Opioids are powerful clinical tools that effectively treat pain and have a place in therapy, but it can be difficult to manage the dangers. Here's a look at some of the abuse-deterrent drugs on the horizon.
Estimates of the healthcare costs attributed to the abuse of prescription opioids run as high as $25 billion in the United States, according to the Centers for Disease Control and Prevention, much of them falling on managed care organizations.
Laurie Wesolowicz, director of Pharmacy Services for Blue Cross Blue Shield of Michigan, says this is one of the biggest challenges facing the industry right now.
“There is wide recognition that there is an opioid addiction epidemic, but the availability of experts to guide the treatment of individuals with substance abuse disorder is currently somewhat limited, including the number of available providers available to prescribe buprenorphine/naloxone for addiction,” Wesolowicz says.
“In addition to the direct costs of the opioid medications, we have significantly higher costs related to ER visits and inpatient stays for certain populations using high doses of opioids, typically for non-medical uses,” she says. “There are also challenges with evaluating the newer therapies to treat opioid addiction and determining how to provide coverage for them.”
However, opioid medications are powerful clinical tools that effectively treat pain and have a place in therapy for individuals with chronic pain,” says Nadina Rosier, North America Practice Leader, Pharmacy, Willis Towers Watson. “The challenges are to achieve a balanced approach to ensuring that individuals who suffer from chronic pain can get the necessary relief while minimizing the potential for negative consequences,” Rosier says.
Current opioids include a mix of branded and generic drugs. Oxycontin tops the list of highest utilization by cost, says Rosier. Others include Fentanyl buccal tablet (Fentora, Teva), oxymorphone hydrochloride Extended Release (Opana ER, Endo Pharmaceuticals), and generic narcotic analgesic combinations such as oxycodone/acetaminophen and hydrocodone/acetaminophen.
According to Wesolowicz , the most important drug in the near-term pipeline is the long-acting subdermal implant of buprenorphine/naloxone (Probuphine, Titan Pharmaceuticals, Inc. and Braeburn Pharmaceuticals).
“The [FDA] advisory panel endorsed approval, but had concerns with the number of patients that required breakthrough medication during the study as well as the limited number of patients actually studied in the trial,” Wesolowicz explains. “As the drug will be intended only for patients already stable on a buprenorphine regimen, there may be challenges with transitioning patients from the stable oral dose to the implanted product which could lead to relapses.
“As the implant can only be placed by a trained physician, the initial uptake of the product, if FDA-approved, may be slow initially but there will be a great demand. I expect the cost of the product to be at least the price of six-months of buprenorphine therapy, if not higher,” Wesolowicz adds.
Other drugs in the pipeline include “tamper-resistant” technology opioid formulations to prevent crushing or other means of product destruction that would allow inhalation or injection of the active opioid,” Wesolowicz says.
“The concern with these types of products is that they are typically priced very high and have a long-patent protection period. A clinical concern is that most of the abuse with oral opioid formulations is done by taking the drugs orally, not by tampering with the product. So you are paying a high premium for a product that if abused, will be taken by mouth,” she says.
Other products in the pipeline include the antidotes for opioid overdose, including various formulations of naloxone. “These products have provided a significant public health benefit by providing a reversal agent that can literally save the life of an individual after an acute overdose,” Wesolowicz says.
“The challenge is finding the most cost-effective way for non-health professionals to administer these products, as well as make them available in an appropriate manner,” she says. “From a health plan perspective, if we see over use of the naloxone products, that is a clear indication that case management should be offered to the patient requiring frequent use of the antidote for opioid overdose.”
According to Kimberly White, MBA, senior consultant at Numerof & Associates, a healthcare consulting firm, there are a number of drugs in the development pipeline that seek to reduce the abuse potential of opioid products. Some of these products seek to change the way opioids are released into the system and reduce the associated “high” (e.g., extended-release formulations and sub-dermal implants), such as twice-daily hydrocodone bitartrate extended-release (ER) tablets from Teva (CEP-33237) and Probuphine. Others, such as Nektar Therapeutics’ NKTR-181, are trying to redesign the product and its rate of entry into the brain to reduce the euphoria that often leads to opioid abuse.
“Due to the current abuse epidemic, there is a primary focus on products that are ‘narcotic antagonists’-medications that counteract the effects of opioid narcotics,” Rosier says. “Some narcotic antagonist medications are on the market today, but there are several in the pipeline with unique delivery systems that could be good alternatives.”
“FDA is also encouraging manufacturers to develop ‘abuse-deterrent formulations’ that would deter misuse or abuse with and difficulty injecting or snorting the drug,” Rosier says.
Prime Therapeutics has studied the costs and clinical events relationship among their members using a controlled substances (CS) score algorithm that identifies potential overuse/abuse of opioids/controlled substances, according to Prime’s Director of Health Outcomes Pat Gleason, PharmD, FCCP, BCPS.
“Our study findings, presented at the 2015 AMCP Annual meeting [in April], found a high-statistically significant-relation between increasing CS score and costs as well as clinical events.”
A one point change in controlled substances score was associated with an increase in $1,488 total healthcare costs, 0.9% increase in hospitalizations, and 1.5% increase emergency department visits.
Previous research demonstrated a prescriber letter intervention, using the CS score 12 or higher and 12 or more CS claims over 90 days as the intervention threshold, was able to reduce the CS score an additional 1.36 points compared to a control group. Findings from this study allow for the translation of the 1.36 point reduction in CS score for a 10,000 life group to potential cost avoidance of $40,480 annually or $0.34 per member per month.
“Health insurers should be actively identifying members who are either at risk for CS misuse/abuse or who appear to be over utilizing CS drugs and engage prescribers,” Gleason says.