A huge ruling against one opioid maker drives a settlement offer from another, an expert panel calls for broader screening for hepatitis C, and a review shows there are more fatal events linked to a multiple sclerosis drug than previously known.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Opioid Pill Court Ruling
Court cases brought by states, counties, and cities against Purdue Pharma, the Sackler family, and Johnson & Johnson took a turn this week when an Oklahoma judge ordered pharmaceutical giant Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis.
Following the ruling, multiple news reports said Purdue Pharma offered up to $12 billion to settle more than 2000 lawsuits against the company. Settlement talks include 10 state attorneys general and Purdue attorneys meeting in Cleveland.
Johnson & Johnson, which said it would appeal the Oklahoma ruling, is reportedly involved in the Cleveland talks as well. In a statement, the company said it “remains open to viable options to resolve these cases, including settlement.”
According to news reports, Purdue attorneys have said the settlement is the only way the company can avoid bankruptcy.
Rising Hepatitis C Virus Rates
The opioid crisis is being blamed for a rise in hepatisis C virus in younger adults, and this week the US Preventive Services Task Force said it is looking to expand its 2013 recommendation on who should be screened for the virus.
The original recommendation targeted baby boomers, based on CDC data that showed those born between 1945 and 1965 accounted for 75% of those living with the infection. But the rise in heroin use over the past decade has led to an increase in HCV infection in younger adults, and the new screening recommendation will include adults from 18 to 79.
Said Douglas K. Owens, MD, MS, of the Stanford Health Policy Center, who chairs the task force, “The explosive growth in HCV has been fueled by the opioid epidemic, with the spread of HCV into younger populations. HCV now kills more Americans than all other reportable infectious diseases combined, including HIV.”
Fatal Adverse Events Linked to MS Drug
The drug alemtuzumab, sold as Lemtrada, may be linked to more fatal adverse events than researchers realized in the past.
The drug for relapsing remitting multiple sclerosis was approved in Europe in 2013 and by FDA in 2014. The discovery of 10 fatal events related to treatment came in a review published in BMS Research Notes that examined records in the European Medicines Agency database.
The adverse events include:
Neutropenia with staphylococcus infection
Autoimmune hemolytic anemia with necrotizing leukoencephalopathy.
In December 2018, FDA warned of rare but serious cases of MS patients treated with alemtuzumab having strokes and tears in the lining of the arteries in their head and neck.
Authors of the new research concluded, “Patients, physicians and regulatory authorities should be aware of the serious risks associated with alemtuzumab treatment, which must be weighed against the high and durable clinical efficacy.”
Chronic Kidney Disease Treatment
FDA has granted fast-track designation to the SGLT2 inhibitor dapagliflozin, sold as Farxiga, to slow the progression of kidney failure and prevent cardiovascular and renal death in patients with chronic kidney disease. The designation allows FDA to expedite review of data from the DAPA-CKD trial, which is set to conclude in 2020 and will look at the drug’s safety and effectiveness in patients with and without diabetes on top of standard of care.
AstraZeneca, which makes dapagliflozin, is separately scheduled to release full results from the DAPA-HF trial, which reports outcomes for the drug in patients with heart failure, including those with and without diabetes.
Said AstraZeneca’s Mene Pangalos, PhD,, “Chronic kidney disease affects an estimated 37 million people in the US,and is often associated with an increased risk of heart disease and stroke. This fast track designation is an important step towards more quickly addressing unmet treatment needs in chronic kidney disease.”
Finally, the intersection of diabetes and cardiovascular care was a theme of the most recent meeting of the Institute of Value-Based Medicine®, held in Arlington, Virginia.