| - |
Nivolumab |
Opdivo® |
Opdivo® is indicated for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in adults. |
Assessment Process Complete |
10th March 2016 |
 |
| 22045 |
Nivolumab |
Opdivo® |
Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 (programmed death ligand 1) expression ≥1%. |
Rapid Review Complete |
20th October 2023 |
|
| - |
Nivolumab |
Opdivo® |
As monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. |
Assessment Process Complete |
12th September 2018 |
|
| - |
Nivolumab |
Opdivo® |
Nivolumab in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC) for RCC. |
Assessment Process Complete |
8th January 2020 |
|
| 21023 |
Nivolumab |
Opdivo® |
Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. |
NCPE Assessment Process Complete |
6th July 2023 |
|
| 23050 |
Nivolumab |
Opdivo® |
In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. |
Rapid Review Complete |
5th June 2024 |
|
| 21018 |
Nivolumab in combination with ipilimumab |
Opdivo® plus Yervoy® |
Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. |
NCPE Assessment Process Complete |
7th September 2022 |
|
| - |
Nivolumab plus ipilimumab |
Opdivo® plus Yervoy® |
For the treatment of advanced melanoma. |
Rapid Review Complete |
9th November 2016 |
|
| 21014 |
Nivolumab plus ipilimumab plus platinum-doublet chemotherapy |
Opdivo® plus Yervoy® |
For the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adult patients whose tumours have no sensitising EGFR mutation or ALK translocation. |
Rapid Review Complete |
30th April 2021 |
|
| 24009 |
Nivolumab+relatlimab |
Opdualag® |
Nivolumab+relatlimab (Opdualag® ) is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%. |
Rapid Review Complete |
16th April 2024 |
|
| - |
Nomegestrol acetate/estradiol |
Zoely® |
Nomegestrol acetate/estradiol (Zoely®) oral contraception |
Rapid Review Complete |
3rd January 2012 |
|
| 20044 |
Nusinersen |
Spinraza® |
For the treatment of 5q spinal muscular atrophy (SMA) in adults patients (>18 years). |
Rapid Review Complete |
29th October 2020 |
|
| - |
Nusinersen |
Spinraza® |
Is indicated for the treatment of 5q spinal muscular atrophy (SMA) |
Assessment Process Complete |
19th December 2017 |
|
| - |
Obeticholic acid |
Ocaliva® |
For the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. |
Assessment process complete |
31st October 2017 |
|
| - |
Obinutuzumab |
Gazyvaro® |
In combination with bendamustine followed by obinutuzumab maintenance for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. |
Assessment process complete |
26th January 2017 |
|
| - |
Obinutuzumab |
Gazyvaro® |
In combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia and with comorbidities making them unsuitable for full-dose fludarabine based therapy. |
Assessment process complete |
2nd April 2015 |
|
| - |
Obinutuzumab |
Gazyvaro® |
In combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma. |
Assessment process complete |
3rd May 2018 |
|
| - |
Ocrelizumab |
Ocrevus® |
For the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. |
Assessment process complete |
4th October 2018 |
|
| - |
Ocrelizumab |
Ocrevus® |
For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
Assessment process complete |
29th August 2018 |
|
| - |
Ocriplasmin |
Jetrea® |
For the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. |
Rapid Review Complete |
11th July 2013 |
|
| 21058 |
Odevixibat |
Bylvay® |
For the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. |
NCPE Assessment Process Complete |
14th March 2023 |
|
| - |
Ofatumumab |
Arzerra® |
In combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy. |
Rapid Review Complete |
18th December 2014 |
|
| - |
Ofatumumab |
Arzerra® |
For the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. |
Rapid Review Complete |
22nd June 2010 |
|
| 21008 |
Ofatumumab |
Kesimpta® |
For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
Assessment process complete |
16th April 2021 |
|
| - |
Oladaterol |
Striverdi®, Respimat® |
As a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). |
Rapid Review Complete |
6th May 2014 |
|
| - |
Olaparib |
Lynparza® |
For the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. |
Assessment process complete |
30th March 2020 |
|
| 22065 |
Olaparib |
Lynparza® |
As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. |
NCPE Assessment Process Complete |
24th September 2024 |
|
| - |
Olaparib |
Lynparza® |
As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. |
Assessment process complete |
17th December 2015 |
|
| - |
Olaparib |
Lynparza® |
For the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. |
Rapid Review Complete |
10th April 2019 |
|
| 21019 |
Olaparib |
Lynparza® |
As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. |
Rapid Review Complete |
15th June 2021 |
|
| - |
Olaparib |
Lynparza® |
As monotherapy for the maintenance treatment of adult patients with PSR high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. |
Assessment process complete |
2nd February 2020 |
|
| 23029 |
Olaparib |
Lynparza® |
Olaparib in combination with abiraterone and prednisone or prednisolone is indicated for the treatment of adult patients with mCRPC in whom chemotherapy in not clinically indicated |
Full HTA submission received from Applicant |
31st January 2024 |
|
| 21011 |
Olaparib |
Lynparza® |
Olaparib in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| - |
Olaparib |
Lynparza® |
As monotherapy for the maintenance treatment of adult patients with BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. This is a sub-group of the entire licensed population. |
Rapid Review Complete |
6th August 2019 |
|
| 24029 |
Olaparib |
Lynparza® |
Olaparib (Lynparza®) is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen |
Rapid Review Complete |
13th August 2024 |
|
| 23014 |
Olipudase alfa |
Xenpozyme® |
As an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B. |
Rapid Review Complete |
31st March 2023 |
|
| - |
Omalizumab |
Xolair® |
As an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. |
Rapid Review Complete |
25th June 2014 |
|
| - |
Omalizumab |
Xolair® |
As an add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1<80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. |
Assessment process complete |
25th June 2015 |
|
| 24033 |
Omaveloxolone |
Skyclarys® |
For the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older |
Rapid Review complete |
29th August 2024 |
|
| - |
Omega-3-acid ethyl esters |
Omacor® |
As an adjuvant treatment in secondary prevention after myocardial infarction in addition to other standard therapy. Omacor® is also indicated for the treatment of endogenous hypertriglyceridaemia as a supplement to diet, when dietary measures alone are insufficient to produce an adequate response. |
Assessment process complete |
22nd April 2013 |
|
| 20049 |
Omeprazole 2mg/ml powder for oral suspension |
Pedippi® |
For the management of Gastro-oesphageal reflux disease (GORD) and Peptic Ulcer Disease (PUD) in children and adult patients. Please refer to the SPC for the full range of licensed indications. The Applicant is seeking reimbursement for a subgroup of the licensed population: Children over 1 month of age for the treatment of reflux esophagitis and symptomatic treatment of heartburn and acid regurgitation in gastro oesophageal reflux disease (GORD); Children over 4 years of age and adolescents in combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori (H. pylori). |
Rapid Review Complete |
11th February 2021 |
|
| 20021 |
Onasemnogene abeparvovec |
Zolgensma® |
For the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene. |
Assessment process complete |
2nd April 2021 |
|
| 20055 |
Opicapone |
Ongentys® |
As adjunctive therapy to levodopa and DOPA decarboxylase inhibitors (L-DOPA+DDCI) in adults with Parkinson’s disease and end-of-dose motor fluctuations in patients not stabilised on such combinations. |
Rapid Review Complete |
18th January 2021 |
|
| - |
Opium Tincture |
Dropizol® |
For severe diarrhoea such as diarrhoea caused by cytostatic medication, radiation or neuroendocrine tumours when use of other anti-diarrhoea treatments have not given sufficient effect. |
Rapid Review Complete |
3rd April 2019 |
|
| 22070 |
Oral Azacitidine |
Onureg® |
For maintenance treatment in adult patients with acute myeloid leukaemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation. |
Rapid Review Complete |
14th March 2024 |
|
| 21061 |
Oritavancin |
Tenkasi® |
For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
Rapid Review Complete |
24th January 2022 |
|
| 22023 |
Osilodrostat |
Isturisa® |
For the treatment of endogenous Cushing’s syndrome in adults. |
Rapid Review Complete |
17th May 2022 |
|
| - |
Osimertinib |
Tagrisso® |
For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor [EGFR] T790M mutation positive non-small cell lung cancer [NSCLC]. |
Assessment process complete |
3rd May 2018 |
|
| 21066 |
Osimertinib |
Tagrisso® |
For adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA Non-Small Cell Lung Cancer whose tumour has epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations. |
NCPE Assessment Process Complete |
14th March 2024 |
|
| - |
Osimertinib |
Tagrisso® |
As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. |
Assessment process complete |
6th August 2019 |
|
