About COVID-19
Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): preliminary results of a randomised, controlled, open-label, platform trial (Preprint, not yet peer reviewed): “Patients allocated to tocilizumab were more likely to be discharged from hospital alive within 28 days (54% vs. 47%; rate ratio 1.23; 95% CI 1.12-1.34; p<0.0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (33% vs. 38%; risk ratio 0.85; 95% CI 0.78-0.93; p=0.0005). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes regardless of the level of respiratory support received and in addition to the use of systemic corticosteroids.”
Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study: “Early initiation of prophylactic anticoagulation compared with no anticoagulation among patients admitted to hospital with covid-19 was associated with a decreased risk of 30 day mortality and no increased risk of serious bleeding events. These findings provide strong real world evidence to support guidelines recommending the use of prophylactic anticoagulation as initial treatment for patients with covid-19 on hospital admission.”
Next coronavirus vaccines may be sprays, pills or printed on demand: The headline speaks for itself.
As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running: ”More than 34 million Americans have received Covid vaccines, but the much-touted system the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.
For now, federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of small sample size, missing critical data or other problems.”
CDC gives road map for safely reopening schools: Masking and hand washing are musts.
”When infection rates in the community are higher, the agency recommends shifting to a combination of in-person and remote learning to minimize the number of people in school buildings at any given time. Fully remote learning is recommended only in certain cases when virus rates are very high.
And while the CDC reiterated that states should prioritize teachers for vaccination, the agency said it is not a prerequisite for reopening.”
About health insurance
Voya finds employees still don’t understand their benefits: “35% of employed individuals do not fully understand any of the employee benefits they’ve selected, according to a new survey by Voya Financial. Millennials in particular have a hard time navigating their benefits, with 54% saying they don't understand their offerings.” 66% say they want employers to help them understand the benefits.
How Much Does a C-Section Cost? At One Hospital, Anywhere From $6,241 to $60,584: The availability of hospital charge data has given the media the opportunity to get “actual” numbers on the spread of these figures. In a related article: How Hospitals Are Faring in Meeting Price Transparency Requirements: The hospitals charge data must be in both consumer-friendly and machine-readable formats. 40% of hospitals are not compliant with the former and 52% are not compliant with the latter. “Overall, most providers were compliant with at least one of the file types, though approximately 30% of providers were not compliant for either. Hospitals that are not compliant have expressed they either have significant resource constraints (COVID-19 or otherwise), a lack of understanding of the ruling, and/or are waiting to see what their competitors are doing.”
The Health Cost of Cost Sharing: The cost-quality tradeoff due to cost sharing has been debated for decades. Cost sharing reduces utilization; but it can cause reductions in necessary as well as unnecessary care. The research from the NBER sheds more light on this issue. You should read the entire abstract below:
”We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in coinsurance, or $10.40 per drug) causes a 22.6% drop in total drug consumption ($61.20), and a 32.7% increase in monthly mortality (0.048 p.p.). Second, we trace this mortality effect to cutbacks in life-saving medicines like statins and antihypertensives, for which clinical trials show large mortality benefits. We find no indication that these reductions in demand affect only ‘low-value’ drugs; on the contrary, those at the highest risk of heart attack and stroke, who would benefit the most from statins and antihypertensives, cut back more on these drugs than lower risk patients. Similar patterns exist for other drug–disease pairs, and irrespective of socioeconomic circumstance. Finally, we document that when faced with complex, high-dimensional choice problems, patients respond in simple, perverse ways. Specifically, price increases cause 18.0% more patients (2.8 p.p.) to fill no drugs, regardless of how many drugs they had been on previously, or their health risks. This decision mechanically results in larger absolute reductions in utilization for those on many drugs. We conclude that cost-sharing schemes should be evaluated based on their overall impact on welfare, which can be very different from the price elasticity of demand.”
Edited Transcript of MOH.N [Molina Health] earnings conference call or presentation 11-Feb-21: Despite increased revenue and membership growth, such factors as COVID-19 and acquisition expenses led to a $100M dip in year over year profits.
Biden moving to withdraw Trump-approved Medicaid work rules: “The Biden administration on Friday will notify states it plans to revoke Medicaid work requirements, starting the process of dismantling one of the Trump administration's signature health policies.” However, a related article, HHS Faces Hurdles Revising Medicare Interpretive Rules, points out that some of Biden’s changes require a 90 day comment period before they can take effect.
About pharma
Bristol Myers Squibb pens $1.3B biobucks pact with Molecular Templates, axes Celgene CAR-T asset: ”Bristol Myers Squibb is putting down up to $1.3 billion on a next-gen engineered toxin body (ETB) cancer platform from Molecular Templates as it cuts an unwanted cell therapy from its Celgene buyout.”
The deal is “worth just $70 million upfront with the rest in milestones…
ETBs represent a new class of targeted therapeutics that act through differentiated mechanisms of action, including the ability to force receptor internalization, deliver therapeutic payloads and directly kill targeted cells through the enzymatic inactivation of ribosomes.”
Gilead's $5B Galapagos black hole widens as pair tosses out phase 3 asset after flop: “Gilead has sunk billions into Galapagos over the past few years, but this is quickly turning into one of the most disastrous biotech deals in recent history [as]… an independent body checked out its phase 3 data for the experimental autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF).
The outcome was not good. Following a regular review of unblinded data, an independent monitoring board “concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies.”
Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod: “After regulatory delays and manufacturing issues caused Bristol Myers Squibb investors to miss out on Celgene contingent value rights, the closely watched CAR-T drug liso-cel has scored an FDA nod.
Friday, the agency endorsed the drug, to be called Breyanzi, to treat patients with certain types of large B-cell lymphoma who haven’t responded to two other systemic treatments or who have relapsed after receiving those treatments.”
US Pays Pfizer, Moderna $3.7B For 200M More Vaccine Doses: “The Biden administration on Thursday ordered a total of 200 million additional doses of the COVID-19 vaccines from Pfizer Inc. and Moderna Inc., purchases that mean all Americans could be vaccinated by the end of the summer, according to President Joe Biden.
The federal government shelled out about $2 billion to Pfizer and its German partner BioNTech, and $1.65 billion to Moderna for the additional doses, according to a joint statement from the U.S. Department of Health and Human Services and the U.S. Department of Defense.”
Regeneron's Evkeeza, carrying big price tag, wins FDA approval in ultra-rare cholesterol disease: “Regeneron has been battling against rival Amgen with their mass-market PCSK9 cholesterol drugs, and now the company is underway with a new launch to match its rival in the ultra-rare disease homozygous familial hypercholesterolemia (HoFH).
Regeneron’s Evkeeza scored approval on Thursday as an add-on to other lipid-lowering therapies in patients 12 and older with HoFH, which affects approximately 1,300 patients in the U.S. The company has a "dedicated and experienced team in place" to support the rollout, a spokesman said. The drug is given once per month through an intravenous infusion…
The new drug is dosed by weight and will carry a list price of about $450,000 per year on average, Regeneron said.”
Hospitals Ask Supreme Court to Take Up 340B, Site-Neutral Payments: “The American Hospital Association (AHA), joined by member hospitals and other national organizations, have filed petitions asking the Supreme Court to reverse two appeals court decisions impacting hospital payments.
The first case involves a lawsuit brought on by the AHA and other organizations challenging the nearly 30 percent cut to Medicare outpatient prospective payment system drug payments for hospitals participating in the federal 340B Drug Pricing Program.
A district court had sided with the hospital groups, ruling that the payment reduction was unlawful. However, an appeals court overturned the decision in July 2020, finding HHS to be within its statutory boundaries with the rate reductions.
The second case hospitals are asking the Supreme Court to consider again involves reductions to Medicare outpatient prospective system payments. This time, AHA and others are challenging a 2019 site-neutral payment policy that reduced rates for clinic visits delivered at off-campus provider-based departments.”
About healthcare IT
Signify Health raises $564M in its IPO driven by investor interest in home care, value-based models: “Signify Health launched in December 2017 as the result of a merger between CenseoHealth and Advance Health. The company provides a value-based care platform that uses advanced analytics and other technology to shift health services toward the home.”
This startup is using telehealth to provide eating disorder therapy, and it just got backing from Optum: “A startup providing online eating disorder therapy has raised $13 million as investors ramp up funding for virtual care providers that target specific behavioral health conditions.
San Diego-based Equip virtually delivers evidence-based eating disorder treatment to families at home and has raised $17 million to date. The series A round was led by Optum Ventures with participation from new investor .406 Ventures and existing investor F-Prime Capital, which led the company’s prior seed round.”