Clinical R&D

BAYER’S NUBEQA® (DAROLUTAMIDE) IS REIMBURSED AND AVAILABLE IN IRELAND

Nubeqa® (darolutamide), which is an oral androgen receptor inhibitor (ARi), has been reimbursed by the HSE and is available in Ireland from 1st April under the High-Tech Drug Arrangements. It is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

Nubeqa has a distinct chemical structure which inhibits the growth of prostate cancer cells while limiting the burden of side effects on patients’ everyday lives. The marketing authorisation in the European Union, granted by the European Commission, was based on results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castrationresistant prostate cancer (nmCRPC). The results of the trial showed a statistically significant improvement in metastasis-free survival (MFS) with darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001). This translates to a 59 percent reduction in the risk of metastasis or death. The median MFS was 40.4 months in the darolutamide arm compared with 18.4 months for the placebo arm – an overall improvement in median MFS of 22 months.

A positive trend in overall survival (OS) was also observed (HR=0.69; 95% CI, 0.53 to 0.88; P=0.003), and all other secondary endpoints demonstrated a benefit in favour of darolutamide. Importantly, the incidence of treatment-emergent adverse events (AEs) with greater than or equal to 5 percent frequency or of grade 3–5 was comparable between darolutamide and placebo arms; only fatigue occurred in more than 10 percent of patients (darolutamide plus ADT resulted in 13.2 percent versus 8.3 percent in patients with placebo plus ADT). Quality of life outcomes were similar between the treatment groups. “We are pleased that Nubeqa® (darolutamide) is now available for patients in Ireland. Darolutamide’s efficacy in preventing the spread of prostate cancer together with its favourable tolerability profile may allow these largely asymptomatic nmCRPC patients to continue their daily living without adding any burden;” said Dr Tristan Cooper, Medical Director at Bayer Ireland. The compound, which is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Bayer is responsible for global commercialisation, with a co-promotion of Bayer and Orion Corporation in certain European markets, including Ireland; France; Germany; Italy; Spain; the UK; Scandinavia and Finland.

PONVORYTM (PONESIMOD),

A ONCE DAILY, ORAL THERAPY APPROVED FOR REIMBURSEMENT IN IRELAND

Janssen, the Pharmaceutical Companies of Johnson & Johnson, has announced that PONVORYTM (ponesimod) has been granted reimbursement in Ireland for the treatment of adults with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.4 Dr Thorsten Giesecke, General Manager, Commercial Business, Janssen Sciences Ireland UC, said: “Multiple sclerosis is a debilitating and degenerative disease. At Janssen, we are dedicated to helping people living with MS and ponesimod is testimony to this commitment, with a particular focus on improving the treatment landscape in relapsing MS, where medical unmet needs among the MS community remain.” Reimbursement in Ireland follows EC approval of ponesimod based on data from the Phase 3 OPTIMUM trial, a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients (aged 18-55 years) in 28 countries.1 The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod (20mg) vs. oncedaily teriflunomide (14mg), an approved first-line oral treatment, in adult patients with RMS.1 The large, Phase 3 study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5 percent (p<0.001) compared with teriflunomide.1 Ponesimod also showed statistically significant superiority on one of the secondary endpoints, combined unique active lesions (CUALs).1 Ponesimod significantly reduced the number of new inflammatory lesions on brain MRI by 56 percent (p<0.0001) at week 108 when compared to teriflunomide.1 Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/ moderate and did not warrant treatment discontinuation.1 The most commonly reported adverse events in either the ponesimod 20mg group or the teriflunomide 14mg group were Alanine Aminotransferase (ALT) enzyme elevations (19.5% vs. 9.4%), nasopharyngitis (19.3% vs. 16.8%), headache (11.5% vs. 12.7%), upper respiratory tract infection (10.6% vs. 10.4%) and alopecia (3.2% vs. 12.7%).1 The safety profile of ponesimod is consistent with the known safety profile of other S1P receptor modulators, although a head-tohead comparison, other than with teriflunomide, is not available.

Further prescribing information can be found at https://www. medicines.ie/medicines/ponvory2-mg-3-mg-4-mg-5-mg-6-mg-7mg-8-mg-9-mg-10-mg-20-mgfilm-coated-tablets-35163/spc

FAMOTIDINE CLONMEL

Following the recall of Ranitidine products in Ireland in 2019, Clonmel Healthcare is delighted to announce the re-introduction of Famotidine Clonmel 20mg and 40mg film-coated tablets, available on prescription to the Irish market.

Famotidine Clonmel is a H2receptor antagonist indicated for the following:

• Prevention of recurrent duodenal ulcers*

• Duodenal ulcer

• Benign gastric ulcer

• Zollinger-Ellison-Syndrome

• Symptomatic treatment of mild reflux oesophagitis*

• Treatment of mild to moderate reflux oesophagitis**

*Refer to 20 mg SmPC. **Refer to 40 mg SmPC.

Famotidine Clonmel is available on all reimbursement schemes including the GMS. The GMS codes are below:

Famotidine Clonmel 20mg Film-coated Tablets x 60; 44452

Famotidine Clonmel 40mg Film-coated Tablets x 30; 44453 Full prescribing information is available on request or alternatively please go to www.clonmel-health. ie. Medicinal product subject to medical prescription. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information. PA 126/344/001-2. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: March 2022. 2022/ADV/FAM/068H.

DYSFUNCTIONAL “EIRCODE LOTTERY” IN IRISH HOME CARE SYSTEM

A report by the newly formed Home Care Providers Alliance, whose members collectively provide more than half of all home care packages and home support in Ireland, has today (24 March) criticised the arbitrary “Eircode lottery” home care assessment currently in place in Ireland. The report, “The Future of Home Care”, outlines the dysfunction in the current home care system, including the inconsistent ways in which care needs are delivered across Ireland, the lack of centralised independent standards and regulation, and State policies that hamper employment and recruitment efforts within the sector. These issues have contributed to a home care waiting list of more than 5,000 people. Currently, home care in Ireland is not allocated equally across Ireland – with assessment and decision criteria varying not only between regions, but sometimes within them – so that those with comparable needs living in different parts of the country can receive completely different home care, leading to an “Eircode lottery”. The report makes a number of recommendations, including calling for the urgent implementation of a statutory home care scheme, which is included in the current Programme for Government, but has not yet been delivered. Such a scheme should include the licensing and regulation of home care providers. The Alliance is calling for a number of measures to help address the ongoing recruitment and retention crisis within the sector. This includes Government reviews of the social welfare system to incentivise part-time workers to take on additional hours, the inclusion of home carers as a critical skill for the purposes of non-EEA permits and strengthened “earn as you learn” programmes.

The Home Care Providers Alliance has been formed by organisations, representative bodies, and companies from across the voluntary, community and private care sectors to identify issues of mutual concern to the sector. The membership of the Home Care Alliance includes Family Carers Ireland (FCI), Home and Community Care Ireland (HCCI) and the National Community Care Network (NCCN). The Home Care Providers Alliance also believes insufficient focus is placed on the quality of care delivered, and that home care provision needs to go beyond providing the bare minimum service. Rather than assistance with just the most basic of care needs, those in receipt of home care should be able to avail of services that also meet nutritional, exercise, mental health and social needs.

The current model of home care provision also prioritises price over quality of care in assessing providers, according to the Home Care Providers Alliance, and this needs to change to prioritise the provision of high-quality care that recipients want and deserve. Former Director General of the HSE, Tony O’Brien, who chaired the meetings of the Home Care Providers Alliance, said, “The Home Care Providers Alliance has come together to identify issues of concern to the entire sector and propose solutions to help end the dysfunction at the heart of the system. “The promised implementation of a Statutory Home Support Scheme, which includes the regulation of providers is long overdue. The introduction of a model that promotes quality care and addresses staffing issues is essential to ensure the care needs of the future are met. “Addressing the recruitment and retention challenges in the sector is crucial to the long-term provision of health care. Without a sustainable workforce, those who need home care, and their families, will continue to face the same challenges many years into the future.

At the launch of the “Future of Home Care” Report by the Home Care Providers Alliance, are: Catherine Cox, Head of Communications and Policy, F.C.I.; Noel O’Meara, Chair of N.C.C.N.; Tony O’Brien, Chair of Home Care Providers Alliance meetings; and Collette Gleeson, Board Member, H.C.C.I.

“The time to act is now.”

ACCORD HEALTHCARE LAUNCH SUNITINIB

Accord Healthcare is delighted to announce the launch of another High-Tech medicine to their already extensive portfolio of High-Tech medicines: Sunitinib 12.5 mg, 25 mg & 50 mg which comes in packs of 28 hard capsules. This medicine is indicated for treatment of:

Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.

Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available from the launch date at www.hpra. ie and for Healthcare Professionals at www.accord-healthcare.ie.

Sunitinib Accord will be available from both full line wholesalers from launch. For further information please contact Accord in Cork on 021 461 9040 or visit www.accord-healthcare.ie

When it comes to your patient’s psoriasis treatment goals

What means everything to the patient? The potential for nothing left on their skin.1,2

* Nothing on the skin: Defined as 75% achievement of PASI90 at Week 16 and ≥50% achievement of PASI 100 at Week 52 in UltIMMa-1 and UltIMMa-2.1 High skin clearance matters to patients: Patients who achieve and maintain high levels of skin clearance (PASI 90-99 or PASI 100) have significantly better HRQoL than those with lower levels of skin clearance (PASI 75-89).2 Sustaining high skin clearance or complete skin clearance is associated with incremental and durable benefits in HRQoL and mental health of psoriasis patients.2

PRESCRIBING INFORMATION (PI). SKYRIZI®▼ (risankizumab) 75 mg solution for injection in pre-

filled syringe; Skyrizi 150 mg solution for injection in pre-filled pen and Skyrizi 150 mg solution

for injection in prefilled syringe. Refer to Summary of Product Characteristics (SmPC) for full information before prescribing. PRESENTATION: Skyrizi 150 mg solution for injection in pre-filled pen/syringe: each prefilled pen/syringe contains 150 mg risankizumab in 1 mL solution. Skyrizi 75 mg solution for injection in pre-filled syringe: each pre-filled syringe contains 75 mg risankizumab in 0.83 ml mL solution. INDICATION: Plaque Psoriasis: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic Arthritis: alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: The recommended dose of Skyrizi is 150 mg by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter (either as two 75 mg pre-filled syringe injections or one 150 mg pre-filled pen or pre-filled syringe injection). Two 75mg pre-filled syringes should be injected for the full 150 mg dose. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available. Overweight patients: No dose adjustment required. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections (e.g. active tuberculosis). SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. If a serious hypersensivity reaction occurs, administration of Skyrizi should be discontinued immediately and appropriate therapy initiated. Excipients with known effect (75 mg solution for injection only): Skyrizi contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose. INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated. PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from Skyrizi therapy, taking into account the benefit of breastfeeding to the child and the benefit of Skyrizi therapy to the woman. Fertility: The effect of Skyrizi on human fertility has not been evaluated. ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification

of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; Website: www.hpra.ie. Suspected adverse events should also be reported to AbbVie Limited on 01-4287900.

LEGAL CLASSIFICATION: POM (S1A). MARKETING AUTHORISATION NUMBERS/PRESENTATIONS: Skyrizi 75 mg solution for injection in pre-filled syringe (Pack of 2 pre-filled syringes): EU/1/19/1361/001; Skyrizi 150 mg solution for injection in pre-filled pen: EU/1/19/1361/002; Skyrizi 150 mg solution for injection in prefilled syringe: EU/1/19/1361/003. Not all presentations may be marketed. Further information is available from: AbbVie Ltd., 14 Riverwalk, Citywest Business Campus, Dublin 24, D24XN32. DATE OF REVISION: November 2021 PI/1361/004 HRQoL, Health-Related Quality of Life; PASI, Psoriasis Area Severity Index. REFERENCES: 1. Gordon KB, et al. Lancet 2018; 392: 650-661. 2. Ryan C et al. Poster presented at the 27th European Academy of Dermatology & Venerology (EADV) Congress 2018; September 12–16; Paris, France. Skyrizi® Summary of Product Characteristics, available on www.medicines.ie. Date of preparation: April 2022 | IE-RISN-220005