About pharma
Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe: “During this economic evaluation study period, launch prices of cancer drugs were substantially higher in the US than in the assessed similar high-income European countries, a gap that increased in the years after approval. Cancer drug prices frequently increased faster than inflation in the US but decreased on inflation-adjusted terms in Europe. Price changes were not associated with clinical benefit in any country [emphasis added].”
Regeneron pinpoints gene variants that protect against obesity, launches search for new drugs: “A team at Regeneron Genetics Center has discovered mutations in the gene GPR75 that protect against obesity, they reported in Science. Now, drug developers at Regeneron are using the company’s VelocImmune technology, which generates antibodies from humanized mice, to find drugs that can mimic the protective properties of the GPR75 variants.”
Eli Lilly, Boehringer Ingelheim's Jardiance posts 'blockbuster' heart failure win, setting up 2021 filings: “Eli Lilly and Boehringer Ingelheim’s Type 2 diabetes med Jardiance has been shown to reduce the risk of death and hospitalization from heart failure in patients with preserved ejection fraction (HFpEF). If approved, Jardiance would become the only therapy to improve outcomes in all heart failure patients, regardless of ejection fraction status or whether they have Type 2 diabetes.
Market analysts at Cantor Fitzgerald warned investors not to overlook the news as it might be an indicator of big things to come for the med.”
Innovation on hold during the pandemic? FDA says no with 29 approvals in first half of 2021: “In 2020, the FDA approved 53 new drugs, the second-most in a single year, after 2018’s bounty of 59.
And the momentum has continued through the first half of 2021. With the FDA endorsing its 29th novel drug on June 30, the industry was slightly ahead of last year’s pace.”
Pharmas' return on $5B spent yearly on patient support programs? Only 3% are using them: survey: “Pharma companies spend more than $5 billion on patient support programs every year, but when it comes to uptake, only 3% of patients are actually using them, according to a new survey from Phreesia Life Sciences.
Taking into account people who have ever used any patient support program, the percentage ticks up a bit, but still only gets to 8%…
So why the low usage? Lack of awareness is one clear factor—fewer than one-fourth (23%) of patients said they were extremely or very familiar with patient support programs, while another 18% said they were somewhat familiar.
However, an even bigger culprit in the dismal usage number is low familiarity, said Liz Herbert, senior research manager at Phreesia. Patients may be aware of pharma's financial or educational programs, but many don’t know details. Nor do they know how, or even whether, they could benefit.”
Read the article for more details. What these figures do not tell is the amount of public relations good-will pharma companies garner by having the programs in place. Look at announcements for very expensive medications and you will always see a disclaimer that they will be provided free to those who cannot afford them.
Supreme Court agrees to hear hospital lawsuit challenging HHS' 340B cuts: “The case called American Hospital Association v. Becerra centers on the Medicare reimbursement rate paid for outpatient drugs and whether the Department of Health and Human Services singled out 340B-covered entities.
HHS traditionally set reimbursement rates for drugs based on the average sales price and applied it across all hospital groups. But the lawsuit said that practice changed in 2018 when HHS singled out 340B hospitals, the lawsuit argues.”
About Covid-19
Scientists identify long-sought marker for COVID vaccine success: “Participants who had higher levels of neutralizing antibodies — as well as ‘binding’ antibodies, which recognize the SARS-CoV-2 spike protein — tended to gain stronger, but not total, protection from a symptomatic infection, the Oxford team determined. The team used a model to estimate the antibody levels that corresponded to different levels of vaccine protection against COVID-19 in trials, ranging from 50% to 90% protection.”
Cambridge researchers spot antimalarial, arthritis drugs for COVID-19 repurposing: “The two drugs, antimalarial therapy proguanil and rheumatoid arthritis medication sulfasalazine, showed they could safety inhibit the replication of the SARS-CoV-2 coronavirus behind COVID-19 in both monkey and human cell lines, according to a new study published in Science Advances.”
COVID Falls From America's #1 Killer to #7 by June: ”The disease was the third leading cause of death for much of 2020, but became the leading cause of death in December 2020 and early 2021, reaching a peak of 3,136 deaths per day in January 2021 and far surpassing U.S. deaths from heart disease and cancer during that time.”
Israel Says Pfizer Vaccine Less Effective in Preventing Delta Variant Infection: “The Pfizer-BioNTech coronavirus vaccine has dropped to 64 percent effectiveness in preventing infection in Israel as the delta variant continues to spread across the country, the Health Ministry said on Monday…
The ministry added that the vaccine is 93 percent effective in preventing hospitalizations and severe symptoms.”
Scientists quit journal board, protesting ‘grossly irresponsible’ study claiming COVID-19 vaccines kill: “Several reputed virologists and vaccinologists have resigned as editors of the journal Vaccines to protest its 24 June publication of a peer-reviewed article that misuses data to conclude that ‘for three deaths prevented by [COVID-19] vaccination, we have to accept two inflicted by vaccination.”
Children and COVID-19: State-Level Data Report: “As of June 24, over 4.03 million children have tested positive for COVID-19 since the onset of the pandemic. Over 8,400 child cases were added to the cumulative total last week. This marks the lowest number of weekly cases reported in the past year, since May 2020.”
Efficacy of Portable Air Cleaners and Masking for Reducing Indoor Exposure to Simulated Exhaled SARS-CoV-2 Aerosols — United States, 2021: From the CDC: “A simulated infected meeting participant who was exhaling aerosols was placed in a room with two simulated uninfected participants and a simulated uninfected speaker. Using two HEPA air cleaners close to the aerosol source reduced the aerosol exposure of the uninfected participants and speaker by up to 65%. A combination of HEPA air cleaners and universal masking reduced exposure by up to 90%.”
CDC: 1K US counties have less than 30% of their population inoculated against COVID-19: “About 1,000 U.S. counties, mostly in the Southeast and Midwest, have COVID-19 vaccination coverage of less than 30 percent, CDC Director Rochelle Walensky, MD, said during a July 1 White House COVID-19 briefing.”
Bharat Biotech's COVID-19 vaccine shows 77.8% efficacy at final analysis: “Bharat Biotech announced that in the final analysis of a Phase III study of Covaxin, the coronavirus vaccine demonstrated an efficacy rate of 77.8%, slightly down from a rate of 80.6% reported at an earlier interim analysis…
Further results showed that Covaxin was 93.4% effective against severe symptomatic COVID-19, with 15 cases in the placebo group versus one in the Covaxin arm, and 63.6% effective against asymptomatic COVID-19. Bharat Biotech added that the vaccine was 65.2% effective against the Delta (B.1.617.2) variant.”
We tried out the first statewide vaccine passport: From MIT Technology Review: “When we tested New York’s Excelsior Pass, we found privacy concerns, technical glitches, and questions over who it’s really for.” Read the article for more specifics about usability problems…starting with downloading the app.
About hospitals and health systems
Tying CEO Compensation To Value-Based Purchasing Scores: “First, there is no association between CEO compensation and value delivered, even after adjusting for the number of hospital beds [emphasis added] (p = 0.10). In fact, the hospital with the worst value score has CEO compensation twice as high as the hospital with the third highest value. Second, there is huge variability in value delivered—even within this select group of major teaching hospitals that one would expect to deliver the highest level of care. There is a three-fold difference between the value delivered at the lowest-value hospital and the highest value, granted the highest-value hospital is an outlier (it is the highest-value teaching hospital in the whole country).”
HOSPITALS CUT 5.5K JOBS IN JUNE: Highlights:
”—Hospitals lost 5,500 jobs, and nursing homes lost 9,600 jobs in June.
—Those losses were slightly offset by 2,900 new jobs in ambulatory services.
—Since February 2020, hospitals have lost 102,000 jobs and nursing homes have lost 360,000 job losses.
—The ambulatory services sector has grown 75,400 jobs in that span.
—There were 15.9 million people attached to the healthcare sector workforce in June.”
Pandemic pivots Ochsner Health to new role: PPE manufacturer: “Ochsner Health is starting a new business to make personal protective equipment (PPE). Not only will Ochsner be making gloves, gowns, masks and N95 respirators, it will manufacture the materials used to make those items, such as the liquid nitrile needed for gloves and the spunbond meltblown spunbond (SMS) laminate fabric needed to make masks, gowns and bouffant hair covers.
Ochsner and Alabama-based construction contractor and property developer Trax Development started a joint venture, SafeSource Direct, with $150 million. SafeSource is putting $73 million toward retrofitting an 80,000-square-foot manufacturing facility that will also serve as a headquarters, and $77 million is going for the development of a new facility.”
Healthcare systems have gotten into the generic pharma business, so this next step is not a big surprise.
Ohio health system to pay $21M to resolve false claims allegations: “Akron (Ohio) General Health System, acquired by Cleveland Clinic in 2015, will pay $21.25 million to resolve allegations that it violated the False Claims Act, the U.S. Justice Department said July 2.
The settlement resolves allegations that the health system, between August 2010 and March 2016, paid certain physicians in excess of fair market value to secure referrals of patients in violation of the Stark Law and submitted claims for services provided to the illegally referred patients in violation of the False Claims Act.”
It is still amazing that hospitals think they can get away with these well-known, illegal practices.
About the public’s health
WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: FYI- published online today.
Ohio providers can deny care on moral grounds under new law: “Ohio physicians, hospitals and insurers can refuse to offer or pay for a medical service if it violates their moral or religious beliefs under a new provision…
The medical conscience clause is included in the state's $74.1 billion 2022-23 budget, which Gov. Mike DeWine signed July 1.
The Ohio Hospital Association, Ohio Children’s Hospital Association, Ohio State Medical Association and Ohio Association of Health Plans issued a joint statement opposing the provision during the state's budget process.”
About healthcare IT
Microsoft advises customers to disable printing until cyber vulnerability fixed: “The Computer Emergency Response Team Coordination Center (CERT/CC), part of the Software Engineering Institute at Carnegie Mellon University, this week reported a critical remote code execution vulnerability impacting the Windows Print Spooler service that allows a remote authenticated attacker to execute arbitrary code with system privileges on a vulnerable system. Until Microsoft fixes the PrintNightmare vulnerability, for which the exploit code is publicly available, the company advises customers to disable printing services where possible.”
Ransomware Hackers Demand $70 Million to Unlock Computers in Widespread Attack: “The cyberattack that started to unfold Friday is estimated to have hit hundreds of mostly small and medium-size businesses and tens of thousands of computers. It quickly set off alarms in U.S. national security circles over concern that it could have far-reaching effects…
The hackers behind the latest incident are known as the REvil ransomware group. They are asking for $70 million to unlock all the affected systems but victims of the group can also pay amounts varying between $25,000 and $5 million directly to unlock their systems even if nobody pays the $70 million.”
Virginia payer Dominion National settles 9-year data breach for $2M: 5 details: “Vision and dental insurance provider Dominion National in April 2019 learned that an unauthorized third party had accessed some of its computer servers since August 2010.
Data stored on the computer servers included current and former member enrollment and demographic information, Social Security numbers, members' postal and email addresses, birth dates, bank account and routing numbers and taxpayer ID numbers.
The data breach affected 2.9 million individuals, according to the HHS data breach portal.”
Northwestern Memorial HealthCare and Renown Health Affected by Elekta Cyberattack: “The data breach was discovered by Stockholm-based Elekta, which provides a software platform used for clinical radiotherapy treatment for cancer and brain disorders. Elekta issued a statement confirming its first-generation cloud-based storage system was accessed by unauthorized individuals, which affected a subset of customers in North America…
In total, 42 healthcare systems are believed to have been affected by the breach. In some cases, affected facilities had to temporarily halt cancer procedures and arrange for patients to continue their treatment at alternative healthcare facilities.”
New Walgreens CEO Sees ‘Tech Enabled Healthcare’ In Future: However, “‘CEO Rosalind Brewer did not provide much of an update on her strategic vision for the company, only to highlight technology will be a key focus and pharmacy will remain the central anchor of the business,’ Mizuho Securities analyst Ann Hynes wrote in a report last week that followed Walgreens fiscal third quarter earnings that beat analysts’ expectations.”
H1 2021 Digital Health Funding: Another Blockbuster Year…In Six Months: “H1 2021 secured $14.7B in digital health funding, already surpassing all of 2020’s funding. The half closed with 372 deals and an average deal size of $39.6M, spearheaded by 48 mega deals which accounted for 59% of total H1 2021 funding. Public exit activity ballooned with 11 closed IPOs and SPACs, with another 11 SPACs expected to close in 2021.”
About insurers
Iowa insurer not required to cover COVID-19 losses, court rules: “A federal appellate court ruled in favor of Cincinnati Insurance Co. on July 2, finding that the insurer did not have to cover losses stemming from COVID-19 restrictions that an Iowa dental clinic faced.
The initial lawsuit against Cincinnati Insurance Co. came after it refused to compensate Oral Surgeons for nonemergency procedures that were canceled because of pandemic restrictions. That lawsuit fell in favor of the insurer, and the plaintiff appealed to the U.S. Court of Appeals for the 8th Circuit.”
One of these cases will be appealed to the Supreme Court; if heard, it could set a major precedent for the insurance industry.
Surprise billing rule also strikes down insurer ED policies: “A major rule that bans surprise medical bills also outlawed policies that let insurers retroactively deny emergency department claims…
UnitedHealthcare faced major blowback when it proposed a similar policy last month. The insurance giant said the goal of the policy was to encourage patients to get care at other sites such as an urgent care facility rather than going to the ED.
The policy was expected to go into effect July 1. However, UnitedHealthcare decided to delay the policy until at least the end of the COVID-19 public health emergency, which is expected to run through the rest of this year.”
Jury Convicts Medical Imaging CEO In $250M Health Fraud: “The CEO of several medical imaging companies was found guilty by a California federal jury Friday in connection with a $250 million scheme that involved bribes, kickbacks and fraud through the state workers' compensation system for medical services. Sam Sarkis Solakyan, 40, operated diagnostic imaging facilities throughout California and was found guilty of one count of conspiracy to commit honest services mail fraud and health care fraud, and 11 counts of honest services mail fraud. According to the U. S. Attorney's Office for the Central District of California, evidence presented at trial showed that Solakyan conspired with others from mid-2013 to November 2016…”