Georgia Gov. Nathan Deal (R) signed into law House Bill 965, The Honorable Jimmy Carter Cancer Treatment Access Act, which is intended to allow more cancer patients in Georgia to receive the treatment given to the former president.
HB 965 was signed into law on May 3.
Carter announced in August 2015 he had been diagnosed with melanoma, the deadliest form of skin cancer, and that it had spread to his brain and liver. He was 91 years old at the time of the diagnosis.
Although he continues to undergo treatment, Carter says his doctors currently find no trace of the lesions.
Legislators Play Doctor
Spurred by that success story, the legislature in Georgia passed HB 965 to prohibit insurers from requiring patients with Stage IV metastatic cancer to demonstrate the futility of less-expensive drugs as a condition of eligibility for more-expensive drugs.
“No health benefit plan issued, delivered, or renewed in this state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers the treatment of stage four advanced, metastatic cancer shall limit or exclude coverage for a drug approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of such drug or drugs,” the law states, “provided, however, that the use of such drug or drugs is consistent with best practices for the treatment of stage four advanced, metastatic cancer and is supported by peer reviewed medical literature.”
At best, the law is a heartwarming, hopeful gesture in the interests of fairness in health care. At worst, it’s a Republican-controlled legislature piling on health mandates and playing doctor without the requisite training.
Miracle Drug Over-Hyped?
Carter’s treatment was a combination of surgery, radiotherapy, and an immunotherapy drug. The drug in question is pembrolizumab, sold in the United States by Merck and Co. under the brand name Keytruda. Instead of killing cancer cells, as chemotherapy and radiation do because normal immune systems cannot, Keytruda is injected into the bloodstream and boosts the immune system to counterattack cancerous cells.
FDA fast-tracked Keytruda for approval in September 2014. Pharmaceuticals analyst EvaluatePharma expects it to be the 14th top-selling product in the United States by 2020. Given Georgia’s new law and the publicity surrounding Carter’s treatment, it could climb even higher on the list.
Unfortunately, this so-called miracle drug that supposedly cured the former president may be overhyped. FDA reports in clinical trials on 173 participants with Stage IV melanoma, “In the half of the participants who received Keytruda at the recommended dose of 2 mg/kg, approximately 24 percent had their tumors shrink. This effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients.”
In other words, Keytruda shrank cancerous tumors in fewer than 21 people—just 12 percent of clinical trial participants—according to FDA. Keytruda’s own website calculates the number of success stories as low as 18.
Despite its low success rate, Keytruda’s price would make it the sixth-most expensive drug on the market, according to data collected by EvaluatePharma in 2013. The treatment costs about $150,000 per patient per year in the United States. As recently as November 2015, Pharmac, New Zealand’s government medication purchaser, rejected the treatment because of its $136,000-per-patient price tag and because of “a lack of long-term data.”
The American Cancer Society estimates more than 10,000 Americans will die of melanoma in 2016. It is noble of legislators to want to ensure as many of these patients as possible have access to the same treatment Carter received. Unfortunately, mandating insurers provide patients with this treatment outside existing protocols will hold out false hope to Georgians. The winsomely titled Honorable Jimmy Carter Cancer Treatment Access Act might also spur lawmakers in other states to replicate the legislation, a move sure to increase insurance costs around the country.
Codifying legislators’ good wishes into a mandate that insurers provide patients with an expensive drug with a slim success rate only wedges costly government intrusion into the private relationships among patients, doctors, and insurers.
Benita Dodd ([email protected]) is vice president of the Georgia Public Policy Foundation.
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