| 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 |
28th August 2023 |
|
| 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 |
|
| 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 |
|
| - |
Hyaluronic acid and co enzyme Q10 |
VisuXL® |
For the treatment of dry eye disease and the treatment of post-surgical intervention following elective surgery and trauma. |
Assessment process complete |
30th November 2017 |
|
| 21042 |
Hydrocortisone modified-release hard capsules |
Efmody® |
For the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and over and adults. |
Assessment process complete |
4th November 2021 |
|
| - |
Hydroxycarbamide |
Siklos® |
For use in the prevention of painful, recurrent vaso-occlusive crises, including acute chest syndrome, in adults, adolescents and children over 2 years of age suffering from symptomatic sickle-cell disease. |
Assessment process complete |
6th September 2011 |
|
| 20020 |
Hydroxycarbamide solution |
Xromi® |
For the prevention of vaso-occlusive complications of sickle cell disease in patients over two years of age. |
Assessment process complete |
14th May 2020 |
|
| - |
Ibrutinib |
Imbruvica® |
For the treatment of patients with chronic lymphocytic leukaemia who have received ≥1 prior therapy, or as a first-line treatment in the presence of del(17p) or TP53 mutation in patients not suitable for chemoimmunotherapy. |
Assessment process complete |
1st October 2015 |
|
| - |
Ibrutinib |
Imbruvica® |
For the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). |
Assessment process complete |
6th October 2015 |
|
| - |
Ibrutinib |
Imbruvica® |
For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). This indication is an extension to the original licence in the relapsed/refractory setting. |
Rapid Review Complete |
24th August 2016 |
|
| 20032 |
Ibrutinib |
Imbruvica® |
As a single agent or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
Rapid Review Complete |
4th August 2020 |
|
| 22054 |
Ibrutinib |
Imbruvica® |
In combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. |
NCPE Assessment Process Complete |
9th February 2024 |
|
| - |
Icatibant |
Firazyr® |
For symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (type I and II HAE). |
Rapid Review Complete |
31st July 2013 |
|
| 23006 |
Icosapent ethyl |
Vazkepa® |
Icosapent ethyl (Vazkepa®) is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (?150 mg/dL [?1.7 mmol/L] and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. |
Full HTA submission received from Applicant |
1st November 2023 |
|
| - |
Idarucizumab |
Praxbind® |
As a specific reversal agent for dabigatran in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: for emergency surgery/urgent procedures or life-threatening or uncontrolled bleeding. |
Rapid Review Complete |
18th December 2015 |
|
| - |
Idebenone |
Raxone® |
For the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON). |
Assessment process complete |
30th August 2018 |
|
| - |
Idelalisib |
Zydelig® |
In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. |
Assessment process complete |
16th February 2016 |
|
| 20040 |
Imipenem/cilastatin/relebactam |
Recarbrio® |
For the treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options. |
Rapid Review Complete |
21st October 2020 |
|
| - |
Imiquimod 3.75% |
Zyclara® |
For topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. |
Rapid Review Complete |
19th September 2013 |
|
| 23041 |
Imlifidase |
Idefirix® |
For desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients. |
Full HTA submission received from Applicant |
22nd April 2024 |
|
| 20051 |
Inclisiran |
Leqvio® |
For the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adult patients, as an adjunct to diet (a) in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or (b) alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. |
Assessment process complete |
23rd March 2022 |
|
