Author: Peter

In a nod to patients clamoring for greater access to experimental medicines, the 21st Century Cures legislation would require companies to publicly disclose their policies for making such drugs available...The language in the bill, which is designed to jump start medical innovation, appeared after complaints that many drug makers make it difficult for patients and their physicians to sort out the process for gaining access to medicines that are not yet approved for use by the Food and Drug Administration...only 19 of 100 drug makers publicly post policies about their programs for obtaining experimental medicines...only one of those companies posted information about specific procedures for making requests, and this company did not list any contact information…the findings underscored arguments by patient advocacy groups and lawmakers that the process for gaining access to experimental medicines is unwieldy, which has also generated criticism of the FDA...

The U.S. Government Accountability Office has published a report...on compounding entitled “ Drug Compounding – FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges.”

Higher prescription drug prices, combined with changes to Medicare and Social Security, could deal a $1.6 billion blow to state budgets next year by forcing them to ratchet up spending on Medicaid…Without congressional intervention, most state Medicaid agencies will have to come up with tens of millions of dollars to cover the bill...The new costs could prompt states to tighten eligibility requirements or cut benefits...The new costs come at a time when many states already are experiencing budget strains...About $1.2 billion of the $1.6 billion projected Medicaid hike for the states is the result of higher prices for prescription drugs in Medicare, the federal health plan for the elderly and disabled people. Medicaid and therefore the states are affected by a group of “dual eligible beneficiaries,” who receive both Medicare and Medicaid benefits because of their low income...

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.

As insurance companies nationwide look for ways to cut costs, commissions for individual plans have been reduced and in some cases eliminated...That has led many of the hundreds of brokers and agents in Nevada to focus on other more-profitable sectors and made it harder for shoppers to find help navigating the complicated and confusing marketplaces for individual health insurance, either private or via the Affordable Care Act exchange...On the Silver State Health Insurance Exchange, the state’s official portal for so-called Obamacare plans, the number of brokers and agents registered to assist users declined from roughly 500 last year to about 150 this year…Nevada’s largest insurer, UnitedHealthCare, said that it will still pay commissions on renewals, though at a lower rate, but not on new policies...Our actions are consistent with our long-stated approach to continually evaluate the dynamics of the market as they evolve, and to refocus our resources as necessary so that we can provide consumers with access to quality care…

Sandoz...announced that it would be donating up to $10 million in generic medicines annually to Americares, an organization that responds to those affected by poverty or disaster with health programs, medicine and medical supplies. The initial donation will include more than 25 Sandoz products for treatment of infections, cardiovascular condition, eyecare, skin conditions and musculoskeletal pain…Limited access to healthcare poses a significant barrier to long-term social and economic development around the world...Sandoz has partnered with Americares since 1989 and Novartis and Sandoz have donated more than $230 million worth of medicine to the organization since then...

Juno Therapeutics Inc said two more patients had died after suffering brain swelling during a trial of its experimental genetically engineered leukemia drug, bringing the total up to five...Juno said...it had voluntarily put the mid-stage study on hold and informed the U.S. Food and Drug Administration earlier this week...The company is still evaluating the cause of the deaths and has not yet decided whether it will continue developing the drug...JCAR015 is an experimental chimeric antigen receptor T-Cell therapy...The FDA, which had imposed a hold on the trial after the first three deaths, lifted it soon after Juno agreed to revert to its original drug regimen that excluded fludarabine...The elimination of fludarabine reduced toxicity but has not proved to be the only contributing factor...

With the recent US Food and Drug Administration approval of a fourth biosimilar medication, these compounds remain a hot topic in many areas of medicine, including nephrology, oncology, endocrinology, gastroenterology, and rheumatology…Despite the growing body of knowledge about biosimilars—and despite their increasing coverage in peer-reviewed journals and presentations—a recent Biosimilars Forum press release reveals that more physician education is needed about these medications...

• What Are Biosimilar Medications?
• What Is the Approval Process of Biosimilars?
• How Many Are Approved, and for What Conditions?
• What Does 'Interchangeable' Mean?
• What Is Extrapolation?
• Are Biosimilars Safe, and Can They Be Trusted?
• Do Patients Know and Trust Biosimilars?
• How Do the Costs of Biosimilars Compare to Biologics?

Medication errors remain fairly common in nursing homes but they appear to result in “surprisingly” low rates of serious impacts affecting residents, according to Australian researchers...researchers set out to assess the prevalence of medication errors leading to hospital admission and deaths in nursing home residents, and to determine the factors associated with these errors...They examined three types of errors – all medication errors, transfer-related medication errors, and potentially inappropriate medications...researchers found that medication errors were common, involving 16% to 27% of residents in studies examining all types of medication errors...Transfer-related medication errors occurred in 13% to 31% of residents, while 75% of residents were prescribed at least one potentially inappropriate medication...investigators noted that it was unclear whether medication errors resulting in serious outcomes were truly infrequent or are under-reported due to the difficulty in ascertaining them.

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