Prescription Opioid Abuse
Earlier this year the FDA debuted a concerted effort to combat opioid abuse in America. The FDA Opioids Action Plan, as it was named, is a multi-pronged approach for dealing with a scourge that has gotten progressively worse.
- Approximately 80 percent of the global opioid supply is consumed in the United States.
- Opioid prescriptions (hydrocodone and oxycodone products) increased from around 76 million in 1991 to nearly 240 million in 2014
- Opioid abuse or dependence increased from 1.4 million in 2004 to 1.9 million in 2013
- Overdose deaths involving prescription opioids such as oxycodone, hydrocodone and morphine have tripled – from 6000 in 2001 to 18,000+ people dying in 2014
The steps listed in the plan deal with ways of handling drug misuse, dependence and overdose both proactively and reactively. To help curtail the crisis the FDA starts with preventative measures: expanded use of advisory committees and a more robust risk-benefit framework for opioid approvals. Next is keeping vigilant to discourage abuse as those drugs are dispersed: expanding and updating Risk Evaluation and Mitigation Strategy (REMS) Programs, more stringent safety labelling, and abuse-deterrent formulations (ADFs). And, lastly, if and when opioid abuse occurs, better access to overdose treatment.
With regard to the latter, last week the FDA instituted a challenge to technology innovators. Called the 2016 Naloxone App Competition, they are inviting “computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to create a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers [first responders, community-based organizations and laypersons] of the prescription drug naloxone – the antidote for an opioid overdose – thereby increasing the likelihood of timely administration and overdose reversal.”
The FDA’s efforts are noble, but may not be enough in the face of a pharmaceutical industry that does not give its profits up easily. And the opioid industry is a behemoth. It is a $24 billion market worldwide, and as noted above, 80% of that goes to America.
To make matters worse, the prospect of garnering even bigger profits has unfortunately led to some unscrupulous dealings within that industry. The recent expose of health care giant Abbott Laboratories and Purdue Pharma LP (the company that developed OxyContin) is just one example. In 2004, Purdue had to pay $10 million to the state of West Virginia, the result of a court case documenting that sales reps from both companies downplayed OxyContin’s addictive qualities to doctors, as well as making boasts about the drug’s efficacy which had no basis in fact. Later, in 2007, Purdue relinquished $600 million in fines after pleading guilty to misleading doctors and the public about OxyContin. While these seem like hefty penalties the companies could certainly afford them. Total sales of OxyContin from 1996 through 2002 was nearly $5 billion.
Even when discounting such distasteful tales of dishonesty that industry has other legitimate avenues to exploit the blight of addiction. Q. Who benefits from the FDA’s naloxone competition? A. The makers of naloxone. (One maker’s AWP per unit soared from $2.52 in 2010 to $18.53 in 2014; another’s list price of a two-dose auto-inject version increased from $575 to $3,750 in a two-year span.) Further, there is a remedy for those who are addicted to painkillers: Suboxone. That’s right, a pill to get off pain pills. Big pharma wins again!
Fortunately, the FDA has help on its side in its campaign against opioid addictions. The Centers for Disease Control and Prevention (CDC) are helping the addicted get the help they so desperately need through their Medication-Assisted Treatment (MAT) program and also through exhorting the benefits of naloxone. Better still, another way the CDC is raising public awareness to the hazards of drug misuse is by offering financial incentives to communities across America who support the CDC’s programs and guidelines. As of March 2016, the CDC has bestowed over $30 million to 29 states to improve safe prescribing practices.
Little by little, insurance companies are entering the fray to help get the crisis under control. Aetna has its own database to track “high risk” patients, alerting their doctors to be watchful for drug abuses. BCBS Massachusetts made a major change to its policy: if a patient is prescribed more than 30 days’ worth of painkillers, the doctor must get prior authorization from the insurance company. Cigna encourages primary care doctors to recommend physical therapy—or even cognitive behavioral therapy—to patients who complain of pain. And just this past May, Cigna announced a partnership with the American Society of Addiction Medicine (ASAM) to study which substance abuse treatments are most effective.
Getting even more insurance companies involved is paramount. Combatting the opioid abuse problems America faces may be an uphill battle but it’s one in which the industry has a strong incentive to engage. Estimated nonmedical use of opioid pain relievers costs insurance companies up to $72.5 billion annually.
Brought to you by Jason Marcewicz, Special Projects Manager
Advanced Medical Strategies