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Chief Growth Officer

HLTH Content Director, Jody Tropeano interviews Manisha Gulati, Chief Operating Officer, Clarify Health and Bhash Parasuraman, Vice President and BU Lead, Rare Disease Patient &amp; Health Impact, Pfizer . They both recently presented on a HLTH GoLIVE series webinar called “Rearchitecting the drug launch model.” The discussion zeroed in on the incentives of regulators, payers, providers, and patients, which are often at odds with each other when it comes to drug launches.

Rearchitecting the Drug Launch Model

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Chief Medical Officer

The adoption of new innovations is often discussed as a bell curve. On the left are the early adopters and on the right are the laggards. How long different innovations take to catch on can vary. When it comes to something like the newest model of iPhone, progression through the bell curve moves fast. Even though there aren’t major consequences to someone being a model or two behind, millions of people quickly seek out the latest and it’s rather simple to do so. In healthcare, we’re typically slower – much slower. Fax machines in 2023 kind of slow. This is a problem. There are real consequences when the broad adoption of new revolutionary therapies takes time. Each passing day, month, and year that patients do not have access to medical advancements leads to less positive and equitable health outcomes. It’s important that we focus not only on the research and development of new treatments, but the distribution of them as well. It’s vital that we create new pathways to get them to patients in the quickest, most effective, and safest way possible. I think that direct-to-patient (DTP) healthcare has the opportunity to be one such new channel.  The <a href="https://www.linkedin.com/pulse/rise-direct-to-patient-healthcare-ro/" target="_blank">rise of the DTP model</a>, including companies like Ro but also <a href="https://medium.com/ro-co/the-dtp-company-index-39650980053c" target="_blank">dozens of others</a>, has already helped millions of patients conveniently access high-quality care. The same advantages that led to this rapid adoption by patients also positions DTP care to become a powerful pathway for new treatments. Let’s look at an example. GLP-1 medications could truly transform obesity treatment for millions of Americans. FDA-approved medications, like Wegovy, have shown to help patients lose <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2032183 (" target="_blank">10-18%</a> of their body weight over the course of a year (for full safety information on Wegovy including boxed warning <a href="https://ro.co/safety-info/wegovy/" target="_blank">see here</a>). It’s rare to get such a powerful new tool in the fight against a wide-spread chronic condition (<a href="https://erictopol.substack.com/p/the-new-obesity-breakthrough-drugs" target="_blank">Dr. Eric Topol’s article</a> spotlights this potential). To reach this potential requires getting the medications to patients who could benefit from these treatments – moving quickly to the right side of the bell curve – this is where DTP care can help. Today, people struggle to access treatment with GLP-1 medications for a variety of reasons. First, patients need access to a provider who can safely and appropriately prescribe them the treatment. With any new treatment, it will take time for providers to be educated on the use of GLP-1 medications for obesity, understanding who is suitable for this treatment, and what the clinical protocols are. Unlike other treatments, this process may be slowed by the unfortunate reality that some providers harbor weight bias and that there are little more than <a href="https://www.abom.org/abom-adds-more-than-1k/" target="_blank">5,000 providers</a> who are board certified in obesity medicine. Ro connects patients to providers who have been through anti-bias training, are educated about treatment with GLP-1 medications, and are kept up-to-date with the latest best practices. This type of expertise, typically limited to those in the immediate vicinity of select providers, is made available to patients nationwide through DTP models. These companies can also scale access to other resources that support patients such as educational materials developed by board-certified obesity providers and other leading clinical experts. While GLP-1 medications can be effective for many patients, that efficacy comes when paired with attentive, ongoing provider care. This kind of care can be difficult to get reliably and affordably for any health need – especially complex chronic conditions. It’s next to impossible to get timely, reliable access to an in-person provider for follow-up appointments, treatment titration, or answers to a question or concern. Look no further than the new charges being levied for <a href="https://www.nytimes.com/2023/01/24/health/emails-billing-doctors-patients.html" target="_blank">patients’ emails</a> for evidence of this. DTP companies like Ro use technology not only to expand the reach of providers, but to enable more frequent patient-provider touchpoints. In the case of treatment with GLP-1 medications, this offers patients the ability to ask questions, track their progress, and respond to potential side effects with their provider. Further, technology can empower providers to better track their patients – through tools like automated check-ins with patients or remote monitoring wearables. This is important with GLP-1 medication treatment, during which patients often experience side effects–particularly at the start of their treatment. Finally, for patients to successfully get treatment with GLP-1 medications, they need to be able to actually fill their prescription. Drug shortages, including GLP-1 medications, have been in the news lately. Often, treatment distribution isn’t directly tied to local need and, because retail pharmacies have thousands of locations, predicting demand can be difficult. Imagine waiting weeks to see your provider and get a prescription only to be told your pharmacy is out-of-stock.  DTP models can integrate many parts of a patient’s care journey – from provider care to pharmacy services. Many DTP companies offer mail-order pharmacy services that conveniently deliver treatments directly to a patient’s door. This integration isn’t just a business decision – it can meaningfully simplify a patient’s care navigation. In the case of GLP-1 medications, this is especially beneficial as they require frequent adjustments to dose and prescription renewal. The development and approval of new treatments and therapies like GLP-1 medications is an incredible accomplishment. But it’s not the end of the road. Our healthcare system must remain equally dedicated to getting these treatments to as many patients who can benefit as possible – and DTP companies like Ro can help. Our <a href="https://ro.co/weight-loss/" target="_blank">Ro Body Program</a>, designed around GLP-1 medications, is but one example of the value that DTP models can offer in rapidly scaling the promise of new treatments to patients who need them.

No Time to Waste: How Direct-to-Patient Care Accelerates Adoption of New Treatments

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CEO & Founder

In response to the COVID-19 pandemic, our team will be interviewing experts from across the ecosystem to bring the HLTH community timely facts and updates. About Dr. Robin Berzin: Dr. Robin Berzin, MD is the founder and CEO of Parsley Health. A Summa Cum Laude graduate of the University of Pennsylvania, Robin completed medical school at Columbia University’s College of Physicians and Surgeons, and trained in Internal Medicine at Mount Sinai Hospital in New York City. She has also trained in functional medicine with the Institute for Functional Medicine. In 2011 she co-founded the physician communication app Cureatr and currently advises numerous startups in healthcare and wellness. Robin founded Parsley Health in order to make whole-body, transformative medicine accessible to everyone through better services and smart technology. HLTH Team: Can you explain how antibody testing for COVID works?  Dr. Robin Berzin: Antibody testing works by detecting whether the specific types of antibodies in your blood match those that correlate with the virus responsible for COVID-19 (the SARS-CoV-2 antigen). Antibody testing is the only known way to detect if you’ve had exposure to the virus in the past. For COVID-19 antibody testing, there are three different subclasses of antibodies that can be used including immunoglobulin M (IgM) which indicates active infection, immunoglobulin (IgG) which indicates recovery after an infection and immunoglobulin A (IgA) which indicates respiratory infection. Antibody testing, in general, is not new. It is routinely used to check for things like HIV and chickenpox. But it’s important to note that not all tests are created equal.  Antibody tests that only look at only one or two of the subclasses of antibodies such as only IgG or only IgM are not as comprehensive as those that test for all three classes (IgG, IgM, IgA), and therefore those tests might miss detecting an infection. Furthermore, many low-quality rapid tests have flooded the market, leading WHO to make a blanket <a href="https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19" target="_blank">recommendation against their use</a> until their quality has been validated.  HLTH Team: What is the accuracy of the tests i.e. any false negatives/positives? If someone tests positive for having had COVID, what does that mean for them in terms of immunity? Dr. Robin Berzin: Every test and every vendor or lab will have a different specificity and sensitivity -- and with FDA’s loosening of regulations around these tests, it’s important for consumers and doctors to individually evaluate the quality of specific test they intend to use.   The test that Parsley Health has selected tests for all three subclasses of antibody: IgM, IgA, and IgG. Our test is 97.14% sensitive, 98.36% specific, which means for every 100 people that have been exposed to the virus, 97 of them will get a positive result. With this specific test the likelihood of a false negative is low.  But there is more to making a diagnosis than sensitivity and specificity. Doctors also need to know the prevalence of a disease in the population, since that influences how they trust and interpret the results. That’s one of the arguments for scaling up antibody testing: it will establish the disease prevalence. This is also the primary reason it’s important to work with a doctor to interpret antibody test results. At this time, it remains unknown how long IgG antibodies will remain in the body and if they will protect people against getting infected again (like they do with chickenpox). The WHO has warned that we don’t yet know if antibodies protect against getting COVID-19 twice, but as we do more antibody testing we anticipate clearer answers.   HLTH Team: When do you expect that antibody testing will be rolled out on a larger scale?  Dr. Robin Berzin: Antibody testing will only be sustainable at a national level when a high-quality self-administered finger prick test is scientifically validated or FDA approved. This type of test will allow people to collect samples at-home, using methods commonly used by diabetics to check their blood-glucose levels. People who want to be tested will still need to work with their doctor to ensure that testing is completed in the proper window of exposure for the test to offer accurate results, but high-quality finger-prick tests will reduce some of the logistical hurdles while increasing scale. Right now, the only way to do the COVID-19 antibody test while keeping an eye on quality control is to require the blood sample to be drawn by a licensed phlebotomist under doctor’s orders. To limit the potential spread of COVID-19 and respect “stay at home” orders, the best way to do that is to utilize mobile phlebotomy services, which come to patient’s homes to draw the sample. This mobile phlebotomy model is higher cost and not as easily scalable as an at-home finger prick test. HLTH Team: Where will people be able to get these tests? Dr. Robin Berzin: Parsley Health is currently offering COVID-19 antibody tests to members in the state of California, where mobile phlebotomy services are robust and enough PPE is in supply for safe sample collection. Our tests are only available via doctor’s orders, through a trusted CLIA-certified and CAP-certified lab, and we hope that other companies will follow the same model to ensure that the tests used are high quality and that the appropriate testing windows are targeted. We hope to scale our testing capabilities nationwide as soon as a high-quality FDA-approved finger prick test is available.   HLTH Team: Will different testing sites be using different tests or all the same? Dr. Robin Berzin: Different companies will be using different tests -- and some will be more precise than others. What is available and where will change quickly as the FDA approvals change. The key things you should look for are: doctor ordered tests that look at at least two antibodies for accuracy (IgM, IgG) and ideally all three (IgM, IgG, and IgA), and make sure that you are doing the test in the appropriate window after exposure (at least 5 days). Lastly, it’s important to ensure quality sample collection, that the lab that is processing the sample is reputable, and that the sample is collected in the safest circumstances possible.  HLTH Team: How were the tests able to receive FDA approval so quickly? What is the clinical evidence behind them? Dr. Robin Berzin: This is where things get complicated and it’s important to understand the nuance. Under emergency circumstances -- such as a pandemic -- the FDA is able to approve the use of tests by consumers prior to receiving an official FDA stamp of approval. That’s what’s happening right now with COVID-19 antibody tests.  What this means is that doctors can now prescribe COVID-19 antibody tests that have been validated (meaning enough tests have been collected to be statistically true) and after testing has been conducted the labs can submit to the FDA to review that validation.   Currently <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers" target="_blank">FDA recommends</a> that health care providers continue to use antibody blood tests to identify who may have been exposed to the virus. But the onus of responsibility sits with health care providers to understand “the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.” With this in mind, results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. A doctor must clinically interpret the test and make a recommendation on care and whether follow-up testing is needed. All of this will become clearer as more testing and FDA reviews are completed over the coming weeks.  HLTH Team: Will there be any costs incurred to the patients receiving the tests? Will they be billed through insurance?  Dr. Robin Berzin: Like the early days of COVID-19 swab testing, insurance companies haven’t quite caught up with the latest testing. Many tests going on right now are not covered by insurance yet, but we are hopeful that insurance companies will soon cover these tests without co-pays so that anyone who thinks they may have COVID can quickly and affordably get a test.  HLTH Team: Any misconceptions out there that you want to clear up about the antibody tests?  Dr. Robin Berzin: Testing is critical to understanding your own health and helping to slow the spread of COVID-19 infection. The more we get community testing out into the world, the faster we can help slow the spread of the disease. Knowing who and who has not mounted an antibody response is critical to our understanding of disease progression. While we don’t know if antibodies translate to immunity, these early tests, particularly the comprehensive antibody test like the one we offer at Parsley Health, will be part of the way that we learn about the virus and how to ultimately defeat it.

COVID-19 Updates with Parsley Health

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Vice President

Digital technologies can improve many parts of the patient experience, and complex therapy journeys are no exception. Reaching and supporting people through their desired channels, at the right time, makes meaningful improvements to their therapy adherence—which results in better health outcomes.  As the demand for patient support services continues to evolve and grow, the technology for person-centered care is finally available. Life sciences companies and manufacturers have the ability to adapt and deliver next-generation patient services to improve patient health in connected ecosystems.  Here are five ways life sciences companies can take action and begin to adapt:  #1: Recognize increasing service and experience expectations from patients. Health consumers have an expectation of services and experiences based on the digital products they use as consumers. Immediacy is now the norm and there really is an app for almost everything. Need a ride or takeout? Open an app and you’re done in two minutes. Need to buy just about anything? It just takes a couple of taps—and you’ll have exactly what you need in two days, if not sooner.   Having experienced these user-friendly and intuitive interactions, patients can’t help but demand them across other facets of their day-to-day life, including healthcare. They want their healthcare experiences to be easy, efficient, and intuitive. When it comes to life sciences organizations, the stakes are high because the patient’s wellness may very well depend on the support they receive in these digital touchpoints.  While the health care industry has been slower to adapt than other sectors, digital transformation is picking up speed. There is an opportunity to shift life sciences patient services from an agent-centered support function to patient-centered. This means more self-service, more workflow automation, and agents equipped with better insights to help patients.  #2: Reframe the patient engagement problem.Delivering a good patient engagement experience is both a data and design challenge. How do you leverage patient data, with appropriate consent, for delivering right-sized service programs? How do you build differentiated web and mobile experiences at scale? Answering these questions reframes engagement in terms that lead to more effective, faster solutions. #3: Advocate for internal management of the patient experience. Outsourcing may have worked in the past, and it may still be an option for specialized service transactions (e.g. prior authorizations), but overall coordination of service delivery for a differentiated patient experience should be handled internally. Manufacturers need to own their patient service platforms to gain a more longitudinal view of patient interactions and data. This approach requires a long-term view of technology investments. It empowers organizations to build deeper relationships with patients, facilitate access, increase trust, and drive adherence. It’s also the leading way to address the growth of specialty products and personalized therapies, which require more integrated patient services.  When patient services programs are outsourced, it’s harder for life sciences organizations to demonstrate, with certainty, how their products are delivering value and making meaningful improvements to their patients’ outcomes.  So, it’s not surprising more and more organizations are choosing to insource the patient engagement platforms in-house.  #4: Ensure the systems being used to build patient services programs are flexible and scalable. Life sciences organizations should aim to deploy and enable a cost-effective platform that is sized for their current situation, while making sure it has a foundation that can scale as they grow and add new services and therapies. To do this, they can start small and take an iterative approach to deployment. It’s wise to demonstrate the value of a new in-house patient services platform by starting with one or two therapies and building from there.  Our Deloitte team recently deployed our industry-leading <a href="https://www2.deloitte.com/us/en/pages/consulting/solutions/patient-engagement.html" target="_blank">ConvergeHEALTH Connect for Life Sciences</a> platform at a global life sciences company to help them meet patients’ needs both today and in the future. Our solution works on top of Salesforce Health Cloud in a way that is flexible and scalable, building unique and transformative capabilities specifically focused on supporting client needs in patient services. This work is just one part of a much larger journey we have taken with this client to transform their patient experience. With the deployment of this award-winning solution, touchpoints across an organization’s support programs are cohesive, facilitating engagement with patients across multiple seamlessly integrated digital channels. Access issues are eliminated, making it possible to meet each patient where they are—engaging in ways that align with individual preferences.  The platform has also been tailored to each of the geographic areas the organization serves. This not only allows companies to configure their engagement for different populations, but it means their new patient services programs can adapt as the industry and patient needs continue to evolve.   #5: Understand that the benefits of a comprehensive patient services experience are already proving to be game-changing.If we have learned nothing else from our four years of successful deployments of ConvergeHEALTH Connect for Life Sciences, we have learned that having a single source of truth for customer interactions generates data and insights that can transform the way life sciences organizations engage with patients across age groups and diverse backgrounds.  Since launching their new platform, the leading global life sciences company we worked with has been able to: <ul><li>Accelerate patient onboarding and access with enrollment streamlined across multiple channels, reducing the time to therapy </li><li>Improve therapy adherence with configurable program management, including helpful education and support touchpoints</li><li>Reduce the administrative burden with the introduction of more efficient document management</li></ul> Conclusion: As life sciences organizations adopt this way of thinking, they’re ready to begin deploying differentiated experiences to provide more meaningful patient engagement, improve health outcomes, build deeper relationships, and support personalized therapies for patients.  Research shows that consistent engagement across multiple channels enables better, faster access to therapies and medications, empowers patients to improve therapy adherence with well-timed support and education, and creates much-needed feedback loops. The faster we can make it the norm, the better everyone’s health can be.  To learn more about how Deloitte collaborates with life sciences organizations to deploy a platform that is ready to provide memorable, scalable patient services, <a href="https://www2.deloitte.com/us/en/pages/consulting/solutions/patient-engagement.html" target="_blank">visit our website</a>.

Reframing the Transformation of Patient Services

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