Panelists Discuss Roadblocks to Accessing Biologics and Other High-Cost Drugs

During a panel session at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, panelists discussed key barriers to accessing biologics and other innovative treatments, as well as how patient advocacy can be leveraged to chip away at those barriers.

Derek Flowers, coalition manager, Alliance for Patient Access, highlighted 3 common barriers to access: prior authorization, step therapy, and nonmedical switching.

Prior authorization

Intended to be a method to stop unnecessary use of costly drugs, prior authorization requires a physician to go through a lengthy process to get a health plan to agree to cover a medication, even if the doctor knows which treatment the patient needs. Due to the lengthy process, the patient’s health could continue to deteriorate, and new symptoms may emerge.

“Not only is it a patient problem, it’s also a problem for physicians and their practices, taking time away from actually treating their patients and spending more time on this administrative work,” said Flowers.

Step therapy

When a patient gets diagnosed with a new condition, and the physician knows what they need to do put the condition under control, a plan may still require the patient to try multiple cheaper medications before they can use the medication the doctor recommends.

Born with a hereditary congenital heart defect, Donnette Smith, president and founder of Mended Hearts, has undergone 5 open heart surgeries, has been treated with stents, and has struggled with high cholesterol. After trying numerous statins, Smith’s cardiologist prescribed her a PCSK9 inhibitor, but Smith’s insurance denied coverage. Smith and her cardiologist went through an appeals process for 2 years, until 2017, when Smith learned that Blue Cross Blue Shield was covering PCSK9 inhibitors for patients with cardiovascular disease.

Still, Smith was denied by her insurance company, and was told she had to go through step therapy again before they would approve the inhibitor. After finally getting approval to initiate treatment in January 2018, Smith’s low-density lipoprotein (LDL) count went down from 282 to 70. Recently, she got notice from her insurance company that they will no longer cover the drug and she will have to go through preauthorization again.

“It’s not just me. There are hundreds of thousands out there just like me,” said Smith. “I run into them all the time and they tell me, ‘I’m just going to give up.’”

Nonmedical switching

Flowers described nonmedical switching as a follow-on to step therapy: once the trial and error process has taken place and the patient has access to the identified treatment, the health plan sometimes finds a cheaper medication used to treat the same condition.

Jeff Hitchcock, president and founder of Children With Diabetes, discussed how nonmedical switching is often used for different insulin products. “While they’re similar, they’re not equivalent,” said Hitchcock. “They’re different molecules, and the companies make them slightly differently. For most people, they might be interchangeable, but they are not for everyone. We’ve been hearing for years about families experiencing forced nonmedical switching by their insurance company from one insulin to another.”

The impact is not just clinical and metabolic, but also financial, said Hitchcock. In addition to experiencing higher copays, there are sometimes hidden financial impacts. Hitchcock gave the example of his daughter, whose plan switched her from one insulin to another without informing her. With her original medication, she was able to use her infusion sets for up to 72 hours, but on the new medication, the infusion sets lasted for about 36 hours, causing her to spend double on insulin sets.

Advocacy

All panelists agreed that a patient’s voice does not go unheard. “When we elevate the patient voice, whether it be a physician’s or whether it be a youth ambassador’s, we always have a higher chance of success,” said Patrick Stone, MD, of the National Psoriasis Foundation.

Flowers emphasized advocacy at the state level, where a lot can get done in a short time. He urged advocates to tell their stories and let their lawmakers know that these barriers do affect people in the state. When advocates see others being successful in other states, it gives them the motivation and power to speak up and share their stories and be confident in what they’re saying, said Flowers.

“The importance of sharing your story cannot be underestimated,” concluded Stone.