Graduate

Peter Burke
Fine Gael
Clare Daly
Independents
4Change
Jan O'Sullivan
Labour
Joan Collins
Independents
4Change
Niamh Smyth
Fianna Fáil
Talks continuing about cystic fibrosis drugs
Several TDs continued to question the Minister for Health in the Dáil about the current status of negotiations with the
manufacturers of the cystic fibrosis (CF) drugs Orkambi and Kalydeco. These included Deputies Marc MacSharry (Fianna
Fáil, Sligo-Leitrim), Clare Daly (Independents4Change, Dublin Fingal), Jan O’Sullivan (Labour, Limerick City), Joan Collins
(Independents4Change, Dublin South Central) and Deputy Billy Kelleher (Cork North Central).
Noting that the HSE had decided last December not to reimburse the company for the price sought, the Minister said
further meetings were held and “the discussions with the company have broadened to include Orkambi, Kalydeco and
further treatments for CF patients. The matter is currently under consideration by the HSE Directorate and by officials
in my Department.
“I expect that this process will conclude in a period of weeks. However, given the scale of the investment, the potential
benefits for Irish patients and the impact of this decision on the health service overall, I believe it is appropriate to allow
this statutory process to be concluded so as to bring certainty to matters.”
The Minister added that he was acutely aware that the last number of months had been a stressful and worrying time
for CF patients and their families. “However, the Government’s priority is to achieve the best outcome for Irish patients
and the health system overall.”
Replying to another question on the issue from Deputy Niamh Smyth (Fianna Fáil, Cavan-Monaghan), Minister Harris
said that, “given the scale of the investment and the potential benefits for Irish patients, I continue to call on all parties to
support the HSE in their engagement, and to provide the space for this process to be concluded”.
“The company must submit
a separate application to
extend a treatment to a new
cohort of patients, or for a
different indication of the drug.
Each application is considered
separately on its merits.”
Deputy Kelleher asked what
was the status of the drug
Translarna for the treatment
of Duchenne muscular
dystrophy, which he said was
currently available to 80% of
eligible persons across the EU
including Northern Ireland,
Scotland, England, Wales and
the Isle of Man.
The Minister said that the
HSE had taken a decision
in January this year not to
reimburse Translarna and had
informed the company of this
decision. “As HSE Leadership
has taken a proposed decision
not to reimburse Translarna,
there is no requirement for
the reimbursement of the
drug to be considered by the
Department of Health or
Cabinet.”
Deputy Dara Calleary
(Fianna Fáil, Mayo) and
Deputy Noel Grealish
(Independent, Galway West)
asked the Minister if further
consideration had been
given to making the drug
Nivolumab-Opdivo available
to cancer patients.
The Minister said
Nivolumab was subject to
separate health technology
assessments for a number of
different indications, and as
a combination therapy with
Ipilimumab for cancer. “The
health technology assessments
completed by the NCPE to
date have not recommended
reimbursement; evaluations
for the other indications are
still ongoing.”
Deputy Pearse Doherty
(Sinn Féin, Donegal) asked
the Minister to provide for
the reimbursement of the
cannabis-based medical
product Sativex for the
treatment of MS sufferers.
The Minister said that
an NCPE health technology
assessment report on
Sativex did not recommend
reimbursement at the
submitted price. The HSE
issued the manufacturers
with notice of its intention not
to reimburse. There were no
negotiations currently taking
place between the HSE and
the manufacturers of Sativex.
James Lawless
Fianna Fáil
Dessie Ellis
Sinn Féin
” The health technology assessments
completed by the NCPE to date have
not recommended reimbursement;
evaluations for the other indications
are still ongoing.”
Dara Calleary
Fianna Fáil
Simon Harris, TD, Minister for Health
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