A second Alzheimer’s drug is set to be banned from use on the NHS, the Telegraph reports.
This week the breakthrough drug lecanemab was declared safe by the medicines regulator but was not approved for use on the NHS by the health service spending watchdog.
Another new drug, donanemab, is even more effective at slowing the progression of Alzheimer’s disease.
Clinical trials showed it could slow cognitive decline by more than a third and halt the disease’s progression, with scientists hailing it as the “greatest treatment ever.”
But health officials say the drug will suffer the same fate as lecanemab: a source told The Telegraph that the National Institute for Health and Care Excellence (Nice), which decides which medicines are available on the NHS, will “certainly” reject the second Alzheimer’s drug.
The draft guidelines released by Nice this week are also unlikely to reverse its decision to reject lecanemab, the people said.
Sources said the precedent set by lecanemab would make it “very difficult” for the Medicines and Healthcare products Regulatory Agency (MHRA) to recommend similar Alzheimer’s drugs, even if they were approved.
Concerns about side effects
The MHRA may not approve donanemab due to concerns about the risk of serious side effects. Both drugs are approved for use in the United States.
Approval of lecanemab by the MHRA, delayed for six months due to difficulties in reaching a regulatory consensus, is believed to have been held up until the last minute after European regulators declared the risks too great.
Sources said Nice’s decision was “much easier” and that costs per patient are expected to be in the range of £50,000 to £100,000 per year.
“Now that Nice has rejected lecanemab, it is certain they will not approve donanemab, which carries twice the risk of serious side effects,” the source said.
Mr Nice said the cost of lecanemab was “significantly above the £20,000-30,000 per year range that is normally considered cost-effective for routine NHS use”. The Telegraph revealed this week that authorities had not taken into account the costs borne by families caring for people with dementia.