| - |
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 |
14th May 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 |
29th April 2024 |
|
| - |
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 |
|
| 21002 |
Pembrolizumab |
Keytruda® |
Is indicated as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults. |
NCPE Assessment Process Complete |
13th October 2022 |
|
| 19051 |
Pembrolizumab |
Keytruda® |
Is indicated as monotherapy or in combination with platinum and 5-fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a combined positive score. |
Assessment Process Complete |
18th May 2021 |
|
| 21059 |
Pembrolizumab |
Keytruda® |
In combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 and who have not received prior chemotherapy for metastatic disease. |
Rapid Review Complete |
13th January 2022 |
|
| 22027 |
Pembrolizumab |
Keytruda® |
Is indicated in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
NCPE Assessment Process Complete |
5th June 2024 |
|
| - |
Pembrolizumab |
Keytruda® |
For the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 (tumour proportion score [TPS] ≥ 50%) with no EGFR or ALK positive tumour mutations and no prior systemic therapy for advanced disease. |
Assessment Process Complete |
10th October 2017 |
|
| - |
Pembrolizumab |
Keytruda® |
Is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab. |
Assessment Process Complete |
29th May 2018 |
|
| 21032 |
Pembrolizumab |
Keytruda® |
In combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS≥10. |
NCPE Assessment Process Complete |
6th July 2023 |
|
| 22041 |
Pembrolizumab |
Keytruda® |
Is indicated in combination with chemotherapy with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥1. |
Rapid Review Complete |
6th July 2022 |
|
| - |
Pembrolizumab |
Keytruda® |
For the first line treatment of unresectable or advanced metastatic melanoma in adults. |
Assessment Process Complete |
9th February 2016 |
|
| - |
Pembrolizumab |
Keytruda® |
For the treatment of unresectable or advanced metastatic melanoma in adults refractory to ipilimumab. |
Assessment Process Complete |
9th February 2016 |
|
| - |
Pembrolizumab |
Keytruda® |
As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. |
Assessment process complete |
25th March 2019 |
|
| 19027 |
Pembrolizumab |
Keytruda® |
In combination with axitinib (Inlyta®), is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. |
Assessment Process Complete |
21st December 2020 |
|
| 22006 |
Pembrolizumab |
Keytruda® |
In combination with lenvatinib (Lenvima®) is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting, and who are not candidates for curative surgery or radiation. |
NCPE Assessment Process Complete |
18th December 2023 |
|
| 23056 |
Pembrolizumab |
Keytruda® |
Pembrolizumab (Keytruda®) In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1. |
Full HTA submission received from Applicant |
2nd May 2024 |
|
| 23070 |
Pembrolizumab |
Keytruda® |
Pembrolizumab (Keytruda®) is indicated in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced, unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 |
Full HTA submission received from Applicant |
1st August 2024 |
|
| 23078 |
Pembrolizumab |
Keytruda® |
Pembrolizumab (Keytruda®) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy*. |
Pre submission consultation scheduled |
24th July 2024 |
|
| 24013 |
Pembrolizumab |
Keytruda® |
Pembrolizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma (NSCLC) at high risk of recurrence in adults. |
Awaiting full HTA submission from Applicant |
12th July 2024 |
|
| 24026 |
Pemigatinib |
Pemazyre® |
Pemigatinib (Pemazyre®) is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. |
Rapid Review Complete |
16th July 2024 |
|
| - |
Pentosan Polysulfate Sodium [PPS] |
Elmiron® |
For the treatment of bladder pain syndrome (BPS) characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition. |
Rapid Review Complete |
24th January 2019 |
|
| - |
Perampanel |
Fycompa® |
For treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. |
Rapid Review Complete |
31st July 2013 |
|
