| 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 |
NCPE assessment ongoing |
11th March 2025 |
|
| 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 |
Awaiting full HTA submission from Applicant |
4th February 2025 |
|
| - |
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 |
|
| - |
Oxycodone/naloxone |
Targin® |
For severe pain, which can be adequately managed only with opioid analgesics. |
Assessment process complete |
13th July 2010 |
|
| 22002 |
Ozanimod |
Zeposia® |
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. |
Rapid Review Complete |
1st February 2022 |
|
| 20045 |
Ozanimod |
Zeposia® |
For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. |
Rapid Review Complete |
23rd November 2020 |
|
| - |
Ozenoxacin |
Dubine® |
For the short term treatment of non-bullous impetigo in adults, adolescents, children, and infants aged 6 months and older. |
Rapid Review Complete |
13th December 2018 |
|
| - |
Palbociclib |
Ibrance® |
For the treatment of women with metastatic hormone receptor-positive, HER2-negative breast cancer. |
Assessment process complete |
28th July 2017 |
|
| - |
Paliperidone palmitate |
Xeplion® |
For maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate, and a long acting injectable treatment is needed. |
Rapid Review Complete |
9th April 2011 |
|
| - |
Panobinostat |
Farydak® |
In combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. |
Rapid Review Complete |
9th February 2016 |
|
| - |
Paritaprevir boosted with ritonavir and ombitasvir with or without dasabuvir |
(Vierkirax®)/(Exviera®) |
Exviera® is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (CHC) in adults. Exviera® must not be administered as monotherapy. Depending on the patient population The recommended co-administered medicinal products for exviera® combination therapy are viekirax® or viekirax® and ribavirin. Viekirax® is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (CHC) in adults viekirax® must not be administered as monotherapy. Depending on the patient population, the recommended co-administered medicinal products for viekirax® are exviera® or exviera® and ribavirin or ribavirin. |
Assessment process complete |
10th February 2016 |
|
| - |
Pasireotide |
Signifor® |
For the treatment of adult patients with Cushing’s Disease for whom surgery is not an option or for whom surgery has failed |
Rapid Review Complete |
11th April 2012 |
|
| 22034 |
Pasireotide LAR |
Signifor® LAR |
For the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. |
Rapid Review Complete |
16th June 2022 |
|
| - |
Patiromer |
Veltassa® |
For the treatment of hyperkalaemia in adults. |
NCPE assessment complete |
23rd November 2020 |
|
| - |
Patisiran |
Onpattro® |
For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. |
Assessment process complete |
20th February 2020 |
|
| 20003 |
Pegaspargase |
Oncaspar® |
As a component of antineoplastic combination therapy in acute lymphoblastic leukaemia in paediatric patients from birth to 18 years. |
Rapid Review Complete |
13th March 2020 |
|
| 21064 |
Pegcetacoplan |
Aspaveli® |
For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least three months. |
NCPE Assessment Process Complete |
24th April 2024 |
|
| 23020 |
Pegunigalsidase alfa |
Elfabrio® |
Pegunigalsidase alfa (Elfabrio®) is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase). |
Rapid Review Complete |
20th October 2023 |
|
| 21057 |
Pegvaliase |
Palynziq® |
for the treatment of patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. |
Assessment process complete |
29th November 2022 |
|
| 20001 |
Pegvaliase |
Palynziq® |
For the treatment of patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. |
Submission Withdrawn Pegvaliase (Palynziq®) HTA ID: 21057 |
18th November 2021 |
|
| - |
Pegylated Interferon beta-1a |
Plegridy® |
Treatment of adult patients with relapsing remitting multiple sclerosis |
Rapid Review Complete |
22nd December 2014 |
|
| 24030 |
Pegylated Liposomal irinotecan |
Onivyde® |
Liposomal irinotecan in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. |
Rapid Review Complete |
22nd August 2024 |
|
| 20028 |
Pegylated liposomal irinotecan |
Onivyde® |
For the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in adult patients who have progressed following gemcitabine based therapy. |
Assessment process complete |
12th November 2021 |
|
| - |
Pembrolizumab |
Keytruda® |
For the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. |
Rapid Review Complete |
27th July 2018 |
|
| - |
Pembrolizumab |
Keytruda® |
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. |
Assessment process complete |
15th August 2019 |
|
| - |
Pembrolizumab |
Keytruda® |
In combination with carboplatin and either paclitaxel or nab-paclitaxel for the treatment of the first-line treatment of metastatic squamous non-small cell lung carcinoma. |
Rapid Review Complete |
26th March 2019 |
|
| 22042 |
Pembrolizumab |
Keytruda® |
Is indicated for the adjuvant treatment of adults and adolescent (≥12 years) with stage IIB or IIC melanoma following complete resection. |
NCPE Assessment Process Complete |
10th March 2024 |
|
| 23058 |
Pembrolizumab |
Keytruda® |
Pembrolizumab as monotherapy for the treatment of mismatch repair deficient or microsatellite instability-high tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. |
Rapid Review Complete |
25th October 2023 |
|
| - |
Pembrolizumab |
Keytruda® |
As monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection. |
Assessment Process Complete |
15th May 2020 |
|
| 22026 |
Pembrolizumab |
Keytruda® |
Is indicated as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. |
NCPE Assessment Process Complete |
10th March 2025 |
|
| - |
Pembrolizumab |
Keytruda® |
As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. |
Rapid Review Complete |
22nd December 2017 |
|
| 21013 |
Pembrolizumab |
Keytruda® |
For the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. |
Rapid Review Complete |
14th May 2021 |
|
