- |
Pertuzumab |
Perjeta® |
Is licensed for the adjuvant treatment, in combination with trastuzumab and chemotherapy, of adult patients with HER2-positive breast cancer at high risk of recurrence. |
Assessment Process Complete |
31st January 2019 |
|
- |
Pertuzumab |
Perjeta® |
The proposed licensed indication is for use (in combination with trastuzumab and docetaxel) in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. |
Assessment Process Complete |
28th August 2013 |
|
- |
Pertuzumab |
Perjeta® |
Is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage BC at high risk of recurrence. |
Assessment Process Complete |
11th May 2016 |
|
20053 |
Pertuzumab and trastuzumab |
Phesgo® |
For the treatment of Early breast cancer and Metastatic breast cancer |
Rapid Review Complete |
6th January 2021 |
|
- |
Phenylephrine Hydrochloride, Tropicamide & Lidocaine Hydrochloride |
Fydrane® |
Is indicated for cataract surgery to obtain mydriasis and intraocular anaesthesia, during the surgical procedure. |
Rapid Review Complete |
20th December 2016 |
|
- |
Piperaquine tetraphosphate/dihidroartemisinin |
Eurartesim® |
For uncomplicated malaria caused by the Plasmodium falciparum parasite |
Rapid Review Complete |
28th May 2012 |
|
- |
Pirfenidone |
Esbriet® |
For the treatment of mild to moderate idiopathic pulmonary fibrosis. |
Assessment Process Complete |
20th March 2013 |
|
- |
Pitavastatin |
Livazo® |
Is indicated for the reduction of elevated TC and LDL-C, in adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia and combined (mixed) dyslipidaemia, when response to diet and other non-pharmacological measures are inadequate. |
Rapid Review Complete |
29th December 2010 |
|
- |
Pitolisant hydrochloride |
Wakix® |
For the treatment of narcolepsy with or without cataplexy and should be initiated by a physician experienced in the treatment of sleep disorders. |
Rapid Review Complete |
15th June 2017 |
|
23054 |
Pitolisant hydrochloride |
Wakix® |
Pitolisant hydrochloride (Wakix®) is indicated in adults, adolescents, and children aged 6 years and older for the treatment of narcolepsy with or without cataplexy |
Rapid Review Complete |
4th October 2023 |
|
- |
Pixantrone |
Pixuvri® |
Is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lynmphomas (NHL). |
Rapid Review Complete |
20th March 2015 |
|
19052 |
Polatuzumab vedotin |
Polivy® |
In combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant (HSCT). |
Assessment Process Complete |
16th February 2021 |
|
22043 |
Polatuzumab vedotin |
Polivy® |
In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). |
NCPE Assessment Process Complete |
5th December 2023 |
|
- |
Polynuclear iron(III)-oxyhydroxide (pn-FeOOH) |
Velphoro® |
Is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Rapid Review |
Rapid Review Complete |
8th October 2014 |
|
- |
Pomalidomide |
Imnovid®) |
In combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. |
Assessment Process Complete |
13th March 2015 |
|
22016 |
Pomalidomide |
Imnovid® |
In combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. |
Rapid Review Complete |
5th May 2022 |
|
- |
Ponatinib |
Iclusig® |
Is indicated for patients in chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation and for Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) patients who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
Assessment Process Complete |
4th January 2016 |
|
21036 |
Ponesimod |
Ponvory® |
For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
Rapid Review Complete |
8th October 2021 |
|
- |
Prasugrel |
Efient® |
For the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention. |
Assessment Process Complete |
1st February 2010 |
|
- |
Pregabalin |
Lyrica® |
For the treatment of Generalised Anxiety Disorder. |
Full HTA Assessment |
15th December 2014 |
|
- |
Pregabalin |
Lyrica® |
For the treatment of peripheral and central neuropathic pain, generalised anxiety disorder and as adjunctive therapy for epilepsy. |
Full HTA Assessment |
12th June 2015 |
|
- |
Progesterone (micronised) |
Utrogestan® |
Progesterone (micronised) is indicated in women for supplementation of the luteal phase during ART cycles. |
Rapid Review Complete |
20th November 2019 |
|
- |
Prucalopride |
Resolor® |
For the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. |
Rapid Review Complete |
29th March 2011 |
|
24006 |
Quizartinib |
Vanflyta® |
Quizartinib is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia that is FLT3-ITD positive. |
Rapid Review Complete |
11th March 2024 |
|
- |
Radium-223 |
Xofigo® |
For the treatment of adults with castration resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. It is for use in the hospital setting. |
Assessment Process Complete |
12th December 2014 |
|
- |
Ramucirumab |
Cyramza® |
In combination with paclitaxel for the treatment of adult patients with advanced GC or gastro oesophageal junction (GEJ) adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy and as monotherapy for the treatment of adult patients with advanced GC or GEJ adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate. |
Assessment Process Complete |
26th July 2016 |
|
- |
Ranolazine |
Ranexa® |
Cost-effectiveness of Ranolazine (Ranexa®) |
Rapid Review Complete |
19th November 2009 |
|
19054 |
Ravulizumab |
Ultomiris® |
For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. |
Assessment Process Complete |
30th May 2022 |
|
20036 |
Ravulizumab |
Ultomiris® |
Indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve, or have received eculizumab for at least 3 months and have evidence of response to eculizumab. |
Assessment Process Complete |
28th July 2022 |
|
- |
Recombinant Human Parathyroid Hormone |
Natpar® |
Is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone. |
Rapid Review Complete |
21st May 2018 |
|
- |
Regadenoson |
Rapiscan® |
Cost-effectiveness of Regadenoson (Rapiscan®) |
Rapid Review Complete |
2nd November 2011 |
|
21065 |
Regdanvimab |
RegkironaTM |
For the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. |
Rapid Review Complete |
10th January 2022 |
|
- |
Regorafenib |
Stivarga® |
For the treatment of patients with gastrointestinal stromal tumours (GIST) who have been previously treated with two tyrosine kinase inhibitors and have progressed or are intolerant to prior treatment with two TKI’s. |
Rapid Review Complete |
6th October 2014 |
|
- |
Regorafenib |
Stivarga® |
For the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy. |
Assessment Process Complete |
1st July 2014 |
|
23017 |
Relugolix |
Orgovyx® |
Indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. |
Rapid Review Complete |
14th March 2024 |
|
21055 |
Relugolix with estradiol and norethisterone acetate |
Ryeqo® |
Is indicated for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. |
Rapid Review Complete |
3rd February 2022 |
|
24018 |
Relugolix with estradiol and norethisterone acetate |
Ryeqo® |
Relugolix with estradiol and norethisterone acetate (Ryeqo®) is Indicated in adult women of reproductive age for symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis. |
Rapid Review Complete |
15th July 2024 |
|
- |
Reslizumab |
Cinqaero® |
Is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. |
Rapid Review Complete |
1st March 2017 |
|
- |
Retigabine |
Trobalt® |
Cost-effectiveness of Retigabine (Trobalt®) |
Rapid Review Complete |
6th April 2011 |
|
24007 |
Rezafungin |
Rezzayo® |
Rezafungin (Rezzayo®) is indicated for the treatment of invasive candidiasis in adults. |
Rapid Review Complete |
26th March 2024 |
|
- |
Ribociclib |
Kisqali® |
In combination with an aromatase inhibitor (AI) is indicated for the treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine based therapy. |
Assessment Process Complete |
13th August 2018 |
|
- |
Ribociclib |
Kisqali® |
Is indicated in combination with an aromatase inhibitor or fulvestrant for the treatment of pre-, peri- and post-menopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine therapy, or in women who have received prior endocrine therapy: |
Rapid Review Complete |
11th July 2019 |
|
- |
Rifaximin |
Targaxan® |
Is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. |
Rapid Review Complete |
7th August 2013 |
|
- |
Rilpivirine |
Edurant® |
In combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/ml. |
Rapid Review Complete |
6th January 2012 |
|
- |
Rilpivirine (R), emtricitabine (F), tenofovir alafenamide (TAF) |
Odefsey® |
For the treatment of adults and adolescents (≥ 12 years, body weight ≥35 kg) infected with HIV 1 without known mutations associated with resistance to the NNRTI class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV 1 RNA copies/ml. |
Rapid Review Complete |
13th July 2016 |
|
22051 |
Rimegepant |
Vydura® |
For the acute treatment of migraine with or without aura in adults; and for the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month. |
NCPE Assessment Process Complete |
18th May 2023 |
|
- |
Rimonabant |
Acomplia® |
For the management of multiple cardiovascular risks in overweight or obese patients in Ireland |
Assessment Process Complete |
16th October 2006 |
|
- |
Riociguat |
Adempas® |
For the treatment of Pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH). |
Rapid Review Complete |
20th May 2014 |
|
23061 |
Risankizumab |
Skyrizi® |
Risankizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The Applicant is seeking reimbursement in a subgroup of the licensed population, as second-line treatment after failure of the first biologic therapy. |
NCPE Assessment Process Complete |
5th June 2024 |
|
22038 |
Risankizumab |
Skyrizi® |
Alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). |
Rapid Review Complete |
30th June 2022 |
|