| - |
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. |
Full HTA submission received from Applicant |
14th February 2023 |
|
| - |
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. |
Pre submission consultation scheduled |
28th March 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 |
|
| 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 |
|
| - |
Incobotulinum Toxin Type A |
Xeomin® |
For the symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults. |
Rapid Review Complete |
6th March 2014 |
|
| - |
Indacaterol |
Onbrez® |
For the treatment of COPD. |
Rapid Review Complete |
15th January 2010 |
|
| 20023 |
Indacterol/glycopyrronium/mometasone furoate |
Enerzair® |
As a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting β2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. |
Rapid Review Complete |
10th June 2020 |
|
| 20024 |
Indacterol/mometasone furoate |
Atectura® |
As maintenance treatment of asthma in adults and adolescents 12 years and older not adequately controlled with inhaled corticosteroids and inhaled short acting β2 agonists. |
Rapid Review Complete |
10th June 2020 |
|
| - |
Infliximab |
Inflectra® |
For the treatment of Rheumatoid Arthritis, Adult Crohn’s disease, Paediatric Crohn’s disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis. |
Rapid Review Complete |
24th September 2013 |
|
| 20012 |
Infliximab |
Remsima SC® |
In combination with methotrexate, is indicated in rheumatoid arthritis for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. |
Rapid Review Complete |
24th March 2020 |
|
| 20042 |
Infliximab |
Remsima® SC |
For treatment of adult patients with Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis in line with the adult indications of the IV formulation. |
Rapid Review Complete |
15th October 2020 |
|
| - |
Ingenol mebutate |
Picato® |
For cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) in adults. |
Rapid Review Complete |
6th December 2012 |
|
| - |
Inhaled insulin |
Exubera® |
Pfizer submitted a report on the clinical and cost effectiveness of inhaled insulin (Exubera®) versus sub-cutaneous insulin in patients with diabetes mellitus in support of their application for reimbursement under the Community Drug Schemes. |
Assessment process complete |
13th July 2006 |
|
| 19034 |
Inotersen |
Tegsedi® |
For the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin (TTR) amyloidosis (hATTR). |
Assessment process complete |
11th February 2022 |
|
| - |
Inotuzumab ozogamicin |
Besponsa® |
As monotherapy for the treatment of adults with relapsed or refractory (R/R) CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). |
Assessment process complete |
14th September 2018 |
|
| - |
Insulin aspart |
Fiasp® |
For the treatment of diabetes mellitus in adults. |
Rapid Review Complete |
14th June 2017 |
|
| - |
Insulin aspart |
NovoRapid® FlexTouch ® |
For the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. |
Rapid Review Complete |
28th August 2014 |
|
| - |
Insulin Degludec |
Tresiba® |
Treatment of diabetes mellitus |
Assessment process complete |
6th May 2015 |
|
| - |
Insulin degludec/liraglutide (IDegLira) |
Xultophy® |
For the treatment of adults with type 2 diabetes mellitus (T2DM) to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or in combination with a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) or basal insulin does not provide adequate glycaemic control. |
Rapid Review Complete |
18th October 2016 |
|
| - |
Insulin Glargine |
Abasaglar® |
For the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. |
Rapid Review Complete |
12th October 2015 |
|
| - |
Insulin Glargine U300 |
Toujeo® |
for the treatment of diabetes mellitus in adults. |
Rapid Review Complete |
2nd July 2015 |
|
| - |
Ipilimumab |
Yervoy® |
For the treatment of advanced (unresectable or metastatic) melanoma in adult patients who have received prior therapy. |
Assessment process complete |
6th September 2011 |
|
| - |
Iron (III) isomaltoside 1000 |
Diafer® |
For the treatment of iron deficiency in patients with chronic kidney disease on dialysis, when oral iron preparations are ineffective or cannot be used. |
Rapid Review Complete |
20th November 2015 |
|
| - |
Iron (III) isomaltoside 1000 |
Monover® |
For the treatment of Iron deficiency anaemia when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly. |
Rapid Review Complete |
20th November 2015 |
|
| - |
Iron isomaltoside 1000 |
MonoVer® |
For the treatment of iron deficiency anaemia in the following circumstances: When oral iron preparations are ineffective or cannot be used and where there is a clinical need to deliver iron rapidly. |
Rapid Review Complete |
2nd February 2011 |
|
| 23024 |
Isatuximab |
Sarclisa® |
Isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone, is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
Rapid Review Complete |
25th May 2023 |
|
| - |
Isavuconazole |
Cresemba® |
For the treatment of invasive aspergillosis |
Rapid Review Complete |
11th May 2016 |
|
| - |
Isavuconazole |
Cresemba® |
For the treatment of mucormycosis in adult patients for whom amphotericin B is inappropriate. |
Rapid Review Complete |
11th May 2016 |
|
| 20027 |
IUB™ Ballerine® |
IUB™ Ballerine® MIDI 15mm diameter SCU300B |
For intrauterine contraception for up to five years. |
Rapid Review Complete |
29th July 2020 |
|
| 20062 |
IUB™ Ballerine® |
IUB™ Ballerine® MIDI 15mm diameter SCU300B |
For intrauterine contraception for up to five years. |
Rapid Review Complete |
17th February 2021 |
|
| - |
Ivacaftor |
Kalydeco® |
For the treatment of cystic fibrosis in patients age 6 years and older who have the G551D mutation |
Assessment process complete |
1st February 2013 |
|
| - |
Ivacaftor |
Kalydeco® |
For the treatment of children with CF aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. |
Assessment process complete |
12th October 2016 |
|
| - |
Ivacaftor |
Kalydeco® |
For the treatment of patients with cystic fibrosis aged 18 years and older who have the R117H mutation in the CFTR gene. |
Assessment process complete |
5th January 2017 |
|
| 22022 |
Ivacaftor/tezacaftor/elexacaftor |
Kaftrio® |
Ivacaftor/tezacaftor/elexacaftor (Kaftrio®) in combination with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. |
Assessment Process Complete |
9th February 2023 |
|
| 23015 |
Ivosidenib |
Tibsovo® |
To be used in combination with azacitidine, as indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy. |
Rapid Review Complete |
17th April 2023 |
|
| 23016 |
Ivosidenib |
Tibsovo® |
For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R 132 mutation who were previously treated by at least one prior line of systemic therapy |
Rapid Review Complete |
17th April 2023 |
|
