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

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...

The Food and Drug Administration’s “black box” warnings and advisories give important safety information about drugs. But they can sometimes go too far and harm more people than they help...Take the FDA’s highly publicized warnings that taking antidepressants increases the risk of suicidality...among children, adolescents, and young adults. We have evidence, as do many others, that these warnings have decreased youths’ access to mental health care and increased suicide attempts...In October 2004, the FDA required a so-called “black box warning” of this risk to be printed on the labels of all antidepressant drugs. It was implemented in January 2005. Two years later, the FDA extended the same warning to include young adults, again based on industry studies...There’s no question that antidepressants can cause harm if used inappropriately. But the FDA failed to recognize — and still won’t acknowledge — that the harms of its public advisories and black box warning on antidepressants for young people more than outweigh the benefits...

As the US Food and Drug Administration continues to navigate a bumpy road toward modernization, a new data enterprise will aim to enhance regulatory decisions on products...The growing number of novel medical products in the US prompted FDA to “refashion” the approaches to drug and device regulations and “create more modern platforms that are better suited to the efficient evaluation of these advances,” said FDA Commissioner Scott Gottlieb...The initiatives already underway...will help “fund the creation of a cross-cutting data enterprise for the generation of evidence, and a more modern and integrated approach to the evaluation of this information,”...Modernization is intended to make regulatory premarket reviews more consistent and predictable to ultimately increase competition among firms and allow for more timely patient access to a greater number of drugs and devices in the US market that are more affordable and of higher quality. This culture shift could also lead to reduced burden and potential cost savings...

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

IBM and CDC experts are hopeful that using a blockchain could help streamline long-running surveys that track patient symptoms and treatments...The Centers for Disease Control and IBM are collaborating on a blockchain-based system that could track public health issues like the ongoing opioid crisis...The new system, which IBM and the CDC’s National Center for Health Statistics have tested using simulated data, could make it easier for the CDC to survey medical providers about data like the reasons patients visit and the symptoms they display...Using the blockchain approach could make it easier to automatically collect the data, keep it secure, and log who’s accessed which parts of it...“There’s a lot of transparency that blockchain seems to offer to us,”...Blockchains are perhaps still most commonly associated with cryptocurrencies, where the secure digital ledgers are used to track who owns each unit of currency, with copies of the ever-growing chain of records automatically duplicated to anyone who wants them. But companies like IBM and Microsoft are exploring how the technology can be used in more traditional industries to sync up data like logs and transaction records between business associates, like health providers and the CDC. The automatic data replication can help maintain a reliable audit trail for more than just digital currency, they say...

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.

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...

About one in eight essential medicines in low- and middle-income countries may be fake or contain dangerous mixes of ingredients that put patients’ lives at risk...Researchers examined data from more 350 previous studies that tested more 400,000 drug samples in low- and middle-income countries. Overall, roughly 14 percent of medicines were counterfeit, expired or otherwise low quality and unlikely to be as safe or effective as patients might expect...“Low-quality medicines can have no or little active pharmaceutical ingredient (and) can prolong illness, lead to treatment failure and contribute to drug resistance,”...“Or it may have too much active ingredient and cause a drug overdose,”...“If it is contaminated or has other active ingredients, then the medication could cause poisoning, adverse drug interactions or avertable deaths.”...The report “provides important validation of what is largely already known,”...“It is important to note that although the study is comprehensive, its narrow scope means it only provides a snapshot of the entire problem, as it is limited to studies conducted in low- and middle-income countries and to those medicines classified as essential by the World Health Organization

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.