Tuesday, April 23, 2019
Monday, April 22, 2019
Medicare predicts smaller increases in annual Part D drug spend
While the Medicare Board of Trustees reported that Part D drug spending in 2018 came in slightly higher than predicted, it lowered its projected growth rates for the next five years due to slower price growth and higher manufacturer rebates.
In its annual report published Monday, the board said 2018 Part D drug expenditures were $95.2 billion, higher than the $94.5 billion projection in its report last year. Part D spending was down from $100 billion in 2017 (see “Medicare Board Predicts a Slowdown in Part B Spending Increases”).
The board said rebates have come in higher than previously assumed, prompting it to lower its 2019-2027 annual Part D spending projections. It now expects Part D expenditures to increase 3.3% to $98.3 billion in 2019. In last year’s report, it estimated 2019 spending to be $103.7 billion. While it projects spending to increase 12.4% to $110.5 billion in 2020 and 9.2% to $120.7 billion in 2021, the figures are lower than the $113.7 billion and $123.2 billion predicted in last year’s report.
Due to slower dispensing of generics and increased use of high cost specialty drugs, the board expects Part D drug costs per beneficiary to increase at a higher rate than other Medicare benefits, such as hospitals and Part B drugs. It estimates per capita Part D spending to increase 4.9% per year on average, compared with a 3.9% average increase projected in last year’s report.
Actual 2018 spending on Part B, which reimburses for physician-administered drugs, came in at $337.2 billion, just under last year’s estimated $339.9 billion. The board slightly raised its predictions for Part B, and now expects 2019 spending to be $367.9 billion compared with $366.5 billion estimated last year.
The Trump administration’s proposed FY20 budget includes requests for changes to Medicare, Medicaid and FDA policies that the White House says would reduce government spending on drugs by $69 billion (see “Trump Wants to Use Budget to Complete Drug Pricing Blueprint”).
Apple sued for $1B by teen claiming glitch in facial recognition software
The report by Bloomberg’s Bob Van Voris states that the lawsuit filed by Ousmane Bah claims that Apple’s facial-recognition software falsely made him a suspect in Apple store theft.
Consumer Reports: Tesla ‘Autopilot’ is no substitute for a human driver
Consumer Reports states: “Tesla’s current driver-assist system, ‘Autopilot,’ is no substitute for a human driver. It can’t dependably navigate common road situations on its own, and fails to keep the driver engaged exactly when it is needed most… Instead of treating the public like guinea pigs, Tesla must clearly demonstrate a driving automation system that is substantially safer than what is available today.”
Lilly to Sell Legacy Antibiotics Brands and Manufacturing Facility in China
Eli Lilly and Company (NYSE: LLY) today announced that it has entered into an agreement to sell the rights in China for two legacy Lilly antibiotic medicines, Ceclor® and Vancocin®, as well as a manufacturing facility in Suzhou, China that produces Ceclor, to Eddingpharm, a China-based specialty pharmaceutical company.
Under the terms of the agreement, Lilly will receive a deposit of $75 million, followed by a payment of $300 million upon successful closing of the transaction. As part of the transaction, all employees at the Ceclor manufacturing facility and certain employees from shared functions will be offered the opportunity to remain at the facility and continue to work with Eddingpharm. Lilly will provide ongoing services to Eddingpharm for a period of time to ensure continuity of product supply and support the smooth transition of the facility.
“Lilly remains committed to improving the health of people in China,” said Julio Gay-Ger, President and General Manager of Lilly China. “This transaction will enable Lilly China to better focus our resources on the exciting new therapies that we are launching in our core therapeutic areas, so that we can bring more life-changing medicines to patients in China.”
Mr. Xin Ni, CEO of Eddingpharm, said: “Ceclor and Vancocin have been on the Chinese market for more than two decades, treating numerous patients and earning the trust of patients and physicians alike. We are very proud to acquire these two brands and to carry on their legacy. We look forward to maintaining high standards of operation, supplying products with the best quality, and serving more patients in need in China.”
The transaction is expected to close in either the latter part of 2019 or early 2020, subject to customary closing conditions and regulatory approval. The transaction will not be reflected in Lilly’s reported results and financial guidance until closing.
Gilead New Data on Viral Hepatitis at International Liver Congress 2019
Gilead Sciences, Inc. (Nasdaq: GILD) announced new data on the use of its chronic hepatitis B (HBV) and hepatitis C (HCV) medicines including safety and efficacy data on Vemlidy® (tenofovir alafenamide 25mg, TAF) in HBV patients previously treated with tenofovir disoproxil fumarate (TDF) and data on Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in difficult-to-cure HCV patient populations. These results, along with data from Gilead’s HBV cure research program, will be presented at The International Liver Congress™ (ILC) 2019 in Vienna, Austria.
“As part of our ongoing commitment to patients living with viral hepatitis, we continue to research the roles of our HBV and HCV medicines across the broadest range of patient populations. These latest data demonstrate that the efficacy of our HCV medicines is consistent in clinical trials and in real-world settings, even in difficult-to-cure patients,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “In HBV, our latest research reinforces the role of Vemlidy in chronic HBV management and the importance of ongoing research in pursuit of an HBV cure.” HBV Treatment: Switching from TDF to Vemlidy In a Phase 3 study, 488 virologically suppressed adult patients with chronic HBV infection receiving once-daily TDF (300 mg) were randomized to remain on TDF or switch to Vemlidy (TAF 25 mg) for 48 weeks. Vemlidy demonstrated non-inferior viral suppression (HBV DNA =20 IU/mL) compared to TDF at Week 48. Switching from TDF to Vemlidy also resulted in improvements in glomerular filtration rate (eGFRCG), a measure of kidney function, and increases in hip and spine bone mineral density (BMD), a measure of bone health, as compared with patients who continued taking TDF. Rates of adverse events and serious adverse events were similar between the two groups. Similar findings were also presented from secondary analyses of two Phase 3 studies of 1,298 patients initially randomized to receive Vemlidy or TDF. Among patients switched from TDF to Vemlidy at Week 96 or Week 144, virologic suppression (HBV DNA <29 IU/mL) was maintained in both groups at Week 192. Increases in both hip and spine BMD and eGFRCG were observed in each group switching to Vemlidy treatment.
LogicBio methylmalonic acidemia treatment gets FDA orphan status
The FDA has granted an orphan designation status for LogicBio Therapeutics’ treatment of methylmalonic acidemia
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