- Novartis Targets Production Streamlining as U.S. Prices Decline (bloomberg.com)
...Novartis AG wants to increase its operating margins by making production and other processes more efficient as it positions for possible further declines in U.S. drug prices...Joerg Reinhardt (chairman) told the newspaper NZZ am Sonntag that his company is taking steps to increase its operating profit margin towards 35 percent in no more than five years, from 32 percent, and is closely watching developments in the U.S...“Many of our 68 plants aren’t being fully utilized. We’re trying to achieve an optimization globally,”...“In other areas too, we need to operate simply and more efficiently, and that includes centralized services as part of our Business Services organization.”...More broadly, “we are preparing for the fact that in the medium term there will be changes in the U.S. pricing system that will affect the entire pharma sector,”...
- Financial disclosure lacking in publication of clinical trials, new research shows (healthcarefinancenews.com)
It's the first study to examine financial conflict of interest in publication of clinical trials that underpin FDA approval of new oncology drugs...A substantial proportion of pharmaceutical industry payments to authors of oncology clinical trials published in major scientific journals are not disclosed, new research shows. The publications focused on clinical trials that tested new cancer drugs...Authors of the research letter examined the federal Open Payments Database to determine payments to oncologists who authored studies in high-impact journals...They then cross-checked the information to determine whether the authors properly disclosed the funding when the results of their clinical trials were published in scientific journals. Depending on the journal, almost half of total funding was not disclosed...
- California May Pass Legislation to Regulate PBMs (policymed.com)
We have previously written about pharmacy benefit managers and the way states are trying to regulate them through legislation and other means. With just one week left of the California session, it is possible that the state will become the most recent to regulate PBMs...California Assembly Bill 315, simply titled Pharmacy benefit management...was recently...revived with an amendment on August 20, 2018...The legislation, if passed, would require PBMs to be licensed by the California Department of Managed Health Care; require that a PBM exercise a duty of good faith and fair dealing in the performance of its contractual duties to a purchaser, and would require the PBM to disclose to a purchaser any conflict of interest that would interfere with the discharge of that duty; require a PBM to periodically disclose to a purchaser, at their request, certain information such as drug acquisition cost, rebates received from pharmaceutical manufacturers, and rates negotiated with pharmacies; require PBMs to notify pharmacy network providers of certain material contract changes at least 30 days before those changes take effect; prohibit PBMs from including in a contract with a pharmacy network provider provisions that prohibit the provider from informing consumers of alternative medication options or from dispensing a certain amount of prescribed medication; and would also create a toll-free provider line for pharmacies to report any PBMs who are in violation of the law.
- Washoe County school board approves Renown contract, will explore other health-care options for next year (thenevadaindependent.com)
The Washoe County School District Board of Trustees voted...to renew contracts with Renown Hospital and its insurance arm while also beginning the process of scouting out alternative options over the next year to address the long-term solvency issues of its health insurance fund...trustees voted unanimously to direct the superintendent to begin a competitive request for proposals process over the next year to explore other health-care options for employees and retirees as the district grapples with the rising costs of health care and an insurance fund balance that isn’t keeping up. They then voted to approve three-year contracts with Renown and Hometown Health...Saint Mary’s Health Network, which had held the longstanding contract to provide coverage to district employees, cried foul about the renewal process for the Renown and Hometown Health contracts this year, saying that it could provide health care more cost effectively but hadn’t been given a fair shot to prove to the district that it could do so. Amber Norris, director of business development and marketing for Saint Mary’s, said at the meeting that the request for proposal is “a move in the right direction” and that the health network looks forward to submitting its proposal...
- Nevada seeks emergency order to block disclosure of physician in planned Dozier execution (thenevadaindependent.com)
Nevada officials have filed an emergency request with the state Supreme Court seeking to block a lower court’s decision to release the identity of the attending physician scheduled to oversee the delayed execution of Scott Raymond Dozier...In an emergency motion...the attorney general’s office, representing the Nevada Department of Corrections, is seeking to block a...decision by District Court Judge Elizabeth Gonzalez. The judge said the state must reveal the name of the physician set to oversee Dozier’s execution to attorneys representing one of the drug manufacturers whose product will be used in the execution...Although Gonzalez’s order would limit disclosure of the physician’s identity to the attorneys for drug manufacturer Alvogen, the state wrote in its emergency request that the attending physician would only oversee the execution “to the extent their anonymity is protected from disclosure” and that even a limited disclosure of individuals involved in the execution wasn’t relevant and would limit the state’s ability to carry out the execution...“The drug manufacturers should not be permitted to go on a fishing expedition for information that can be used to harass individuals who assist the State in carrying out lawful executions,” attorneys with the state wrote in the filing. “The intended effect is to scare people away from assisting the State. This tactic is well-documented and, unfortunately, has been effective in stopping executions.”
- Drug companies to receive name of Nevada’s execution doctor (reviewjournal.com)
A judge ruled...that the Department of Corrections must reveal the name of the attending physician in the planned execution of Scott Dozier, but the name may be revealed only to the attorneys who represent the makers of drugs in the state’s lethal injection protocol...Assistant Solicitor General Jordan Smith, who represents the prison system, told District Judge Elizabeth Gonzalez that publicly revealing the name could lead to death threats...Todd Bice, an attorney for Alvogen Inc., which makes the sedative midazolam, said the company’s lawyers wanted to ensure that the doctor who is expected to oversee capital punishment is a licensed physician...Gonzalez is expected to hear further arguments...in the fight over the use of the three drugs in Nevada’s lethal injection cocktail.
- Wave of Opioid Litigation Spreads to Canada With Fresh Lawsuit (bloomberg.com)
A Canadian province has launched a proposed class-action lawsuit against the opioid industry, targeting companies from the nation’s biggest grocer Loblaw Cos. to Oxycontin-maker Purdue Pharma Inc., marking a new front of international action against the industry...British Columbia filed its claim...against more than 40 manufacturers, wholesalers and distributors of opioids, seeking to recover “millions of dollars in opioid-related health care costs incurred by the provincial government,” Attorney General David Eby said in a statement...The suit accuses companies of contributing to “an epidemic of addiction”...in Canada. The class action is probably the first such lawsuit outside of the U.S...If the court certifies British Columbia’s claim as a class action, other Canadian provinces and territories will be able to join...
- About 1 in 5 hospitals mark up drug prices at least 700 percent, study finds (healthcarefinancenews.com)
Nearly one in five hospitals mark up medicine prices 700 percent or more, according to a new analysis from The Moran Company, prepared for The Pharmaceutical Research and Manufacturers of America...This means that if a hospital purchased a medicine for $150, a 700 percent markup could result in patients being billed $1,050, according to the study. And the analysis also found that 320 hospitals – eight percent of those included in the study – marked up some medicine prices more than 1,000 percent...The analysis used Centers for Medicare and Medicaid Services data that included total costs and charges for all medicines from 3,792 hospitals. On average, those hospitals marked up the price of medicines nearly 500 percent, consistent with an analysis of 20 medicines previously conducted by Moran...Markups on medicine prices often lead to higher reimbursement by health plans. More than half of commercial payers reimburse hospital outpatient departments as a percent of billed charges. Hospitals have incentives to increase markups as higher charges are associated with greater profitability...
- Drug supply post-Brexit may occur at the expense of pharma R&D (pharmaceutical-technology.com)
With less than a year left for the UK to leave the EU, ensuring an undisrupted flow of medicines in between the UK and the EU following Brexit is a growing concern among drug developers and regulatory agencies...On 23 August the UK’s Department of Health and Social Care has asked pharmaceutical companies that supply drugs to National Health Service patients to ensure a minimum of six weeks of additional supply of medicines over and above their usual buffer stocks, due to a potential disruption of medicine imports from the EU in the event of a no-deal Brexit. While the UK still may remain part of the EU’s drug approval system following Brexit, the uncertain regulatory environment post-Brexit is urging drugmakers to prepare for the worst...The actions that will need to be implemented by the pharmaceuticals industry, such as stockpiling of medicines, duplicating facilities in both the UK and the EU area, and establishing alternative trade routes are expected to be highly costly measures...drugmakers are on their own to implement these changes, and recent survey results reported by the EMA indicate that some drugmakers have not taken sufficient steps to maintain the continuous supply of their products following Brexit.
- How Can Medicare Save A Billion Bucks? Use Generics (ptcommunity.com)Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents (jamanetwork.com)
In 2016, the cost difference between the amount that the Medicare Part D drug program spent on brand-name combination medications and the estimated cost for generic constituents for the same number of doses was $925 million, according to an investigation in the Journal of the American Medical Association...a retrospective analysis of Medicare drug spending from 2011 through 2016, looked at 29 brand-name oral combination medications, separated into three categories: medications that were available in generic form at identical doses; generic medications available at different doses; and therapeutically equivalent generic substitutes. The savings for all three categories was in the millions of dollars, with the largest discrepancy (an estimated $471 million) seen with the therapeutically equivalent generic substitutes. The authors also found that for the 10 most costly combination products that were available throughout the entire study period, the listed Medicare spending could have been an estimated $2.7 billion lower if the generic constituents had been prescribed.