Takeda’s Adcetris has now been backed by the National Institute for Health and Care Excellence as an option to treat systemic anaplastic large cell lymphoma (sALCL), a very rare and aggressive cancer of the lymphatic system, on the NHS in England and Wales.

Back in June the cost watchdog said it was minded not to recommend routine funding for the drug and asked Takeda for a revised probabilistic cost-effectiveness analysis.

Now, a final appraisal determination published by the Institute recommends Adcetris (brentuximab vedotin) as an option for treating relapsed or refractory sALCL, but only if patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and the company provides the drug as per the terms of a commercial access agreement with NHS England.

The drug has been available on the NHS in England via the CDF since April 2013, and will now transition to baseline commissioning in the next three months for eligible patients.

Takeda has welcomed the “positive” guidance but said it is disappointed with the ECOG restriction, given that it is “not aligned with clinical experience or consistent with how other medicines for lymphoma have been appraised”.

According to the firm, there was no discussion regarding the ECOG restriction at either of the two appraisal committee meetings nor was the proposed restriction included in the previous ACD for consultation.

Furthermore, “previous access to brentuximab vedotin via the Cancer Drugs Fund (CDF) had no ECOG status restriction and Takeda is not aware on any data that would support this restriction,” the group stressed.

“Overall, we are pleased with the positive NICE decision, however it is disappointing that NICE has added a last minute ECOG restriction that could result in a small number of patients no longer having access to the medicine and being left with limited options,” said Adam Zaeske, Takeda UK general manager.