CMS proposes pulling model that ties Part B drug prices to those paid overseas

 The Biden administration has pulled a Trump-era regulation that ties Medicare Part B prices for certain products to prices paid overseas.

The proposed rule released Friday by the Centers for Medicare & Medicaid Services comes in response to a series of legal defeats that the Biden administration faced over the controversial model.

The model would tie the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries.

The Trump administration released an interim final rule on Nov. 27, 2020, for the model, which had a Jan. 1, 2021 start date.

However, four lawsuits were filed the next month asking for a delay to the effective date of the model. A federal judge agreed to an injunction to keep the rule from taking effect.

That injunction has been delayed several times after the Department of Health and Human Services asked for more time to decide what to do on the rule.

HHS was facing another deadline as the latest stay expired on Aug. 9 and the last order hinted that another one may not be granted since the agency had half a year to decide how to proceed with the rule.

CMS said that the agency got 1,166 comments on the Nov. 2020 interim final rule. A majority of them were worried about starting the model in the midst of the COVID-19 pandemic and the quick start date that ran afoul of the court.

“If finalized, our proposal would allow us to take time to further consider the issues identified by commenters and would address the Nov. 2020 interim final rule’s procedural deficiencies by rescinding it,” the agency said.

The decision is a big win for the pharmaceutical industry and the hospital industry that was worried about cuts in Medicare drug reimbursements for Part B drugs, which are dispensed in an office setting.

The American Hospital Association wrote to CMS in January that the model could hurt some providers by reimbursing them less for “for some critical medicines such as cancer drugs. Some providers will close and their patients will have to deal with the fallout.”

https://www.fiercehealthcare.com/payer/cms-proposes-pulling-model-ties-part-b-drug-prices-to-those-paid-overseas

No discounts here: Biotech EQRx eyes $1.8B in SPAC deal for lofty discount drug goal

 After raising $750 million in private financing since January 2020 on its towering mission to rewrite the life sciences pricing model, EQRx has now tapped the public markets for another $1.8 billion in a special purpose acquisition company deal. 

Before getting into the SPAC details, a quick catch-up: EQRx hired a former Sanofi chief operating officer of research in July, secured a phase 3 win for a cancer drug with partner CStone Pharmaceuticals in June and inked an artificial-intelligence-powered drug discovery partnership that same month.

Now, the Cambridge, Massachusetts-based biotech is linking arms with blank-check company CM Life Sciences III to go public on the Nasdaq under, you guessed it, the ticker "EQRX." The deal values EQRx at $3.65 billion.

Follow the money, because there's usually high-profile names attached. EQRx will add Amy Abernethy, M.D., Ph.D., the former principal deputy FDA commissioner, to its board. Serial biotech founder Alexis Borisy will move from CEO to executive chairman. To complete a trifecta of moves, Melanie Nallicheri was promoted from president and chief operating officer to CEO.

With an anticipated $1.8 billion in proceeds, including $1.2 billion from private investment in public equity, the combined company will have a whopping $2 billion on the balance sheet to fund 10-plus programs. 

That medicine lineup includes two oncology assets with positive phase 3 data, aumolertinib and sugemalimab. 

EQRx and partner CStone said sugemalimab, an anti-PD-L1 antibody, met its primary endpoint in a phase 3 clinical trial of patients with stage 3 non-small cell lung cancer (NSCLC) in May. 

The other phase 3 data? EQRx's aumolertinib resulted in a clinically significant improvement in progression-free survival compared to AstraZeneca's Iressa in first-line treatment for NSCLC, the company and partner Hansoh Pharma also announced in May. 

EQRx now has the cash to work on a pipeline of 10-plus programs and further its drug discovery partnerships with Exscientia and AbCellera Biologics thanks to the SPAC deal. 

https://www.fiercebiotech.com/biotech/eqrx-will-raise-1-8b-through-a-spac-combination-for-lofty-discount-drug-goal

Midlife Blood Amyloid Levels Tied to Late-Life Dementia

 Midlife plasma amyloid beta (Aβ) levels in cognitively normal people were associated with risk of dementia or mild cognitive impairment (MCI) 25 years later, an analysis of a large community study showed.

Among 2,300 people, each standard deviation increase in plasma Aβ40 (67 pg/mL) at midlife was associated with 15% higher risk of late-life MCI or dementia (relative risk ratio [RRR] 1.15, 95% CI 1.01-1.29), reported Kevin Sullivan, PhD, MPH, of the University of Mississippi Medical Center in Jackson, and co-authors.

Every standard deviation increase in midlife plasma Aβ42 (10 pg/mL) was associated with 13% lower risk of later MCI or dementia (RRR 0.87, 95% CI 0.77-0.98), the researchers wrote in Neurology.

Doubling of the Aβ42/Aβ40 ratio at midlife up to the median level was associated with 37% lower risk of late-life MCI or dementia, (RRR 0.63, 95% CI 0.46-0.87), they added.

"A doubling of this ratio under this threshold at midlife was associated with a 37% lower risk of MCI or dementia, which is comparable to about 5 years of younger age, and a doubling of this ratio under this threshold at late-life was comparable to about 3 years younger age," Sullivan said.

The results are promising, but "we are likely still a little ways off from these blood tests having any routine use in clinical care," Sullivan told MedPage Today. "The far more likely and immediate use for these assays is in better recruitment and screening into Alzheimer's disease clinical trials, specifically targeting individuals whose plasma Aβ levels suggest they may be at higher risk of current or future amyloid accumulation in the brain and cognitive impairment."

"Although multiple studies have shown that plasma Aβ42/Aβ40 is correlated with established measures of brain amyloidosis, the field has needed large studies demonstrating that it predicts progression to dementia," noted Suzanne Schindler, MD, PhD, of Washington University School of Medicine in St. Louis, who wasn't involved with the research.

"The current study used an impressive cohort of 2,284 participants with a long period of follow-up and further supports the use of plasma Aβ42/Aβ40 as a predictor of future dementia," Schindler told MedPage Today.

"One weakness is that plasma Aβ42 and Aβ40 were measured in 2014 using assays expected to have lower performance than more recent, high precision assays," she noted. "However, the study did clearly demonstrate that lower plasma Aβ42/Aβ40 is associated with a higher risk of progression to mild cognitive impairment or dementia."

The researchers evaluated 2,284 participants in the Atherosclerosis Risk in Communities (ARIC) cohort study who had normal cognition in midlife, with an average age of 59.2 at midlife assessments and 76.9 at late-life measurements. More than half of participants were female (57%) and 22% were Black.

Over 25 years of follow-up, 859 participants (38%) remained cognitively normal, 502 (22%) were classified as having dementia, 832 (36%) were classified as having MCI but not dementia, and 91 (4%) died without any cognitive impairment classification. Plasma Aβ42 and Aβ40 levels increased significantly from midlife to late-life on average, but changes were highly variable, the researchers said.

Measured at midlife, but not late-life, lower plasma Aβ42 was associated with higher risk of dementia and marginally higher risk of MCI. Higher plasma Aβ40 was associated with higher risk of MCI and dementia, whether measured at midlife or late-life. Associations were independent of age, sex, education, race, APOE4, and cardiovascular risk factors.

The analysis had several limitations, Sullivan and co-authors acknowledged. It used an older testing method to estimate plasma amyloid beta that may not be as precise as newer assays, and there may also have been some degree of survivor bias, since only participants with later measurements had plasma Aβ assayed at midlife.

Disclosures

The study was supported by the National Heart, Lung, and Blood Institute, National Institute for Neurological Disorders and Stroke, National Institute on Aging, and National Institute on Deafness and Other Communication Disorders.

Sullivan reported no disclosures relevant to the manuscript; co-authors reported relationships with Biogen, DIAN study, Lilly Pharmaceuticals, University of Southern California, Samus Therapeutics, Third Rock, Roche, and Alzeca Biosciences.

Primary Source

Neurology

Source Reference: Sullivan KJ, et al "Association of midlife plasma amyloid-β levels with cognitive impairment in late life: The ARIC Neurocognitive Study" Neurology 2021; DOI: 10.1212/WNL.0000000000012482.

https://www.medpagetoday.com/neurology/alzheimersdisease/93919

Obamacare architect Ezekiel Emanuel shortlisted for FDA chief

 Former health advisor to Barrack Obama and architect of Obamacare Ezekiel Emanuel, has been pitched for the role of commissioner for the Food and Drug Administration, reports said Friday. 

Emanuel served on President Biden’s COVID-19 transition advisory board following his November 2020 win and has become an ally for the administration, first reported Politico.

The University of Pennsylvania bioethicist has not yet been approached for the job but is one of several contenders, officials with knowledge of the process told the publication. 

Filling the top job with the FDA has become increasingly important as the country awaits the federal stamp of approval for the coronavirus vaccine.

President Biden said the FDA is hoping to secure approval for the vaccine by the fall, though whether the president will be able to secure an FDA commissioner by then remains questionable.

Texas Republican Sen. Ted Cruz has blocked dozens of the president’s nominees to top jobs in protest of Biden’s sanction reversal on the Russia-Germany Nord Stream 2 pipeline. 

Several of the nominees he has prevented from entering into the Senate confirmation process are not related to policies affecting the pipeline. 

But Cruz has shown no sign of removing his barriers until Biden reinstates sanctions. 

"I'm leveraging and holding the Biden administration's nominees to get the admin to impose sanctions mandated by Congress to stop Biden's multi-billion dollar gift to Putin, the Nord Stream 2 pipeline," Cruz said in a tweet last month.

Administration officials have not given any hints at when they may be considering announcing Biden’s nominee to lead the FDA but told the publication they have "strong acting leadership in place" who play an "important role in our COVID-19 response."

https://www.foxbusiness.com/politics/obama-health-advisor-shortlisted-as-fda-head

Exact Sciences said to approach Invitae about merger

 Exact Sciences Corp. has approached Invitae Corp., the genetic-testing company backed by Cathie Wood’s Ark Investment Management, about a possible merger, according to people familiar with the matter.

The companies are not in active talks and should a deal be reached it would likely be a low-premium, all-stock merger, the people said, asking not to be identified because the matter isn’t public. There is no guarantee that an agreement will be announced.

A representatives for Exact Sciences and Invitae declined to comment.

Invitae offers genetic testing for a range of diseases, including hereditary cancer and cardiology. Its shares fell 3.9% to close at $29.66 in New York trading Friday, giving the company a market value of about US$5.9 billion. Invitae rose 13% in after-market trading.

The stock had rallied earlier in the week on positive results.

Exact Sciences fell to 5.6% to US$102.00, giving it a market value of about US$17.5 billion.

Testing companies that handle cancer screening have been busy merging as they come up with new ways to detect diseases before they get out of control. Last year, Illumina Inc. agreed to buy Grail Inc. for roughly $8 billion while Exact Sciences agreed to pay about $2.15 billion for Thrive Earlier Detection Corp.

Wood is the biggest holder of Invitae shares with a stake of about 11%, according to data compiled by Bloomberg. Its stock jumped in March when she described it as “one of the most important companies in the genomic revolution.”

SoftBank Group Corp. led a US$1.15 billion investment in the company in April.

Wood’s firm also has a 6.2% stake in Exact Sciences.

https://www.theedgemarkets.com/article/exact-sciences-said-approach-invitae-about-merger

Flu vaccine may provide vital protection against COVID-19

 In a newly published study, physician-scientists at the University of Miami Miller School of Medicine have shown that the flu vaccine may provide vital protection against COVID-19.

The study, titled "Examining the potential benefits of the influenza vaccine against SARS-CoV-2: A retrospective cohort analysis of 74,754 patients," was published in the peer-reviewed scientific journal PLoS One on August 3. This was the largest study of its kind and analyzed deidentified patient records from around the world, which strongly suggested that the annual flu shot reduces the risks of stroke, sepsis, and DVT in patients with COVID-19. Patients with COVID-19 who had been vaccinated against the flu were also significantly less likely to visit the emergency department and be admitted to the intensive care unit.

"Having access to the real-time data of millions of patients is an incredibly powerful research tool," added Dr. Singh, who conducted the study with medical student Susan Taghioff and plastic surgery resident Benjamin Slavin, M.D., both of whom were lead authors. "Together with asking important questions, my team has been able to observe an association between the flu vaccine and reduced morbidity in COVID-19 patients."

Sharing findings with scientists and general public

The researchers previously presented their preliminary data findings at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), receiving international attention. Now that the full study has been published, the authors are extremely excited to share their detailed findings for the first time with both the general public and scientific community.

The study was conducted using patient records from a number of countries, including the U.S., the U.K., Germany, Italy, Israel and Singapore. The team screened de-identified electronic health records on the TriNetX research database for more than 70 million patients to identify two groups of 37,377 patients. The two patient groups were then matched for factors that could influence their risk of susceptibility to severe COVID-19, including but not limited to age, gender, ethnicity, smoking, and health problems such as diabetes, obesity, and chronic obstructive pulmonary disease.

Members of the first study group had received the flu vaccine two weeks and six months prior to being diagnosed with COVID-19. Those in the second group also had a positive COVID-19 diagnosis but were not vaccinated against the flu. The incidence of 15 adverse outcomes (sepsis; strokes; deep vein thrombosis or DVT; pulmonary embolism; acute respiratory failure; acute respiratory distress syndrome; arthralgia or joint pain; renal failure; anorexia; heart attack; pneumonia; emergency department visits; hospital admission; ICU admission; and death) within 30, 60, 90 and 120 days of testing positive for COVID-19 were then compared between the two groups.

The analysis revealed that those who had not had the flu shot were significantly more likely (up to 20% more likely) to have been admitted to the ICU. They were also significantly more likely to visit the emergency department (up to 58% more likely), to develop sepsis (up to 45% more likely), to have a stroke (up to 58% more likely) and a DVT (up to 40% more likely). The risk of death was not reduced.

Avoiding Adverse Outcomes

The investigators were also able to calculate how many COVID-19-positive patients would need to receive an influenza vaccine to avoid one adverse outcome. Notably, they found that only 176 patients needed to have received a flu vaccine to prevent one ED visit within 120 days of testing positive for COVID-19. Additionally, only 286 patients needed to have received their flu vaccine to prevent one case of sepsis, which is known to be the most expensive condition to treat in the U.S. health care system. Last, for every 440 patients who were up to date on their flu shot, one ICU admission was prevented.

Although it isn't exactly known yet how the flu vaccine provides protection against COVID-19, most theories speculate that the flu shot may boost the innate immune system -; general defenses we are born with that do not protect against any one specific illness.

The results, said study authors, strongly suggest that the flu vaccine may protect against several severe effects of COVID-19. However, they strongly recommend that people receive COVID-19 vaccines as well their annual influenza vaccine. They add that more research, in the form of prospective randomized control trials, is needed to prove and better understand the possible link but, in the future, the flu shot could be used to help provide increased protection in countries where the COVID-19 vaccine is in short supply or even aid in the ongoing struggle against breakthrough cases in those individuals already vaccinated against COVID-19.

"Continued promotion of the influenza vaccine also has the potential help the global population avoid a possible 'twindemic' -; a simultaneous outbreak of both influenza and coronavirus," Taghioff said. "Regardless of the degree of protection afforded by the influenza vaccine against adverse outcomes associated with COVID-19, simply being able to conserve global health care resources by keeping the number of influenza cases under control is reason enough to champion continued efforts to promote influenza vaccination worldwide."

Source:

University of Miami Miller School of Medicine

Journal reference:

Taghioff, S.M., et al. (2021) Examining the potential benefits of the influenza vaccine against SARS-CoV-2: A retrospective cohort analysis of 74,754 patients. PLOS ONE. doi.org/10.1371/journal.pone.0255541.

https://www.news-medical.net/news/20210804/Flu-vaccine-may-provide-vital-protection-against-COVID-19-study-shows.aspx

Japan studying giving 3rd coronavirus vaccine shots next year

 Japan has begun a study on whether it should administer third shots of the coronavirus vaccine next year, officials said Friday.

Spurred by the likelihood of vaccine efficacy waning over time and the need to respond to highly infectious virus variants, the government will proceed with the study while trying to secure the supply of at least 200 million doses next year, the officials said.

Tokyo will reach a decision on the matter after taking into consideration the situation of virus infections and how other governments are dealing with COVID-19 booster shots.

Overseas, Israel's booster shots have already been in full swing for people aged 60 or older, while Germany is scheduled to start providing third COVID-19 shots for the elderly in September. Sweden has also decided to do likewise, possibly in the fall, with Britain preparing to start offering booster shots in September.

Japan's vaccination program was launched in February, initially for health care workers. It was expanded to the elderly in April and later to other members of the public.

The country's minister in charge of vaccination efforts, Taro Kono, said July 30 Japan "will likely administer next year" third doses of COVID-19 vaccine.

The government struck a contract in July to receive an additional 50 million doses of Moderna Inc.'s coronavirus vaccine from the beginning of 2022. Discussions are also under way to secure 150 million doses of the vaccine developed by Novavax Inc. starting in early 2022.

As judgment on the necessity of booster shots varies among nations, Japan will collect data on clinical trials conducted abroad and study not only on the necessity but also whether it should allow a person's third dose to be from a different company than the one that developed their first and second doses, the officials said.

On Thursday, Moderna said its coronavirus vaccine maintained 93 percent efficacy through six months after the second shot, but pointed to the likelihood of the need for a third booster shot afterward to protect against new variants, citing a decline in antibody levels.

Meanwhile, World Health Organization chief Tedros Adhanom Ghebreyesus on Wednesday called on some advanced countries to suspend their ongoing or planned administration of third shots until at least the end of September, saying fair access to COVID-19 vaccines among all countries is a higher priority.

Noting that many people must work to make a living even amid the pandemic, the WHO chief told a press conference, "While hundreds of millions of people are still waiting for their first dose, some rich countries are moving towards booster doses."

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Japan-studying-giving-3rd-coronavirus-vaccine-shots-next-year-36097406/