Self Care

Ten months after Acelyrin landed $250 million for mid-stage clinical development of an in-licensed immunology drug that could compete against blockbuster Novartis and Eli Lilly drugs, the biotech has raised $300 million more.

The new cash follows the report over the summer of positive Phase 2 data for izokibep, an antibody mimetic that blocks interleukin-17A. Los Angeles-based Acelyrin plans to use the latest fundraising haul to fund Phase 3 tests of its drug in psoriatic arthritis and axial spondyloarthritis.

Acelyrin’s Series C round of funding was the biggest biotech cash infusion of the past week. Here’s a recap of other notable financings:

Capstan Therapeutics emerged from stealth with $165 million raised to date as it works to advance toward the clinic with cell therapies engineered inside a patient’s body. The startup, which has operations in San Diego and Philadelphia, is based on research from University of Pennsylvania scientists with expertise in cell therapy and messenger RNA.

—Radiopharmaceuticals developer RayzeBio closed a $160 million Series D financing, which the company will apply toward more clinical tests of its lead asset, RYZ-101. A Phase 1b study is underway in neuroendocrine tumors; the company says Phase 3 tests could begin as early as next year. The FDA has also cleared the company to begin testing the radiopharmaceutical in non-small cell lung cancer.

Nimbus Therapeutics, a biotech company whose drug discovery approach is based on computational techniques, raised $125 million to back clinical development of programs in autoimmune diseases and oncology. One of those programs is blocks an enzyme called TYK2, which the Cambridge-based biotech is developing for moderate-to-severe plaque psoriasis and active psoriatic arthritis. The biotech is chasing Bristol Myers Squibb drug Sotyktu, whose recent FDA approval made it the first approved TKY2 inhibitor for moderate-to-severe plaque psoriasis.

—ATP, a venture capital firm formerly known as Apple Tree Partners, has merged three of its portfolio companies to form Galvanize Therapeutics, which is now backed by $100 million. San Carolos, California-based Galvanize is developing a pulsed electric field energy technology to treat various disorders including chronic bronchitis, cardiac arrhythmias solid tumors, as well as drug delivery. The new financing is a Series B round led by Fidelity Management & Research Company with participation from Intuitive Surgical, ATP, and Gilmartin Capital.

Forge Biologics, a company that operates as a gene therapy contract manufacturer while also developing its own therapies, closed a $90 million round. Columbus, Ohio-based Forge will use the new capital to expand its offerings to clients and bolster its manufacturing platform. The Series C financing was co-led by Drive Capital and Aisling Capital with an additional investor that remains undisclosed.

—SparingVision, a biotech developing gene therapies to treat inherited eye disorders, has raised €75 million. The Paris-based company will use the cash to begin clinical testing of two therapies, SPVN06 and SPVN20. SparingVision also plans to advance CRISPR-based gene-editing programs covered under a partnership with Intellia Therapeutics. The Series B round of financing was co-led by Jeito Capital and UPMC Enterprises. 4Bio Capital, Bpifrance, the RD Fund, and Ysios Capital also participated.

—Pretzel Therapeutics launched with $72.5 million to finance development of technology that modulates mitochondria, the energy-producing components of cells. Mitochondrial dysfunction is associated with more than 50 diseases, both rare and common. Waltham, Massachusetts-based Pretzel’s platform takes three approaches to affect mitochondrial function: genome correction, genome expression modulation, and mitochondrial control. Arch Venture Partners and Mubadala Capital led Pretzel’s Series A round.

Novome Biotechnologies raised $43.5 million for its gut microbiome approach to treating disease. The South San Francisco-based biotech’s lead program is in mid-stage testing for hyperoxaluria, in which people lack an enzyme needed to break down a compound in leafy greens called oxalate. Novome’s experimental treatment is comprised of bacteria engineered to break down oxalate. Tencent led Novome’s Series B financing.

—Carver Biosciences, a new company founded by Princeton University molecular biologist Cameron Myhrvold, emerged with an unspecified amount of seed financing led by Khosla Ventures. Boston-based Carver is developing antivirals that employ the CRISPR gene-editing system along with the RNA-directed Cas13 enzyme to target respiratory viruses. Myhrvold, whose research included developing Cas13-based technologies for studying viral host RNAs, founded Carver last year and will serve as the chair of the biotech’s scientific advisory board.

Picture: Feodora Chiosea, Getty Images

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The need for understandable and transparent pricing for medical services in the U.S. has increased in urgency with the continuing rise of out-of-pocket healthcare costs.

Americans are delaying healthcare because they are unsure of the cost or they cannot afford it. A recent Willis Tower Watson (WTW) survey of 9,600 U.S. workers showed that 4 in 10 people deferred healthcare in the past year, with 28% delaying or canceling a medical procedure and 17% not filling a prescription.

Recent federal mandates are inching price transparency forward with the goal of improving care while reducing waste and reigning in costs. With lab values as the basis for 70 percent of medical decisions, lab testing transparency for price and appropriate use is essential to lowering costs for patients.

But price transparency goes beyond reducing costs. It will realign how labs, providers, and payers work together to order, approve, and pay for the right care that moves us closer to the Triple Aim of improving the patient experience, improving the health of populations, and reducing costs.

You can’t flip a transparency switch

Unfortunately, the lab testing industry can’t flip a switch and make transparency universal.

With healthcare affordability as a big concern, Americans are becoming more involved in managing their care, and that includes switching health insurance plans to secure the best benefits and reduce out-of-pocket costs. To help support these consumer decisions, recent federal regulations were enacted.

  • The No Surprises Act stipulates that out-of-network facilities, including the clinical labs that serve them, may not bill patients for the balance of their charges, known as “balance billing,” which is now illegal. The No Surprises Act went into effect at the start of this year, but 1 in 5 Americans surveyed by Morning Consult say they received surprise medical bills since January 1, 2022. In fact, 32% said the unexpected bill originated from lab work collected at an in-network facility but was sent out-of-network for analysis.
  • The Transparency in Coverage Rule requires health insurers and employers that pay directly for workers’ medical care to post data on what they pay hospitals, doctors, and other providers. For now, this mandate will be a data dump that won’t make it easy for patients to gather price information.

Even with the government stepping in to improve access to pricing data and reduce unexpected costs, we are still far from having universal lab testing transparency. Achieving full transparency will require: 1) coordinated education, 2) simpler data access, and 3) the strategic implementation of payment integrity programs to eliminate unnecessary lab tests while identifying underutilized tests that improve patient care and outcomes.

Location, location, location

Education about the impact of lab testing location on cost has to move “upstream” in the care process. Today, that often happens after the lab test has occurred. Patients and their physicians need to understand and discuss which lab testing locations bring the most value and inform the best care.

The lab test location can result in increased costs, over-testing, and unnecessary tests.

Hospital-owned labs are typically paid more than independent labs. Lab tests performed at hospital-owned labs are generally 2.5 to 4.5 times the cost of an independent lab. Avalon’s analysis of paid claims demonstrates that hospital outpatient labs are paid on average 300%-400% of Medicare’s independent diagnostic fee schedule. Hospitals frequently argue they need to charge more to support their specialty test innovation and development. That doesn’t hold true for routine testing, though. For example, some hospitals will be reimbursed $100 for a routine test, while an independent or non-hospital lab will be reimbursed on average $20 for the same test, performed on the same machine.

Physician office lab testing is more costly and more frequent. When physician offices have their own lab equipment, our analysis of paid claims demonstrates that physician offices are reimbursed on average 120% to 130% of Medicare’s independent diagnostic fee schedule for those tests. In addition, the frequency of lab testing increases when the laboratory testing is performed in the physician’s office. When the elapsed time between tests is less than the time it takes for the body to produce new chemicals in the body (measured by the half-life of the chemical) this is not a clinically useful frequency of testing.

Our analysis of paid claims demonstrates independent labs conduct the most clinically useless test units. The laboratory industry develops the test order menus from which physicians order labs. While developing panels, which represent useful tests commonly ordered together, the labs will add additional tests that are not useful to the physician’s diagnostic evaluation. This is known as panel stuffing in the industry. Panel stuffing is a wasteful practice that adds unnecessary tests (those that don’t comply with a health insurance plan’s published policies) within routine lab panels and increases test costs for patients.

Consider that several labs add an experimental subcomponent analysis of Vitamin D to the Vitamin D panel menu. Also, consider that many labs, on the menu for evaluation of thyroid, include seven unique tests when two are important to the most common clinical scenarios. This raises the cost of routine thyroid testing from around $30 to about $137.

Lab tests that lack clinical indications can lead to unneeded sample collection from patients as well as a higher risk of false-positive results and unnecessary costs. We identified that on average there is approximately $2 per member/per month worth of obvious waste in processed claims. This represents the total amount allowed for the testing. Patients, on average, pay 1/3 of the cost at the point of service and payers pay the other 2/3 of that cost. Another way to look at this same data is that for every 1 million members with health benefits, approximately $24MM dollars of useless testing is reimbursed per year, with patients paying $8MM of that out of pocket.

Promoting lab testing at the right location—for both cost and care—may be harder than it sounds. Physicians who are part of health systems may be pressured and/or incentivized to send patients to the affiliated hospital labs. Plus, payers are often hesitant to educate their members about lower-cost lab testing options because of various provisions in their contracts with hospitals.

Sharing the facts about lab testing locations will require a national education campaign—much like the campaign conducted for the $0 co-pay generic drugs—to motivate patients to insist on having lab testing performed at lower-cost locations and to only pay for tests that benefit patient care.

Right test, right time, right care

Patients, providers, and payers all want the right care. Appropriate lab testing is a critical driver behind this. The demand for lab testing is growing as more providers recognize the importance lab results play in confirming the diagnosis, monitoring patients’ treatment responses, and monitoring diseases significant to public health (i.e., Covid-19). The high prevalence of chronic and acute diseases, an aging population, and advancements in genetic testing are also fueling this growth. There is an expected  10% compounded annual growth rate through 2029.

Receiving the right care should be as simple as having the right lab test at the right time (in the right location). However, the current healthcare ecosystem includes trends that undermine the journey to this valuable goal. When looking closely at the 13+ billion lab tests performed annually across the U.S., 30% of lab tests are unnecessary, 30% of patients don’t receive the tests they need, and 1 in 3 genetic tests are ordered in error.

When you consider that lab testing is the gateway for diagnosis and treatment of many conditions, it transforms each test from being a passive event to a critical data point for proactive value-based care success. With this backdrop, a payment integrity program that includes lab benefit management can serve as a strategic lever to curb these negative testing trends and advance the Triple Aim.

With sound science at the core, payment integrity programs provide input from policies developed by independent clinical boards on what types of tests are not evidence-based and emphasize the appropriate units for routine and genetic testing. This process flags non-adherent tests (from both panel stuffing and inappropriate genetic test orders) and underutilized tests that can inform patient care, especially in cancer care. The ultimate impact is for patients to receive the right tests at the right time to better inform diagnoses and care plans, reduce waste in time and treatments that are not helping patients, and achieve cost alignment that drives the right outcomes.

As the U.S. healthcare industry continues to advance value-based care and population health, lab testing price transparency and payment integrity programs should be a priority.

Photo: champc, Getty Images

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clinical wearables

The wearable technology market is growing rapidly. With more than 30 percent of adults in the United States using the devices, the global market is set to exceed $380.5 billion by 2028. As the market evolves, wearables are expected to get more personal, powerful and stylish. And, we’re starting to see wearables transition from fitness to health devices. However, many device manufacturers are overlooking the most important aspect to consumers who want to use their devices for healthcare purposes: improved device accuracy and FDA clearance.

Wearable technology first appeared on the market in the early 2000s in the form of step counters, sleep trackers and general wellness devices. They didn’t include the wide variety of features currently available like heart rate, body temperature, or activity level monitoring. They weren’t intended to serve a medical application, and there certainly wasn’t a focus on whether they were providing users with accurate data under all circumstances. That’s a reality that still holds true today – the majority of devices currently on the market are still inconsistent in the accuracy of the data they provide users. This presents challenges for consumers who assume the data is accurate or “close enough” because they’re using this data to better understand their health or to potentially raise concerns with their physician. Until wearable technology companies position themselves as medical device companies, these devices are going to continue to come up short when applied to a medical setting.

Wearable companies tend to shy away from seeking FDA clearance for a few key reasons. First, they see themselves as consumer device manufacturers, not medical device companies, so they don’t organize themselves to produce a medical-grade device. Often, they aren’t hiring employees with medical device product development backgrounds, nor are they creating an infrastructure that can support developing such a device. Second, it’s costly to go this route. It can often take longer to develop, iterate, test and hone your product to the specifications required to receive FDA clearance. Some manufacturers have blurred the distinction between wellness and medical devices by seeking FDA approval for a specific feature of their device, like Apple and FitBit gaining FDA clearance for ECG monitoring and atrial fibrillation detection. This type of blended device approval, where aspects of the technology have clearance, but not the device overall – will only continue to muddy the waters as consumer devices wade into the medical device environment.

There are significant advantages for consumers related to data privacy when using a wearable device that has FDA clearance, as the protection of personal medical data (Protected Health Information, or PHI) was mandated by the agency with the introduction of the Health Insurance Portability and Accountability Act (HIPAA) . Because user data and privacy concerns are top of mind, especially when it comes to women’s health, users can rest assured that their health data is treated with the same level of security as their medical records. As consumers better understand their right to medical privacy, they will have higher expectations for wellness wearables that aren’t bound to data privacy regulations. When FDA clearance is granted, it will communicate a stamp of approval that means privacy controls are in place which prevent access to a person’s PHI without their permission.

There’s a significant opportunity for medical grade wearable manufacturers in telehealth and virtual healthcare visits, which surged to new heights during the pandemic. The convenience and accessibility appeal to patients and practitioners so much so that the telehealth market has stabilized at a rate 38 times higher than pre-pandemic levels. Consider that 80 percent of United States residents live in what is considered healthcare deserts. These can be in rural areas and inner cities, and what it implies is that medical grade FDA approved wearable devices have an opportunity to truly help detect potential health issues and provide medical professionals with data about a patient’s particular situation without the need to travel for medical care.

The lines between consumer and medical grade devices will continue to blend together as the market evolves. For companies looking to enter the medical device wearable arena, my advice is to take the best of both worlds and develop a product that offers what you would expect from a medical device in terms of accuracy, reliability, data quality and FDA approval. Then, pair that with what you would expect from a consumer device – aesthetic appeal, comfort, usability, and cost effectiveness. Bringing high quality, reliable devices that consumers trust and want to use to the market not only sets the bar higher for other players, but it also helps support a healthcare environment that is more accessible and equitable for people around the world.

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Third Harmonic Bio is joining the public markets with a $183.3 million IPO that’s a stark outlier in the context of the near absence of new stock offerings in 2022. Record inflation, rising interest rates, and recessionary fears have chilled public financing activity in the year to date.

Not only has Third Harmonic pulled off a stock sale, but it was also able to boost the deal size. Wednesday evening, the biotech offered 10.9 million shares priced at $17 each, which was the midpoint of its targeted price range. When the company set financial terms for the IPO last week, it aimed to sell 9 million shares. Third Harmonic shares are slated to begin trading Thursday on the Nasdaq under the stock symbol “THRD.”

Cambridge, Massachusetts-based Third Harmonic is an inflammation and allergy biotech whose main asset, licensed from Novartis, has potential applications in several conditions. The small molecule, THB001, is designed to block KIT, a receptor that regulates mast cells, a type of immune cell. Mast cells play a role in many inflammatory conditions and blocking it has shown efficacy in some disorders, such as asthma. With the ability to selectively block KIT compared to other small molecule drugs, THB001 could avoid off target effects, the company said in its IPO filing.

So far, Third Harmonic has generated encouraging early Phase 1 data for its small molecule. Its lead disease target is chronic urticaria, an inflammatory skin disorder that leads to hives. Third Harmonic’s effort to block KIT trails a drug from Celldex Therapeutics. The Celldex drug, barzolvolimab, is in early clinical development for urticaria and other inflammatory disorders. But as an antibody, the Celldex drug is given as an intravenous infusion. The formulation of Third Harmonic’s drug as a more convenient oral pill should give it a dosing edge.

With the IPO cash, Third Harmonic plans to press ahead with multiple clinical trials testing its drug candidate. Between $80 and $90 million is earmarked for continuing clinical development of THB001 in urticaria by completing a Phase 1b study and starting a Phase 2 study, according to the IPO filing. The company expects to report initial data from the Phase 1b study in the first half of 2023. Applications to begin the Phase 2 tests in the U.S. and Europe are expected in the first half of 2024.

Another $30 million to $40 million of the IPO cash is planned for clinical development of the drug in other indications, including the completion of a Phase 1b test in asthma. Preliminary data from the asthma study are expected in the second half of 2024, according to the filing.

As of the end of the second quarter of this year, Third Harmonic reported having $112.7 million in cash and cash equivalents. The biotech projects that its cash reserves plus the funds from the IPO will support operations through 2025.

Here’s a look at some other stock market news this week for biotech companies:

No IPO for Elicio

Cancer immunotherapy developer Elicio Therapeutics is withdrawing its planned IPO. The Boston-based biotech had initially filed to go public in 2021, when financial conditions were more friendly for stock offerings. In a Sept. 13 letter to the Securities and Exchange Commission, Elicio offered no reason for the withdrawal other than to say it does not plan to pursue the stock offering at this time.

Elicio left the door open for a future IPO, asking the commission to credit the fees paid so far toward future use. The company’s lead drug candidate, ELI-002, is in Phase 1/2 testing as a potential treatment for cancers characterized by the KRAS mutation.

Know Labs’ stock finds a new home

Shares of medical diagnostics technology company Know Labs, which previously traded over the counter, have been uplisted to the NYSE American Exchange. Those shares are set to begin trading on Friday under a new stock symbol: “KNW.”

Seattle-based Know Labs says its technology directs electromagnetic energy through a substance or material to capture a unique molecular signature. The company is using this “Bio-RFID” technology to develop a non-invasive glucose monitor that provides users real-time information about their blood glucose.

Photo: Spencer Platt, Getty Images

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In June, President Joe Biden signed an executive order asking the federal health and education departments to expand access to gender-affirming medical care. While it’s wonderful to see the evolution of Biden and Harris’s personal and political stances on LGBTQIA+ issues, many LGBTQIA+ people remain skeptical of government protections around LGBTQIA+ healthcare.

The surge of anti-LGBTQIA+ legislation like Florida Senate Bill 1834 and House Bill 1557, known colloquially as the “Don’t Say Gay” bill, highlights how many spaces are still unsafe for LGBTQIA+ people and how much work we need to do to not only legally protect their rights, but to challenge and diminish anti-LGBTQIA+ values. It is imperative that medical practitioners, educators, and law-makers alike understand the extent of the trauma that this group of people have experienced at the hands of systems and individuals that, in theory, exist to protect people. Only by acknowledging this can LGBTQIA+ people begin to heal and build back trust in these systems.

Members of the community often feel like they need to educate their practitioners and medical providers, which can be exhausting and disheartening. This might looks like practitioners defaulting to assumptions of heterosexuality with patients or a provider making inaccurate assumptions about a patient’s sexual behaviors and basing their diagnosis and treatment plan off it. Heteronormative language and anti-LGBTQIA+ practices are woven throughout our current healthcare system, and it will take active effort to unlearn those practices. Below are some key practices that can greatly improve the experiences LGBTQIA+ people have in a healthcare setting.

1. Removing Unnecessary Gendered Language 

LGBTQIA+ individuals already have disproportionately low access to healthcare services—and the healthcare options they have often are not equipped to meet their needs. A crucial piece of ensuring access to comprehensive healthcare is ensuring that transgender and nonconforming patients see themselves represented in the materials, language, and services that healthcare services provide. For example, if the language on a clinic’s website or advertisement is highly gendered and labels services for “men” and “women,” it is an indication that the institution might not be a welcoming place for a nonbinary or gendernonconforming person. If gendered services make assumptions about patients’ body parts, this is a clear indication that transgender and gender expansive people have not been considered. Minimizing gendered language as much as possible and training staff to avoid making assumptions about patients’ bodies and needs is the surest way to minimize harm.

2. Ask for Required Information in a Clear Way 

It’s always best practice to remove gendered language when it is not necessary, but when information often associated with body parts, gender, or sex is needed from a patient, it can be beneficial to ask for additional patient information. For example, if you require a patient’s sex assigned at birth, also asking for a patient’s gender identity shows that you understand the difference in these questions and want to respect your patients.

On the other hand, if you only require “gender” or “sex,” patients again might be confused what information is being asked of them, causing confusion later on in the appointment, at pharmacies, or at labs. Additionally, it is important that practitioners treat patients using the correct reference ranges for their bodies. If clinicians do not ask for this information in a clear way, it could lead to patients receiving inaccurate treatment which is concerning from both legal and health standpoints. Having this information available for staff will also minimize assumptions about a patient’s gender identity or the body parts they have. Making these questions a routine part of the intake process will help guide and set an expectation for any staff who are new to the language or conversations.

3. Introduce Yourself with Your Pronouns & Ask What Name Patients Use 

For this same reason, providers and practitioners should be in the habit of introducing themselves with their pronouns as well as asking patients theirs. Some people only do this when introducing themselves to people they assume are queer based on their appearance, but queer people do not look any certain way, and it is best to avoid assumptions about anyone’s identity based on the way they present themself.

Normalizing these questions and processes is exceptionally important if a patient is going through a healthcare process that touches multiple businesses. For example, a doctor might ask a patient for the name they go by as well as their legal name (sometimes referred to as a deadname). Many people go by a different name than their legal name, so adopting the practice of asking patients the name they use is a way to be inclusive. If a doctor has adopted this practice but not properly communicated with a lab or pharmacy, a patient might not know what name they need to say to get the tests or medication they require. This might lead to a patient having a painful and invalidating experience with another touchpoint in the medical system.

4. At-Home Testing 

At-home testing allows LGBTQIA+ people to take charge of their own wellbeing and needs, making healthcare more accessible than ever. This model offers individualized and comprehensive care to individuals with a variety of needs: they might live in rural areas, not have the time or funds to travel to in-person appointments, or require the safety and comfort of selecting the space where they take their appointment. This model also reduces potential harm in spaces like public transportation and the pharmacy, since patients can bypass steps that have historically been barriers to care.

As remote healthcare becomes increasingly popular, it is even more important to center LGBTQIA+ people when building inclusive and gender-affirming businesses. Learning from businesses who provide gender-affirming healthcare services is a great place to start, as they likely have been intentional about the language they use to promote their services and interact with their patients.

No one reaches a point of gender competence; language is constantly evolving and we are all learning together how to use new language and what language feels validating and affirming for ourselves. Look to organizations led by LGBTQIA+ people and resources made by LGBTQIA+ people to engage in ongoing learning, rather than having that education come from patients. While taking the time to routinely read up on gender-affirming best practices and to facilitate staff trainings might take time, this is time well spent investing in the LGBTQIA+ community. All of these efforts will be noticed—and they could even be life-saving.

Photo credit: sasirin pamai, Getty Images

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In recent years, telehealth emerged worldwide as an indispensable resource at a time when in-person visits weren’t an option. Telehealth undoubtedly provides many benefits for both patients and providers, including increased access to services, greater convenience, reduced clinical overhead costs, and deeper insights into patients’ lives. But telehealth falls short of comprehensive care for a growing subset of patients — those with significant and multiple chronic conditions.

Before we can consider telehealth as part of ongoing, longitudinal healthcare, there are major issues that need to be addressed, including integration with traditional healthcare services, and inequities among patient subgroups that arise out of economic, infrastructure, and technological barriers.

We also need to integrate additional capabilities, such as remote patient monitoring, to get more comprehensive patient data and drive specific interventions.

Technology and healthcare as we know it today

Telehealth is a subset of the rapidly evolving field of digital health. Telehealth refers to patients’ ability to interact with physicians and therapists virtually, and also encompasses a number of remote monitoring capabilities, including pulse oximeters and blood glucose meters to treat conditions such as high blood pressure and diabetes respectively.

Historically, telehealth was primarily used to serve patients in rural populations who could not easily access healthcare facilities. Recently however, telehealth has quickly become the fastest growing modality for providing healthcare, revolutionizing how doctors and patients interact.

Before the onset of the pandemic, the national volume of telehealth services was projected to reach 3.6 million visits. But telehealth usage surged during the pandemic as patients sought safe ways to access treatment and actual volumes exceeded 120 million visits at the height of the pandemic and through the rest of 2020.

The shortcomings of telehealth for vulnerable populations 

The widespread adoption of telehealth indicates that this technology may actually exacerbate disparities in access, particularly when it comes to vulnerable populations in the U.S. including racial and ethnic minorities, non-English speakers, people with low incomes, and the elderly.

Take the population of seniors, for example. Over time, seniors who heavily rely on telehealth, may find themselves with less social interaction and be less likely to leave their homes after major life events such as losing loved ones or retiring. Primary care provided predominantly through telehealth services also limits a provider’s ability to perform physical examinations and doesn’t get seniors into interactive settings that can help combat the effects of social determinants of health, like loneliness and isolation.

To provide more comprehensive care that holistically improves health outcomes for vulnerable patient populations, care teams need to integrate digital advancements — remote monitoring devices, virtual visits, mobile health apps — with longitudinal care plans, peer support, and programs that address social determinants of health.

The future of the care team and tools they’ll use

As technology evolves, we can continue to develop innovative care models that leverage telehealth services to improve patient care. The concept of the provider needs to move well beyond the physician, to include the use of digital tools as well as a multidisciplinary care team, family, caregivers, and peer support. Telehealth that adds rather than substitutes holds the promise of more effective, equitable, and accessible patient care for even the most vulnerable populations.

The combination of digital technologies with more traditional healthcare allows care teams to unobtrusively track health states and outcomes in a way that only technology or brick-and-mortar hospitals cannot.

Take, for example, someone with congestive heart failure who has gained weight. With a digital scale and a wearable device that measures vital signs, a care provider can monitor fluctuations in oxygen and pulse to know if the patient is at risk for a congestive heart failure exacerbation, allowing for early intervention.

Additionally, by integrating peer support into comprehensive treatment plans, we can help close the growing communication gap between patients with chronic conditions and the doctors that support their care. While peer support is rarely integrated into traditional treatment plans, studies have shown that it improves clinical outcomes for a wide range of chronic mental and physical health conditions by fostering recovery and promoting empowerment.

Peer support efforts that are designed to fulfill the unique psychosocial and health needs of people with chronic health conditions, can actually have an positive impact on them, and in some cases, can lower hospitalization rates.

The more we view healthcare holistically, as an ecosystem comprising patients, physicians, caregivers, and technology, the better we will be able to improve patients’ health outcomes and overall quality of life.

Photo: elenabs, Getty Images

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In his 2022 State of the Union Address, President Biden declared: “Let’s end cancer as we know it.” It’s a sentiment he is sure to return to in a speech on Monday. No doubt this is a bold ambition and a worthy goal for a disease that is currently the second leading cause of death in the United States.

The President is “supercharging” the 2016 Cancer Moonshot effort launched during the Obama administration. The supercharged Cancer Moonshot calls for cutting the cancer death rate by at least 50% over the next 25 years and aims to “improve the experience of people and their families living with and surviving cancer.”

When it comes to improving cancer outcomes, much attention is paid to investments in diagnostics, clinical research and novel therapies. However, an equal amount of focus should be given to ensuring more patients have access to the high-quality care and treatment options that already exist. It has been estimated that approximately 25% of deaths (around 130,000 Americans annually) occur because cancer patients do not have access to or are unable to take advantage of optimal evidence-based care that is available today.

Cancer is a complex and difficult journey, characterized by complicated diagnostics, highly specialized treatment options and a myriad of touchpoints with the healthcare system. There is broad evidence defining the insights, skills, and tools necessary to help patients successfully navigate their cancer journey, but a variety of barriers exist in actually bringing this evidence to the care delivery system.

One of the keys to overcoming these challenges is in value-based care design. In this context, value is bringing every patient the right care at the right time, reducing unnecessary tests and treatments, days spent in a hospital, and associated costs. In order to be effective, value-based design requires innovative payment models between payers and providers, structured to reward achieving higher-value care. Notable examples of such models include the Oncology Care Model (OCM), a 5-year program that provided financial incentives for oncologists to reduce total cost of care while reaching benchmark performance targets, as well as its recently announced successor program, the Enhancing Oncology Model.

The experience of the cancer journey–and its outcomes– can be transformed by addressing critical support needs at pivotal phases of the journey, navigating the patient through clinical touchpoints and addressing psychosocial barriers. Through value-based care models that align the incentives of all stakeholders, effective, evidence-based care coordination along the cancer journey can measurably improve outcomes, enhance the patient experience, and lower costs.

Peri-diagnostic phase: Improving patient access is key to better outcomes

The peri-diagnostic phase is considered the earliest stage in a patient’s cancer journey, when a cancer diagnosis is suspected but not yet confirmed. This is often a difficult period for the patient, filled with uncertainty and anxiety. During this stage, access to the right care at the right time is critical, but far too often impeded.

One important example of this is access to primary care. Primary care providers play an important role in early cancer detection, given they are able to spot worrying symptoms through regular annual physicals and screenings. However, around 25% of Americans lack access to primary care. What’s more, in 2019 over one-third of Medicare beneficiaries did not visit a primary care physician within the last year. Studies have shown that for certain cancers, clinical outcomes, quality of life, and overall survival are all improved with a shorter time to diagnosis. Healthcare stakeholders must be incentivized to invest in programs that facilitate greater access to ongoing primary care to improve timely interventions at this early but critical stage in the cancer journey.

For patients who do have a PCP, other access challenges often exist. If a PCP suspects one of their patients has cancer, they will direct the patient to get further testing or to see an oncology specialist. Getting to the appropriate specialist can be challenging due to a host of factors. For example, access to quality care might be limited depending on where the patient lives, their race or ethnicity, their ability to pay office co-pays or transportation fees, and a myriad of other challenges. These social determinants of health are a source of variability and inequity in access to cancer care.

Thankfully, there are many programs that seek to address the issue of equitable access. An example of one such program is cancer navigation, which reduces barriers to care by ensuring all patients receive optimal support outside the four walls of the oncology clinic, regardless of external factors. If a patient is struggling to access care for any number of psychosocial reasons, a cancer care navigator, equipped with a “whole-person” (holistic) view of a patient, can provide information on financial assistance programs, coordinate rideshare services, or guide them to government-sponsored or community resources. With the right assistance, gaps in care can be addressed and patients can be quickly and seamlessly connected to the appropriate specialist support, as soon as they need it.

Treatment phase: Coordinated care outside the four walls of the clinic

Once cancer treatment begins, effective coordination between the different members of the care team can help reduce patient morbidity, mortality and costs while improving patient and caregiver experience. However, given the inherent complexities, logistics and longitudinal nature of cancer care, this level of coordination can be especially difficult.

Care navigation can play a valuable role during this time period as well. A dedicated cancer care navigator can act as an extension of the provider team, serving as their eyes and ears outside of the clinic by monitoring the patient’s health status more closely during the treatment course. This can be accomplished through systematic and proactive collection of patient-reported outcomes (PROs). In today’s digital world, patients can benefit significantly from systems that monitor health status remotely, intervene when appropriate, and keep the entire care team informed.

Such monitoring can spur clinical intervention when appropriate, help reduce ED visits and hospitalizations, and improve the patient and caregiver experience. Proactive symptom management programs have shown to lead to a 60% reduction in ED visits and 50% reduction in hospitalizations in some cases. In addition, PROs can be critical in helping physicians design interventions that address a patient’s unique needs. By leveraging these approaches, patient monitoring and care can be “always on” rather than restricted to in-office physician visits.

Survivorship phase: Paving a clear path forward

Following treatment, many patients will be on medication, sometimes for the rest of their lives, and their cancer will be cured or treated effectively as a chronic condition. As of January 2019, there were an estimated 16.9 million cancer survivors in the United States, a number that is projected to increase to 22.2 million by 2030.

A large number of these patients will also have a medical comorbidity, further complicating their care journey. A clear plan for how other chronic conditions will be managed, how surveillance for recurrent cancer will be determined, and steps to prevent and/or detect new cancers is necessary. It is important for the care team to have access to standardized, patient and provider-friendly tools that clarify who is responsible for what aspect of care, thus improving outcomes as well as the patient experience.

End of life: A care plan that aligns with patient goals

If treatment fails to halt or reverse the effects of the disease, a different set of decisions need to be made. Too often, arduous and costly treatment continues to the very end of life, despite minimal chance of a meaningful benefit. Ongoing discussions between patients, providers, and caregivers about the patient’s goals, preferences, and decisions for future care, known as advance care planning (ACP), can help assure that low-value care is avoided near the end of life. One study showed that approximately 70% of US adults express preferences for less aggressive treatments near the end of life and that 89% say that doctors should discuss end-of-life preferences with their patients. However, the rate of these discussions occurring between patients and their doctors is very low, and documentation of the outcome of these discussions even lower.

There are multiple system, provider, and patient factors at play for these low rates. Solutions that include a standardized approach to engaging the patient through a trusted care team member, such as a care navigator, who can communicate both with the patient and provider in a systematic way, can facilitate these discussions and ensure clear and consistent documentation of their outcomes.

Referrals to hospice care (inpatient or at-home) can significantly improve patient quality of life, and giving patients and their caregivers agency in these decisions is critical to delivering quality care. Designated care navigators can help the patient, caregiver and clinician team manage that difficult transition to end-of-life care with compassion and the patient’s best interests in mind. In the NY/NJ area (known for being one of the most expensive regions in the U.S. to receive healthcare), improving hospice utilization in cancer patients undergoing active treatment has led to up to $18,990 per patient in annual cost savings.

A better journey with better results

While ambitious, the Cancer Moonshot’s goals are achievable, using tools that already exist. Novel therapies and breakthrough research will always be helpful levers, but substantial progress toward effective and affordable cancer care can be made simply through the more equitable delivery of proven interventions, and the use of existing technology that brings those interventions to scale. To “fuel” the Moonshot initiative even further, we must also explore alternative payment models that effectively align the incentives of stakeholders across the cancer care continuum to deliver higher-value care at a lower cost.

It’s time to fundamentally improve the cancer journey, while ensuring that resources are used more wisely. The pandemic showed that the healthcare system can respond and evolve when confronted by an existential threat. With cancer care, there is a great deal that can be done now to significantly improve experience, outcomes and costs. We only need to better apply the expertise and tools we already have at hand.

Photo: Main_sail, Getty Images

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Fueled by the pandemic that boosted at-home consumer testing for Covid-19 as well as by increased investment over the last few years, the diagnostics industry is rapidly developing at-home testing capability.

However, it would be wise to focus less on features and more on the user experience.

“I have been in many different companies, financial services, healthcare gaming, et cetera, and people tend to focus on the product. How good is the product? Is it the most advanced? Does it have the most features? Does it have all of these kinds of things? I would rather have less features, 50% less features and a fantastic experience,” said Susan Moon, senior vice president, Customer & Digital Experience Team, Exact Sciences. [Exact Sciences makes and sells the at-home Cologuard colorectal-cancer screening tool. ] 

Moon was speaking Friday at the MedtechVision 2022, a hybrid conference organized by MedtechWomen. Her co-panelists were Archana Dubey chief clinical officer, AliveCor and Maital Rasmussen, chief commercial officer, Octave Bioscience and the panel was moderated by Lilly Li, principal, Northpond Ventures.

The focus on the consumer experience is especially key in the world of at-home diagnostics. First, because taking note of the consumer experience is part and parcel of developing a patient-centric healthcare world that everyone is striving for. And secondly, because, many consumers especially in the U.S. have a certain “opening the box” experience for tech devices driven by the likes of Apple.

“Think about when you open, uh, iPhone box or when you first got your Apple watch, right?” Moon prompted the audience. It’s like, pleasure.  You open it up. There are no instructions. It automatically starts. It’s very logical. That’s what has to happen to this space in, in care and in diagnostic tests and wearables, all of those kinds of things, because if they can’t figure it out, they’re not gonna do it or they’re gonna do it incorrectly. And that creates even more dissatisfaction.”

A good consumer/patient experience also helps to acquire an intangible commodity that has been sparse among certain sections of American society especially as it relates to Covid vaccines: trust.

“I think it’s applies to all of us who are working in MedTech — member experience is where you win trust,” said Dubey with AliveCor that has developed a mobile, personal EKG device that connects to a person’s smartphone to help monitor heart health. “So your EKG changes when you are running, when you are laying down, when you’re even in your sleep suits sometimes. And when the symptom happens, you have to make a doctor’s appointment. It’s two months away to get an EKG [appointment] …and  you will miss the diagnoses. So [our founder] took that big old [EKG] cart and put it in this credit card like device in the hands of people where they live, when, where heart disease or heart care is happening.”

Taking something that was only available in a clinical setting and democratizing that technology to be accessible in the home built trust between people who bought the device for use at home and AliveCor, Dubey said.

Another panelist implied that the focus on experience – be it the consumer/patient’s experience or the physician’s experience – needs to be in the DNA of the entire organization.

“It’s a whole company actually, it’s from the design of the product and it’s from the person who picks up the phone and it’s from the sales people. So you wanna create experiences, not only for the patients, but also for the physicians that actually supposed to, endorse it and bring it to the patient themselves,” said Maital Rasmussen, chief commercial officer, Octave Bioscience. “So it’s really — experiences is a currency right now.”

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Rural areas are particularly vulnerable, and delivering healthcare services while ensuring a positive patient experience presents a unique set of challenges.

Couple those challenges with the increasingly complex compliance and regulatory environment, whether it’s the Omnibus Burden Reduction rule or complying with HIPAA changes amid increasing cyber threats, navigating the rural healthcare landscape can be tricky.

Increasingly, rural hospitals are closing their doors, and rural medical centers are having trouble attracting the talent they need to maintain operations.

An analysis from the Federal Reserve Bank of Richmond revealed that hospitals nationwide have 105,000 fewer workers than in February 2020, a roughly 2% decline. Rural providers acutely feel the pinch.

Maintaining, let alone enhancing the patient experience, is near impossible for resource-constrained rural healthcare providers. Often, providers struggle with streamlining their operations and don’t act quickly or decisively.

If there is a silver lining to the Covid-19 pandemic, it has been a catalyst for change that many rural and community practices and hospitals wanted to make but did not for various reasons.

Insurance regulations

As insurance becomes increasingly complex, many health organizations have needed additional staff to keep up with the requisite paperwork. The costly proposition is not one most hospitals can afford amid the shifting landscape.

Finding the talent and expertise needed to navigate complex regulations is a multi-pronged dilemma, especially in many rural areas suffering from population declines. But not doing so can prove more costly in the long run.

Organizations must simplify their process to meet the regulatory requirements and evolve as regulations change. That is especially true for patients with two insurance plans — a commercial plan and Medicaid as the secondary.

A system that can handle the complexities of rural health settings and alert the billing department when payments are made and when to act serves as a pressure valve to an overburdened department.

The right technology partner can help streamline the management of insurance regulations, including Medicare and Medicaid. While not without cost implications, technology partners can securely house necessary documentation, maintain records and process payments to help alleviate the regulatory burden on already stretched teams.

The cybersecurity threat

Every year seems to be worse than the year before regarding cybersecurity. Hackers and bad actors have increasingly set their sights on healthcare recently.

The reasons are varied, but providers are likely to pay ransoms to restore IT services, considering that it is a matter of life and death and that private health data is a profitable commodity on the dark web. The median ransom is $75,000, making cybersecurity one of the most critical investments hospitals can make.

Rural providers’ lean IT teams and limited budgets hinder the investments they can make. Every investment is critical, and health IT platforms must include built-in security solutions.

Amid the Covid-19 pandemic, the Office for Civil Rights released multiple waivers to help ease the burdens of complying with HIPAA. However, as the world emerges and moves on from the pandemic, HIPAA will again be a top compliance priority.

Technology is a partner

Whether minimizing the time staff members need to review electronic health records (EHR) to help offset staff shortages, streamlining the billing process and giving unprecedented insights into patient records, the right technology can provide critical support to healthcare teams.

Ultimately, navigating the complex compliance and regulatory environment requires new solutions to long-standing issues. Against new and long-standing challenges, rural providers must adapt to position their organizations for future success and stability.

Solutions that empower health care providers to transform their operations digitally will play a key role here. Providers must make strategic investments that reap long-term returns, particularly in cybersecurity, analytics and cloud-based platforms.

For example, data-driven analytics will empower rural providers to understand better how different social determinants of health (SDOH) impact their population. This insight will help organizations apply for grants that benefit and elevate community-centric programs.

Additional investments in broadband access at the federal level will help close the digital divide. Doing so will allow more patients to access health services via telehealth and patient portals.

The pandemic brought a new focus on health inequities, as long-disadvantaged communities encountered worse outcomes from Covid-19.

We’re faced with unprecedented headwinds. Many rural and community practices and hospitals have scaled back their services to maintain some level of operations.

Technology can help organizations navigate these headwinds and position themselves for future success. The time to act is now — before a new regulation mandates it.

Photo: marekuliasz, Getty Images

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How can drug developers design therapies around cellular networks rather than a single target?

That is the question Arpeggio Biosciences is seeking to answer — and with a new influx of funds. The Boulder, Colorado-based startup announced the close of a $17 million Series A financing round on Wednesday, bringing its total funding to date to more than $20 million.

The funding was led by Builders VC, with participation from Khosla Ventures, TechU Ventures, FundersClub, Alice Zhang, Fifty Years, Tencent, ATEM Capital, Formic Ventures, Tau Ventures, Milad Alucozai of BoxOne Ventures and
and Matthew De Silva of Longtail Capital.

Arpeggio is a preclinical therapeutics company whose technology platform is focused on measuring the transcriptome — which refers to the full range of mRNA molecules expressed by an organism — at scale. It was founded in 2018 by CEO Joey Azofeifa and CTO Tim Read. The pair met at the University of Colorado, where they were completing PhD research that dealt with the intersection of machine learning and transcriptomics (the study of the transcriptome). 

The startup’s founders launched the company because they were interested in the idea of designing therapies to elicit specific effects on the transcriptome, which Azofeifa called “kind of a crazy idea,” in a recent interview.

“Typically when we think about drug development, we think about one protein or one enzyme at a time,” he said. “But if there’s one thing that the human genome has taught us, it’s that one gene does not equal one disease. It’s really a whole network of many small genetic changes that can give rise to something like autoimmunity or cancer metastasis.”

Arpeggio has built technology that can monitor activity of more than 100,000 mRNA transcripts from diseased and healthy cells after they are exposed to stimuli like small molecules, biologics or antisense oligonucleotides. The startup uses machine learning to reconstruct the biological networks affected by the stimuli and matches molecules to diseases where they could be therapeutically beneficial. This technology can illuminate new mechanisms of how drugs work, according to Azofeifa.

The startup will put half of the funds it raised toward maturing its own drug pipeline. It is currently working with contract research organizations to design better molecules for the treatment of mesenchymal tumors, Azofeifa said. 

Arpeggio will use the other to scale its partnerships with pharma companies. Under these partnerships, pharma companies send Arpeggio drugs so it can assess the impact these treatments have on the transcriptome, and the startup sells that intelligence back to these drugmakers. 

The company has partnered with more that 40 pharma companies so far, including Forma Therapeutics, Intrinsic Medicine and Treventis. The company could also go on to co-develop drugs with its pharma partners in the future — a scenario in which Arpeggio would collect royalties or milestone payments for drug success, Azofeifa pointed out.

While there are plenty of companies that do drug screens, such as Recursion Pharmaceuticals and Insilico Medicine, Azofeifa contends that Arpeggio is the only one focusing on the effect drugs have on the transcriptome. Other companies can measure things like whether a drug kills cells or whether it activates the immune system, but he said they do not “capture the true effect that drugs can have on the entire network of RNA.”

Photo: Christoph Burgstedt, Getty Images

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