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U.S. regulators have approved new competition for EpiPen, the emergency allergy medicine that made Mylan a poster child for pharmaceutical company greed...The Food and Drug Administration on Thursday approved Adamis Pharmaceuticals Corp.'s product, which should go on sale later this year...Symjepi is a syringe prefilled with the hormone epinephrine…Adamis says its product is easier to use than Mylan's EpiPen, a spring-loaded syringe filled with a set dose that comes with a training device...Symjepi also is smaller than EpiPen, so it's easier to fit in a pocket or purse. Most children and adults with severe food or insect allergies carry a device wherever they go and leave a spare at home, school or work...Just three years ago, EpiPens accounted for nearly 90 percent of both revenue and prescriptions filled in the U.S. for epinephrine injectors and syringes...In the first quarter of this year, brand-name EpiPens only drew about 60 percent of epinephrine device prescriptions, while generic EpiPens - mostly Mylan's - had captured 38 percent of prescriptions...

Nevada Gov. Brian Sandoval signed into law...the nation's strictest requirements for pharmaceutical companies to reveal how they set certain prescription drug prices...The bipartisan legislation focuses on insulin - one of many life-sustaining prescription treatments sold in the U.S. at prices that have skyrocketed over the last decade...The law requires drugmakers to annually disclose the list prices they set, profits they make and discounts they give market middlemen on insulin...They must also give state officials written explanations of any insulin price hikes that surpass the previous year's inflation rate...The bulk of the legislation takes effect in October, but the first disclosures will be due on April 1, 2018...insulin manufacturers will face fines of $5,000 daily if they fail to provide the data without explaining why...pharmacy benefit managers, suggested that the law's "costly fiduciary mandate" resembles legislation that federal courts have previously rejected based on violations of federal benefits laws...In addition to the insulin-specific requirements, Nevada's law will outlaw "gag rules" that bar pharmacists from suggesting alternate or less-expensive prescription options...All drugmakers will also have to register sales representatives who market prescription drugs in Nevada...

Centene Corp. says it will begin offering coverage under the Affordable Care Act for insurance exchanges in Missouri, Kansas and Nevada next year at a time other insurers are pulling out of such marketplaces...Centene announced the expansion Tuesday. It didn't specify whether its foray into Missouri and Kansas will fill a 32-county void that will result from Blue Cross and Blue Shield of Kansas City's decision to leave that individual insurance marketplace next year...That Blue Cross decision affects about 67,000 people, and 25 Missouri counties will be left with no insurance provider under the exchanges unless another company steps in to sell coverage...Centene also plans to expand in Florida, Georgia, Indiana, Ohio, Texas and Washington...It says 90% of its exchange customers are eligible for subsidies.

The decision has major implications for the pharmaceutical industry because it will dictate how long brand-name makers of biologic drugs can keep near-copies, called biosimilars, off the market. Even the six months at issue in the case can mean hundreds of millions of dollars in sales...Health insurers expect biosimilars to be cheaper than original brands, like generics, saving consumers billions of dollars each year...Novartis said in a statement that the ruling "will help expedite patient access to life-enhancing treatments."...Amgen spokeswoman Kelley Davenport said the company was disappointed but "will continue to seek to enforce our intellectual property against those parties that infringe upon our rights."...The companies disagreed on how to apply that law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version...In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval, a ruling the Supreme Court reversed...Writing for the court, Justice Clarence Thomas said that the decision was not based on policy arguments, but rather, the "plain language" of the biosimilar law itself...

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Nevada is attempting to join 31 other states in expediting health care for immigrant children from low-income families...Implementing speedier coverage will hinge on whether President Donald Trump's administration grants the state permission...If so, an estimated 5,000 minors with green cards, refugee youth and certain other young immigrants will become eligible for Medicaid sooner than previously expected...Gov. Brian Sandoval signed Senate Bill 325...It ends the current five-year wait period for children with residency paperwork to get on government-subsidized health insurance.

Every day, countless people across America order prescription drugs from pharmacies in other countries as they hunt for something increasingly elusive — affordable medications...Under most circumstances, importing medicines is illegal...And it is time to scrap this prohibition, unless Congress finds another way to drive down drug costs...Sixty percent of Americans say lower drug costs should be a top priority, and a whopping 72 percent support the idea of importing medicines from Canada, according to a recent Kaiser Family Foundation poll...8 percent of adults surveyed reported that they or someone in their household have already bought prescription drugs from outside the U.S...Meanwhile, the cost of 20 widely used drugs is three times cheaper in Canadian than in New York pharmacies...

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

Lawyers for a Massachusetts pharmacy executive convicted of fraud for his role in a 2012 U.S. meningitis outbreak that killed 64 people asked a judge to order a new trial, charging that prosecutors misbehaved in providing evidence to the jury...Barry Cadden, co-founder of the now-defunct New England Compounding Center, was cleared of second-degree murder charges but was found guilty in March of racketeering and fraud for his role in shipping injectible steroids tainted with fungus linked to the deadly outbreak that also sickened 753 people in 20 states...Cadden's attorneys argued that prosecutors overreached in the number and severity of criminal charges that they filed against him. The attorneys said the prosecutors misled the jury by providing them a binder filled with laboratory tests showing that vials of steroids shipped by NECC were tainted but not providing comparable reports submitted by defense attorneys showing the vials were sterile.

Two of the world’s top drug companies and a local pharma are in the hot seat in South Africa as competition officials launched a probe into "excessive pricing" on lifesaving cancer meds...South Africa’s competition commissioner Tembinkosi Bonakele announced...that his agency would probe pricing on cancer drugs from Roche, Pfizer and Aspen Pharmacare, according to the Competition Commission of South Africa’s official Twitter account...Roche is under investigation for breast cancer drug pricing, according to the commission, while Pfizer’s lung cancer drug pricing is included in the inquiry...Aspen said the probe is for "suspected abuse of dominance" in the cancer drug market...In announcing the probe, the South African commissioner pointed to patents as a driver of high drug prices…Under South African law, the Department of Health "establishes a universal fixed price" for pharma products...Commissioner Bonakele said the probe will "look at patents and how they get abused,"..."A perpetual monopoly aided by patents is unlawful,"…