HIV Treatment Option Yeztugo Unavailable Under CVS Health Plans Due to Formulary Limitations

Health initially declined to cover yeztugo, a new twice-yearly HIV prevention injection, raising concerns about access to the groundbreaking drug.">
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CVS Health Initially Blocks Coverage for New HIV Prevention Drug, Yeztugo

Washington, D.C. – CVS Health, a Major Pharmacy Benefit Manager, Has Initially Decided Not to Approve Coverage For Yeztugo, A New HIV prevention Drug. The Decision Raises Concerns About Access To The Groundbreaking Medication Amidst Hopes For Advancing HIV Prevention Efforts.

Yeztugo, Developed By Gilead Sciences, Received U.S. Food and Drug Administration Approval In June As A Long-Acting Injectable PrEP (Pre-exposure Prophylaxis) Medication, Requiring Doses Only Twice Annually. advocates Have Hailed yeztugo As A Meaningful Advancement In The Fight Against HIV/AIDS.

The Potential Impact Of Limited Access

Experts Warn That The Drug’s Potential To Curb The HIV/AIDS Epidemic Will Be Severely Diminished If Cost Barriers Prevent widespread Adoption. Gilead Sciences Announced An Annual Retail Price of $26,218 For Yeztugo Without Insurance Coverage.

According To Reports From Reuters And Bloomberg, A CVS Health Spokesperson Confirmed On August 21St That The Company Would “For Now” Exclude Yeztugo From Its Commercial And Affordable Care Act Plans. David Whitrap, The CVS Spokesperson, Stated That The Company Conducts Thorough Clinical, Financial, And Regulatory Reviews For New Medications.

Carl Schmid, Executive Director Of The HIV + Hepatitis Policy Institute, Criticized CVS Health’s Decision. “The Entire World Is Excited By this Drug And Its Potential Contribution To Preventing and Eventually Ending HIV,” Schmid Said. “Though, A Drug will Only Work If People Can Access It, And Right Now CVS Health Is Shamefully Blocking People, Unlike Other Payers.”

Drug	Manufacturer	Administration	Estimated Annual Cost (Without Insurance)	FDA Approval Date
Yeztugo	Gilead Sciences	Injection (Twice Yearly)	$26,218	June 2024

Schmid Urged CVS Health To Reconsider, Emphasizing Its Past Commitment To HIV Prevention. He Also Called For Regulatory Oversight To ensure Compliance Wiht Federal And State PrEP Coverage Mandates.

Gilead Sciences Optimistic about Broader Coverage

Gilead Sciences Expressed Confidence In Securing Coverage With Other Insurers. The Company Indicated it is indeed On Track To Achieve 75 Percent U.S. Insurer Coverage By The End Of 2024 And 90 Percent By June 2026.

Did You Know? PrEP, when taken as prescribed, can reduce the risk of getting HIV from sex by about 99%.

Pro Tip: If you are concerned about HIV prevention options, discuss PrEP with your healthcare provider to determine if it’s right for you.

What Impact Will This Coverage Decision Have On HIV Prevention Rates? How Can We Ensure Equitable Access To Innovative HIV Prevention Technologies Like Yeztugo?

Understanding HIV Prevention: A Past Perspective

The Advancement Of HIV Prevention Strategies Has Been A Gradual Process Marked By Significant Milestones. Early Approaches Focused Primarily On Safe Sex Practices And Blood Screening, But The Introduction Of Antiretroviral Therapy (ART) In The Mid-1990s Revolutionized HIV Treatment And Prevention. The Finding That ART Could Reduce Viral Load To Undetectable Levels,rendering The Virus Untransmittable – Known as “Undetectable = Untransmittable” (U=U) – has Transformed The Landscape Of HIV prevention.

PrEP,Approved By The FDA In 2012,Represented Another Major Breakthrough,Offering A Prophylactic Option For individuals At High Risk Of HIV Acquisition. Yeztugo, With Its Longer-Acting Injectable Formulation, Builds Upon These Advances, Potentially Addressing Challenges Related To Adherence Associated With Daily Oral PrEP.

Frequently Asked Questions About Yeztugo and HIV Prevention

1. what is Yeztugo? Yeztugo is a new injectable medication for HIV prevention (PrEP) administered twice a year.
2. How effective is Yeztugo? Clinical trials have shown Yeztugo to be over 99% effective in preventing HIV infection.
3. Why is CVS Health not covering Yeztugo? CVS Health states it is conducting standard clinical, financial, and regulatory reviews.
4. What is PrEP? PrEP stands for pre-exposure prophylaxis, a medication taken to prevent HIV infection.
5. Is PrEP affordable? The cost of PrEP can vary, but many insurance plans cover it, and assistance programs are available.

Share your thoughts on the accessibility of new HIV prevention drugs in the comments below!

What steps can patients take to appeal CVS Health’s formulary exclusion of Yeztugo?

Understanding the Yeztugo Access Issue

Recently, significant concern has arisen within the HIV community regarding access to Yeztugo (rilpivirine hydrochloride), a long-acting injectable HIV treatment. CVS Health, a major pharmacy benefits manager (PBM), has made the decision to exclude Yeztugo from its formularies, effectively making it unavailable to many individuals covered by CVS Health plans. This impacts access to innovative HIV therapies and raises questions about formulary management and patient care. This article will delve into the specifics of this limitation, explore the reasons behind it, and outline potential avenues for patients seeking access to Yeztugo.

What is Yeztugo and Why is it Vital?

Yeztugo represents a significant advancement in HIV treatment. It’s a complete regimen – a two-drug combination administered as an intramuscular injection once every two months. This offers several benefits over daily oral medications:

Improved Adherence: Long-acting injectables reduce the burden of daily pill-taking, potentially improving adherence to treatment. Medication adherence is crucial for viral suppression and preventing drug resistance.

Discretion & Convenience: Injections offer greater discretion and convenience for individuals who may face stigma or challenges with daily medication routines.

Potential for Reduced Side effects: Some patients may experience fewer side effects with long-acting injectables compared to oral medications.

Enhanced Quality of Life: For many,the reduced frequency of medication administration translates to a better quality of life.

Yeztugo is approved for adults living with HIV-1 who are virologically suppressed on a stable oral regimen and have no known resistance mutations. It’s a valuable option for those seeking alternatives to daily pills.

Why is CVS health Limiting Access to Yeztugo?

The primary reason cited by CVS Health for the formulary exclusion is cost. PBMs negotiate drug prices with manufacturers, and if they cannot reach an agreement they deem favorable, they may exclude a drug from their formulary.

Here’s a breakdown of the factors at play:

High Drug Cost: Yeztugo is a relatively new and expensive medication. The cost per injection is significantly higher than many generic oral HIV medications.

PBM Negotiation: CVS Health likely attempted to negotiate a lower price with Janssen, the manufacturer of Yeztugo.

Formulary Management: PBMs utilize formularies to manage costs and encourage the use of preferred medications.

Generic Alternatives: The availability of effective and affordable generic oral HIV medications influences formulary decisions.

CVS Health maintains that it aims to provide affordable access to medications while ensuring value for its plan sponsors and members. however, patient advocates argue that excluding innovative treatments like Yeztugo limits patient choice and potentially compromises care.

Impact on Patients Covered by CVS Health Plans

The exclusion of Yeztugo from CVS Health formularies has a direct and significant impact on patients:

Loss of Treatment Option: Individuals who were benefiting from Yeztugo or were considering it as a treatment option are now unable to access it through their CVS Health plan.

Potential Disruption of Care: Patients currently on Yeztugo may be forced to switch back to daily oral medications, potentially disrupting their viral suppression.

Financial Burden: Switching to choice treatments may involve different co-pays or out-of-pocket costs.

Appeals Process: Patients and their healthcare providers can appeal the formulary exclusion,but the process can be time-consuming and may not be successful.

Navigating the Formulary Exclusion: What Can Patients Do?

Despite the limitations, several avenues exist for patients seeking access to Yeztugo:

1. Appeal the Decision: Work with your healthcare provider to submit a formal appeal to CVS Health. A strong appeal should detail the medical necessity of Yeztugo for your specific situation, highlighting potential benefits over alternative treatments.
2. Prior Authorization: Explore if a prior authorization can be obtained, demonstrating medical necessity.
3. manufacturer Assistance Programs: