CELEBRATE!! We kept prior authorization and step therapy out of the Six Protected Classes!

Late yesterday, the Centers for Medicare and Medicaid Services (CMS) released a ruling stating that the Department of Health and Human Services (HHS) will continue barring Medicare Part D plans from applying the drug utilization management tools prior authorization and step therapy for beneficiaries taking HIV antiretroviral drugs. This is a huge win for people living with HIV!

AAHIVM is proud to have been leading the charge on raising awareness of the dangers of this proposed rule for the past five months. Much of our success is thanks to YOU, our passionate and vocal members and credentialed providers. Thank you for signing onto letters, calling your representatives and writing op-eds in your local papers. It truly made a difference!

House Oversight Committee Reviews Gilead’s Truvada:  What Comes Next

Yesterday, the House of Representatives Committee on Oversight and Reform held a public hearing on “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments”  to explore the marketing of Truvada, a medication sold by Gilead for both HIV treatment and prevention (as PrEP). In the US, Truvada currently sells for $2100 per month and generated $3 billion in revenue for Gilead in 2018.

Representative Elijah Cummings, Chair of the Oversight Committee, noted that daily dosing of Truvada costed about $200 per month in 2003, when the FDA approved it. It now costs $2000 per month, or about $70 per pill. In Australia, a month-long supply of Truvada currently sells for $8 per month.

Last week, Gilead publicly agreed to donate up to 2.4 million vials of Truvada to the CDC each year for the next 11 years – for distribution to uninsured individuals who are at high risk of HIV acquisition.  They will donate it as a contribution toward the national “Ending the AIDS Epidemic Plan.”  Given the CDC’s estimate that about 1.1 million Americans could benefit from PrEP if available, the Kaiser Family Foundation estimates that this donation could cover 36% of the population in need of PrEP.

Congress members at the May 16 hearing noted that Truvada will go off-patent on September 2020 and be replaced with Descovy, Gilead’s next patented form of PrEP.

To date, only about 150,000 people in the U.S. have ever used PrEP.  Of them, 75% have been white men living in either the northeastern US or on the west coast.  Many of those at highest risk of HIV (such as homeless youth) are in the greatest need of PrEP.  They are also hard to reach without well-designed community outreach and other services.

Tim Horn, Director of Medication Access and Pricing for the National Alliance of State and territorial AIDS Directors, talked in his testimony about Gilead’s Medication Assistance Program for those without insurance and its Copay Assistance Program for those with commercial insurance. While helpful, he said, it is “not a substitute for functioning public health and healthcare systems.”  He added that, “a long-term sustainable approach to PrEP access requires a competitive generic market.” He warned that “federal, state, and community partners should be cautious not to allow the present and future of existing patchwork measures to build an artificial market for Gilead’s Descovy, which is expected to be approved for PrEP by the end of this year. Doing so will undercut the ability of the generic market for TDF/FTC to bring down costs – for our public payers, our commercial payers, and, most importantly, people vulnerable to HIV infection.”