The NCPE does not recommend the reimbursement of lumacaftor + ivacaftor (Orkambi) for cystic fibrosis patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene at the submitted price. Patients on Managed Access Programme will continue on Orkambi
The NCPE recommends that Sativex® not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.
The NCPE recommends that patiromer (Veltassa®) 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.
Chronic migraine: The NCPE recommends that fremanezumab (Ajovy®), for the prophylaxis of migraine in adult patients with chronic migraine who have failed three or more migraine-preventive treatments, be considered for reimbursement. *
Episodic migraine: The NCPE recommends that fremanezumab (Ajovy®), for the prophylaxis of migraine in adult patients with episodic migraine who have failed three or more migraine-preventive treatments, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. *
The NCPE recommends that atezolizumab (Tecentriq®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommend that dabrafenib and trametinib be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommend that apalutamide (Erleada®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.*
The NCPE recommends that letermovir be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommends that pembrolizumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommends that durvalumab be considered for reimbursement if cost effectiveness can be improved relative to existing treatments.*
The NCPE recommends that Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.
The NCPE recommends that olaparib (Lynparza®) for this indication not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommends that burosumab (Crysvita®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments**
The NCPE recommend that axicabtagene ciloleucel (Yescarta®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.*
The NCPE recommends that patisiran (Onpattro®) is not considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments
The NCPE recommends that lutetium (177Lu) oxodotreotide (Lutathera®) not be considered for reimbursement*.
The NCPE recommends that olaparib (Lynparza®), for this indication, not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommends that nivolumab in combination with ipilimumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommends that dupilumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.
The NCPE recommends midostaurin (Rydapt®) for AML not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. *
The NCPE recommends that venetoclax in combination with rituximab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.*
The NCPE recommends that nivolumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.*
Chronic Migraine: The NCPE recommends that erenumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.*
Episodic Migraine: The NCPE recommends that erenumab not be considered for reimbursement.*
The NCPE recommends that darvadstrocel (Alofisel®) not be considered for reimbursement.*
The NCPE recommends that tisagenlecleucel (Kymriah®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.*
The NCPE recommends that tisagenlecleucel (Kymriah®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.*
The NCPE recommends that pembrolizumab (Keytruda®), prescribed in combination with platinum chemotherapy plus pemetrexed for the first line treatment of non-squamous NSCLC, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.
Niraparib (Zejula®) which is indicated as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. The NCPE recommends that niraparib (Zejula®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments
The NCPE recommends that osimertinib 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.
Following NCPE assessment of the company submission, gemtuzumab ozogamicin (Mylotarg®) (with daunorubicin and cytarabine) is not considered cost effective for the treatment of patients ≥ 15 years with previously untreated, de novo CD33-positive acute myeloid leukaemia, except acute promyelocytic leukaemia, and therefore is not recommended for reimbursement at the submitted price.
The NCPE recommends that rivaroxaban + aspirin 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 levodopa and carbidopa intestinal gel (Duodopa®) 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.
