The Truth About Fail First Policies and Pain - Call for a Change

Rebecca West is fighting two difficult battles. Every day she lives with chronic pelvic pain, a condition she has endured for more than a decade. And now, she faces an uphill battle to maintain access to the medications that help her manage that pain.

“I can’t find a doctor who will prescribe me a long-term opioid,” West said, noting that every physician she’s seen agrees that an opioid therapy will help her manage her pain, yet won’t prescribe it because of the current climate. “I can’t find help and I don’t know what to do anymore.”

Shaina Smith understands. Smith lives with chronic pain, a sensation that radiates through her body due to a condition she will always have. Despite receiving a crushing, chronic diagnosis, she feels lucky. Because, she doesn’t need opioids to manage her pain.

Smith, the director of state advocacy for the U.S. Pain Foundation, knows the frustrations and fear that have settled across the pain community due to an opioid epidemic that is claiming more than 90 American lives every day. Smith’s friends who need opioids to manage pain are scared that their physicians will scale back or remove their opioid prescriptions in response to the current crisis and national conversation.

“Chronic pain patients don’t want to be on opioids. Sometimes it’s the only thing that helps them get through the day,” Smith said. “It’s the only mechanism that allows them to tolerate their pain.”

To say the water is choppy is to be forgiving when describing the landscape that the pain community is currently forced to navigate. Between regulations, reluctant healthcare providers and required step therapy from insurers, the pain community is effectively enduring both their physical ailment along with a battle to acquire the medications they need to manage it.

“All patients deserve at least an option,” Smith said.

Some patients simply can’t endure it all. Psychology Today and the Pain News Network, citing anecdotal evidence, report that suicides among chronic pain patients are on the rise, with a rate that is twice as high within the chronic pain community than outside of it. By that standard, it is plausible to estimate that up to 20,000 Americans are taking their own lives every year due to chronic pain.

And that’s the heavy fallout, according to pain advocates, that comes from limited access to pain management tools.

“There is a real tendency to trivialize pain now,” Dr. Steve Passik, Vice President of Scientific Affairs at Collegium, said. “We have a cultural belief that we’re all supposed to be John Wayne and sort of tough it out.”

Passik watched as his mother, a woman who lived with debilitating osteoarthritis, faced seemingly endless challenges when trying to obtain the pain treatment she needed. And she wasn’t alone in her struggle. Insurers have implemented “Fail First” or step therapy guidelines that require patients to progress through failed treatment options before receiving coverage for alternate options that may be safer or more effective, and may be the treatment their physician originally prescribed.

“No one intervention is right for everybody,” Passik said. “Opioid therapy is not a one-size-fits-all thing.”

But it appears regulators and payers are treating it that way.

For Amy Goldstein, the anxiety for all stakeholders in the pain community is palpable. As director of the State Pain Policy Advocacy Network under the Academy of Integrative Pain Management, she is hearing apprehension from every angle. She hears from chronic pain patients who are nearly defeated about their inability to access the medication they’ve used for years.

“In the current environment, opioids are scary to a lot of people,” Goldstein said, noting that providers are also discouraged by their inability to effectively treat people with chronic pain. “A lot of providers are just not comfortable prescribing opioids right now.”

Steve Adler, a physician assistant specializing in pain management in Arizona, would classify the current environment as “frustrating.” Adler, who has practiced in pain management for 13 years, has rarely found a chronic pain patient who becomes an addict. Yet, his patients tell him daily that they feel they’re being penalized by stiffer regulations due to an addiction crisis which they haven’t influenced.

Dr. Jeffrey Fudin, a pharmacist and professor of pharmacy in New York, said the co-liability that pharmacists now agree to when filling opioid prescriptions, knowing the drugs could potentially fall into the wrong hands, makes the job more challenging than it already is. He said the “Fail First” policies used by insurance companies do not guarantee a safer prescription, and he believes the regulations adopted by the insurance industry are contradictory.

“It pits the pharmacists against the prescribing physician,” Fudin said of current guidelines related to opioid prescribing. “Some of these patients are being cut off. They’re in a panic. There’s really two epidemics. There is an opioid abuse epidemic. But there is also an epidemic of undertreated pain patients. It is horrible.”

Yet, many of those on the front lines of the opioid crisis believe there is a different way forward.

An emerging technology within the pharmaceutical industry involves developing and employing abuse-deterrent formulas (ADF) for medications that have the ability to effectively treat a patient yet also have the potential of being abused or misused. But, like any pharmaceutical advancement, the availability of these ADFs depends on insurance companies.

Bill Carpenter sees the benefits of ADFs with clarity. As the father of a son who struggles with an addiction to heroin and as the mayor of a Massachusetts town that has been hit hard by addiction and the crimes associated with it, he can empathize with both sides of the crisis.

“There are folks with chronic pain who need pain relief and who these opiate painkillers make sense for,” he said. “How do we protect the rights and help the suffering of people who are suffering from chronic pain, without flooding the streets of the city with painkillers that are going to be abused?”

ADFs represent an advancement, significantly hindering its users from being able to manipulate a medication, resulting in misuse or potential abuse. Yet, insurers require patients to fail other treatment options first, before being granted coverage for an abuse-deterrent formula.

Progress on the acceptance of abuse-deterrent formulas is slow, but it is moving forward as influential thought leaders begin to pool their voices on the subject. The Food and Drug Administration (FDA) released a statement in November that supported the development and use of opioids with abuse-deterrent properties, calling the innovation a “promise for a meaningful public health benefit.”

And, more than a dozen states have passed legislation regarding the process and exceptions to “Fail First” policies, which is a start.

“There’s a strong interest in the opioids that are available with ADF qualities to limit the potential tampering of those for an unintended use,” Goldstein said. “Our concern is there may be prescribers who aren’t comfortable prescribing opioids if they don’t have an ADF. So, we need to make sure those are available.”