The promise of precision medicine is exciting. That healthcare can use technology upfront, mainly in the form of diagnostic tests, to accurately determine risk for disease development or recurrence; to stratify patients for response to drugs and procedures; to determine patient outcomes –has led to the executive initiatives and Moonshot programs leading healthcare progress today. But achievements in precision medicine depend on the commercialization of well-validated diagnostic tests that are appropriately valued and paid for in our healthcare system.
This is not happening today because diagnostic tests are caught a vicious cycle: inadequate financing leads to poor clinical validation, which leads to low or no reimbursement, which leads back to inadequate financing.
Alva10 aims to break the cycle of commoditization in diagnostics, and bring radically new tests to bear on value-based healthcare.
The most difficult part of bringing a new technology into the healthcare market is rarely the technical aspect. Most companies fail because of the commercial challenges – especially market access and reimbursement. This is where Alva10 puts its energy and resources: establishing the value of the healthcare product through our unique solution. Our proprietary mathematical models allow us to assess both market access potential and the true value of a novel product . We help realize precision medicine by working with diagnostic companies to commercialize new tests through reimbursement and market entry, based on the value that such diagnostic tests bring to the healthcare system – and ensuring that managed care agrees with that determination of value.
We focus on aligning incentives of diagnostic companies with payers in a unique model that takes into account both stakeholders. Our proprietary algorithm determines both the likelihood of market success, and value to the healthcare system, that allows us to lobby for market-based reimbursement. Traditional reimbursement consultants are unable to achieve this.
In 2014, AdvaMedDx calculated that diagnostics accounted for 70% of treatment decisions while only accounting for 2% of healthcare costs. How did we get here?
Under CMS, diagnostics have functioned on a cost-plus business model, where tests are paid for at a small margin over cost. This does not allow for innovation and clinical validation of novel, complex diagnostics, and is the exact opposite of the value-based pricing model the therapy industry employs: one in which new drugs that demonstrate significant improvement in patient outcomes are financially rewarded. When companies set drug prices, they engage private and government insurance companies in multi-tiered discussions that result in a value-based reimbursement amount for their therapy. When diagnostics companies set their assay prices, they do so under the reimbursement price ceiling set by the Medicare Clinical Laboratory Fee Schedule – a menu of outdated, low-cost laboratory techniques that account for time and materials, but not for the cost of development, clinical validation, or the value to the healthcare system.
This leads to values that paralyze the diagnostics industry: a $329.51 assay becomes the gateway to a $153,000 drug (Example: EGFR T790M for Tagrisso).
Diagnostics needs a sustainable, investment-friendly solution to appropriately value the contribution of this testing in the healthcare system, and reverse this downward value spiral once and for all. This is why Alva10 exists.
America's Health Insurance Plans (AHIP) has stated that "delivery and payment system reform is how we ensure that the right medical care gets to the right person at the right time and at the right price." At Alva10, we believe that delivery and payment reform of diagnostics is how we ensure that goal of Precision Medicine is met.
After all, diagnostics are the medical tools that can determine if a patient will or will not respond to therapy, experience adverse events, or harbor a risk for future disease - and this testing is non-invasive enough to follow the patient forward in time. Although diagnostic technology has come a long way, its cost-plus valuation by payers indicates that the value equation is not yet solved. This issue has massive clinical consequences for patients - but it also has staggering financial consequences for payers.
Health plans are beginning to conceptualize the cost of not having a diagnostic to predict non-response or adverse events to the novel, costly therapies that have emerged in the marketplace. What role do payers play in the development of diagnostics? What role should they play?
Alva10 is answering these questions for health plans. Through innovative partnerships, value modeling, education modules, and research strategies - Alva10 is bringing the modern diagnostic industry to bear on the analytics trends and drug utilization concerns of health plans today.
Interested? Email us at email@example.com
We partner with diagnostic companies that are looking to make a difference - via platforms, diagnostic testing, or pivot in long-term development strategy. Our team has decades of expertise in strategic decision making, clinical validation and development, sales and marketing, reimbursement and value.
Pre-Commercial? Even better.
Pre-commercial diagnostics are in an ideal position for critical clinical trial, evidence development, value modeling, and market access improvements. We look forward to hearing how we can help bring your diagnostics to patients - by getting them through the payers.
Meet our LEADERSHIP
Hannah Mamuszka, CEO
Ms Mamuszka is a senior executive in the Cambridge, MA biotech community, with extensive experience in both drug and diagnostic development, validation, and commercialization. With more than 20 years experience in healthcare from the bench to the business side, Ms Mamuszka believes that diagnostics are the key to Precision Medicine. Her thorough command of cutting-edge science compliments her business acumen when evaluating the complex diagnostics deals that shape this industry. She is a well-respected voice for diagnostics in the industry, and a natural choice to bring change to this field.
Prior to founding Alva10, Ms Mamuszka was VP of Business Development at Exosome Diagnostics, where she led some of the earliest deals in the liquid biopsy diagnostic space. Earlier in her career, she was Global Director for Pharma Services at Exiqon A/S (now QIAGEN), and worked on the NDA for Bortezmib (Velcade) at Millennium Pharmaceuticals (now Takeda).
Ms Mamuszka writes a column for the Journal of Precision Medicine on the increasing value of diagnostics in our healthcare system. She is a competitive marathon runner.
Lena Chaihorsky, V.P. Payer Innovation
Lena has spent her career studying reimbursement and the managed care industry from the perspective of diagnostics. She believes that reimbursement, as one of the most misunderstood and dynamic aspects of healthcare, is ripe for innovation.
Leveraging her background in biology and mathematics, Lena is working to match the price of new diagnostics to payer value through improvements in the reimbursement process. Lena most recently led the reimbursement strategy of QIAGEN’s global molecular diagnostics portfolio and has broad experience in diagnostics commercialization, sales, contracting, and reimbursement. Earlier, she held multiple leadership roles at AmniSure International until its successful strategic sale. She has personally performed every step in the reimbursement spectrum of a diagnostic, and takes both a product-specific and portfolio-wide view of the healthcare products she brings to payers. She is passionate about driving reimbursement toward value-based care, and bringing clarity and change to a field that healthcare reform has put into flux.
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Alva10 Founder named one of Top 5 Women to Watch in Boston Biotech
Alva10 would like to thank Leah Kinthaert for naming Founder Hannah Mamuszka to Future of BioPharma's Top 5 Women to Watch in Boston Biotech List!
Mission Possible: Moving Diagnostics to the Forefront of Precision Medicine
Follow along in the Journal of Precision Medicine as Hannah Mamuszka charts out the history of diagnostics in Precision Medicine and new paths forward in the age of value based care. New to the periodical? See the first installment here.
Don't Miss Us! Alva10 at the Precision Medicine Leaders Summit: San Diego, CA
Join the Alva10 team on Wednesday, August 23 at 5 PM for a 'Mission Possible' Roundtable on bringing diagnostics to the forefront of Precision Medicine. Conference runs from August 21-24. Full agenda
Latest Installment of 'Mission Possible': Now Available!
Missed the latest from our 'Mission Possible' series? Catch up here
Don't Miss Us! Alva10 at the WorldCDx Conference: Boston, MA
Join the Alva10 team on Tuesday, October 17 for a workshop on the evolving role of In Vitro Diagnostics in Precision Medicine. Agenda here
Mark Your Calendars! Alva10 at the Q1 Diagnostic Coverage & Reimbursement Conference: Boston, MA
Join the Alva10 team on December 4 at 2 PM as they discuss value based care and coming to consensus with payers on diagnostics. Conference runs from December 4-5. Download full agenda here