The United Kingdom’s National Institute for Health and Care Excellence (NICE) concluded that Adcetris (brentuximab vedotin) is not a cost-effective option when given as a second-line therapy to people with CD30-positive cutaneous T-cell lymphoma (CTCL).
The decision means that, pending a review in February, these patients may not be able to be treated with the Seattle Genetics therapy on the National Health Service (NHS).
This draft guidance follows results of a Phase 3 clinical trial — called ALCANZA (NCT01578499) — showing that Adcetris outperformed standard treatment with the chemotherapy agent methotrexate or Targretin (bexarotene, by Ortho Dermatologics) at stopping progression of CTCL.
The study included 128 patients. Adcetris led to a reduction in tumor size in 56% of patients, compared to 12.5% on one of the standard treatments. It also extended the time patients lived without disease worsening from a median of 3.5 months to 16.7 months, cutting the risk of disease progression or death by 73%.
However, Adcetris was associated with increased frequency of severe side effects, with 44 patients experiencing peripheral neuropathy, characterized by tingling or pain in the fingertips or toes. Adcetris was also regarded as the cause of one of four deaths occurring in the respective group.
“This drug has been shown to offer some people much more time until their cancer spreads,” Rose Gray, Cancer Research UK‘s policy manager, said in a press release. Gray further said that NICE acknowledged the unmet treatment needs of people with CTCL, so this decision likely will be received with disappointment.
The reason for the rejection was that this trial only assessed the therapy’s efficacy, thereby not routinely recording the care patients needed after stopping treatment with Adcetris.
As such, NICE considered uncertain how many patients go on to further treatment, such as a stem cell transplant, which, although able to cure CTLC, is risky and expensive. Also unclear, NICE said, was whether receiving Adcetris without a subsequent stem cell transplant could prolong patients’ lives.
Altogether, these factors meant that NICE couldn’t accurately determine how costly the entire course of treatment would be, thereby precluding precise assessments of cost effectiveness.
“We urge the manufacturer, NICE and NHS England to work together before NICE reviews this decision again in February,” Gray said.
CTCL is a subset of non-Hodgkin’s lymphoma affecting the skin. It is characterized by flat red patches on the skin’s surface that can develop into tumors and can affect physical and psychological well-being.
CTCL can itself be divided into distinct forms, only some of which have the CD30 molecule on the surface of cancer cells. Adcetris works by binding to the CD30 molecule, then delivering a compound called monomethyl auristatin E that is able to kill cancer cells.
In May 2018, NICE recommended Adcetris and two other lymphoma therapies — Trisenox (arsenic trioxide, by Teva Pharmaceutical Industries) and Rydapt (midostaurin, by Novartis) — to be covered by the NHS.
