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Though the vast majority of specialty physicians know what biosimilars are, their knowledge about these emerging medications falls short, according to a survey by the Biosimilars Forum...Of 1,201 U.S. physicians polled, 76.8% had heard the term biosimilars within the previous month...Yet respondents exhibited five key gaps in knowledge: defining biologics, biosimilars and biosimilarity; understanding the biosimilar approval process and the Food and Drug Administration’s use of totality of evidence to assess biosimilars; appreciation that biosimilars’ safety profile is expected to be the same as that of the originator biologic; understanding how the FDA makes decisions for extrapolation of indications; and defining interchangeability and the related rules regarding pharmacy-level substitution...With four biosimilars approved by the FDA and more than 60 in development, the survey highlights the need for greater biosimilars education for physicians and health care professionals...

Drums? What drums?...Yet another foreign company tried to fool the US Food and Drug Administration, but without success...The latest example occurred when Beijing Taiyang Pharmaceutical, an ingredients maker, refused to let FDA inspectors enter a warehouse after noticing drums used for storing chemicals through a window. The next day, the inspectors were allowed in, but saw a "significant" number of drums were gone. But employees would not say where the drums were taken or what had been stored inside them...This sort of behavior...is an ongoing problem for the agency...a big fib. At the time of the November 2015 inspection, Beijing Taiyang told the FDA inspectors they had stopped making a certain ingredient two months earlier. But the inspectors reviewed electronic audit trails on instruments and found the company conducted numerous analyses of the ingredient prior to the inspection...But the FDA remained unconvinced. The agency pointed out that its inspectors noticed that the batch numbers on the recently made ingredients corresponded with a batch numbering system for actual products, according to the warning letter.

Express Scripts disclosed this week that the U.S. Attorney’s offices in New York and Massachusetts had demanded information about two different issues: financial ties with pharma companies, and relationships among drugmakers, patient assistance programs and the specialty pharmacies that fill prescriptions...Specifically, the federal prosecutors in New York want information about money changing hands between Express Scripts and pharma companies. That would include rebates that drugmakers pay to win favorable reimbursement deals for their products...The newly disclosed Express Scripts probes aren’t the first DOJ demands for information about PBM-pharma relationships. In a series of financial filings in May, it became clear that the DOJ was looking for information across the industry. Johnson & Johnson, Merck & Co. and Endo International all said they were being asked for info...secrecy could be coming to an end. Politicians and patient advocates are calling for more transparency from PBMs and drugmakers alike, and obviously, the DOJ is doing the same.

Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

A long-running debate in Nevada’s medical community is heating up, with doctors challenging a new regulation that would enable dental hygienists to administer Botox to patients for either medical or cosmetic reasons...The State Board of Dental Examiners...last month approved rules that would extend the privilege to licensed dental hygienists...But the Nevada State Medical Association, which represents the state’s practicing physicians, is pushing back. It says use of the toxin should not be extended to dental hygienists, who can be licensed after as little as two years of study at an accredited college, and that dentists should be restricted to applying it to certain areas of the head...Dentists...have called the dispute a "turf war," arguing that physicians are attempting to protect a lucrative and increasingly common medical procedure.

As Americans grapple with the rising cost of medicines, a contentious ballot measure in California is being billed as a fix to an intractable national problem...Known as Proposition 61, the proposal would require state agencies to pay no more for prescription drugs than the Department of Veteran Affairs, which receives a federally mandated 24 percent discount from manufacturers. In theory, that would lower drug costs for up to 7 million residents of California who get insurance coverage for their medicines through various state agencies, including low-income residents on the state version of Medicaid...the measure has merits and flaws. Ultimately, the California Drug Price Relief Act is a well-intentioned proposal that clearly sends a strong message to the pharmaceutical industry — but the details should also give us pause...Prop 61 is imperfect and, ideally, pricing should be addressed on a national level. But the measure sends a needed message that the status quo is unsustainable. Until the pharmaceutical industry recognizes this sad reality, there will be more — and better — propositions before voters...

It may not feel like it, but Nevadans who get their health insurance courtesy of the Affordable Care Act can consider themselves relatively lucky as 2017 comes into focus...Yes, they will pay an average of 11 percent more in premiums for their coverage than they did this year. And, yes, many will only be able to pick from plans offered by a single insurer...But it could have been far worse. Proof lies just across the border in Arizona, where some premiums are skyrocketing by triple digits and most insurers have fled the market...A new federal report on insurance premium prices released earlier this week and a county-level analysis published...by the Associated Press and consulting firm Avalere Health painted a comprehensive picture of the state of ACA health care insurance entering 2017...It wasn’t pretty...report by the Department of Health and Human Services showed that premiums for a midlevel benchmark plan will increase an average of 25 percent in 2017 across the 39 states served by the federally run online market, including Nevada...HHS officials noted that a majority of those who purchase plans through HealthCare.gov and its state-run counterparts – including Nevada’s Silver State Health Insurance Exchange — receive financial assistance and may not see their out-of-pocket expenses increase much, if at all. It may not feel like it, but Nevadans who get their health insurance courtesy of the Affordable Care Act can consider themselves relatively lucky as 2017 comes into focus.

Experts from across the valley have taken a hard look at both the city and state’s mental health care situation, and most agreed that, in order to fix things, it will take time, new professionals and lots of money...Nevada has the fewest clinicians of any state — that’s providers who can sit with you and know what to do. In Nevada, only one in three adults that has mental illness will be able to get help. Only one in two children who have severe mental illness can get any help. There’s not enough of us to go around....the shortage of professionals is the root of many of the problems...part of that is infighting between various designations of health care professionals, which ultimately leads to state licensing complications...We don’t have enough professionals, and when professionals try to move here from out of state, we don’t certify them so they can get to work...positive sign that the Nevada Legislature is discussing collapsing all of the licensing boards — for anything to do with behavioral health — into one entity...our system is so poor that most professionals are celebrating this. We believe it will streamline the system, provide resources and bring professionals into the field...

Memo to biopharma executives: when talking to shareholders, take care to tell the whole truth and nothing but the truth...That’s the message delivered this week to Arena Pharmaceuticals after a federal appeals court ruled...that shareholders can proceed with a lawsuit alleging the company deliberately withheld crucial information about a potential problem with a widely anticipated diet drug...At issue was a series of statements Arena executives made in 2009 about the progress they were making in winning Food and Drug Administration approval for the Belviq (lorcaserin) diet pill... company executives made or issued statements expressing confidence that the pill would be approved, because safety and effectiveness had been demonstrated through clinical trials and animal studies. Here’s the rub: while the reference to animal studies mentioned the need to ensure there was no risk that cancer seen in rats could develop in humans, Arena did not disclose a dispute about study results with the FDA...Whether the shareholders prevail remains to be seen...The ruling only means that the shareholders get to fight another day. But the court is sending a signal that if drug makers are going to describe trial results and discussions with the FDA, they should not dress up information, a common predilection in a world where exciting investors is a high priority.

Sara Belanger With The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network