health: You can ask federal agency to stop limiting access to a life-saving cancer treatment

At issue is a class of medicine called radioimmunotherapy (RIT) in which there are two FDA-approved drugs for treatment of some forms of non-Hodgkin lymphoma. Given in two doses a week apart, RIT specifically targets the cancerous cells and mostly leaves the healthy cells alone, meaning far fewer side effects.

Better yet, not a single study has shown any treatment to have the success that RIT can have for the types of lymphoma for which it is approved. I personally know patients who took RIT in clinical trials as long as 15 years ago and who have led normal, healthy lives since.

This is remarkable because of the nature of the disease for which RIT is approved. It generally responds to chemotherapy but invariably returns and requires stronger treatment. Remission periods decrease with each successive treatment, and the whole cycle repeats until no options remain.

For many patients who've actually gotten RIT, the treatment has shown to stop that deadly cycle in its tracks, so you'd think it would be widely accessible and easily available. It isn't.

Full disclosure: Next month, it'll be nine years since RIT came to my rescue after two failed chemotherapy treatments. But in a painful twist of fate, in February 2009, my mother-in-law, Lisa de Parry, died from a lymphoma complication less than a week away from treatment with RIT. It was unavailable through her physician in Florida, and getting her to a facility that administered it took overcoming obstacles and time — time that cost Lisa the chance to take the one treatment that may have prolonged her life.

Clearly, accessibility — or lack of it — can have a devastating effect on families. While my family has experienced the best and worst outcomes when RIT is easily accessible and when it isn't and I naturally have a personal interest in it, I also know that what happens to RIT can affect treatments for other cancers and even other diseases. And in the bigger picture, I believe that people with all kinds of illnesses deserve to have all options equally available.

Like all medical advances, it took years to develop RIT. German bacteriologist Paul Ehrlich was the first to propose the idea of compounds that would specifically target diseased cells and avoid healthy ones. Magic bullets, he called them. Ehrlich didn't realize his dream, but he did win a Nobel prize in 1908 for his work on the immune system.

It would take generations of scientists and technology to catch up before magic bullets could succeed, but success didn't come easily. Dashed dreams followed high hopes, and by the 1980s, only a handful of scientists persisted in trying to develop a magic bullet for the treatment of cancer.

Dr. Mark Kaminski, director of the University of Michigan Multidisciplinary Lymphoma Clinic, was one of them. In April 1990, he and nuclear medicine physician Dr. Richard Wahl were the first to open a clinical trial testing RIT in humans. The results exceeded anyone's expectations.

Dr. Kaminski recalls standing in the lab with Dr. Wahl looking at a CT scan of Patient #4.

"This gentleman had a one-kilogram mass in his abdomen. That's bigger than a 48-ounce steak, and it had disappeared. We had never seen anything like that. We just sort of looked at each other and nodded. We knew we were on to something very special."

Indeed, they were. It took nearly a century, but Dr. Kaminski and Dr. Wahl finally found a treatment that identified, targeted, and destroyed cancerous cells while mostly sparing healthy ones. Magic bullets were no longer a dream but a reality that had the potential to cure cancer, found at last in a lab right here in Ann Arbor.

Dr. Kaminski's drug became known as Bexxar. Another company began working on its version of an RIT treatment, and it became known as Zevalin. The drugs were finally approved by the FDA in 2002 and 2003.

Studied independently of each other, these two drugs showed the same: patients fared better with radioimmunotherapy than they did with chemotherapy. Is RIT a panacea? No cancer treatment works for everyone all the time, but now — 21 years after Dr. Kaminski's first clinical trial began — nothing, and I mean nothing, has shown to produce more complete responses or longer durations of response.

You would think that this would mean booming sales. Not so. Few patients ever get RIT, and it's underutilized for all the wrong reasons.

First, oncologists have to refer patients to nuclear medicine physicians or to radiation oncologists for administration of the treatment. Thus they lose the income from treatments they can administer — namely, chemotherapy and monoclonal antibody therapy.

This financial disincentive has been well documented in such publications as the Journal of the National Cancer Institute and the New York Times. Not only is this bad for lymphoma patients, but it's disincentivized the development of RIT for other types of cancers because the two approved RIT drugs have not been commercially successful.

Underlying all this is a powerful government agency called CMS — Centers for Medicare and Medicaid Services. CMS sets reimbursement rates for every drug, medical device and procedure known to man or woman for its Medicare beneficiaries, but private insurers generally follow CMS, so what CMS does affects everybody.

In 2007, CMS nearly sent RIT into medical history when it proposed a reimbursement rate at less than half its cost. It took an uprising of outraged patients and congressional intervention to overturn its ruling.

Some progress has since been made, but reimbursement still limits patient access because the folks at CMS still can't seem to grasp that this treatment — as approved by the FDA — is a single therapeutic regimen with four components. In the case of Bexxar, no single component is approved by the FDA as a stand-alone treatment. It takes all four to complete the therapy.

CMS, however, only classifies one component of Bexxar as therapeutic and reimburses for it appropriately. It misclassifies two others as "diagnostic," (patients have already been diagnosed!) and one as a "supply." The result is that reimbursement rates are set below actual cost and hospitals lose money on every dose.

No wonder few facilities offer it, and those are mostly large academic institutions. Anybody should be able to figure out that hospitals have no incentive to use treatments on which they lose money.

Besides the implications of underutilization on the very lives of patients, there's another big rub. Both Bexxar and Zevalin were developed in part with funding by the National Institutes of Health (NIH), which spends billions on research paid for by taxpayers, and yet precious little research develops into therapies that make it through the rigorous FDA approval process — in 2010, two for cancer out of a total of 21 approvals.

When a therapy finally passes all the scrutiny before finally reaching patients, how does one government agency — CMS — then limit patient access to a treatment that was partially funded and fully approved by its sister agencies, NIH and FDA? In the case of RIT, CMS is denying the fruits of NIH success to the very people who paid for it in the first place.

Is it just me or does this seem like a case of dysfunctional government and bureaucratic bungling? Don't we taxpayers have the right to ready access a return on our investment, especially one that has shown to save lives? I'm pretty sure I know how Lisa would answer that question.

And here's another rub. As the debate over government spending rages on, RIT is cost effective.

In real numbers, my own case is not unusual. In a period of eight months, I started two different chemotherapy regimens, but never finished either because my disease progressed during treatment. Additionally, chemo caused quite a bit of collateral damage which required costly treatment and a couple of hospitalizations to rescue me from it. All this added up to $162,410 — for everything that didn't work!

At the time I was slogging through chemo, RIT was under FDA review. Thankfully, it became available in the nick of time. More the point of this piece, the cost of my RIT treatment — the drugs, the scans, the bloodwork and the doctor's appointments — was $36,929. That's 77 percent less than everything that didn't work and $4,103 per year for the nine years I've been in remission — a bargain as cancer treatment goes.

The cost for many of the drugs I took has increased, but the cost of RIT has remained about the same, so today, the spread between what did and didn't work would be even greater. You would think CMS would be jumping for joy at a treatment that can reduce costs.

If CMS did the math, it would realize that alternative treatments are often more costly and they often require costly treatment for side effects — and certainly, costs increase with frequency of treatment.

Given the recurring nature of the disease, doesn't it just seem logical to give treatments that have the potential to produce the longest periods of remission — when no money is spent — at least the chance for doctors to consider them equally among all the treatment options, based on what's best for the patient rather than on lack of reimbursement?

And doesn't it seem logical to open the door for hospitals to offer a treatment that minimizes costly and potentially dangerous side effects, to which elderly patients on Medicare are especially susceptible?

If the government is serious about reducing health care costs, appropriate classification of Bexxar can be part of the solution. And it's a win-win: for patients, increased access to an excellent treatment option and for taxpayers, reduced cost. What's not to love?

The fix is simple: re-classify the components of RIT so that they are properly reimbursed. But a fix won't come easily. I've been involved in this issue for four years, and it's been a hard struggle that's been waged primarily by patients and survivors — and we continue to wage it.

What can you do? Each year, CMS accepts comments to its proposed rates for the following year. The comment period is open until Aug. 30. A petition has been started which will be delivered to CMS Administrator Dr. Donald Berwick, asking him to make the changes that are necessary to improve patient access to this life-saving and cost-saving treatment.

You can help by taking a minute or two to sign the petition. You'll be helping cancer patients and sending a message to Washington that NIH-funded, FDA-approved drugs should be appropriately and fully paid for.

The Roller Coaster Chronicles and the soon-to-be-released "Adventures In Cancer Land." Find her on Facebook or email her.