| - |
Exenatide |
Bydureon® |
For the treatment of type II diabetes mellitus combined with Metformin, Sulphonylurea, Thiazolidinedione, Metform and SU and Metformn and TZD in adults who have not acheived glycaemic control on maximally tolerated doses of these oral therapies. |
Rapid review complete |
9th June 2011 |
 |
| - |
Fampridine |
Fampyra® |
For the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). |
Assessment process complete |
17th August 2012 |
|
| 22060 |
Faricimab |
Vabysmo ® |
For the treatment of adult patients with neovascular (wet) age-related macular degeneration. |
Full HTA submission received from Applicant |
12th June 2024 |
|
| 22061 |
Faricimab |
Vabysmo ® |
For the treatment of adult patients with visual impairment due to diabetic macular oedema (DMO). |
Full HTA submission received from Applicant |
12th June 2024 |
|
| 21069 |
Fedratinib |
Inrebic® |
For the treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis who are JAK inhibitor–naive or have been treated with ruxolitinib. |
Rapid Review Complete |
20th January 2022 |
|
| 23048 |
Fenfluramine (Fintepla®) |
Fintepla® |
Fenfluramine (Fintepla®) is indicated for seizures associated with Dravet Syndrome (as an add-on therapy for patients two years of age and older). |
NCPE Assessment Process Complete |
3rd July 2024 |
|
| 23051 |
Fenfluramine |
Fintepla® |
Fenfluramine (Fintepla®) is indicated for patients (two years of age and older) with Lennox-Gastaut Syndrome as an add-on therapy to other anti-epileptic medicines. |
NCPE Assessment Process Complete |
16th September 2024 |
|
| - |
Ferric maltol |
Feraccru® |
For the treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD) in adult patients. |
Assessment process complete |
6th September 2016 |
|
| - |
Ferumoxytol |
Rienso® |
For the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). |
Assessment process complete |
17th August 2012 |
|
| 24005 |
Fezolinetant |
Veoza™ |
Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. |
Awaiting full HTA submission from Applicant |
24th April 2024 |
|
| - |
Fidaxomicin |
Dificlir® |
For the treatment of CDI also known as CDAD in adult patients. Rapid Review |
Assessment process complete |
5th February 2013 |
|
| 20047 |
Filgotinib |
Jyseleca® |
As monotherapy or in combination with methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. |
Rapid Review Complete |
16th November 2020 |
|
| 21048 |
Filgotinib |
Jyseleca® |
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. |
Assessment process complete |
10th December 2021 |
|
| 22012 |
Finerenone |
Kerendia® |
For the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. |
NCPE Assessment Process Complete |
22nd August 2023 |
|
| 23077 |
Finerenone |
Kerendia® |
Finerenone (Kerendia®) is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes (T2D) in adults. |
Rapid Review Complete |
23rd January 2024 |
|
| - |
Fingolimod |
Gilenya® |
For the treatment of highly active relapsing-remitting multiple sclerosis. |
Full Assessment Complete |
22nd September 2011 |
|
| - |
Fluocinolone acetonide intravitreal implant |
Iluvien® |
For the treatment of vision impairment associated with chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies. |
Rapid Review Complete |
1st March 2016 |
|
| 20050 |
Fluocinolone acetonide intravitreal implant |
Iluvien® |
For the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. |
Assessment process complete |
21st December 2020 |
|
| - |
Fluoride toothpaste |
Duraphat® 5,000 ppm |
For the prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries). |
Rapid Review Complete |
7th January 2020 |
|
| - |
Fluticasone furoate/ umeclidinium/ vilantero |
Trelegy™ Ellipta™ |
For the maintenance treatment of adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA. |
Assessment process complete |
19th June 2018 |
|
| - |
Fluticasone furoate/vilanterol |
Relvar™ Ellipta™ |
For both (i) the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta-2-agonist. and (ii) for symptomatic treatment of patients with COPD with a FEV1<70% of predicted normal (post-bronchodilator) in patients with an exacerbation history despite regular bronchodilator therapy. |
Rapid Review Complete |
23rd December 2013 |
|
| - |
Follitropin delta |
Rekovelle® |
For controlled ovarian stimulation (COS) for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. |
Assessment process complete |
16th August 2017 |
|
| 23019 |
Fondaparinux |
Arixtra® |
Fondaparinux (Arixtra®) is indicated for the prevention of Venous Thromboembolic Events, treatment of Acute coronary syndrome, treatment of Superficial vein thrombosis, treatment of Deep vein thrombosis and acute Pulmonary Embolism. |
Rapid Review Complete |
12th November 2024 |
|
| 21015 |
Formoterol fumarate dihydrate, glycopyrronium, budesonide |
Trixeo Aerosphere® |
For the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. |
Rapid Review Complete |
30th April 2021 |
|
| 23007 |
Foslevodopa/foscarbidopa |
Produodopa® |
Foslevodopa/foscarbidopa (Produodopa®) is indicated for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. |
Rapid Review Complete |
14th March 2024 |
|
| 23018 |
Fostemsavir |
Rukobia ® |
Fostemsavir (Rukobia ®) in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. |
Rapid Review Complete |
20th April 2023 |
|
| - |
Fremanezumab |
Ajovy® |
For prophylaxis of migraine in adults who have at least four migraine days per month. |
Assessment process complete |
7th September 2020 |
|
| 24031 |
Fruquintinib |
Fruzaqla® |
For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF agents, and anti EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine tipiracil or regorafenib |
Rapid Review Complete |
16th September 2024 |
|
| 20052 |
Galcanezumab |
Emgality® |
For the prophylaxis of migraine in adults who have at least four migraine days per month. |
Assessment process complete |
13th January 2021 |
|
| - |
Gefitinib |
Iressa® |
For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR. |
Assessment process complete |
5th November 2010 |
|
| - |
Gemtuzumab ozogamicin |
Mylotarg® |
For combination therapy with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive AML, except acute promyelocytic leukaemia. |
Assessment process complete |
4th July 2019 |
|
| 19043 |
Gilteritinib |
Xospata® |
For the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation. |
Assessment process complete |
3rd March 2021 |
|
| 20041 |
Glasdegib |
Daurismo® |
In combination with LDAC (low-dose cytarabine), for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia in adult patients who are not candidates for standard induction chemotherapy. |
Rapid Review Complete |
9th October 2020 |
|
| - |
Glecaprevir/Pibrentasvir |
Maviret® |
For the treatment of chronic hepatitis C virus (HCV) infection in adults – pangenotypic GT1-6. |
Assessment process complete |
17th August 2017 |
|
| 23055 |
Glofitamab |
Columvi® |
Glofitamab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. |
Rapid Review Complete |
3rd October 2023 |
|
| - |
Glucosamine sulfate |
Dona® |
For the treatment of oestoarthritis in the Irish Healthcare setting. |
Assessment process complete |
7th June 2009 |
|
| - |
Glycerol phenylbutyrate |
Ravicti® |
For use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (UCDs). |
Assessment process complete |
20th June 2018 |
|
| - |
Glycopyrronium bromide |
Seebri Breezhaler® |
As a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). |
Assessment process complete |
17th August 2012 |
|
| - |
Glycopyrronium bromide |
Sialanar® |
For symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. |
Assessment process complete |
13th June 2017 |
|
| - |
Golimumab |
(Simponi®) |
For the treatment of moderate to severe rheumatoid arthritis. |
Assessment process complete |
11th May 2010 |
|
| - |
Golimumab |
Simponi® |
For the treatment of moderately-to-severely active UC in patients who have failed or are intolerant to conventional treatments. |
Assessment process complete |
31st October 2013 |
|
| - |
Grass pollen allergen extract |
Oralair® |
For the treatment of allergic grass pollen rhinitis with or without conjunctivitis in adults, adolescents and children (above the age of 5) with clinically relevant symptoms confirmed by a positive cutaneous test and/or a positive titre of the specific IgE to the grass pollen. |
Assessment process complete |
13th October 2011 |
|
| - |
Guanfacine hydrochloride |
Intuniv® |
For the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. It must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. |
Assessment process complete |
18th December 2015 |
|
| - |
Guselkumab |
Tremfya® |
For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. |
Assessment process complete |
6th February 2018 |
|
| 20059 |
Guselkumab |
Tremfya® |
For the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. |
Assessment process complete |
17th February 2021 |
|
| 23008 |
House dust mite allergen extract |
Actair® |
Dermatophagoides pteronyssinus and Dermatophagoides farinae in equal parts (Actair®) is indicated for the treatment of moderate-to-severe house dust mite (HDM)–induced allergic rhinitis (AR) or rhinoconjunctivitis diagnosed by clinical history and a positive test of HDM sensitisation (skin prick test [SPT] and/or specific immunoglobulin E [IgE]) in adolescents (aged 12-17 years) and adults. |
Rapid Review Complete |
24th February 2023 |
|
| 20016 |
House Dust Mite Extract |
Acarizax ® |
Is indicated in adult patients (18-65 years) with HDM allergic asthma not well controlled by inhaled corticosteroids (ICS) and associated with mild to severe house dust mite allergic rhinitis. Diagnosis should be confirmed by clinical history and a positive test of HDM sensitisation (skin prick test and/or specific IgE). |
NCPE Assessment Process Complete |
24th February 2023 |
|
| 20015 |
House Dust Mite Extract |
Acarizax ® |
For the treatment of adult patients (18-65 years) diagnosed by clinical history and a positive test of HDM sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. |
Assessment process complete |
30th April 2020 |
|
| - |
Human alpha1-proteinase inhibitor (A1PI) |
Prolastin® |
For long-term augmentation therapy in subjects with alpha1-proteinase inhibitor deficiency (phenotypes PiZZ, PiZ(null), Pi (null,null) and PiSZ) within the limits of moderate airflow obstruction (FEV1 35-60%) and the evaluation of the clinical condition (disability). |
Assessment process complete. |
8th June 2017 |
|
| - |
Human alpha1-proteinase inhibitor |
Respreeza® |
For maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null, null), PiSZ). Patients are to be under optimal pharmacologic and nonpharmacological treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency. |
Assessment process complete |
9th December 2016 |
|
