Thursday, 5 March 2020
Department of Health
Medicinal Products Reimbursement
581. To ask the Minister for Health if his attention has been drawn to the serious delays in the reimbursement of daratumumab Darzalex combination therapy (details supplied) for patients with multiple myeloma; the reason for the delay; when the therapy will be reimbursed and made available to patients here; and if he will make a statement on the matter. [2825/20]
800. To ask the Minister for Health if his attention has been drawn to the delay in the reimbursement of daratumumab combination therapy (details supplied) for persons with multiple myeloma; the reason for the delay; if he will direct the HSE to follow through on its approval decision made in 2019; and when the therapy will be reimbursed and made available to persons here. [3571/20]
801. To ask the Minister for Health if clarity will be provided to clinicians and patients regarding when daratumumab Darzalex combination therapy (details supplied) will be made available as a treatment option for persons with relapsed and or refractory myeloma. [3572/20]
I propose to take Questions Nos. 581, 800 and 801 together.
The HSE has statutory responsibility for medicine pricing and reimbursement decisions in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013 which specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the 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.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria. These reimbursement criteria are comprehensive and must all be carefully considered by the HSE when deliberating reimbursement applications, particularly as many of these reimbursement decisions represent multi-million euro investments by the State.
The HSE has received an application for the reimbursement of daratumumab (Darzalex) as indicated for use in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The HSE has advised that, following a positive recommendation from the Drugs Committee, this application is receiving active consideration by the Executive Management Team. The HSE has also confirmed that it is in contact with the applicant company and will keep them updated of all developments in relation to this matter.