The Medicines Management Programme has Managed Access Protocols in place for a number of medicines as part of the reimbursement approval process.
This section contains information on medicines that are subject to Managed Access Protocols. Reimbursement criteria for each Managed Access Protocol is individual. Please refer to the relevant link for information on individual Managed Access Protocols.
Acoramidis (Beyonttra®)
Acoramidis (BEYONTTRA®) and tafamidis (Vyndaqel®) are used in wild-type or variant/hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
A Managed Access Protocol (MAP) is in place for these medicines. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of acoramidis or tafamidis on the High Tech Arrangement.
Applications for reimbursement approval for these medicines will only be considered from consultants with specialist registration with the Irish Medical Council in a specialism relevant to the diagnosis and management of ATTR-CM (i.e. cardiology), who have agreed to the terms of this MAP and have been approved by the HSE (‘approved consultants’).
The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transferring reimbursement approval will only be considered from approved consultants.
A copy of the MAP for medicines for the treatment of transthyretin amyloidosis in adult patients with cardiomyopathy and the relevant application forms can be found below.
For further information, please contact mmp@hse.ie.
Atopic Dermatitis
A Managed Access Protocol (MAP) is in place for medicines for the treatment of moderate-to-severe atopic dermatitis. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of abrocitinib (Cibinqo®), dupilumab (Dupixent®), tralokinumab (Adtralza®) or upadacitinib (RINVOQ®) on the High Tech Arrangement.
Applications for reimbursement approval of abrocitinib (Cibinqo®), dupilumab (Dupixent®), tralokinumab (Adtralza®) and upadacitinib (RINVOQ®) for the treatment of moderate-to-severe atopic dermatitis on the High Tech Arrangement will only be considered from consultant dermatologists with a specialist registration in dermatology, registered with the Irish Medical Council, practising in the healthcare system in the Republic of Ireland, and who have agreed to the terms of the MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for high tech medicines for the treatment of atopic dermatitis can be found below.
For further information, please contact mmp@hse.ie.
atypical Haemolytic Uremic Syndrome (aHUS) - Ravulizumab (Ultomiris®)
Ravulizumab (Ultomiris®) for the treatment of atypical Haemolytic Uremic Syndrome (aHUS) is reimbursed from 1 March 2026. A Managed Access Protocol (MAP) is in place for ravulizumab. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of ravulizumab.
Applications for reimbursement approval for ravulizumab for the treatment of aHUS will only be considered from consultants with specialist registration in nephrology, haematology or paediatrics (with a special interest in nephrology) with the Irish Medical Council and who have agreed to the terms of the MAP and been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transfer of reimbursement approval will only be considered from approved consultants.
A copy of the MAP for ravulizumab for the treatment of aHUS and the application form for individual reimbursement approval, can be found below.
For further information, please contact mmp@hse.ie.
Medicines for atypical Haemolytic Uremic Syndrome (aHUS) Application Form - Ravulizumab (Ultomiris®)
Bempedoic Acid
Bempedoic acid 180 mg film-coated tablets (Nilemdo®) and bempedoic acid 180 mg plus ezetimibe 10 mg film-coated tablets (Nustendi®) are reimbursed on the Community Drug Schemes from 1st September 2024. A Managed Access Protocol (MAP) is in place for bempedoic acid 180 mg film-coated tablets (Nilemdo®) and bempedoic acid 180 mg plus ezetimibe 10 mg film-coated tablets (Nustendi®). This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of bempedoic acid 180 mg film-coated tablets (Nilemdo®) and bempedoic acid 180 mg plus ezetimibe 10 mg film-coated tablets (Nustendi®) on the Community Drug Schemes.
GPs and hospital prescribers, once user-registered with the HSE-Primary Care Reimbursement Service (PCRS), will be authorised to submit an application on an individual patient basis, through the special drug request (SDR) section on the ‘GP Application Suite’ or under ‘Services for Hospitals’ on the PCRS website. A separate application for reimbursement approval must be submitted for each individual.
A copy of the MAP for bempedoic acid 180 mg film-coated tablets (Nilemdo®) and bempedoic acid 180 mg plus ezetimibe 10 mg film-coated tablets (Nustendi®) can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol Bempedoic Acid and Bempedoic Acid + Ezetimibe (PDF, 822 KB, 12 pages)
Bulevirtide
Bulevirtide (Hepcludex®) for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV- RNA positive adult patients with compensated liver disease, is reimbursed on the High Tech Arrangement from 1 May 2025. A Managed Access Protocol (MAP) is in place for bulevirtide. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of bulevirtide under the High Tech Arrangement.
Applications for reimbursement approval for bulevirtide under the High Tech Arrangement, will only be considered from consultants in infectious diseases or consultant hepatologists and gastroenterologists registered with the Irish Medical Council, who are experienced in the treatment of patients with HDV infection, and who have agreed to the terms of this MAP and have been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for bulevirtide for the treatment of chronic HDV infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease and the application form for individual reimbursement approval, can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Bulevirtide (Hepcludex®) (PDF, 618 KB, 8 pages)
Bulevirtide (Hepcludex®) Application Form (PDF, 631 KB, 6 pages)
Eculizumab
Eculizumab is approved for reimbursement by the HSE for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS) through a Managed Access Process. This funding application process is in place solely to address long-term chronic funding issues for these indications and is not designed to assist hospitals in making acute financial decisions. Therefore, short-term in-patient management remains within the in-patient hospital governance.
For further information relating to the long-term funding of eculizumab for PNH and aHUS, please contact mmp@hse.ie.
Applications for individual reimbursement approval will only be considered from consultant haematologists or nephrologists.
The Application Forms can be found below.
Application Form for Eculizumab for aHUS (PDF, 737 KB, 7 pages)
Application Form for Eculizumab for PNH (PDF, 639 KB, 5 pages)
Entrectinib (Rozlytrek®) - Lung Cancer
Entrectinib (Rozlytrek®) as monotherapy for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer not previously treated with ROS1 inhibitors is reimbursed on the High Tech Arrangement. A Managed Access Protocol (MAP) is in place for entrectinib for the treatment of ROS1-positive non-small cell lung cancer from 1st October 2024. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of entrectinib for the treatment of ROS1-positive non-small cell lung cancer on the High Tech Arrangement.
Applications for reimbursement approval for entrectinib for the treatment of ROS1-positive non-small cell lung cancer on the High Tech Arrangement will only be considered from consultant medical oncologists registered with the Irish Medical Council who have agreed to the terms of this MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for entrectinib and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
Entrectinib (Rozlytrek®) - Application Form (PDF, 597 KB, 4 pages)
Entrectinib (Rozlytrek®) - NTRK Gene Fusion
Entrectinib (Rozlytrek®) and larotrectinib (Vitrakvi®) are used for the treatment of solid tumours displaying a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. A Managed Access Protocol (MAP) is in place for these medicines, reimbursed on the High Tech Arrangement. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of entrectinib or larotrectinib for the treatment of solid tumours displaying an NTRK gene fusion on the High Tech Arrangement.
Applications for reimbursement approval for entrectinib or larotrectinib for the treatment of solid tumours displaying an NTRK gene fusion on the High Tech Arrangement will only be considered from consultant medical oncologists, registered with the Irish Medical Council, who have agreed to the terms of this MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for entrectinib (Rozlytrek®) and larotrectinib (Vitrakvi®) for the treatment of solid tumours displaying an NTRK gene fusion, and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
NTRK Gene Fusion Therapies Application Form (PDF, 719 KB, 7 pages)
Fostemsavir (Rukobia®)
Fostemsavir (Rukobia®) for the treatment of adults with multi-drug resistant human immunodeficiency virus-1 for whom it is not possible to construct a suppressive anti-viral regimen, is available from December 2024.
A Managed Access Protocol (MAP) is in place for fostemsavir (Rukobia®). This outlines the criteria that must be satisfied in order for a patient to be recommended for approval of funding for fostemsavir (Rukobia®).
Applications for funding approval for fostemsavir for the treatment of multi-drug resistant human immunodeficiency virus-1 under hospital pricing approval will only be considered from consultants, with specialist registration with the Irish Medical Council in the speciality of infectious diseases or genitourinary medicine, practicing in a designated centre, and who have agreed to the terms of this MAP and been approved by the HSE.
The approved consultant must submit an application for individual funding approval for each patient.
A copy of the MAP for fostemsavir (Rukobia®) and application form for individual funding approval can be found below.
For further information, please contact mmp@hse.ie.
Fostemsavir (Rukobia®) Application Form (PDF, 615 KB, 7 pages)
hATTR - Polyneuropathy
Inotersen (Tegsedi®), patisiran (Onpattro®) and vutrisiran (Amvuttra®) are used in hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
A Managed Access Protocol (MAP) is in place for these medicines. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of patisiran or vutrisiran under hospital pricing approval or inotersen on the High Tech Arrangement.
Applications for reimbursement approval for these medicines will only be considered from consultants registered with the Irish Medical Council, with experience in the diagnosis and management of hereditary transthyretin amyloidosis in specialist centre(s) in Ireland, who have agreed to the terms of this MAP and been approved by the HSE.
The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved consultants.
A copy of the MAP for medicines used in hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy and the relevant application forms can be found below.
For further information, please contact mmp@hse.ie.
Hereditary Angioedema
A Managed Access Protocol (MAP) is in place for medicines for routine prevention of recurrent attacks of hereditary angioedema (HAE), incorporating berotralstat and lanadelumab. This outlines the criteria that must be satisfied for a patient to be recommended for reimbursement of berotralstat or lanadelumab on the High Tech Arrangement.
Applications for reimbursement approval for berotralstat or lanadelumab for routine prevention of recurrent attacks of HAE on the High Tech Arrangement will only be considered from consultant immunologists from five specialist centres in Ireland who have agreed to the terms of this MAP and have been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP and application form for Medicines for Routine Prevention of Recurrent Attacks of Hereditary Angioedema can be found below.
For further information, please contact mmp@hse.ie.
Larotrectinib (Vitrakvi®)
A Managed Access Protocol (MAP) is in place for entrectinib (Rozlytrek®) and larotrectinib (Vitrakvi®) for the treatment of solid tumours displaying a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of entrectinib or larotrectinib for the treatment of solid tumours displaying an NTRK gene fusion on the High Tech Arrangement.
Applications for reimbursement approval for entrectinib or larotrectinib for the treatment of solid tumours displaying an NTRK gene fusion on the High Tech Arrangement will only be considered from consultant medical oncologists, registered with the Irish Medical Council, who have agreed to the terms of this MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for entrectinib (Rozlytrek®) and larotrectinib (Vitrakvi®) for the treatment of solid tumours displaying an NTRK gene fusion, and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
NTRK Gene Fusion Therapies Application Form (PDF, 719 KB, 7 pages)
Lidocaine (Versatis®)
Lidocaine 700 mg medicated plaster (Versatis®) is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection known as post-herpetic neuralgia (PHN) in adults.
The HSE Medicines Management Programme (MMP) has reviewed the evidence available to support the use of lidocaine 700 mg medicated plaster (Versatis®). (A further review was conducted in 2021 to update clinical evidence relevant to the use of lidocaine medicated plaster.)
Following this review and based on best practice recommendations, the Primary Care Reimbursement Service (PCRS) introduced changes to the reimbursement of lidocaine 700 mg medicated plaster (Versatis®) from 1 September 2017. This process supports appropriate use of this medication while ensuring those with an indication of PHN continue to have access to reimbursement for this treatment.
All clinicians (i.e. GPs and hospital prescribers), can submit an application for individual reimbursement approval of lidocaine 700 mg medicated plaster (Versatis®).
A copy of the Lidocaine Prescribing and Cost Guidance document can be found below.
For further information, please contact mmp@hse.ie.
Lidocaine Prescribing and Cost Guidance (PDF, 913 KB, 25 pages)
Liraglutide (Saxenda®) for Adolescents
Liraglutide (Saxenda®) for weight management in adolescents is reimbursed on the Community Drug Schemes, specifically the Drugs Payment and General Medical Services schemes, from 1st February 2026. A Managed Access Protocol (MAP) is in place for liraglutide (Saxenda®) for weight management in adolescents. This outlines the criteria that must be satisfied in order for an adolescent patient to be recommended for reimbursement of liraglutide (Saxenda®) for weight management on the Community Drug Schemes.
Applications for reimbursement approval of liraglutide (Saxenda®) for weight management in adolescents, will only be considered from consultants with specialist registration with the Irish Medical Council in a specialism relevant to obesity management in adolescent patients (e.g. endocrinology, paediatrics). Consultants must have access to a multi-disciplinary team as part of Child and Adolescent Obesity Services to deliver lifestyle interventions for patients, and have agreed to the terms of this MAP and been approved by the HSE. The approved consultant must submit an online application for individual reimbursement approval for each adolescent patient.
The managed access of liraglutide (Saxenda®) for weight management in adolescents includes two phases of reimbursement approval. Phase 1 reimbursement support is for an initial duration of six months. For continued reimbursement support after this time, a second reimbursement application (phase 2) is required.
A copy of the MAP for liraglutide (Saxenda®) for weight management in adolescents can be found below.
For further information, please contact mmp@hse.ie.
Liraglutide (Saxenda®) for Adults
Liraglutide (Saxenda®) 6 mg/ml solution for injection in pre-filled pen is available for reimbursement on the Community Drug Schemes from 1st January 2023. A Managed Access Protocol (MAP) is in place for liraglutide (Saxenda®) for a subgroup of the licensed indication, defined as:
“Adult patients, as an adjunct to a reduced-calorie diet and increased physical activity for weight management, with an initial body mass index of ≥ 35 kg/m2 with prediabetes and high-risk of cardiovascular disease. Treatment should be discontinued for patients who have not lost ≥ 5 % of their initial body weight after 12 weeks of treatment at the 3 mg/day dose”.
This MAP outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of liraglutide (Saxenda®).
A clinician must submit an online application for individual reimbursement approval for each patient. All clinicians (GPs and hospital prescribers), once user-registered with the HSE - Primary Care Reimbursement Service (PCRS), can apply for reimbursement of liraglutide (Saxenda®).
The MAP of liraglutide (Saxenda®) includes two phases of reimbursement approval. Phase 1 reimbursement support is for an initial duration of six months (24 weeks). For continued reimbursement support after this time, a second reimbursement application is required to determine the patient’s response to treatment after 12 weeks of liraglutide (Saxenda®) at the 3 mg/day dose. Total duration of reimbursement support is two years (24 months) from the date of the initial Phase 1 application. Due to the information that is required to be submitted, the clinician responsible for the initiation of treatment should complete the online application.
A copy of the MAP for liraglutide (Saxenda®) for weight management in adults, reimbursement information for prescribers and reimbursement information for pharmacists can be found below.
For further information, please contact mmp@hse.ie.
Saxenda® reimbursement information for prescribers (PDF, 774 KB, 1 page)
Saxenda® reimbursement information for pharmacists (PDF, 513 KB, 1 page)
Migraine
A Managed Access Protocol (MAP) is in place for medicines for the management of episodic and chronic migraine. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of atogepant, erenumab, fremanezumab, galcanezumab or rimegepant under the High Tech Arrangement, or eptinezumab under Hospital Pricing Approval.
Applications for reimbursement approval for atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab and rimegepant for the management of episodic and chronic migraine under the High Tech Arrangement/ Hospital Pricing Approval will only be considered from consultant neurologists registered with the Irish Medical Council, who have agreed to the terms of this MAP and have been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for Medicines for the Management of Episodic and Chronic Migraine can be found below.
For further information, please contact mmp@hse.ie.
Nusinersen (Spinraza®)
Nusinersen (Spinraza®) has been available for reimbursement under hospital pricing approval since July 2019. A Managed Access Protocol (MAP) is in place for nusinersen. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of nusinersen under hospital pricing approval.
The prescribing of nusinersen (Spinraza®) under hospital pricing approval is confined to consultant neurologists with experience in the diagnosis and management of Spinal Muscular Atrophy (SMA) in specialist centre(s) in Ireland, who have agreed to the terms of this MAP and have been approved by the HSE.
The clinician must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved consultants.
A copy of the HSE-Managed Access Protocol for Nusinersen (Spinraza®) and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Nusinersen (Spinraza®) (PDF, 654 KB, 10 pages)
Application Form for medicines for the treatment of Spinal Muscular Atrophy (PDF, 563 KB, 5 pages)
Odevixibat (Bylvay®)
Odevixibat (Bylvay®) for the treatment of progressive familial intrahepatic cholestasis in patients aged six months or older is reimbursed on the High Tech Arrangement from 1st December 2024. A Managed Access Protocol (MAP) is in place for odevixibat. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of odevixibat on the High Tech Arrangement.
Applications for reimbursement approval for odevixibat on the High Tech Arrangement will only be considered from consultant hepatologists and gastroenterologists registered with the Irish Medical Council, who are experienced in the management of progressive familial intrahepatic cholestasis, and who have agreed to the terms of this MAP and have been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP and application form for odevixibat (Bylvay®) can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Odevixibat (Bylvay®) (PDF, 678 KB, 10 pages)
Odevixibat (Bylvay®) Application Form (PDF, 733 KB, 7 pages)
Onasemnogene abeparvovec (Zolgensma®)
Onasemnogene abeparvovec (Zolgensma®) was approved for reimbursement in Ireland on 8th October 2021 following joint assessment and negotiations under the Beneluxa Initiative. A Managed Access Protocol (MAP) is in place for onasemnogene abeparvovec which outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement.
The prescribing of onasemnogene abeparvovec (Zolgensma®) is confined to consultant neurologists with experience in the diagnosis and management of Spinal Muscular Atrophy (SMA) in specialist centre(s) in Ireland, who have agreed to the terms of the MAP and have been approved by the HSE.
The clinician must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved consultants.
A copy of the HSE-Managed Access Protocol for onasemnogene abeparvovec (Zolgensma®) and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Onasemnogene abeparvovec (Zolgensma®) (PDF, 639 KB, 9 pages)
Application form for medicines for the treatment of Spinal Muscular Atrophy (PDF, 563 KB, 5 pages)
Paroxysmal Nocturnal Haemoglobinuria (PNH) - Crovalimab (Piasky®)
Crovalimab (Piasky®) as monotherapy for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH):
- In patients with haemolysis with clinical symptom(s) indicative of high disease activity
- In patients who are clinically stable after having been treated with a complement C5 inhibitor for at least the past six months
is reimbursed from 1 February 2026. A Managed Access Protocol (MAP) is in place for crovalimab for the treatment of PNH. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of crovalimab.
Applications for reimbursement approval for crovalimab will only be considered from consultants with specialist registration in haematology with the Irish Medical Council, who have agreed to the terms of the MAP and been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transfer of reimbursement approval will only be considered from approved consultants.
A copy of the MAP for crovalimab as monotherapy in the treatment with PNH and the application form for individual reimbursement approval, can be found below.
For further information, please contact mmp@hse.ie.
Paroxysmal Nocturnal Haemoglobinuria (PNH) - Iptacopan (FABHALTA®)
Iptacopan (FABHALTA®) as monotherapy for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) is reimbursed on the High Tech Arrangement from 1st December 2025. A Managed Access Protocol (MAP) is in place for iptacopan. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of iptacopan on the High Tech Arrangement.
Applications for reimbursement approval for iptacopan on the High Tech Arrangement, will only be considered from consultants with specialist registration in haematology with the Irish Medical Council, who have agreed to the terms of this MAP and been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transferring reimbursement approval will only be considered from approved consultants.
A copy of the MAP for iptacopan as monotherapy in the treatment of adult patients with PNH and the application form for individual reimbursement approval, can be found below.
For further information, please contact mmp@hse.ie.
Iptacopan (FABHALTA®) Reimbursement Application Form (PDF, 557 KB, 6 pages)
Paroxysmal Nocturnal Haemoglobinuria (PNH) - Pegcetacoplan (ASPAVELI®)
Pegcetacoplan (ASPAVELI®) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adult patients who are anaemic after treatment with a complement C5 inhibitor for at least three months is reimbursed from 1 March 2026. A Managed Access Protocol (MAP) is in place for pegcetacoplan. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of pegcetacoplan.
Applications for reimbursement approval for pegcetacoplan will only be considered from consultants with specialist registration in haematology with the Irish Medical Council, who have agreed to the terms of the MAP and been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transfer of reimbursement approval will only be considered from approved consultants.
A copy of the MAP for pegcetacoplan for the treatment of PNH in adult patients who have haemolytic anaemia and the application form for individual reimbursement approval, can be found below.
For further information, please contact mmp@hse.ie.
Paroxysmal Nocturnal Haemoglobinuria (PNH) - Ravulizumab (Ultomiris®)
Ravulizumab (Ultomiris®) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) is reimbursed from 1 March 2026. A Managed Access Protocol (MAP) is in place for ravulizumab. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of ravulizumab.
Applications for reimbursement approval for ravulizumab will only be considered from consultants with specialist registration in haematology with the Irish Medical Council, who have agreed to the terms of the MAP and been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transfer of reimbursement approval will only be considered from approved consultants.
A copy of the MAP for ravulizumab for the treatment of adult patients with PNH and the application form for individual reimbursement approval, can be found below.
For further information, please contact mmp@hse.ie.
Medicines for Paroxysmal Nocturnal Haemoglobinuria (PNH) Application Form - Ravulizumab (Ultomiris®)
PCSK9 Inhibitors
A Managed Access Protocol (MAP) is in place for PCSK9 inhibitors. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of evolocumab on the High Tech Arrangement.
Applications for reimbursement approval of evolocumab on the High Tech Arrangement will only be considered from consultants registered with the Irish Medical Council, with specialist registration in a relevant specialism, who have agreed to the terms of this MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for PCSK9 inhibitors can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol PCSK9 Inhibitors (PDF, 805 KB, 11 pages)
HSE Managed Access Protocol PCSK9 Inhibitors Summary (PDF, 651 KB, 1 page)
Prurigo Nodularis (Dupilumab (Dupixent®))
A Managed Access Protocol (MAP) is in place for medicines for the treatment of moderate-to-severe prurigo nodularis in adults. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of dupilumab (Dupixent®) on the High Tech Arrangement.
Applications for reimbursement approval of dupilumab (Dupixent®) for the treatment of moderate-to-severe prurigo nodularis in adults on the High Tech Arrangement will only be considered from consultant dermatologists with a specialist registration in dermatology, registered with the Irish Medical Council, practising in the healthcare system in the Republic of Ireland, and who have agreed to the terms of the MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for Dupilumab (Dupixent®) for the treatment of moderate-to-severe prurigo nodularis in adults can be found below.
For further information, please contact mmp@hse.ie.
Risdiplam (Evrysdi®)
Risdiplam (Evrysdi®) is used in the treatment of 5q-Spinal Muscular Atrophy (SMA). A Managed Access Protocol (MAP) is in place for Risdiplam (Evrysdi®). This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of Risdiplam on the High Tech Arrangement.
The prescribing of Risdiplam on the High Tech Arrangement will only be considered from consultant neurologists or consultant paediatricians with a special interest in neurology, with specialist registration with the Irish Medical Council in the specialities of neurology or paediatrics, who have experience in the diagnosis and management of SMA and are practicing in specialist centre(s) in Ireland, and who have agreed to the terms of this MAP and have been approved by the HSE (‘approved consultants’).
The clinician must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved consultants.
A copy of the HSE Managed Access Protocol for risdiplam and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Risdiplam (Evrysdi®) (PDF, 868 KB, 10 pages)
Application form for medicines for the treatment of Spinal Muscular Atrophy (PDF, 571 KB, 5 pages)
Rivaroxaban 2.5 mg
Rivaroxaban 2.5 mg co-administered with aspirin, for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events, is reimbursed on the Community Drug Schemes from 1st October 2022. A Managed Access Protocol (MAP) is in place for rivaroxaban 2.5 mg. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of rivaroxaban 2.5 mg on the Community Drug Schemes.
All clinicians (i.e. GPs and hospital prescribers), can submit an application for individual reimbursement approval of rivaroxaban 2.5 mg. A separate application for reimbursement approval must be submitted for each patient.
A copy of the MAP for rivaroxaban 2.5 mg and Anticoagulation Prescribing Tips, can be found in the Related Files section below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Rivaroxaban 2.5 mg (PDF, 655 KB, 10 pages)
Romosozumab (Evenity®)
Romosozumab (Evenity®) is reimbursed on the High Tech Arrangement from 1st November 2024. A Managed Access Protocol (MAP) is in place for romosozumab for the treatment of severe osteoporosis. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of romosozumab for the treatment of severe osteoporosis on the High Tech Arrangement.
Applications for reimbursement approval for romosozumab for the treatment of severe osteoporosis on the High Tech Arrangement will only be considered from consultants with specialist registration with the Irish Medical Council in a specialism relevant to the management of osteoporosis (e.g. endocrinology, gerontology, rheumatology), and who have agreed to the terms of the MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for romosozumab can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol Romosozumab (PDF, 502 KB, 7 pages)
Sacubitril and Valsartan (Entresto®)
Sacubitril and valsartan (Entresto®) is reimbursed on the Community Drug Schemes from 1st December 2017. A managed access approach is undertaken with criteria that must be satisfied in order for a patient to be recommended for reimbursement of sacubitril and valsartan (Entresto®) on the Community Drug Schemes.
GPs and hospital prescribers, once user-registered with the HSE-Primary Care Reimbursement Service (PCRS), will be authorised to submit an application on an individual patient basis, through the special drug request (SDR) section on the ‘GP Application Suite’ or under ‘Services for Hospitals’ on the PCRS website. A separate application for reimbursement approval must be submitted for each individual.
Due to the information that is required to be submitted, the clinician responsible for initiation of treatment should complete the online application.
A copy of sacubitril and valsartan - Entresto® clinical and reimbursement information and correspondence issued to prescribers can be found below.
For further information, please contact mmp@hse.ie.
Sacubitril and valsartan - Entresto® clinical and reimbursement information (PDF, 768 KB, 2 pages)
Severe Asthma
A Managed Access Protocol (MAP) is in place for medicines for the treatment of severe asthma. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of benralizumab, dupilumab, mepolizumab and tezepelumab on the High Tech Arrangement and benralizumab, mepolizumab and reslizumab under Hospital Pricing Approval.
Applications for reimbursement approval for benralizumab, dupilumab, mepolizumab, reslizumab and tezepelumab for the treatment of severe asthma on the High Tech Arrangement / under Hospital Pricing Approval will only be considered from consultant respiratory physicians or consultant paediatricians with a special interest in respiratory medicine, with specialist registration with the Irish Medical Council in the specialities of respiratory medicine or paediatrics, who specialise in severe asthma and are practicing within a severe asthma centre, and who have agreed to the terms of this MAP and been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for Medicines for the Treatment of Severe Asthma can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - Medicines for the Treatment of Severe Asthma (PDF, 643 KB, 17 pages)
Tafamidis (Vyndaqel®)
Acoramidis (BEYONTTRA®) and tafamidis (Vyndaqel®) are used in wild-type or variant/hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
A Managed Access Protocol (MAP) is in place for these medicines. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of acoramidis or tafamidis on the High Tech Arrangement.
Applications for reimbursement approval for these medicines will only be considered from consultants with specialist registration with the Irish Medical Council in a specialism relevant to the diagnosis and management of ATTR-CM (i.e. cardiology), who have agreed to the terms of this MAP and have been approved by the HSE (‘approved consultants’).
The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transferring reimbursement approval will only be considered from approved consultants.
A copy of the MAP for medicines for the treatment of transthyretin amyloidosis in adult patients with cardiomyopathy and the relevant application forms can be found below.
For further information, please contact mmp@hse.ie.
Teduglutide (Revestive®)
Teduglutide (Revestive®) for the treatment of Short Bowel Syndrome (SBS) with Type III intestinal failure in patients aged one year and older, is reimbursed on the High Tech Arrangement from January 2021.
A Managed Access Protocol (MAP) is in place for teduglutide (Revestive®). This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of teduglutide on the High Tech Arrangement.
Applications for reimbursement approval of teduglutide on the High Tech Arrangement will only be considered from consultants in two specialist centres in Ireland who have agreed to the terms of this MAP and been approved by the HSE (‘approved consultants’).
The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved consultants.
A copy of the MAP for teduglutide and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
THC/CBD (Sativex®)
Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) (Sativex®) was added to the High Tech Arrangement on 1st October 2023. A Managed Access Protocol (MAP) is in place for THC/CBD (Sativex®). This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of THC/CBD (Sativex®) under the High Tech Arrangement.
The prescribing of THC/CBD (Sativex®) under the High Tech Arrangement is confined to consultant neurologists registered with the Irish Medical Council, who have agreed to the terms of the MAP and who have been approved by the HSE.
The approved prescriber must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved prescribers.
A copy of MAP for THC/CBD (Sativex®) and a clinical and reimbursement information document can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - THC and CBD (Sativex®) (PDF, 534 KB, 9 pages)
Sativex® clinical and reimbursement information document (PDF, 669 KB, 1 page)
Tolvaptan (Jinarc®)
A Managed Access Protocol (MAP) is in place for tolvaptan (Jinarc®) for the treatment of autosomal dominant polycystic kidney disease (ADPKD). This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of tolvaptan under the High Tech Arrangement.
Applications for reimbursement approval for tolvaptan for the treatment of ADPKD under the High Tech Arrangement will only be considered from consultant nephrologists registered with the Irish Medical Council, who have agreed to the terms of this MAP and have been approved by the HSE. The approved consultant must submit an application for individual reimbursement approval for each patient.
A copy of the MAP for tolvaptan and the application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
Voretigene neparvovec (Luxturna®)
Voretigene neparvovec (Luxturna®) is available for reimbursement under hospital pricing approval from August 2023. A Managed Access Protocol (MAP) is in place for voretigene neparvovec. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of voretigene neparvovec under hospital pricing approval.
The prescribing of voretigene neparvovec (Luxturna®) for reimbursement under hospital pricing approval is confined to consultant ophthalmologists, with expertise in the care and treatment of patients with inherited retinal dystrophy, and the presence of or affiliation with a retinal surgeon experienced in sub-retinal surgery and capable of administering voretigene neparvovec (Luxturna®) in specialist centre(s), who have agreed to the terms of the MAP and have been approved by the HSE.
The approved prescriber must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved prescribers.
A copy of the MAP for voretigene neparvovec (Luxturna®) and application form for individual reimbursement approval can be found below.
For further information, please contact mmp@hse.ie.
HSE Managed Access Protocol - voretigene neparvovec (Luxturna®) (PDF, 811 KB, 7 pages)
Voretigene neparvovec (Luxturna®) Application Form (PDF, 557 KB, 7 pages)