Reason for request

Reassessment

Summary of opinion  

Favourable opinion for maintenance of reimbursement in the “treatment of patients withsporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function”.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of RAPAMUNE (sirolimus) remains substantial in “sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function”.


Clinical Added Value

Comments without ASMR value

The Committee considers that the data provided by the RAPALAM study do not modify the previous conclusions concerning the clinical added value of RAPAMUNE (sirolimus).


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