- Medicare Part D drug spending spikes by 77% (healthcarefinancenews.com)
Despite a decrease in the number of prescriptions for brand-name drugs going down, Part D spending and out-of-pocket costs both spiked up from 2011 to 2015, according to a new report from the Office of the Inspector General...The total reimbursement for all brand-name drugs in Part D rose by 77 percent from 2011 to 2015 even though there was a 17-percent drop in prescriptions for those drugs. Even after taking into account manufacturer rebates, reimbursement for Part D brand-name drugs still swelled by 62 percent during that time period,...the number of beneficiaries shouldering at least $2000 in out-of-pocket costs per year nearly doubled across the five-year time span and unit costs for brand-name drugs rose nearly 6 times faster than inflation...for small, rural or struggling hospitals whose razor thin margins are already the source of angst for c-suiters, watching drug spend totals steadily rise could force painful decisions like opting to not modernize EHRs or update equipment...
- Wireless system can power devices inside the body (news.mit.edu)
MIT researchers, working with scientists from Brigham and Women’s Hospital, have developed a new way to power and communicate with devices implanted deep within the human body. Such devices could be used to deliver drugs, monitor conditions inside the body, or treat disease by stimulating the brain with electricity or light...The implants are powered by radio frequency waves, which can safely pass through human tissues...in animals, the researchers showed that the waves can power devices located 10 centimeters deep in tissue, from a distance of 1 meter...Even though these tiny implantable devices have no batteries, we can now communicate with them from a distance outside the body. This opens up entirely new types of medical applications...An overarching aspiration is that regulators will provide input to the design and may incorporate framework elements and learnings into regulatory programs. .
- June 8 Pharmacy Week in Review: Drug Shortages, Folic Acid and Erectile Dysfunction, and Precision Medicine in Cancer Treatment (pharmacytimes.com)
Kelly Davio, host, the Pharmacy Times News Network's Pharmacy Week in Review.
- White House: Trump’s drug pricing plan will make the rest of the world pay its fair share (cnbc.com)
First, the president's plan would cut domestic drug prices by dismantling the burdensome government approval and reimbursement policies that inhibit healthy competition. Second, the plan would combat foreign government policies that devalue intellectual property rights and create unfair pricing systems that force drug manufacturers to sell to foreign buyers at unreasonably low prices...President Trump's plan would stop overpricing of drugs at home and underpricing abroad...Government policies that restrict competition...the lengthy drug approval process erects large entry barriers for both brand-name drugs and their cheaper generic counterparts. FDA's work to facilitate timely generic entry is estimated to have saved Americans billions of dollars...doctors are given precisely the wrong incentive when prescribing: the system reimburses them at higher rates when they prescribe more expensive drugs, ultimately funded by our tax dollars...There is no free lunch. If neither Americans nor foreigners pay for the R&D to develop new drugs, then soon nobody will receive new treatments...
- Gottlieb Proposes Modernization of Drug Review Office (biopharminternational.com)
...FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”...Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.
- ISPE Field-Tests Quality Program (biopharminternational.com)
The International Society of Pharmaceutical Engineering announced...that it is field-testing the design principles of a comprehensive industry-led program of self-evaluation of pharmaceutical quality program with industry colleagues, senior leaders, and regulators. The vision for the program is to evolve the focus from submission of harmonized quality metrics as given in recent FDA guidance documents to establishing a framework for advancing the state of pharmaceutical quality, while at the same time continuing to align with the purpose outlined by FDA...ISPE believes this approach will deliver on the objectives outlined by FDA and will increase the value to industry...
- FDA sends warning letters to nine online marketers over opioids (reuters.com)
The...Food and Drug Administration...sent warning letters to nine online networks operating a total of 53 websites to stop illegally marketing unapproved versions of opioid medications...The regulator said... it is taking additional steps with these warning letters by going right to the source of the illegal supply of unapproved and misbranded versions of opioid drugs, including tramadol and oxycodone...The internet is virtually awash in illegal narcotics...Drug dealers and rogue website operators are using the internet to fuel the opioid crisis...The regulator has requested responses from the nine companies within 10 working days, or they may be subject to product seizure or injunction.
- 5 Ways Pharmacists Can Help Prevent Suicide (pharmacytimes.com)How Suicide Quietly Morphed Into a Public Health Crisis (nytimes.com)
With the recent deaths of Spade and Bourdain, health care professionals are also concerned about suicide contagion, a phenomenon in which high-profile suicides influence patients to attempt or committ suicide themselves...pharmacists can play a key role in preventing suicide...pharmacists are ideally situated to assist those in need because of their frequent interactions with patients and access to medical records...However, pharmacists are often unprepared to properly respond to signs of suicide risk, as very few pharmacy schools incorporate suicide prevention courses into their curricula...here are 5 ways pharmacists can help patients who are contemplating suicide...
- Identify at-risk patients.
- Monitor medication use and mental health.
- Collaborate with the health care team.
- Refer to suicide prevention resources.
- Be encouraging and empathetic.
- This Week in Managed Care: June 8, 2018 (ajmc.com)
Kelly Davio, welcome to This Week in Managed Care from the Managed Markets News Network
- U.S. drug prices hit by insurer tactic against copay assistance: analysis (reuters.com)
A recently adopted tactic by...health plans to limit the financial assistance drugmakers provide directly to consumers for prescription medicines is taking a toll on drug prices, according to a new analysis...Real...drug prices, including discounts and rebates, fell 5.6 percent in the first quarter of this year, compared to a 1.7 percent drop in the same period a year ago, according to...research analyst Richard Evans...He attributed most of the decline to ‘copay accumulator’ programs introduced by pharmacy benefits managers...drugmakers have increasingly offered so-called ‘copay assistance’ cards, similar to a debit card, that consumers can use at the pharmacy counter to reduce their out-of-pocket costs...these payments insulate consumers from the real costs of their drugs and can push them toward more expensive medications when a cheaper option is available...Beginning in January, Express and other pharmacy benefits managers introduced a new ‘copay accumulator’ approach, refusing to allow copay assistance payments to contribute toward a patient’s deductible before insurance kicks in...That has forced drugmakers to either keep paying out-of-pocket costs for a consumer, or risk them ditching a medicine because they can no longer pay for it....