HAPPY NEW YEAR!
About pharma
5 worst pharma deals of the decade: Some cautionary examples for the near future.
Provision in Spending Bill Paves Way for Follow-On Insulins: Sometimes it takes a while for news to “percolate.” Buried in more than 1,500 pages of the fiscal 2020 spending bill is an expanded definition of a biological product that now includes chemically synthesized polypeptides, such as insulin. The change makes it easier for competitors to introduce biosimilar insulins so prices can be lowered.
More drugmakers hike U.S. prices as new year begins: “Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi SA were planning to increase prices on more than 200 drugs in the United States on Jan. 1. Nearly all of the price increases are below 10% and the median price increase is around 5%…”
Novo Nordisk's new insulin affordability offerings now available in the US: Novo Nordisk launched its “My$99Insulin” program for its authorized generics. “All patients can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens of any combination of insulins from Novo Nordisk Inc. for $99.”
Standard of Evidence Expanded in New FDA Guidance: “In its first updated guidance in more than 20 years on acceptable trial design, the FDA said substantial evidence from a trial proving effectiveness could be gained from one trial instead of two, one adequate well-controlled trial plus confirmatory evidence or reliance on a previous finding of effectiveness from an approved drug.
The FDA has decided that in some cases the traditional two-trial model can be replaced by other types of trial designs more suited to the study of rare diseases... five types of control are mentioned in the draft guidance: placebo, dose comparison, no treatment, active treatment and historical control.”
Comments on the draft guidance are due Feb. 21, 2020.
About the public’s health
Prevention of tuberculosis in macaques after intravenous BCG immunization: Tuberculosis kills more people than any other infectious agent. To prevent the illness, a vaccine, BCG, has been used for about 100 years, but with widely variable success. This research article shows promise in greatly enhanced effectiveness by administering the vaccine intravenously instead of into the skin, as has been the practice.
About healthcare IT
International evaluation of an AI system for breast cancer screening: This article is highlighted in most major media today. For example: Google’s DeepMind A.I. beats doctors in breast cancer screening trial. This study compares the AI system to a single radiologist reading. But a standard procedure is to have two radiologists read a mammogram. With this double reading, the AI system performs similarly. Further, some of the radiologists had not received special further training in mammography. The AI system is getting really good; if it continues to improve, it may be able to substitute for radiologists in the near future.
Trump administration’s compromise vape ban provokes public health outcry: Public health groups are angry that the president backtracked on part of his promise to curtail vaping. Yesterday the White House announced that fruity and minty cartridges would be banned, but not menthol, as previously promised. Further, e-liquids for “open tank” products that typically are sold by vape shops will now be allowed. An administration “official said the outcome was a compromise between administration officials pushing a comprehensive ban promised by Trump in September and others worried about the political fallout stemming from potential job losses in thousands of vape shops across the country.”
About health insurance
Tenth Circuit Upholds HHS Risk Adjustment Methodology: A number of ACA health plans, particularly the consumer-sponsored startups (COOPs) have sued the federal governments over methodologies it used to pay (or, in this case, not pay) them back for losses that started in 2014. One challenge was to the risk adjustment formula. In this ruling, “the Tenth Circuit upheld HHS’ risk adjustment methodology, concluding that HHS’ use of a statewide average premium and the adoption of a budget-neutral program were not arbitrary and capricious. HHS acted reasonably in explaining why it used the statewide average premium in the risk adjustment methodology for 2014 through 2016. Because HHS subsequently issued new rules covering the 2017 and 2018 methodologies, the challenges over the rules for those years are moot.” If upheld, HHS would not owe these plans any payments (almost all COOPs went bankrupt).
About healthcare quality
Changes in Quality of Care after Hospital Mergers and Acquisitions: Hospital combinations result in increased charges. The participants argue, however, that quality improvement justifies the expense. However, this research shows that: “Hospital mergers and acquisitions were associated with modest deterioration in patient experiences, small and nonsignificant changes in readmission and mortality rates, and inconclusive effects on performance on clinical-process measures. These findings challenge arguments that hospital consolidation, which is known to increase prices, also improves quality.”
Adding Patient-Reported Outcomes to Medicare’s Oncology Value-Based Payment Model: At the end of 2020, CMS will roll out its Oncology Care First (OCF) model, replacing the previous Oncology Care Model (OCM). Reflecting the evolution of payment and evaluation systems, this new model will have two new features: capitation and patient-reported outcomes. Similar changes in other advanced payment models cannot be far behind.