Written Answers Nos. 186-187
186. Deputy Jennifer Murnane O'Connor asked the Minister for Health when funding and approval for the immunotherapy drug pembrolizumab will become available for persons with bladder cancer which has migrated to their lungs; and if he will make a statement on the matter. [16442/20]
Amharc ar fhreagraThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
I am advised by the HSE that it has received an application for the reimbursement of pembrolizumab (Keytruda®) for two indications related to urothelial carcinoma:
1) Pembrolizumab (Keytruda®) indicated for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) 10.
2) Pembrolizumab (Keytruda®) indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
The application for the reimbursement of pembrolizumab with respect to the above indications has been assessed by the NCPE and the HSE Drugs Group, in line with the 2013 Act. The Drugs Group has given a positive recommendation for the application which has been progressed to the HSE Executive Management Team (EMT).
The application remains under consideration with the HSE. The HSE will make a final decision with respect to this application in line with the 2013 Health Act.
187. Deputy John McGuinness asked the Minister for Health if a hospital appointment will be expedited for a person (details supplied). [16458/20]
Amharc ar fhreagraIn response to the Covid-19 pandemic the HSE had to take measures to pause most elective scheduled care activity with effect from the end March 2020. This was to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work. This decision was in line with the advice issued by National Public Health Emergency Team (NPHET) and in accordance with World Health Organisation guidelines, and the National Action Plan.
To ensure services are re-introduced in a safe, clinically-aligned and prioritised way, the HSE launched its Strategic Framework for ‘Service Continuity in a Covid Environment’ on 24th June 2020. Its implementation will ensure service resumption is done in an integrated way. This will involve a phased approach to ensure community services are strengthened. The Framework will also consolidate new ways of working and build on international knowledge. The HSE is currently developing a Service Continuity Roadmap for the resumption of services across the health system. My Department, the HSE and the National Treatment Purchase Fund are currently working together to evaluate the impact of Covid 19 on Scheduled Care waiting lists, in order to be prepared to address pent up demand.
Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to investigate the matter and provide you with a direct response.
