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May 12, Wisconsin Health News
The state added an additional opioid-addiction treatment to its preferred list for Medicaid patients Wednesday, after law enforcement and legislators raised concerns about a current preferred drug that they say is being smuggled into jails.
The Medicaid Pharmacy Prior Authorization Advisory Committee classified the medication Zubsolv, which comes in a tablet, as a preferred drug for treating opioids. The committee also kept Suboxone, a film strip that dissolves under the tongue, on its preferred list.
In April, two associations representing sheriffs in Wisconsin wrote Medicaid Director Michael Heifetz that the "thin and malleable" strips have become "leading contraband" in jail, as inmates can abuse the drug. The associations suspected Medicaid-eligible families were "partially responsible" given jail demographics.
Rachel Currans-Henry, director of the Bureau of Benefits Management in the department's Division of Medicaid Services, said Wednesday that adding Zubsolv gives providers and members another option.
"There is an increased cost of this for the department," she said. "But in the interest of ensuring that we are addressing a public health epidemic in the state and the country, we believe that the benefits outweigh the costs."
Heifetz said they have "to balance all these things."
"We cannot just look through one lens," he said. "We have to look through a number of lenses, the taxpayer lens, the clinical lens and in this situation the law enforcement lens as well, which is a rarity for us."
Marquette County Sheriff Kim Gaffney, president of the Badger State Sheriffs' Association, hoped the decision would make a difference.
"On behalf of sheriffs across the state, we are hopeful that more opioid treatment options in the Medicaid program will reduce the prevalence of film strips and them being smuggled into jails," he said in a statement.
At a public hearing before the committee took its vote, Assembly Committee on Corrections Chair Mike Schraa, R-Oshkosh, demonstrated how the strip could be concealed under a stamp.
The strip is easier to "sneak into" jails than pills, cigarettes and other contraband, sometimes coming in through children's artwork or Bibles, he said.
"There's no good reason for the government to fuel the black market with this product," he said.
He was also concerned because Wisconsin Attorney General Brad Schimel has joined more than 40 other states to sue Indivior, the maker of Suboxone, alleging that the company switched from a tablet to a film to ensure patent protection and discourage the development of generics.
William Mullen, managed care clinical advisor for medical affairs at Indivior, encouraged the committee to "open the formulary for all" medication-assisted treatments approved by the Food and Drug Administration for opioid addiction.
That would allow doctors to choose what works best for their patients, he said. But Mullen cautioned that all drugs that contain buprenorphine, like Suboxone and Zubsolv, have a potential for abuse, misuse and diversion.
"The company will continue work with the FDA to address misuse, abuse and diversion," he said.
Lawmakers approve bills targeting opioid addiction
The Senate and Assembly passed a number of bills that are part of Gov. Scott Walker's special session targeting opioid addiction Tuesday.
The proposals originated from a preliminary report issued in January by a task force co-chaired by Rep. John Nygren, R-Marinette, and Lt. Gov. Rebecca Kleefisch.
"With the nine special session bills advanced today, the Senate has taken several great strides towards helping to combat our state's ongoing opioid crisis," Senate Majority Leader Scott Fitzgerald, R-Juneau, said in a statement.
But Democrats questioned whether the bills go far enough.
"After years of struggles, we're taking baby steps when we should be making major strides to improve outcomes and strengthen community safety," Senate Democratic Leader Jennifer Shilling, D-La Crosse, said in a statement.
The Senate approved proposals that would:
The Assembly approved the bills last month, so they now head to Walker's desk for his approval.
The chamber also approved two additional bills Tuesday that are part of the package but haven't been taken up by the Senate. Those measures would:
The Senate Committee on Education approved two bills Monday that are part of a special session ordered by Gov. Scott Walker to tackle the opioid epidemic.
A bill that would provide $50,000 to help establish a recovery charter school, which would serve 15 high school students in recovery from substance use disorder, passed out of committee 6-1. Sen. Steve Nass, R-Whitewater, voted against it.
An additional proposal providing $200,000 a year to expand the use of a substance abuse screening by the Department of Public Instruction passed 7-0. The Assembly has already approved both measures.
April 26, 2017
Today, Inspirion Delivery Sciences LLC announced that RoxyBond (oxycodone hydrochloride) tablets CII have been approved by the FDA for oral use to manage severe pain requiring an opioid analgesic and for which alternative treatments are insufficient, according to a press release.
“Inspirion is pleased to receive FDA approval for our second abuse-deterrent product, RoxyBond, which is intended to address the long-standing unmet need for immediate-release abuse-deterrent opioids,” Stefan Aigner, MD, CEO of Inspirion, said in the release. “There are nearly 18 million prescriptions for immediate-release oxycodone hydrochloride annually in the U.S. alone.”
RoxyBond uses physical and chemical barriers without aversive agents or opioid antagonists to deter abuse even when subjected to manipulation or extraction, and it is the first and only immediate-release opioid analgesic approved with abuse-deterrent label claims, according to the release. The drug is approved in dosages of 5 mg, 15 mg and 30 mg. According to the release, inactive ingredients in RoxyBond make misuse and abuse more difficult, and in head-to-head trials with another approved oxycodone immediate-release tablet, RoxyBond had higher resistance to cutting, crushing, grinding or breaking, as well as passage through a needle. Furthermore, RoxyBond indicated resistance to extraction in selected household and laboratory solvents under various conditions, whether intact or manipulated. The tablet also makes developing solutions for IV injection difficult. However, it is still possible for abuse to occur via the intranasal, oral and IV route, according to the release.
Researchers performed a clinical abuse potential study.
“As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration,” Lynn R. Webster, MD, principal investigator from PRA Health Sciences, said in the release.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 0, with one abstention, to recommend approval of RoxyBond on April 5, 2017, according to the release.
“Oxycodone immediate-release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse,” Jeffrey Gudin, MD, department director of the Pain Management Center Englewood Hospital and Medical Center, said in the release.
Curbing opioid abuse has been a focus over the last several months for the FDA, which earlier this year approved several pain relief agents that are specifically manufactured to make them more difficult to abuse.
Citing the “epidemic of overdose deaths,” the CDC issued guidelines for primary care physicians and other medical professionals for opioid prescriptions last year.
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April 18, Wisconsin Health News
Gov. Scott Walker has signed into law a bill ending state penalties for those who possess cannabidiol without psychoactive effect if they have written certification from a doctor.
The bill also directs the state's Controlled Substances Board to reschedule CBD oil, which is derived from marijuana and sometimes used to treat seizures in children, within 30 days following a change at the federal level. The bill passed the Senate 31-1, and the Assembly 98-0.
The bill builds on a 2014 law that aimed to make the drug available with a prescription in the state. But supporters said that providers weren't able to prescribe the drug, which is still illegal to obtain under federal regulations.
Wisconsin will receive $7.6 million from the federal government to combat opioid addiction, the Department of Health and Human Services announced Thursday night.
HHS is providing $485 million to all 50 states, the District of Columbia and six U.S. territories. The funding, made available under the 21st Century Cures Act, will go toward prevention, treatment and recovery services.
States were awarded funding based on rates of overdose deaths and unmet need for treatment. Florida received the most money at $27.2 million, while five territories received $250,000 each.
Gov. Scott Walker directed the Department of Health Services to seek the funding in an early January executive order. DHS can re-apply for additional funding next year.
Source: WI Health News
by Bob Davis | March 9, 2017
On Monday, March 6th, Republican leadership introduced the American Health Care Act (AHCA). The AHCA is Republican’s plan to repeal and replace the Affordable Care Act (ACA).
The American Society of Addiction Medicine (ASAM) is very concerned that the AHCA’s proposed changes to our health care system will result in reductions in health care coverage, particularly for vulnerable populations including those suffering from the chronic disease of addiction, and we cannot support this bill in its current form.
More than 20 million Americans currently have health care coverage due to the ACA, including millions of Americans with addiction. The ACA expanded Medicaid, required health plans to cover essential health benefits such as addiction treatment, and mandated plans to treat mental health services at parity with medical and surgical services. This coverage is a critical lifeline for people with addiction, many of whom were unable to access treatment before the ACA’s expansion of Medicaid, and has reduced the burden of the opioid epidemic and saved lives.
The AHCA will roll back these important provisions and will certainly reduce access addiction treatment and reverse much or all progress made on the opioid crisis last year.
The AHCA passed out of the House Ways and Means Committee and is being considered by the House Energy and Commerce Committee.
Wisconsin Society of Addiction Medicine563 Carter Court, Suite B,Kimberly, WI 54136
