Tecartus NICE Decision 2026: Why the NHS is Withdrawing CAR-T for MCL
For patients with Mantle Cell Lymphoma (MCL), the promise of CAR-T therapy has always been about long-term survival where few other options exist. That promise hit a major regulatory wall on Christmas Eve 2025.
In a move that shocked the haematology community, the National Institute for Health and Care Excellence (NICE) issued draft guidance recommending against the routine NHS commissioning of Tecartus (brexucabtagene autoleucel) for relapsed or refractory MCL.
The decision hinges on a stark data divergence: while initial clinical trials suggested patients could survive for four years, real-world data from the Cancer Drugs Fund (CDF) showed median survival in NHS practice was closer to 2.5 years.
This article provides a detailed breakdown of the Tecartus NICE decision, the “fitness gap” that led to the withdrawal recommendation, and the critical February 2026 appeal led by major UK blood cancer charities. We also clarify the confusing split in access, where Tecartus remains available for leukaemia patients even as it faces removal for lymphoma.
The December 2025 Verdict: Why NICE Recommended Against Routine Use
The transition from the Cancer Drugs Fund (CDF) to routine commissioning is the most dangerous period in a cancer drug’s lifecycle. Tecartus had been available to MCL patients in England through the CDF since 2021. This temporary funding allowed patients to access the treatment while NICE collected further data to verify if the drug offered value for money.
On 24 December 2025, that review period concluded with a negative recommendation in Draft Guidance GID-TA11545.
The Cost-Effectiveness Barrier
NICE operates within strict financial limits. To be approved for routine use, a treatment must typically fall below an Incremental Cost-Effectiveness Ratio (ICER) of £30,000 per Quality-Adjusted Life Year (QALY).
During the CDF period, the price of Tecartus was discounted, but the total cost of delivery, including complex manufacturing, hospital stays for cytokine release syndrome (CRS) management, and intensive care support, remained high.
When the committee reviewed the updated evidence, they found that the cost of keeping a patient alive with Tecartus was significantly higher than the standard of care, which typically involves chemoimmunotherapy regimens like R-BAC (rituximab, bendamustine, and cytarabine).
Because the clinical benefits in the real world were less than predicted, the cost per year of quality life gained skyrocketed, pushing Tecartus well above the acceptable threshold for NHS spending.
Key Policy Note: According to the official appraisal documents from NICE, the committee acknowledged the treatment is “clinically effective” but could not justify the cost based on the survival data collected from UK hospitals between 2021 and 2025.
The Survival Gap: Real-World NHS Data vs. ZUMA-2 Trials
Why did the data change so drastically? The withdrawal recommendation comes down to a discrepancy between clinical trials and real-world clinical practice.
The initial approval of Tecartus was based on the ZUMA-2 trial, a pivotal study that showed impressive durability. In that controlled environment, median overall survival approached four years. However, the data collected from actual NHS patients showed a median survival of just 2.5 years.
The “Fitness” Factor
This 1.5-year drop is not necessarily a failure of the drug itself, but rather a reflection of the patient population.
Clinician’s Insight: The Selection Bias
In trials like ZUMA-2, patients are carefully selected. They often have fewer comorbidities (other health conditions), better performance status, and haven’t exhausted every other possible treatment line.
In the real-world NHS setting, the patients receiving Tecartus were often:
- Older and frailer than trial participants.
- Had undergone more prior lines of unsuccessful chemotherapy.
- Had a higher burden of disease at the time of infusion.
When you treat a “sicker” population, the outcomes naturally decline. Unfortunately, NICE’s economic models are ruthless: if survival drops, the calculated value of the drug drops with it.
The “Managed Access” Trap
This situation highlights a systemic risk in the UK’s drug approval pipeline known as the CDF Trap.
Drugs enter the Cancer Drugs Fund with a “promise” to replicate trial data. If they fail to do so, the “managed access” agreement expires, and the drug is withdrawn. Tecartus is the highest-profile victim of this mechanism in 2026, serving as a warning for other high-cost cell therapies currently in the fund.
The February 2026 Appeal: Can Charities Save Access for MCL?
The draft guidance was not the final word. The severity of withdrawing the only CAR-T therapy for Mantle Cell Lymphoma triggered an immediate and coordinated response from the patient advocacy community.
On 30 January 2026, a coalition led by Anthony Nolan, Blood Cancer UK, and Lymphoma Action formally submitted an appeal against the NICE decision.
The “No Alternatives” Argument
The core of the appeal rests on the lack of viable alternatives. Unlike other cancers where a withdrawal simply means reverting to a slightly less effective drug, removing Tecartus leaves relapsed MCL patients with few curative options.
Advocates argue that NICE failed to adequately weight the “severity modifier”, a scoring adjustment used to give leniency to treatments for severe conditions with no other options.
Paul’s Story:
Patient advocates have highlighted cases like that of Paul Madley, a patient who has spoken publicly about his experience. For patients like Paul, R-BAC chemotherapy offers palliation (symptom control) rather than the potential cure that CAR-T represents. The charities contend that stripping this lifeline is a “backward step” for UK cancer care.
Patient Continuity Protocols
A major concern for patients and families is the status of current treatment. It is vital to clarify that this decision is not retroactive.
- If you have already started treatment: Funding is secured. You will continue to receive Tecartus as planned.
- If you are on the waiting list: Clinicians are currently rushing to initiate funding requests before any final guidance is published.
- Future patients: If the appeal fails, new patients will not be eligible for NHS-funded Tecartus after the final guidance publication date (expected mid-February).
[Anthony Nolan – Tecartus Appeal Statement]
Obe-cel (Aucatzyl) vs. Tecartus: The New Landscape for B-cell ALL
While the door is closing for MCL patients, the situation for Acute Lymphoblastic Leukaemia (ALL) is completely different. This has caused significant confusion among patients who see “Tecartus withdrawal” headlines and assume it applies to all indications.
Tecartus remains available via the Cancer Drugs Fund for adults (26+) with relapsed or refractory B-cell ALL.
However, the landscape for ALL is shifting due to the arrival of a competitor: Aucatzyl (obecabtagene autoleucel), also known as obe-cel.
The New Standard: Obe-cel
In November 2025, NICE recommended obe-cel for routine commissioning. Unlike Tecartus, which is still in the CDF for ALL, obe-cel has graduated to full NHS funding.
Mechanism of Action Difference
Why is the NHS favouring obe-cel? The answer lies in toxicity.
- Tecartus uses a standard binding mechanism that engages T-cells aggressively. This is effective but leads to high rates of Cytokine Release Syndrome (CRS) and neurotoxicity (ICANS).
- Obe-cel features a unique “fast off-rate” binding domain. It latches onto the cancer cell, delivers a kill signal, and then detaches quickly.
Why this matters:
This “fast off” mechanism reduces the risk of the immune system overreacting. Clinical data suggests obe-cel causes fewer severe cases of CRS compared to Tecartus. For the NHS, this translates to shorter hospital stays and lower intensive care costs, making obe-cel a more cost-effective option for the ALL patient group.
[NIHR Evidence – Obe-cel vs Standard of Care]
What Happens Next? Key Dates and Future Alternatives
For patients and haematologists, the next few weeks are critical. The timeline below outlines the key dates for the finalization of the Tecartus NICE decision.
The 2026 Decision Timeline
| Date | Event | Significance |
| 24 Dec 2025 | Draft Guidance Published | NICE recommends against routine use for MCL. |
| 30 Jan 2026 | Appeal Submitted | Charities formally challenge the decision. |
| 02 Feb 2026 | Appeal Scrutiny | NICE appeal panel reviews the validity of the challenge. |
| 11 Feb 2026 | Final Guidance Expected | The “Final Appraisal Document” (FAD) is published. If the appeal is rejected, withdrawal becomes official. |
The Pipeline: Is There Hope Beyond Tecartus?
If Tecartus is permanently withdrawn for MCL, the focus will shift to emerging therapies currently in the trial or approval pipeline:
- Sonrotoclax: A next-generation BCL-2 inhibitor showing promise in trials for patients who have failed BTK inhibitors.
- Pirtobrutinib: A non-covalent BTK inhibitor that works even in patients who have developed resistance to standard drugs like ibrutinib.
- Liso-cel (Lisocabtagene maraleucel): Another CAR-T therapy that may seek approval for MCL, potentially with a better cost-profile than Tecartus.
These treatments are currently under evaluation, with decisions expected later in 2026 and 2027.
Summary of the Tecartus NHS Status
The Tecartus NICE decision represents a collision between clinical hope and economic reality. While the therapy offers a potential cure, the NHS accountability framework demands that real-world results justify the high price tag.
Key Takeaways:
- MCL Withdrawal: NICE has recommended withdrawing Tecartus for Mantle Cell Lymphoma due to real-world survival data falling short of trial predictions (2.5 years vs 4 years).
- Appeal Pending: A decision on the charity appeal is expected by mid-February 2026. Until then, the withdrawal is not final.
- ALL Access: Tecartus remains available for adult ALL patients, though the new therapy obe-cel is becoming the preferred routine option due to a better safety profile.
- Safety Net: Patients currently receiving treatment will not have their funding cut.
The scrutiny of CAR-T therapies is intensifying. As these treatments move from experimental phases to mainstream care, manufacturers must prove they can deliver trial-grade results in real-world NHS hospitals. For the 600 patients eligible for Tecartus each year, the hope is that the appeal will find a middle ground, perhaps a price renegotiation, that keeps this lifeline open.
Are you or a loved one affected by this decision? For the most up-to-date support and information on the appeal process, we recommend joining the Blood Cancer UK Community or contacting your clinical team immediately.
FAQs
Is Tecartus still available on the NHS for Mantle Cell Lymphoma?
As of early February 2026, it is technically still available for patients already in the system or those who can secure funding before the final guidance is published. However, if the negative recommendation is upheld on 11 February, new patient starts will likely cease for routine NHS funding.
What happens if the appeal by Anthony Nolan is successful?
If the appeal panel finds that NICE failed to follow its own processes or acted unfairly, the decision will be sent back to the committee for re-evaluation. This would “pause” the withdrawal and extend access to Tecartus while new terms are negotiated.
Why was Tecartus withdrawn from the Cancer Drugs Fund?
It was not “withdrawn” in the sense of being banned; rather, its temporary funding period ended. All drugs in the CDF must eventually be evaluated for routine use. Tecartus failed this evaluation because the real-world data collected during its time in the CDF did not show it was cost-effective enough for permanent funding.
What is the difference between Tecartus and Aucatzyl (Obe-cel)?
Both are CAR-T therapies that target CD19 on cancer cells. Tecartus is used for Mantle Cell Lymphoma and ALL. Aucatzyl (obe-cel) is a newer therapy currently approved for ALL. Obe-cel uses a “fast off-rate” mechanism that tends to cause less severe side effects (like cytokine release syndrome) compared to Tecartus.
Can I still get CAR-T therapy for MCL in the UK privately?
Yes. NICE decisions only affect NHS funding. If you have private health insurance or are self-funding, Tecartus (brexucabtagene autoleucel) remains a licensed and approved treatment in the UK, provided your consultant deems it clinically appropriate.
Does this decision affect patients with Acute Lymphoblastic Leukaemia (ALL)?
No. The negative recommendation applies specifically to Mantle Cell Lymphoma. Adults with B-cell ALL can still access Tecartus through the Cancer Drugs Fund, or access the newer therapy, obe-cel, via routine commissioning.
What does ‘Final Draft Guidance’ mean for cancer patients?
“Final Draft Guidance” is the last step before a decision becomes law. It signals NICE’s intention to say “no.” However, it is subject to appeal. Once the appeal is resolved, the “Final Appraisal Document” is issued, which binds the NHS to comply legally within 90 days.
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