Gilead Undeterred by Uncertainty Surrounding Pre-Exposure Prophylaxis Portfolio Despite Questions from Preventive Task Force
Tristan Manalac, the author of this article, sheds light on the current uncertain status of the U.S. Preventive Services Task Force (USPSTF). Reports suggest that HHS Secretary Robert F. Kennedy Jr. may dismiss all 16 members, raising concerns from major medical organisations.
The USPSTF plays a critical role in preventive health recommendations, which directly affect insurance coverage under the Affordable Care Act (ACA). If the USPSTF's membership is changed or its mission is disrupted, it could delay or alter future preventive service guidelines, including those for HIV prevention drugs like Gilead's Yeztugo.
Yeztugo, Gilead's HIV PrEP drug, had a strong launch in Q2, with almost all analysts congratulating the pharma. The company's total revenue for Q2 was $7.1 billion, a 1% increase over consensus estimates, and its HIV portfolio contributed to a 7% year-on-year growth in revenue, bringing in $5.1 billion.
If the USPSTF issues a high-grade recommendation (A or B) for Yeztugo as an HIV PrEP medication, insurance coverage without cost sharing would be required under the ACA. However, political or ideological shifts in the Task Force could alter evidence assessments or delay updates in guidelines, potentially jeopardizing or complicating coverage access for such preventive medications.
The USPSTF, established in 1984 and consisting of independent scientific experts in preventive medicine, makes recommendations for preventive services, including Gilead's HIV PrEP drug Yeztugo, that insurers must cover. The Health Secretary has power over the panel's composition and recommendations, as ruled by the Supreme Court in June.
Gilead's commercial officer, Johanna Mercier, commended the company's launch teams for being ready to start distribution immediately after approval. The company slightly lifted its full-year outlook, expecting to make $28.3 billion to $28.7 billion in 2022, up from its previous guidance of $28.2 billion to $28.6 billion.
The potential overhaul of the USPSTF has major implications for preventive care coverage under the ACA, including for HIV PrEP drugs like Yeztugo. Disruption or politicization of the USPSTF risks undermining timely, evidence-based guidance affecting millions of Americans’ access to medications like Yeztugo.
You can read more about this topic on Our Website, and the article can be found at tristan.manalac@our website. Tristan Manalac's professional profile can be found on LinkedIn. For further enquiries, you can contact him via email at [email protected].
The article was published on various platforms including Twitter, LinkedIn, Facebook, Email, and Print. Gilead did not provide sales figures for Yeztugo during its first earnings call since the FDA approval in June. The company's teams have made around 25,000 customer calls since approval.
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- Tristan Manalac discusses the potential impact of changes in the USPSTF's membership or mission on health and wellness, particularly on insurance coverage for preventive medications like Gilead's HIV PrEP drug, Yeztugo, under the Affordable Care Act (ACA).
- In the context of finance and investing, any disruption or politicization of the USPSTF's role in making evidence-based recommendations could affect the market outlook for pharmaceutical companies like Gilead, as changes in preventive service guidelines might impact their revenue streams.
- Tristan Manalac also highlights the business implications of the potential overhaul of the USPSTF, as the revised guidelines could potentially jeopardize or complicate coverage access for medications like Yeztugo, affecting millions of Americans and potentially influencing investment decisions in the health-and-wellness and pharmaceutical sectors.
