| - |
Abatacept |
Orencia® |
In combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. |
NCPE Assessment Process Complete |
11th November 2013 |
 |
| 20033 |
Abemaciclib |
Verzenios® |
For the treatment of women with hormone receptor positive , human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. |
Rapid Review Complete |
27th July 2020 |
|
| 22020 |
Abemaciclib |
Verzenios® |
in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence. |
NCPE Assessment Process complete |
5th June 2024 |
|
| - |
Abiraterone Acetate |
Zytiga® |
Treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel-based chemotherapy. |
NCPE Assessment Process Complete |
22nd May 2012 |
|
| - |
Abiratone |
Zytiga® |
Treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated |
NCPE Assessment Process Complete |
7th March 2014 |
|
| - |
Abiraterone acetate |
Zytiga® |
Treatment of newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). |
No HTA dossier submitted |
15th November 2018 |
|
| 21056 |
Abrocitinib |
Cibinqo® |
For the treatment of moderate-to-severe atopic dermatitis in adults aged 18 years and older who are candidates for systemic therapy. |
Rapid Review Complete |
23rd December 2021 |
|
| 20063 |
Acalabrutinib |
Calquence® |
For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy. |
Rapid Review Complete |
4th February 2021 |
|
| 23012 |
Acalabrutinib |
Calquence® |
Indicated as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The Applicant is seeking reimbursement in a subgroup of the licensed population: as monotherapy for previously untreated CLL without 17P deletion or TP53 mutation, in adult patients unsuitable for chemoimmunotherapy and venetoclax in combination with obinutuzumab. |
Company no longer intend to submit a full HTA dossier |
11th March 2024 |
|
| - |
Aceclofenac |
Vitafen® |
For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. |
Rapid Review Complete |
24th January 2017 |
|
| - |
Aclidinium bromide |
Eklira Genuair® |
For treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). (Maintenance bronchodilator) |
Rapid Review Complete |
26th October 2012 |
|
| - |
Aclidinium bromide/formoterol fumarate dihydrate |
Brimica®/Genuair® |
For treatment to relieve symptoms in adult patients with COPD. (Maintenance bronchodilator) |
Rapid Review Complete |
9th February 2015 |
|
| - |
Adalimumab |
Humira® |
In combination with methotrexate for polyarticular juvenile idiopathic arthritis in children and adolescents (4-17yrs) in patients who have had an inadequate response to DMARDs. Also licensed as monotherapy in cases of intolerance to MTX or when continued therapy with MTX is inappropriate. |
Rapid Review Complete |
2nd June 2011 |
|
| - |
Adenuric |
Febuxostat® |
A xanthine oxidase inhibitor for the treatment of gout. |
Rapid Review Complete |
8th December 2009 |
|
| - |
Afatinib |
Giotrif® |
As monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). |
Rapid Review Complete |
15th October 2013 |
|
| - |
Aflibercept |
Eylea® |
For the treatment of neovascular (wet) age-related macular degeneration (AMD). |
Rapid Review Complete |
21st December 2012 |
|
| - |
Aflibercept |
Zaltrap® |
For the treatment of metastatic colorectal cancer in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. |
NCPE Assessment Process Complete |
12th February 2014 |
|
| - |
Agomelatine |
Valdoxan® |
For the treatment of major depressive disorder. |
NCPE Assessment Process Complete |
3rd September 2009 |
|
| - |
Alectinib |
Alecensa® |
For the treatment of patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib. |
Rapid Review Complete |
27th February 2017 |
|
| - |
Alectinib |
Alecensa® |
For the first-line treatment of adult patients with ALK+ advanced NSCLC |
NCPE Assessment Process Complete |
15th January 2019 |
|
| 24017 |
Alectinib |
Alecensa® |
As adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence. |
Rapid Review complete |
2nd July 2024 |
|
| - |
Alemtuzumab |
Lemtrada® |
For adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features |
NCPE Assessment Process Complete |
25th June 2014 |
|
| - |
Alirocumab |
Praluent® |
For the treatment of both primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia |
NCPE Assessment Process Complete |
6th June 2017 |
|
| - |
Alogliptin |
Vipidia® |
For adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. |
Rapid Review Complete |
30th October 2013 |
|
| 20035 |
Alpelisib |
Piqray® |
Is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2 -negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. |
NCPE Assessment Process Complete |
21st December 2021 |
|
| 19038 |
Alutard SQ® honey bee and Alutard SQ® wasp venoms |
Alutard SQ® |
As allergy immunotherapies for patients with a documented history of generalised and/or systemic IgE-mediated allergic reactions due to sensitisation to honey bee venom (Apis mellifera) and wasp venom (Vespula spp.), respectively. |
Rapid Review Complete |
11th March 2020 |
|
| - |
Ambrisentan |
Volibris® |
For the treatment of patients with Functional Class II or III pulmonary arterial hypertension. |
Full HTA Assessment |
4th July 2014 |
|
| - |
Amifampridine |
Firdapse® |
For the treatment of Lambert Eaton Myasthenic Syndrome (LEMS) |
Rapid Review Complete |
9th December 2011 |
|
| 20048 |
Amikacin Sulfate |
Arikayce® liposomal nebuliser dispersion |
For the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| 24044 |
Amivantamab |
Rybrevant® |
Amivantamab in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI) |
Rapid Review Complete |
13th December 2024 |
|
| 22004 |
Amivantamab |
Rybrevant® |
For the treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy. |
NCPE Assessment Process Complete |
28th April 2023 |
|
| 24032 |
Amivantamab |
Rybrevant® |
Amivantamab (Rybrevant®) in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion |
Awaiting full HTA submission from Applicant |
3rd December 2024 |
|
| - |
Amsacrine |
Amsidine® |
For the induction and maintenance of remission in acute leukaemia of adults. |
Rapid Review Complete |
21st February 2017 |
|
| 22059 |
Anakinra |
Kineret® |
For the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) of at least 6 ng/ml. |
Rapid Review Complete |
29th September 2022 |
|
| 20014 |
Andexanet alfa |
Ondexxya® |
For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. |
NCPE Assessment Process Complete |
27th May 2022 |
|
| 23027 |
Anifrolumab |
Saphnelo® |
Anifrolumab (Saphnelo®) is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy. |
Full HTA submission received from Applicant |
30th May 2024 |
|
| - |
Apalutamide |
Erleada® |
For the treatment of non-metastatic castration resistant prostate cancer (nmCRPC) at high risk of developing metastatic disease. |
NCPE Assessment Process Complete |
4th August 2020 |
|
| 20010 |
Apalutamide |
Erleada® |
For the treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy. |
NCPE Assessment Process Complete |
3rd March 2022 |
|
| - |
Apixaban |
Eliquis® |
For the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery. |
NCPE Assessment Process Complete |
19th June 2012 |
|
| - |
Apixaban |
Eliquis® |
For treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. |
Rapid Review Complete |
13th August 2014 |
|
| - |
Apixaban |
Eliquis® |
For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. |
NCPE Assessment Process Complete |
21st May 2013 |
|
| - |
Apremilast |
Otezla® |
For moderate to severe chronic plaque psoriasis. |
NCPE Assessment Process Complete |
27th January 2016 |
|
| - |
Apremilast |
Otezla® |
Alone or in combination with DMARDs, for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. |
NCPE Assessment Process Complete |
29th April 2016 |
|
| - |
Argipressin acetate |
Embesin® |
For the treatment of catecholamine refractory hypotension following septic shock in patients older than 18 years. A catecholamine refractory hypotension is present if the mean arterial blood pressure cannot be stabilised to target despite adequate volume substitution and application of catecholamines. |
Rapid Review Complete |
11th October 2019 |
|
| - |
Aripiprazole |
Abilify Maintena® |
For maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole |
Rapid Review Complete |
7th August 2014 |
|
| 24019 |
Artesunate |
Artesunate Amivas® |
For the initial treatment of severe malaria in adults and children. |
Rapid Review complete |
26th June 2024 |
|
| 22053 |
Asciminib |
Scemblix® |
For the treatment of Adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase, who have previously been treated with two or more tyrosine kinase inhibitors. |
Rapid Review Complete |
20th October 2023 |
|
| - |
Asenapine |
Sycrest® |
For the treatment of moderate to severe manic episodes associated with biopolar 1 disorder in adults. |
Rapid Review Complete |
6th September 2011 |
|
| - |
Aspirin 81mg/Esomeprazole 20mg |
Axanum® |
Prevention of thrombotic cardiovascular and cerebrovascular events in patients requiring continuous low-dose acetylsalicylic acid treatment, and who are in need of prophylaxis against acetylsalicylic acid associated gastric and /or duodenal ulcers. |
Rapid Review Complete |
16th May 2012 |
|
| - |
Ataluren |
Translarna® |
For the treatment of DMD resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 5 years and older. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing. |
NCPE Assessment Process Complete |
29th April 2016 |
|
