Background
In late-May, Congress passed, and the President signed in to law, the
Right to Try Act
, which gives terminally ill patients a direct pathway to access experimental treatments that have not yet been approved by the Federal Drug Administration (FDA). This new federal law largely follows the nearly 40 states that have already passed a version of Right to Try (RTT) over the last four years. As of this time, only one patient is known to have taken advantage of the RTT process under the various state laws.
RTT is meant to be an alternative treatment process for the few patients who do not qualify under the current FDA Expanded Access program. This FDA program allows patients, with physician approval, to ask the FDA and drug companies for access to experiment drugs. Expanded Access has been available since 2009 for patients with life-threatening illnesses who have exhausted all available treatment options and are seeking experimental treatments not currently on the market. Many of these patients do not meet the criteria for the preferred route of a clinical trial. Recent surveys have shown that the FDA has approved nearly 99% of these Expanded Access requests.
Right to Try Overview
RTT is aimed at allowing terminally ill patients access to experimental drug therapies that have successfully completed a FDA Phase I clinical trial, but have not yet completed Phase II, III, nor received FDA approval.
Under RTT, a physician would have to approve of the use of an experimental drug and ask the drug manufacturer for approval to use on behalf of the patient. The drug manufacturer can approve or deny the request. Therefore, the drug company is under no obligation to provide access to an experiment drug based on a request. In some cases, the drug company may in fact not have enough drug availability for a full regimen.
Upon approval, the drug company would then give a price to the patient, which must be the actual cost, plus shipping of the drug. If approved by the drug company, insurance is not mandated to cover either drug costs or side effects under RTT, meaning the patient would be personally responsible for any associated costs unless the employer decided to cover such costs, and it was outlined in the health plan documents that stipulates the benefits and services covered under the plan.
While the new federal RTT law allows drug companies to charge patients for use of their investigational products, it does not provide a federal funding mechanism, nor does it mandate insurance coverage of the drugs or the side effects. To be clear, it includes no requirement for insurers to pay for the products.
A large portion of the RTT law provides liability protection for manufactures, sponsors, physicians and hospitals, among others. The federal law contains two threshold requirements for this protection, namely that the state statute must authorize the treatment and the patient must be diagnosed with a terminal illness. The effect of the protections of the law s to allow terminally ill patients to use these treatments without putting the physician or the drug manufacturer (or the manufacturer’s regulatory approval applications) at risk. By protecting patients, physicians and the drug sponsor from this risk, the aim is that patients who otherwise have no course of treatment may seek a new treatment course for terminal illness.
Summary of RTT Responsibilities
- Physicians must contact drugmakers to request treatments for their patients.
- A drug must have passed at least Phase I clinical trials. An estimated 11% of the drugs that pass Phase 1 ultimately get FDA approval.
- Drugmakers and physicians are protected from liability.
- Drug companies can refuse to provide the products.
- Insurers are not required to cover the cost of care for side effects from an experimental drug.
- Patients would be responsible for the entire cost of the experimental treatment.
- Treatments would cost only what drugmakers pay to produce and ship the drug.
- In 19 of the 38 states that enacted right-to-try laws, insurers can deny hospice care to patients who have used an experimental drug.
It is important to note that RTT was widely opposed by Democrats in Congress, and a number of patient advocacy groups, on the grounds that it took away the safeguards granted under the FDA's program to ensure patient safety. Critics have argued the legislation is unnecessary since the FDA already approves nearly all patient requests under the Expanded Access program to access yet unapproved drugs.
What Does This Mean for Self-Funded Health Plans?
First and foremost, insurance coverage of the experimental drugs under RTT, and any side effects, is not mandated or required. It will be important to look at how current plan documents are drawn up regarding access and payment of experimental drugs. Of course, an employer can always ask for such coverage to be included but, of course, normal underwriting could be used to determine premium rates, etc. There may also be open ended questions about how a patient who may have potential side effects from a RTT drug would be considered a new employee/ beneficiary with a “pre-existing” condition. It is, however, unlikely that further legislative intent or FDA rules will address insurance coverage considering that coverage is not mandated and, thus, left to insurance providers and their clients.
Consider several things in understanding RTT and self-funded obligations: First, out of 38 states with RTT laws, only one patient has ever taken advantage of it. Most policymakers and regulators do not believe a federal law will change much of the current dynamics regarding experimental drugs. Two, consider looking at how your plans currently covers experimental drug treatments and side effects under the FDA Expanded Access program. Third, also understand that many of the state laws offer safe harbors and have their own requirements, with the federal law serving as an overlapping law primarily meant to offer liability protection, not to mandate insurance coverage. Lastly, have discussions with your various employer groups as to what coverage their current plan documents contain and how they want to treat participants in RTT. While looking at treatment of participants under Expanded Access may be important, so too will be reviewing and, potentially, making changes to plan documents to ensure they are consistent with how employers and insurers want to treat RTT related expenses.
If you have additional questions or would like to discuss the new
Right to Try
law
further, please contact Ryan Work at
rwork@siia.org
.
