A bill that would allow terminally ill patients access to drugs not fully vetted by the Federal Drug Administration was passed Monday by the state legislature’s House Health and Human Services Committee.

House Bill 94, sometimes called "Right to Try," would restrict participation to the terminally ill who have exhausted all other treatment options. It would also require physicians to discuss the potential known outcomes and side effects of the medication with the patients.

For the past two weeks lawmakers have grappled with the bill and the possible liabilities it could expose to pharmaceutical companies, doctors and insurers. Those concerns, though, were hammered out with a pair of amendments. One is an informed consent clause that protects physicians, drug makers and hospitals from liability and another that provides clarification on instances when insurance companies may deny coverage.

The informed consent clause requires the physician to discuss the potential known outcomes and side effects – both positive and negative – with a terminally ill patient who is interested in trying investigational drugs. A patient is only eligible if they have been diagnosed with a terminal illness and all other treatment options have been exhausted.

While the bill goes to the floor of the House of Representatives, Republican Rep. Gage Froerer, the bill’s sponsor, and Rep. Edward H. Redd, R-Logan, will work on an amendment that expands the protection to cover not just physicians, but all health care providers that treat the patient. Kathleen Kaufman, government relations chair for the Utah Nurses Association, suggested this amendment.

Insurance companies are not required to cover the investigational treatment, and may deny coverage of any harm caused by the treatment for up to six months from the day a patient begins treatment. Pre-existing conditions and benefits the patient already receive would continue.

The informed consent clause makes sure that the patient knows he or she is responsible for any hospital bills if the treatment goes poorly.

While they aren’t required to, insurance companies may still choose to continue to cover the patient, according to Kelly Atkinson, who represents the Utah Health Insurance Association, a trade organization that represents insurance companies like Altias and Regence. Under the bill, only treatment related to the investigational drug is exempt from coverage.

Rep. Michael S. Kennedy, R-Alpine, asked about how the state would be impacted if patients wind up taking a trip to the emergency room that their insurance company won’t pay for.

If a patient goes to the ER, there is a cost to be paid, said Kennedy, “and I know who is underneath that,” he said. “It’s the state taxpayers, on some level, through some sort of tax deduction or tax write off, or Medicaid or federal government Medicare, somebody’s going to pay for the service, but the tax payer is underneath all of that.”

Jonathan Johnson, chairman of Promote Liberty, a political action committee, is announcing a non-profit that will raise money for patients who cannot afford the risk of taking the investigational drugs without the help of an insurance company.
Kennedy suggested the responsibility be shifted to the pharmaceutical companies that benefit from any data collected and positive anecdotes.

“On some level, they’re subject to losing their intellectual capital because they are donating it to this individual, but they’re held harmless from whatever adversity may come,” Kennedy said. “They get valuable data from every individual that comes through this.”

Since manufacturers have the option whether or not to provide the investigational drug or device, Froerer felt that the only way companies would participate is if they were held harmless.

Multiple Utahans testified in favor of the bill, citing family members that could have benefited from it. Cristina Casanova Might, executive director for the NGLY-1 Foundation, testified in favor of bill, as it would give her seven-year-old son access to investigational treatment. Her son has NGLY-1, a rare genetic mutation and will die without the treatment, EPI 743, which has entered into stage three approval trials with the FDA. The drug is held up because there have only been 25 diagnosed cases—too few to justify a clinical trial.

Rep. Eric K. Hutchings, R-Salt Lake, whose mother died from a terminal illness, spoke in favor of the bill.

“People like to feel like their life has a noble meaning, and if for no other reason than to participate in the furthering of a potentially life-saving process … to feel like what you’re doing might benefit the next person or the next generation,” Hutchings said. “There’s just something good, something right, about being able to do that and offer that and add that into the equation.”