It is now looking likely that some patients with relapsed/refractory (R/R) Hodgkin lymphoma will be able to get routine access to Takeda’s Adcetris on the NHS after a major u-turn by cost regulators.
Adcetris (brentuximab vedotin) is cleared in Europe to treat CD30-positive Hodgkin's lymphoma patients with: relapsed or refractory hodgkin's lymphoma after autologous stem cell transplant; a high risk of disease relapse or progression; and relapsed or refractory disease after two previous therapies when autologous stem cell transplant or multi-agent chemotherapy is not an option.
But late last year the National Institute for Health and Care Excellence published draft guidelines rejecting use of the drug - which is currently available in England to patients via the Cancer Drugs Fund (CDF) in certain indications - despite new evidence and a drop in its price, because of what it classed as “uncertainties” in the evidence.
Now, in a complete turnaround, the Institute has published a final appraisal determination recommending long-term funding for Adcetris as an option for adult patients with CD30+ve R/R Hodgkin lymphoma following an ASCT (autologous stem cell transplantation), as long as Takeda continues to providie the drug at the price agreed with NHS England in the commercial access agreement.
NICE has also recommended funding via the CDF for adult patients with CD30+ve R/R Hodgkin lymphoma following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, if the conditions of the managed access agreement are followed.
Takeda said that although this funding route does not yet provide the certainty of long-term access that it was aiming for, the firm is confident that with support from the clinical community, the additional data that NICE is looking for can be provided quickly, and “will do everything in its power to ensure the NICE re-appraisal of this indication, after the data collection period, leads to full approval and provides the security of long-term funding”.
On the down side, the company said it is disappointed that the third patient population reviewed by NICE, representing Hodgkin lymphoma patients at increased risk of disease relapse or progression after ASCT, has not been recommended.
“This is a group of patients that can have a poor outlook and limited treatment options, and this decision will prevent guaranteed access to an evidence-based medicine that could offer them a significantly improved chance of a long term remission,” Takeda noted.
Jonathan Pearce, chief executive of the Lymphoma Association, said the charity is “delighted” with NICE’s u-turn allowing use of Adcetris in two out of three indications, which will be “a great relief to many Hodgkin lymphoma patients and their families who would otherwise face no or limited treatment options.”
However, he also noted that, “given the potential impact brentuximab can have on patient outcomes and long-term survival, it has been frustrating how long it has taken for a recommendation to be agreed between NICE and the manufacturing company.
“Too many families have had to live unnecessarily with uncertainty and anxiety during this time. Unfortunately, this will continue for some families while the treatment for use in pre stem cell transplant patients is further assessed through the CDF. We can only hope that all those involved will work together to expedite the final decision on access to brentuximab for other indications.”