Tuesday, May 12, 2015

Evidence about proton beam efficacy

Source: The National Association for Proton Therapy
Starting in 2011, I raised concerns about the proliferation of very expensive proton beam radiation therapy centers, made possible by investors who leverage the extra payments for use of this treatment modality that have been authorized by CMS and private insurers.  I asserted, based on my contacts in the radiation therapy profession, that the use of proton beam technology offered no significant advantage over lower cost intensity-modulated radiation therapy (IMRT) in most cases.  In short, I characterized proton beam developments as an example of the medical arms race, a rush by hospitals to compete on a high cost approach that offered little value to the public.

Now comes a thoughtful analysis published by the Health Technology Assessment Program of the Washington State Health Care Authority: Proton Beam Therapy, Final Evidence Report. The analysis was carried out by the Institute for Clinical and Economic Review (ICER), an independent non-profit health care research organization "dedicated to improving the interpretation and application of evidence in the health care system."

First, ICER gives the context for the early interest in this modality:

Initial use of proton beam therapy (PBT) focused on conditions where sparing very sensitive adjacent normal tissues was felt to be of utmost importance, such as cancers or noncancerous malformations of the brain stem, eye, or spinal cord. In addition, proton beam therapy was advocated for many pediatric tumors because even lower-dose irradiation of normal tissue in pediatric patients can result in pronounced acute and long-term toxicity (Thorp, 2010). There are also long-standing concerns regarding radiation’s potential to cause secondary malignancy later in life, particularly in those receiving radiation at younger ages. Finally, radiation may produce more nuanced effects in children, such as neurocognitive impairment in pediatric patients treated with radiotherapy for brain cancers (Yock, 2004).

Then, they set up the current issue of concern:

The construction of cyclotrons at the heart of proton beam facilities is very expensive ($150-$200 million for a multiple gantry facility); accordingly, as recently as 10 years ago there were fewer than 5 proton beam facilities in the United States (Jarosek, 2012). More recently, however, the use of PBT has been expanded in many settings to treat more common cancers such as those of the prostate, breast, liver, and lung. With the growth in potential patient numbers and reimbursement, the construction of proton centers has grown substantially. There are now 14 operating proton centers in the U.S. Eleven additional centers are under construction or in the planning stages, and many more are proposed.

The bulk of the report looks at the best available evidence:

We focused primary attention on randomized controlled trials and comparative cohort studies that involved explicit comparisons of PBT to one or more treatment alternatives and measures of clinical
effectiveness and/or harm.

The summary:

We judged PBT to have superior net health benefit for ocular tumors, and incremental net health benefit for adult brain/spinal tumors and pediatric cancers. We felt PBT to be comparable to alternative treatment options for patients with liver, lung, and prostate cancer as well as one noncancerous condition (hemangiomas). Importantly, however, the strength of evidence was low for all of these conditions. We determined the evidence base for all other condition types to be insufficient to determine net health benefit, including two of the four most prevalent cancers in the U.S.: breast and gastrointestinal (lung and prostate are the other two). 

Not exactly a ringing endorsement for adding billions of dollars to America's health care budget.  The original concept behind PBT was to have just a few across the country, to which patients who could most benefit would travel.  The idea was not to have as many as currently exist and are planned.

The results published by ICER hold little sway with the hospitals that have bought these machines.  Here's a sample web page from the The University of Florida Health Proton Therapy Institute:

In case you can't read the small image, it says:

Proton radiation is most effective in the treatment of localized cancers that have not metastasized or spread to other parts of the body.
These include:

Click through on any of those links and you can find clinically unsupported assertions about the benefits of this technology.  Taking prostate as an example:

Traditional prostate cancer treatment involving surgery or radiation carries the risk of serious toxicity and side effects. The potential long-term impact of these side effects on quality of life forces men to make a difficult choice during a stressful time. Proton radiation for prostate cancer treatment, however, offers an innovative method of radiation treatment intended to lower the risk of prostate cancer treatments and side effects.

For treating cancer of the prostate, proton therapy offers multiple benefits:

  • Excellent control of tumors, thanks to more precise targeting of radiation
  • Lower risk of damage to healthy tissue surrounding the prostate cancer
  • Better quality of life for patients undergoing prostate proton therapy treatments
An alternative to traditional prostate cancer treatment, proton radiation for prostate cancer delivers precise doses of radiation with a lower risk of side effects.

With ICER's help, we now see that this verbiage is a lie.

So what we have in place in America is simply this:

Federal reimbursement policy supports the construction and operation of high cost, unnecessary machines.

Investment bankers rely on the above to offer hospitals financing plans, operational plans, and marketing plans for something the public doesn't need.

Hospitals engage in direct-to-consumer advertising in which they present misleading and inaccurate information about the benefits of the machines.

And we wonder why US health care costs keep rising.


Anonymous said...

Wonderful post. But fear not, Paul -- some of the planned proton facilities are starting to lose financing, and one project (Chicago, I believe?) went completely belly-up. Hopefully the empty promise will scare future investors away as well.

Barry Carol said...

The key culprit here, in my opinion, is the payer, especially CMS. If the evidence is clear that PBT is no better than less expensive treatment options for certain types of cases, it shouldn’t pay any more than it does for the less expensive treatment option(s).

I find it hard to blame patients who probably think something like this: I always thought that more expensive care must be better care. To minimize the risk of undesirable long term side effects, I would prefer the most advanced treatment option. If I experience those negative side effects anyway, at least I know I opted for the most advanced treatment. If I went for the less expensive option and had the negative side effects, I would always wonder if they could have been avoided with state of the art treatment.

The best way to dissuade hospitals from investing too much in PBT equipment is to ensure that higher costs (than alternative treatments) are not rewarded with higher payments. The CMS mentality historically has been to reimburse hospitals for their costs, including capital costs, whether or not higher cost treatment options produce better patient outcomes. As CMS moves toward paying for value instead of volume it should also stop reimbursing hospitals for incremental costs that don’t improve outcomes. Private insurers should move in the same direction whether CMS does or not.

Ahier said...

Great post! Thank you for this...

Unknown said...

I have been diagnosed with prostate cancer, and I am relatively young at age 57. I have studied proton therapy and want to have it, however, my insurance has denied paying for it. Maybe because of your story. However, the Mayo Clinic has a video on their website showing proton therapy that suggests it is more precise and doesn't damage as many cells as IMRT since there is no exit pattern. How can IMRT be the same if it continues to travel through your body, past the tumor? I believe the proliferation of the centers is good, but I also believe that as your report says that there is tremendous marketing and pressures for profit. I am looking into paying for it myself, The Mayo Clinic quoted me $288,000 which I believe is abuse since that's about 6 times the amount they will get for the bulk of the patients they treat on Medicare....and, the few insurance companies that finally approve the treatment will negotiate an adjustment that will probably bring the cost down to a range that's close to the amount they pay for Medicare. I pray that insurance companies read this, see the value in proton treatment and start approving the coverage. I also pray that proton treatment providers begin being fare with their cancer patients that are in a bad spot and need to pay cash. They should offer a cash price similar to the amount they are getting paid for all the patients on Medicare. And not take advantage of a distressed cancer patient by charging them $288,000 which is about 6 times there average collection for this service. If the patient is then offered IMRT, instead, which the insurance company will cover, but according the Mayo's marketing video, more dangerous to the patient. Why would they not accept a cash price equal to what they are getting for other proton patients, rather than force a vulnerable patient to accept IMRT, that they say is inferior when promoting Proton Beam Therapy. That said, I encourage all readers to study the benefits of proton beam therapy and please be active, anyway you can, in getting insurance companies to support this treatment and in the meantime getting hospitals and other providers to be compassionate to the cancer patient by lowering the cash price to the amount they normally collect. Prayers to all my fellow cancer patients and survivors.

Don Nelson said...

I was told at Mayo Clinic Phoenix in 2016 that all varieties of Radiation therapy were billed at the same rate (to insurance companies I guess)and It sounded to me like a good way to solve the non coverage issue of PBT. Did I hear incorrectly?
Let's be realistic: would a hospital send the 150 million or more on the proton beam technology if it were not better than the older technology that they already have?
Don N.