas like the brain stem, eye, or spinal cord, and for treating pediatric cancer patients without exposing children to unnecessary radiation. However, there is little evidence that PBT is more effective than controlling conventional radiation treatment for more common cancers like lung, breast, or prostate cancer. 

Show me the evidence…

In a 2014 comprehensive summary of evidence on proton beam therapy, the independent non-profit Institute for Clinical and Economic Review evaluated the effectiveness of PBT on patient outcomes including tumor recurrence, quality of life, and mortality. Researchers found that PBT offers a superior net health benefit for eye tumors and an incremental benefit for pediatric cancers and tumors in the brain and spine. For liver, lung, and prostate cancer, PBT is comparable to conventional radiology; for all other cancers, there was insufficient evidence to determine net health benefit. 

Source: Proton Beam Therapy Final Evidence Report, Washington Health Care Authority, 2014

The ICER report highlighted the overall low strength of evidence for PBT. Five of the six randomized controlled trials did not compare PBT to an alternative treatment. In the non-randomized studies, researchers found “major differences in patient demographics and baseline clinical characteristics” between patient groups. Out of 42 studies, only two were categorized as “good quality” evidence.

Even leaders of proton beam centers have acknowledged that the evidence isn’t really there. “Part of the challenge is that there hasn’t been a lot of clinical evidence to promote proton therapy,” said Stuart Klein, executive director of the University of Florida Proton Therapy Institute in Jacksonville, in Modern Healthcare. However, Klein is convinced that “as time goes on, the level of clinical evidence is going to increase.”

Most of the hospitals and academic centers that have been creating multi-million PBT machines are non-profit, which means that taxpayer dollars are funding this expensive, ineffective treatment that the builders know isn’t proven to work. 

Industry-funded advocacy

Given the lack of evidence for proton beam therapy compared with existing therapies, it’s not surprising that insurers have balked at paying for PBT for all but a few types of cancer. This phenomenon, coupled with advances in traditional radiation therapy over the past few years, means that proton therapy centers are having trouble finding patients, and are subsequently hemorrhaging money

Proton beam manufacturers and centers aren’t letting that stand. They are putting pressure on insurers to cover proton therapy treatment through their advocacy group, the Alliance for Proton Therapy Access. APTA recently put out a report chronicling the stories of patients whose proton beam therapy was denied, blaming the insurance industry, and listing the “patients’ bill of rights” for timely proton beam treatment.

The APTA report focuses on the stories of rejected cancer patients, asserting that patients have a right to the treatment their doctor recommends without dealing with delays and denials from insurance companies – and who can argue with that? Indeed, insurance companies often deny claims without adequate review or information. But APTA is deliberately blurring the lines between treatment that is necessary and recommended, and treatment that is not proven to be more effective. Their report doesn’t just include stories of patients with eye and brain cancer, or children with cancer – it includes patients with common cancers, for whom there is no evidence that PBT is more effective. In fact, the report states that “cancer patients of all ages” need access to PBT (emphasis mine). 

Just like with the controversial FDA approval of Sarepta’s drug for Duchenne Muscular Dystrophy, industry leaders with a stake in PBT are hiding behind patient stories to promote their own agenda. Just take a look at the APTA board members: Four industry leaders, one head of a PBT center, and two patients. Those who stand to gain financially from PBT coverage are taking a page right out of Sarepta’s handbook, creating “slickly packaged testimony” from cancer patients and encouraging patient advocates to take up the fight for their rights.

Don’t fall for this trick. Patients have the right to the medical treatment they need to get better, without a fight from insurance. They do not deserve to have their stories used to further industry gains based on unproven, expensive treatments.