Will Liraglutide Make It To WHO's Essential Medicines List?

Researchers from the Department I of Internal Medicine, Evidence-based Medicine Research Group, University Hospital of Cologne and Cochrane Haematology have sought the inclusion of CD19-directed chimeric antigen receptor (CAR) T-cells as a therapeutic group for the treatment of relapsed or refractory aggressive large B-cell lymphoma (LBCL) on the WHO’s model EML.

The group has requested a square box listing; the square box symbol is essentially use to denote therapeutic alternatives to the listed medicine that may be considered for selection in national essential medicines lists.

The results of the group’s review are based on three large multicentric randomized controlled trials. They noted that evidence suggests that CAR T-cell therapy may improve overall survival (OS) compared to the established treatment standard of immunochemotherapy, high-dose chemotherapy and autologous stem-cell transplantation.

“With survival follow-up still ongoing, the evidence is of low certainty. However, considering that over half of the participants in the control arms received CAR T-cells as the next-line treatment after treatment failure, the beneficial effect of CAR T-cells might be underestimated and not adequately represented by the OS estimate,” they said in their application.

The applicants recognize that CAR-T treatment is technologically demanding and resource intensive, among other factors and also noted that such therapy had not been introduced in lower- or middle-income countries, though it is of importance in nearly all fields of malignant hematology.

“Given the evidence that indicates superior efficacy over standard-of-care in the treatment of LBCL, we propose the inclusion of CD19-directed CAR T-cells in the EML. This could significantly help to increase accessibility and lower costs for healthcare systems and patients ,” the applicants said.

Asked whether the WHO review could have limited impact even if such therapies are placed on the model EML, given little scope for most nations to adapt these to their own needs against the backdrop of technology/patent barriers, and prohibitive pricing, WHO spokesperson Dr Margaret Harris said that the absolute cost of a medicine is not per se a parameter defining a medicine’s eligibility for an EML.

“Neither is patent status per se a criterion to list or not list a medicine. We are not in a position to comment on specific applications as they are in progress,” Harris added.

Novartis’s Kymriah (tisagenlecleucel) is among the products referred to in the application to the WHO