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The Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued...by a federal judge...The ruling came in response to a lawsuit filed by state residents who claim the drugs are "medically necessary," and that the decision by the Washington State Health Care Authority to provide coverage to only the sickest patients had caused them harm...In a strongly worded...opinion, United States District Court Judge John Coughenour agreed with their argument. He wrote that the facts "clearly favor" their contention that state policy violates federal law. In his view, the evidence "establishes that there is a consensus among medical experts and providers that the life-saving [drugs] are medically necessary" for all hepatitis C patients...This is the first time a federal court has declared that widespread restrictions across a state Medicaid program is illegal for hepatitis C medicines...The opinion is only the latest instance in which a public or private insurer has been forced to reconsider its coverage policies toward hepatitis C medicines, which helped trigger a wave of controversy over the cost of prescription drugs...

If things go as some people hope, northwest Las Vegas could be getting a Level III trauma center at MountainView Hospital...The plan has been under consideration for years but needed updated numbers to show demand...The possibility of MountainView getting approval is not assured. The Regional Trauma Advisory Board did not support its application when the hospital first formally explored the possibility in October...The biggest pushback that we’re getting in the current system is from the existing trauma centers, and many people publicly are concerned that this would have a detrimental effect on UMC...It’s important to remember that the Level III trauma centers take care of the more minor cases, and if it turns out to be something significant, they send the patient to the Level I or II centers. So, looking at the current system, and Siena being a Level III, 85 percent of the people they see either get discharged from the emergency center or get sent to a Level I or Level II facility. They see less than four patients a year who should have gone to a Level I or II center right off the bat. So, the impact is three or four patients a year...At current population levels, MountainView is expected to handle roughly two trauma cases a day, said Swenson, adding the area sees 500 to 600 trauma cases annually.

One day after recommending approval of a new diabetes drug made by Novo Nordisk A/S, a U.S. advisory panel...recommended approval of a similar product made by Sanofi SA…combination drug, iGlarLixi, for patients with type 2 diabetes...IGlarLixi combines Sanofi's insulin drug Lantus with its experimental diabetes treatment lixisenatide, a member of a class of drugs known as GLP-1 agonists...Lixisenatide by itself is an experimental drug. The panel discussed FDA concerns that the drug may cause more allergic reactions than others in the class but were satisfied that its safety and efficacy was broadly in line with others in its class...An FDA approval decision on lixisenatide is expected in July and on iGlarLixi in August...

As a crucial deadline nears for a closely watched regulatory decision, two Republican senators are urging the Food and Drug Administration to approve a controversial drug to treat Duchenne muscular dystrophy...In a letter sent last Friday, the senators expressed "disappointment" that an FDA advisory panel last month voted not to recommend eteplirsen to combat the disease, which is a rare and fatal genetic disorder that causes muscles to waste away...The panel determined the drug was not effective...The FDA is scheduled to decide whether to approve the drug...by this coming Thursday...its decision is being closely watched as a litmus test for the agency, which is grappling with increasingly assertive patient groups that want the agency to take a more expansive view toward approving medicines for unmet medical needs...The advisory panel, which consisted of scientists and doctors who are not FDA employees, voted seven to three, with three abstentions, against recommending approval. But asked whether accelerated approval should be granted, the vote was much closer vote: seven said no and six said yes. The agency is not obligated to accept panel recommendations, but usually does so.

There’s an unfortunate irony for people who rely on morphine, oxycodone, and other opioid painkillers: The drug that’s supposed to offer you relief can actually make you more sensitive to pain over time. That effect, known as hyperalgesia, could render these medications gradually less effective for chronic pain, leading people to rely on higher and higher doses. A new study...the first to look at the interaction between opioids and nerve injury for months after the pain-killing treatment was stopped—paints an especially grim picture. An opioid sets off a chain of immune signals in the spinal cord that amplifies pain rather than dulling it, even after the drug leaves the body...Yet drugs already under development might be able to reverse the effect...spinal cord...microglia—sentinels of the nervous system that scout for infection...release inflammatory signaling molecules into the spinal cord, which activate neurons that shoot pain signals up to the brain...Researchers are...exploring drugs that interrupt this pathway to treat pain or improve the performance of opioids. A clinical trial recently launched at Yale University, for example, will test whether an antibiotic that inhibits glial cells prevents the inflammatory effects of opioids.

Brian Haug, president of The American Journal of Managed Care. Welcome to This Week in Managed Care, from the Managed Markets News Network.

Drug-resistant superbugs account for an estimated 700,000 deaths worldwide today, but that number could rise to 10 million within the next few decades unless new antibiotics are developed...That’s according to a new report commissioned by the UK government, which is proposing a provocative solution to the problem: a 10-year, $40 billion global fund to provide incentives to develop new superbug-fighting drugs...Under the proposed scheme, any drug maker that comes up with a useful antibiotic could receive a reward of around $1 billion...Governments are expected to provide much of the funding. But the report...also calls for a tax on any drug maker that fails to invest in new antibiotic research — and companies are already balking at the proposal. Industry trade groups quickly denounced the "pay or play" provision as "punitive" and warned it would "undermine goodwill."

The deadline for a final marketing decision at the FDA on Sarepta’s Duchenne muscular dystrophy drug eteplirsen arrives on Thursday. And the lead up to D-day continues to see patient advocates and their supporters passionately squaring off against some prominent experts who believe that an approval based on data regulatory insiders have deemed woefully inadequate would create a dangerous precedent at the FDA...Quite a few analysts give Sarepta only a 15% to 20% chance of success in gaining an accelerated approval this week, and that figure would likely be much lower if not for the powerful lobbying campaign that has enlisted the support of some prominent newspapers and politicians...The FDA's job is to get drugs out on the market that are proven safe and effective...there simply were not enough data in place from the corporate sponsor to make that possible. At the same time, companies shouldn't be deluding patients and families into thinking that they have enough data to go to the FDA. They shouldn't approach the FDA unless they truly have the available data to get approved. Relying on patient testimonials and lobbying is not the path to drug approval...There’s only one thing that’s absolutely certain at this point: Whichever way the FDA turns, there will be a storm of protest.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The implant promises to treat opioid addiction without the hassle of a daily pill. And the company marketing the drug is so confident it’ll work, it’s planning to offer insurers a twist on a money-back guarantee: If the new device doesn’t save them money, they’ll get a refund...The implant, branded as Probuphine, relies on four tiny rods implanted under the skin to dispense the drug buprenorphine for six months at a time. The Food and Drug Administration is expected to decide on Friday whether to approve it...Braeburn Pharmaceuticals...has commercial rights to the implant...plans to price the implant "competitively" with other injectable drugs for neuropsychological conditions…"We are going to put our money where our mouth is," said Braeburn CEO Behshad Sheldon. "We believe that when you guarantee compliance with a medicine, it is going to save money in the long run."...The FDA rejected the implant the first time it came before the agency in 2013, requesting more data demonstrating its efficacy.