Even generic buprenorphine is expensive — sometimes more expensive than the branded versions, the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law was told by witnesses at its Sept. 22 hearing, “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.” “The unnecessarily high price attached to these medications increases the cost of health care, and reduces patient access to these medications,” said Eric Ketcham, M.D., representing the American College of Emergency Physicians. Ketcham, the director of New Mexico Treatment Services, an opioid addiction treatment clinic, said that during that week in September, the generic versions of buprenorphine-naloxone cost more than the brand names — $10.42 a tablet, amounting to $625.28 for a 30-day supply. This is despite the fact that there are multiple manufacturers, and that there is a generic.
“We could endlessly debate the factors that have contributed to the rise of this widespread and deadly epidemic in America, and how best to curb its growth,” said Ketcham. However, the fact is that there are solutions in treatment with buprenorphine, “which should be a low-cost medication,” he said. Methadone is a low-cost medication but can only be given in the context of opioid treatment programs, which have limited space.
“Congress must ensure that buprenorphine, and buprenorphine/naloxone combination medications, are affordable as prescriptions,” said Ketcham, adding that naloxone, the medication that reverses opioid overdoses and therefore can prevent death, should also be more affordable.
“Surveying local pharmacies in northwest New Mexico (all from national pharmacy chains), the wholesale price paid by the pharmacy for generic 8 mg buprenorphine sublingual tablets recently increased from $2.37/tablet to $5.57/tablet,” Ketcham said. “Most opioid-dependent patients are treated with two tablets daily, and thus a 30-day supply costs $334.20.” The pharmacies have a margin of less than 2 percent, which they use to pay for packaging, said Ketcham. If the patient doesn’t have adequate insurance and must also pay out of pocket for seeing the physician in order to get the prescription, the entire process may be unaffordable for the patient, said Ketchum. The end result is unfilled prescriptions.
For patients on Medicaid, the program pays the full retail price, he said, noting that “state Medicaid budgets are bearing a substantial burden trying to cover each patient’s regular monthly supply of buprenorphine at an annual cost of more than $4,000 each.”
Suboxone, made by Indivior, only comes in film. Zubsolv and Bunavail, the two other brand names of buprenorphine-naloxone, come in tablets. Generics only come in tablets, because Indivior holds the patent on film.
Acute opioid withdrawal can only be prevented by consuming opioids — and that is what methadone and buprenorphine are. Without these medications, people must turn to other opioids, including heroin or fentanyl, to avoid the symptoms of withdrawal, which include abdominal pains, vomiting, diarrhea, severe muscle cramps, tremor, twitching, headaches, dysphoria and sometimes seizures. The street price of diverted buprenorphine is similar to the retail prices in northwest New Mexico, which is usually marked up 50 percent above current prescription prices, said Ketchum.
Also testifying at the hearing were Robin Feldman, professor at the University of California, Hastings College of Law, who talked about how pharmaceutical companies, by changing the delivery system (as Reckitt Benckiser did with Suboxone), can prolong their patents and therefore their profits, and three representatives of the pharmaceutical industry: Anne McDonald Pritchett, Ph.D., vice president for policy and research from Pharmaceutical Research and Manufacturers of America; David Gaugh, senior vice president for sciences and regulatory affairs from the Generic Pharmaceutical Association; and Mark Merritt, president and CEO of the Pharmaceutical Care Management Association. All testimony, and a video of the entire hearing, can be found at https://judiciary.house.gov/hearing/treating-opioid-epidemic-state-competition-markets-addiction-medicine/.