| - |
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 |
|
| 23031 |
Itopride Hydrochloride |
Progit® |
Treatment of gastrointestinal symptoms of functional dyspepsia caused by reduced gastrointestinal motility. |
Rapid Review Complete |
7th July 2023 |
|
| 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. |
NCPE 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. |
Awaiting full HTA submission from Applicant |
5th July 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 |
Full HTA submission received from Applicant |
16th February 2024 |
|
| - |
Ixazomib |
Ninlaro® |
In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
Assessment process complete |
18th December 2017 |
|
| - |
Ixekizumab |
Taltz® |
For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. |
Rapid Review Complete |
26th July 2016 |
|
| - |
Ixekizumab |
Taltz® |
For the treatment of active PsA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies |
Rapid Review Complete |
20th November 2018 |
|
| 21046 |
Ketoconazole |
Ketoconazole HRA® |
For the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years. |
Rapid Review Complete |
13th December 2021 |
|
| - |
Lacosamide |
Vimpat® |
As monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. The Applicant is seeking reimbursement for an extension to the product license to cover children (≥4 years of age) and adolescents (≤ 15 years of age). |
Rapid Review Complete |
31st October 2017 |
|
| __ |
Lanadelumab |
Takhzyro® |
For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. |
Assessment process complete |
26th June 2020 |
|
| - |
Lapatinib |
Tyverb® |
For the treatment of women with previously treated advanced or metastatic HER2 positive breast cancer. |
Assessment process complete |
28th January 2008 |
|
| 19050 |
Larotrectinib |
Vitrakvi® |
For patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. |
NCPE Assessment Process Complete |
6th July 2023 |
|
| 21053 |
Latanoprost/Timolol |
Fixapost® |
In adults (including the elderly) for the reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta‐blockers or prostaglandin analogues. |
Rapid Review Complete |
6th December 2021 |
|
| - |
Ledipasvir/sofosbuvir |
Harvoni® |
For the treatment of Chronic Hepatitis C (CHC) infection (Genotye 1, 3 and 4) in adults. |
Assessment process complete |
20th November 2015 |
|
| - |
Lenalidomide |
Revlimid® |
For the treatment of adult patients with previously untreated multiple myelomas (MM) who are not eligible for transplant (licence extension). |
Rapid Review Complete |
20th November 2015 |
|
| - |
Lenvatinib |
Kisplyx® |
In combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. |
Rapid Review Complete |
18th May 2017 |
|
| 22057 |
Lenvatinib |
Kisplyx® |
For the treatment of adults with advanced renal cell carcinoma, in combination with pembrolizumab, as first-line treatment |
Rapid Review Complete |
22nd September 2022 |
|
| - |
Lenvatinib |
Lenvima® |
For the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine. |
Rapid Review Complete |
10th July 2015 |
|
| - |
Lenvatinib |
Lenvima® |
As monotherapy for the treatment of adult patients with advanced or unresectable HCC who have received no prior systemic therapy. |
Rapid Review Complete |
16th August 2018 |
|
| - |
Lesinurad |
Zurampic® |
For the treatment of hyperuricaemia in adult patients with gout who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor. |
Assessment process complete |
6th December 2018 |
|
| - |
Letermovir |
Prevymis® |
For the prophylaxis of cytomegalovirus (CMV) reactivation or disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). |
Assessment process complete |
20th May 2020 |
|
