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Medicinal Products Reimbursement

Dáil Éireann Debate, Tuesday - 24 July 2018

Tuesday, 24 July 2018

Ceisteanna (1319, 1444, 1445, 1505, 1711)

Frank O'Rourke

Ceist:

1319. Deputy Frank O'Rourke asked the Minister for Health if consideration has been given to a drug company's submission to add the drug Translarna to the drug reimbursement scheme (details supplied); and if he will make a statement on the matter. [32420/18]

Amharc ar fhreagra

Brendan Smith

Ceist:

1444. Deputy Brendan Smith asked the Minister for Health his plans to make the drug Translarna available through the HSE for the small number of young persons needing this particular medication in view of its availability in neighbouring jurisdictions and in 22 European countries in total; and if he will make a statement on the matter. [32933/18]

Amharc ar fhreagra

Jack Chambers

Ceist:

1445. Deputy Jack Chambers asked the Minister for Health further to Parliamentary Question No. 125 of 13 June 2018, the status of developments in the process of negotiations for the funding of the drug Translarna; the length of time the application process will take; his views on whether a two year long application process is too long a time period for many of those that require access to this drug (details supplied); and if he will make a statement on the matter. [32934/18]

Amharc ar fhreagra

James Browne

Ceist:

1505. Deputy James Browne asked the Minister for Health if he will request the HSE to engage with a company (details supplied) regarding the drug Translarna; and if he will make a statement on the matter. [33218/18]

Amharc ar fhreagra

Niamh Smyth

Ceist:

1711. Deputy Niamh Smyth asked the Minister for Health further to Parliamentary Question No. 158 of 23 May 2018, if correspondence from a person (details supplied) in relation to same will be examined; the timeframe for the drug to be made available here; and if he will make a statement on the matter. [34349/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 1319, 1444, 1445, 1505 and 1711 together.

The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act does not give the Minister for Health any powers in this regard.

The Act specifies the criteria to be applied in reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE.

Ataluren (Translarna) is a high cost medicine for the treatment of a subgroup of patients with Duchene muscular dystrophy, a rare disease.  Ataluren has conditional market authorisation from the European Medicines Agency for Europe - the condition being that the company carries out further clinical trials to determine the clinical efficacy of the drug.

Applications for reimbursement of ataluren were considered by the HSE Drugs Committee and Leadership Team in 2016 and 2017.  The HSE's final decision was that it was not in a position to fund the medicine on the basis of the current clinical evidence of effectiveness and the prices being sought by the applicant company.

The HSE informed the applicant of this decision, in keeping with the requirements of the 2013 Act. The applicant appealed the decision to the High Court, as part of the statutory process under Section 27 of the 2013 Act.

On 6 July 2018, my Department was informed by the HSE that a settlement of the High Court action had been reached. 

The Terms of Settlement stipulate that, in the event that the applicant submits a new reimbursement application for ataluren, it would be reviewed by the HSE in a timely fashion, having regard to the relevant statutory framework.

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