| Assessment Status | Rapid Review complete |
| HTA ID | 24017 |
| Drug | Alectinib |
| Brand | Alecensa® |
| Indication | As adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence. |
| Assessment Process | |
| Rapid review commissioned | 24/05/2024 |
| Rapid review completed | 02/07/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of alectinib for this indication compared with the current standard-of-care, on the basis of the proposed price relative to currently available therapies. |
Latest NCPE Advice
Amivantamab (Rybrevant®). HTA ID: 24032
| Assessment Status | Rapid Review Complete |
| HTA ID | 24032 |
| Drug | Amivantamab |
| Brand | Rybrevant® |
| Indication | Amivantamab (Rybrevant®) in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion |
| Assessment Process | |
| Rapid review commissioned | 31/07/2024 |
| Rapid review completed | 30/09/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of amivantamab for this indication compared with the current standard of care. |
Andexanet alfa (Ondexxya®). HTA ID: 20014
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20014 |
| Drug | Andexanet alfa |
| Brand | Ondexxya® |
| Indication | For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. |
| Assessment Process | |
| Rapid review commissioned | 12/03/2020 |
| Rapid review completed | 23/04/2020 |
| Rapid review outcome | A full HTA is required to assess the clinical effectiveness and cost-effectiveness of andexanet alfa compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/04/2020 |
| Pre-submission consultation with Applicant | 26/01/2021 |
| Full submission received from Applicant | 26/10/2021 |
| Preliminary review sent to Applicant | 13/12/2021 |
| NCPE assessment re-commenced | 31/01/2022 |
| Factual accuracy sent to Applicant | 27/04/2022 |
| NCPE assessment re-commenced | 04/05/2022 |
| NCPE assessment completed | 27/05/2022 |
| NCPE assessment outcome | The NCPE recommends that andexanet alfa (Ondexxya®) 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 April 2023.
Apalutamide (Erleada®). HTA ID: 20010
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20010 |
| Drug | Apalutamide |
| Brand | Erleada® |
| Indication | For the treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy. |
| Assessment Process | |
| Rapid review commissioned | 26/02/2020 |
| Rapid review completed | 23/03/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of apalutamide for this indication compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 24/03/2020 |
| Pre-submission consultation with Applicant | 15/06/2020 |
| Full submission received from Applicant | 20/04/2021 |
| Preliminary review sent to Applicant | 01/11/2021 |
| NCPE assessment re-commenced | 26/11/2021 |
| Factual accuracy sent to Applicant | 09/02/2022 |
| NCPE assessment re-commenced | 17/02/2022 |
| NCPE assessment completed | 03/03/2022 |
| NCPE assessment outcome | The NCPE recommends that apalutamide (Erleada®) in combination with androgen deprivation therapy 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 2023.
Artesunate (Artesunate Amivas®). HTA ID: 24019
| Assessment Status | Rapid Review complete |
| HTA ID | 24019 |
| Drug | Artesunate |
| Brand | Artesunate Amivas® |
| Indication | For the initial treatment of severe malaria in adults and children. |
| Assessment Process | |
| Rapid review commissioned | 29/05/2024 |
| Rapid review completed | 26/06/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that IV Artesunate Amivas® 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.
Atezolizumab (Tecentriq®) for triple-negative breast cancer.
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Atezolizumab |
| Brand | Tecentriq® |
| Indication | In combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. |
| Assessment Process | |
| Rapid review commissioned | 03/07/2019 |
| Rapid review completed | 19/07/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atezolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/07/2019 |
| Pre-submission consultation with Applicant | 07/10/2019 |
| Full submission received from Applicant | 13/01/2020 |
| Preliminary review sent to Applicant | 05/05/2020 |
| NCPE assessment re-commenced | 29/05/2020 |
| Factual accuracy sent to Applicant | 06/08/2020 |
| NCPE assessment re-commenced | 14/08/2020 |
| NCPE assessment completed | 01/09/2020 |
| NCPE assessment outcome | The NCPE recommends that atezolizumab (Tecentriq®) 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 March 2022.
Atogepant (Aquipta®) for prophylaxis of episodic migraine. HTA ID: 23059
| Assessment Status | Rapid Review Complete |
| HTA ID | 23059 |
| Drug | Atogepant |
| Brand | Aquipta® |
| Indication | Atogepant is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. |
| Assessment Process | |
| Rapid review commissioned | 20/09/2023 |
| Rapid review completed | 26/10/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atogepant on the basis of the proposed price relative to currently available therapies. |
Atogepant (Aquipta®). HTA ID: 23039
| Assessment Status | Rapid Review Complete |
| HTA ID | 23039 |
| Drug | Atogepant |
| Brand | Aquipta® |
| Indication | Prophylaxis of migraine in adults who have at least 4 migraine days per month |
| Assessment Process | |
| Rapid review commissioned | 10/07/2023 |
| Rapid review completed | 21/08/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atogepant for this indication 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.
Avelumab (Bavencio®)
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Avelumab |
| Brand | Bavencio® |
| Indication | For the treatment of adults with metastatic Merkel Cell Carcinoma. |
| Assessment Process | |
| Rapid review commissioned | 17/10/2017 |
| Rapid review completed | 21/11/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 22/11/2017 |
| Pre-submission consultation with Applicant | 11/12/2017 |
| Full submission received from Applicant | 16/03/2018 |
| Preliminary review sent to Applicant | 12/07/2018 |
| NCPE assessment re-commenced | 10/08/2018 |
| Factual accuracy sent to Applicant | 06/09/2018 |
| NCPE assessment re-commenced | 20/09/2018 |
| NCPE assessment completed | 08/10/2018 |
| NCPE assessment outcome | The NCPE recommends that avelumab (Bavencio®) for the treatment of metastatic Merkel Cell Carcinoma not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. |
The HSE has approved reimbursement “approval is restricted to second line” following confidential price negotiations May 2019.
Avelumab (Bavencio®). HTA ID: 19046
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 19046 |
| Drug | Avelumab |
| Brand | Bavencio® |
| Indication | Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. |
| Assessment Process | |
| Rapid review commissioned | 29/10/2019 |
| Rapid review completed | 02/01/2020 |
| Rapid review outcome | Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. |
| Full pharmacoeconomic assessment commissioned by HSE | 07/01/2020 |
| Pre-submission consultation with Applicant | 18/02/2020 |
| Full submission received from Applicant | 31/07/2020 |
| Preliminary review sent to Applicant | 02/02/2021 |
| NCPE assessment re-commenced | 09/03/2021 |
| Follow-up to preliminary review sent to Applicant | 24/03/2021 |
| NCPE assessment re-commenced | 14/04/2021 |
| Factual accuracy sent to Applicant | 28/05/2021 |
| NCPE assessment re-commenced | 04/06/2021 |
| NCPE assessment completed | 23/06/2021 |
| NCPE assessment outcome | The NCPE recommends that avelumab in combination with axitinib 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 Medicinal Goods) Act 2013
Avelumab (Bavencio®). HTA ID: 21001
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21001 |
| Drug | Avelumab |
| Brand | Bavencio® |
| Indication | As monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed with first line platinum-based induction chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 25/01/2021 |
| Rapid review completed | 03/03/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of avelumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 24/03/2021 |
| Pre-submission consultation with Applicant | 20/04/2021 |
| Full submission received from Applicant | 10/06/2021 |
| Preliminary review sent to Applicant | 28/09/2021 |
| NCPE assessment re-commenced | 22/10/2021 |
| Factual accuracy sent to Applicant | 29/11/2021 |
| NCPE assessment re-commenced | 06/12/2021 |
| NCPE assessment completed | 22/12/2021 |
| NCPE assessment outcome | The NCPE recommends that avelumab (Bavencio®), for first-line maintenance treatment of adult patients with bladder cancer who are disease free following platinum-based chemotherapy, 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 2022.
Axicabtagene Ciloleucel (Yescarta®)
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Axicabtagene Ciloleucel |
| Brand | Yescarta® |
| Indication | For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 10/09/2018 |
| Rapid review completed | 18/10/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of axi-cel compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 22/10/2018 |
| Pre-submission consultation with Applicant | 03/12/2018 |
| Full submission received from Applicant | 20/03/2019 |
| Preliminary review sent to Applicant | 15/10/2019 |
| NCPE assessment re-commenced | 13/11/2019 |
| Follow-up to preliminary review sent to Applicant | 13/12/2019 |
| NCPE assessment re-commenced | 20/12/2019 |
| Factual accuracy sent to Applicant | 04/02/2020 |
| NCPE assessment re-commenced | 11/02/2020 |
| NCPE assessment completed | 21/02/2020 |
| NCPE assessment outcome | The NCPE recommend that axicabtagene ciloleucel (Yescarta®) 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 April 2022.
Axicabtagene ciloleucel (Yescarta®). HTA ID: 22066
| Assessment Status | NCPE Assessment Process complete |
| HTA ID | 22066 |
| Drug | Axicabtagene ciloleucel |
| Brand | Yescarta® |
| Indication | For the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. |
| Assessment Process | |
| Rapid review commissioned | 27/09/2022 |
| Rapid review completed | 10/11/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of axicabtagene ciloleucel compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/11/2022 |
| Pre-submission consultation with Applicant | 21/03/2023 |
| Full submission received from Applicant | 06/09/2023 |
| Preliminary review sent to Applicant | 01/03/2024 |
| NCPE assessment re-commenced | 28/03/2024 |
| Factual accuracy sent to Applicant | 31/07/2024 |
| NCPE assessment re-commenced | 08/08/2024 |
| NCPE assessment completed | 16/10/2024 |
| NCPE assessment outcome | The NCPE recommends that axicabtagene ciloleucel (Yescarta ®) 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
Aztreonam-avibactam (Emblaveo®). HTA ID: 24037
| Assessment Status | Rapid Review complete |
| HTA ID | 24037 |
| Drug | Aztreonam-avibactam |
| Brand | Emblaveo® |
| Indication | For the treatment of the following infections in adult patients: • Complicated intra-abdominal infection (cIAI) • Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) • Complicated urinary tract infection (cUTI), including pyelonephritis. Aztreonam-avibactam is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. |
| Assessment Process | |
| Rapid review commissioned | 23/09/2024 |
| Rapid review completed | 25/10/2024 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that aztreonam-avibactam 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.
Baricitinib (Olumiant®) for atopic dermatitis. HTA ID: 21050
| Assessment Status | Rapid Review complete |
| HTA ID | 21050 |
| Drug | Baricitinib |
| Brand | Olumiant® |
| Indication | Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 09/11/2021 |
| Rapid review completed | 16/12/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that baricitinib 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.
Baricitinib (Olumiant®) for moderate to severe atopic dermatitis. HTA ID: 20056
| Assessment Status | Rapid Review complete |
| HTA ID | 20056 |
| Drug | Baricitinib |
| Brand | Olumiant® |
| Indication | Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 14/12/2020 |
| Rapid review completed | 28/01/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that baricitinib 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.
Bazedoxifene (Conbriza®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Bazedoxifene |
| Brand | Conbriza® |
| Indication | Treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of verterbral fractures has been demonstrated; efficacy on hip fractures has not been established. |
| Assessment Process | |
| Rapid review commissioned | 20/09/2011 |
| Rapid review completed | 02/11/2011 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Beclometasone /formoterol (Fostair®) for COPD. HTA ID 23037
| Assessment Status | Rapid Review Complete |
| HTA ID | 23037 |
| Drug | Beclometasone /formoterol |
| Brand | Fostair® |
| Indication | Beclometasone / formoterol (Fostair®) for COPD. HTA ID 23037 Symptomatic treatment of patients with severe chronic obstructive pulmonary disease [COPD] (forced expiratory volume [FEV1] <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. |
| Assessment Process | |
| Rapid review commissioned | 10/07/2023 |
| Rapid review completed | 20/07/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Fostair® for this indication 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.
Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®). HTA ID: 23033
| Assessment Status | Rapid Review Complete |
| HTA ID | 23033 |
| Drug | Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide |
| Brand | Trimbow® |
| Indication | Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®) is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disorder (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA). |
| Assessment Process | |
| Rapid review commissioned | 21/06/2023 |
| Rapid review completed | 19/07/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Trimbow® for this indication 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.
Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®). HTA ID: 23034
| Assessment Status | Rapid Review Complete |
| HTA ID | 23034 |
| Drug | Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide |
| Brand | Trimbow® |
| Indication | Beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow®) for the maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year |
| Assessment Process | |
| Rapid review commissioned | 21/06/2023 |
| Rapid review completed | 19/07/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Trimbow® for this indication 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.
Beclometasone/formoterol (Fostair®) for asthma. HTA ID: 23038
| Assessment Status | Rapid Review Complete |
| HTA ID | 23038 |
| Drug | Beclometasone/formoterol |
| Brand | Fostair® |
| Indication | Beclometasone/formoterol (Fostair®) is indicated for the regular treatment of asthma where use of a combination product (inhaled corticosteroid [ICS] and long-acting beta2-agonist [LABA]) is appropriate: -in patients not adequately controlled with ICS and 'as needed' inhaled rapid-acting beta2-agonist; or -in patients already adequately controlled on both ICS and LABA. |
| Assessment Process | |
| Rapid review commissioned | 10/07/2023 |
| Rapid review completed | 20/07/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Fostair® for this indication 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.
Bedaquiline (Sirturo®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Bedaquiline |
| Brand | Sirturo® |
| Indication | For use as part of an appropriate combination regimen for pulmonary MDR‑TB in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| Assessment Process | |
| Rapid review commissioned | 23/01/2015 |
| Rapid review completed | 20/02/2015 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Full HTA not required. The NCPE however recommend that if reimbursed that use of bedaquiline be subject to certain conditions.
Belatacept (Nulojix®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Belatacept |
| Brand | Nulojix® |
| Indication | In combination with corticosteroids and a mycophenolic acid (MPA), for prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen. |
| Assessment Process | |
| Rapid review commissioned | 15/11/2011 |
| Rapid review completed | 23/01/2012 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
Belimumab (Benlysta®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Belimumab |
| Brand | Benlysta® |
| Indication | As add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. |
| Assessment Process | |
| Rapid review commissioned | 11/08/2011 |
| Rapid review completed | 31/08/2011 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
Not considered cost-effective due to non-submission of full pharmacoeconomic evaluation.
Belimumab (Benlysta®) for lupus nephritis. HTA ID: 23021
| Assessment Status | Rapid Review Complete |
| HTA ID | 23021 |
| Drug | Belimumab |
| Brand | Benlysta® |
| Indication | Belimumab is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. |
| Assessment Process | |
| Rapid review commissioned | 24/04/2023 |
| Rapid review completed | 16/05/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of belimumab 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.
Belimumab (Benlysta®) for systemic lupus erythematosus. HTA ID: 23022
| Assessment Status | Rapid Review Complete |
| HTA ID | 23022 |
| Drug | Belimumab |
| Brand | Benlysta® |
| Indication | Belimumab is indicated as add-on therapy in patients aged five years and older with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. |
| Assessment Process | |
| Rapid review commissioned | 24/04/2023 |
| Rapid review completed | 29/05/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of belimumab 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.
Benralizumab (Fasenra®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Benralizumab |
| Brand | Fasenra® |
| Indication | As add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists. |
| Assessment Process | |
| Rapid review commissioned | 15/01/2018 |
| Rapid review completed | 14/02/2018 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended at the Submitted Price |
The HSE has approved reimbursement following confidential price negotiations; April 2019
Benralizumab (Fasenra®) Autoinjector. HTA ID: 20018
| Assessment Status | Rapid Review complete |
| HTA ID | 20018 |
| Drug | Benralizumab |
| Brand | Fasenra® |
| Indication | As an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists. |
| Assessment Process | |
| Rapid review commissioned | 31/03/2020 |
| Rapid review completed | 28/04/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that benralizumab not be considered for reimbursement under high tech drug arrangements 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 2021
Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Bictegravir/emtricitabine/tenofovir alafenamide |
| Brand | Biktarvy® |
| Indication | Treatment of adults infected with HIV-1 without any known mutations associated with resistance to the individual components. |
| Assessment Process | |
| Rapid review commissioned | 30/04/2018 |
| Rapid review completed | 07/06/2018 |
| Rapid review outcome | Full pharmacoeconomic assessment not recommended. The NCPE recommends that Biktarvy® not be considered for reimbursement at the submitted price in accordance with the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013. |
The HSE has approved reimbursement following confidential price negotiations December 2018.
Bilastine (Drynol®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Bilastine |
| Brand | Drynol® |
| Indication | Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. |
| Assessment Process | |
| Rapid review commissioned | 10/03/2011 |
| Rapid review completed | 23/03/2011 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation not Recommended. |
Blinatumomab (Blincyto®) CD19+ BCP-ALL
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Blinatumomab |
| Brand | Blincyto® |
| Indication | As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (BCP-ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1%. |
| Assessment Process | |
| Rapid review commissioned | 19/08/2019 |
| Rapid review completed | 23/09/2019 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that blinatumomab 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 February 2021.
Blinatumomab (Blincyto®) (paediatric ALL)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Blinatumomab |
| Brand | Blincyto® |
| Indication | Treatment of paediatric patients aged 1 year and older with Philadelphia chromosome negative B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation |
| Assessment Process | |
| Rapid review commissioned | 15/01/2019 |
| Rapid review completed | 30/01/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of blinatumomab 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 2019
Blinatumomab (Blincyto®). HTA ID: 21031
| Assessment Status | Rapid Review complete |
| HTA ID | 21031 |
| Drug | Blinatumomab |
| Brand | Blincyto® |
| Indication | Treatment of paediatric patients (aged 1 year plus) with high-risk first-relapsed Ph- CD19+ B-precursor acute lymphoblastic leukaemia as part of consolidation therapy. |
| Assessment Process | |
| Rapid review commissioned | 05/07/2021 |
| Rapid review completed | 03/08/2021 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that blinatumomab 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 May 2022.
Boceprevir (Victrelis®)
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Boceprevir |
| Brand | Victrelis® |
| Indication | As add-on therapy to pegylated interferon and ribavirin for the treatment of patients infected with Hepatitis C Genotype 1. |
| Assessment Process | |
| Full submission received from Applicant | 19/08/2011 |
| NCPE assessment completed | 17/01/2012 |
| NCPE assessment outcome | Reimbursement Recommended |
We consider boceprevir a highly cost-effective therapy when added to peginterferon-ribavirin for the treatment of patients infected with genotype 1 hepatitis C virus in the Irish healthcare setting.
Bosentan (Tracleer®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Bosentan |
| Brand | Tracleer® |
| Indication | Treatment pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO Functional Class (FC) III and WHO FC II. It is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. |
| Assessment Process | |
| Rapid review commissioned | 27/06/2014 |
| Rapid review completed | 04/07/2014 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Bosutinib (Bosulif®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Bosutinib |
| Brand | Bosulif® |
| Indication | Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. |
| Assessment Process | |
| Rapid review commissioned | 09/08/2013 |
| Rapid review completed | 18/09/2013 |
| Rapid review outcome | At the current price a full HTA would be required. |
The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.
Brentuximab vedotin (Adcetris®)
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Brentuximab vedotin |
| Brand | Adcetris® |
| Indication | Treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma following autologous stem cell transplant or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and is also indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma. |
| Assessment Process | |
| Rapid review commissioned | 28/11/2012 |
| Rapid review completed | 21/12/2012 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full submission received from Applicant | 16/09/2013 |
| NCPE assessment completed | 11/04/2014 |
| NCPE assessment outcome | Reimbursement not Recommended |
December 2015
The HSE has approved reimbursement following confidential price negotiations.
Brentuximab vedotin (Adcetris®) for CD30+ cutaneous T-cell lymphoma (CTCL)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Brentuximab vedotin |
| Brand | Adcetris® |
| Indication | Treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (license extension). |
| Assessment Process | |
| Rapid review commissioned | 07/02/2018 |
| Rapid review completed | 06/03/2018 |
| 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.
The HSE has approved reimbursement following confidential price negotiations, December 2022.
Brentuximab vedotin (Adcetris®) for CD30+ Hodgkins lymphoma. HTA ID: 19058
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 19058 |
| Drug | Brentuximab vedotin |
| Brand | Adcetris® |
| Indication | Treatment of adult patients with CD30+ Hodgkin’s lymphoma at increased risk of relapse or progression following autologous stem cell transplant. |
| Assessment Process | |
| Rapid review commissioned | 30/12/2019 |
| Rapid review completed | 29/01/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of brentuximab vedotin compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 05/02/2020 |
| Pre-submission consultation with Applicant | 19/05/2020 |
| Full submission received from Applicant | 11/01/2021 |
| Preliminary review sent to Applicant | 12/07/2021 |
| NCPE assessment re-commenced | 06/08/2021 |
| Factual accuracy sent to Applicant | 24/09/2021 |
| NCPE assessment re-commenced | 30/09/2021 |
| NCPE assessment completed | 22/10/2021 |
| NCPE assessment outcome | The NCPE recommends that brentuximab vedotin 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 Medicinal Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations, December 2022.
Brentuximab vedotin (Adcetris®). HTA ID: 21010
| Assessment Status | Rapid Review complete |
| HTA ID | 21010 |
| Drug | Brentuximab vedotin |
| Brand | Adcetris® |
| Indication | In combination with cyclophosphamide [C], doxorubicin [H] and prednisone [P] (CHP) in combination for use in adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). |
| Assessment Process | |
| Rapid review commissioned | 24/03/2021 |
| Rapid review completed | 23/04/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of brentuximab vedotin (Adcetris®) 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.
The HSE has approved reimbursement following confidential price negotiations, December 2022.
Brigatinib (Alunbrig®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Brigatinib |
| Brand | Alunbrig® |
| Indication | As monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. |
| Assessment Process | |
| Rapid review commissioned | 19/11/2018 |
| Rapid review completed | 11/12/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of brigatinib 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; June 2019
Brigatinib (Alunbrig®). HTA ID: 20031
| Assessment Status | Rapid Review complete |
| HTA ID | 20031 |
| Drug | Brigatinib |
| Brand | Alunbrig® |
| Indication | As monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK-inhibitor. |
| Assessment Process | |
| Rapid review commissioned | 16/06/2020 |
| Rapid review completed | 06/08/2020 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that brigatinib 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 2020
Brimonidine (Mirvaso®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Brimonidine |
| Brand | Mirvaso® |
| Indication | Treatment of facial erythema of rosacea in adult patients. |
| Assessment Process | |
| Rapid review commissioned | 09/04/2014 |
| Rapid review completed | 06/05/2014 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Not Recommended |
Brivaracetam (Briviact®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Brivaracetam |
| Brand | Briviact® |
| Indication | As adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy. |
| Assessment Process | |
| Rapid review commissioned | 15/02/2016 |
| Rapid review completed | 22/03/2016 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended at the submitted price. |
The HSE has approved reimbursement following confidential price negotiations.
Brodalumab (Kyntheum®)
| Assessment Status | Rapid Review complete |
| HTA ID | - |
| Drug | Brodalumab |
| Brand | Kyntheum® |
| Indication | Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. |
| Assessment Process | |
| Rapid review commissioned | 25/07/2017 |
| Rapid review completed | 29/08/2017 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended at submitted price |
The HSE has approved reimbursement following confidential price negotiations January 2018.
Brolucizumab (Beovu®). HTA ID: 20009
| Assessment Status | Rapid Review complete |
| HTA ID | 20009 |
| Drug | Brolucizumab |
| Brand | Beovu® |
| Indication | Treatment of neovascular (wet) age-related macular degeneration. |
| Assessment Process | |
| Rapid review commissioned | 26/02/2020 |
| Rapid review completed | 07/04/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical and cost effectiveness of brolucizumab 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.
Bulevirtide (Hepcludex®). HTA ID: 22067
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22067 |
| Drug | Bulevirtide |
| Brand | Hepcludex® |
| Indication | Chronic hepatitis delta (CHD) infection in plasma (or serum) HDV RNA-positive adult patients with compensated liver disease. |
| Assessment Process | |
| Rapid review commissioned | 06/10/2022 |
| Rapid review completed | 10/11/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of bulevirtide compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/11/2022 |
| Pre-submission consultation with Applicant | 10/01/2023 |
| Full submission received from Applicant | 06/09/2023 |
| Preliminary review sent to Applicant | 06/10/2023 |
| NCPE assessment re-commenced | 09/11/2023 |
| Factual accuracy sent to Applicant | 19/01/2024 |
| NCPE assessment re-commenced | 26/01/2024 |
| NCPE assessment completed | 22/02/2024 |
| NCPE assessment outcome | The NCPE recommends that bulevirtide 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.
Buprenorphine and naloxone (Zubsolv®). HTA ID: 22037
| Assessment Status | Rapid Review complete |
| HTA ID | 22037 |
| Drug | Buprenorphine/Naloxone |
| Brand | Zubsolv® |
| Indication | As substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who agreed to be treated for addiction. |
| Assessment Process | |
| Rapid review commissioned | 26/05/2022 |
| Rapid review completed | 21/06/2022 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that Zubsolv® 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.
Buprenorphine/Naloxone (Suboxone®)
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Buprenorphine/Naloxone |
| Brand | Suboxone® |
| Indication | Management of opiate addiction |
| Assessment Process | |
| Full submission received from Applicant | 02/01/2014 |
| NCPE assessment completed | 22/05/2014 |
| NCPE assessment outcome | Reimbursement Not Recommended |
Pharmacoeconomic Evaluation completed in November 2007. Suboxone cannot be considered a cost effective option for patients attending HSE clinics or in the community setting in Ireland.
Pharmacoeconomic Reassessment completed in 2014. The NCPE does not consider Suboxone® to be cost-effective compared to methadone for the treatment of opioid dependence.
Burosumab (Crysvita®)
| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Burosumab |
| Brand | Crysvita® |
| Indication | Treatment of X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons. |
| Assessment Process | |
| Rapid review commissioned | 22/11/2018 |
| Rapid review completed | 21/12/2018 |
| Rapid review outcome | A full HTA is recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 08/01/2019 |
| Pre-submission consultation with Applicant | 12/02/2019 |
| Full submission received from Applicant | 03/07/2019 |
| Preliminary review sent to Applicant | 23/10/2019 |
| NCPE assessment re-commenced | 19/11/2019 |
| Factual accuracy sent to Applicant | 14/02/2020 |
| NCPE assessment re-commenced | 06/03/2020 |
| NCPE assessment completed | 12/03/2020 |
| NCPE assessment outcome | The NCPE recommends that burosumab (Crysvita®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments** |
*The NCPE have revised the timeline for burosumab due to new information received after the factual accuracy stage, which necessitated additional revisions to be made to the final appraisal document.
**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 May 2021.
