Drugmaker warns US data rules threaten access to Alzheimer’s treatment
Eisai has warned that mandatory data collection by US health authorities could restrict patient access to the Japanese drugmaker’s new Alzheimer’s treatment.
The company said a decision by Centers for Medicare and Medicaid Services to restrict financial support for Leqembi to Alzheimer’s patients whose doctors participate in a health agency database could have “unintended consequences”.
Rival drugmaker Eli Lilly, which is developing a similar Alzheimer’s drug, has also criticised CMS for linking reimbursement to a registry.
Wall Street analysts have said the registry requirement could delay uptake of Leqembi in the short term, as it would require physicians to sign up for a “CMS-facilitated portal”, but that it was not a big challenge over the longer term.
“We see the ongoing registry requirement (coupled with previously anticipated infrastructure build/prescriber education) as likely slowing initial uptake for the category. Our longer-term expectations for the market remain unchanged,” said JPMorgan, which forecasts the new class of anti-amyloid drugs could generate $25bn in peak sales.
CMS said in a statement it is committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for Alzheimer’s disease.
This story originally appeared on: Financial Times - Author:Jamie Smyth
