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Major Settlement Raises Questions About Evidence-Based Value in Cancer Care


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An Oklahoma jury recently awarded $25.5 million to the widower of a 53-year-old woman diagnosed with stage IV nasopharyngeal cancer who was denied coverage for proton therapy by her health insurer, Aetna. The patient’s family subsequently raised $92,000 to cover her proton therapy at The University of Texas MD Anderson Cancer Center in Houston. However, on returning home following treatment, the woman contracted herpetic encephalitis, leading to her death. The lawsuit was filed shortly thereafter.

In a nine-to-three decision, the jury determined that Aetna acted in bad faith when it denied coverage for proton therapy. In a statement, the jury forewoman said the monetary award was meant to get Aetna’s attention with regard to how it evaluates appeals and requests. According to Aetna,1 the woman was denied coverage because “medical studies have not proven that this procedure [proton therapy] is effective for the treatment of [her] condition [nasopharyngeal cancer].”

A jury of 12 laypersons listened to weeks of complicated legal issues, coverage policy contract interpretation, and dense scientific data before rendering a verdict that, aside from this specific case, has broader implications for the U.S. health-care system. The clinical nuances between intensity-modulated radiation therapy (IMRT) and proton therapy in nasopharyngeal cancer were far more difficult for the jury to process than a simple sentiment: America’s largest health insurance company denied cancer treatment for a woman fighting for her life.

For-profit health insurance carriers make coverage decisions by evaluating best practices and evidence-based data. It is a multifaceted process that sometimes comes at loggerheads with providers and patients, as in the case above. In this case, Aetna suffered severe monetary punishment for making a coverage decision that some experts in the oncology community might agree with.

Less Toxicity in Rare Cancer

The standard treatment for nasopharyngeal cancer is IMRT and chemotherapy—an approach associated with considerable toxicities due to high doses of radiation delivered to normal tissues in the path of the beams. One advantage of proton therapy is more precise dose-delivery, which can reduce damage to healthy tissue and lessen toxicities.

Steven J. Frank, MD

Steven J. Frank, MD

Steven J. Frank, MD, Professor of Radiation Oncology and Medical Director of the Proton Therapy Center at MD Anderson Cancer Center, told The ASCO Post, “Due to the rarity of nasopharyngeal cancer in North America, large prospective randomized trials comparing proton therapy vs photon therapy are unlikely to be performed. That said, in a matched case-control study of intensity-modulated proton therapy (IMPT) vs IMRT at MD Anderson, patients with nasopharyngeal cancer treated with IMPT had a 60% reduction in malnutrition and gastrostomy-tube dependency over patients treated with IMRT.”2

Dr. Frank continued, “The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Onology for Head and Neck Cancers consider proton therapy to be a safe and effective cancer treatment and support its role in the radiation management of base-of-skull tumors, such as nasopharyngeal cancer.”3

A Lack of Data

The first proton accelerator for medical use in the United States was launched in 1990 at Loma Linda University in California, adding a promising, cutting-edge tool in radiotherapy. The precision characteristics of proton therapy may offer advantages over photon techniques in terms of toxicities. However, except for a few rare pediatric cancers, no prospective studies have definitively compared proton therapy with IMRT. There are no randomized trials showing patients with cancer live longer with proton therapy. In a randomized trial of advanced lung cancer, proton therapy did not reduce toxicities.4

Moreover, proton therapy is much costlier than conventional radiotherapy techniques that may have similar outcomes. A recent study published in the Journal of Clinical Oncology compared the toxicities and cost of proton radiation and stereotactic body radiotherapy with IMRT for prostate cancer among men younger than 65 years with private insurance.5 A total of 693 patients treated with proton therapy were matched to 3,465 patients treated with IMRT. The investigators found that proton therapy was associated with a lower risk of composite urinary toxicity but a higher risk of bowel toxicity. The mean radiation cost was $115,501 for proton therapy and $59,012 for IMRT.

Lack of substantive data confirming a survival advantage for proton therapy over other radiotherapies has not stopped the proliferation of proton centers around the world— most aggressively in the United States, which has 28 centers and 23 under construction. The price of building a proton center runs upward of $235 million. According to Loma Linda University, a multiroom proton center can be 40 times as expensive to build as a center that delivers conventional IMRT.6


If you look at the literature in advanced nasopharyngeal cancer, there are no studies that show a substantial benefit for proton therapy over IMRT….
— Ezekiel J. Emanuel, MD, PhD

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Health policy expert Ezekiel J. Emanuel, MD, PhD, Chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania, has characterized the unfettered expansion of proton therapy centers as a “medical arms race” that adds billions of dollars to our already financially stressed health-care system. Asked about the Aetna settlement, Dr. Emanuel said, “That is more of an internal review process, something I’m sure Aetna and other insurers will examine. But the bigger question is: Do we want a social policy that says insurers ought to be required to cover treatments with unproven benefits determined by reasonably conducted studies? These studies should determine whether an intervention prolongs life or has significantly less adverse side effects than another intervention.”

Dr. Emanuel continued: “If you look at the literature in advanced nasopharyngeal cancer, there are no studies that show a substantial benefit for proton therapy over IMRT. And just because Medicare covers an intervention does not mean it is standard of care.… Naturally, the huge [settlement] number in this case gets attention, but our system is constantly paying for medical interventions without proven value.”

In addition, he noted, “Just like every medical therapy, proton-beam radiation may be harmful. In 2018, the National Cancer Institute published a consensus warning that proton therapy may have unexpectedly caused brainstem necrosis in children, a devastating, but rare, complication of radiation.7 For the vast majority of adults with cancer, it is still not clear proton therapy provides benefits.” 

DISCLOSURE: Dr. Frank is on the scientific advisory board of Varian and Breakthrough Chronic Care; a board member of National Comprehensive Cancer Center; has received grants from Eli Lilly and Elekta; is a founder/board member of C4 Imaging; has received grants and personal fees from Hitachi for a phase III trial; and honoraria from Augmenix/Boston Scientific. Dr. Emanuel reported no relevant conflicts of interest.

REFERENCES

1. Ault A: Insurer faces $25.5m payout after denial of proton therapy. Medscape. November 16, 2018. Available at medscape.com. Accessed May 21, 2019.

2. Holliday EB, et al: Proton therapy reduces treatment-related toxicities for patients with nasopharyngeal cancer. Int J Part Ther 2:19-28, 2015.

3. Dimitrios Colevas A, et al: NCCN Guidelines Insights: Head and Neck Cancers, Version 1.2018. J Natl Comp Ca Network 16(5), 2018 (early release online).

4. Liao Z, et al: Bayesian adaptive randomization trial of passive scattering proton therapy and intensity-modulated photon radiotherapy for locally advanced non–small-cell lung cancer. J Clin Oncol 36:1813-1822, 2018.

5. Pan HY, et al: Comparative toxicities and cost of intensity-modulated radiotherapy, proton radiation, and stereotactic body radiotherapy among younger men with prostate cancer. J Clin Oncol 36:1823-1830, 2018.

6. Orenstein BW: Proton therapy and cost. Radiology Today 16:22, 2015.

7. Haas-Kogan D, et al: National Cancer Institute workshop on proton therapy for children. Int J Radiat Oncol Biol Phys 101:152-168, 2018.


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