Generic Prostate Cancer Therapy Nears EU Approval

Generic Enzalutamide Approved in Europe: Will US Patients Ever See Affordable Prices?

European approval highlights stark pricing disparities as uninsured Americans face $100,000+ annual costs while Europeans pay a fraction—and why mail-order isn't the answer

The European Medicines Agency's November 2025 recommendation to approve generic enzalutamide (Enzalutamide Accordpharma by Accord Healthcare) marks another milestone in expanding global access to this critical prostate cancer therapy. But for American patients—particularly those without insurance—the news underscores a painful reality: the same medication that will cost Europeans perhaps $500-$1,500 monthly out-of-pocket will continue to cost uninsured Americans $8,000-$11,000 per month, despite generic versions already being available in the US market.

This pricing disparity raises an obvious question: Can US patients simply order the medication from European pharmacies? The answer is a clear no—and understanding why reveals the deep structural problems in American pharmaceutical pricing that won't be solved by individual workarounds.

SIDEBAR: Could Relocating to Portugal Save $100,000+ Annually?

An Expatriate Option for Desperate Patients

Given the staggering cost differences—$96,000-$132,000 annually in the US versus potentially $2,000-$13,000 in Portugal—some patients ask a provocative but rational question: Could I actually move to Europe and save money?

The surprising answer: Yes, significantly.

How Portugal's Healthcare Works for American Expats

Portugal offers universal healthcare through the Serviço Nacional de Saúde (SNS). Americans can access this system by:

Obtaining a residence permit (D7 Passive Income Visa most common for retirees)
Registering with local health center
Receiving a healthcare user number (número de utente)

Portugal ranks 23rd globally in healthcare quality (Numbeo 2025) and 22nd in cancer survival rates.

Real Cost Comparison

US Annual Costs (Uninsured):

Generic enzalutamide: $96,000-$132,000
Oncology visits/imaging: $7,000-$14,000
Total: $103,000-$146,000

Portugal Annual Costs:

Generic enzalutamide with SNS reimbursement: $2,000-$11,000
Oncology consultations: $60-$240
Imaging/labs: $100-$500
Private insurance (optional): $400-$2,000
Total healthcare: $2,160-$13,740

With private insurance: $1,700-$8,000 annually

Complete Financial Picture

Year 1 Total Costs:

Relocation expenses: $8,500-$24,000
Annual living expenses: $15,300-$29,800
Healthcare: $1,700-$12,800
Total: $25,500-$66,600

Compared to US healthcare alone: $103,000-$146,000

Year 1 savings: $36,400-$120,500 (even including all living expenses)

Subsequent years' savings: $60,000-$129,000 annually

Living Costs in Portugal

Monthly expenses (comfortable lifestyle):

Rent (1-bedroom): €600-€1,200 ($655-$1,310)
Utilities: €80-€150
Food: €250-€400
Healthcare: €0-€150
Other: €240-€380
Total: €1,170-€2,280 ($1,275-$2,485/month)

D7 Passive Income Visa Requirements

Proof of passive income: ~$9,900/year minimum
Health insurance for first year
Clean criminal record
Portuguese accommodation
Processing: 2-4 months
Path to permanent residency: 5 years

Important Considerations

Advantages:

90-95% healthcare savings
High-quality care (Portugal ranks 14th in Europe)
English widely spoken in urban areas
Strong expat community
Mediterranean climate
Access to all EU healthcare systems
Life expectancy: 82.8 years

Challenges:

Public system wait times (private insurance solves this)
Initial relocation logistics
Distance from US family/friends
Medicare doesn't cover overseas care
Must establish new oncology relationship

Quality assurance: Portugal's cancer survival rates exceed many US states, and major cities have internationally accredited cancer centers (Instituto Português de Oncologia).

Is This Realistic?

Absolutely. Thousands of Americans relocate to Portugal annually, many specifically for healthcare access. This is:

Completely legal
Well-established pathway
Increasingly common
Supported by bilateral agreements

The Stark Reality

It's actually cheaper for an uninsured American to move to another continent, pay all living expenses, and receive cancer treatment there than to simply buy medication in the United States.

For patients facing medical bankruptcy, expatriation isn't extreme—it's rational survival.

Next Steps for Serious Consideration

Consult Portuguese immigration attorney
Research oncologists at Instituto Português de Oncologia
Verify enzalutamide availability in Portuguese pharmacies
Visit Portugal for exploratory assessment
Calculate specific visa income requirements
Plan medical records transfer
Consult international tax advisor

For IPCSG members interested in this option, contact leadership to connect with members who have successfully relocated to Portugal or other European countries.

The European Approval: Proven Therapy, Broader Access

The EMA's Committee for Medicinal Products for Human Use recommended marketing authorization for Accord Healthcare's generic version of Xtandi (enzalutamide, Astellas Pharma), which has been authorized in the EU since 2013. The medication blocks multiple steps in the androgen receptor-signaling pathway, effectively starving prostate cancer cells of the hormones they need to grow.

The clinical foundation remains compelling. In the landmark AFFIRM trial, patients receiving enzalutamide achieved median overall survival of 18.4 months compared to 13.6 months for placebo—nearly five months longer. The PREVAIL study showed 65% of enzalutamide-treated patients remained free of radiographic progression at 12 months versus just 14% on placebo, with a 29% reduction in death risk.

The EMA recommendation covers extensive clinical scenarios across the prostate cancer treatment spectrum, from high-risk biochemical recurrent disease through metastatic castration-resistant prostate cancer, both as monotherapy and in combination with androgen deprivation therapy. Enzalutamide Accordpharma will be available in 40-mg, 80-mg, and 160-mg film-coated tablets.

The US Generic Landscape: Available But Unaffordable

Generic enzalutamide has been available in the US since late 2024, following September 2024 patent expirations. Multiple manufacturers launched versions, including Teva, Accord Healthcare (through its US subsidiary), and Sandoz. However, the pricing has been disappointing.

Current US pricing reality:

Generic enzalutamide: $8,000-$11,000 per month ($96,000-$132,000 annually)
Brand-name Xtandi: $13,000-$15,000 per month
Generic discount: Only 20-40% versus the typical 80-90% seen with other drugs

For insured patients, the situation varies widely depending on formulary coverage, prior authorization requirements, and copay structures. For the uninsured, these prices are simply catastrophic.

European Pricing: The Stunning Contrast

While specific pricing for Enzalutamide Accordpharma awaits publication, European pharmaceutical pricing patterns suggest:

Expected European costs:

Generic retail: €500-€1,500 per month ($540-$1,620 USD)
With national health coverage: €0-€100 per month out-of-pocket
Brand Xtandi: €2,500-€3,500 per month before coverage

The disparity in stark terms:

Uninsured US patient: $96,000-$132,000 annually
European patient with insurance: $0-$1,300 annually
European paying full cash price: $6,500-$19,400 annually

An uninsured American pays 15-20 times more than an insured European, and 5-8 times more than a European paying full retail cash price.

Why Mail-Order from Europe Won't Work

Given these price differences, many patients naturally wonder about ordering from European pharmacies. The answer involves multiple layers of legal, practical, and safety barriers.

Legal Prohibitions

US law strictly regulates drug importation. The FDA maintains that personal importation is illegal for most prescription medications, including enzalutamide. While the agency may exercise enforcement discretion for small quantities (typically 90-day supplies) of medications for personal use, this discretion only applies when:

The medication is not available in the US
It poses no unreasonable health risk
The individual provides prescriber documentation

Since generic enzalutamide is already available from multiple US manufacturers, it fails the "not available" criterion. Customs and Border Protection can seize packages, hold them pending documentation, or subject them to import duties and fees.

The Trump Administration's Position

The incoming Trump administration has emphasized drug importation, but only through state-run programs—not individual purchases. The administration has created pathways for states to import drugs from Canada (not Europe) and is facilitating importation programs that could save states millions. However, individuals are not allowed to import drugs on their own and must rely on state-run programs.

Florida's Cautionary Tale

Florida received FDA approval in January 2024 to import drugs from Canada—the first state to achieve this milestone. The plan specifically included medications for chronic conditions including prostate cancer, with projected savings of $180 million annually.

Nearly two years later, the program has not imported a single pill.

Multiple obstacles emerged:

Canadian opposition: The Canadian government stated that bulk importation won't solve US drug prices and has taken action to safeguard Canadian supply. Health groups warned that "the Canadian medicine supply is not sufficient to support both Canadian and U.S. consumers."
Manufacturer resistance: Pharmaceutical companies actively work to prevent exports, limiting Canadian supply to domestic needs
Regulatory burden: Each drug requires separate FDA pre-approval before importation
Legal challenges: Ongoing litigation and regulatory complications

Florida has spent over $80 million on contracts but received FDA extensions (current authorization expires November 6, 2025) because implementation has stalled completely.

Why European Importation Is Even Worse

While Florida focused on Canada, importing from Europe faces additional barriers:

No enforcement discretion exists for European imports
Europe isn't part of any approved US importation framework
Greater shipping times and customs scrutiny
Incompatible regulatory systems between EU and US
Track-and-trace system incompatibilities
Temperature control concerns during international shipping

Safety Risks

Beyond legality, safety concerns are substantial:

Counterfeit risk: Many online "pharmacies" claiming European sources operate scams
No quality assurance: No FDA oversight of imported products
No recourse: If you receive ineffective, contaminated, or no medication, you have virtually no legal recourse
Storage concerns: Enzalutamide requires proper storage; international shipping provides no temperature guarantees

Bottom line: Do not attempt to order enzalutamide from European pharmacies. The legal risks, safety concerns, and practical barriers far outweigh theoretical savings.

Understanding the US Pricing Problem

The fundamental disparity stems from structural differences in how healthcare systems operate.

A 2024 RAND Corporation report found US drug prices were 2.78 times higher than in 33 other high-income countries. For brand-name drugs, US prices averaged 4.22 times higher—and even after manufacturer rebates, remained more than triple other nations' prices.

Key structural differences:

1. No Government Price Negotiation: Drug prices in the US are set by pharmaceutical companies and negotiated by private insurers. European governments negotiate directly with manufacturers to cap prices their state-funded systems will pay.

2. System Complexity: The US system involves pharmacy benefit managers (PBMs) who add layers of complexity and cost. The lack of transparency in the drug supply chain creates conditions favorable to limited competition and price maximization.

3. No Price Controls: US consumers bear the full cost of development work, marketing expenditures, and profit-seeking by all supply chain entities. The FDA has relaxed direct-to-consumer advertising regulations—a practice banned or severely limited in most other nations—further increasing consumption of high-priced drugs.

4. Patent Extensions and Loopholes: All supply chain entities have become skilled at finding regulatory loopholes to maximize profits, including creatively expanding patent life and recategorizing drugs as "orphan drugs" for rare diseases to preserve monopolies.

Current Policy Developments

The Trump administration has indicated several pharmaceutical policy priorities, though dramatic near-term changes are unlikely given that generic competition is already established.

Administration initiatives include:

Creating pathways for states to import drugs from Canada (though not Europe)
Tying US prices to lower international prices through "Most Favored Nation" policies
Increasing generic and biosimilar availability (which can be 80% cheaper than brand alternatives)
Improving disclosure of pharmacy benefit manager fees
Considering expanded importation from countries beyond Canada

However, implementation faces significant challenges. Research suggests that international reference pricing in Europe resulted in short-term budget savings, but list prices quickly converged to those of major markets without sustained reductions. Access to innovative medicines actually deteriorated in many EU countries using these approaches.

The Inflation Reduction Act (passed under the previous administration) made progress primarily for Medicare beneficiaries:

Allows Medicare to negotiate prices for select drugs (enzalutamide wasn't initially selected)
Caps Medicare Part D out-of-pocket costs at $2,000 annually starting 2025
Imposes rebates on manufacturers raising prices faster than inflation

These provisions help insured seniors but don't address the crisis facing uninsured patients.

Practical Solutions for US Patients

Rather than attempting illegal importation, patients should pursue legitimate options:

For Uninsured Patients

1. Patient Assistance Programs (PAPs)

Astellas Pharma: Offers patient assistance for Xtandi, potentially at no cost
Generic manufacturers: Teva, Accord, and Sandoz have assistance programs
Eligibility: Typically requires household income below 500% of Federal Poverty Level (approximately $75,000 for individuals, $155,000 for families)
Requirements: US citizenship or legal residency, annual re-enrollment

2. Non-Profit Foundations

Patient Access Network Foundation
HealthWell Foundation
These typically assist with copays for insured patients but may have programs for the uninsured

3. Discount Programs

GoodRx, SingleCare: May reduce costs to $7,500-$9,500 monthly for generics
Still prohibitively expensive but better than full retail

4. Obtain Insurance Coverage

State Medicaid: If your state expanded Medicaid under the ACA, you may qualify
ACA Marketplace: Check eligibility for subsidized coverage during open enrollment
COBRA: Expensive but may be cheaper than paying cash for enzalutamide

5. Clinical Trials

May provide enzalutamide or alternatives at no cost
Contact NCI-designated comprehensive cancer centers

6. Comprehensive Cancer Centers

Many have financial assistance programs
Some have pharmaceutical company relationships for compassionate use
340B program pharmacies serving low-income populations may offer better prices

For Insured Patients

1. Review 2026 Formularies

Contact your Part D plan or insurer about coverage for generic versus brand enzalutamide
Some plans have significantly lower copays for generics

2. Optimize Coverage

Consider switching plans during open enrollment if current coverage is poor
Request 90-day supplies for better per-unit pricing
Ask about mail-order pharmacy options

3. Address Coverage Issues

Document any problems with generic substitution
Appeal prior authorization denials with oncologist support
Monitor for mid-year formulary changes

4. Discuss Options with Your Oncologist

While generics must demonstrate bioequivalence, have informed discussions about brand versus generic
Consider treatment alternatives if cost is prohibitive

The Uncomfortable Truth

The European generic enzalutamide approval highlights a profound injustice: an uninsured American facing metastatic castration-resistant prostate cancer could literally die because they cannot afford medication that costs 15-20 times more than in Europe—for no defensible reason other than healthcare system structure.

The approval will likely have minimal direct impact on US prices in the short term. Generic competition already exists domestically, yet prices remain dramatically higher than in other developed nations. Real solutions require systemic reform: government price negotiation (as every other developed nation employs), universal healthcare coverage, or both.

Until then, patients must navigate a complex patchwork of assistance programs, hoping to qualify for help rather than being guaranteed affordable access as a right. The most important immediate step for any patient struggling with enzalutamide costs is to aggressively pursue patient assistance programs and work with oncology social workers or patient navigators to identify all available resources.

The Path Forward

Recent developments suggest bipartisan recognition that pharmaceutical pricing needs reform, though approaches differ. The combination of Medicare negotiation authority, state importation programs (if they ever become operational), increased generic competition, and continued public pressure may gradually improve the situation.

For prostate cancer patients and advocates, the key message is clear: while European generic approval represents progress for global access, American patients need systemic solutions, not individual workarounds. Advocacy for comprehensive pricing reform remains essential, as does ensuring that every patient knows about and can access existing assistance programs.

Sources and References

Medscape Medical News. "Generic Prostate Cancer Therapy Nears EU Approval." November 2025. https://www.medscape.com/
European Medicines Agency. "Enzalutamide Accordpharma - CHMP Recommendation." November 2025. https://www.ema.europa.eu/
Scher HI, Fizazi K, Saad F, et al. "Increased survival with enzalutamide in prostate cancer after chemotherapy (AFFIRM)." New England Journal of Medicine. 2012;367(13):1187-1197. doi:10.1056/NEJMoa1207506
Beer TM, Armstrong AJ, Rathkopf DE, et al. "Enzalutamide in metastatic prostate cancer before chemotherapy (PREVAIL)." New England Journal of Medicine. 2014;371(5):424-433. doi:10.1056/NEJMoa1405095
The White House. "Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices." April 15, 2025. https://www.whitehouse.gov/fact-sheets/2025/04/
NPR. "Trump Administration Plans To Allow Imports Of Some Prescription Drugs From Canada." July 31, 2019. https://www.npr.org/2019/07/31/746905508/
KFF Health News. "Trump Approves Final Plan to Import Drugs From Canada 'for a Fraction of the Price.'" September 29, 2020. https://kffhealthnews.org/news/trump-approves-final-plan-to-import-drugs-from-canada/
Foley & Lardner LLP. "FDA: Major Policy Shift Authorizes Florida's Plan to Import Drugs from Canada." January 11, 2024. https://www.foley.com/insights/publications/2024/01/
Florida Executive Office of the Governor. "Florida Becomes First in the Nation to Have Canadian Drug Importation Program Approved by FDA." January 5, 2024. https://www.flgov.com/
CBS News. "Florida Gov. DeSantis' Canadian drug import plan goes nowhere after FDA approval." November 20, 2024. https://www.cbsnews.com/news/florida-desantis-fda-canadian-drug-imports/
Partnership for Safe Medicines. "Drug importation in Florida." June 6, 2025. https://www.safemedicines.org/florida-importation-2019
Health Canada. "Statement from Health Canada on FDA decision on Florida bulk drug importation plan." January 8, 2024. https://www.canada.ca/en/health-canada/news/2024/01/
Jones Day. "Canadian Drug Importation May Undermine Intellectual Property Protection." May 23, 2024. https://www.jonesday.com/en/insights/2024/05/
KFF. "What to Know About the FDA's Recent Decision to Allow Florida to Import Prescription Drugs from Canada." August 9, 2025. https://www.kff.org/health-costs/
CNBC. "Why Americans pay so much more for prescription drugs." May 14, 2025. https://www.cnbc.com/2025/05/14/
Euronews. "Which countries in Europe pay the most for medicines and why is it still less than in the US?" May 13, 2025. https://www.euronews.com/health/2025/05/13/
Johns Hopkins Bloomberg School of Public Health. "Tariffs and U.S. Drug Prices." June 17, 2025. https://publichealth.jhu.edu/2025/tariffs-and-us-drug-prices
Medical Xpress. "Q&A: The economic forces that drive prescription drug prices." October 31, 2025. https://medicalxpress.com/news/2025-10-qa-economic-prescription-drug-prices.html
The Conversation. "Why the US has higher drug prices than other countries." October 2, 2025. https://theconversation.com/why-the-us-has-higher-drug-prices-than-other-countries-111256
Science Direct. "Referencing Drug Prices of Other Countries May Not Sustainably Lower Prices in the United States: Lessons From Europe." July 1, 2025. https://www.sciencedirect.com/science/article/abs/pii/S1098301525024222
SWI swissinfo.ch. "Despite Trump's bold claims, medicine prices in Europe won't rise anytime soon." May 19, 2025. https://www.swissinfo.ch/eng/medicine-access/
KFF Health News. "Biden Is Right. The US Generally Pays Double That of Other Countries for Rx Drugs." March 6, 2024. https://kffhealthnews.org/news/article/fact-check-biden-prescription-drug-prices-nation-comparison/
RAND Corporation. "International Prescription Drug Price Comparisons: Estimates Using 2022 Data." February 1, 2024. https://www.rand.org/pubs/research_reports/RRA788-3.html
Global Citizen Solutions. "Portugal Healthcare: A Guide for Expats in 2025." November 2025. https://www.globalcitizensolutions.com/portugal-healthcare-foreigners/
The Golden Portugal. "How To Access Portugal Healthcare For Expats." August 18, 2025. https://www.thegoldenportugal.com/healthcare-system-in-portugal-for-expats/
International Living. "Guide to Healthcare and Medical Care Costs in Portugal 2024." October 25, 2023. https://internationalliving.com/countries/portugal/health-care-in-portugal/
IMIN Portugal. "Portugal Healthcare System for Expats and Citizens in 2025: Complete Guide." July 16, 2025. https://imin-portugal.com/blog/portugal-healthcare-system/
Global Citizen Solutions. "Health Insurance in Portugal: Complete Guide for Expats in 2025." November 2025. https://www.globalcitizensolutions.com/health-insurance-in-portugal/

This article is for informational purposes only. Treatment and financial decisions should be made in partnership with your healthcare team. For assistance navigating patient assistance programs or expatriate healthcare options, contact IPCSG leadership or your oncology social worker.

Newsletter compiled for the Informed Prostate Cancer Support Group

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