“One should judge a society by how it looks after the sick and vulnerable” – part toru
Chris Higgins – Muscular Dystrophy Association
Chris introduced himself as Chief Executive of Muscular Dystrophy Association. He was present to give the MDA’s perpective on high-cost medicines. Chris told the seminar that the MDA covers over forty neuro-muscular conditions, including Pompe Disease. All forty conditions are rare, he said.
Chris acknowledged Pompe Disease patients, Freda and Allyson, who were sitting in the audience. He thanked both women for supporting him, at the seminar.
Chris opened his talk by saying that Freda and Allyson “should be given a fair go”. They deserved the opportunity for a longer, and higher quality of life, so they can achieve their full potential. He said that going by what Freda and Allyson had been saying at the Forum, that family/whanau were really important to both women.
He added that family members of people suffering neuro-muscular diseases were important. Chris said that Freda’s grandchildren should not be deprived of growing up and getting to know their nana.
He said Allyson’s husband shouldn’t be deprived of the opportunity of having a long marriage with his wife. And Allyson’s children shouldn’t have to watch their mother slowly get worse, and then eventually be deprived of her altogether.
“And believe me, if you’ve ever been through the experience of having your mother die, it is a truly devastating experience. It just never leaves you.”
Chris then outlined his Association’s concerns. He spoke of being worried that the health system seemed unable to respond to the needs of people living with rare conditions such as Pompe Disease. He asked if other people with neuro-muscular diseases have to go through the same processes as Freda and Allyson have had to face.
Chris said that as new advances are made with drugs to treat neuro-muscular conditions such as Pompe Disease, and other rare diseases, that Freda and Allyson’s experiences will be repeated over and over again, as the relatively small numbers of sufferers result in high-priced treatments.
Chris then questioned whether Pharmac’s NPPA Scheme system was actually becoming a mechanism to justify their decisions to denying treatments, rather than providing access to much-needed medicines for rare diseases. He added,
“We’re concerned that Pharmac seems to have the ability to ration resources using cost-benefit criteria which do not seem to be applied anywhere else within the New Zealand health system. So it seems to be one rule for some, and another rule for others… because of that, MDA members, and I’m sure it applies to a lot of people in this room, as well, are starting to feel really discrimnated against by the New Zealand health system. Seems if you have a rare condition, you don’t get the same consideration from the health system as other people.”
Chris said that discrimination is inconsistent with medicines strategies as well as community values and ethics.
He said there seemed no political will to require Pharmac to relax its cost-benefit criteria, so access becomes a reality rather than a vain hope.
Chris then dropped a quiet ‘bombshell’,
“We’re coming to the point where [the] MDA has lost confidence that Pharmac will ever grant it’s members access to high cost medicines.”
Chris told the seminar that his group, in conjunction with others, will continue to support their members who are suffering rare diseases.
But Chris expressed a view that he did not believe that it would be a long term solution for the future. Instead, he offered a solution to this problem, by advocating for a separate agency, outside of Pharmac, of an “orphan drugs access programme”,
“We see that operating within the Ministry of Health but outside of Pharmac. And we see it as having access criteria which are a lot more relaxed than Pharmac’s, and [which] acknowledge the particular requirements of people living with rare conditions… the thresholds need to be different… and people need to be given a fair go.”
He added that a different mechanism will better address the medicines requirements of rare disease sufferers, and which are more equitable and reflective of community values.
Chris offered an ‘olive branch’ to the Health system and stated that the MDA is willing to collaborate with both the Ministry of Health and NZORD (New Zealand Organisation for Rare Diseases) in designing an affordable and mutually satisfactory alternative programme.
Jenny works for the support group, Lysosomal Diseases New Zealand. She gave a brief outline of events over the last few years – some of which has been covered by others at the seminar. She referred to one application, for treatment for Gaucher’s disease patients, that had “sat” on Pharmac’s desk for two years before being prompted to make a decision. Funding for that application was finally granted.
A subsequent application, for enzyme replacement therapy (ERT) for another rare disease was declined for a number of reasons, including, she said, that the applicants were “too sick” and “not sick enough“, etc..Some of those patients are now on clinical trials (Allyson) and some are untreated (Freda).
Jenny said that the 2008 election gave her group hope. The extension of Herceptin treatment from 9 weeks to 12 months was a campaign pledge from John Key in 2008 (see: 12-month Herceptin treatment now available) – and was enacted within a month of National being elected into office.
“The Minister of Health funded [an extension to] herceptin, and we thought this is actually a really good step. And we might get some of our other Enzymes [Replacement Therapies – ERT] across the threshold.
The Minister pledged to improve access to specialised medicines…… we took families to Wellington so they could meet the politicians, and tell their stories.”
Jenny’s group thought they were making progress in 2009 when a little boy, with Hunter’s Syndrome, was quickly given Pharmac funding to receive enzyme replacement therapy (ERT). Adult patients with similar conditions, though, were untreated and without funding for ERT.
Despite a Ministerial review to investigate how adults could gain access to treatment, there was no change, Jenny told the seminar.
Furthermore, in 2010, Allyson’s application for myozome (ERT) was declined by Pharmac, even though the Agency acknowledged there would be stabilisation and improvement to Allyson’s health through treatment.
An appeal to Pharmac’s decision was also rejected.
By 2011, Jenny said,
“We really ramped it up. We put a call out to the community and we asked our families to go and talk to their own local politicians; brief them about what we were doing; what we needed; about the issues around access to medicines. And John [Forman] and Chris Higgins got a meeting with Tony Ryall, who said to them that the ‘EC’ (exceptional circumstances) review would solve the problem.
Jenny’s group made submissions to Pharmac about the (revised EC scheme), the NPPA Scheme, stating that they believed that people with rare disorders would not make it past the threshold and “would be cut out”.
In September, three more applications were made to Pharmac for treatment for Pompe Disease. They were all declined said Jenny.
In desperation, the group brought a patient with Pompe Disease from the United States to New Zealand, so she could “tell her story” to Pharmac, politicians, and to the media,
“But still that didn’t make a change.”
Jenny then told the seminar about their experience in trying to seek a meeting with Prime Minister John Key,
“We went to Parliament to request a meeting with the Prime Minister. We got turned out. They got the security [guards] and we got bailed out of Parliament.”
Jenny read out a statement from Labour’s deputy leader, who called the decision to forcibly evict Jenny’s group, “cowardly and disrespecful”. (For more in-depth information how rare-disease sufferers have been treated by this government, see: Lysosomal Diseases New Zealand News & Issues . See Party responses here: Political party commitments on Myozyme and orphan drugs )
The National government had stated that the ‘new’ NPPA (Named Patient Pharmaceutical Assessment ) Scheme would solve the problem of funding for rare diseases,
“The High Costs Highly Specialised Medicines Review – a National promise – recommended PHARMAC review its Exceptional Circumstances process. PHARMAC did that and the result is a new scheme
to replace the old one called “Named Patient Pharmaceutical Assessment”. It starts next March and its budget is expected to go up from $4 million to $8 million in the first year.” – Jackie Blue
Jenny said that in August last year, her group tested the new NPPA process by submitting an application for treatment for Freda (see previous blogpost). Like Allyson, Freda has Pompe Disease – but is receiving no treatment whatsover.
“We thought we’ve got nothing to lose, let’s see if it works,” said Jenny.
“Well guess what,” she asked, “It didn’t work. She got declined.”
Freda “was not eligible” because, amongst other reasons,
“Pharmac had not provided a pathway forward for their new scheme for rare diseases. So in October we went to the Health Select Committee to ask for help. They sent us to the Minister. Then to the Ministry. Back to the Minister. And he said go and talk to Pharmac.”
They had nowhere else to go, except on a bureacratic roundabout.
Health Minister, Tony Ryall, simply refused to address their problems in any meaningful way.
Jenny outlined the stress on families whose loved ones were either not receiving medication because Pharmac refuse to fund treatment, or, were forced to fly to Australia every two weeks to be part of clinical drug trials,
“That’s a huge stress on their families. We shouldn’t have to do this when there are treatments available in New Zealand. And our patients say ‘it’s like genocide – they pay their taxes, they’ve contributed to society, why can’t we have a fair go?’.
Jenny then asked, “Where to from here? I guess we’ll have to have a Plan B for what [comes] next.”
Blogger’s note: With each passing story that I write up for this blogpost, I am more and more impressed by the sheer heroism of these good people.
See previous related blogpost: Health Minister circumvents law to fulfill 2008 election bribe?
John Forman introduced the next speaker, saying that the seminar had heard from patients and from support groups, but there were very few people who could contribute to this issue from an academic viewpoint. He said that few people with an academic or professional background were willing to challenge or criticise Pharmac and that many tended to have a sympathy for the core role that Pharmac has.
John explained that Dr Greg Coyle had written his University Ph.D thesis on the role of Pharmac and how it manages exceptional circumstances.
“It is exactly the topic that we’re interested in, and it’s exactly the kind of academic rigour, independent of a direct patient interest or family interest in this issue.”
Dr Greg Coyle
– Health Researcher
– Principal Advisor to the Salvation Army
Dr Coyle voiced his appreciation for meeting the members of the Forum the previous night (27 February),
“I want to thank the people I met last night…It was important to me for me to meet some of the people that I thought about; researched; and wrote about. And I’m the better for that.”
Following Dr Coyle’s very personal remarks that were directed to those present at the seminar, he launched into his pre-prepared speech and power-point present.
This blogger will re-print some of his main statements and the rest of the text of his speech can be found here: How does the operation of PHARMAC’s ‘Community Exceptional Circumstances’ policy align with the distributive justice principles of fairness and equity?
“Thank you for inviting me to talk about my research. The subject was fairness and how we might know if agencies are being fair when we ration health care, particularly pharmaceuticals, in New Zealand.”
“…Today I would like to spend a few minutes talking about my study into PHARMAC’s operation of the exceptional circumstances policy (now renamed the Named Patient Pharmaceutical Assessment scheme). This policy of PHARMAC’s was interesting to me because it is located at the very boundary where the needs of the whole society and the needs of an individual meet.
Examples of how we ration healthcare in New Zealand in an explicit manner are very rare. I do not wish to suggest that health rationing is rare –it most certainly is not –but it is mainly done in an implicit manner and patients and families often will not be aware that it is even happening. PHARMAC is one agency which is explicit about limiting care. Many of you know this well.”
“…So the questions I suspect that you want answered is how much cost for the treatment of a person with a rare diseases is too much? As a country do we have processes to decide this? Are the processes rational and fair? Would providing more money for public health mean that other sectors like education, police, welfare, public housing or recovering from natural disasters would be given less? ”
“…John Rawls, an American philosopher, developed a theory of ‘justice as fairness’the chief purpose of which was to ensure that utilitarian and consequentialist thinking, in meeting the greater good, would not sacrifice the position of individuals. He presented the principle that each person is to have an equal right to the most extensive liberty compatible with a similar liberty of others. However when social and economic inequalities are to be arranged, they should be arranged so that they are both to the greatest benefit of the least advantaged and attached to positions and offices which are open to all under the conditions of fairness and equality.”
“…Amartya Sen, a contemporary welfare economist, philosopher and winner of a Nobel Prize for economic science in 1998, developed a contemporary widely held view of distributive justice…
… He clarified perceptions of distributive justice in terms of a person’s capability to experience justice. Sen’s notions of justice are ultimately linked with the capability of people and how their lives are lived in the world.”
“… Sen held that the reach of health equity is immense and health care must be of primary importance in any discussion on social equity and justice;
“…health equity cannot but be a central feature of social arrangements in general”.”
“… Consequently, using these two philosophers, I posed the question of PHARMAC:
How does the operation of PHARMAC’s Community Exceptional Circumstance’policy align with the distributive justice principles of fairness and equity as described by John Rawls and Amartya Sen?”
“…I decided to distill their theories into four questions which decision-makers could ask of themselves to discover (or simply begin to debate) whether their decisions are fair and just.
Here are my 4 questions. I use the term ‘distribution’to mean decision, policy, funding or delivery of a service:
1. Would the most advantaged in society accept this distribution if they, at an instant, found themselves to be the least advantaged in society and requiring such distribution for themselves?
2. Is this distribution arranged so that it is attached to positions and offices which are open and accountable to all?
3. Is this distribution based on the efficiency of substantive opportunities and on procedural fairness in defining efficiency?
4. Is this distribution based on information available to decision makers about the capability of this person to do things he/she has good reason to value?”
“… We see the two purposes for PHARMAC in the governing legislation. One is to approve subsidy on an adequate range of quality pharmaceuticals for the general community. The second purpose is to approve subsidy for citizens whose needs are not met by the general schedule and considered exceptional.”
“… The evidence showed that in PHARMAC’s first purpose, general allocative policies have been highly successful in procuring an adequate range of quality medicines at internationally low prices.
PHARMAC has saved the New Zealand health system approximately $1.17 billion in 14 years. This has been achieved by methods of utilitarian efficiency analyses relying heavily on the Quality Adjusted Life Years calculation. PHARMAC has also expertly utilised subsidising and purchasing decisions based on evidence of clinical effectiveness.”
“… However, in PHARMAC’s second purpose, its success has been achieved, in part, by managing the claims of individuals in exceptional circumstances in a way that has not closely aligned the Rawls’and Sen’s principles of fairness, equity, openness and consistency.
The research shows that using the functions required of it by governing legislation, PHARMAC well achieves its statutory purpose. However, in doing so, PHARMAC must deal with the tension between justice as fairness to individuals whose needs are exceptional, and fairness to the needs of wider society.”
“… There are three structural problems here. The first is that PHARMAC has no stated philosophical principal on which to base its decision-making other than limiting expenditure to achieve its budget, which is not a principle but an outcome.
The Minister, parliament, the courts, the Ombudsman, DHBs, the pharmaceutical industry, doctors or patients have no way of knowing if the decisions being made by PHARMAC are fair to both the community and the individual. ”
“… The second problem is that PHARMAC and its committees claim to use the 9 decision making criteria to guide decision making. However, my research showed that the priority, or weighting, of the criteria are never explained. So one cannot know which criteria were met or not met when PHARMAC comes to a rationing decision. ”
“… The third problem is that under these conditions PHARMAC will always feel embattled and defensive because it cannot serve both purposes and adequately protect the Minister from criticism. My research showed that PHARMAC Community Exceptional Circumstances Committees don’t record the reasons for their decisions because they would most certainly be challenged. If I was a panelist I am not sure I would record the reasons for my decisions either because of the hazard of doing so.”
“… The pharmaceutical industry has worked out how to squeeze PHARMAC in the media over funding for pharmaceuticals for rare diseases particularly if these drugs are available overseas or the drug company has made a new drug available for a short period provided to individuals on compassionate grounds. Pressure groups, such as your own, highlight individual cases in the media appealing to the ‘Rule of Rescue’to raise public sympathy and put pressure on PHARMAC.”
“… PHARMAC’s claim that it simply does not have the budget for $500,000 a year for drugs for a single person is quite true. But the government does have budgets for other things for example $30 million for a sports stadium in Christchurch, $8m a year on ministerial limousines, assisting a private boarding school in Wanganui for $3.8m, a greater than $350m tax subsidy for the Lord of the Rings and Hobbit pictures or the government considering recapitalizing the state coal company for $400m… I could go on. ”
“… and one million for the penguin!” [Not in pre-prepared speech notes.]
“… In this first purpose they are world beaters and we should celebrate the relatively large savings PHARMAC has made…
… However in this system the needs of the individuals with rare diseases will always take second place. To achieve budgetary control over the community pharmaceutical schedule and provide for people in exceptional circumstances are contradictory purposes. The first purpose is explicit meso-level rationing and the second purpose is explicit micro-level rationing. They are not the same and cannot be treated the same way.”
“… Well what system for analysing pharmaceuticals for rare diseases would I propose?
Firstly I believe PHARMAC should continue to do what it does well which is carefully analysing clinical effectiveness and cost utility in the approval of subsidy for medicines for public hospitals and the general community.
(Slide 14) I believe the second purpose of PHARMAC, to approve subsidy for medicines for individuals with rare diseases should be handled by another agency administered by the Ministry of Health. Shall we call it the ‘Rare Diseases Funding Agency’ Its chair and members should be appointed by the Minister of Health.”
“… The Rare Diseases Funding Agency in New Zealand would be similar to PHARMAC in that it would have a fixed budget determined by parliament for the specific purpose of deciding on all claims not just for pharmaceuticals, but also for home support and other necessary assistance for people with rare diseases in the community. The agency would need to implement the medicine strategy including the objectives of efficient use of resources and fairness and equity considerations. I have no idea what the level of funding should be, but a starting point would be transferring PHARMAC’s budget for ‘Named Patient Pharmaceutical Assessment’scheme, I believe is $8m, to the Agency.”
“… Or, here’s an idea, a reallocation of a proportion of the savings made by PHARMAC could also be made to the Rare Diseases Funding Agency.”
“… Finally, there should be consideration of the fairness of decisions to individuals. Fairness can be a consideration because the Rare Diseases Funding Agency is separated off from the funding of pharmaceuticals of the wider public.
The agency should demonstrate openness and transparency about it decisions. ”
“…A good model of openness and accountability to consider might be the investigation and reporting mechanisms of the Office of the Health and Disability Commissioner which I hold to be exemplary.
Clearly PHARMAC and the Rare Diseases Funding Agency would have boundary issues and it would be in both agencies’interest to have a cooperative relationship.”
“… I believe that there will never be a time when all the pharmaceutical or other health needs of people who suffer rare or common diseases will be able to be met. This day will never come. But such an agency which I am proposing, underpinned by distributive justice principles, will provide an accountable, cost effective and fair system for analysing and managing the limited resources which are available for this purpose.”
“…In summary, (Slide 15) I submit that the current PHARMAC system delivers incredible value on behalf of the general community but it does not deliver justice as fairness to individual claimants who suffer rare diseases. I believe a new Rare Diseases Funding Agency, such as I have described, would.”
(Blogger’s Note: It’s apparent that a general concensus throughout the seminar was that Pharmac’s role to fund treatment for patient’s with rare diseases was not working well, and that a new agency was needed to undertake this responsibility
Lucy has been advising NZORD of legal matters in relation to access to medicines for rare diseases. She has been undertaking this role for a couple of years. She said this has been of limited success, and likened it to trying to put a square peg in a round hole.
“But it doesn’t necessarily need to be this way. The legal framework feels like it should be capable of making these decisions.”
Lucy said that the Health Minister and Ministry “make all the right noises” when it comes to accessing treatments for rare conditions. She referred to various agencies, laws, and documents which all indicate a need to improve access to highly specialised medicines.
Lucy said that all the documents which refer to specialised medicines and principals of fairness, equity, and distributive justice (prompted with a whisper from Dr Coyle), and affordability, should allow people to have a “fair go”. She read from legislation and Statement of Intent relating to Pharmac,
“… including in exceptional circumstances providing for subsidies for pharmaceuticals not in the Schedule.”
She pointed out that rare disease should be the “exceptional circumstances” – “they’re the diseases that are so rare, hardly anyone has them.”
Lucy pointed out that these are the drugs that Pharmac will never fund because they don’t meet their narrow cost-benefit, health-economics basis – which Pharmac uses so well for mass-market medications.
“And why would we fund these things?” she asked. “We would fund them because, we don’t want to abandon our citizens. We mount hugely exprensive rescue operations to rescue people stuck up on mountains even thought they’ve taken themselves up there. “
Lucy said that Pharmac considers that it doesn not need to take into account issues of morality, fairness, equity, and community values, because of the way legislation has been enacted. So they do not take those factors into account.
As a lawyer, Lucy said she would be assisting NZORD to ensure that Pharmac does take those factors into consideration, when making decisions.
“I don’t agree with their argument that fairness means the same processing criteria for everyone. Because it can’t be fair to say from the outset that this whole subset of patients will never be funded; ‘just rule them out’. There must be cases within that subset that deserve to be funded.”
Lucy added that in all cases the onus is on Pharmac’s decision makers to make their decisions with humility, empathy, and with respect,
“I think that Pharmac is exceptionally proud of the system that it’s developed and the $1.7 billion of savings that it’s achieved for the Schedule. Such that, ‘they shall not be questioned’. And I think that;’s really insulting for the people who don’t fit within that process.”
Lucy agreed with suggestions that a fundamental change to the system was required. She said that in the meantime “legally we have what we have”.
At the conclusion of the speakers’ addresses, there was ample time to mingle and ask questions. In a room full of people with serious medical conditions – many life-threatening – there was a strong feeling of cheerful optimism. Never underestimate the human ability for hope…
This blogger wishes to thank the fine people who invited me to attend the Forum; to hear their stories; and who trusted me to present those same stories in an appropriate, respectful, and honest way.
The thing that struck me the most was that these were ordinary New Zealanders who most likely have never thumbed their noses at authority; have never engaged in protest activity; and are your typical Middle Class fellow-Kiwis.
They are also people who’ve not been well treated by the system – including politicians who often promise The World – but when held to account – find shabby excuses not to help those who desperately need it.
This country – our government – could help sufferers of rare diseases. The money is there. Perhaps politicians could cut some of the subsidies they give to businesses; build one less motorway; take a bus instead of chauffered limousines (which Green MPs do very well); or any other number of savings.
The money is there.
It’s the will to spend it on medicines, which is lacking.
And to Allyson and Freda – you two are fabulous! My thoughts are with you both (and all the others who I met at the Forum, and those I didn’t). May the politicians and others in high positions of decision-making hang their heads in shame for how they’ve let you down.
You’re simply the best.
So who uttered the quote, “One should judge a society by how it looks after the sick and vulnerable”?
Look for yourself,
Fine words, Mr Prime Minister. Perhaps these people would like to know how deeply you believe them…
**Update** **Update** **Update** **Update** **Update** **Update**
NZORD has annnounced that it will be approaching the Office of the Ombudsman.
Previous related blogposts
Priorities? (19 Oct 2011)
Terminal disease sufferer appeals to John Key (12 Nov 2012)
Pharmac: The politics of playing god (16 June 2011)
$500,000 a year to keep toddler alive (5 Feb 2013)
Rare disease sufferers want pricey treatments (1 March 2013)
Rare disease takes awful toll on boy (1 March 2013)
Facebook: Support for Jethro Morrow Facebook Page
Facebook: NZ Rare Disease Day
Website: NZ Rare Disease Day
Website: Pompe Network
Facebook: Lysosomal Diseases New Zealand
Website: Lysosomal Diseases New Zealand
Facebook: NZ Organisation for Rare Disorders
Website: NZ Organisation for Rare Disorders
Pompe Support: Petition to Government Fund Myozyme for Pompe Patients
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