Mindera Health™ Announces Coverage with Evidence Project with Highmark, Inc. to Advance Moderate-to-Severe Psoriasis Patient Care and Reduce Specialty Drug Spending

Project will evaluate Mind.Px’s™ impact on physician “trial and error” prescribing behavior and overall net savings by prescribing the correct biologic class the first time

SAN DIEGO, CA – April 11, 2023 – Mindera Health™, the developer of Mind.Px, the first realization of precision medicine in psoriasis, has initiated a coverage with evidence project with Highmark Inc. and its health plan affiliates for Pennsylvania, West Virginia and Delaware. The program will evaluate trends in physician utilization, patient outcomes, drug switching, and overall net savings versus a control group.

In the United States, psoriasis affects more than three percent^[i] of the population, leading to healthcare costs of more than $110 billion annually.ⁱⁱ Specialty drug spending for psoriasis is escalating at exponential rates, and biologics are often identified by payers, employers and pharmacy benefit managers as being in their top drug expenditures each year.[ii]^I Furthermore, successful patient responses to currently available biologic treatments are roughly 52 percent^iv, leading to trial-and-error patient treatments and increased healthcare costs.

Mind.Px is a predictive test that uses a dermal biomarker patch that allows for rapid and painless extraction of mRNA from skin, followed by transcriptomic analysis and machine learning-derived classifiers to provide actionable results for clinicians with >92 percent positive predictive value^v. By matching the patient to the right drug class before treatment begins, a recent study used a budget impact model to predict the potential costs savings associated with Mind.Px and returned annual cost savings ranging from $5,138 to $13,141 per patient^vi.

“Use of Mind.Px can effectively minimize the trial-and-error approach to psoriasis treatment and provide physicians, patients, and payers with a powerful tool to guide the individual patient to an efficacious drug class based on their transcriptomics — the true vision of precision medicine,” commented George Mahaffey, President and CEO of Mindera Health. “We look forward to working with Highmark to accelerate the emergence of new technologies, like Mind.Px, to advance psoriasis patient care while reducing unnecessary spending.”

About Mind.Px™

Mind.Px is the flagship test of Mindera Health, designed to prospectively predict a patient’s response to expensive biologic drug classes prior to therapeutic selection and treatment. Using a scalable, minimally invasive dermal biomarker patch that captures over 7,000 biomarkers per sample along with data analytics, Mind.Px materially improves patient outcomes and significantly reduces healthcare system costs of expensive biologic treatments.

About Mindera Health™

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, next-generation sequencing, and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera Health is a CLIA and CAP certified laboratory and has received ISO 13485:2016 certification. Find out more at www.minderahealth.com.

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^I Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057.

ⁱⁱ Pilon D, Teeple A, Zhdanava M, et al. The economic burden of psoriasis with high comorbidity among privately insured patients in the United States. J Med Econ. 2019;22(2):196-203. doi:10.1080/13696998.2018.1557201.

ⁱⁱⁱ Source: Prime Therapeutics 2012-2015 and 2019-2020 posters entitled “Prevalence and Cost of Autoimmune Specialty Drug Use by Indication.”

^iv Enos CW, et al. Psoriasis severity, comorbidities, and treatment response differ among geographic regions in the United States. JID Innovations. 2021;1:100025.

^v Mindera Health. Data on file.

^vi Wu J, Montgomery P, Long B, et al. An economic evaluation of the budget impact of precision medicine testing for the treatment of psoriasis. SKIN The Journal of Cutaneous Medicine. 2021;5(4):372-387. doi:10.25251/skin.5.4.6

 

Mindera Health™ Appoints Linh H. Le as Chief Financial Officer and Chief Operating Officer

Industry Veteran will assist in commercialization of Mind.Px^TM to implement precision medicine for biologic treatment of moderate-to-severe psoriasis

SAN DIEGO, CA – March 14, 2023 – Mindera Health, the developer of Mind.Px™, the first realization of precision medicine in psoriasis, has appointed Mr. Linh H. Le as Chief Financial Officer and Chief Operating Officer. He will be responsible for all financial activities as well as many operational functions to enable a scalable strategy as Mindera expands its reach.

Mr. Linh H. Le brings more than two decades of work experiences in the healthcare space, stemming from several industry sectors including molecular diagnostics, infectious diseases, and medical devices. He comes to Mindera from Predicine, where he served as Chief Financial Officer, leading key financial and infrastructure changes that enabled scalability and operational excellence across the enterprise. His prior experience includes Ambry Genetics, where he was Chief Operating Officer, and Medtronic Diabetes Group, where he has held various leadership positions of increased responsibilities over a span of fourteen years. Before his time at Medtronic, Linh’s experiences include leadership roles at the Walt Disney Company and management advisory services with PricewaterhouseCoopers.  Lastly, Linh began his professional career in the assurance practice of KPMG, providing attestation services in the healthcare and technology practices where he earned his CPA designation.  Linh was named LA Times CFO of the year in 2022.

The cost burden due to specialty drug spending on biologics prescribed to treat moderate-to-severe psoriasis in the United States is substantial. Estimated healthcare costs for treating this three percent^[i] of the population exceeds $110 billion annually.ⁱⁱ Specialty drug spending for psoriasis is escalating at exponential rates and biologics are often identified by payers as being one of their top drug expenditures each year.[ii]^I Furthermore, successful patient responses to currently available biologic treatments are roughly 52 percent^iv, leading to trial-and-error patient treatments and increased healthcare costs.

Mind.Px is a predictive test using a patented dermal biomarker patch that allows for rapid and painless extraction of mRNA from skin, followed by transcriptomic analysis and machine learning-derived classifiers to provide actionable results for clinicians with >92 percent positive predictive value^v. Incorporation of this precision medicine test to match the individual patient to the right drug class before treatment begins lowers costs and improves patient outcomes.s

“We are pleased to add a highly experienced professional to our Executive Team,” says George Mahaffey, President and CEO of Mindera Health. “Linh’s very successful track record and intimate familiarity with diagnostic reimbursent environments are valued additions to our team.”

“Joining Mindera at this exciting stage of commercial and corporate development is a wonderful opportunity,” says Mr. Le. “I look forward to bringing my experience to this seasoned commercial team to continue and accelerate market adoption of Mind.Px.  Together, we will revolutionize healthcare in a meaningful way by improving the quality of life for our patients through precision medicine.”

About Mind.Px™

Mind.Px is the flagship test of Mindera Health, designed to prospectively predict a patient’s response to expensive biologic drug classes prior to therapeutic selection and treatment. Using a scalable, minimally invasive dermal biomarker patch that captures over 7,000 biomarkers per sample along with data analytics, Mind.Px materially improves patient outcomes and significantly reduces healthcare system costs of expensive biologic treatments.

About Mindera Health

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, next-generation sequencing, and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera Health is a CLIA and CAP certified laboratory and has received ISO 13485:2016 certification. Find out more at www.minderahealth.com.

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^I Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057.

ⁱⁱ Pilon D, Teeple A, Zhdanava M, et al. The economic burden of psoriasis with high comorbidity among privately insured patients in the United States. J Med Econ. 2019;22(2):196-203. doi:10.1080/13696998.2018.1557201.

ⁱⁱⁱSource: Prime Therapeutics 2012-2015 and 2019-2020 posters entitled “Prevalence and Cost of Autoimmune Specialty Drug Use by Indication.”

^iv Enos CW, et al. Psoriasis severity, comorbidities, and treatment response differ among geographic regions in the United States. JID Innovations. 2021;1:100025.

^V Mindera Health. Data on file.

Mind.Px provides clinically actionable information to physicians prior to treatment choice that significantly reduces “trial and error” biologic drug prescribing behavior, leading to improved psoriasis patient outcomes and reductions in wasted spending

 

SAN DIEGO, CA – July 26, 2022 – Mindera Health announces the publication, in the Journal of Drugs in Dermatology, of the recommendations from an expert consensus panel that supports adequate demonstration of clinical utility of the flagship Mind.Px precision medicine test if positive results from the MATCH Study are achieved.

Agreed-upon proof of clinical utility in a real-world setting is defined as the concordant use of test results by a physician in patient management decision-making that results in a positive health benefit for the patient. It is often required to eliminate barriers to coverage by payers, with the goal of ultimately improving patient care. This unique panel comprised dermatology key opinion leaders with expertise in psoriasis along with current and former chief medical officers from large payers or health systems. The panel reviewed clinical and economic study designs aimed at delineating net savings and wasted spending.

The MATCH Study is a 16-week randomized clinical utility evaluation of the pre-treatment impact of Mind.Px on biologic drug response rates in patients with psoriasis. The study is currently enrolling and approximately 100 of the targeted 200 patients are currently active. Interim analysis of physician concordance revealed a statistically significant change in physician prescribing behavior when provided Mind.Px test results. Indeed, these results show that physicians are 100% concordant with the results of Mind.Px if formulary restrictions are not taken into account. If physicians are required to comply with formulary restraints, the concordance rate is 93%. In the absence of access to Mind.Px precision medicine data, physicians prescribe biologics that are consistent with the test results 62.9% of the time.¹

Specialty drug spending is escalating at exponential rates, and biologics are often identified by payers, employers, and pharmacy benefit managers as being among their top drug expenditures each year.² Mind.Px addresses this directly with high physician utility (93%+) to optimize formulary performance. Mindera Health is in discussions with a variety of plans.

“We are extremely pleased to see that the expert panel consensus validates our MATCH Study design, accelerating our ability to engage with payers, brokers, and PBMs. By proactively addressing clinical utility, we now can continue very robust conversations with each of these stakeholders on how we can move forward with pilots or coverage decisions,” says George Mahaffey, President and CEO of Mindera Health.

About Mind.Px™

Mind.Px is the flagship test of Mindera Health, designed to prospectively predict a patient’s response to expensive biologic drug classes prior to therapeutic selection and treatment. Using a scalable minimally invasive dermal biomarker patch that captures over 7,000 biomarkers per sample and data analytics, Mind.Px materially improves patient outcomes and significantly reduces healthcare system costs of expensive biologic treatments.

About Mindera Health™

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, Next-Generation Sequencing, and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera Health is a CLIA- and CAP-certified laboratory and has received ISO 13485:2016 certification. Find out more at www.minderahealth.com.

 

¹ “Trial-and-Error Prescribing Behavior is Modified by a Psoriasis Precision Medicine Tool: Preliminary Findings from the MATCH Study.” SCALE 2022, May 2022, Nashville, TN.
² “Prevalence and cost of autoimmune specialty drug use by indication in a 4.4 million member commercially insured population continuously enrolled four years, 2012 to 2015.” AMCP 2016, October 2016, National Harbor, MD; “Prevalence and cost of autoimmune specialty drug use by indication in a commercially insured population, January 2019 through June 2020.” AMCP 2021, April 2021, National Virtual Meeting.

Pilot designed to use clinical utility and patient outcomes to validate cost savings and address wasted spend and net savings from “trial and error” medicine

 

SAN DIEGO, CA – April 28, 2022 – Mindera Health™, the developer of the groundbreaking Dermal Intelligence™ platform – the first realization of precision medicine in psoriasis, has initiated a pilot program in California and Texas with a national health insurance company to assess the company’s groundbreaking Mind.Px™ test. The pilot program will evaluate trends in physician utilization, patient outcomes, drug switching and overall net savings versus a control group.

Mind.Px™ uses a painless dermal biomarker patch (DBP) to link each moderate to severe psoriasis patient with the most effective therapy for that unique patient, creating immense savings for the healthcare system and improving patient outcomes. The Mind.Px™ DBP and AI technology predict (91% PPV) the appropriate biologic drug class for an individual patient prior to treatment. By matching the patient to the right drug class before treatment begins, payers can potentially save up to $15,000 per patient in preventable “trial and error” medicine and could provide savings of millions of dollars for small groups up to hundreds of millions of dollars for large plans.

“Utilizing a pilot to validate our predicted costs saving while improving patient outcomes is the first of many steps in the accelerating national coverage of Mind.Px” says George Mahaffey, President, and CEO of Mindera Health.

Specialty drug spending is escalating at exponential rates, and biologics are often identified by payers, employers and pharmacy benefit managers as being in their top drug expenditures each year.[i] Mind.Px addresses this directly with high physician utility (90%+) to optimize formulary performance.

Ann Deren-Lewis, Chief Commercial Officer adds “Mind.Px is meant to reduce the trial-and-error process of prescribing biologics and help pharmacy benefit managers and insurance providers cut down on excessive spending while improving patient outcomes.”

 

About Mind.Px™

Mind.Px is the flagship test of Mindera Health, designed to prospectively predict a patient’s response to expensive biologic drug classes prior to therapeutic selection and treatment. Using a scalable minimally invasive dermal biomarker patch that captures over 7,000 biomarkers per samples and data analytics, Mind.Px materially improves patient outcomes and significantly reduces healthcare system costs of expensive biologic treatments.

About Mindera Health™

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, Next-Generation Sequencing, and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera Health is a CLIA and CAP certified laboratory and has received ISO 13485:2016 certification. Find out more at www.minderahealth.com.

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[i] Source: Prime Therapeutics 2012-2015 and 2019-2020 posters entitled “Prevalence and Cost of Autoimmune Specialty Drug Use by Indication.”