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THE HSE AND Vertex Pharmaceuticals last month struck a deal to make Orkambi and Kalydeco available to cystic fibrosis (CF) patients from 1 May.
Campaigners welcomed the development, which came after long-running negotiations.
CF, an inherited chronic disease that primarily affects the lungs and digestive system, can greatly impact the lifespan of those with the debilitating condition.
About 1,200 children and adults have CF in Ireland, which has more cases of it per head of population than any other country.
Cystic Fibrosis Ireland has said around 500 people in this country have the potential to benefit from Orkambi (patients aged 12 and older) and Kalydeco (children aged two to five).
The cost of Orkambi, about €159,000 per patient per year, was the primary sticking point. In 2016, the National Centre for Pharmacoeconomics (NCPE) assessed the drug and didn’t deem it cost-effective. The deal for both drugs is expected to cost the State in the region of €300 million over the next five years.
Under the Freedom of Information Act, TheJournal.ie has received copies of the emails exchanged between the Department of Health and Vertex prior to the agreement being reached.
Media reports
On 27 November, the Sunday Business Post reported that the HSE’s drugs committee was set to recommend against funding the medication.
Three days later, Simon Lem, Vertex’s Vice President for North Europe, wrote to Health Minister Simon Harris about the article.
Lem stated: “Vertex was disappointed to learn via the media over the weekend that the Health Service Executive (HSE) is considering not recommending Orkambi for the treatment of CF in the Republic of Ireland.
“Having continually engaged in good faith with the HSE since Orkambi was licensed over one year ago, Vertex had hoped that an agreement was within reach and is surprised by the latest developments…
“Vertex subsequently met with HSE representatives six times in five months, presenting a range of specific workable proposals that could expedite access for all eligible patients. At no time during the process did we receive a counter-offer or guidance from the HSE on decision making criteria.
“Proposals from Vertex included, for example, guarantees of budget certainty for the HSE, novel access schemes and ways to reduce the timelines on future reimbursement decisions.
“Vertex therefore refutes allegations by the HSE of failing to meaningfully engage and, the publically quoted budget impact figure of €392m is incorrect, unrealistic and does not reflect discussions to date with the HSE.”
Lem said Vertex has “spent over 15 years and hundreds of millions of dollars to date developing medicines for CF”, adding: ”Our mission is to cure the disease and we have a pipeline of medicines we are developing in pursuit of this mission.
Orkambi remains an important step forward for the treatment of CF, helping patients stay out of hospital, breathe more easily, gain weight and live longer lives. Recent clinical data has shown that Orkambi reduces annual lung deterioration by 42%.
“The present situation and manner in which information or misinformation is being communicated is causing undue fear and confusion for the patient community. We remain committed to finding a solution.
“We therefore call on you, as the responsible Minister, to intervene directly ahead of a decision by the HSE in the mutual interests of patients, clinicians and industry.”
‘Meaningful engagement’
In an email sent to Lem on 7 December 2016, Shaun Flanagan, Chief Pharmacist of the HSE’s Corporate Pharmaceutical Unit, asked if representatives for Vertex were “available for additional discussions”.
He added that the HSE was informed two Vertex staff members, Rebecca Hunt and Dr David Gillen, “told a small group of patients at a meeting on 5 December that Vertex were prepared to discuss further options”.
“Can you confirm if this is correct and whether Vertex have moved from the position of 1 December 2016 when you confirmed to us that the “final offer” remained the final offer.”
In response, Lem wrote: “We would like to continue our meaningful engagement, and would be available to meet at your earliest convenience.
“We are eager to reach a resolution as soon as possible, so with that in mind, would request the HSE and Vertex ensure the appropriate people are in the room who will be able to conclude an agreement, should one be reached. We are also open to having a representative from the Department of Health in attendance and suggest this could be beneficial to the process.”
In a later email sent to the HSE and Health Minister, Vertex’s Senior Vice President Simon Bedson wrote: “We are very much looking forward to meeting with the HSE and to putting an end to the uncertainty and anxiety that this process has caused to people living with cystic fibrosis (CF) and their caregivers.
Over the past year as we have been working toward an agreement with you, we have gotten to know many of these patients. With each passing day, they are progressively getting sicker and losing lung function. We share their sense of urgency to join the thousands of patients around the world who already have access to Orkambi.
“We believe we have a shared goal – to help these patients obtain Orkambi as soon as possible. As such, we feel strongly that the outcome of our next meeting should be a definitive resolution of this matter, which has already taken too long.
“To achieve this resolution, it’s critical that this meeting happen with the right people around the table, including the senior decision makers from both Vertex and the HSE.”
Bedson also asked the HSE to commit to postponing its final decision on the deal beyond 12 December, “pending resolution of our discussions”.
‘Deeply concerned’
In emails exchanged on 1 February, Lem wrote to Minister Harris, stating: “We are deeply concerned about media reports this morning that the HSE is considering rejecting our proposal that was developed after careful consideration and with input from the agency. We are acutely aware of the distress caused by this sort of speculation and have contacted the HSE to request urgent rassurance that these reports are unsubstantiated.
“More than two weeks have passed since we submitted our proposal to provide access to Kalydeco and Orkambi to the HSE. In this time, We have received daily calls from patients, and their families desperate for a solution. We understand that the proposal is going through the process but we share the frustrations with the apparent lack of urgency to make these medicines available to those who need them.”
Lem added that thousand of patients with CF have access to these drugs in other countries and “Ireland should not be an exception”.
In response, Harris’ private secretary David O’Connor told Lem: “The Minister has asked me to reply to thank you for your email and to say that the HSE has indicated that no decision has been reached regarding Orkambi and the matter is currently under consideration by the HSE Directorate. You may be interested to note that the Taoiseach also clarified this matter in the Dail this morning.”
The Dáil exchange he was referring to saw Enda Kenny tell Labour leader Brendan Howlin: “The suggestions in some media reports that the discussions and negotiations have broken down are not true. The HSE re-entered into negotiations with Vertex, the manufacturer of Orkambi, in December following a decision by HSE leadership that it was unable to reimburse Orkambi at the price offered at that time by the company…
The HSE subsequently met with Vertex in December and in January with a view to significantly reducing the cost of Orkambi for cystic fibrosis sufferers so that the State is in a position to fund the drug and provide it for Irish patients.
Kenny went on to say the HSE was considering the issue, adding that a decision on reimbursement would “be made on objective, scientific and economic grounds”.
“Decisions are now based on clinical and medical accuracy in light of the quality of life afforded to the patient and the extent of the improvement,” he added.
‘An extraordinarily difficult time’
Negotiations continued in the subsequent weeks, before a deal was reached on 11 April.
At the time, Harris said he recognised this had been “an extraordinarily difficult time for cystic fibrosis patients, for their families and for their friends as they have been waiting for this process to conclude”.
“With regard to Orkambi for the treatment of cystic fibrosis patients aged 12 and older, following an application by the company, the treatment was assessed in line with the statutory process, following which the HSE called on Vertex to re-enter negotiations.
“Further meetings were held with the manufacturer in December and early January. The discussions with the company broadened to include Kalydeco and further treatments for CF patients…
“I am pleased that we are now in a position to reassure people we are now in the concluding stages of an agreement as I outlined earlier and expect the further work in the coming days will bring this matter to finality,” Harris said.
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I cannot work as I am the full time carer of my special needs son, I have no other means of earning extra money. I get €209 per week carers allowance to care for him at home however, if my son were to go into a care home it would cost the state €2,880 approx per week and like most family carers that is a big difference in cost to the state. I have been on the housing waiting list for the past 9 years, and am in private rented accommodation and heading into my 60′s. I live in fear everyday of my landlord wanting to put the rent up and I cannot afford anymore money and we end up homeless on the street. We already do without most things that people enjoy, like a treat now and again, 3 meals a day when I can only afford to have 2 a day and that would consist of instant noodles and maybe mash and fried egg. Please don’t always put poorer down because we don’t have the money to buy a house and depend on social housing scheme. I wish FFG would do something about housing people and at least the rental income is going back to the state instead of going to Landlords on a large scale and free’s up the private rental market to those who can afford it if they so choose.
@Charliegrl80: I don’t think anybody would think you shouldn’t be housed by the state. There are other people who have made that difficult by taking from social welfare by doing nothing. Never forget landlords pay over half of the rent to the state. That is more than the state would get from renting the place themselves
@Kal Ipers: the people you talk about would be a small minority. The vast majority of people on social welfare would have stories like this and qualify for housing.
@Deborah Behan: Don’t confuse him with facts. Like the party he supports, he wants us all to focus on said minority, using language like scroungers etc.
@Deborah Behan: Facts please about the ‘vast majority’ If you have some data then we could have an informed debate.
@Deborah Behan: please tell me what political party I support because I would love to know. Several people have claimed I am loyal to all the main ones so what ever your answer is you are wrong just like them.
Blaming any one party for this situation is just stupid as it takes quite a while to get to pension and numerous parties are responsible. Or there are people responsible for their own situations at least in some situations. I don’t think they are the minority from my own personal experiences
@Mary Murphy: @Mary Murphy – the landlord with multiple properties that wants to see the return of bedsits. I’m afraid to say that most people of your calibre don’t have ‘informed debates’. You just hoover up the money and say ‘I’m alright Jack’.
People pray for housing but fine gael deliver nothing but promises and lies
@Richard Doherty: and then the people vote in ff/fg in the election…
@Richard Doherty: I forgot fg are the ones putting up the rent all over the country OH NO WAIT THATS NOT RIGHT IN THE SLIGHTEST
@Patrick Sage: Daniel Donovan: FG between them have a very large portfolio of property so it is in their interests to drag their heels on this issue. The Irish people are flooded with charities and I think it’s about time those who are well heeled take a proportionate amount of responsibility. fG are public servants on fat salaries and could give much more to the community, not invite property vultures in as tax free charities.
Re the Catholic Church, it is class discriminating and has fostered this spirit in the nation, as most of us have been educated by them. Hardly surprising our politicians are lacking in compassion or have a genuine interest to improve things for the homeless.
@Ruth Mannion: Can you tell used what is in this large portfolio of properties? Last I heard less than a 3rd rented properties and most were just average houses. Where are you getting this information?
@Ruth Mannion:
Did u make that up all on your own or did u get it on the internet?
@Richard Doherty: Maybe people should do more than pray.
Vultures gonna ensure huge problems ahead. FFG sold all…
@Willy Malone:
Maybe certain people should start paying their mortgage in that case….
@Fred Joyson: Or developers pay back the 100 billion they cost the taxpayer. Or is it the little guy has to pay for every thing.
“Isn’t there something awful about our society, which is very, very rich, that so many people are praying for a house of their own and not getting it?”
In one word….yes.
@Patty Cullinane: isn’t there something wrong that people can go from cradle to grave and never work but live off someone else’s toil and sweat.
@BigSFLou..ny: Those pensioners worked all their lives until they retired. They are all homeless except for the few who are only housed because of a charity set up by Willie Bermingham. Yes, it is awful.
@Fiona Fitzgerald: How do you know that? I know a relative that had a house and then retired early kept taking out loans on the house until he had to sell. He did to himself. I know people who sold homes and drank the money and then got council housing.
People can fall on hard times but some people are there through their own action.
@BigSFLou..ny: thank god the SCU is ‘winding down’. From your comment…the only thing wrong with this, is that it isn’t happening fast enough.
@Fiona Fitzgerald: why didn’t the save some money and buy a house?
@BigSFLou..ny: The man in the article retired. That means he worked. Not all people in his position are the never worked type. Some people lose their jobs, some people are renters at retirement age and the pension cant pay their rent and feed them. Hope you never loser your job, and if you do, hope you’re not surrounded by people with your depressing lack of empathy/
I prayed fir a bike once but God doesn’t work that way. So I stole a bike and prayed for forgiveness.
@Patrick Sage: but its ok for the government to steal?
@Patrick Sage: your on some bang
@Patrick Sage: thanks for your concern Patrick but, I was joking I have never stolen a bike or anything for that matter.
You seem very knowledgable on catholicism.
Money is the root of all evil- Timothy 6:10 Old testament- yet the last time I attended mass the collection box was passed around twice no less.and afterwards I was handed a form from my parish priest asking my consent to set up a direct debit from my account to his for €20p/m that literally was the last time I was in mass.
@Maggie O’Connor:
And you have been the local bicycle ever since
@Maggie O’Connor: prayed to win the lotto too, once you get a free house its a license to live off the state for life and it will just keep raining benefits the likes that cant be achieved by the heavily taxed middle earners.
the fight for free homes for all continues blame the bankers, developers and everyone but yourself ahh the easy life
@paul smith: here it is again, another comment about getting ‘free houses’.
Can you please tell me…where is this mythical land of ‘free houses’?
@Christy Nolan: did my comments annoy you that much Christy?.. I’m glad.
@paul smith: I work full time Paul never claimed benefits in my life Thank myself and no one else for it. Where did you get the idea ? Mass bashing is more fun than I thought.. really gets under peoples skin.
The answer to the question, why are Irish people obsessed with home ownership
@Emachine: The cost of rent vs a mortgage would be one reason…
@Oroku Saki: the article itself is the answer to the question.
@Oroku Saki:
A 300k mortgage will cost about 1700 a month. What point are u making?
Lads your not getting it, it’s we who voted them weasels in the first place….
@Karl Doran: People who make little or no effort in life tend to always blame others for their woes.
@Stephen Winterson: pretty narrow minded view stephen.
You think basing an economy around ever rising house prices is sensible?
Let me speak to you in a language you can understand. Big business – FDI – needs workers. Workers need to be housed. If Housing is expensive – wages must rise to pay for it. Eventually FDI says “housing too expensive, wages too high, relocate”.
The right wing, neoliberal “house prices must rise” model will sink your own ship.
So rather than blaming the poor – think about your own selfish interests.
Paid my mortgage off by the time I was 49 and boy was it difficult At times
900k are not below the poverty line because they earn less than €13k. How many do this as supplementary income to a household? I just hate figures being used to exaggerate problems
@Kal Ipers: There were 920,700 workers in 2017 who didn’t pay income tax as they earned under €13,000!
Vote for Sinn Fein next time people
@Shane Lad: they’ll Rob the taxpayer alright to pay for the rest. No thanks budster.
@Shane Lad:
Yeah, and watch the economy implode
Another impact of our dysfunctional housing policies. The problems are easily fixed but vested interests hold sway. Eventually, maybe after pensioners or even kids start dieing on our streets from hypothermia the political class (and electorate) will get the message and take on the vested interests.
Easy fix number 1 : Land cannot be rezoned unless first owned by the local council. This will take out the speculators and the resale cost to developers would be dependent on the number of social units in the developers plans.
Easy Fix No 2: Increase tax on second and subsequent properties. This will release more units onto the market for prospective home owners.
Easy Fix No 3 : Introduce proper tenant / landlord laws. They can do it on the continent why cant we? Proper protection for landlord and tenant.
Easy Fix No 4 : Rent controls. I mean proper rent controls.
Easy Fix No 5 : In the 1980′s when this country was broke, when emigration was rife and jobs as rare as hens teeth the government built more social housing than they do now. We are supposed to be a rich country. Where is da money? Build more social / affordable housing!
Hmm most people save first never mind the praying. Some people see social housing like a packet of sweets they want to have. Think I’ll have me one if them.
@Alan McCartney: and how are you supposed to save first if you’re working on the average industrial wage and your rent is 2/3 if your income ?
@Stephen Adam: well then you’re already in a house??.
@Stephen Adam: Myself and my missus rented a room (and later on, moved back with my folks) when we were saving for our mortgage. So our rent wasn’t 2/3 our income.
@Michael O’Neill: I see Michael. And what do you say to people who can’t do ether?
Do you think it is a sensible way to order society that people in their 30s – are forced to move back in with their parents – in their 60s and 70s – to be able to save for a home, only to be told that there aren’t enough houses.
Cop on.
What about average mortgage?
Don’t worry about pensioners. After abortion becomes legal attention will turn to euthanasia and getting rid of some of those pesky old pensioners. They have become too much of a burden on the state and we will have to kill some of them off but it will be done in a “caring, compassionate way” through legislation.
I’m sorry but if you’re homeless our praying for a house in this country you have obviously made some incredible stupid and irresponsible decisions in your life. Take responsibility and dig yourself out of the hole you got yourself in instead of lucky for the nanny state to bail you out. There’s no culpability for anything in this country, always someone else’s fault.
@Daniel Donovan: are you suggesting we take personal responsibility for our own lives? But what about the free sh*t for everyone brigade? Outraged lefty liberal bigotry in 3,2,1….
@Daniel Donovan: well, well, aren’t we the model citizen? No compassion or respect for people with real sometimes insurmountable problems? If you ever really suffered hardship you’d have a better understanding and show a bit more respect.
@Ruth Mannion:
Its not the people who are ‘down on their luck’ that annoy people, its the huge amount of lazy layabouts that want to spouse off of the tax payer to have a ‘free’ life.
@Nick Allen: Can you quantify these layabouts you speak off ?? You know, the ones costing the state billions???
@Ruth Mannion: I have compassion and respect for people that have suffered hardship. I don’t for people that don’t get off their asses and help themselves.
The trouble in Ireland is that the latter group get lumped in with the former which increases our costs hugely and means the former group don’t get the help we need.
This won’t change until our lefty leaning idiots cop on and start making some non populist decisions.
@Ruth Mannion: Actually this is all about compassion and respect. It’s called tough love. In the end, we will all be better off if the state didn’t bail out people, banks and investors that made bad decisions in their lives and, instead, people take responsibility for their actions.
Ireland is a failed society and needs adults in charge to fix it – urgently.
Highest GDP growth rate in EU is meaningless when single income workers paying the high rate of income tax of 42% on €36,000 p.a. ,cant afford to buy a home.
Starter homes in France: €160,000 … Starter homes in Ireland: €260,000
Voters need to bring their brains to the Polling booths next time.
https://www.change.org/p/referendum-on-family-home-special-status-in-ireland
Ask mammy or daddy they should sort you out
Shouldn’t that headline re “praying to keep their house”
Wrong state pension is 973 euros a month when we get our five euro rise
It’s an indictment of the FF and FG political gombeen idiots we elect to run the country.
What’s the emphasis on starter homes for,surely most homes are purchased to provide a lifetime residence..
They won’t be able to pay a mortgage either.
have your say