ICER’s NASH Panel Shows Some Enthusiasm For Resmetirom, None For OCA
The cost-effectiveness group voted by a slight margin that Madrigal’s non-alcoholic steatohepatitis drug offers benefit above lifestyle changes alone, but decisively that Intercept’s candidate does not.
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ICER’s Final NASH Report Urges Step Therapy, Specialist Prescribing, Equitable Access
When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.
‘Leaps of Faith:’ ICER Meeting Suggests Reimbursement Hurdles For NASH Drugs
Lack of long-term clinical outcomes data on a slowly progressing, common condition combined with a rapidly changing treatment space for obesity and health system cost issues may present problems for two NASH treatments even if they win accelerated approval from US FDA.
Intercept, Madrigal Get Ready For NASH Commercialization
With a 22 June US FDA action date for obeticholic acid in non-alcoholic steatohepatitis, Intercept is thinking ahead to launch plans. Madrigal said it plans a Q2 filing for its NASH drug and hopes to find an ex-US commercial partner.