FDA Action Brings Hope to Cancer Patients

New guidance allows reimbursements at a time when patients need it most.

The cost of a tank of gas.

Imagine if that’s all that stood between you and your cancer treatment. In 2010, Crystal F’s 4-year-old daughter, Nevaeh, was diagnosed with a Neuroblastoma — a fatal cancer of the nerve tissue. Crystal was already struggling to put food on the table, but now she had to figure out how to pay for the gas to regularly drive 170 miles roundtrip to get to the clinical trial that could save her daughter’s life.

This is the cancer quagmire that many late stage cancer patients face every day. They must decide between paying for basic life expenses and the travel costs associated with participating in advanced research that offers a second chance at life. Yes, some trial sponsors claim to offer patients reimbursement for these travel costs, but often patients either never see a dime or it takes months to receive a check. When a patient is living paycheck to paycheck, they don’t have months to wait.

Recent FDA action, however, could radically change this situation for millions of cancer patients. Moreover, it could ultimately lead us to greater oncology innovation and new treatment possibilities.

In January the FDA made the groundbreaking decision to issue new guidance that gives the green light for trial sponsors to reimburse patients for travel expenses. This is a practice that has traditionally been viewed as coercion, but according to Lazarex Cancer Foundation, a California based non-profit that helps patients navigate clinical trials and offers reimbursement for out-of-pocket travel expenses to clinical trials, leaving travel expenses up to the patient leads to low patient enrollment and high drop-out rates. The new FDA guidance could therefore improve both patient trial enrollment and retention.

The FDA action was the result of a series of discussions with Lazarex. After supporting more than 3,000 patients over the past decade, Lazarex Founder and Chairman of the Board, Dana Dornsife, raised the red flag. She pointed out the critical need to clarify that reimbursement does not, in fact, influence a patient to participate in a clinical trial, but rather it allows them an opportunity to participate.

Lazarex sees first-hand what happens when patients are reimbursed for travel expenses. For Crystal, mom of Nevaeh, the reimbursement for gas and parking at the clinical trial site allowed her daughter to stay enrolled in the trial. Today Nevaeh is 10 years old, her Neuroblastoma has all but disappeared, and she is thriving. Without the reimbursement, Nevaeh’s outcome would likely have been very different.

The following is the new, key language which the FDA now includes as official guidance: “FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.” (Read full regulatory guidelines here.)

This simple language lays down a critical new cornerstone in advancing the cancer conversation. The next step is to take this language and turn it into action. We must not only pave a new path forward, but walk the path and work to change these following factors:

1. The current system isn’t working.

Without fully enrolled clinical trials, developing advanced treatments — and even a cure — is not possible. In our current system, the enrollment goals of clinical trials fall significantly short. Multiple studies show that as few as 3% of cancer patients enroll in clinical trials. According to a Tufts study, 37% of clinical trials fail because they don’t enroll enough patients, and 11% of clinical trials fail to enroll a single patient. That means that — despite billions of dollars invested — nearly half of all sound and potentially life-saving clinical trials fail simply due to low enrollment. Many patients, once enrolled, can’t afford to stay the course for years.

2. Cost barriers.

Clinical trials are rarely conveniently located. On average, a patient has to travel 544 miles to participate in the trial for which they’re eligible. Expenses add up quickly, and travel costs are one of the top barriers to access.

3. Minority participation is dismally low.

In order to create cancer treatments that work for our diverse population, we must have a diverse patient population enrolled in clinical trials. Of the 3% of cancer patients who DO enroll in clinical trials, only a fraction represent minority groups. That stymies our ability to develop and identify the new treatment options that we need for all cancer patient populations.

4. We must educate the public about clinical trials.

Myths still exist. Here are the facts:

· Clinical trials are critical when it comes to improving care. Every treatment on the market today has gone through a clinical trial, and every treatment to come must go through a trial.

· In oncology trials, there are no placebos. Instead, patients receive the standard of care.

· Patients involved in clinical trials are not guinea pigs; they are heroes. Their participation is absolutely necessary if we are to make progress toward developing effective treatments.

· Clinical trials can offer hope to a late stage patient who has been told there is nothing more their doctor can do.

· A clinical trial can be considered as a first-line treatment. It’s an opportunity to take advantage of tomorrow’s treatments today.

5. Many doctors still fail to suggest clinical trials to their patients.

After a patient has failed standard care, most physicians want to help them find a clinical trial option. However, for some providers, finding the time to research patient eligibility is nearly impossible. Many doctors are already pressed for time. Engaging in the clinical trial discussion requires a higher level of patient care that many simply do not have the time for.

THERE IS A VIABLE SOLUTION:

In an attempt to create sustainable change, Lazarex Cancer Foundation created the IMPACT program (Improving Patient Access to Cancer Clinical Trials) to engage every player on the field, from oncologists to industry to patients. The goal is to create a new system that allows for a more natural and seamless flow of patients from their oncology clinics to trials and for reimbursement to patients, which may aid in bringing more advanced treatments to market.

Following a 3 year pilot study at Massachusetts General Hospital, IMPACT improved patient enrollment by 29% and minority participation by 44%. The IMPACT program is now rolling out at UCSF and UCS.

There is no question clinical trials can offer a lifeline to late stage cancer patients who have failed standard care. Participating means hope. Hope breeds possibility. Reimbursement — having the ability to pay for that tank of gas — can be the difference between life and death.

#danadornsife #lazarex #lazarexcancerfoundation