Morning Briefing
Summaries of health policy coverage from major news organizations
Ohio Attorney General Targets PBMs In Battle Against High Drug Prices: States Are 'Hiring The Fox To Guard The Henhouse'
Fresh off filing a lawsuit alleging that a pharmacy benefit manager overcharged his state, Ohio鈥檚 attorney general is now proposing a series of legislative reforms that would toughen oversight of these controversial middlemen. The move by Attorney General Dave Yost comes amid escalating concern among Ohio officials over the prescription drug contracts administered by PBMs on behalf of the state Medicaid program and other agencies. In doing so, Yost appears to be suggesting a blueprint for other states that are grappling with rising drug costs and starting to scrutinize PBM business practices as one possible way to alleviate the financial strain. (Silverman, 4/22)
In the latest row over monopolies on medicines, Blue Cross Blue Shield of Louisiana filed a lawsuit accusing a Johnson & Johnson (JNJ) subsidiary of filing 鈥渟ham鈥 patent litigation in a bid to unfairly thwart generic competition to its best-selling Zytiga prostate cancer treatment. Having won an initial patent in 2004, Janssen Biotech three years later began pursuing additional claims with the U.S. Patent and Trademark Office, but was repeatedly rejected. By 2014, though, the subsidiary won an extension for one patent and was granted another, extending its monopoly on the drug until December 2016, according to the lawsuit filed last week in Richmond, Va. (Silverman, 4/22)
A dispute between makers of treatments for opioid use disorder is drawing attention to an obscure way that drugs can qualify for longer monopoly periods 鈥 and highlighting the lengths that some companies go to preserve those monopolies. The Food and Drug Administration鈥檚 鈥渙rphan drug鈥 designation is supposed to be for rare diseases with a population of fewer than 200,000 patients. The companies that have won聽the designation can then apply for seven years of exclusive sales from the time the products are initially approved, compared to three to five years given for most other drugs. (Siddons, 4/22)
Two years after Maine adopted a law that would ban drug makers from giving gifts to doctors, state officials are now moving to clarify the limits, an effort likely to prompt another fierce battle by the pharmaceutical industry. Although the Maine law has been on the books since June 2017, the state Board of Pharmacy had not attempted to set parameters for gift giving or other forms of payment. Now, the board is proposing a $250 limit on speaking fees, an undefined 鈥渕inimal value鈥 for food and beverage at conferences, and 鈥渞easonable鈥 travel and lodging expenses for doctors who speak on behalf of drug makers. (Silverman, 4/18)
Pharmacists and some health experts are opposing a proposal to permit the bulk importation of drugs from Canada to Maine, arguing that it could result in unsafe drugs being brought into the state and have unintended consequences, such as causing drug shortages in Canada. Proponents of Senate President Troy Jackson鈥檚 bill say those fears are unfounded, and believe it could be one of several proposals that would help to rein in prescription drug prices in Maine. (Lawlor, 4/24)
If you weren鈥檛 already aware, the era of emerging biotechs has arrived. Last year, these companies accounted for 72% of 2,853 late-stage drugs in the collective industry pipeline, up from 65% of 2,083 medicines in 2013. Meanwhile, 47% of the therapies launched in the U.S. in 2018 were attributed to emerging biotechs, which were defined as spending less than $200 million annually on R&D and having less than $500 million in revenue. (Silverman, 4/23)
Sanofi Genzyme (SNY) makes most of its money developing really complicated drugs for rare diseases. But for the next decade it will make a nice little profit in a far simpler way: by flipping its real estate. The Cambridge-based drug maker turned heads last year when it leased two whole buildings 鈥 about 900,000 square feet 鈥 at Cambridge Crossing, a huge mixed-use development that鈥檚 underway north of the MBTA鈥檚 Lechmere Station. (Logan, 4/23)
When it comes to improving its image, the best that the pharmaceutical industry can do is go sideways. Just 41% of patient groups thought the pharmaceutical industry had an 鈥渆xcellent鈥 or 鈥済ood鈥 reputation last year, which is within striking distance of the 43% notched in 2017 and 38% in 2016, according to a survey by PatientView, a research firm that canvassed more than 1,500 patient groups from 78 countries between last November and this past February. And once again, pricing is a huge Achilles鈥 heel. (Silverman, 4/18)
The state may have to pay millions of dollars more in treatment costs for inmates infected with hepatitis C, following a federal judge鈥檚 ruling Thursday that said prison officials have been 鈥渄eliberately indifferent鈥 in caring for thousands of inmates infected with the virus. The ruling could potentially cost the Florida Department of Corrections as much $20 million more than what it is already paying to treat inmates with the virus, said Senate Criminal and Civil Justice Appropriations Chairman Jeff Brandes, who recently got a preliminary briefing from the department on the issue. (Shedden, 4/22)
Attorney General Dave Yost isn鈥檛 sure whether pharmacy benefit managers are bilking taxpayer money from the state. But he wants lawmakers to pass reforms so he and other state officials can find out. On Thursday, Yost laid out four recommendations for state lawmakers to improve transparency for 鈥淧BMs鈥 -- middlemen who negotiate drug prices on behalf of state employees, public retirees, injured workers, and Medicaid recipients. (Pelzer, 4/22)