Following NCPE assessment of the company submission, cladribine (Mavenclad®) is considered cost-effective for the treatment of adult patients with highly active relapsing MS as defined by clinical or imaging features and therefore is recommended for reimbursement.

The NCPE recommends that cabozantinib (Cabometyx®) for the treatment of advanced or metastatic clear-cell RCC not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends for the infantile presentation, that sebelipase alfa (Kanuma®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. For the paediatric adult presentation, sebelipase alfa has not demonstrated robust evidence of additional clinical benefit and recommends that sebelipase alfa not be considered for reimbursement. These recommendations should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that pembrolizumab (Keytruda) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that selexipag not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that evolocumab should not be reimbursed unless cost effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that naltrexone/bupropion (Mysimba ®) should not be considered for reimbursement. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that osimertinib (Tagrisso®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that obinutuzumab (Gazyvaro®) in combination with chemotherapy followed by obinutuzumab maintenance therapy for this indication should not be considered for reimbursement, unless cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The NCPE recommends that eliglustat (Cerdelga ®) should not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria as specified in the Health (Pricing and Supply of Medical Goods) Act 2013.