Proton beam therapy – radiation oncology group weighs in on the evidence (and lack thereof)

Usually when I make suggestions to journalists about things to cover, I urge them to report on questions of evidence for two of the fastest growing and most expensive medical technologies:  proton beam radiation therapy and robotic surgery.

Recently, the American Society for Radiation Oncology issued a new model policy for proton beam therapy.

In it, the group states that proton beam therapy is supported for use in what should be categorized as relatively uncommon cancers:

  • Ocular tumors, including intraocular melanomas
  • Tumors that approach or are located at the base of skull, including but not limited to chordoma and condrosarcomas.
  • Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated
  • Primary hepatocellular cancer treated in a hypofractionated regimen
  • Primary or benign solid tumors in children treated with curative intent and occasional palliative treatment of childhood tumors when at least one of the four criteria noted above apply
  • Patients with genetic syndromes making total volume of radiation minimization crucial such as but not limited to NF-1 patients and retinoblastoma patients

For other uses, ASTRO says that some some patients enrolled in either an IRB-approved clinical trial or in a multi-institutional patient registry adhering to Medicare requirements should be covered by insurance. (An IRB is an institutional review board.)  Some uses in this category include:

• Head and neck malignancies

• Thoracic malignancies

• Abdominal malignancies

• Pelvic malignancies, including genitourinary, gynecologic and gastrointestinal carcinomas

But for the granddaddy of applications – the one that pays the bills when the uncommon conditions don’t – prostate cancer – ASTRO states that “the comparative efficacy evidence is still being developed.

“In order for an informed consensus on the role of PBT for prostate cancer to be reached, it is essential to collect further data, especially to understand how the effectiveness of proton therapy compares to other radiation therapy modalities such as IMRT and brachytherapy. There is a need for more well-designed registries and studies with sizable comparator cohorts to help accelerate data collection. Proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or registry.”

Treatment cost for prostate cancer may run beyond $30,000.

The trade organization for proton beam centers says there are now 14 proton centers in operation in the US with 12 more in development.

The Mayo Clinic is building two proton facilities – one in Rochester, MN and one in Scottsdale, AZ – at an estimated investment of more than $370 million.  In reaction, Dr. Ezekiel J. Emanuel, chair of the University of Pennsylvania’s Department of Medical Ethics & Health Policy, wrote:

“With Medicare reimbursement so generous, and patients and doctors eager for the latest technology, building new machines is sane, profitable business for hospitals like Mayo.

But it is crazy medicine and unsustainable public policy.”

A recent paper in the Journal of the American College of Radiology suggested how unsustainable continued proliferation of proton beam technology may be for the centers investing in this technology- UNLESS evidence and reimbursement for the more lucrative and more common adult uses – like the golden goose that is the prostate – comes through.  The paper concluded:

“The mission to preferentially treat pediatric patients involves accepting a loss for one-third of pediatric patients before allocating any overhead. After averaging gross expenses over total operating hours, 60% of the pediatric patients were found to be treated at a net loss.

Given insurance constraints and unique costs associated with the pediatric population, proton beam therapy centers devoted to children should not be expected to be markedly profitable. For centers that do choose to accept pediatric patients, those patients must be balanced with patients producing higher net reimbursement.”


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