Author: Peter

Gilead Sciences Inc….secured U.S. approval for its newly acquired CAR-T therapy, giving adult patients with a certain type of lymphoma and few other options a promising new treatment that offers the hope of remission for some...The regulatory OK...puts Gilead at the forefront of cancer cell therapy development and validates the biotech's decision to buy the drug's original developer, Kite Pharma Inc...Gilead will market the therapy under the brand name Yescarta (axicabatagene ciloleucel) at an annual cost of $373,000 — a price that underscores the affordability challenges presented by the personalized nature of CAR-T treatment…Throughout the development of Yescarta, Kite stayed neck and neck with the larger and well-resourced Novartis AG. While Novartis can claim the landmark of winning the first ever approval of a CAR-T therapy, Gilead's near $12 billion takeover of Kite is a worthy second prize.

A federal prosecutor told jurors...that a Massachusetts pharmacist gambled with patients’ lives by making drugs in unsafe ways that led to a deadly 2012 fungal meningitis outbreak, but a defense lawyer said he was no murderer...Glenn Chin, a former supervisory pharmacist at New England Compounding Center, made drugs in filthy conditions, producing mold-tainted steroids in the process...Those steroids were shipped out to healthcare facilities nationally and then injected into patients, leading to an outbreak that sickened 778 people, including 76 people who died…“Make no mistake, Glenn Chin is not sitting in this court room because he was negligent or careless,”... “He is here because of his deliberate choices.”...Chin directed “massive corner cutting” in...NECC’s so-called clean rooms where the drugs were made, prioritizing production over cleaning and failing to properly test or sterilize drugs.

Anthem Inc. plans to create its own pharmacy benefit manager in a move that will cut ties with the big insurer's current partner, Express Scripts Holding Co...The new PBM, dubbed IngenioRx...Anthem has also signed onto a five-year agreement with CVS Health Corp. that will provide prescription fulfillment and claims processing services, as well as other benefits like larger scale. The agreement is slated to begin on Jan. 1, 2020, after Anthem's contract with Express Scripts expires... Anthem leadership said the pivot will save an estimated $4 billion annually once IngenioRx becomes fully integrated…our new PBM will be focused on managing the total cost of healthcare to improve affordability for our members...

Pharma companies have faced a gamut of allegations over the years, but a new lawsuit ups the ante by alleging several drugmakers paid bribes in Iraq that helped fuel terrorism...the lawsuit alleged that top pharma companies Pfizer, Roche, Johnson & Johnson and AstraZeneca paid bribes to secure healthcare contracts in Iraq. Those payments ultimately supported terrorism that hurt or killed U.S. service members...More than 100 veterans or their family members are suing the drugmakers under the Anti-Terrorism Act...The lawsuit said the "terrorist-finance mechanism was straightforward: the terrorists openly controlled the Iraqi ministry in charge of importing medical goods, and defendants—all of which are large Western medical-supply companies—obtained lucrative contracts from that ministry by making corrupt payments to the terrorists who ran it."

Orphan medicines account for only about 8% of total U.S. drug spending, new research shows, even as the number of rare disease drugs on the market has jumped sharply over the past five years..In 2016, the U.S. spent $36 billion on orphan indications of approved drugs — up nearly seven-fold from 2000...Both pharma and biotech alike have focused more investment in recent years into developing new drugs for rare diseases, lured by the prospect of greater pricing power and higher barriers to entry for competitors...While some orphan drugs command prices in the hundreds of thousands of dollars...the median annual cost across the board was $32,000. For the top 10 drugs by use, such as Roche's Gazyva (obinutuzumab), that figure dropped to just under $15,000.

Kelly Davio, welcome to This Week in Managed Care from the Managed Markets News Network

Shares of Imprimis Pharmaceuticals Inc sky-rocketed as much as 91 percent on Thursday, after the company said it would launch a cheaper alternative to Allergan Plc’s controversial dry eye drug, Restasis, by next month...Imprimis’ therapy will cost 99 cents for a month’s supply, with refills starting at $79 a month and the company will start selling prescriptions on Nov. 1, Imprimis’ Chief Executive Mark Baum told Reuters...a U.S. judge on Monday invalidated the patents on Allergan’s Restasis on grounds that they cover ideas that are obvious and analysts now expect generic competition for the drug as soon as next year...Imprimis, which makes compounded medications for costly prescription drugs, on Thursday said it would offer a customizable topical formulation of cyclosporine — an off-patent chemical used in Restasis...If successful in bringing forward a product, Imprimis’ compounded cyclosporine-based formulation will have not been tested in controlled trials, FDA reviewed or approved...

State officials are committing more than $1 million to fight prescription opioid abuse in Nevada...The Assembly's Interim Finance Committee...unanimously approved the five-point plan to combat prescription drug abuse...Attorney General Adam Laxalt's office put forward the initiative...My office’s ‘Prescription for Addiction’ opioid initiative creates an opportunity to face the epidemic that touches our families, friends and loved ones, and to promote prevention in Nevada...this initiative...includes the purchase of drug incinerators, the distribution of Naloxone to first responders, funding allocated toward prevention and education efforts, and the creation of an investigative position to assist with federal efforts to curb opioid abuse...The plan is being paid with a $5.3 million settlement with Volkswagen to settle allegations that the carmaker cheated on emissions tests.

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A federal judge...denied a request by pharmaceutical companies to immediately block a Nevada law requiring them to detail diabetes drug prices and disclose manufacturing costs and research investments come July...The reason, he said: July is more than nine months away...“I don’t see immediate and irreparable harm here,” U.S. District Judge James Mahan said after hearing arguments for and against the request in Las Vegas. Mahan said he might reconsider if the request were made in March or April, but he facetiously added, “My crystal ball is broken.”...At Tuesday’s hearing, Robert Weiner, who represented the pharmaceutical groups, argued that acts as a penalty for companies wanting to raise prices after Nov. 1 and before the July disclosure date...“This is a competitive disadvantage, and it chills us now,” Weiner said...Arguing against the injunction, Las Vegas Chief Deputy Attorney General Linda Anderson said the law is intended to protect diabetes patients in Nevada.