NEW YORK – The UK's National Institute for Healthcare Excellence (NICE) on Thursday recommended the National Health Service make acalabrutinib (AstraZeneca's Calquence) available as a treatment for previously untreated chronic lymphocytic leukemia with a 17p deletion or TP53 mutation.
NICE is also recommending the drug as an option for previously untreated CLL patients who don't have these biomarkers and for whom the current standard of care, chemotherapy plus rituximab (Genentech/Biogen's Rituxan), is unsuitable, as well as for CLL patients who have received prior treatment. NICE estimated that 2,395 patients each year will be eligible for treatment with acalabrutinib.
"As the most common type of leukemia in England, more targeted treatment options are very much needed and welcomed," Meindert Boysen, deputy chief executive and director of the Center for Health Technology Evaluation at NICE, said in a statement. "Acalabrutinib is considered by patient experts who submitted evidence to NICE's independent appraisal committee to be generally well tolerated and could cause fewer side effects than existing NHS treatments."
The list price for a 30-day pack of acalabrutinib capsules is £5,059 ($7,016). AstraZeneca has a commercial arrangement with the NHS to provide the drug at an undisclosed discount.
In the US, acalabrutinib was approved in 2019 to treat all patients with chronic lymphocytic leukemia, small lymphocytic leukemia, and mantle cell lymphoma.