What is Regorafenib (Stivarga)?
Regorafenib, sold under the brand name Stivarga, is an oral prescription medication used to treat several types of cancer [1.7.4]. It is classified as a multi-kinase inhibitor, a type of targeted therapy that interferes with the growth and spread of cancer cells in the body [1.6.6]. The U.S. Food and Drug Administration (FDA) has approved regorafenib for:
- Metastatic Colorectal Cancer (mCRC): For patients who have been previously treated with other specific chemotherapies [1.7.4].
- Hepatocellular Carcinoma (HCC): A type of liver cancer, for patients who have previously been treated with the drug sorafenib [1.7.4].
- Gastrointestinal Stromal Tumors (GIST): A rare cancer of the digestive system that cannot be surgically removed or has spread, specifically for patients who did not respond to previous treatments with imatinib and sunitinib [1.6.4, 1.7.4].
Regorafenib works by blocking multiple proteins (kinases) involved in tumor angiogenesis (the formation of new blood vessels that supply the tumor), oncogenesis (tumor growth), and the tumor microenvironment [1.6.1]. By inhibiting these pathways, it can help slow or stop the progression of cancer [1.2.3].
The Sticker Shock: How Much Does Regorafenib Cost Without Insurance?
The retail price of regorafenib for a patient without insurance coverage is exceptionally high. A typical treatment cycle involves taking the medication for the first 21 days of a 28-day cycle, often using 84 tablets of the 40 mg strength [1.7.4].
Without insurance, the cost for this 84-tablet supply can range drastically, from approximately $6,000 to more than $23,000, depending on the pharmacy [1.3.1, 1.3.7, 1.2.3]. For instance, some price guides list the cost for 84 tablets at over $23,200 [1.3.1]. This high price makes the medication inaccessible for the vast majority of people without comprehensive insurance or financial aid.
Is a Generic Version of Regorafenib Available?
As of late 2025, there is no FDA-approved, therapeutically equivalent generic version of Stivarga (regorafenib) available in the United States [1.5.7]. This lack of generic competition is a major factor contributing to its high cost.
Patients may encounter fraudulent online pharmacies attempting to sell illegal or counterfeit generic versions of Stivarga [1.5.7]. While some international online pharmacies may offer generic regorafenib manufactured in other countries at a lower price, these products are not regulated by the FDA and could be unsafe or ineffective [1.5.5, 1.5.7]. It is crucial to source this medication through reputable channels.
Why is Regorafenib So Expensive?
The high price of regorafenib is due to a combination of factors common to many modern cancer drugs:
- Research and Development: Developing a targeted therapy like regorafenib involves immense R&D costs, including extensive preclinical studies and multi-phase clinical trials to prove its safety and efficacy [1.6.1].
- Specialty Drug Status: As a targeted therapy for specific, often advanced-stage cancers, it is considered a specialty drug. These drugs for smaller patient populations often carry higher price tags to recoup development costs.
- Lack of Generic Competition: As mentioned, the absence of an FDA-approved generic in the U.S. means the brand-name manufacturer, Bayer, faces no direct price competition [1.5.7].
- Complex Manufacturing: The synthesis of complex molecules like regorafenib is a sophisticated and costly process.
Strategies to Reduce the Cost of Regorafenib
Fortunately, several programs exist to help patients afford this vital medication. Patients should never assume they have to pay the full retail price.
Access Services by Bayer
The manufacturer of Stivarga, Bayer, runs a comprehensive support program called Access Services by Bayer [1.4.5]. This program provides several avenues for assistance:
- $0 Co-Pay Program: For patients with commercial or private health insurance, Bayer offers a co-pay assistance program. Eligible patients may pay as little as $0 out-of-pocket for their prescription, with an annual benefit of up to $25,000 [1.4.4, 1.4.7]. Patients enrolled in government-funded programs like Medicare or Medicaid are not eligible [1.4.4].
- Bayer US Patient Assistance Foundation: For patients who are uninsured or underinsured, Access Services can provide referrals to this independent, non-profit foundation. The foundation may provide the medication for free to patients who meet certain income and eligibility requirements [1.4.5].
Third-Party Charitable Foundations
Several independent, non-profit organizations offer financial assistance for cancer medications. These foundations may help with co-pays, co-insurance, and deductibles. They are often a crucial resource for patients on Medicare who cannot use manufacturer co-pay cards.
Key organizations include:
- Patient Access Network (PAN) Foundation [1.4.6]
- HealthWell Foundation [1.4.6]
- Patient Advocate Foundation Co-Pay Relief Program [1.4.6]
These programs have specific eligibility criteria, usually based on income relative to the Federal Poverty Level, and require that the patient have a confirmed diagnosis for which the drug is FDA-approved [1.4.6].
| Cost-Saving Option | Who It's For | How It Works | Key Benefit |
|---|---|---|---|
| Stivarga $0 Co-Pay Program | Commercially insured patients | Reduces or eliminates out-of-pocket co-pay costs. | Can lower cost to $0, up to $25,000/year [1.4.7]. |
| Bayer US Patient Assistance Foundation | Uninsured or underinsured patients | Provides free medication to those who meet income and other criteria. | Access to medication at no cost [1.4.5]. |
| Third-Party Foundations (PAN, HealthWell) | Insured patients (including Medicare) needing co-pay help | Provides grants to cover co-pays, deductibles, and co-insurance. | Helps cover costs not covered by insurance [1.4.6]. |
| International/Non-Approved Generics | Patients exploring all options | Purchased from online pharmacies; not FDA-approved in the U.S. | Lower purchase price, but carries safety and legality risks [1.5.5, 1.5.7]. |
Managing the Total Cost of Care
The price of the drug is only one part of the financial picture. Regorafenib can cause significant side effects that require medical management, adding to the overall cost of care [1.7.1]. Common side effects include hand-foot skin reaction (HFSR), high blood pressure, diarrhea, and fatigue [1.7.2, 1.7.4]. Managing these may require additional prescriptions (e.g., creams for HFSR, anti-hypertensives), more frequent doctor visits, and lab tests, all of which contribute to a patient's financial burden [1.2.4].
Conclusion
To answer the question, 'How much does regorafenib cost without insurance?', the answer is a figure that is out of reach for nearly everyone: potentially over $20,000 per month [1.3.1]. However, this sticker price is not the price most patients end up paying. Through the manufacturer's robust assistance programs for both insured and uninsured individuals, and with support from independent charitable foundations, the cost of this life-extending therapy can be significantly reduced or even eliminated. Patients and their healthcare providers should proactively contact Access Services by Bayer as the first step to navigating the financial hurdles and securing access to treatment.
For more information on financial support, visit the official Stivarga patient website: https://www.stivarga-us.com/access-services-by-bayer [1.4.5].
