[ICKSH 2025] Reimbursement policy determines success or failure of blood cancer treatment

"Clinical outcomes alone are not enough. We must also consider how a new drug affects the patient’s life and its broader societal impact."

These are the words of Professor Andrew Davies, Chair of the UK National Cancer Institute Lymphoma Research Group and Professor of Haematological Oncology at University Hospital Southampton.

Professor Davies emphasized the growing role of novel therapies in treating diffuse large B-cell lymphoma (DLBCL), calling for a comprehensive reimbursement evaluation system that goes beyond simple efficacy assessments.

The UK’s NICE (National Institute for Health and Care Excellence), operating under a single-payer healthcare system, evaluates cost-effectiveness not only based on clinical benefits such as survival gains, but also considers various elements including unmet patient needs, societal burden reduction, and productivity recovery when determining reimbursement eligibility.

NICE’s economic evaluation structure is designed to more accurately reflect how therapies affect patients’ real-world quality of life. Blood cancer treatments are reviewed at the same level as solid tumors, and deliberations involve not only clinical experts but also health economists and patient advocacy groups.

In contrast, Korea’s health insurance review system has become rigidly centered around overall survival (OS), delaying access to reimbursement for anticancer drugs, especially in the field of hematologic malignancies.

“New therapies such as CAR-T and bispecific antibodies, where timing and rapid access are critical, require different evaluation indicators,” Davies said. “We need a structured approach that integrates medical, economic, and societal perspectives to improve patient access.”

Korea Biomedical Review recently met with Professor Davies during his visit to Korea for the 2025 International Congress of the Korean Society of Hematology (ICKSH 2025), held at Grand Walkerhill Seoul from March 27 to 29, to hear his insights on the changing paradigm of blood cancer treatment through the lens of DLBCL and the direction Korean reimbursement policies should take.

Question: Lymphoma treatment experienced its first major breakthrough with the development of rituximab. Now, with the introduction of antibody-drug conjugates (ADCs), bispecific antibodies, and CAR-T therapies, we are entering a second leap forward. What is your take on the situation?

Answer: For conditions like DLBCL, the emergence of these new options has marked a turning point. Just a short while ago, treatments were limited to chemotherapy and antibody drugs. Now, the landscape has expanded significantly, which is welcome news for both patients and clinicians.

DLBCL, the most common type of B-cell lymphoma, accounts for about one-third of non-Hodgkin lymphomas (NHLs) and is characterized by its aggressive progression. Nonetheless, many DLBCL patients now undergo first-line treatment with curative intent.

The introduction of R-CHOP, which includes rituximab, brought about a significant improvement in outcomes. More recently, combining the ADC polatuzumab vedotin (brand name Polivy) with R-CHP has enabled a new approach known as the Pola-R-CHP regimen. Clinical studies have demonstrated meaningful improvements in treatment outcomes and a reduction in relapses, with around 80 percent of patients surviving for two to three years or longer.

For patients who relapse or do not respond to initial treatment, alternatives like bispecific antibodies and CAR-T therapies are viable. Bispecific antibodies such as glofitamab (Product name: Columvi) and epcoritamab (Product name: Epkinly) work by linking T cells to malignant B cells, allowing for improved efficacy and safety over traditional chemotherapy.

In addition, patients achieving partial remission through Pola-R-CHP can be further treated using stem cell mobilization therapies, marking a shift away from traditional chemotherapy-based treatment.

Q: Are ADCs, bispecific antibodies, and CAR-T therapies reimbursed in the U.K.?

A: Yes. The U.K. operates a single-payer healthcare system in which NICE evaluates drugs for cost-effectiveness and reimbursement suitability. All DLBCL therapies must pass NICE’s rigorous review to be reimbursed.

The DLBCL therapies mentioned—Pola-R-CHP, bispecific antibodies, and CAR-T therapies—have been approved following cost-effectiveness evaluations. These drugs also met the willingness-to-pay threshold, which reflects the price society is willing to pay for a given health benefit.

Pola-R-CHP, for instance, is reimbursed as a first-line treatment for previously untreated DLBCL patients aged under 80 with an International Prognostic Index (IPI) score between two and five, based on the pivotal POLARIX trial.

For patients who relapse within 12 months after first-line treatment, CAR-T therapies such as axicabtagene ciloleucel (Product name: Yescarta) and lisocabtagene maraleucel (Product name: Breyanzi) are reimbursed as second-line treatments. If relapse occurs after 12 months, chemotherapy or stem cell therapy is prioritized.

In the third-line setting, treatments including tisagenlecleucel (Product name: Kymriah), glofitamab, and epcoritamab are also reimbursed.

Additionally, patients who did not receive Pola-R-CHP as first-line therapy, particularly elderly patients ineligible for CAR-T or bispecific therapies, may be treated with a combination of polatuzumab vedotin, bendamustine, and rituximab.

Because NICE serves as a centralized body for reimbursement decisions, it can take a holistic view of drug usage across treatment stages and evaluate all associated cost structures.

Patient advocacy for access to new drugs is also strong in the U.K., with a well-informed public pushing for improved access. NICE aims to make balanced decisions that consider clinical evidence, unmet needs, and social necessity.

Q: In Korea, these drugs are either not reimbursed or face significant restrictions.

A: In the U.K., regulatory agencies do not limit drug assessments to clinical efficacy but also take a broader societal view. For instance, as more patients achieve remission or survive without relapse, they reenter the workforce, reducing societal and healthcare burdens while contributing to national productivity.

If Pola-R-CHP is used in the first-line setting and reduces relapses, it can ease the economic burden of second- and third-line treatments. Studies show that Pola-R-CHP reduces future relapse and refractory cases by about 23 percent compared to R-CHOP. Patients who are treated from the outset with Pola-R-CHP and achieve a cure may avoid the physical and psychological toll of subsequent treatment rounds. Thus, reimbursing Pola-R-CHP for first-line use is highly significant.

The physical, psychological, and economic burden of relapse should not be underestimated. It affects not only individual lives but also the national healthcare system. Using effective therapies early to prevent disease progression is essential.

Q: Korea’s health insurance review agency tends to focus on OS as the primary metric when evaluating cost-effectiveness.

A: I don’t believe focusing solely on OS is appropriate in DLBCL. A more suitable approach would involve evaluating both OS and progression-free survival (PFS), which reflects a drug’s ability to prevent disease progression.

For example, the POLARIX trial showed that after two years, mortality rates were similar between the Pola-R-CHP and R-CHOP arms. However, newer five-year follow-up data indicate a widening survival benefit in favor of Pola-R-CHP. I expect additional follow-up data to confirm that this regimen continues to reduce mortality risk over time.

Q: Some Korean lymphoma specialists have proposed limiting reimbursement eligibility to patients with IPI scores of 3–5. What is your view on this compromise?

A: As a clinician and scientist, I want to emphasize that subgroup analysis must be interpreted cautiously. The POLARIX trial was designed to evaluate all patients with IPI scores between 2 and 5. When we analyze specific subgroups, we cannot assume the same level of statistical power as the full study.

That said, focusing on IPI 3–5 patients for reimbursement is a practical solution. This high-risk group represented about two-thirds of the POLARIX population, and the clinical benefits observed in this subgroup are meaningful.

Recent five-year follow-up data also showed greater therapeutic benefits in the IPI 3–5 group. Given their urgent treatment needs, this appears to be a reasonable interim step. Other countries have adopted similar risk-based reimbursement models.

Q: Could you share your perspective on the clinical relevance and role of bispecific antibodies in relapsed/refractory DLBCL?

A: In the U.K., bispecific antibodies are reimbursed for third-line treatment, allowing faster access for patients. Many third-line patients are in poor health and cannot tolerate chemotherapy or long hospital stays.

CAR-T therapies are effective but not suitable for all patients, and the manufacturing process introduces delays. Some patients may deteriorate while waiting for treatment.

Bispecific antibodies can be administered immediately, often beginning the day after a treatment decision is made. Their simplified dosing allows patients to receive treatment at nearby hospitals. Remission rates are high and sustained over time.

For instance, a three-year follow-up of glofitamab data presented at ASH showed a 40 percent complete remission (CR) rate in relapsed/refractory DLBCL patients. Many patients also achieved minimal residual disease (MRD) negativity, which is encouraging.

Adverse events are also more manageable than with CAR-T. Most cytokine release syndrome (CRS) cases are grade 1 and can be controlled by well-trained clinicians.

It is unfortunate that Korean patients are unable to access these therapies due to systemic issues. The available data clearly show that bispecific antibodies offer strong clinical utility compared to existing third-line treatments. I hope Korean regulators will listen to both healthcare professionals and patients and make evidence-based reimbursement decisions.

Q: In Korea, blood cancer therapies face more difficulty being listed for reimbursement compared to solid tumors. Has this issue been raised in the U.K., and how is expertise ensured in the U.K. reimbursement review process?

A: Yes, the U.K. has seen slower reimbursement of blood cancer treatments compared to solid tumors. This is partly due to the smaller patient population and less available clinical data for blood cancers.

However, such discrepancies are not fair to patients and should be addressed. NICE does not operate separate committees for hematologic and solid tumors, but its multidisciplinary panels include oncology experts.

Within these panels, subgroups focused on blood cancers review relevant data and provide input during the reimbursement process.

Importantly, NICE includes clinicians alongside cost-effectiveness experts in its deliberations. This allows reimbursement decisions to reflect integrated medical, economic, and societal considerations.