Written answers

Wednesday, 21 April 2021

Photo of John LahartJohn Lahart (Dublin South West, Fianna Fail)
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1681. To ask the Minister for Health when CAR T-cell therapy will be available in Ireland in view of the €8.18 million spend on same abroad by the HSE between 2019 and 2020; if he is considering expediting approval for the therapy in order that immunocompromised patients will not be required to go abroad in order to receive lifesaving treatment; and if he will make a statement on the matter. [18631/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. Under the 2013 Act, the Minister for Health has no role in individual reimbursement decisions.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In line with the 2013 Health 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.

In making a relevant reimbursement decision on a given medicine, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness, and its potential or actual budget impact.

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 HSE has advised that there are currently four pricing/reimbursement applications for CAR T-cell therapies underway.

On 18 September 2018, the HSE received applications for pricing / reimbursement of Tisagenlecleucel (Kymriah) for the following indications:

- For the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and

- For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Following the rapid review process, the NCPE completed full health technology assessments (HTAs) for both of the above indications in August 2019 and September 2019, respectively. The NCPE recommended in both cases that Tisagenlecleucel not be approved for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

The HSE conducted commercial negotiations with respect to both of these indications in February and June 2020.

At its October 2020 meeting, the HSE Drugs Group considered Tisagenlecleucel for the ALL indication, reviewing the HTA report and the outputs of the commercial negotiations. The Drugs Group concluded that it did not have sufficient information to proceed with a recommendation and requested that further engagements be conducted with the applicant with a view to addressing the uncertainty in both the clinical and cost-effectiveness evidence.

At its November 2020 meeting, the HSE Drugs Group considered Tisagenlecleucel for the DLBCL indication, reviewing the HTA report and the outputs of the commercial negotiations. The Drugs Group was unable to support reimbursement at that time, having considered all of the criteria of which is obliged to take account.

In March 2021, the HSE received final updated information from the applicant. At its April 2021 meeting, the HSE Drugs Group again considered both applications and will now progress recommendations to the HSE Executive Management Team (EMT).

The HSE has advised that, on 6 September 2018, the HSE received a separate pricing/reimbursement application for Axicabtagene ciloleucel (Yescarta) 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.

Having completed a rapid review and a full HTA with respect to this indication, the NCPE recommended in February 2020 that Axicabtagene ciloleucel not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

The HSE conducted commercial negotiations with the applicant company in July 2020.

The HSE Drugs Group included this application on its meeting agendas in October and November 2020. Following extensive deliberations, the Drugs Group recommended that further commercial discussions be held with the applicant.

Following receipt in February 2021 of additional information and a revised commercial offer from the applicant, the HSE Drugs Group again considered Axicabtagene ciloleucel at its April 2021 meeting. The Drugs Group requested that further commercial engagements be held with the applicant company before the submission of any recommendation to the HSE EMT.

The HSE has also advised that, on 2 March 2021, it received a pricing/reimbursement application for Autologous anti-CD19-transduced CD3+ cells (Tecartus). On 22 March, the NCPE completed a rapid review with respect to this application and recommended that a full HTA was required. The HSE commissioned a full HTA on 31 March, as per agreed processes.

All of the four above applications remain under consideration with the HSE. The HSE EMT is the decision-making body for the reimbursement of medicines under the Health Act 2013 and it will, following receipt of the outcome of the Drugs Group's respective deliberations, make decisions on whether each of the above applications will be approved for reimbursement.

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