In a letter published online in Annals of Internal Medicine(annals.org) Oct. 10, a team of researchers from Yale University, Yale New Haven Hospital and the Veterans Affairs Connecticut Healthcare System in New Haven suggested that Medicare Part D formularies could be used to restrict opioid prescribing and help fight the opioid abuse epidemic in the United States.
The authors analyzed CMS data to see what role Medicare Part D formularies may have played in restricting opioid prescribing in 2006, 2011 and 2015. They compared coverage for all available doses of commonly used short- and long-acting opioid medications, excluding methadone. Data were available for 324, 244 and 389 formularies in 2006, 2011 and 2015, respectively.
Specifically, the authors sought to determine the median proportion of drug-dosage combinations that formularies
- did not cover;
- covered but did not restrict; and
- restricted through prior authorization requirements, step therapy or quantity limits.
- A team of researchers in Connecticut analyzed CMS data to see what role Medicare Part D formularies may have played in restricting opioid prescribing in 2006, 2011 and 2015.
- The authors found that formularies increasingly used quantity limits and, to a lesser extent, prior authorization to restrict daily allowable prescribed dosing of opioids between 2006 and 2015.
- One FP expert noted that although restricting opioid prescribing can succeed in reducing the number of prescriptions written, it can also negatively affect family physicians and their patients.
They also calculated whether prescribed dosages were limited to less than 50 morphine milligram equivalents per day (MME/d) or to 50 to 90 MME/d, or whether dosages greater than 90 MME/d were permitted.
The researchers found that in 2006 and 2011, more than two-thirds of drug-dosage combinations had no opioid prescribing restrictions. That figure dropped to only about one-third in 2015.
The authors also found that few formularies required step therapy, but requirements for prior authorization increased with time (from a median of 0 percent in 2006 and 2011 to 4.4 percent in 2015).
A bigger change was seen in the median proportion of drug-dosage combinations that were restricted through quantity limits, which increased from 8.9 percent in 2006 to 22.2 percent in 2011 and 71.1 percent in 2015.
Also, dose restrictions to less than 50 MME/d increased from a median of 2.2 percent of drug-dose combinations in 2006 to 4.4 percent in 2011 and 13.3 percent in 2015.
Formularies increased coverage for hydrocodone-acetaminophen at all dosages from 2006 to 2015. And although no formularies required prior authorization or step therapy for this drug, the daily dosage was increasingly restricted for both the 5 mg/325 mg and 7.5 mg/325 mg formulations, with a greater proportion of formularies limiting prescriptions to less than 90 MME/d in this timeframe.
Restrictions on MME/d for the 10 mg/325 mg formulation increased slightly from 2011 to 2015, with about 80 percent of formularies allowing prescribing at levels higher than 90 MME/d in 2015.
"Medicare Part D formularies increasingly used quantity limits and, to a lesser extent, prior authorization to restrict daily allowable prescribed dosing of prescription opioids between 2006 and 2015," the authors said. "Despite increased formulary restrictiveness, unrestrictive coverage persisted for many opioids, especially at high doses, including for drugs commonly associated with overdose."
The example of formulary coverage for hydrocodone-acetaminophen showed that formularies typically were less restrictive at higher doses, which the researchers attributed to prescribers maintaining identical quantity limits regardless of dose, thus allowing for higher prescribed MME/d levels.
"Given that higher doses are associated with higher overdose rates, limiting prescribed MME per day or requiring prior authorization or step therapy for high-dose opioids may facilitate better adherence to CDC prescribing recommendations," the authors concluded.
Family Physician Expert's Perspective
Robert "Chuck" Rich, M.D., of Bladenboro, N.C., the AAFP's representative on the AMA Task Force to Reduce Opioid Abuse, told AAFP News he agrees with the authors that introducing prior authorization processes and formulary limits for these drugs can help fight the opioid abuse crisis.
According to Rich, who previously served as the chair of AAFP's Commission on Health of the Public and Science, a CDC Morbidity and Mortality Weekly Report(www.cdc.gov) published in July analyzed retail prescription data from QuintilesIMS to assess opioid prescribing in the United States from 2006-2015, including rates, amounts, dosages and durations prescribed. National-level prescribing data were scrutinized for the entire 2006-2015 period; county level data also were examined for 2010-2015.
Among that study's findings were that about half of U.S. counties saw decreases in the amount of opioids prescribed from 2010-2015, with some of the most substantial reductions occurring in states that initiated specific interventions intended to curtail excessive opioid prescribing.
For Rich, the implications are clear: "From the QuintilesIMS data, the more restrictive a state's prescribing policies were, the greater the percentage drop in opioid prescriptions that were written," he said.
He cautioned, however, that although restricting opioid prescribing can succeed in reducing the number of prescriptions written, it can also negatively affect family physicians and their patients.
"The more barriers you introduce regarding opioid prescribing, the greater the likelihood that providers of all types will drop their opioid prescribing privileges if they care for small numbers of chronic pain patients, and the increased likelihood that patients, particularly those on higher MME dosages, will sustain gaps in their prescription fills," Rich said. "All of which would ultimately have an impact on access to pain care."
If increased formulary restrictions are implemented, Rich said it will be important for health care professionals to consider how best to safely taper patients with legitimate chronic pain who are already on high-dose MME formulations off their medications.
He said he's seeing more opioid prescribing restrictions at the national level through the use of formulary limits and prior approval processes by Medicare Advantage plans and national pharmacy benefits plans, as well as at the local level through similar practices by Medicaid formularies and local pharmacy benefit plans, along with state-passed legislation limiting opioid prescribing.
Supporting Resources, Efforts
The AAFP has for years emphasized educating its members about appropriate opioid prescribing and has devoted a great deal of time to developing policies, guidelines and tools to help facilitate safe prescribing, Rich said.
Among these resources are a chronic pain management toolkit and a free members-only CME webcast on chronic opioid therapy. Another featured resource is the Academy's "Chronic Pain Management and Opioid Misuse: A Public Health Concern" position paper.
"Also, I must recognize our residency programs and the medical schools that have stepped up the training of our students and residents regarding safe prescribing," Rich added.
At the community level, Rich pointed to efforts such as his home state of North Carolina's lauded Project Lazarus(www.projectlazarus.org), which educates prescribers, patients, family members and others in the community about safe opioid prescribing and has contributed to reducing the number of opioids prescribed throughout the state.
Finally, Rich said when considering efforts to restrict opioid prescribing, it's important to remember that family physicians and other stakeholders need to advocate for patients with chronic pain, who are at the center of this issue and who require continued pain management. That includes those battling cancer, he said.
"Many of our cancer treatments leave the cancer patient suffering from various forms of chronic pain, and those patients need compassionate pain care including, as appropriate, chronic opioid therapy," said Rich.