As naloxone prominence increase in opioid fight, so does price

The price of naloxone, a drug used to reverse the effects of an opioid overdose, has skyrocketed in the past few years. Despite complaints from lawmakers and national advocacy groups such as Harm Reduction Coalition, the price increases have come at a time when public health officials cite the record number of overdose deaths – more than 27,000 in the U.S. in 2014 – with almost 19,000 from prescription opioids and over 10,000 heroin-related, 16 and 28 percent increases from the previous year.

President Obama recently signed a law aimed at addressing the growing opioid crisis in the U.S. and naloxone is at the forefront of the conversation, as it is often the drug of choice to reverse the effects of opioids on the brain and can limit or stops a heroin or prescription opioid overdose. The Comprehensive Addiction and Recovery Act of 2016 increases the availability of naloxone, strengthens prescription drug monitoring programs (PDMPs) by assisting states with monitoring and tracking prescription drug diversion, and expands prevention and educational efforts with teens and other adult populations.

The most common formulation of naloxone used by police departments, hospitals, and addiction advocacy organizations is made by Amphastar Pharmaceuticals, which raised concerns after it increased the list price of 10 injectable naloxone from $120 to $330 in October 2014. In the last decade, Hospira’s injectable dose has gone from 92 cents in 2005 to more than $15 in 2014. Meanwhile, Kaleo Pharma raised the price of its naloxone product, Evzio, several times in since 2015. In November 2015, the price went up to $375, followed by an increase to $1,875 in February 2016; the single-dose auto-injector price is now at $2,250.

According to Truven Health Analytics, the rise in price has been partly driven from the lack of competition. The price hikes jumped in frequency and volume in 2008 after several manufacturers stopped producing the drug, leaving Hospira and Amphastar as the sole manufacturers of naloxone. Mylan and Kaleo only introduced naloxone products in 2014, but only Mylan, Amphastar, and Hospira make the cheaper, injectable versions. Kaleo makes the auto-injector.

The demand for naloxone is not likely to decrease in the near future, as Congress is considering requiring that physicians co-prescribe the drug with every opioid prescription.

HHS throwing water on the opioid epidemic fire

As the opioid epidemic in the United States continues, HHS announced a group of new actions to build on the HHS Opioid Initiative–which focuses on (1) improving opioid prescribing practices; (2) expanding access to medication-assisted treatment (MAT) for opioid use disorder; and (3) increasing the use of naloxone to reverse opioid overdoses–and the National Pain Strategy, the federal government’s first coordinated plan to reduce the burden of chronic pain in the U.S.

The new actions include a Final rule expanding access to buprenorphine, a medication to treat opioid use disorder, and other MATs. HHS also launched more than a dozen new scientific studies on opioid misuse and pain treatment and soliciting feedback to improve and expand prescriber education and training programs. The department took other steps on opioids in response to physician concerns about financial incentives to prescribe the drugs.

MAT Final rule

In a Final rule (81 FR 44712, July 8, 2016), the Substance Abuse and Mental Health Services Administration (SAMHSA) took action allowing more patients to receive buprenorphine prescriptions each year. Practitioners must have a waiver to prescribe buprenorphine–to be eligible for the waiver, the practitioner must have additional credentialing in addiction medicine or addiction psychiatry from a specialty medical board and/or professional society, or practice in a qualified setting. Under the waiver, the number of patients to whom they may prescribe the MAT is limited annually; under the Final rule, practitioners who have had a waiver to prescribe buprenorphine for up to 100 patients for one year or more, may now obtain a waiver to treat up to 275 patients. A supplemental notice of proposed rulemaking (81 FR 44576, July 8, 2016) asked for input on increasing the highest patient limit for qualified physicians to treat opioid use disorder under the Controlled Substances Act to 275. The proposal would help assure compliance with the MAT Final rule by adding reporting requirements for MAT prescribers.

Opioid misuse research and training

According to a request for information (81 FR 44640, July 8, 2016), deaths related to opioid analgesic–a class of prescription drugs such as hydrocodone, oxycodone, morphine, and methadone used to treat both acute and chronic pain–overdose have quadrupled since 1999. To fill knowledge gaps and improve the country’s ability to fight the opioid epidemic, HHS is launching more than 12 new scientific studies on opioid misuse and pain treatment. It released a related report and inventory on the opioid misuse and pain treatment research being conducted or funded by its agencies, which will help stakeholders and external funders of research avoid unnecessarily duplicating research. In addition, HHS developed activities that support opioid prescriber education, and seeks comment on current HHS prescriber education and training programs and proposals that would augment ongoing HHS activities.

Elimination of potential financial incentive to prescribe opioids

In an advance release of its Proposed rule for the hospital outpatient prospective payment system (OPPS), CMS suggested eliminating any potential financial incentive for doctors to prescribe opioids based on patient experience survey questions. The Hospital Value-Based Purchasing (VBP) Program ties payments to performance measures, including a pain management dimension. Providers and other stakeholders have told CMS that they are concerned about the pain management dimension putting pressure on staff to prescribe unnecessary opioids; the agency proposed removing the pain management dimension for purposes of the Hospital VBP Program “in an abundance of caution.” For more on the OPPS Proposed rule, see Patient-focused and physician-supporting changes proposed for OPPS and ASCs, Health Law Daily, July 7, 2016.