Removing the Insurance Roadblock: I Propose the Cancer Patient Treatment Coverage Act

With breakthrough cancer therapies coming to market rapidly, the insurance industry -- not the FDA, not ineffective treatments -- has become the greatest risk to cancer patients' lives.

The Cancer Patient Treatment Coverage Act ("CPTCA") I propose would mandate coverage for all cancer patients for treatments and supportive treatments (like molecules to stimulate the bone marrow) once approved by the FDA for any indication, if ordered by a board-certified cancer specialist.

Forty-years after the United States government launched the 'War on Cancer,' patients are beginning to reap its rewards. Breakthroughs are reported nearly every month in the medical literature. These generally fall into one of two categories: a drug (small molecule) blocking a highly specific activation mechanism in cancer cells; or, the body's immune system harnessed to attack the cancer cells.

This marks a paradigm shift in cancer therapy. The "old" cancer drugs were basically poisons, and the mission was to find a dose and timing that would make the cancer cell more vulnerable to the poison than normal cells. Tumor cell biologists did not have the tools at that time to determine more subtly what was awry in the cancer cell, to attack that mechanism instead of poisoning all cells.

Nevertheless,in some cancers, the poisons worked like a charm, but for most of the major diseases (lung cancer, colon cancer, breast cancer, prostate cancer), its positive effects were not great.

The Food and Drug Administration has done an admirable job of keeping up with rapidly changing science. Recognizing the lower toxicity profile, and the great promise of these new agents compared to the older ones, FDA has moved quickly to grant approvals without compromising the rigor of the studies required that sponsors must show to receive market clearance.

One wishes one could say the same for the insurance industry. Although the Patient Protection and Affordable Care Act ("ACA", often dubbed "Obamacare") has enabled 90 percent of the country now to have insurance coverage, and one cannot be denied insurance due to prior illnesses, the insurers themselves have not shed their old ways.

A word of explanation. For any drug to be approved by FDA, it must demonstrate safety and effectiveness in a defined patient population. That is the only way to determine whether it is active against the tumor at doses that patients can tolerate.

As a consequence, a sponsor will conduct a study, e.g., in a certain type of lung cancer, where the patients in the control group, who do not receive the experimental agent, are as closely matched as possible to the treatment group. Hence, when the agent is approved for marketing, it is approved for the "indication" of that form of lung cancer, and usually "after standard treatments" have failed.

But, the oncology community can readily envision the rational use of that drug in other cancers, in the same cancer but at earlier stages, and so forth. Indeed, for these new cancer agents, it probably makes less sense to consider them as applicable to a particular tumor than it is to the cellular abnormality they target regardless of the origin of the cancer. It can take a long time for the sponsor (i.e., the pharmaceutical or biotechnology company) to test all these different potential uses.

But, the insurance companies rely on the narrow "approved indication" to deny coverage for any other cancer. Try to use a drug that blocks a "check point" in cancer cells that is approved for lung cancer, say, in brain cancer, and the insurance company will say, "nyet."

Historically, the "nyets" were handled either by oncology groups studying the drug over several years in other cancers and reporting their results in medical journals establishing a "standard of care." This made it difficult for the insurance industry to maintain its position. But, again, this takes years.

The CPTCA focuses health policy on the cancer patient, not the insurance company. The insurance companies' simplest course is to quote the approved indication and say "no." At that point, it becomes a fight between the patient with his doctor against the insurer, a fight neither has time for. The physician can spend better time with his patients, and every day a patient is delayed is not only one of anguish, but also danger.

The insurance company, however, has "all the time in the world".

Let us not allow the insurance industry to cause the fruits of the 'war on cancer' to rot, sitting on the shelves but not covered for most patients. Instead, let us make approved cancer therapies and supportive treatments available to all cancer patients, even those who have cancers not studied with the treatment (i.e., the vast majority of patients), so long as prescribed by a cancer specialist.

Otherwise, precious time, and precious people, will be lost.

Will you join me in supporting the Cancer Patient Treatment Coverage Act? If so, send a link of this article to your Member of Congress and Senator, and demand its rapid enactment.