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Self Care

When Pat Paulson’s son told her he was feeling anxious and depressed at college, Paulson went through her Blue Cross Blue Shield provider directory and started calling mental health therapists. No providers in the Wisconsin city where her son’s university is located had openings. So she bought a monthly subscription to BetterHelp, a Mountain View, California, company that links people to therapists online.

Her son felt uncomfortable with his first BetterHelp therapist. After waiting several weeks, he saw a second therapist, whom he liked. But she wasn’t available the following week.

Despite the switch and the wait, Paulson is grateful she was able to find her son help. “He was getting to the point where he was ready to give up trying to find someone,” she said.

Many U.S. adults aren’t able to find help because of a shortage of therapists. Nearly 40% are struggling with mental health or substance abuse issues, according to the Centers for Disease Control and Prevention.

So millions of people are turning to online companies like BetterHelp that have sprung up in the past several years, advertising quick access to therapy. Often backed by venture capital firms, these for-profit businesses offer a wide mix of services, including one-on-one and group video therapy visits with licensed professionals, supportive texting, coaching videos, and prescriptions for medications.

In their ads, some of the companies feature testimonials from celebrities like Olympic athletes Simone Biles and Michael Phelps. But veteran therapists and officials from leading mental health professional associations say there’s limited evidence of the new online providers’ effectiveness.

“There are fundamental questions about what these companies are doing and whether they are reaching people who really need help,” said Dr. John Torous, director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston and chair of the American Psychiatric Association’s Health Information Technology Committee. “They may be doing wonderful work, but it’s hard to know when we don’t have that data.”

Dr. Varun Choudhary, chief medical officer at Talkspace, an online and mobile-based therapy provider, said online companies can help patients who face financial, cultural, and accessibility barriers to traditional therapy. He said clients may want the convenience of getting care online at home.

“By bringing together patients on a teletherapy platform, Talkspace expands capacity to deliver treatment,” he said. The company, headquartered in New York, says it has served more than a million people with 3,000 providers across all 50 states, and it charges $400 or more per month for four weekly live sessions.

Research suggests therapy delivered online can be effective and, spurred by the covid-19 pandemic, many individual therapists are offering sessions with their patients online. But the rapid proliferation of the online commercial therapy industry worries some traditional mental health professionals who have raised concerns about aggressive advertising for online services and whether patient care is compromised by inadequate training and pay for therapists working at some digital companies. In addition, news reports have detailed questionable prescription protocols, after which federal law enforcement launched probes of one company.

“Online companies inundate the internet with appealing ads that make promises about treating depression and anxiety,” said Marlene Maheu, a clinical psychologist and founder of the Telebehavioral Health Institute, who trains practitioners in best online practices and evaluates services for employers who may want to offer them as benefits to workers. “But can you trust them with your kid who’s in trouble?”

Therapy via Text

Studies have found face-to-face video psychotherapy visits and other mental health sessions to be just as effective as in-person encounters. But veteran mental health professionals are skeptical of some online providers’ texting practices and services that do not involve real-time video therapy. Research support for the efficacy of texting and similar services is scarce. On its own sites and publications, the American Psychological Association has barred advertising from one online mental health company on the grounds that its services do not meet the APA’s criteria for evidence-based therapy.

“Our concern there is that a patient will leave a text and it might be hours before the therapist responds,” said Vaile Wright, senior director for innovation at the American Psychological Association. “We don’t have peer-reviewed research to support that this is effective.”

Psychologist Bradley Boivin, who worked as an independent contracting therapist with BetterHelp for three months last year, said he had such strong concerns about the extensive use of texting for therapy that he told his clients he wouldn’t do it.

Boivin, who now works for a private practice in Scottsdale, Arizona, said other BetterHelp therapists told him they felt pressured to reply to client texts at all hours of the day. A BetterHelp compensation sheet obtained by KHN shows therapists get paid by the number of text words they read and write.

Alon Matas, founder and president of BetterHelp, which spent more than $7 million in December to advertise on 556 podcasts, defended the use of texting, saying his company’s therapists are not expected to respond immediately to clients’ texts. Each therapist uses professional judgment to decide when is the right time to use messaging and “how it’s best suited for each individual member,” he said.

Many therapists working at online companies are independent contractors, with no liability insurance or health insurance from the company, according to officials at associations for mental health professionals.

The online companies often attract therapists who are less experienced because the pay is typically lower than what therapists in private practices generally earn, according to Laura Groshong, director of policy and practice for the Clinical Social Work Association. “This is a way for new clinicians to get a foot in the door, and that’s something people should know,” she said.

The BetterHelp compensation sheet shows that the company pays therapists on a sliding scale based on how many hours per week they work — $30 per hour for the first five hours, $35 for the next five, etc., topping out at $70 per hour for any hours in excess of 35. That’s less than the typical $100 to $200 per session that private-practice therapists around the country charge clients.

Matas said the sheet does not reflect that therapists’ base hourly compensation by his company may be supplemented with monthly stipends, payments for group sessions, bonuses, and caseload incentives. BetterHelp has more than 25,000 therapists in its network, and Matas said it effectively pays up to 60% more than the median compensation for licensed therapists in every metropolitan area where it has therapists.

A Virtual Pharmacy

There also are concerns about online companies whose clinicians prescribe psychiatric drugs — either controlled substances that are potentially addictive such as Adderall, or antidepressants such as Zoloft that are not addictive but have potentially dangerous side effects.

Federal law requires doctors to see a patient in person before prescribing controlled drugs, which are those tightly regulated by the government because they can be abused. The federal government waived that provision under public health emergency rules issued early in the covid pandemic. Officials are considering whether to extend that waiver whenever the public health emergency period is over.

That review has been roiled by recent law enforcement actions following news reports in March. The Justice Department and the Drug Enforcement Administration are investigating Cerebral, a San Francisco online-prescribing company, for possible violations of the Controlled Substances Act for its prescribing of Adderall. The company told news organizations it has not been accused of violating the law and it would pause prescribing Adderall and other controlled drugs for attention-deficit/hyperactivity disorder. In a statement to KHN last month, it said, “Cerebral is fully cooperating with the Justice Department investigation.”

The DEA declined to comment on the probe, and the Department of Justice did not respond to KHN.

In a letter to the editor responding to a Bloomberg News article describing practices at Cerebral that included short patient appointments, aggressive advertising, and pressure on providers to prescribe drugs, Cerebral’s founder and CEO, Kyle Robertson, said his company did not give quotas or targets to clinicians to prescribe drugs. Cerebral “follows clinical prescribing guidelines based on the latest research,” he wrote.

The company’s directors removed him from his position in May.

The Cerebral allegations are “a wake-up call to everyone in the industry,” said Thomas Ferrante, an attorney at Foley & Lardner, which represents some online companies. “It’s a reminder that health care is a highly regulated space.”

“Companies like Cerebral are wrecking telemedicine for everyone,” said Piper Buersmeyer, a psychiatric nurse practitioner who is the majority owner of Med Rx Partners, an online and in-person service that evaluates patients and prescribes medications in Vancouver, Washington. “They are destroying trust.” She said she was concerned that some companies do not adequately evaluate patients’ mental health issues before prescribing medicines.

Other companies also advertise directly to consumers about aid in obtaining medication. For instance, Hims & Hers, another San Francisco telehealth firm, has run ads offering to provide “medication for anxiety and depression in less than 24 hours” after clients fill out a short form and connect online with a Hims & Hers provider. A spokesperson for the company, Sam Moore, said providers prescribe drugs only after following “evidence-based clinical protocols.”

Dr. Bob Kocher, president of Lyra Clinical Associates in Burlingame, California, said the optimal treatment pairs talk therapy with medication when needed. That generally works better than medication alone, he said. But he is concerned that some online therapy providers may not perform an adequate clinical evaluation of patients before and after they prescribe, may rely too much on patients’ self-diagnosis, and may not provide enough talk therapy.

“It’s not always clear it’s depression,” said Kocher, a practicing internist. Prescribing medications without adequate diagnostic work or continuing talk therapy, he added, would be “worrisome, because antidepressants are not without their own serious risks, including suicide.”

Based on her experience reviewing some online companies for employers and training therapists in online settings, Maheu is concerned that companies may not give their therapists training in how to deliver safe, effective, and ethical therapy online. As a trainer of online providers herself, she teaches therapists how to de-escalate suicidal or other crisis situations over the video screen. Meanwhile, there’s little government or professional regulation to protect consumers, she added. “What’s happening is a corporate takeover of behavioral health care by digital entrepreneurs,” Maheu warned. “This industry is a catastrophe waiting to happen.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Photo credit: Olga Strelnikova, Getty Images

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More than one in eight federally qualified health centers (FQHCs) are “fiercely committed” to remaining independent of hospital affiliation, according to a recent report conducted by Porter Research on behalf of NextGen Healthcare. FQHCs differ from other primary care centers and hospitals because they receive federal funds to increase access to care for marginalized communities. They serve nearly 29 million patients annually.

However, a slew of obstacles are challenging FQHCs’ financial stability — including workforce shortages, the expansion of Medicaid, evolving payment models and increasing regulatory requirements. Given these challenges, it is vital that FQHCs face work together more closely, the report argued. 

For the report, Porter Research garnered data from more than 50 executives at mid- to large-size FQHCs across the country to understand more about their organizations’ unique needs. 

Part of FQHCs’ funding and reimbursement is tied to clinical quality and financial metrics, which are measured on an annual basis by the Health Resources and Services Administration’ Uniform Data System. This system provides insights into the overall quality of care delivered at FQHCs versus the total cost to deliver that care. This process places a critical importance on the health centers’ ability to accurately report on the care they are providing, said Srinivas Velamoor, NextGen’s chief growth and strategy officer.

FQHCs’ data needs are further complicated by their unique positioning as last-mile delivery entities for integrated healthcare in marginalized communities. Velamoor said this means they need broader visibility into individual medical and behavioral health data, as well as data on patients’ social determinants of health, including housing status, financial circumstances, social isolation and access to food and transportation.

To ensure that FQHCs’s data needs are met, Velamoor recommends the following actions: simplifying and expanding interoperability and public data exchange programs, increasing access to patient data directories, and accelerating partnerships with non-FQHC community organizations. He also recommended that FQHCs collaborate with one another. 

“FQHCs deliver some of the most complex healthcare services under one organization in all of ambulatory care,” Velamoor said. “While some larger organizations have resources to address the needs of their populations, they don’t necessarily have the perspective that working collaboratively affords. For those that lack resources, pooling capabilities can help accelerate their ability to scale and evolve capabilities and address individual shortages.”

Further, the patient populations that FQHCs serve share a similar socioeconomic profile, one that is less advantaged than the patient populations served by private health systems. Collaboration between FQHCs allows them to learn from each other to meet the evolving needs of their communities, according to Velamoor.

“Collaboration also provides a safety net entity for vulnerable populations in key ZIP codes that can more effectively ensure appropriate coverage across the health continuum,” he said. “This requires collaboration with not just other FQHCs but non-FQHC community organizations that can provide visibility into patient and community needs.”

The report found that 72 percent of participants are willing to work with like-minded organizations, including other FQHCs, to pool data and glean more insights.

NextGen piloted an example of this type of collaboration last year when it launched the NextGen Community Health Collaborative. The initiative seeks to provide FQHCs with data benchmarking, comparative analytics and reporting services, as well as a forum for members to share best practices for improving community health.

Photo: metamorworks, Getty Images

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A UK startup has secured breakthrough device designation for a prescription-based software product using virtual reality to treat people with serious mental illness.

The designation from the U.S. Food and Drug Administration should help speed adoption of the therapy, developed by Oxford VR, according to Deepak Gopalakrishna, the company’s CEO and co-founder.

He credited the designation, in part, to a recent clinical trial that demonstrated the efficacy of the therapy, called gameChange. Published in April in The Lancet Psychiatry, the trial results showed that gameChange made a difference over six weeks of treatment for people who previously had been too anxious to visit a store, ride a bus or even leave home.

The product brings other potential benefits, as well, Gopalakrishna said. It can lower costs and broaden access for a relatively expensive subset of patients suffering from severe mental illness, Gopalakrishna said in an interview. They make up about 5.6% of the U.S. population, according to data from the National Mental Health Institute.

“There’s just not enough well-trained therapists to be able to meet the demands of the people who need that care,” he said.

Other digital health startups are working to address the shortage of mental health professionals and find new ways to deliver care. They include BetterHelp, Limbix Health, Octave and Spring Health. The latter recently published research showing its workplace-based program, which uses machine learning to customize care, has saved money for employers.

For its trial, Oxford VR studied gameChange’s impact on 346 patients. Roughly half used the VR product in conjunction with their usual care, while the other half received only their usual care. The most severe patients saw a 49% reduction in avoidance behaviors, a 41% reduction in paranoia and a 21% increase in quality of life after six weeks of care.

The study’s authors include Daniel Freeman, a psychology professor at Oxford University and co-founder of Oxford VR. His research underpins the gameChange software.

The research on gameChange appears promising, said John Torous, director of digital psychiatry at Beth Israel Deaconess Medical Center in Boston, which is affiliated with Harvard Medical School. The challenge for digital mental health in general has been scaling up from small studies to widespread implementation, he said.

Providers may struggle to fit new technology into existing workflows or lack the skills needed to make it work, he said in a phone interview.

“Do you need a VR expert on staff to help people use it or can existing staff manage it?” he asked to point out a question that providers may have with respect to adopting the technology. 

When it comes to Oxford VR, that would be a no. Gopalakrishna said that Oxford VR has sought to make gameChange as simple as possible for both patients and the providers who oversee its use. So no VR-trained expert is needed nor do users need any extra technical training.  

The company does offer training and tech support to clinic staff to get them started, he said. The training includes how to assist patients in translating their VR experience into the real world. 

“For us, it’s literally drag-and-drop easy,” Gopalakrishna said.

In a traditional approach to cognitive behavioral therapy, a therapist might take a patient out into the world, Gopalakrisha said. If and when they encounter a situation that triggers anxiety, the therapist provides guidance to lessen the effect.

“That leaves a lot to chance,” Gopalakrishna said. It also is costly, as a therapist may spend months with an individual patient.

Instead, gameChange recreates the stressful situations in virtual reality and guides patients, with the help of an automated therapist. Even though patients are in virtual reality, they perceive the situations as real, Gopalakrishna said. The software can run on any commercially available VR headset.

The goal is not to replace therapists but to expand their capacity to treat patients, Gopalakrishna said. Instead of seeing a therapist every week, for example, patients could alternate weekly between the therapist and gameChange, potentially doubling the capacity of the therapist.

Backed by the trial results and FDA clearance, Oxford VR has been rolling out gameChange at clinics operated by the National Health Service and at providers in the U.S. Gopalakrishna declined to identify them.

In the UK, Oxford VR is paid out of any cost savings that arise from the use of gameChange, Gopalakrishna said. The company operates under a range of payment models in the U.S. but it expects to be reimbursed primarily out of bundled payments paid to providers for taking care of patients.

Most patients use gameChange in a clinical setting. However, the product is available for home use under a program with the Wounded Warrior Project, a nonprofit that focuses on U.S. veterans suffering physical injuries or mental illness. 

Founded in 2017, Oxford VR raised $12.5 million in a Series A round in February 2020. Investors included Optum Ventures, Luminous Ventures, Oxford Sciences Innovation, Oxford University Innovation and GT Healthcare Capital Partners.

The company also offers a VR product designed to help patients overcome anxious social avoidance. 

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phone, text, texting, cell phone, smartphone

The rising levels of both type 1 and type 2 diabetes in American youth is quickly becoming a major public health concern. Data from the Centers for Disease Control and Prevention shows that 210,000 of the estimated 26.9 million Americans with diagnosed diabetes in 2018 were children and adolescents younger than age 20.

To help address this problem, New York City-based Mount Sinai is adopting a tech approach. It is partnering with mPulse Mobile, a company that sells its AI-based mobile patient messaging platform to health plans and health systems. Together with a group of teenage community members, the two partners have created a text message-based youth diabetes prevention program focused on integrating healthy behaviors into teens’ lives.

The partnership began after Dr. Nita Vangeepuram, a pediatrician and researcher at Mount Sinai, attended a webinar near the tail end of 2017 in which mPulse was explaining its technology. She reached out to the company to see how they could collaborate to address rising levels of youth diabetes, which she thinks is a widely overlooked issue in medicine. Chris Nicholson, mPulse’s founder and CEO, said he still remembers a shocking statistic Dr. Vangeepuram shared with him during those initial talks: that roughly half of U.S. youth are projected to have diabetes by 2050 unless healthcare providers deploy targeted interventions.

To “bend the trend,” as Nicholson put it, Mount Sinai and mPulse began working with a group of teenage community members living in East Harlem to develop text messaging campaigns focused on diabetes prevention. The partners wanted to work with East Harlem teens for two reasons, the first being that the neighborhood has one of the highest rates of diabetes in New York CIty. The other reason is that the area is racially diverse — an important consideration Black and Brown communities are more vulnerable to diabetes. 

Before developing the texting program, Dr. Vangeepuram conducted qualitative research with teenage subjects to determine which mobile technology is most effective at reaching teens. They reported they would rather access health content through texting than social media or apps. Teens told her that they preferred texting because it was a mode of communication they already used frequently and it did not require them to log in or download something.

Mount Sinai and mPulse involved East Harlem teens throughout the entire process of building the texting program, employing an approach Dr. Vangeepuram called the “youth participatory action research framework.” She said this refers to the idea that young people should be actively involved in research meant to create a positive change in their health.

The “community action board” of teens helped Mount Sinai researchers and mPulse develop a texting program that comprises five buckets: goal setting, cultivating healthy behaviors, maintaining motivation, tailored diet and exercise guidance and a photo diary. The messaging content was created based on what the youth community members said would best speak to their needs as it pertains to their financial circumstances, home life and busy schedules. 

Once a teen who is enrolled in the program engages with the texts, mPulse’s algorithm continually tailors its messages based on relevancy, according to Nicholson. For example, some teens enrolled in the program receive tailored exercise plans that can fit into their class and work schedules.

“When we learn something about an individual — when they communicate a barrier — we must present them with the next best action, a strategy that can combat that barrier or come at it from a different perspective,” Nicholson said.

To measure the impact of the program, Dr. Vangeepuram said her team will look at metrics such as how many teens enroll in the program, how often they respond to messages and how many users stay engaged over a long period of time. Down the road, the team will look at metrics such as East Harlem teens’ weight and hemoglobin A1C levels to determine how much of an impact their program is having on teenage diabetes rates.

Dr. Vangeepuram readily admitted the irony that the program is trying to reduce teenage diabetes through screens, the very thing that is blasted as the culprit causing the American childhood obesity epidemic. 

“We’re sort of spinning this idea on its head to figure out how we can actually use these tools, to our benefit,” she said. “It’s an exciting thing to think about. If teens are texting anyway, we might as well do good with it.

Photo: diego_cervo, Getty Images

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When people hear about a healthcare accelerator, they usually think of an incubator program in which digital health companies receive investments for strengthening their technology. That is not the case for Boston Medical Center’s Health Equity Accelerator.

After being inundated with data on racial health disparities that continue to disproportionately affect Black and Brown patients in the U.S., BMC launched the accelerator in November. Its goal is to quicken the timeline between discovering inequities and implementing action plans to address them, said Elena Mendez-Escobar, co-executive director of the accelerator. 

“BMC has a history of 150 years as a safety net hospital, so it’s always been focused on health equity,” she said. “Many institutions have worked on health equity for a long time, but they haven’t had the explicit and intentional focus on race and ethnicity that we think is lacking.”

Seventy percent of BMC’s patients identify as Black or Latino, according to Mendez-Escobar. Because of this, the hospital not only has a responsibility to close racial health equity gaps, but it also has a wealth of its own data to dive into to understand which disparities are affecting patients of color the most.

The accelerator’s researchers analyzed BMC data to identify the following five clinical areas with the most pressing racial health inequities: maternal and child health, infectious diseases, behavioral health, chronic conditions, and oncology and end-stage renal disease. To address the health inequities in these clinical areas, the accelerator forms cross-functional teams of clinical experts, researchers and healthcare staff to talk with patients and determine which changes BMC should make to its care delivery models.

For example, after the accelerator’s researchers found that BMC’s Black maternity patients were 1.7 times more likely to experience severe complications during birth than its White maternity patients, it put together a multidisciplinary team. The team — which featured doulas, midwives, physicians, operational experts and researchers — examined the problem by completing literature reviews, applying analytics to EMR data and conducting focus groups with patients. 

Within a couple months, they found the main reason why BMC’s Black patients are having more complications has to do with preeclampsia, a serious pregnancy complication characterized by high blood pressure. Preeclampsia’s only cure is delivery, so a patient’s care team must make quick decisions about inducing labor or undergoing a C-section. The longer it takes for these decisions to be made, the higher the patient’s risk of hemorrhaging. The accelerator’s research found that care teams were taking longer to make these decisions for Black patients, causing them to hemorrhage more.

BMC quickly took a number of steps to address this finding, such as expanding its doula program and disseminating patient-facing videos on preeclampsia to increase patient agency. The hospital also expanded its hypertension remote monitoring program so it could catch preeclampsia cases earlier and updated its clinical protocols so there is less variation in how long it takes to make child delivery decisions during preeclampsia episodes. To measure the impact of these changes, BMC will look at metrics such as preeclampsia complications and mortality rates among Black maternity patients.

Having the health equity accelerator in place allowed BMC to implement these interventions rapidly. Mendez-Escobar pointed out that the accelerator was established to speed up the clinical changes and outreach efforts that should always come as a result of health equity research.

Instead of focusing on copious research articles and yearslong trials, academic medical centers can often create an action plan for a health equity problem in three or four months if they have a dedicated program to do so, she said.

Photo: gmast3r, Getty Images

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Wall Street sign

Bausch + Lomb’s $630 million IPO was the biggest one in the second quarter of this year. It was also an outlier. The steep drop off in IPO activity continued in the most recent quarter, which saw the number of completed new stock offerings dip to levels last seen in the Great Recession of the late 2000s.

The 21 IPOs that raised $2.1 billion in the second quarter made it the slowest second quarter for IPOs since 2009, according to a new report from IPO research firm Renaissance Capital. By comparison, the second quarter of last year tallied 118 newly public companies that raised $40.7 billion. It turned out to be the peak. IPOs dipped in the third and fourth quarters of last year. In the first quarter of this year, activity plummeted to just 18 IPOs. Renaissance said factors holding new IPOs in check include recession fears and record inflation.

“New issuers are still waiting for better conditions, and meaningful IPO activity is unlikely to resume until returns improve,” Renaissance said in the report.

The large life science IPOs in the second quarter are exceptions. Bausch + Lomb is a well-known brand with a broad portfolio of eyecare products commercialized around the world. It’s also no stranger to the public markets. Bausch + Lomb traded on the New York Stock Exchange for nearly 50 years until it was acquired by private equity firms in 2007. HilleVax raised $200 million from its IPO. While the vaccine developer is not as well known as Bausch + Lomb, it spun out of pharmaceutical giant Takeda Pharmaceutical with a norovirus vaccine candidate that has already successfully demonstrated proof of concept in Phase 2 testing in adults. Both companies are less risky investment bets compared to some of early-stage companies that have been trying to go public.

HilleVax priced shares at the midpoint of its targeted price range, and the company was able to boost the deal size by offering more shares. However, Bausch + Lomb’s strong balance sheet and growing business were not enough to offset the dampening effects of the financial markets. The company priced its IPO at $18 per share, well below the $21 to $24 per share range that the company had set. PepGen, a biotech in early-stage clinical development, was able to raise $108 million from its IPO. But the genetic medicines delivery company priced its stock offering below the targeted price range so it needed to sell more shares to top the $100 million mark.

A year ago, an IPO topping $100 million was common. In the second quarter, just six IPOs crossed that threshold. The median deal size in the second quarter was $22 million, which Renaissance said marked a multi-decade low. The firm calculated that just 25% of newly public companies finished the second quarter above their IPO prices. Shares of Bausch + Lomb, HilleVax, and PepGen are all trading below their offering prices.

Financial conditions continue to hold down new efforts to go public. New filings have sunk to a six-year low, Renaissance said. The pipeline of companies that have already filed remains full, even if it’s not moving much. In some cases, companies are postponing IPO plans indefinitely. Bausch Health Companies, the firm that had acquired Bausch + Lomb and adapted its name before spinning out the eyecare business, had also planned to spin off the skincare business named Solta Medical. Last month, Bausch Health said it was suspending the Solta IPO, citing the challenging market conditions. SPAC deals are not doing any better. Though such deals were hot in 2021, Renaissance counted just 15 blank check IPOs and 19 merger completions in the second quarter.

The sluggish financial conditions are leading some publicly traded companies to pursue alternative financial strategies. Radius Health is going private via a buyout by two private equity firms. In explaining the rationale for the deal, company executives cited the rough markets, particularly for biotech companies. Blueprint Medicines found a way to raise money without tapping the financial markets. Last week, the company agreed to sign over some of the royalties it’s owed for two cancer drugs in exchange for $575 million upon the close of the deals. In the years to come, these financing agreements could bring Blueprint up to $1.25 billion in total capital.

Photo: Angela Weiss/AFP, via Getty Images

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Novartis is paying $100 million now for the opportunity to shorten the regulatory review of a rare disease drug candidates in the indeterminate future, a move that could save time and bring a potential blockbuster product to the market sooner, assuming it passes FDA muster.

The Swiss pharmaceutical giant has reached a deal to buy a priority review voucher from Mallinckrodt Pharmaceuticals. Such vouchers stem from an FDA program intended to incentivize the development of drugs for rare or neglected diseases. Voucher holders can shave the standard 10-month review time down to six months.

Companies can obtain a voucher by winning approval for a rare disease drug. In such cases, the voucher that’s awarded may be applied to a future product candidate. The other way to get a voucher is to buy one from a company that already has one. That’s what Novartis is doing. Dublin, Ireland-based Mallinckrodt earned its priority review voucher by landing FDA approval last year for StrataGraft, a regenerative medicine treatment for burn injuries. This product is made by growing human skin cells to form a scaffold upon which a burn patient’s own skin cells can grow.

Mallinckrodt has been reorganizing under bankruptcy protection. As an asset that can be monetized, the StrataGraft priority review voucher became part of the company’s reorganization plan. According to that plan, the trustee overseeing the company’s unsecured claims had the right to consult in Mallinckrodt’s marketing and sale of the voucher. The document also specifies that these creditors will receive 35% of proceeds from a sale of the voucher. That means that the $100 million transaction breaks down to $65 million for Mallinckrodt and $35 million for the creditors. According to a Mallinckrodt regulatory filing, that payment will be directed to a trust set up for general unsecured claims under the Chapter 11 plan. In mid-June, Mallinckrodt announced that it had emerged from bankruptcy.

Novartis has plenty of experience with priority review vouchers. The company applied a voucher to autoimmune drug Ilaris, seeking to expand the drug’s approval to gouty arthritis. The FDA rejected that drug application in 2011 and asked the company to provide more clinical data. Novartis was awarded priority review vouchers in 2017 with the approval for CAR T cancer therapy Kymriah and in 2019 for the approval of Egaten for the treatment of fascioliasis, a neglected tropical disease. The FDA’s 2019 approval of Zolgensma, the first gene therapy for spinal muscular atrophy, also came with a rare pediatric disease priority review voucher. Novartis successfully redeemed one of its vouchers with the 2019 approval of Beovu, an antibody drug that treats the wet form of age-related macular degeneration.

More recent transactions include Albireo Pharma’s sale of a voucher last year for $105 million, and BioMarin Pharmaceuticals’ February voucher sale that brought in $110 million. Albireo earned its voucher for Bylvay, a treatment for pruritus in patients with a rare liver disease; BioMarin for the approved dwarfism drug Voxzogo. In May, the voucher that BridgeBio Pharma earned from the  approval of metabolic disorder drug Nubrilvy sold for $110 million. In each instance, the voucher purchasers were not disclosed.

Photo: John Slater, Getty Images

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Currently, according to Tufts researchers, clinical trials in a variety of therapeutic areas experience patient dropout rates close to 20%, with the consent process being the number one factor contributing to this figure.

Additionally, according to Advarra, “35% of patients who dropped out of a study early reported that it was difficult to understand the Informed Consent Form”.

It is critical that the consent process be tailored to ensure that participants understand what’s being asked of them and how their data will help further future disease treatment.

The Solution: eConsent

Why?
1. eConsent simplifies overly long and complex forms as it can be tailored to different audiences & have interactive, engaging elements.
2. Medable eConsent enables the enrollment of underrepresented and geographically diverse populations through remote consenting, something that has been shown to reduce screening timeline periods by 50%.

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A Bristol Myers Squib cancer drug made by engineering a patient’s own immune cells is now approved to treat patients in earlier stages of their disease, a regulatory decision that expands the number of patients that can be reached with this type of personalized cell therapy. The decision could also give BMS an edge over a rival cell therapy marketed by Gilead Sciences.

The CAR T-therapy from BMS, named Breyanzi, was initially approved last year as a treatment for diffuse large B-cell lymphoma, (DLBCL) a type of non-Hodgkin lymphoma in which the body produces abnormal B lymphocytes. Standard treatment is chemotherapy plus the antibody drug Rituximab. When that treatment doesn’t work or the cancer relapses, the next treatment option is an autologous stem cell transplant.

Breyanzi’s initial approval made it a third-line treatment for DLBCL patients whose cancer relapsed or has not responded to two earlier therapies. The expanded approval of the drug announced late Friday moves the drug up in the treatment hierarchy and makes it a second-line therapy for patients whose disease has relapsed within 12 months of the initial chemotherapy regimen. That matches the expanded approval earlier this year of Gilead Sciences’ cell therapy, Yescarta. Furthermore, Breyanzi’s additional approval also covers those who are not eligible for a stem cell transplant.

Leo Gordon, an investigator in Breyanzi’s PILOT study and a professor of medicine at Northwestern University, said factors that may make patients bad candidates for a stem cell transplant include age, poor kidney or heart function, or low scores according to an assessment of frailty. Usually, such patients would receive palliative care to ease the cancer’s symptoms.

“We thought there was a possible place for CAR T-therapy,” Gordon said during an interview earlier this month at the annual meeting of the American Society of Clinical Oncology. “The purpose of this is to get another option for patients for what is considered to be the standard [of care treatment]. That’s why this is an important group to look at.”

CAR T-therapy is a personalized treatment made by harvesting a patient’s T cells and engineering them to target a protein on the surface of cancer cells. Those immune cells are multiplied in a lab and then infused back into the patient. Expanded approval of Breyanzi was based on the results of two studies evaluating the drug as a second-line therapy.

The TRANSFORM study evaluated Breyanzi in 184 patients still eligible for a stem cell transplant. The main goal was to measure how long a patient remains free of certain cancer complications. At one year, 45% of patients treated with Breyanzi achieved this mark compared with 24% of those who received standard therapy. Event-free survival in the treatment group was an estimated 10.1 months compared with 2.3 months in the control arm. Of those patients who received standard treatment, nearly half went on to receive an autologous stem cell transplant.

Measuring complete response and overall response were the main goals of PILOT, an open-label study that enrolled patients with a median age of 73. Gordon said that efficacy in PILOT was similar to what was observed in healthier and younger patients who were evaluated in tests of the drug as a third-line therapy. The median duration of response has not yet been reached but in the 61 patients, 54% achieved a complete response. “That is actually better than what we would expect for a transplant,” Gordon said.

The major safety risks of CAR T-therapies as a class include an immune response called cytokine release syndrome and toxic effects in the brain. Gordon said the cytokine release syndrome cases observed in the latest Breyanzi study were mild to moderate. While some patients had severe neurotoxicity, Gordon said no one had to go to the intensive care unit and everyone recovered. About 20% of patients were treated on an outpatient basis.

In a research note sent to investors on Monday, William Blair analyst Matt Phipps noted that compared to Yescarta, Breyanzi’s broader label as a second-line treatment gives it access to a bigger pool of patients that Gilead’s drug is not approved to treat.

“We assume around 40% of patients are refractory or will relapse at some point following first-line therapy, and with 50% of these patients being transplant ineligible, around 6,000 patients per year could be eligible for Breyanzi based on PILOT,” Phipps wrote. “Thus, this approval clearly provides Bristol Myers with a bigger opportunity with less CAR T-competition.”

Breyanzi accounted for $87 million in total revenue in 2021, according to BMS’s financial reports. For the first quarter of this year, the drug tallied $44 million in sales. Phipps said that Breyanzi’s new approval and broad label are positive signs for BMS as the company looks to other drugs that can offset patent expirations facing key products in coming years. He added that BMS projects Breyanzi could top $3 billion in annual sales by the end of the decade.

Photo by Bristol Myers Squibb

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Americans’ search for the right provider often begins with browsing physicians’ online profiles, the way one might look for a new hairstylist or plumber. These digital profiles — such as those found on a health system’s website, health plan directory or third-party healthcare website like Zocdoc or Healthgrades — must be robust in order to best attract and retain patients, according to a new report

Kyruus, a startup focused on software to help pair patients with providers, sponsored the study that surveyed 100 primary care physicians and 100 specialist physicians about their digital provider profiles. The survey, which was conducted in April, included providers who have been in practice for more than a year, spend 20 hours or more per week seeing patients, are employed by a hospital or health system and treat patients in ambulatory settings. Nearly all respondents said that it is important for the hospitals or health systems that employ them to take a more active role in managing their profiles.

“A robust digital presence is a must-have for providers today,” said Karen Conley, Kyruus’ senior vice president of clinical services. “Our latest consumer research shows that nearly 60% of consumers use the internet when searching for care, so it’s important for providers to be searchable online to attract new patients.”

The survey found that providers focus on three top reasons for maintaining a strong digital profile: to showcase professional experience, to display academic research and publications, and to improve visibility to referring providers. Respondents said that they usually prefer to be involved in the creation and maintenance of their online profiles, as accuracy is vital and helps providers distinguish themselves for referring providers and patients seeking care.

To strengthen patient acquisition, providers want to make their profiles appear everywhere prospective patients may search online for care online, but they expressed this is difficult to ensure on their own. Two-third of respondents said it is important for healthcare organizations to be more active in channel expansion for their providers’ online presence. Health plan directories made the top of the list of external digital channels where respondents wanted their healthcare organization to more actively manage their profile, slightly edging out Google and third-party provider search websites.

Providers said having a more ubiquitous online presence will help them maintain visibility among a patient base that is demanding more digital resources.

“Today’s consumers are more digitally savvy and providers who offer a comprehensive online profile are helping to ensure they are proactively answering their patients’ questions about insurances accepted, services, locations, and even appointment availability,” Conley said. “The latter is especially important because our consumer research tells us that consumers may switch providers if they have to wait too long for an appointment.”

The report suggested that healthcare organizations need to actively engage their providers when building and expanding their digital profiles, encouraging them to continually improve and maintain their own profile information.

It also recommended that hospitals and health systems establish a clinically-led data governance strategy to ensure the accuracy and security of the data included in physicians’ online profiles. 

“While providers place great value on their online profiles, most do not have the time or know-how to create and maintain digital profiles on their own,” Conley said. “That’s why it’s important for healthcare organizations to establish a provider engagement program to guide the process and a data governance strategy that puts controls and reviews in place to ensure provider profiles stay accurate and up-to-date.”

Photo: ijeab, Getty Images

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