| Assessment Status | Rapid Review Complete |
| HTA ID | 22023 |
| Drug | Osilodrostat |
| Brand | Isturisa® |
| Indication | For the treatment of endogenous Cushing’s syndrome in adults. |
| Assessment Process | |
| Rapid review commissioned | 21/04/2022 |
| Rapid review completed | 17/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osilodrostat compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Latest NCPE Advice
Osimertinib (Tagrisso®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | 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 | |
| Rapid review commissioned | 26/02/2016 |
| Rapid review completed | 22/03/2016 |
| Rapid review outcome | Reimbursement not recommended at this point in time |
| Updated clinical evidence submitted by the Applicant | 21/12/2016 |
| Rapid Review completed | 10/01/2017 |
| Rapid Review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 30/01/2017 |
| Pre-submission consultation with Applicant | 20/03/2017 |
| Full submission received from Applicant | 02/06/2017 |
| Preliminary review sent to Applicant | 28/07/2017 |
| NCPE assessment re-commenced | 24/11/2017 |
| Factual accuracy sent to Applicant | 21/12/2017 |
| NCPE assessment re-commenced | 16/01/2018 |
| NCPE assessment completed | 16/01/2018 |
| NCPE assessment outcome | An updated submission incorporating new clinical evidence, a new cost-effectiveness model and budget impact model was submitted by the applicant at the end of the NCPE assessment process, during the factual accuracy check of the NCPE’s final report. This submission will be considered following a re-commissioning of the full pharmacoeconomic assessment by the HSE. |
| Full pharmacoeconomic assessment re-commissioned by HSE | 18/01/2018 |
| NCPE assessment commenced | 19/01/2018 |
| Preliminary review sent to Applicant | 23/02/2018 |
| NCPE assessment re-commenced | 06/03/2018 |
| Factual accuracy sent to Applicant | 06/04/2018 |
| NCPE assessment re-commenced | 13/04/2018 |
| NCPE assessment completed | 03/05/2018 |
| NCPE assessment outcome | The NCPE recommends that osimertinib (Tagrisso®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations; July 2020.
Osimertinib (Tagrisso®) for the first-line treatment of metastatic NSCLC
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | 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 | |
| Rapid review commissioned | 19/07/2018 |
| Rapid review completed | 07/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of osimertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/08/2018 |
| Pre-submission consultation with Applicant | 08/10/2018 |
| Full submission received from Applicant | 21/01/2019 |
| Preliminary review sent to Applicant | 13/05/2019 |
| NCPE assessment re-commenced | 28/05/2019 |
| Factual accuracy sent to Applicant | 19/07/2019 |
| NCPE assessment re-commenced | 30/07/2019 |
| NCPE assessment completed | 06/08/2019 |
| NCPE assessment outcome | The NCPE recommends that osimertinib not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations; October 2020
Oxycodone/naloxone (Targin®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Oxycodone/naloxone |
| Brand | Targin® |
| Indication | For severe pain, which can be adequately managed only with opioid analgesics. |
| Assessment Process | |
| Full pharmacoeconomic assessment commissioned by HSE | 05/05/2010 |
| NCPE assessment completed | 12/07/2010 |
13/07/2010
We do not recommend reimbursement of oxycodone/naloxone (Targin®) under the Community Drugs Schemes at the proposed price.
19/10/2010
Following a price revision oxycodone/naloxone (Targin®) is now reimbursed under the Community Drugs Schemes.
Ozanimod (Zeposia®) for Ulcerative Colitis. HTA ID: 22002
| Assessment Status | Rapid Review Complete |
| HTA ID | 22002 |
| Drug | Ozanimod |
| Brand | Zeposia® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 10/01/2022 |
| Rapid review completed | 01/02/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ozanimod compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
The HSE has approved reimbursement following confidential price negotiations, December 2022.
Ozanimod (Zeposia®). HTA ID: 20045
| Assessment Status | Rapid Review Complete |
| HTA ID | 20045 |
| Drug | Ozanimod |
| Brand | Zeposia® |
| Indication | For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. |
| Assessment Process | |
| Rapid review commissioned | 06/10/2020 |
| Rapid review completed | 23/11/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ozanimod compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
The HSE has approved reimbursement following confidential price negotiations August 2021
Ozenoxacin (Dubine®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Ozenoxacin |
| Brand | Dubine® |
| Indication | For the short term treatment of non-bullous impetigo in adults, adolescents, children, and infants aged 6 months and older. |
| Assessment Process | |
| Rapid review commissioned | 12/11/2018 |
| Rapid review completed | 13/12/2018 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that ozenoxacin cream not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
Palbociclib (Ibrance®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Palbociclib |
| Brand | Ibrance® |
| Indication | For the treatment of women with metastatic hormone receptor-positive, HER2-negative breast cancer. |
| Assessment Process | |
| Rapid review commissioned | 20/09/2016 |
| Rapid review completed | 28/09/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 10/10/2016 |
| Pre-submission consultation with Applicant | 11/11/2016 |
| Full submission received from Applicant | 20/12/2016 |
| Preliminary review sent to Applicant | 24/05/2017 |
| NCPE assessment re-commenced | 30/05/2017 |
| Follow-up to preliminary review sent to Applicant | 13/06/2017 |
| NCPE assessment re-commenced | 15/06/2017 |
| Additional follow-up to Preliminary Review sent to Applicant | 16/06/2017 |
| NCPE assessment re-commenced | 21/06/2017 |
| Factual accuracy sent to Applicant | 04/07/2017 |
| NCPE assessment completed | 28/07/2017 |
| NCPE assessment outcome | Reimbursement not recommended. |
The HSE has approved reimbursement following confidential price negotiations; June 2018.
Paliperidone palmitate (Xeplion®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Paliperidone palmitate |
| Brand | Xeplion® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 23/03/2011 |
| Rapid review completed | 09/04/2011 |
Panobinostat (Farydak®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Panobinostat |
| Brand | Farydak® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 26/01/2016 |
| Rapid review completed | 09/02/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
Not considered cost-effective due to non-submission of full pharmacoeonomic evaluation
Paritaprevir boosted with ritonavir and ombitasvir (Vierkirax®) with or without dasabuvir (Exviera®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Paritaprevir boosted with ritonavir and ombitasvir with or without dasabuvir |
| Brand | (Vierkirax®)/(Exviera®) |
| Indication | 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 | |
| Rapid review commissioned | 21/12/2014 |
| Rapid review completed | 13/01/2015 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 15/01/2015 |
| NCPE assessment completed | 10/02/2016 |
| NCPE assessment outcome | Reimbursement recommended in certain sub-populations of patients with genotype 1 & 4 |
Pasireotide (Signifor®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pasireotide |
| Brand | Signifor® |
| Indication | For the treatment of adult patients with Cushing’s Disease for whom surgery is not an option or for whom surgery has failed |
| Assessment Process | |
| Rapid review commissioned | 29/03/2012 |
| Rapid review completed | 10/04/2012 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.
Patisiran (Onpattro®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Patisiran |
| Brand | Onpattro® |
| Indication | For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. |
| Assessment Process | |
| Rapid review commissioned | 07/12/2018 |
| Rapid review completed | 03/01/2019 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 09/01/2019 |
| Pre-submission consultation with Applicant | 26/02/2019 |
| Full submission received from Applicant | 28/06/2019 |
| Preliminary review sent to Applicant | 18/10/2019 |
| NCPE assessment re-commenced | 15/11/2019 |
| Follow-up to preliminary review sent to Applicant | 22/11/2019 |
| NCPE assessment re-commenced | 06/12/2019 |
| Factual accuracy sent to applicant | 31/01/2020 |
| NCPE assessment re-commenced | 13/02/2020 |
| Factual Accuracy #2 sent to Applicant | 18/02/2020 |
| NCPE assessment re-commenced | 19/02/2020 |
| NCPE assessment completed | 20/02/2020 |
| NCPE assessment outcome | The NCPE recommends that patisiran (Onpattro®) is not considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations October 2021
Pegaspargase (Oncaspar®) powder for solution for injection/infusion. HTA ID: 20003
| Assessment Status | Rapid Review Complete |
| HTA ID | 20003 |
| Drug | Pegaspargase |
| Brand | Oncaspar® |
| Indication | As a component of antineoplastic combination therapy in acute lymphoblastic leukaemia in paediatric patients from birth to 18 years. |
| Assessment Process | |
| Rapid review commissioned | 05/02/2020 |
| Rapid review completed | 13/03/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that pegaspargase (Oncaspar®) be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
The HSE has approved reimbursement, March 2020
Pegcetacoplan (Aspaveli®). HTA ID: 21064
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21064 |
| Drug | Pegcetacoplan |
| Brand | Aspaveli® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 13/12/2021 |
| Rapid review completed | 26/01/2022 |
| Rapid review outcome | Rapid Review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegcetacoplan compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
| Full pharmacoeconomic assessment commissioned by HSE | 23/02/2022 |
| Pre-submission consultation with Applicant | 17/10/2022 |
| Full submission received from Applicant | 26/05/2023 |
| Preliminary review sent to Applicant | 05/12/2023 |
| NCPE assessment re-commenced | 16/01/2024 |
| Follow-up to preliminary review sent to Applicant | 02/02/2024 |
| NCPE assessment re-commenced | 09/02/2024 |
| Factual accuracy sent to Applicant | 08/03/2024 |
| NCPE assessment re-commenced | 19/03/2024 |
| NCPE assessment completed | 24/04/2024 |
| NCPE assessment outcome | The NCPE recommends that pegcetacoplan not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Pegvaliase (Palynziq®) HTA ID: 21057
For further details of previous submission see: Pegvaliase (Palynziq®) HTA ID: 20001
| Assessment Status | Assessment process complete |
| HTA ID | 21057 |
| Drug | Pegvaliase |
| Brand | Palynziq® |
| Indication | 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 | |
| Full submission received from Applicant | 18/11/2021 |
| Preliminary review sent to Applicant | 21/03/2022 |
| NCPE assessment re-commenced | 22/04/2022 |
| Follow-up to preliminary review sent to Applicant | 02/06/2022 |
| NCPE assessment re-commenced | 24/06/2022 |
| Factual accuracy sent to Applicant | 08/08/2022 |
| NCPE assessment re-commenced | 16/08/2022 |
| NCPE assessment completed | 29/09/2022 |
| NCPE assessment outcome | The NCPE recommends that pegvalisae (Palynziq®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Pegylated Interferon beta-1a (Plegridy®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pegylated Interferon beta-1a |
| Brand | Plegridy® |
| Indication | Treatment of adult patients with relapsing remitting multiple sclerosis |
| Assessment Process | |
| Rapid review commissioned | 25/11/2014 |
| Rapid review completed | 22/12/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Pegylated Liposomal irinotecan (Onivyde). HTA ID: 24030
| Assessment Status | Rapid Review Complete |
| HTA ID | 24030 |
| Drug | Pegylated Liposomal irinotecan |
| Brand | Onivyde® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 24/07/2024 |
| Rapid review completed | 22/08/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegylated liposomal irinotecan compared with the current standard of care. |
Pegylated liposomal irinotecan (Onivyde®). HTA ID: 20028
| Assessment Status | Assessment process complete |
| HTA ID | 20028 |
| Drug | Pegylated liposomal irinotecan |
| Brand | Onivyde® |
| Indication | 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 | |
| Rapid review commissioned | 13/06/2017 |
| Rapid review completed | 13/07/2017 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended.
The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven. |
| Rapid review re-commissioned | 15/06/2020 |
| Rapid review completed | 14/07/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegylated liposomal irinotecan compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 14/07/2020 |
| Pre-submission consultation with Applicant | 07/09/2020 |
| Full submission received from Applicant | 04/03/2021 |
| Preliminary review sent to Applicant | 02/09/2021 |
| NCPE assessment re-commenced | 04/10/2021 |
| Factual accuracy sent to applicant | 20/10/2021 |
| NCPE assessment re-commenced | 29/10/2021 |
| NCPE assessment completed | 12/11/2021 |
| NCPE assessment outcome | The NCPE recommends that peg-IRI + 5FU + LV not be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.
Pembrolizumab (Keytruda ®) for Urothelial Carcinoma 1L
| ssessment Status | Rapid Review Complete |
| HTA ID | – |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | For the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 06/12/2017 |
| Rapid review completed | 21/12/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Following an amendment of the product licence by the EMA, a new rapid review was commissioned by the HSE. | |
| Rapid review commissioned | 21/06/2018 |
| Rapid review received | 10/07/2018 |
| Rapid review completed | 27/07/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies |
The HSE has approved reimbursement following confidential price negotiations – February 2021.
Pembrolizumab (Keytruda®) 1L NSCLC with chemotherapy
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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 | |
| Rapid review commissioned | 14/08/2018 |
| Rapid review completed | 29/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 14/09/2018 |
| Pre-submission consultation with Applicant | 22/10/2018 |
| Full submission received from Applicant | 20/12/2018 |
| Preliminary review sent to Applicant | 14/06/2019 |
| NCPE assessment re-commenced | 10/07/2019 |
| Factual accuracy sent to Applicant | 31/07/2019 |
| NCPE assessment re-commenced | 09/08/2019 |
| NCPE assessment completed | 15/08/2019 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®), prescribed in combination with platinum chemotherapy plus pemetrexed for the first line treatment of non-squamous NSCLC, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medial Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations – February 2021.
Pembrolizumab (Keytruda®) 1L squamous NSCLC with chemotherapy
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 25/02/2019 |
| Rapid review completed | 25/03/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with carboplatin and either paclitaxel or nab-P compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
The HSE has approved reimbursement following confidential price negotiations – February 2021.
Pembrolizumab (Keytruda®) as monotherapy for unresectable or metastatic gastric, small intestine, or biliary cancer (2L+).
| Assessment Status | Rapid Review Complete |
| HTA ID | 23058 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 20/09/2023 |
| Rapid review completed | 25/10/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
Pembrolizumab (Keytruda®) for Classical Hodgkin Lymphoma
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 06/12/2017 |
| Rapid review completed | 21/12/2017 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations – November 2018.
Pembrolizumab (Keytruda®) for colorectal cancer. HTA ID: 21002
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21002 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 08/02/2021 |
| Rapid review completed | 03/03/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 24/03/2021 |
| Pre-submission consultation with Applicant | 21/04/2021 |
| Full submission received from Applicant | 21/01/2022 |
| Preliminary review sent to Applicant | 10/06/2022 |
| NCPE assessment re-commenced | 08/07/2022 |
| Factual accuracy sent to Applicant | 07/09/2022 |
| NCPE assessment re-commenced | 19/09/2022 |
| NCPE assessment completed | 13/10/2022 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab be considered for reimbursement if cost effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013
The HSE has approved reimbursement following confidential price negotiations April 2023.
Pembrolizumab (Keytruda®) for persistent, recurrent or metastatic cervical cancer. HTA ID: 22041
| Assessment Status | Rapid Review Complete |
| HTA ID | 22041 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 16/06/2022 |
| Rapid review completed | 06/07/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard-of-care. |
The company has not submitted a HTA dossier to the NCPE, therefore the cost effectiveness of the technology could not be proven.
Pembrolizumab (Keytruda®) for Urothelial Carcinoma 2L
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 06/12/2017 |
| Rapid review completed | 21/12/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 04/02/2018 |
| Pre-submission consultation with Applicant | 12/02/2018 |
| Full submission received from Applicant | 03/10/2018 |
| Preliminary review sent to Applicant | 05/12/2018 |
| NCPE assessment re-commenced | 18/01/2019 |
| Factual accuracy sent to Applicant | 06/03/2019 |
| NCPE assessment re-commenced | 20/03/2019 |
| NCPE assessment completed | 25/03/2019 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®) be considered for reimbursement for this indication if cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations – February 2021.
Pembrolizumab (Keytruda®) in combination with lenvatinib (Lenvima®) for endometrial carcinoma. HTA ID: 22006
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22006 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 07/02/2022 |
| Rapid review completed | 04/03/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with lenvatinib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/04/2022 |
| Pre-submission consultation with Applicant | 09/05/2022 |
| Full submission received from Applicant | 21/02/2023 |
| Preliminary review sent to Applicant | 03/08/2023 |
| NCPE assessment re-commenced | 05/09/2023 |
| Follow-up to preliminary review sent to Applicant | 19/09/2023 |
| NCPE assessment re-commenced | 06/11/2023 |
| Factual accuracy sent to Applicant | 01/12/2023 |
| NCPE assessment re-commenced | 11/12/2023 |
| NCPE assessment completed | 18/12/2023 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab, in combination with lenvatinib, not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Pembrolizumab (Keytruda®). HTA ID: 23056
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23056 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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. |
| Assessment Process | |
| Rapid review commissioned | 07/09/2023 |
| Rapid review completed | 03/10/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/11/2023 |
| Pre-submission consultation with Applicant | 05/12/2023 |
| Full submission received from Applicant | 02/05/2024 |
| Preliminary review sent to Applicant | 19/12/2024 |
| NCPE assessment re-commenced | 31/01/2025 |
| Factual accuracy sent to Applicant | 15/04/2025 |
| NCPE assessment re-commenced | 23/04/2025 |
| NCPE assessment completed | 12/05/2025 |
| NCPE assessment outcome | The NCPE recommends that Pembrolizumab (Keytruda®) not be considered for reimbursement, for this indication, unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013
Pembrolizumab (Keytruda®). HTA ID: 23070
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23070 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | 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 |
| Assessment Process | |
| Rapid review commissioned | 21/11/2023 |
| Rapid review completed | 18/12/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 09/01/2024 |
| Pre-submission consultation with Applicant | 30/01/2024 |
| Full submission received from Applicant | 01/08/2024 |
| Preliminary review sent to Applicant | 09/05/2025 |
| NCPE assessment re-commenced | 06/06/2025 |
| Follow-up to preliminary review sent to Applicant | 01/07/2025 |
| NCPE assessment re-commenced | 10/07/2025 |
| Additional follow-up to Preliminary Review sent to Applicant | 24/07/2025 |
| NCPE assessment re-commenced | 25/07/2025 |
| Factual accuracy sent to Applicant | 01/08/2025 |
| NCPE assessment re-commenced | 12/08/2025 |
| NCPE assessment completed | 25/08/2025 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab, in combination with fluoropyrimidine and platinum-containing chemotherapy, not be considered for reimbursement, for this indication unless cost effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Polihexanide (Akantior®). HTA ID: 25045
| Assessment Status | Rapid Review Complete |
| HTA ID | 25045 |
| Drug | Polihexanide |
| Brand | Akantior® |
| Indication | Polihexanide (Akantior®) for the treatment of Acanthamoeba Keratitis in adults and children from 12 years of age. |
| Assessment Process | |
| Rapid review commissioned | 10/07/2025 |
| Rapid review completed | 14/08/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that polihexanide (Akantior®) not be considered for reimbursement at the submitted price*. |
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Ravulizumab (Ultomiris®). HTA ID: 19054
| Assessment Status | Assessment Process Complete |
| HTA ID | 19054 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | 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 | |
| Rapid review commissioned | 04/12/2019 |
| Rapid review completed | 02/03/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
| Full pharmacoeconomic assessment commissioned by HSE | 04/03/2020 |
| Pre-submission consultation with Applicant | 28/06/2021 |
| Full submission received from Applicant | 05/11/2021 |
| Preliminary review sent to Applicant | 28/02/2022 |
| NCPE assessment re-commenced | 25/03/2022 |
| Factual accuracy sent to Applicant | 29/04/2022 |
| NCPE assessment re-commenced | 10/05/2022 |
| NCPE assessment completed | 30/05/2022 |
| NCPE assessment outcome | The NCPE recommends that ravulizumab (Ultomiris®), for the treatment of adult patients with PNH, be considered for reimbursement provided certain conditions are met*. These are that the cost of ravulizumab should not exceed any eculizumab products currently available or anticipated to be available in the near future. A price premium over eculizumab is not justified given that both treatments appear to have similar efficacy. In addition, ravulizumab did not demonstrate an improvement in treatment-related burden compared with eculizumab in clinical trials. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Ravulizumab (Ultomiris®). HTA ID: 20036
| Assessment Status | Assessment Process Complete |
| HTA ID | 20036 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | 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 | |
| Rapid review commissioned | 24/07/2020 |
| Rapid review completed | 21/08/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab (Ultomiris®) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/08/2020 |
| Pre-submission consultation with Applicant | 28/06/2021 |
| Full submission received from Applicant | 05/11/2021 |
| Preliminary review sent to Applicant | 24/03/2022 |
| NCPE assessment re-commenced | 21/04/2022 |
| Follow-up to preliminary review sent to Applicant | 29/04/2022 |
| NCPE assessment re-commenced | 05/05/2022 |
| Additional follow-up to Preliminary Review sent to Applicant | 25/05/2022 |
| NCPE assessment re-commenced | 16/06/2022 |
| Factual accuracy sent to Applicant | 08/07/2022 |
| NCPE assessment re-commenced | 15/07/2022 |
| NCPE assessment completed | 28/07/2022 |
| NCPE assessment outcome | The NCPE recommends that ravulizumab not be considered for reimbursement unless cost effectiveness can be improved relative to comparator treatments*. This recommendation should consider the imminent introduction of eculizumab biosimilars. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Ravulizumab (Ultomiris®). HTA ID: 25012
| Assessment Status | Rapid Review Complete |
| HTA ID | 25012 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | Ravulizumab (Ultomiris®) is indicated as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive. |
| Assessment Process | |
| Rapid review commissioned | 17/02/2025 |
| Rapid review completed | 12/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab compared with the current standard of care. |
Ravulizumab (Ultomiris®). HTA ID: 25013
| Assessment Status | Rapid Review Complete |
| HTA ID | 25013 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | Ravulizumab (Ultomiris®) is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin 4 antibody positive. |
| Assessment Process | |
| Rapid review commissioned | 17/02/2025 |
| Rapid review completed | 14/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab compared with the current standard of care. |
Ribociclib (Kisqali®). HTA ID: 24045
| Assessment Status | Rapid Review Complete |
| HTA ID | 24045 |
| Drug | Ribociclib |
| Brand | Kisqali® |
| Indication | Ribociclib in combination with an aromatase inhibitor (AI) is indicated for the adjuvant treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. |
| Assessment Process | |
| Rapid review commissioned | 13/11/2024 |
| Rapid review completed | 19/12/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that ribociclib not be considered for reimbursement at the submitted price*. |
* This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Ropeginterferon alfa-2b (Besremi®). HTA ID: 23004
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23004 |
| Drug | Ropeginterferon alfa-2b |
| Brand | Besremi® |
| Indication | Ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. |
| Assessment Process | |
| Rapid review commissioned | 20/01/2023 |
| Rapid review completed | 15/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ropeginterferon alfa-2b compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/03/2023 |
| Pre-submission consultation with Applicant | 03/05/2023 |
| Full submission received from Applicant | 20/07/2023 |
| Preliminary review sent to Applicant | 27/11/2023 |
| NCPE assessment re-commenced | 03/01/2024 |
| Factual accuracy sent to Applicant | 26/06/2024 |
| NCPE assessment re-commenced | 15/07/2024 |
| NCPE assessment completed | 15/08/2024 |
| NCPE assessment outcome | The NCPE recommends that ropeginterferon alfa-2b (Besremi®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Rucaparib (Rubraca®). HTA ID: 25011
| Assessment Status | Rapid Review Complete |
| HTA ID | 25011 |
| Drug | Rucaparib |
| Brand | Rubraca® |
| Indication | Rucaparib (Rubraca®) is indicated as monotherapy 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. |
| Assessment Process | |
| Rapid review commissioned | 17/02/2025 |
| Rapid review completed | 24/03/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that rucaparib not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
Ruxolitinib (Opzelura®). HTA ID: 25004
| Assessment Status | Rapid Review Complete |
| HTA ID | 25004 |
| Drug | Ruxolitinib |
| Brand | Opzelura® |
| Indication | Ruxolitinib (Opzelura®) is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. |
| Assessment Process | |
| Rapid review commissioned | 09/01/2025 |
| Rapid review completed | 17/02/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ruxolitinib cream for this indication compared with the current standard of care. |
Sacituzumab govitecan (Trodelvy®). HTA ID: 23079
| Assessment Status | Rapid Review Complete |
| HTA ID | 23079 |
| Drug | Sacituzumab govitecan |
| Brand | Trodelvy® |
| Indication | Sacituzumab govitecan is indicated for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. |
| Assessment Process | |
| Rapid review commissioned | 21/12/2023 |
| Rapid review completed | 26/01/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sacituzumab govitecan compared with the current standard of care. |
Sacubitril/valsartan (Entresto®)
| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Sacubitril/valsartan |
| Brand | Entresto® |
| Indication | For the treatment of symptomatic chronic heart failure with reduced ejection fraction if adult patients. |
| Assessment Process | |
| Rapid review commissioned | 06/11/2015 |
| Rapid review completed | 30/11/2015 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full submission received from Applicant | 07/03/2016 |
| NCPE assessment completed | 08/07/2016 |
| NCPE assessment outcome | Reimbursement Recommended |
The NCPE considers valsartan/sacubitril (Entresto) cost-effective for the current licensed indication and recommends reimbursement.
The HSE has approved reimbursement following confidential price negotiations October 2017.
Selpercatinib (Retsevmo®) for advanced RET fusion-positive thyroid cancer. HTA ID: 25034b
| Assessment Status | Rapid Review Complete |
| HTA ID | 25034b |
| Drug | Selpercatinib |
| Brand | Retsevmo® |
| Indication | Selpercatinib (Retsevmo®) is indicated in adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate). |
| Assessment Process | |
| Rapid review commissioned | 15/05/2025 |
| Rapid review completed | 01/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selpercatinib compared with the current standard of care. |
Selpercatinib (Retsevmo®) for advanced RET-mutant medullary thyroid cancer. HTA ID: 25034a
| Assessment Status | Rapid Review Complete |
| HTA ID | 25034a |
| Drug | Selpercatinib |
| Brand | Retsevmo® |
| Indication | Selpercatinib (Retsevmo®) Is indicated in adults and adolescents 12 years and older with advanced rearranged during transfection (RET)-mutant medullary thyroid cancer. |
| Assessment Process | |
| Rapid review commissioned | 15/05/2025 |
| Rapid review completed | 01/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selpercatinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this recommendation may be found here.
Selumetinib (Koselugo®). HTA ID: 22032
| Assessment Status | NCPE assessment process complete |
| HTA ID | 22032 |
| Drug | Selumetinib |
| Brand | Koselugo® |
| Indication | For the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above. |
| Assessment Process | |
| Rapid review commissioned | 10/05/2022 |
| Rapid review completed | 25/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selumetinib (Koselugo®) compared with the current standard-of-care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/07/2022 |
| Pre-submission consultation with Applicant | 20/09/2022 |
| Full submission received from Applicant | 29/01/2024 |
*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.
Resubmission of HTA
| Assessment Process | NCPE assessment process complete |
| Full submission received from Applicant | 29/01/2024 |
| Preliminary review sent to Applicant | 15/08/2024 |
| NCPE assessment re-commenced | 17/10/2024 |
| Factual accuracy sent to Applicant | 06/11/2024 |
| NCPE assessment re-commenced | 14/11/2024 |
| NCPE assessment completed | 13/12/2024 |
| NCPE assessment outcome | The NCPE recommends that selumetinib (Koselugo®) not be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Semaglutide 2.4 mg (Wegovy®) in adolescent patients. HTA ID: 25025
| Assessment Status | Rapid Review Complete |
| HTA ID | 25025 |
| Drug | Semaglutide |
| Brand | Wegovy® |
| Indication | Semaglutide 2.4 mg (Wegovy®) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with: ∙ obesity (Body Mass Index (BMI) ≥ 95th percentile as defined on sex and age-specific BMI growth charts) and ∙ body weight above 60 kg^ |
| Assessment Process | |
| Rapid review commissioned | 21/03/2025 |
| Rapid review completed | 01/05/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that semaglutide not be considered for reimbursement at the submitted price*. |
^ The applicant is seeking reimbursement in a subpopulation of the licensed adolescent population, specifically:
- adolescent patients between the ages 12 and 17 years (inclusive) with a body weight above 60kg,
- with a BMI > 99.6th percentile,
- and two or more of the comorbidities as defined by Children’s Health Ireland (CHI) complex obesity referral form criteria.
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
Serplulimab (Hetronifly®). HTA ID: 25021
| Assessment Status | Rapid Review Complete |
| HTA ID | 25021 |
| Drug | Serplulimab |
| Brand | Hetronifly® |
| Indication | Serplulimab (Hetronifly®) in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). |
| Assessment Process | |
| Rapid review commissioned | 10/03/2025 |
| Rapid review completed | 15/04/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that serplulimab not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
Somapacitan (Sogroya®). HTA ID: 23060
| Assessment Status | Rapid Review Complete |
| HTA ID | 23060 |
| Drug | Somapacitan |
| Brand | Sogroya® |
| Indication | Somapacitan (Sogroya®) is indicated for the replacement of endogenous growth hormone in children aged three years and above and adolescents with growth failure due to growth hormone deficiency (GHD), and in adults with GHD. |
| Assessment Process | |
| Rapid review commissioned | 25/09/2023 |
| Rapid review completed | 27/11/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that somapacitan not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Sufentanil Citrate (Dzuveo®) HTA ID: 23062
| Assessment Status | Rapid Review Complete |
| Drug | Sufentanil Citrate |
| Brand | Dzuveo® |
| Indication | For the management of acute moderate to severe pain in adult patients |
| Assessment Process | |
| Rapid review commissioned | 02/10/2023 |
| Rapid review resubmission required | 04/12/2023 |
| Rapid review completed | 22/12/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that sufentanil citrate not be considered for reimbursement at the submitted price*. |
*This recommendation should be considered while also having regard to the criteria specified in
the Health (Pricing and Supply of Medical Goods) Act 2013.
Sulthiame (Ospolot®) oral suspension. HTA ID: 25030
| Assessment Status | Rapid Review Complete |
| HTA ID | 25030 |
| Drug | Sulthaime |
| Brand | Ospolot® |
| Indication | Sulthiame (Ospolot®) oral suspension is indicated for the treatment of Self-Limited Epilepsy with Centrotemporal Spikes (SeLECTS) (former Rolandic epilepsy) in children and adolescents aged three years and above who are non-respondent/intolerant to other treatments or without other therapeutic alternatives. |
| Assessment Process | |
| Rapid review commissioned | 11/04/2025 |
| Rapid review completed | 27/05/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that sulthiame (Ospolot®) oral suspension not be considered for reimbursement at the submitted price. |
This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
Tadalafil (Adcirca®)
| Assessment Status | Rapid Review Complete |
| HTA ID | – |
| Drug | Tadalafil |
| Brand | Adcirca® |
| Indication | In adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organisation (WHO) Functional Class (FC) II and III, to improve exercise capacity. |
| Assessment Process | |
| Rapid review commissioned | 13/07/2011 |
| Rapid review completed | 21/09/2011 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
| May 2014 | In accordance with the Health Act (Pricing and Supply of Medical Goods) 2013 (section 18(4)), the HSE has requested the NCPE to re-examine the cost effectiveness of Tadalafil (Adcirca®). |
| Rapid review commissioned | 09/05/2014 |
| Rapid review completed | 23/05/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |