We are kicking off the Amboy Street Ventures’ Industry Insights series, which features a collection of pieces authored by experts in the women’s health and sexual health space.
Introduction to the author – Laura Clark-Kelly
Laura Clark-Kelly, a highly respected expert in women’s healthcare, brings over 30 years of experience in launching and commercializing women’s health products. With an impressive career spanning influential roles at Bayer, Genentech, Sanofi, Pfizer, Aetna, United, Blue Cross Blue Shield, and Medco/Express Scripts, Laura possesses a comprehensive understanding of the intricate dynamics of the women’s healthcare landscape.
Laura’s unwavering belief in broad access to medications/devices has driven her success in gaining commercial and Medicaid access for numerous products, ensuring that they reach the hands of patients.
Navigating the Payer Maze
Women’s healthcare is essential and rapidly evolving, with a growing emphasis on providing comprehensive coverage for a wide range of products & services. However, achieving adequate payer coverage for women’s health services can be a complex and challenging process. In this blog, we will explore the importance of early engagement with payers, shed light on the nuances of the commercial and Medicaid space and discuss distribution considerations and the significance of patient copay responsibility. Finally, we examine the recent experiences of three women’s healthcare Pharmaceutical companies: Evofem, Agile Therapeutics, and TherapeuticsMD.
Early Engagement with Commercial and Medicaid
The number of lives covered by commercial and Medicaid insurance in the United States is significant. In the US the top 5 National Commercial health plans insure approximately 121 million lives while Medicaid covers approximately 65 million. These plans will play a crucial role in shaping the landscape of private equity investments, as their coverage decisions and reimbursement policies influence the market viability and financial prospects of women’s health services and related investments.
When developing new women’s health products and services, engaging with payers early in the pipeline planning process is crucial. Ideally, payer engagement should begin during the clinical development phase, even before FDA approval, to ensure sufficient time for negotiation, data exchange, and alignment on coverage policies. By involving payers from the outset, companies gain insights into the payer landscape, reimbursement policies, and coverage requirements. Understanding the specific needs and preferences of payers allows for tailored strategies that increase the chances of obtaining favorable coverage.
Navigating the commercial and Medicaid space is essential in ensuring adequate coverage for women’s health services. These markets have distinct characteristics and requirements, necessitating tailored strategies. For instance, commercial payers may focus on cost-effectiveness, while Medicaid programs often prioritize access and affordability. Moreover, state laws and procedures vary widely. Understanding the nuances of each market allows for targeted messaging, pricing, and negotiation approaches that align with payer expectations.
Beyond payer coverage, distribution considerations and patient copay responsibility are integral factors in ensuring accessibility to women’s health services. Efficient distribution networks should be considered to reach target populations effectively. Additionally, understanding patient copay responsibilities is crucial for evaluating affordability and ensuring that financial burdens do not hinder access to vital services.
Experiences of Evofem, Agile Therapeutics, and TherapeuticsMD
Evofem, Agile Therapeutics, and TherapeuticsMD provide valuable case studies highlighting the challenges faced in obtaining payer coverage. Evofem, for instance, experienced reimbursement issues with their non-hormonal contraceptive, Phexxi, despite FDA approval. Early discussions with payers could have helped identify potential barriers and enabled targeted negotiation strategies. Agile Therapeutics faced challenges in securing coverage for Twirla, their contraceptive patch. By understanding payer preferences and conducting market research, Agile Therapeutics could have customized their approach and addressed potential concerns earlier in the process. Similarly, TherapeuticsMD faced reimbursement hurdles with their hormone therapy products. In both cases, a proactive engagement with payers might have yielded more favorable outcomes.
Navigating the payer maze to ensure adequate coverage for women’s health services requires early engagement with payers, comprehensive market research, and a nuanced understanding of the commercial and Medicaid space. Moreover, optimizing distribution networks and addressing patient copay responsibilities are essential in promoting accessibility to women’s health services. The negative experiences observed by Evofem, Agile Therapeutics, and TherapeuticsMD highlight the importance of proactive communication and tailored strategies. It is critical that a thorough payer access analysis and understanding of the intricacies of the healthcare landscape is performed – look before you leap!
We look forward to bringing you more from women’s health and sexual health experts in this Industry Insights series. Stay tuned!
