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Government failure to approve Amyloidosis treatment ‘cruel’

Minister lacks ‘recognition of the pain and suffering Amyloidosis patients endure’ - ATTR Amyloidosis Awareness group

Padraig Mac Lochlainn

Donegal TD Pádraig Mac Lochlainn has slammed the government's failure to approve the drug Patisiran as 'cruel'.

“Cruel” was Donegal TD Pádraig Mac Lochlainn’s description of Government failure to approve the drug Patisiran for people with an Amyloidosis diagnosis.

According to Mr Mac Lochlainn, Patisiran was a “proven treatment” and has been approved by the European Medicines Agency (EMA), which was responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.

Speaking to Donegal Live, Deputy Mac Lochlainn said Ireland was extremely slow at licencing drugs, which have received EMA approval.

He added: “I tabled a Dáil question to Health Minister Simon Harris asking if his attention had been drawn to the ‘ongoing campaign by families of persons with amyloidosis here to be provided with the drug Patisiran as is the case in Northern Ireland’ and if he would make a statement on the matter.”

Mr Harris replied: “The ‘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 licenced indications, which have been granted market authorisation by the EMA 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 including the health needs of the public, cost effectiveness, potential or actual budget impact and efficacy.

“I am advised by the HSE that it has received an application for the reimbursement of Patisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

“In January 2019, a full health technology assessment was commissioned by the HSE. This assessment was completed in February 2020 with the National Centre for Pharmacoeconomics (NCPE) recommending that Patisiran is not considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. The HSE will assess this application for reimbursement in line with the 2013 Health Act.”

The recently established All Ireland ATTR Amyloidosis Awareness group said Minister Harris’ response “lacked any recognition of the pain and suffering Amyloidosis patients endure.”

According to Pádraig Mac Lochlainn, Ireland was extremely slow to approve EU licensed drugs.

He added: “I was contacted by a number of families in the Letterkenny area. Amyloidosis has a particular impact in Donegal.

“It is important to stress Amyloidosis is an umbrella term. There are various different types. Martin McGuinness impacted by this disease but not every case is the same. It can affect the body in different ways.

“I understand that in Ireland it takes 775 days to sign off on EU approved drugs. The Response from the Minister was very disappointing, especially to say Patisiran is not an economically viable option based on other alternatives.

“The issue is that Patisiran is available to people just over the border. If you are live in Derry or West Tyrone, you can get this drug and I am led to understand that it is having a very positive impact on people’s lives,” said Mr Mac Lochlainn.

Deputy Mac Lochlainn added there was “no drug out there that comes anywhere near Patisiran.”

He said: “For the Minister to say there are more affordable options is unbelievable. There may be other options, but they are derisory in terms of their impact in helping people with an Amyloidosis diagnosis.

“The difficulty is that the situation in Ireland is we are way behind in licencing drugs. In the EU, the average time is 493 days. In Ireland, it is 775 days, about 60 percent longer.

“We saw it with the Cystic Fibrosis treatment, Orkambi. It is just cruel. I am just going to call it what it is. I am not happy with the response. I cannot accept that on the Island of Ireland you would have an outcome that is really, really helpful in terms of improving the quality of people’s lives and it is a different story in Donegal.

“The clinical results are excellent by all accounts. I have to say, for me, I would be driven by the patients and who have raised this with me. They are obviously those who are living with this condition in Donegal and their families. They have said to me ‘Listen, this is just cruel to look across the border and we cannot get it here.’ I don’t intend to leave it at that. I intend to continue to raise this issue with the Minister, whoever the minister is going to be,” said Pádraig Mac Lochlainn.

The Buncrana TD said the key question was why Patisiran was not available to people in Donegal but it was to people in the Six Counties.








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