Package advice on ciltacabtagene autoleucel (Carvykti®) for the treatment of relapsing and refractory multiple myeloma (RRMM)
The National Health Care Institute advises the Minister not to include ciltacabtagene autoleucel (Carvykti®) for the treatment of adult patients with relapsing and refractory multiple myeloma (RRMM) in the basic healthcare package for this indication. The reason for this advice was cilta-cel being placed in the ‘lock procedure’ for expensive medicinal products.
Registered indication
Reimbursement is requested for the treatment of adult patients with relapsing and refractory multiple myeloma (RRMM), who have received at least 3 previous treatments, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and in whom disease progression has been demonstrated during or after the last therapy.
Package advice
The National Health Care Institute advises the Minister not to include ciltacabtagene autoleucel (Carvykti®) in the basic healthcare package for this indication.
The cost-effectiveness analysis provided by the marketing authorisation holder is of insufficient quality, despite the fact that the market authorisation holder has been given the opportunity to improve it. As a result, the National Health Care Institute cannot provide a methodologically reliable estimate of cost-effectiveness. Nor can it give the Minister an indication of the price reduction required to get close to an acceptable level of cost-effectiveness.
The National Health Care Institute is aware that the outcome of our will be disappointing both for patients and practitioners. The National Health Care Institute, therefore, invites the marketing authorisation holder to modify and better substantiate the pharmaco-economic analysis.