In this week’s Innovation Partners BioBlog, we share highlights from the world of healthcare. In Texas, a judge deemed the ACA unconstitutional since the individual mandate has dropped to $0. The Cigna/ExpressScripts merger clears another hurdle, and Democrats seek to push forward a bill to block drug price increases it deems “unjustified.” These and more top stories in this week’s BioBlog.
Senate Democrats introduce bill to allow government to block drug price rises
Four senators introduced a new bill that would allow the federal government to block drug price increases if they are deemed unjustified. The bill would allow the Department of Health and Human Services to stop drug price increases it deems excessive. The move comes after public outcry against the rise in the price of drugs such as insulin, which has been on the market for years yet continue to increase in price.
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Amgen Terminates $540 Million Developmental Deal with Advaxis
Advaxis disclosed this week that Amgen has terminated its collaboration on an immuno-oncology program. Advaxis stated that Amgen issued a written notice that it will withdraw its partnership on the development of ADX-NEO, a preclinical program that uses Advaxis’ proprietary Listeria monocytogenes attenuated bacterial vector. The vector is designed to activate a patient’s immune system to respond to unique mutations or neoepitopes. The partnership with Amgen is set to end on February 8, 2019. Advaxis said it is currently enrolling patients for an early-stage trial and will have to evaluate whether or not to find a new developmental partner for the ADX-NEO program.
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FDA to Facilitate Access to Unapproved Drugs
The FDA plans to launch a program in 2019 that will give patients access to unapproved drugs. The goal is to remove barriers for patient access to unapproved or investigational drugs, especially when such drugs may be a patient’s last hope in so-called ‘compassionate use’ scenarios. The project involves the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
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Texas judge strikes down ACA as unconstitutional, but long legal path remains
A Texas federal judge ruled the Affordable Care Act unconstitutional, a move which could send the controversial law back to the Supreme Court. At issue is the individual mandate, which the judge and 20 attorneys general deemed inseparable from the law; by reducing the mandate to $0, the Tax Cuts and Jobs Act stopped the individual mandate from functioning as a tax. This now makes the mandate unconstitutional. The fight will continue to rage, adding to the cloudy picture for the ACA’s future.
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Cigna-Express Scripts nears finish line with approvals from California and New York
Cigna’s $67billion acquisition of Express Scripts continues apace after clearing several regulatory hurdles in California and New York. Final approval from New Jersey is still pending. The DOJ has already cleared the deal back in September, leaving just a few states to finalize their approvals. Both companies agreed not to increase premiums to pay for acquisition costs.
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More Than 300 Groups Seek Halt to CMS’ Plans for Global Drug Pricing Index
A coalition of more than 300 patient advocacy groups, drug companies, medical associations, and others sent a request to Congress to stop CMS from using an index based on drug prices in other countries to determine reimbursement for Part B therapies. The groups claim that this would hurt the elderly and people with disabilities. CMS estimates that using an international price index instead of the average sales price will reduce drug spending by approximately 30%. Opponents believe that this might create roadblocks that would preclude physicians from prescribing medications not on the index.
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Study highlights long wait times in Canada under single-payer system. Does that make it a bad idea for U.S.?
Does a single-payer system mean longer wait times for patients to see specialists? A new study examines our closest neighbor, Canada, and their healthcare system. Canada has had a single payer system since 1984. Canadians wait, on average, 20 weeks to see a specialist. Recent data indicates that the median wait time of 19.8 weeks was shorter than the wait of 21.2 weeks reported in 2017, but the wait time was still 113% longer than it was in 1993. Opponents of a single-payer system in the United States point to this as a significant drawback.
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