| Assessment Status | Rapid Review Complete |
| HTA ID | 23024 |
| Drug | Isatuximab |
| Brand | Sarclisa® |
| Indication | Isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone, is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| Assessment Process | |
| Rapid review commissioned | 09/05/2023 |
| Rapid review completed | 25/05/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of isatuximab in combination with carfilzomib and dexamethasone compared with the current standard of care. |
Latest NCPE Advice
Isavuconazole (Cresemba®) for the treatment of invasive aspergillosis.
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Isavuconazole |
| Brand | Cresemba® |
| Indication | For the treatment of invasive aspergillosis |
| Assessment Process | |
| Rapid review commissioned | 11/04/2016 |
| Rapid review completed | 11/05/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended at the submitted price |
The HSE has approved reimbursement following confidential price negotiations: April 2018.
Isavuconazole (Cresemba®) for the treatment of mucormycosis
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Isavuconazole |
| Brand | Cresemba® |
| Indication | For the treatment of mucormycosis in adult patients for whom amphotericin B is inappropriate. |
| Assessment Process | |
| Rapid review commissioned | 11/04/2016 |
| Rapid review completed | 11/05/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
The HSE has approved reimbursement following confidential price negotiations: April 2018.
Isavuconazole (Cresemba®). HTA ID: 25016
| Assessment Status | Rapid Review Complete |
| HTA ID | 25016 |
| Drug | Isavuconazole |
| Brand | Cresemba® |
| Indication | Isavuconazole (Cresemba®is indicated for patients from one year of age to < 18 years for the treatment of invasive aspergillosis, and mucormycosis in patients for whom amphotericin B is inappropriate. |
| Assessment Process | |
| Rapid review commissioned | 26/02/2025 |
| Rapid review completed | 25/03/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that isavuconazole 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.
Itopride Hydrochloride (Progit®) 23031
| Assessment Status | Rapid Review Complete |
| HTA ID | 23031 |
| Drug | Itopride Hydrochloride |
| Brand | Progit® |
| Indication | Treatment of gastrointestinal symptoms of functional dyspepsia caused by reduced gastrointestinal motility. |
| Assessment Process | |
| Rapid review commissioned | 06/06/2023 |
| Rapid review completed | 07/07/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that itopride 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.
IUB™ Ballerine® MIDI 15mm diameter SCU300B. HTA ID: 20027
| Assessment Status | Rapid Review Complete |
| HTA ID | 20027 |
| Drug | IUB™ Ballerine® |
| Brand | IUB™ Ballerine® MIDI 15mm diameter SCU300B |
| Indication | For intrauterine contraception for up to five years. |
| Assessment Process | |
| Rapid review commissioned | 15/06/2020 |
| Rapid review completed | 29/07/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that IUB™ Ballerine® SCU300B 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.
IUB™ Ballerine® MIDI 15mm diameter SCU300B. HTA ID: 20062
| Assessment Status | Rapid Review Complete |
| HTA ID | 20062 |
| Drug | IUB™ Ballerine® |
| Brand | IUB™ Ballerine® MIDI 15mm diameter SCU300B |
| Indication | For intrauterine contraception for up to five years. |
| Assessment Process | |
| Rapid review commissioned | 21/12/2020 |
| Rapid review completed | 17/02/2021 |
| Rapid review outcome | Following resubmission of a rapid review, a full HTA is not recommended. The NCPE recommends that IUB™ Ballerine® SCU300B 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.
The HSE has approved reimbursement. August 2021.
Ivacaftor (Kalydeco®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Ivacaftor |
| Brand | Kalydeco® |
| Indication | For the treatment of cystic fibrosis in patients age 6 years and older who have the G551D mutation |
| Assessment Process | |
| Rapid review commissioned | 13/08/2012 |
| Rapid review completed | 22/08/2012 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 24/10/2012 |
| NCPE assessment completed | 21/01/2013 |
| NCPE assessment outcome | Reimbursement not recommended at the submitted price |
21 January 2013
In view of the very high acquisition cost (€234,804 per patient per annum), the significant budget impact (approximately €28 million per annum) and the inability of the manufacturer to demonstrate cost-effectiveness the NCPE cannot recommend reimbursement of ivacaftor at the submitted price.
01 February 2013
The NCPE recommendation led to follow-up discussions between the HSE Corporate Pharmaceutical Unit and the company, Vertex Pharmaceuticals. Following these discussions a positive recommendation was made by the HSE Drugs Group, supporting the provision of ivacaftor (Kalydeco®) for Irish CF patients, whilst at the same time significantly reducing the budget impact of the drug.
Ivacaftor (Kalydeco®) for patients with CF 2 years +
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Ivacaftor |
| Brand | Kalydeco® |
| Indication | For the treatment of children with CF aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. |
| Assessment Process | |
| Rapid review commissioned | 19/11/2015 |
| Rapid review completed | 18/12/2015 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 18/03/2016 |
| NCPE assessment completed | 12/10/2016 |
| NCPE assessment outcome | Reimbursement not recommended at the submitted price |
The HSE has approved reimbursement following confidential price negotiations.
Ivacaftor (Kalydeco®) for the treatment of CF patients with the R117H mutation.
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Ivacaftor |
| Brand | Kalydeco® |
| Indication | For the treatment of patients with cystic fibrosis aged 18 years and older who have the R117H mutation in the CFTR gene. |
| Assessment Process | |
| Rapid review commissioned | 14/01/2016 |
| Rapid review completed | 10/02/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 15/04/2016 |
| NCPE assessment completed | 05/01/2017 |
| NCPE assessment outcome | Reimbursement not recommended at the submitted price |
The HSE has approved reimbursement following confidential price negotiations.
Ivosidenib (Tibsovo®) monotherapy. HTA ID: 23016
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23016 |
| Drug | Ivosidenib |
| Brand | Tibsovo® |
| Indication | For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R 132 mutation who were previously treated by at least one prior line of systemic therapy |
| Assessment Process | |
| Rapid review commissioned | 08/03/2023 |
| Rapid review completed | 17/04/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ivosidenib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/06/2023 |
| Pre-submission consultation with Applicant | 05/09/2023 |
| Full submission received from Applicant | 16/02/2024 |
| Preliminary review sent to Applicant | 01/11/2024 |
| NCPE assessment re-commenced | 29/11/2024 |
| Follow-up to preliminary review sent to Applicant | 11/12/2024 |
| NCPE assessment re-commenced | 17/12/2024 |
| Factual accuracy sent to Applicant | 12/02/2025 |
| NCPE assessment re-commenced | 21/02/2025 |
| NCPE assessment completed | 07/03/2025 |
| NCPE assessment outcome | The NCPE recommends that ivosidenib 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.
Ixazomib (Ninlaro®)
| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Ixazomib |
| Brand | Ninlaro® |
| Indication | In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| Assessment Process | |
| Rapid Review Commissioned | 23/11/2016 |
| Rapid review completed | 16/01/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 23/01/2017 |
| Pre-submission consultation with Applicant | 06/02/2017 |
| Full submission received from Applicant | 01/06/2017 |
| Preliminary review sent to Applicant | 04/08/2017 |
| NCPE assessment re-commenced | 31/08/2017 |
| Factual accuracy sent to applicant | 20/11/2017 |
| NCPE assessment re-commenced | 04/12/2017 |
| Applicant factual accuracy check | 07/12/2017 |
| NCPE assessment re-commenced | 12/12/2017 |
| NCPE assesment completed | 18/12/2017 |
| NCPE assessment outcome | Reimbursement not recommended. |
The HSE has approved reimbursement following confidential price negotiations – December 2018.
Ixekizumab (Taltz®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Ixekizumab |
| Brand | Taltz® |
| Indication | For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 28/06/2016 |
| Rapid review completed | 26/07/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended at the submitted price |
September 2016
The HSE has approved reimbursement following confidential price negotiations.
Ixekizumab (Taltz®) for psoriatic arthritis
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Ixekizumab |
| Brand | Taltz® |
| Indication | For the treatment of active PsA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies |
| Assessment Process | |
| Rapid review commissioned | 16/10/2018 |
| Rapid review completed | 19/11/2018 |
| Rapid review outcome | Full pharmacoeconomic assessment is not recommended. The NCPE recommends that ixekizumab 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
Ketoconazole (Ketoconazole HRA®). HTA ID: 21046
| Assessment Status | Rapid Review Complete |
| HTA ID | 21046 |
| Drug | Ketoconazole |
| Brand | Ketoconazole HRA® |
| Indication | For the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years. |
| Assessment Process | |
| Rapid review commissioned | 26/10/2021 |
| Rapid review completed | 13/12/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that ketoconazole 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.
The HSE has approved reimbursement following confidential price negotiations, December 2022.
Lacosamide (Vimpat ®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lacosamide |
| Brand | Vimpat® |
| Indication | As monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. The Applicant is seeking reimbursement for an extension to the product license to cover children (≥4 years of age) and adolescents (≤ 15 years of age). |
| Assessment Process | |
| Rapid review commissioned | 11/09/2017 |
| Rapid review completed | 31/10/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended at the submitted price |
Lanadelumab (Takhzyro®)
| Assessment Status | Assessment process complete |
| Drug | Lanadelumab |
| Brand | Takhzyro® |
| Indication | For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. |
| Assessment Process | |
| Rapid review commissioned | 19/03/2019 |
| Rapid review completed | 23/05/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lanadelumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/05/2019 |
| Pre-submission consultation with Applicant | 20/06/2019 |
| Full submission received from Applicant | 04/10/2019 |
| Preliminary review sent to Applicant | 14/02/2020 |
| NCPE assessment re-commenced | 13/03/2020 |
| Factual accuracy sent to Applicant | 22/05/2020 |
| NCPE assessment re-commenced | 03/06/2020 |
| NCPE assessment completed | 26/06/2020 |
| NCPE assessment outcome | The NCPE recommends that lanadelumab 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 September 2021
Lapatinib (Tyverb®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Lapatinib |
| Brand | Tyverb® |
| Indication | For the treatment of women with previously treated advanced or metastatic HER2 positive breast cancer. |
| Assessment Process | |
| Full pharmacoeconomic assessment commissioned by HSE | 03/12/2007 |
| NCPE assessment completed | 28/01/2008 |
| NCPE assessment outcome | Reimbursement recommended. |
Lapatinib could be considered cost-effective in Ireland. However in view of the uncertainty surrounding the ICER, we (NCPE) suggest conditional reimbursement under the High Tech Drugs scheme.
Latanoprost/Timolol (Fixapost®). HTA ID: 21053
| Assessment Status | Rapid Review Complete |
| HTA ID | 21053 |
| Drug | Latanoprost/Timolol |
| Brand | Fixapost® |
| Indication | In adults (including the elderly) for the reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta‐blockers or prostaglandin analogues. |
| Assessment Process | |
| Rapid review commissioned | 16/11/2021 |
| Rapid review completed | 06/12/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Fixapost® 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.
The HSE has approved reimbursement April 2022.
Lebrikizumab (Ebglyss®). HTA ID: 25008
| Assessment Status | Rapid Review Complete |
| HTA ID | 25008 |
| Drug | Lebrikizumab |
| Brand | Ebglyss® |
| Indication | Lebrikizumab (Ebglyss®) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40kg who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 05/02/2025 |
| Rapid review completed | 19/02/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lebrikizumab 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.
Ledipasvir/sofosbuvir (Harvoni®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Ledipasvir/sofosbuvir |
| Brand | Harvoni® |
| Indication | For the treatment of Chronic Hepatitis C (CHC) infection (Genotye 1, 3 and 4) in adults. |
| Assessment Process | |
| Rapid review commissioned | 14/11/2014 |
| Rapid review completed | 18/12/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 18/03/2015 |
| NCPE assessment completed | 20/11/2015 |
| NCPE assessment outcome | Reimbursement Recommended for Genotype 1 and 4. |
Lenacapavir (Sunlenca®). HTA ID: 25047
| Assessment Status | Rapid Review Complete |
| HTA ID | 25047 |
| Drug | Lenacapavir |
| Brand | Sunlenca® |
| Indication | Lenacapavir (Sunlenca®) in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. |
| Assessment Process | |
| Rapid review commissioned | 25/07/2025 |
| Rapid review completed | 08/08/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that lenacapavir (Sunlenca®) 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.
Lenvatinib (Kisplyx®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lenvatinib |
| Brand | Kisplyx® |
| Indication | In combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. |
| Assessment Process | |
| Rapid review commissioned | 05/05/2017 |
| Rapid review completed | 18/05/2017 |
| 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.
Lenvatinib (Kisplyx®). HTA ID: 22057
| Assessment Status | Rapid Review Complete |
| HTA ID | 22057 |
| Drug | Lenvatinib |
| Brand | Kisplyx® |
| Indication | For the treatment of adults with advanced renal cell carcinoma, in combination with pembrolizumab, as first-line treatment |
| Assessment Process | |
| Rapid review commissioned | 15/08/2022 |
| Rapid review completed | 22/09/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lenvatinib in combination with pembrolizumab for first-line treatment of patients with advanced RCC compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Lenvatinib (Lenvima®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lenvatinib |
| Brand | Lenvima® |
| Indication | For the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine. |
| Assessment Process | |
| Rapid review commissioned | 05/05/2015 |
| Rapid review completed | 09/07/2015 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations. January 2016.
Lenvatinib (Lenvima®) for HCC
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lenvatinib |
| Brand | Lenvima® |
| Indication | As monotherapy for the treatment of adult patients with advanced or unresectable HCC who have received no prior systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 07/08/2018 |
| Rapid review completed | 16/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lenvatinib 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 May 2021.
Lesinurad (Zurampic®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Lesinurad |
| Brand | Zurampic® |
| Indication | For the treatment of hyperuricaemia in adult patients with gout who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor. |
| Assessment Process | |
| Rapid review commissioned | 15/03/2017 |
| Rapid review completed | 20/03/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 29/03/2017 |
| Pre-submission consultation with Applicant | 22/05/2017 |
| Full submission received from Applicant | 07/06/2018 |
| Preliminary review sent to Applicant | 18/07/2018 |
| NCPE assessment re-commenced | 15/08/2018 |
| Factual accuracy sent to Applicant | 15/11/2018 |
| NCPE assessment re-commenced | 21/11/2018 |
| NCPE assessment completed | 06/12/2018 |
| NCPE assessment outcome | The NCPE recommends that lesinurad 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.
Letermovir (Prevymis®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Letermovir |
| Brand | Prevymis® |
| Indication | For the prophylaxis of cytomegalovirus (CMV) reactivation or disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). |
| Assessment Process | |
| Rapid review commissioned | 12/03/2018 |
| Rapid review completed | 10/05/2018 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/05/2018 |
| Pre-submission consultation with Applicant | 09/07/2018 |
| Full submission received from Applicant | 02/04/2019 |
| Preliminary review sent to Applicant | 29/08/2019 |
| NCPE assessment re-commenced | 27/09/2019 |
| Follow-up to preliminary review sent to Applicant | 25/11/2019 |
| NCPE assessment re-commenced | 05/12/2019 |
| Factual accuracy sent to Applicant | 24/04/2020 |
| NCPE assessment re-commenced | 01/05/2020 |
| NCPE assessment completed | 19/05/2020 |
| NCPE assessment outcome | The NCPE recommends that letermovir 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 March 2021.
Levodopa (Inbrija®). HTA ID: 25044
| Assessment Status | Rapid Review Complete |
| HTA ID | 25044 |
| Drug | Levodopa |
| Brand | Inbrija® |
| Indication | Levodopa (Inbrija®) is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. |
| Assessment Process | |
| Rapid review commissioned | 04/07/2025 |
| Rapid review completed | 07/08/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that levodopa powder for inhalation (Inbrija®) 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.
Further information on the status of this decision may be found here.
Levodopa 20mg/ml + carbidopa monohydrate 5mg intestinal gel (Duodopa®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Levodopa 20mg/ml + carbidopa monohydrate 5mg intestinal gel |
| Brand | Duodopa® |
| Indication | For the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. A positive test of the clinical response to Duodopa® administered via a temporary nasoduodenal tube is required before a permanent tube is inserted. |
| Assessment Process | |
| Rapid review commissioned | 13/03/2013 |
| Rapid review completed | 16/04/2013 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 25/06/2018 |
| Pre-submission consultation with Applicant | 05/07/2018 |
| Full submission received from Applicant | 10/09/2018 |
| Preliminary review sent to Applicant | 05/12/2018 |
| NCPE assessment re-commenced | 14/01/2019 |
| Follow-up to preliminary review sent to Applicant | 30/01/2019 |
| NCPE assessment re-commenced | 15/02/2019 |
| Factual accuracy sent to Applicant | 19/03/2019 |
| NCPE assessment re-commenced | 02/04/2019 |
| NCPE assessment completed | 14/06/2019 |
| NCPE assessment outcome | The NCPE recommends that levodopa and carbidopa intestinal gel (Duodopa®) 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.
Levodopa/carbidopa/entacapone intestinal gel (Lecigon®). HTA ID: 21068
| Assessment Status | Rapid Review Complete |
| HTA ID | 21068 |
| Drug | Levodopa/carbidopa/entacapone intestinal gel |
| Brand | Lecigon® |
| Indication | For the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson’s medicinal products have not given satisfactory results. |
| Assessment Process | |
| Rapid review commissioned | 20/12/2021 |
| Rapid review completed | 17/02/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that levodopa/carbidopa/entacapone intestinal gel 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.
The HSE has approved reimbursement following confidential price negotiations-November 2022.
Levofloxacin (Quinsair®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Levofloxacin |
| Brand | Quinsair® |
| Indication | For the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with Cystic Fibrosis. |
| Assessment Process | |
| Rapid review commissioned | 10/02/2016 |
| Rapid review completed | 01/03/2016 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations.
Levonorgestrel intrauterine delivery system LNG IUS 12 (Kyleena®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Levonorgestrel intrauterine delivery system LNG IUS 12 |
| Brand | Kyleena® |
| Indication | For contraception for up to 5 years. |
| Assessment Process | |
| Rapid review commissioned | 08/02/2017 |
| Rapid review completed | 16/03/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Levonorgestrel Intrauterine System (Levosert®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Levonorgestrel Intrauterine System |
| Brand | Levosert® |
| Indication | For contraception and for the treatment of heavy menstrual bleeding. |
| Assessment Process | |
| Rapid review commissioned | 28/08/2019 |
| Rapid review completed | 23/10/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that levonorgestrel-IUS (Levosert®) be considered for reimbursement. |
Levonorgestrel intrauterine system LNG-IUS (Jaydess®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Levonorgestrel intrauterine system LNG-IUS |
| Brand | Jaydess® |
| Indication | For contraception for up to three years. |
| Assessment Process | |
| Rapid review commissioned | 07/03/2013 |
| Rapid review completed | 25/03/2013 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Lidocaine 5% plasters (Versatis®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Lidocaine 5% plasters |
| Brand | Versatis® |
| Indication | For the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN). |
| Assessment Process | |
| Rapid review commissioned | 09/09/2010 |
| Rapid review completed | 22/10/2010 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 10/06/2015 |
| NCPE assessment completed | 24/09/2015 |
| NCPE assessment outcome | Reimbursement Not Recommended |
The NCPE concludes that the cost effectiveness of the 5% lidocaine plaster has not been demonstrated.
Linaclotide (Constella®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Linaclotide |
| Brand | Constella® |
| Indication | For the treatment of symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults. |
| Assessment Process | |
| Rapid review commissioned | 28/05/2013 |
| Rapid review completed | 28/06/2013 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Linaclotide (Constella®) is to be reimbursed under the Community Drugs Schemes subject to conditions.
Linagliptin (Trajenta®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Linagliptin |
| Brand | Trajenta® |
| Indication | For treatment of type 2 diabetes mellitus to improve glycaemic control in adults, as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment, as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control, in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. |
| Assessment Process | |
| Rapid review commissioned | 18/08/2011 |
| Rapid review completed | 06/09/2011 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Lipegfilgrastim (Lonquex®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lipegfilgrastim |
| Brand | Lonquex® |
| Indication | For reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). |
| Assessment Process | |
| Rapid review commissioned | 20/08/2013 |
| Rapid review completed | 20/09/2013 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Liposomal daunorubicin and cytarabine |
| Brand | Vyxeos Liposomal® |
| Indication | For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes. |
| Assessment Process | |
| Rapid review commissioned | 28/09/2018 |
| Rapid review completed | 08/11/2018 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 14/11/2018 |
| Pre-submission consultation with Applicant | 15/01/2019 |
| Full submission received from Applicant | 31/05/2019 |
| Preliminary review sent to Applicant | 02/10/2019 |
| NCPE assessment re-commenced | 06/11/2019 |
| Factual accuracy sent to Applicant | 28/02/2020 |
| NCPE assessment re-commenced | 09/03/2020 |
| NCPE assessment completed | 16/04/2020 |
| NCPE assessment outcome | The NCPE recommends that Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®) 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 February 2021.
Liquid Paraffin Ointment (VitA-POS Opthalmic®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Liquid Paraffin Ointment |
| Brand | VitA-POS Opthalmic® |
| Indication | For the treatment of mild to moderate form of dry eye. |
| Assessment Process | |
| Rapid review commissioned | 15/01/2014 |
| Rapid review completed | 27/01/2014 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Liraglutide (Saxenda®) in adolescent patients. HTA ID: 24001
| Assessment Status | Rapid Review Complete |
| HTA ID | 24001 |
| Drug | Liraglutide |
| Brand | Saxenda® |
| Indication | Liraglutide is indicated as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: • obesity (body mass index (BMI) corresponding to ≥30 kg/m2 for adults by international cut-off points) and • body weight above 60 kg* |
| Assessment Process | |
| Rapid review commissioned | 05/01/2024 |
| Rapid review completed | 09/02/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that liraglutide not be considered for reimbursement at the submitted price*. |
*The Applicant is requesting reimbursement in a subgroup of the licensed population, namely:
Adolescent patients between the ages 12 to 16 years with a BMI greater than the 99.5th percentile and two or more of the following co-morbidities:
- Uncontrolled metabolic complications.
- Biomechanical complications requiring treatment or limited mobility.
- Shortness of breath.
- Significant psychosocial complications or concerns.
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Liraglutide (Saxenda®). HTA ID: 19039
| Assessment Status | Assessment process complete |
| HTA ID | 19039 |
| Drug | Liraglutide |
| Brand | Saxenda® |
| Indication | As an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial body mass index (BMI) of ≥30kg/m2 (obese), or ≥27kg/m2 to <30kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. The Applicant is seeking reimbursement in a subgroup of the licensed population, that is, as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with an initial body mass index of ≥35kg/m2 with pre-diabetes and high risk of cardiovascular disease. |
| Assessment Process | |
| Rapid review commissioned | 18/09/2019 |
| Rapid review completed | 24/10/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of liraglutide (Saxenda®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/10/2019 |
| Pre-submission consultation with Applicant | 12/11/2019 |
| Full submission received from Applicant | 08/06/2020 |
| Preliminary review sent to Applicant | 21/08/2020 |
| NCPE assessment re-commenced | 23/10/2020 |
| Follow-up to preliminary review sent to Applicant | 30/11/2020 |
| NCPE assessment re-commenced | 08/12/2020 |
| Factual accuracy sent to Applicant | 15/01/2021 |
| NCPE assessment re-commenced | 22/01/2021 |
| NCPE assessment completed | 09/02/2021 |
| NCPE assessment outcome | The NCPE recommends that liraglutide 3mg (Saxenda®) 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 January 2023.
Liraglutide (Victoza®)
| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Liraglutide |
| Brand | Victoza® |
| Indication | For treatment of adults with type 2 diabetes mellitus. |
| Assessment Process | |
| Rapid review commissioned | 01/09/2009 |
| Rapid review completed | 07/10/2009 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 26/10/2016 |
| Pre-submission consultation with Applicant | 21/02/2017 |
| Full submission received from Applicant | 29/08/2017 |
| Preliminary review sent to Applicant | 17/08/2018 |
| NCPE assessment re-commenced | 30/10/2018 |
| Factual accuracy sent to Applicant | 07/02/2019 |
| NCPE assessment re-commenced | 18/02/2019 |
| NCPE assessment completed | 07/03/2019 |
| NCPE assessment outcome | The NCPE recommends that liraglutide (Victoza®) 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
Lisdexamfetamine dimesylate (Tyvense®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lisdexamfetamine dimesylate |
| Brand | Tyvense® |
| Indication | For Attention Deficit Hyperactivity Disorder in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate. |
| Assessment Process | |
| Rapid review commissioned | 09/02/2013 |
| Rapid review completed | 28/02/2013 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |
Lomitapide (Lojuxta®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lomitapide |
| Brand | Lojuxta® |
| Indication | As an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). |
| Assessment Process | |
| Rapid review commissioned | 09/09/2014 |
| Rapid review completed | 15/09/2014 |
| 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.
Loncastuximab tesirine (Zynlonta®). HTA ID: 23053
| Assessment Status | Rapid Review Complete |
| HTA ID | 23053 |
| Drug | Loncastuximab tesirine |
| Brand | Zynlonta® |
| Indication | Loncastuximab tesirine (Zynlonta®) is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 17/08/2023 |
| Rapid review completed | 01/09/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of loncastuximab tesirine compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
Lorlatinib (Lorviqua®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lorlatinib |
| Brand | Lorviqua® |
| Indication | As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), following disease progression on: (i) alectinib or ceritinib as the first ALK-targeted treatment, or (ii) crizotinib and at least one other ALK-targeted treatment. |
| Assessment Process | |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that lorlatinib 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.
The HSE has approved reimbursement following confidential price negotiations (October 2019).
Lorlatinib (Lorviqua®) for 1L ALK positive NSCLC. HTA ID: 21071
| Assessment Status | Rapid Review Complete |
| HTA ID | 21071 |
| Drug | Lorlatinib |
| Brand | Lorviqua® |
| Indication | As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. |
| Assessment Process | |
| Rapid review commissioned | 22/12/2021 |
| Rapid review completed | 13/01/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that lorlatinib 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.
The HSE has approved reimbursement following confidential price negotiations – October 2022.
Lornoxicam (Xefo®)
| Assessment Status | Rapid Review Complete |
| HTA ID | - |
| Drug | Lornoxicam |
| Brand | Xefo® |
| Indication | For the short-term relief of acute mild to moderate pain and symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis |
| Assessment Process | |
| Rapid review commissioned | 23/06/2011 |
| Rapid review completed | 07/07/2011 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Not Recommended |