Hemgenix is a one-time gene therapy made by CSL Behring, developed with uniQure, and approved by the FDA in November 2022 for adults with hemophilia B. The label covers adults who currently use factor IX prophylaxis, have current or historical life-threatening bleeding, or have repeated serious spontaneous bleeding episodes. A single intravenous infusion delivers a working copy of the factor IX gene. The 2026 list price is $3.5 million per treatment, which is why coverage rules matter more than any discount.
Pricing for Hemgenix works differently from a pill or pen. Treatment centers buy the product and bill the payer under HCPCS code J1411, so the cost shows up as a medical claim rather than a pharmacy claim. The Medicare hospital outpatient payment limit in Q3 2026 is $3,691,450 per therapeutic dose, and CMS publishes no office-based Part B rate. Commercial reimbursement varies by contract, and some payers negotiate outcomes-based agreements with CSL Behring. Patients should compare this with lifetime factor IX prophylaxis, which can cost several hundred thousand dollars a year in 2026, and review Medicare biologic infusion Part B versus Part D rules before treatment.
Medicare price negotiation does not reach Hemgenix in 2026. The Inflation Reduction Act of 2022 covers only selected single-source drugs, and a biologic must be licensed for 11 years before selection, so Hemgenix (licensed November 2022) cannot be chosen until the early 2030s. Neither the 2026 Round 1 list nor the 2027 Round 2 list includes it, so no Maximum Fair Price exists. For background on how negotiation works, see the IRA drug negotiation explainer. Patients weighing costs should also review Medicare eligibility rules and the federal poverty level tables that drive assistance eligibility.
What Hemgenix Costs by Point of Pay (2026)
The price you pay depends almost entirely on WHERE you pay. The same hemgenix can cost many times more at a hospital than at your local pharmacy:
2026 Hemgenix Price by Point of Pay| Where you pay | Typical cost | Notes |
|---|
| Manufacturer list price (2026) | $3,500,000 per infusion | One-time treatment; not sold at retail pharmacies |
| Medicare hospital outpatient payment limit (Q3 2026) | $3,691,450 per therapeutic dose | No office-based ASP published; 20% Part B coinsurance applies in Original Medicare |
| Original Medicare Part B patient share (2026) | 20% coinsurance after $283 deductible; no annual cap | A Medigap plan or employer retiree coverage usually absorbs the coinsurance |
| Commercial insurance (2026) | Deductible plus coinsurance up to plan out-of-pocket maximum | Prior authorization required; single-case agreements are common |
| Medicaid (2026) | $0 to $4 nominal copay in most states | Coverage rules and prior authorization vary by state; see Medicaid income limits |
Hemgenix cost by coverage type (2026). Payment-limit figure reflects Q3 2026 CMS hospital outpatient data as compiled by third-party billing references; confirm with your treatment center's billing office.
Source: CSL Behring, CMS Medicare Part B payment files, hospital outpatient APC data
Why Hospitals Charge So Much
Hemgenix reaches the patient through a hospital or specialty treatment center that buys the product at acquisition cost and bills the payer. The 2026 list price is $3.5 million, and hospitals in the 340B Drug Pricing Program can obtain it at a discounted 340B price, though the patient's claim is still billed at the payer's negotiated or statutory rate. Facility charges also add pharmacy handling, infusion suite time, pre-treatment lab work, and post-infusion monitoring for liver enzyme changes.
Itemized bills for Hemgenix deserve careful review because a small percentage error is enormous in dollars. A facility markup of just 5 percent on a $3.5 million product in 2026 equals $175,000. Patients should request the itemized statement, confirm the J1411 units billed (one unit per therapeutic dose), and verify the facility did not bill separate charges for supplies already bundled in the drug payment. The medical bill analyzer can flag duplicate or unbundled line items.
HCPCS J-Codes: What Appears on Your Bill
Hemgenix is billed under a single HCPCS Level II code in 2026. Confirm the code and units on your explanation of benefits.
HCPCS J-codes for Hemgenix| Code | Description | What to look for |
|---|
| J1411 | Injection, etranacogene dezaparvovec-drlb, per therapeutic dose | Billed units should equal 1 per treatment. Multiple units or a repeat claim signals a billing error, since Hemgenix is a one-time therapy. |
Administration is billed separately under an infusion code (CPT 96365 series) by the treatment facility. Coding verified against CMS HCPCS quarterly updates.
Source: https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system
Patient Assistance Programs
Patients with no insurance face the full $3.5 million list price in 2026, which no household can pay, so the CSL Behring patient assistance program is the realistic route for the uninsured. CSL Behring runs HEMGENIX Connect for benefit verification and a $0 copay assistance program for commercially insured patients. Uninsured and underinsured patients under CSL Behring's published income limit (reported at 250 percent of the federal poverty level, so confirm on the CSL page) can apply for free product through the company's patient assistance program.
Patient assistance programs for Hemgenix| Manufacturer program | Cost / Benefit | How to apply |
|---|
| HEMGENIX Connect | Case management, insurance investigation, and access to financial assistance | hemgenix.com/support/patient-services or 1-833-436-0021 |
| CSL Behring Copay Assistance | Can reduce eligible out-of-pocket costs to $0 for commercially insured patients | csl.com CSL Behring USA support and assistance programs |
| CSL Behring Patient Assistance Program | Free Hemgenix for eligible uninsured or underinsured patients | 1-844-727-2752 |
| NeedyMeds and RxAssist directories | Lists CSL Behring program contacts and other hemophilia foundations | needymeds.org |
A manufacturer coupon or copay card cannot be used with Medicare, Medicaid, TRICARE, or VA coverage because of the federal anti-kickback statute (42 U.S.C. § 1320a-7b). Government-insured patients should use HEMGENIX Connect and the income-based patient assistance program instead, and ask a hemophilia treatment center social worker about independent charity foundations.
Source: CSL Behring USA support and assistance programs, hemgenix.com, RxAssist
Medicare Part D
Hemgenix is generally billed to Medicare Part B, not Medicare Part D, because a clinician-administered infusion given at a hospital outpatient department falls under medical benefits. The 2026 Part D annual out-of-pocket cap of $2,100 therefore does not protect Original Medicare patients from the Part B 20 percent coinsurance after the $283 deductible. In theory, 20 percent of the $3,691,450 hospital outpatient payment limit is roughly $738,290 in 2026, which is why Medigap or employer retiree coverage matters before treatment.
Medicare Advantage plans cap in-network medical spending at an annual maximum out-of-pocket limit set by CMS (about $9,250 for in-network services in 2026), which is a major protection for a $3.5 million claim. Medicare Advantage plans often require prior authorization and may steer patients to specific centers of excellence. Patients should confirm the treatment center is in network and that the plan has approved J1411 in writing before scheduling the infusion. Under Part D, formulary tier rules do not apply because Hemgenix is not a pharmacy-dispensed drug.
Common Hemgenix Billing Errors
Before paying any Hemgenix bill in 2026, check for these issues:
- Prior authorization missing or expired on the date of infusion, leading to a retroactive denial of the full $3.5 million claim. Get written approval that lists the treatment date window.
- More than one unit of J1411 billed. Hemgenix is one therapeutic dose per lifetime, so duplicate units are a red flag.
- Out-of-network facility or physician fees when the drug itself was approved in network. Ask for a network exception or single-case agreement before treatment.
- Separate charges for pre-infusion lab work, liver monitoring, or supplies already bundled into the facility payment.
- Copay assistance not applied to a commercially insured claim because the facility billed the wrong payer order. Ask HEMGENIX Connect to confirm the claim routing.
Frequently Asked Questions
What does Hemgenix cost without insurance in 2026?
Hemgenix has a list price of $3,500,000 for a single infusion in 2026, and no pharmacy chain, GoodRx coupon, or cash-discount program sells it. Walmart, Costco, Kroger, CVS, and Walgreens do not stock gene therapies. Uninsured patients should contact HEMGENIX Connect at 1-833-436-0021 and the CSL Behring patient assistance program at 1-844-727-2752, because the full price is unrealistic to pay. Facility charges for pre-infusion labs and monitoring add to the total.
Is there a generic or biosimilar for Hemgenix?
No. No generic or biosimilar of Hemgenix exists as of 2026, and none is expected in the near term because gene therapies are complex vector-based products with no established generic pathway. Pfizer's competing hemophilia B gene therapy Beqvez was withdrawn from the market in 2025. The alternative is lifelong factor IX prophylaxis, which is covered by most plans and costs less per year but must be given continuously.
How do I apply for the CSL Behring patient assistance program for Hemgenix?
Call HEMGENIX Connect at 1-833-436-0021 or the CSL Behring patient assistance program at 1-844-727-2752. Your hematologist completes the prescriber section with DEA, state license, and NPI numbers. You submit proof of income, US residency, and insurance status. Applications go by fax through your prescriber's office, and approved product ships to your treatment center. Common denial reasons are income above the limit, missing signatures, and existing coverage that pays for the drug.
Can I use a Hemgenix savings card or manufacturer coupon with Medicare?
No. The federal anti-kickback statute (42 U.S.C. § 1320a-7b) bars manufacturer coupons and copay cards for patients with Medicare, Medicaid, TRICARE, or VA coverage. CSL Behring copay assistance, which can reduce eligible costs to $0, is for commercially insured patients only. Medicare patients should confirm Medigap or Medicare Advantage limits and apply to the income-based patient assistance program if eligible. Original Medicare has no annual out-of-pocket cap on the 20 percent Part B coinsurance in 2026.
What if my insurance denies coverage for Hemgenix?
Request the written denial, then file an internal appeal within 180 days (60 days for Medicare Advantage) with a letter of medical necessity from your hematologist. Ask for a peer-to-peer review, and if the plan requires prior factor IX prophylaxis (step therapy), request an override with documented bleeding history. If the internal appeal fails, request external review through your state department of insurance. HEMGENIX Connect case managers can help with each step.
Does the IRA negotiated price apply to Hemgenix?
No. Hemgenix is not one of the drugs selected for Medicare price negotiation under the Inflation Reduction Act in 2026 (Round 1) or 2027 (Round 2), so no Maximum Fair Price applies. A biologic must be licensed 11 years before selection, and Hemgenix was licensed in November 2022. Medicare Part D's $2,100 annual out-of-pocket cap in 2026 also does not apply because Hemgenix is normally billed under Medicare Part B as a medical benefit.
Do I qualify for the CSL Behring patient assistance program?
Eligibility generally requires that you are uninsured or underinsured, live in the United States, have a Hemgenix prescription from a US prescriber, and meet the income limit. CSL Behring's limit is reported at 250 percent of the federal poverty level, which equals $39,900 for a household of 1 and $82,500 for a household of 4 in 2026, but confirm the current threshold with the program. Government-insured patients may need to show Extra Help or other coverage was denied.
How does Hemgenix compare with Roctavian, Beqvez, and factor IX products?
Hemgenix and Beqvez treat hemophilia B (factor IX deficiency), while Roctavian (BioMarin) treats hemophilia A. Beqvez was withdrawn in 2025, leaving Hemgenix as the available hemophilia B gene therapy in 2026. Factor IX products such as Alprolix or Idelvion are repeat infusions with ongoing yearly costs. Hemgenix costs $3,500,000 once, so the total-cost comparison depends on your current bleeding rate, dosing, and how long your plan expects you to stay enrolled.
