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Tuesday, June 30, 2020

US Congress faces pressure to maintain telehealth after COVID-19

The coronavirus pandemic has forced healthcare systems around the world to make greater use of telehealth services during lockdown, and lawmakers in the US want to see if those changes could be permanent.
Representative Robin Kelly (Democrat – Illinois) tabled a bill in the House on at the beginning of the month that would ask the Department of Health and Human Services (DHHS) to study the effects of changes to telehealth caused by COVID-19 on the federal Medicare and Medicaid programmes.
The schemes provide healthcare cover to the over-65s and those on low-income, respectively, and Rep Kelly and the co-signatories of bill HR 7078 want the DHHS to provide data on the types of telehealth and their costs during the outbreak, as well as uptake.
They also want to gauge whether greater use of telehealth has increased the risk of fraud and other illicit activities like ransomware attacks or cybersecurity breaches, and what has been done by the federal government to mitigate those risks.
The bill asks for an interim report from the DHHS within a year of the emergency ending, and a final version by the end of 2024, and also asks for funding to be made available for states to carry out their own assessments.
There are other state- and federal-level initiatives underway to try to make the changes enforced by the coronavirus pandemic a permanent feature of the US healthcare landscape.
Last month, for example, a group of more than 30 members of Congress wrote a letter to House Speaker Nancy Pelosi and her counterpart in the Senate, Mitch McConnell, to ask that emergency approval of behavioural telehealth services be extended for a transition period after the crisis ends.
These services are “proving to be an extremely successful approach in ensuring that patients are receiving mental health and addiction care during this trying and unprecedented time,” said the letter.
In particular, reimbursement of audio telephone consultations has been a lifeline for people living in rural communities and those without video-enabled telecoms devices, it added.
The signatories want Congress to maintain these provisions “for a reasonable transition period following the COVID-19 emergency period to collect appropriate data to provide an adequate amount of time to determine which of those flexibilities should be continued permanently.”
The moves come against a backdrop of resistance among some in Congress, who argue that there isn’t enough data to support the expansion of technology in healthcare delivery.
Rep Kelly told Politico that her bill aims to change that by gathering “as much information and really study the issue quickly before…regulations run out.”
Commenting on the increasing pressure on Congress to make these changes permanent, Lux Research analyst Danielle Bradnan said that legislators are concerned about broadband internet access, payer reimbursement, and licensure barriers – as currently, medical licenses are only valid for specific states.
The telehealth sector “should pay close attention to how these concerns are addressed because policy changes may mean greater opportunities for clients that can provide thoughtful connectivity support, as well as more opportunities to provide telehealth tools (including remote monitoring devices) to a wider and more homogeneous array of healthcare providers.”
She adds: “With legislative support, clients should expect the telehealth landscape to grow rapidly, as many telehealth companies have been ready for years and need to develop a strategy now in order to be competitive.”

NHS England agrees to deal for Vertex’ cystic fibrosis triple

June 30, 2020

NHS England has agreed a deal with Vertex for its three-drug cystic fibrosis therapy Kaftrio, just days after the EMA’s human medicines committee recommended approval of the drug.
The deal means that CF patients in England will be among the first in Europe to access Kaftrio (tezacaftor/ivacaftor/elexacaftor) when the EMA grants formal approval to the drug, according to NHS England chief executive Sir Simon Stevens.
It means that treatment will shortly be available for around 7,000 people in England, including as many as 300 patients with rare mutations, which fall outside of the scope of EMA approvals.
The news was greeted ecstatically by the CF community which had feared that a prolonged negotiation over pricing could delay the drug’s availability, as happened with Vertex’ two-drug therapy Orkambi (lumacaftor/ivacaftor).
“The inclusion of patients with rare genetic types and conclusion of this access arrangement, ahead of licensing and without the need for a painful community campaign is particularly welcome,” said patient group CF Voices.
“Patients shouldn’t have to lobby, beg, or expose their private lives in the media, to receive access to the most effective treatments,” it added.
The CF Trust also said the deal is “fantastic news”, but added “there is more to do and we will not stop until everyone with CF across the UK has access to life-saving drugs.”
Under the deal, eligible patients – aged 12 or over who have two copies of the F508del mutation gene, or one copy of F508del and a minimal function (MF) mutation – will be able to get treatment with Kaftrio as a combination regimen with Vertex’ single-agent drug Kalydeco (ivacaftor).
Kaftrio is the first drug that works in patients with the F508del and MF mutations, who account for around 90% of the overall CF population, and in trials led to improved lung function as well as quality of life scores.
“CF will be changed forever for the majority of the community with this news,” said CF Voices, whilst acknowledging “the 10% who currently don’t have a suitable treatment for their loved one’s type of CF, of whom we are thinking today”.
“The proactive behaviour of NICE, NHS England, and Vertex…in this situation is to be highly commended.”
Vertex said the new expanded treatment covers the new triple was well as Kalydeco, Orkambi and Vertex’ other two-drug combination Symkevi (tezacaftor/ivacaftor), as well as “any future additional licensed indications for all of these medicines”.
The company says it is also negotiating with the health authorities in Scotland, Wales and Northern Ireland and hopes to unveil equivalent agreements in those countries as quickly as possible.
As part of the agreement, Vertex has agreed to submit Orkambi, Symkevi and Kaftrio to the National Institute for Health and Care Excellence (NICE) – within an agreed timeframe – to allow for “a period of real-world data collection on the medicines”.
Prices will then be adjusted as necessary, following full NICE appraisal, to ensure that taxpayers “continue to get a good deal,” said NHS England.

HHS extends partnership with retailers to boost COVID-19 testing

The U.S. Department of Health and Human Services said on Tuesday it would extend its partnership with private pharmacies and grocery chains to provide better access to COVID-19 testing.
The partnership with CVS Health Corp, Rite Aid Corp, Walgreens boots Alliance Inc, Kroger and Walmart Inc has been scaled up to more than 600 COVID-19 testing sites across the country.
About 70% of the testing sites under the program are located in areas that have moderate-to-high vulnerability to the virus.
The partnership has been extended at a time when drive-through coronavirus testing sites have been popping up across the country, and seeks to ramp up testing, reduce pressure on emergency rooms, while keeping patients in their cars to avoid spreading the infection.

Akero reports additional positive data on lead candidate in NASH patients

Akero Therapeutics (NASDAQ:AKRO) jumps +43% AH, after the company announce results of a 16-week analysis of secondary and exploratory endpoints from its Phase 2a BALANCED study of its lead candidate efruxifermin (EFX), formerly known as AKR-001, in nonalcoholic steatohepatitis (NASH) patients.
Of the 40 responders who had end-of-treatment biopsies, 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score across all dose groups. 28% achieved at least a two-stage improvement in fibrosis.
Also, 48% of responders achieved NASH resolution with no worsening of liver fibrosis (scarring).
Improvements in glycemic control and dyslipidemia (elevated cholesterol or fats in the blood), as well as weight loss, were also observed across all dose groups.
On safety front, EFX was generally well tolerated, and there were two Serious Adverse Events, one of which occurred prior to dosing; the most frequent AEs were mild to moderate gastrointestinal events, which were transient in nature
The company previously reported that each of the 28, 50 and 70 mg EFX dose groups met the primary endpoint compared to placebo.
AKR-001 is an engineered human Fc-FGF21 fusion protein designed to induce the benefits of the endogenous hormone FGF21 which can potentially reduce liver fat, mitigate inflammation and reverse fibrosis. It is administered once per week via subcutaneous injection.

U.S. could see 100,000 new Covid-19 cases per day – Fauci

The United States may soon record as many as 100,000 new cases of Covid-19 a day if the current trajectory of the outbreak is not changed, the director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, warned on Tuesday.
The number of new cases is currently hovering around 40,000 per day.
Fauci’s remarks, made during an appearance before the Senate Health, Education, Labor, and Pensions Committee, came as the number of new cases in some Southern and Southwestern states has soared.
Some states that had moved to reopen businesses and activities quickly in response to frustration with lockdowns are finding themselves forced to dial back on some moves. California has closed bars in some counties, for instance, and New Jersey announced this week that it would not reopen indoor dining as planned.
“Clearly we are not in total control right now,” Fauci told the committee, warning that far worse conditions are ahead without new efforts to tamp down spread.
“It is going to be very disturbing, I will guarantee you that,” he said.
“What was thought to be unimaginable turns out to be the reality we’re facing right now,” Fauci said, adding that “outbreaks happen, and you have to deal with them in a very aggressive, proactive way.”
Fewer than 20 countries have recorded more than 100,000 cases in total. Canada, for instance, has confirmed about 106,000 Covid-19 cases since the outbreak began.
Public health and infectious diseases experts, who have been gravely concerned about the way the U.S. response has unfolded, concurred with Fauci’s assessment.
“It’s unfortunately just a simple consequence of math plus a lack of action,” said Marm Kilpatrick, an infectious diseases dynamics researcher at the University of California, Santa Cruz. “On the one hand it comes across as ‘Oh my God, 100,000 cases per day!’ But then if you actually look at the current case counts and trends, how would you not get that?”
A daily count of 100,000 new cases a day could occur within about three to six weeks, warned Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy.
States with rapidly rising case numbers — Texas for instance — are struggling to care for patients; if the numbers rise to the level Fauci is predicting, hospitals be overwhelmed, Osterholm warned.
“We have to understand if we have 100,000 cases a day, we will have a crisis in intensive care units around the country,” he said, warning that many hospitals still don’t have adequate supplies of protective equipment, and more health workers will die if the outbreak spirals further out of control.
The Centers for Disease Control and Prevention estimates that 88,000 health workers in the U.S. have been infected with Covid-19 and 481 have died.
Osterholm said the U.S. needs to come to a consensus about how to control Covid-19. That’s going to take national leadership, he said.
“This country has to come to grips with: What is it that we’re willing to accept?” Osterholm said. “And I think if we leave it up to every governor, I think that is short-sighted. We need a national consensus of what are we trying to do. And then each state can … tailor it to what fits them. But right now, we don’t have a national consensus.”
He advocates finding a middle ground between total shutdown — for which there is waning support in the country — and the rapid reopening that some states have embraced. “It’s got to be something in the middle.”
The country needs to think about what restrictions it can live with as a means of suppressing transmission of the SARS-CoV-2 virus, and about how to compensate businesses that are may be forced to stay shut as a consequence, Osterholm said, pointing to bars as an example of a type of business that may need to remain closed while transmission rates are high.

New FDA tool that aims to inform cancer care ‘has glaring gap’

A new Food and Drug Administration platform gives cancer patients and physicians a way to comb through data on the experiences of clinical trial participants — but experts say it’s missing critical details to make that information actually useful to patients.
The website, called Project Patient Voice, is a publicly searchable database of patient-reported outcomes, or information on symptoms and side effects collected by surveying participants during a clinical trial. Those reports often aren’t included in a drug’s labeling once it’s approved, meaning the public almost never sees them. The tool is designed to give patients and their health care providers more information as they navigate cancer treatment decisions, particularly when it comes to weighing the potential long- and short-term side effects of a given therapy.
So far, there is only one study on the pilot version of the site, which provides general information about a trial and a breakdown of how often patients experienced certain symptoms and how severe they were. What it doesn’t include: demographic information about the people who filled out the surveys or an analysis of how symptoms might have differed when broken down by age, gender, or race.
“I would anticipate the patient-reported outcomes might differ by ethnic group, by age, by employment status,” said Rob Carlson, an oncologist and chief executive of the National Comprehensive Cancer Network, a nonprofit alliance of cancer centers. “Those sorts of demographic information would be very important in trying to interpret.”
The lack of demographic data is of particular concern, given long-standing disparities in clinical trials. A 2018 analysis of FDA data by ProPublica found that, in the vast majority of trials for cancer drugs approved since 2015, fewer than 5% of patients were Black, despite the fact that Black individuals make up about 13% of the U.S. population.
“If I’m an African American woman, who is 45, and newly diagnosed with breast cancer, I don’t know if that experience is applicable to me,” said Shonta Chambers of the Patient Advocate Foundation, referring to the outcomes shared on Project Patient Voice.
Vishal Bhatnagar, an oncologist at the FDA who helped design the website, said the agency considered including demographic information, but ultimately decided against it because that data is already available on Drug Trials Snapshots, a separate FDA site that provides demographic data on clinical trials.
“We didn’t want redundancy and duplication,” said Bhatnagar.
But experts said that while leaving information like demographics off the site might avoid redundancy, it also makes the site less usable for patients who don’t have a sophisticated knowledge of the system.
Combining that data could provide more insight for patients. Take, for example, the first trial displayed on Project Patient Voice: the AstraZeneca lung cancer treatment Tagrisso. The corresponding Drug Trial Snapshot for that trial shows that the risk of “serious adverse events” — side effects that result in death, hospitalization, disability, or other life-threatening situations — was higher in white patients than Asian patients. Deadly and life-threatening side effects were also more common for patients over 65 than for those under 65 years of age. And out of 409 patients in the trial, only four were Black.
That could be valuable information for patients and providers to take into consideration.
Bhatnagar noted that the information on Project Patient Voice is meant to be read and discussed in the company of a health care professional, a caveat also listed at the top of the page. He added that the site was initially thought of as a jumping-off point for health care providers to talk with their patients.
But needing a medical professional to interpret the information diminishes the value of a platform that is supposed to be patient-centric, Chambers said.
“It’s ‘Patient Voice’ but it’s not in patient language,” she said. “This is information from patients for patients to patients, but it’s not written in that way.”
Even with a provider involved, some experts worried that the tool, in its current form, isn’t accessible enough to be helpful.
“I hate to use the word, but the data has to be sanitized,” said Otis Brawley, an oncology and epidemiology professor at John Hopkins University and former head of the American Cancer Society. “You can’t put the raw data there and expect the American population — the patients nor the physicians — reading that data to be able to synthesize the un-sanitized data into what one should do.”
Bhatnagar said that the agency will continue to refine Patient Project Voice. The team is collecting responses from patients and will host a public workshop in mid-July to discuss trial design for collecting patient-reported data and to hear feedback on the site.
“The bottom line is that Project Patient Voice is an important step in empowering patients and assisting in patient-centered decision making,” said Carlson. “And we should expect it to evolve over time, hopefully to become more useful, definitely more user-friendly, and more accessible.”