What is Alyftrek?
Alyftrek is a brand-name prescription medication approved by the U.S. Food and Drug Administration (FDA) on December 20, 2024, to treat cystic fibrosis (CF) [1.4.1, 1.4.8]. Manufactured by Vertex Pharmaceuticals, it is indicated for patients aged six years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene [1.2.1, 1.5.2].
Alyftrek combines three active ingredients—vanzacaftor, tezacaftor, and deutivacaftor—into a single, once-daily oral tablet [1.2.3]. These ingredients work together as a CFTR modulator. Vanzacaftor and tezacaftor are 'correctors' that help the defective CFTR protein form the right shape and move to the cell surface, while deutivacaftor is a 'potentiator' that helps the protein channel stay open longer [1.2.5, 1.4.4]. This combined action helps improve the flow of salt and water across cell membranes, thinning the thick, sticky mucus that causes severe complications in the lungs and other organs in people with CF [1.2.3]. It is considered a next-generation treatment and an alternative to the popular twice-daily medication, Trikafta [1.4.7].
How Much Does Alyftrek Cost?
The primary concern for many patients and providers is the significant expense of this breakthrough therapy. The manufacturer has set the wholesale acquisition cost (list price) for Alyftrek at approximately $370,269 per year [1.3.4, 1.3.6]. This price point is about 7% higher than that of its predecessor, Trikafta [1.3.3, 1.3.4].
It is crucial to understand that the list price is not typically what a patient pays out-of-pocket. The final cost depends on a variety of factors, primarily the patient's insurance plan. Pharmacy discount card websites show that the average retail price for a 30-day supply can be over $34,000, with coupon prices potentially lowering it to around $28,000 [1.3.2, 1.3.1]. However, these prices reflect the cost without insurance and can vary by pharmacy. For most patients, insurance coverage will be the main determinant of their expense.
Factors Influencing the Final Cost of Alyftrek
Several elements play a role in determining a patient's final out-of-pocket cost for Alyftrek.
Insurance Coverage and Prior Authorization Alyftrek is classified as a specialty medication [1.2.3]. This means that insurance companies nearly always require prior authorization before they will approve coverage. The prior authorization process involves the doctor submitting documentation to the insurance provider to prove that the medication is medically necessary for the patient's condition. The patient's specific plan details—including deductibles, copayments, and coinsurance—will dictate the final cost after the deductible is met.
Financial Assistance Programs Recognizing the high cost, the manufacturer, Vertex Pharmaceuticals, offers a patient support program called Vertex Guidance & Patient Support (GPS) [1.2.7]. This program is designed to help patients and their families navigate insurance challenges, understand their benefits, and identify financial assistance options. Eligible patients may receive help with their copay costs. Patients interested in this support can call 1-877-752-5933 or visit the program's website for more information [1.2.7].
No Generic Alternative Currently, Alyftrek is only available as a brand-name medication. There is no generic version on the market [1.2.7]. Generic drugs are typically much cheaper than their brand-name counterparts, but developing a generic equivalent for a complex specialty drug like Alyftrek is a lengthy process that can only begin after the brand-name drug's patents expire.
Alyftrek vs. Trikafta: A Cost and Dosing Comparison
One of Alyftrek's main advantages is its once-daily dosing regimen, which can improve convenience and adherence for patients [1.2.4]. Here’s how it compares to Trikafta:
| Feature | Alyftrek | Trikafta |
|---|---|---|
| Active Ingredients | vanzacaftor/tezacaftor/deutivacaftor | elexacaftor/tezacaftor/ivacaftor |
| Dosing Frequency | Once Daily [1.2.4] | Twice Daily [1.3.3] |
| Annual List Price | ~$370,269 [1.3.4, 1.3.6] | ~$346,048 [1.3.4] |
| Efficacy (Lung Function) | Non-inferior to Trikafta [1.2.4] | Established baseline |
| Efficacy (Sweat Chloride) | Superior reduction vs. Trikafta [1.4.4] | Established baseline |
While Alyftrek demonstrated in clinical trials that it was not inferior to Trikafta in improving lung function and was superior in reducing sweat chloride (a key indicator of CF), its list price is higher [1.2.4, 1.3.4]. The choice between the two may come down to physician and patient preference regarding dosing convenience, tolerability, and insurance coverage.
Important Safety Information
Alyftrek carries a boxed warning, the most serious warning from the FDA, for the risk of liver damage and liver failure [1.2.7, 1.4.3]. Liver function tests are required before starting the medication and must be monitored regularly throughout treatment. The most common side effects observed in clinical trials included cough, headache, upper respiratory tract infections, and fatigue [1.2.7]. Additionally, eye exams are recommended for pediatric patients to monitor for cataracts [1.2.7].
Conclusion
How much does Alyftrek cost? The answer is complex. While the annual list price is over $370,000, very few patients will pay this amount. The actual out-of-pocket cost is determined by a combination of insurance coverage, pharmacy choice, and eligibility for financial aid. The introduction of a once-daily, highly effective CFTR modulator is a significant advancement for the cystic fibrosis community. However, navigating its high cost requires patients to work closely with their healthcare providers and to proactively seek assistance from programs like Vertex GPS to make the treatment accessible.
For more information directly from the manufacturer, you can visit the Vertex Pharmaceuticals patient support page.
