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Myriad Genetics Comments on UnitedHealthcare’s Updated Medical Policy for Pharmacogenetic Testing

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Myriad Genetics (NASDAQ: MYGN) responds to UnitedHealthcare's decision to restrict access to multi-gene panel pharmacogenetic tests, including GeneSight, under commercial and individual exchange benefit plans effective January 1st, 2025. The company strongly disagrees with UnitedHealthcare's assessment of insufficient evidence for GeneSight's efficacy. The policy change does not affect Medicare Advantage and managed Medicaid plans. GeneSight, approaching 3 million tests to date, is used for medications prescribed for depression, anxiety, ADHD, and other psychiatric conditions. Myriad is actively engaging with UnitedHealthcare to maintain enrollee access and will discuss financial implications in their upcoming Q3 2024 earnings call.

Myriad Genetics (NASDAQ: MYGN) risponde alla decisione di UnitedHealthcare di limitare l'accesso ai test farmacogenetici multi-gene, inclusi GeneSight, sotto i piani di benefici commerciali e di scambio individuale, a partire dal 1° gennaio 2025. L'azienda esprime un forte dissenso verso la valutazione di UnitedHealthcare riguardo alla mancanza di evidenze sufficienti per l'efficacia di GeneSight. Il cambiamento della politica non influisce sui piani di Medicare Advantage e Medicaid gestiti. GeneSight, che ha raggiunto quasi 3 milioni di test fino ad oggi, è utilizzato per i farmaci prescritti per depressione, ansia, ADHD e altre condizioni psichiatriche. Myriad sta attivamente collaborando con UnitedHealthcare per mantenere l'accesso degli iscritti e discuterà le implicazioni finanziarie nella loro prossima call sugli utili del Q3 2024.

Myriad Genetics (NASDAQ: MYGN) responde a la decisión de UnitedHealthcare de restringir el acceso a pruebas farmacogenéticas de panel múltiple, incluyendo GeneSight, bajo los planes de beneficios comerciales e intercambio individual, a partir del 1 de enero de 2025. La compañía expresa su fuerte desacuerdo con la evaluación de UnitedHealthcare sobre la insuficiencia de evidencia respecto a la eficacia de GeneSight. El cambio de política no afecta los planes de Medicare Advantage y Medicaid gestionados. GeneSight, que está cerca de 3 millones de pruebas hasta la fecha, se utiliza para medicamentos prescritos para depresión, ansiedad, TDAH y otras condiciones psiquiátricas. Myriad está comprometido activamente con UnitedHealthcare para mantener el acceso de los inscritos y discutirá las implicaciones financieras en su próxima llamada de ganancias del Q3 2024.

Myriad Genetics (NASDAQ: MYGN)는 UnitedHealthcare가 상업적 및 개인 교환 혜택 계획에 따라 GeneSight를 포함한 다유전자 패널 약물 유전자 검사 접근을 제한하기로 한 결정에 응답하며, 이 결정은 2025년 1월 1일부터 시행됩니다. 회사는 GeneSight의 효능에 대한 UnitedHealthcare의 '증거 부족' 평가에 강하게 반대합니다. 정책 변경은 Medicare Advantage 및 관리 Medicaid 계획에는 영향을 미치지 않습니다. 현재까지 거의 300만 건의 검사에 이르는 GeneSight는 우울증, 불안, ADHD 및 기타 정신 질환에 대해 처방되는 약물에 사용됩니다. Myriad는 등록자의 접근을 유지하기 위해 UnitedHealthcare와 적극적으로 협력하고 있으며, 다가오는 2024년 3분기 수익 전화 회의에서 재정적 영향을 논의할 것입니다.

Myriad Genetics (NASDAQ: MYGN) réagit à la décision d'UnitedHealthcare de restreindre l'accès aux tests pharmacogénétiques à panel multi-gènes, y compris GeneSight, dans le cadre des plans de prestations commerciales et d'échange individuel, à compter du 1er janvier 2025. L'entreprise n'est pas d'accord avec l'évaluation d'UnitedHealthcare concernant le manque de preuves suffisantes de l'efficacité de GeneSight. Le changement de politique n'affecte pas les plans Medicare Advantage et Medicaid gérés. GeneSight, qui a réalisé près de 3 millions de tests à ce jour, est utilisé pour des médicaments prescrits pour la dépression, l'anxiété, le TDAH et d'autres conditions psychiatriques. Myriad s'engage activement avec UnitedHealthcare pour maintenir l'accès des assurés et discutera des implications financières lors de leur prochaine conférence sur les bénéfices du T3 2024.

Myriad Genetics (NASDAQ: MYGN) reagiert auf die Entscheidung von UnitedHealthcare, den Zugang zu multi-gen-panel-pharmakogenetischen Tests, einschließlich GeneSight, unter kommerziellen und individuellen Austausch-Leistungsplänen ab dem 1. Januar 2025 einzuschränken. Das Unternehmen ist entschieden mit der Bewertung von UnitedHealthcare hinsichtlich unzureichender Beweise für die Wirksamkeit von GeneSight nicht einverstanden. Die Politikanpassung hat keine Auswirkungen auf Medicare Advantage und verwaltete Medicaid-Pläne. GeneSight, das bis heute fast 3 Millionen Tests umfasst, wird für Medikamente zur Behandlung von Depressionen, Angstzuständen, ADHS und anderen psychiatrischen Erkrankungen eingesetzt. Myriad engagiert sich aktiv im Dialog mit UnitedHealthcare, um den Zugang der Versicherten zu erhalten, und wird die finanziellen Auswirkungen in ihrem bevorstehenden Gewinnaufruf für das 3. Quartal 2024 erörtern.

Positive
  • GeneSight test has reached nearly 3 million tests performed
  • Coverage under Medicare Advantage and managed Medicaid plans remains unaffected
  • Recent favorable coverage determinations from other health plans
Negative
  • UnitedHealthcare restricting access to GeneSight test from January 1st, 2025
  • Potential negative impact on revenue from commercial and individual exchange benefit plans
  • Major insurance provider questions test's efficacy

Insights

This policy change by UnitedHealthcare represents a significant setback for Myriad Genetics' GeneSight test coverage. The restriction affects commercial and individual exchange plans starting January 1st, 2025, though Medicare Advantage and Medicaid plans remain unaffected. The timing and scope of this decision are particularly concerning as GeneSight has reached nearly 3 million tests to date.

The immediate financial impact could be substantial given UnitedHealthcare's market position as one of the largest private insurers. The policy change may trigger a domino effect, potentially influencing other commercial insurers' coverage decisions. However, recent favorable coverage determinations from other health plans and state biomarker legislation provide some counterbalance.

The market implications extend beyond immediate revenue impact. With 70-75% of antidepressants prescribed in primary care settings, this policy change could significantly affect Myriad's market penetration strategy. The company's strong response and immediate engagement with UnitedHealthcare suggest they anticipate material financial consequences. Investors should closely monitor the upcoming Q3 earnings call for detailed financial impact assessment and mitigation strategies.

SALT LAKE CITY, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, was informed on Friday, November 1, 2024, of an updated medical policy from UnitedHealthcare restricting access to multi-gene panel pharmacogenetic tests, including Myriad’s GeneSight test, under its commercial and individual exchange benefit plans, effective January 1st, 2025.

After initial review of the updated policy, the company strongly disagrees with UnitedHealthcare’s inclusion of GeneSight in its decision to change its coverage policy of multi-gene panels based on its rationale that there is insufficient evidence of efficacy to support coverage of GeneSight. Myriad is actively engaging with UnitedHealthcare to discuss the large body of evidence for Myriad’s proprietary and clinically differentiated mental health medication test, GeneSight, and is seeking to ensure that enrollees continue to have access to the test.

“We are surprised and disappointed by UnitedHealthcare’s actions and reaffirm our conviction in the clinical validity and utility of GeneSight, which we believe is supported by clinical evidence, including peer-reviewed research studies,” said Paul J. Diaz, President and CEO, Myriad Genetics. “We are amidst an ongoing mental health crisis and the primary care setting is where 70-75% of antidepressants are prescribed.1 Approaching 3 million tests to-date, the strong demand for GeneSight, a category-leading pharmacogenomic test for more than 60 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions, reflects the need for GeneSight as an important tool for healthcare providers, especially primary care providers, to help patients suffering from depression and anxiety to find the right medication treatment when historical trial and error methods have failed.”

The company does not believe that the updated policy affects coverage of GeneSight by UnitedHealthcare under Medicare Advantage and managed Medicaid plans. Myriad remains encouraged by recent favorable coverage determinations of other health plans for GeneSight based on its clinical validity and utility and state biomarker legislation. The company has no reason to believe that UnitedHealthcare’s position on this topic impacts any other existing or previous coverage determinations for GeneSight.

The company is scheduled to hold its third quarter 2024 earnings conference call after the market closes on Thursday November 7, 2024, and intends to provide additional information regarding its engagement with UnitedHealthcare and its initial views on the potential financial ramifications to the company of this policy change.

About the GeneSight Test
The GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for more than 60 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The GeneSight test can help inform clinicians about how a patient’s genes may impact how they metabolize and/or respond to certain psychiatric medications. Tens of thousands of clinicians have ordered the GeneSight test for almost three million patients in order to receive genetic information that is unique to each patient. The GeneSight test supplements other information considered by a clinician as part of a comprehensive medical assessment. The clinical validity, clinical utility and economic utility of the GeneSight test have been evaluated in multiple peer-reviewed publications. Learn more at GeneSight.com.

About Myriad Genetics 
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.   

Safe Harbor Statement 
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to Myriad’s engagement with UnitedHealthcare and seeking to ensure that enrollees continue to have access to the test. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

1 Majtabai R, et al. J Clin Psychiatry. 2008 Jul;69(7):106574.

Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com

Media Contact
Glenn Farrell
(385) 318-3718
PR@myriad.com


FAQ

When will UnitedHealthcare's restriction on Myriad Genetics (MYGN) GeneSight test begin?

UnitedHealthcare's restriction on GeneSight test will begin January 1st, 2025.

How many GeneSight tests has Myriad Genetics (MYGN) performed to date?

Myriad Genetics is approaching 3 million GeneSight tests performed to date.

Which insurance plans will still cover Myriad Genetics (MYGN) GeneSight test?

Medicare Advantage and managed Medicaid plans will continue to cover the GeneSight test.

What conditions does Myriad Genetics (MYGN) GeneSight test cover?

GeneSight tests for medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions.

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