The National Centre For Pharmaco-Economics got it wrong. In September 2011, the number crunchers at the NCPE conducted an economic evaluation of ipilimumab (Yervoy®) for the treatment of advanced (unresectable or metastatic) melanoma in adult patients who 
received prior therapy. The submission included a budget impact assessment for ipilimumab therapy based on a cost per dose exceeding €20,000 and an average cost per treatment (four cycles) exceeding €85,000. 

The National Centre for Pharmaco-Economics is identical in many ways to the UK system used to ration cancer drugs. The UK has the worst survival rates in many cancers for which records are kept. The NCPE decided that the probability of ipilimumab being cost effective over a willingness to pay range of €20,000/QALY (per quality adjusted life year) to €45,000/QALY was 0%. QALY is based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for being dead. If the extra years would not be lived in full health, for example if the patient would lose a limb, or be blind or have to use a wheelchair, then the extra life-years are given a value between 0 and 1 to account for this. The NCPE decided that a minimum cost of 20,000 euro (limited to 10 years) per annum to preserve a life was too expensive for the HSE and Insurance Companies. NCPE estimated total costs at  €4.8million - €7.4 million in 2012 increasing to €5.3 million - €8.2 million in 2016 and decided -"We cannot recommend reimbursement at the submitted price". 

As was subsequently exposed by Professor John Crown, the actual cost of Ipilimumab would be substantially less than NCPE estimated. Professor Crown rightly referred to the cost of Ipilimumab as an 'Investment' and so it has come to pass.  Health Canada has approved ipilimumab as a first-line therapy in adults with unresectable or metastatic melanoma. This means that Canadians with newly diagnosed advanced melanoma, regardless of the subtype, will be eligible to receive ipilimumab as their initial treatment. The long term savings both in human and financial costs cannot be overestimated. Invasive surgery with all the resultant costs has long been the first treatment for melanoma patients. The insurance companies who have refused to pay for ipilimumab on the recommendation of NCPE and subsequently dumped their customers back into the public system must be compelled to reverse their decisions. 

The NCPE got it wrong because it failed to consider the opinions of eminent experts or to look at other factors beyond immediate outlay, ipilimumab was and is an 'investment' in cancer care, not a cost. 

That moment I found out I had cancer was the last moment of my old life. I sat down on the floor as the doctor's words washed over me. I had no inkling that I had cancer, it wasn't on radar. Shock is a common reaction for most people and understandably so. Many thoughts ran through my mind but the one that didn't was depression. Four years on, the battle against depression is often more difficult than the battle against cancer. I get breaks from fighting cancer, periods where I'm waiting for it to move. I'm in one of those periods right now but the depression is a constant, it doesn't give me a break.

Cancer affects your emotional health. Most patients, families, and caregivers face some degree of depression, anxiety, and fear. These feelings are normal responses to fighting cancer and can be caused by many things, including the loss of control over life events, having to deal with changes in body image, fear of death, suffering and pain. Family members and caregivers can have these feelings, too. They can feel angry because someone they love has cancer, frustrated that they “can’t do enough,” or resentful because they have to do more at home. As the cancer situation changes, they all must cope with new stressors along with the old, and their feelings often change. People dealing with cancer that’s spread and is making the person feel worse often have more emotional distress than those dealing with early-stage cancers. Major depression is substantially more common in people with cancer than in the general population.

In the public health system, Oncologists will treat your cancer but your head is your own business. One particular memory that stays with me was when I was sitting across from a well meaning white coat who said-
"You have to remove the stresses from your life".
It would have taken hours to explain to him that I was financially distressed, that the more ill I became the more my wife (now x) loathed the very sight of me or that the reality of withering away and pissing my last on a trolley in a strange A & E was deeply frightening. Even if I had told him, there was nothing he could do about it.

I was lucky to have a good GP who could tell that I was an emotional train wreck. He worked to help me trough the most traumatic periods. A combination of medication and having someone to talk to in the Gary Kelly Cancer Support Center alleviated the constant thoughts of suicide that dogged me. 

Friends can be a great support but the longer you remain ill the less of them you will see. The specter of death frightens people, dealing with your mortality often reminds them of their own. In reality, you are lucky if one person sticks with you through thick and thin. A line from the movie 'The Beach' sums it up best for me - 

"I guess the important thing is to get eaten and die, in which case there's a funeral and somebody makes a speech and everybody says what a good guy you were, or get better, in which case everyone can forget about it. Get better or die. It's the hanging around in between that really pisses people off".

On the upside, cancer treatments are improving. The particular cancer I have has seen massive improvements in survival rates with breakthrough medications. That I and others have to fight a niggardly government to cover the cost of these medications is a little reported scandal. Government is the biggest stressor in my life these days, property tax, water charges and countless other vile cuts and nasty charges ensure that my quality of life is minimal. Long term illness practically guarantees poverty. At a time when I should be making the most of my life, I am instead making choices between food and bills. I pay the ones that can land me in jail but others just mount with no end in sight. Cancer is not a fluffy pink experience, it is a blue, blue time. So if you're a bloke too busy to get to the doctor, make time, get a once over. Early intervention leads to better results.

The most incredible cancer advancement in the fight against Malignant Melanoma made the front page of the Herald Sun Austalia yesterday. Manufactured by Merck Sharp and Dohme, the drug known as MK-3475 will be given free to patients with no other options under a special access program while clinical trials continue.

Hailed by oncologists as a miracle treatment, results show up to half of advanced melanoma patients receiving the drug known as MK-3475 respond to the treatment, compared with between 10 and 20 per cent using the most effective current treatment, ­ipilimumab (Yervoy).

The Herald Sun campaigned for the Australian Government to cut red tape and fast-track access to MK-3475. Last week following the extensive campaign by cancer doctors, support groups and Merck Sharp and Dohme, the Therapeutic Goods Administration approved a limited release of the drug. The Therapeutic Goods Administration is part of the Australian Government Department of Health and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. MK-3475 is just one of a number of similar immunotherapy drugs in development that use the immune system to fight cancer. The treatment will be granted to a handful of extreme cases each month. 

The extreme case that garnered attention right across Australia was that of Ron Walker. "Ron" Walker AC CBE is a former Lord Mayor of Melbourne and prominent Australian businessman, renowned for his work in managing sporting events. Mr Walker had his lifesaving treatment in the US as part of a clinical trial in early 2013, then personally appealed to his friend Prime Minister Tony Abbott, Health Minister Peter Dutton and drug companies to improve cancer drug access in Australia.

“Before I had the drug and I was diagnosed, I had a group of four doctors talk to me and Barbara and the consequences were very clear: it was just a matter of time. I was offered the opportunity to be part of the experiment and I seized upon it straight away, and just look at what happened to me. Without the drug, I wouldn’t be here - it is absolutely so simple,” Mr Walker said.

Its Australian release follows a similar move in the US, which came three months too late to save Melbourne-born dad Nick Auden, whose heart-wrenching Save Lachy’s Dad viral campaign raised the plight of victims. In the US, the development of PD-1 medications was hailed as a breakthrough and fast-tracked by the Food and Drug Administration.

Merck Sharp and Dohme associate medical director Colin Yoeman said the Special Access Scheme would allow treatment only for patients with advanced stage three or four melanoma that were not suitable for survival treatment. Crucially, in order to access MK-3475, patients must have been previously treated with the drug ipilimumab.

Two years ago, Ipilimumab was approved for purchase in Ireland following a very public campaign by advanced Melanoma sufferers and Joe Duffy's Liveline radio show on RTE. It had been disapproved for use on cost basis alone by the National Centre for Pharmacoeconomics who consider the cost effectiveness of all new medicines following receipt of an application for reimbursement under the Community Drugs Schemes. High cost products and those with significant budget impact are subjected to formal pharmacoeconomic assessment.

This week we learned from Joe Duffy that individual Insurance companies are now refusing to cover the cost of ipilimumab. A blog highlighting some of the issues and relevant pod casts are available here - 

Malignant melanoma is diagnosed in approximately 700 people annually and it claims 100 lives a year. Merck Sharp and Dohme has invested over 2.2 billion euro in Ireland in the last five decades. It employs 2,300 people in 8 sites across the country. We have a very good relationship with Merck Sharpe and Dohme and it is not inconceivable that MSD would be willing to allow the same access to MK-3475 in Ireland as in Australia.


Ipilimumab is the stepping stone to MK-3475. It is imperative that it is available to the very small few who will die without it. Until recently, Melanoma was one of the most deadly forms of cancer. Now there is real hope that lives can be saved immediately. May is Melanoma Awareness Month and this time, for the first time, there is genuine hope for the long term survival of advanced melanoma patients. 


ADDENDUM 


I wrote to Merck Sharp & Dohme yesterday-

Dear Merck Sharp & Dohme,
I would be most grateful if you would take the time to read the following blog regarding MK-3475 -

http://www.ramshornrepublic.com/in-the-valley-blog/melanoma-miracle

I have Malignant Melanoma and work to raise awareness of medical developments in this area. May I first express my heartfelt thanks for the life saving progress you have made. May I also ask if you will make MK-3475 available in Ireland on the same compassionate basis as in Australia. The number of patients who would qualify is really very small. MSD has a long history of employment and investment in Ireland and in Irish people. I truly hope that you will oblige once again and help to improve the outcomes for Irish people suffering with this terrible disease.

Yours sincerely,

Martin McMahon

THE GRACIOUS REPLY-

Dear Mr McMahon,
Many thanks for your enquiry about MK-3475 compassionate use in malignant melanoma. A compassionate use programme will be available in Ireland later this year for eligible patients but I am precluded from  giving you any further information. Please ask your oncologist to contact us as he/she must apply on your behalf. Alternatively your oncologist may contact Idis, the company that will be managing the compassionate use programme for MSD, to register your details at

Tel: + 44 1932 824 123
Email: mk3475row@idispharma.com.

 Yours Sincerely,
Cathal O’Ceallaigh
Dr. Cathal O’Ceallaigh MB BSc MBA MRCPI
Associate Director of Medical Affairs 

In 2012 a relative living in Canada tipped me off to a drug called 'Yervoy' which was getting some good results with malignant melanoma. Over the course of a fortnight I researched the drug online. I learned more in that two weeks than I had learned in the two years I had spent as an Oncology patient. 

The National Centre for Pharmacoeconomics conducts the health technology assessment (HTA) of pharmaceutical products for the Health Service Executive (HSE) in Ireland in collaboration with the HSE Corporate Pharmaceutical Unit (HSE-CPU). Basically, this centre decides the price of your life. They had added up the X and Y of giving stage 4 melanoma patients a final throw of the dice and come up with X + Y = Too expensive to try.

At the quoted price of 80 thousand euro, ipilimumab (Yervoy) was a price too far for an Irish Government throwing a million euro an hour at bank debt. 80k is steep, on that we can all agree but it doesn't have to be that expensive. All of the complex reasons behind expensive drugs boil down to one issue - Intellectual Property. Once patented, the Intellectual property owner of the drug enjoys a 20 year right to charge any price they want. Profit is the primary motivator for multinational drugs companies. The CEO of Germany’s largest pharmaceutical company Bayer AG said that their oncology drug Nexavar was being created for “Western patients who can afford” Nexavar rather than “the Indian market”.

Several years ago thirty-nine companies took the South African government to court over a law that made medicines more affordable. The South African government resisted. In 2001, owing to pressure from the public and from European governments, the companies dropped the case.

Patent reforms are currently being discussed by the South African government. The SA Trade Minister was recently reported as saying that his government was “striking a balance between innovation, affordable medicines, and to modernise our IP regime”.

WHO Director General Margaret Chan strongly supported South Africa. Director Chan stated that “no government should be intimidated by interested parties for doing the right thing in public health”.

Ireland, like many other countries suffering under imposed austerity, is demanding a better deal from large pharmaceutical companies. Patients are caught in the cross fire between profits and austerity. 

A dozen years ago, the Indian pharmaceutical company Cipla produced generic HIV/AIDS drugs that treated a patient for 300 dollars a year. The branded product’s cost was more than thirty times more expensive at 10,000 dollars per patient a year. Today the Indian generic version is below 80 dollars. India supplies 70 percent of the HIV/AIDS drugs obtained by the United Nations Children’s Fund (UNICEF), the Global Fund and the William J. Clinton Foundation for developing countries.

India has managed to keep the exorbitant prices of drugs down by either denying a patent (as in the case of Novartis’ Glivec) or by issuing a compulsory licence for a patented drug (Bayer’s Nexavar). India has a vast, largely home grown, pharmaceutical sector specializing in the reverse engineering of expensive drugs and selling generic versions at affordable prices. In recent times India has felt the full force of big Pharma, six Indian companies were recently bought up by large foreign firms. The Indian drug market may yet be dominated by multinationals again. It is uncertain whether they will continue to supply the developing world with cheap generic medicines when this may be in conflict with their own branded products.

India is the main supplier of affordable medicines to Africa and other developing countries.International health organisations such as UNAIDS, UNITAID and Doctors Without Borders have raised their serious concerns that these recent trends may threaten this role which has serious and far reaching consequences. Millions will die if India cannot produce the new HIV/AIDS medicines in the future. Three years ago during a visit to India, Michel Sidibe , executive director of UNAIDS said that it was a matter of Life and Death.

The pricing of life saving drugs in Ireland has recently come into focus again. Ipilimumab was made available following intense publicity of the situation by Joe Duffy on his Liveline radio show and heartbreaking stories from brave people like Cathy and Peter who have since passed away. Some health insurance providers have made the decision to exclude ipilimumab as a treatment option. In the drive toward Universal Health Insurance more and more drugs will be denied. Everybody switching or buying health insurance needs to examine the small print very carefully and ask specific question about particular drugs (some still in development). Your future may well depend on how your insurance company is pricing life.

From this weeks Liveline podcasts on the subject 

Wednesday 14th
- http://www.rte.ie/radio/utils/radioplayer/rteradioweb.html#!rii=9%3A20578790%3A53%3A14%2D05%2D2014%3A

Thursday 15th - http://www.rte.ie/radio/utils/radioplayer/rteradioweb.html#!rii=9%3A20579633%3A0%3A%3A

Friday 16th- http://www.rte.ie/radio/utils/radioplayer/rteradioweb.html#!rii=9%3A20580429%3A53%3A16%2D05%2D2014%3A

On the 15th of October 2013, Minister for Health, Dr. James Reilly stated:
“I am very happy to announce that I have secured additional funding of €37 million to provide for free GP care for children up to and including 5 years of age as a key element of this Government’s programme of health reform”.

If ever a statement exposed the disingenuous nature of this Fine Gael/Labour government, Reilly's statement was it. This was an untruth coached in 'friendly' political rhetoric in a transparent attempt to once again con the electorate. 

The true factual position is that the government planned to cut 666 million euro from the existing health budget, 43 million of this was going to come through increased charges and a further 113 million euro through a ruthless cull of existing medical cards. The first step was to increase the prescription charges by 66% resulting in a 5 fold increase in prescription charges in 4 years. Not satisfied with kicking ill, disabled and elderly people in teeth once, on January 1st 2014, the gross income limits for Medical Cards for people 70 years or older was reduced to €500 per week for single people and to €900 per week for a couple. Instantly, the number of people entitled to a legitimate medical card was reduced by 20,000. 28% of over 65's live alone and two thirds of these are women. 

And the kicks kept coming - Up to 18,000 more people lost their medical cards through what was called a 'tightening up' on how much a person could earn before they lost their medical card. Then came the real nasty - the Fine Gael/Labour government, embarked on what they called 'Probity' of discretionary medical cards. Discretionary medical cards had for years been a safety net for those who did not come within the rigid income limits. Health service medical officers were allowed to apply discretion in cases where people might be above the income threshold but would suffer undue financial hardship by accessing medical services. In 2012 the HSE service plan projected 85,000 discretionary medical cards for that year. In 2013 the numbers projected were slashed to 22,328. By the beginning of this year discretionary medical cards were re-written out of history. The final nail in the coffin came from the Junior Health Minister, Alex White who said that there was “no such entity” as discretionary medical cards.

In a spectacular crash and burn, it was finally admitted by the coalition that the 113 million savings in medical card probity was utter balderdash and the figure was revised down to 50 million euro. The misery this 50 million euro cull of medical cards has caused and is causing is now center stage with the advent of the twitter hashtag 'cardwatch'. GP's and citizens are posting examples of the Fine Gael/Labour pogram against the most vulnerable in our society. 

On the 30th of April the Fine Gael Parliamentary met and discussed the widespread anger at the medical card cull. The next day, Dr Reilly said he was considering introducing a ‘third- tier’ medical card. He stated:
“We’ve asked the TDs to give a list of any of the hard cases they have, the ones that they feel should have been given cards" .
Regardless of how Minister Reilly spins it, this is a recognition that discretionary medical cards were issued on a need basis and are an essential part of our health care system. Thousands upon thousands of people have been put through needless stress, humiliation and hardship only to have to go, once again, to a TD in order to have their overwhelming medical needs addressed and assessed by non-medical political representatives as was always the case with discretionary medical cards.

All of this hardship could have been avoided had Reilly and this government been honest in the first instance. I have re-written Reilly's statement of 15th October 2013 as we now know it should have been written:

"Fine Gael are going to slash the health budget by 666 million euro. Labour will cheer us on as we do it. We don't care how ill, disabled or elderly you are. Your health is not our concern. In order to save face and fool the gullible, we will sell this attack on the most vulnerable as an 'additional' 37 million euro to provide free health care to perfectly healthy under 5's, that should get us a few votes".

VERY DICEY REILLY

Ready for take-off, the beautiful G-DUNS hot air balloon in the equally breathtaking grounds of one of the Royal County's most elegant and best kept secrets - Bellinter House.
http://www.bellinterhouse.com/

Making memories with my children has always been hugely important to me. Since the cancer diagnosis it has been firmly at the top of my 'to-do' and 'doing' lists. So when Leo Forde, my twitter buddy, asked if I would like to fly in his beautiful balloon with my girls Katie & Lily, I jumped at the opportunity. 

Leo Forde @ http://waterstore.ie

Pre-flight checks were the first order of business when we arrived in the grounds of Bellinter House. The ground crew are a well practiced bunch of jovial balloon enthusiasts. The weather was perfect with hardly a breath of wind. Ideal ballooning conditions.

I didn't bat an eyelid when Leo's basket was gently lifted off the trailer with a 'Learner' sign attached. Leo spent many hours learning to fly solo before his licence was awarded. The training is as vigorous as that for the pilot of a small aircraft. The 'L' plate is ballooning humour, a humour as gentle and majestic as the balloons themselves.
 
The relative silence was suddenly shattered by an airborne daredevil.

The daredevil swooped in shedding altitude by turning in tight circles above us. The agility and skill of this man with a fan on his back and parachute over his head enthralled all present in particular the children. The small crowd gathered outside Bellinter House oohed and ahhed in the glorious sunshine as he put on a display to take our breaths away.

As the children played in the perfectly manicured gardens of Bellinter house, I did the boy thing and immersed myself in the mechanics of ballooning.
The whole kit and caboodle fits into a deceptively small trailer. Basket, balloon and gas cylinders are easily contained within the trailer making overseas expeditions comparatively easy. Leo has flown in Italy and elsewhere where weather conditions better lend themselves to ballooning.

The balloon itself is stored in a heavy sack and is drawn out like a magician pulls a handkerchief from his sleeve. When fully extended I began to see for the first time just how large the balloon actually is. 

It was all hands on deck to spread the deflated balloon out.

The balloon is inflated with cold air first as it lies on the ground. The red fan in the picture blows enough air to almost fully fill the cavernous space without lifting it from the ground. As always, it is a group effort.

Strong arms are needed to hold open the balloon mouth. These two gentlemen completed the job with practiced ease. 

The view of the inside was something really special (below).

The children were having a whale of a time running and climbing as both balloons were being inflated. For safety reasons they had to keep a reasonable distance away but I did sneak this photo of three smiling faces.

Leo's NAPPS balloon was almost ready to come to life. I stood well back as the burners roared into life and forced hot air in pushing the cold air out. And then the two balloons lifted silently form their horizontal positions to their fully vertical magnificence with the fabulous Bellinter House in the background.

One last safety talk and we were off. Katie and Lily held hands apprehensively as we soared into the blue sky. The butterflies in my stomach subsided as the sturdiness of the handmade basket quickly became apparent.

The G-DUNS Balloon floated lazily past the Boyne river as children in homes below came out to wave and yell.

Katie and Lily quickly relaxed into the experience as we soared above Royal Tara Golf Club. We could see people come out of their houses and stop their cars on the side of the country roads to watch and wave at the balloons above.

There really is something intoxicating about the oldest form of manned flight and oh the views.......

An aerial view of horse stud farm.

We saw fairy forts in the middle of lush green fields and recently born lambs frolicking to and fro bewildered at the sight above. Apart from the occasional blasts from the burner silence reigned supreme. Even Lily grew tired of asking questions and just basked in the wonderful experience. 

Daredevil paid us a visit one last time before we disappeared beyond his range. 

Landing was as gentle as take off. Leo picked his spot and lowered us in. Two soft bumps and we were down. The ground crew were there before us. Everything was packed up in minutes and my two girls were left beaming like a pair of cheshire cats.

Thanks Leo for making a truly majestic memory. Special thanks to Brian Meegan, Tom Forde, Andrejs Cailkovskis, Breda Farrell, Aiden Murphy, Grahame Green, Ciaran Wright, Barry Cronin & Ray Bergin.