General medicines policy issues

Nine participants stated they were unfamiliar with the policy. However, four demonstrated a tacit understanding. It was questioned how policy intentions and decisions are made, in the context of being achievable: How do you attain that?...what is the right way to make those overall policy decisions… (pharmaceutical industry stakeholder, PI)

All participants believed medicines make a positive contribution to health. Differing levels of impact on health were noted. There was uncertainty as to how the impact is or could be quantified. The lost opportunity from not capturing and accessing data efficiently was voiced by two academics for treatment and outcomes monitoring: …we are not asking questions about patient health status before and after…so you can really see what is going on, at the GP level. Because that's at least as important as hospitalisation data (Academic, Ac)

Conversely, one participant said he would prefer to see more investment in epidemiology, as opposed to increasing the medicines budget, in a desire to preserve health.

Low socioeconomic patients were considered to have a higher burden of disease. Affordability to prescribers was described as the major issue, which may be compounded by the 2013 raise in prescription copayment from NZ$3 to NZ$5.

Despite access enablers, such as the High User Cards and Community Services Cards, it was questioned whether those in need are utilising them. One general practitioner (GP) said cost-sensitive patients could be managed with prudent prescribing and education on priorities: You could get all your medicines for less than a pack of cigarettes. It's educational priorities and various other things, where the effort needs to go rather than reducing the cost much further (GP)

The opposite situation of the misuse of access was described: I initially struggled to understand how somebody could pull up outside a pharmacy in a Mercedes Benz and…present their scripts for their family and handover their Community Services Card…As soon as they get in the country; they put the money into a family trust…So the wealth of the individual gets assessed, which qualifies them for a Community Services Card and then they wave that around (Pharmacist, Ph)

Sole supplyⁱ provision raised issues in terms of: supply outages when switching supplier (and having to pay for the alternative option) options for patient intolerance and vulnerability if a significant disruption in supply occurs (eg, a disaster destroying a supplier's warehouse).

There was an additional reference to policies and funding needing to be consistent and interlinked, especially for priority areas. ‘Quit-Line’ was given as an example: a NZ$40 million funded smoking cessation programme, described as having markedly less evidence than the appropriate medicines (which were not funded for many years). Budgetary constraints were the reason given for this. Equally, the government funding of ‘alternative medicines’ was described as something which needed a debate: …government is providing funding for people to obtain alternative medicines…real debate to be had…money better spent some place else in the healthcare system? (Pharmceutical Industry, PI)

One doctor voiced frustration at PHARMAC's Pharmacology and Therapeutics Advisory Committee (PTAC)ⁱⁱ being ‘generalists’ who override the recommendation of their subcommittee. With patient subtyping and genomic medicine on the horizon, he considered that ‘generalists’ may not understand what they are assessing and dismiss research, thereby inhibiting access. Access is then through an ability to pay for litigation and decided by a non-medical expert.

With demographic changes increasing the demand for healthcare services and a general movement towards increasing costs of new medicines, there was concern for future affordability of medicines. It was suggested that funding may move away from being population based and move towards funding health outcomes. An academic suggested that changes in copayments, taxation or medicines classification status may result. The oncologist had concerns that the lack of research (research being an attracter) being conducted within New Zealand will compound the low availability of future medical specialist prescribers. Extending prescribing ability to non-doctors was considered a help. However, for oncology, a medical specialist was still considered to be required to make treatment decisions.

Ethnicity issues

Most of the issues presented related to socioeconomic variables and are presented under General Medicines Policy Issues.

Those with poor English speaking skills were described as having access to an English speaking relative or even interpreters if needed: I think if they can access General Practice or the Hospital system, their access to the medications is just as good as anybody else's. I'm not aware of any specific ethnic problems in accessing our medicines… (GP)

One GP felt strongly that Māori and Pacifica access inequities are evident and are resulting in poorer health outcomes. He believes his colleagues are treating everyone the same but with inequitable risk: earlier intervention, improved communication, education and patient engagement are required: I think the key issue is the prescribers have a poor understanding of inequalities. Because, the prescribers generally approach things as; I treat everyone the same…they must have an inequity lens on anyone they see…but if the quality of your discussion and the quality in the way in which you prescribed that was poor i.e., you culturally are incompetent and you have a disconnect with the patient… (GP)

Other issues related to Asian ethnicities wanting treatment (oncology setting) irrespective of the likely outcomes and the use of alternative treatments, for example, St John's Wort or vitamin C injections impacting on medical treatment. One of the doctors had issues with alternative practitioners recommending such treatments.

Pharmaceutical Management Agency

There was general appreciation shown towards PHARMAC's strategy of creating competition in order to achieve a lower purchasing price. This was seen as advantageous for the purchase of a greater range of medicines, in the context of a fixed budget.

The budget was defined as the threshold for provision, which was considered too small by an academic and pharmaceutical industry stakeholder, causing a focus on cost as the driver of value and provision, thereby contributing towards ‘static efficiency’: If Pharmac's objective is to stay within budget then it's doing well…improve the health of New Zealanders within a capped pharmaceuticals budget…it's doing moderately well…objective were to improve the health of New Zealanders taking into account the financial constraints of Vote Health…it's doing poorly because it should be fighting for a better share of Vote Health (Ac)

A public service (PS) stakeholder offered the following standpoint: ‘You can always achieve more with more’ (in terms of a bigger budget), but an analytical framework is not in place that would define whether the medicines budget receives a fair proportion of ‘Vote Health’ or not.

PHARMAC's budget is determined at regularly defined intervals but medicines enter the marketplace sporadically. This has resulted in concerns from oncologists who believe that extra funding may not be available to cater the needs of patients.

The Private Health Care Organisation (PHCO) stakeholder thought PHARMAC's approach of requiring new and more expensive medicines to be better than standard medicines a ‘completely acceptable approach’. It was suggested by the PHCO and an academic that their approach could be more widely adopted, both overseas and with the expansion of PHARMAC's role to medical devices: …the expertise PHARMAC has built up…is something that we could learn from and borrow from, for the wider health sector…I'd like to see them take on medical devices, because that is absolutely scandalous that these products are getting onto the market without being properly evaluated… (Ac)

There was caution given by one pharmacist that PHARMAC's expansion into hospital medicines (in an acute care setting of moribund disease) may limit choices. Concern was shown for risk, if New Zealand is leading the world in this type of provision.

Provision was described as having a utilitarian focus: ‘The greatest good for the greatest number’ (PS) and described as being: you get what you need—not what you want. One doctor questioned whether the lost opportunity from not treating someone is being measured. Rare disorder patients were mentioned and are discussed under High Cost Medicines. The distinction was made that provision of a medicine in a cost-effective manner, which PHARMAC achieves, is not the same as delivering healthcare: I find some of their PR a little bit irritating…bray on about the marvellous healthcare they're delivering…delivering medicines in a cost effective manner but that's not saying it's delivering healthcare… (PHCO)

Questioning PHARMAC's undertaking of economic modelling received very favourable comments from 15 of the participants. Three participants were not familiar with economic modelling: I think it's world leading actually. No one else dares do it. That's the crazy thing. Here we are little old New Zealand and we dare do it (Ac) Well I mean, as a tax payer you could argue that for the majority of the products they get in, they've done a really good job of driving cost out of the system (PI) Technically it's very good. PHARMAC considers clinical effectiveness and cost effectiveness…they make trade-offs…they look at the QALYs and the number of people affected and how their quality of life will be improved and so on, I think is a very good model (PS)

It was suggested that the cost–benefit of returning an individual to their normal daily activities should be considered by PHARMAC, such as what Accident Compensation Corporation does when assessing intervention options.

A pharmaceutical industry stakeholder and academic were concerned that the required economic modelling submitted by suppliers is adjusted with unknown ‘in-house’ variables, making it hard for suppliers to understand decisions. This was contrasted against Medsafe's practice, where decision modelling is transparent: Pharmac receives a dossier from the company…Assumptions of statistical models get changed…QALYs get changed…population who will use the product get changed…that should be part of a scientific debate…companies don't know what information is being used to make the decisions on their products…we would like a right of reply to those…It happens with MedSafe…Not as though it could potentially negatively affect evidence based decisions (PI)

Delays in the submission process of up to 8 years, described as a ‘medicines waiting list’, were a matter of concern for an academic, pharmaceutical industry stakeholder and PGR, all of whom thought access was related to cost. There was a suggestion from one academic to follow Australia's submission process and outsource assessments from independent bodies.

Trans Pacific Partnership Agreement

Very few participants were familiar with the TPPA, which some referred to as speculation and no facts. One participant refused to make any comments related to the TPPA.

There was acknowledgement that trade deals are complex and often require compromises and trade-offs. New Zealand was referred to as a ‘small country’ and ‘we need our trade partners’. There was concern that already ‘big amounts’ are being spent on healthcare and the ‘benefits are low’ and if there is a resultant increase in the cost of medicines, where would resources come from to offset any cost increases.

The main issues were: (1) patent extension, delaying generic entry into the market, thereby prolonging a higher cost of provision; (2) industry influencing supply (described as an issue of sovereignty) may result not only in quicker access to new medicines, but also in an increase in public campaigns and appeal processes if PHARMAC's decisions are unpopular with the pharmaceutical industry or patient groups; and (3) transparency requests in PHARMAC's assessment process caused the most concern and confusion. One academic said he did not think PHARMAC could be more transparent and that transparency might mean the industry discloses its pricing processes and the results of all clinical trials.

In general, scepticism was voiced as to what the driving force is behind the agreement and what the benefits would be for New Zealand—with the USA being a protected market (heavily subsidised). Australia was described by a pharmaceutical industry representative as getting ‘trounced’ over their agreement with the USA, losing a lot of their pharmaceutical production and jobs as a result: Forget it…wouldn't even bother going along to the negotiations (PHCO); …tell the US to bugger off quite frankly. You either put everything on the table and we talk about it or no, you don't…We should learn from what happened in Australia… (PI)

Conversely, another participant suggested that while ‘America’ has influence, it may become limited as a result of the influence of China's developing economy and differing ideas around protection and new opportunities may develop: …a hugely developing economy in the form of China that basically has total disregard for such things…so the ability for America…is probably going to be limited in the world of the future, and maybe different forms of protection of ideas will kind of evolve…it's very hard to predict how the market might respond or what kind of new opportunities develop (PS)

A pharmaceutical industry stakeholder said Medicines New Zealand (New Zealand's prescription medicines representative association, same title as the policy) is attempting to ensure that its USA equivalent understands New Zealand's medicines system: …working quite hard to ensure…our sister organisation in the US is effectively asking the US government to achieve out of the process, is well enough informed to understand actually what the New Zealand model does achieve, what it doesn't achieve and how that can be improved…So we're working hard to make sure it's a process that actually benefits New Zealanders as well, and all of the transparency, timeliness, appeals—those aspects that we've discussed, are exactly I think what the US is likely to be asking for (PI)

Most considered that New Zealand's current ability to access generic medicines or independence in procuring medicines should be upheld. If not, funds may need to be redirected from other services or patient copayments would need to rise, in order to compensate a likely increase in the cost of medicines.

High-cost medicines

A GP questioned the necessity of continuing the Special Authority (SA)ⁱⁱⁱ status for a medicine once the appropriate use of a medicine has been established. Not all participants were familiar with the Named Patient Pharmaceutical Assessment (NPPA)^iv access scheme. Most high-cost medicines were described as being ‘breakthrough’ or ‘expensive’ and are restricted, to control spending. One participant said, if it was ‘dirt cheap’, there would be ‘no argument’, indicating the case even if the medicine did not have clear health benefits: My bet, is that PHARMAC would listen to anyone that agrees with them saying no. Because it's expensive…They are diametrically opposed for a reason and the reason is cost (Ph) The Rabbits in charge of the lettuce patch (M)

One PS stakeholder thought there to be no inappropriate blocking of access to medicines, as no complaints about access had been received at their level. Equally, another PS stakeholder commented that there are patients accessing medication costing up to NZ$500 000/year: …So it's not that the system can't cope with treatments that are high cost, it's just that we would expect a return for that cost and for it to be justifiable in terms of what we value (PS)

A small group of patients were described as not having access to high-cost medicines. Access was described as ‘the collective good’. On the other hand, ‘people dying from a lack of access to very cheap and simple therapies’ was described. It was suggested that it is DHB's remit to look after its population. A statement was made if we are advocating treatment at any cost: It's a question of who pays for all these things. I think if you have pretence; like there is in the USA, that cost isn't of any relevance…then you're going down the wrong path (PHCP)

The oncologist described the NPPA process as inefficient and that a comprehensive and referenced application takes him up to 6 h, potentially impacting on his clinic time and perversely hindering patient access. He suggested PHARMAC at a nominal cost could employ someone to aid in information gathering and, in the process, develop expertise.

Additionally, the oncologist believes oncology has the stigma that everyone dies but individual survival may be greater than the median survival assessment. This issue was presented in comparing the availability of two to three drugs in Australia that are unavailable in New Zealand.

Questions were posed: (1) is it fair to give fourth-line or fifth-line chemotherapy and not give a first-line treatment, for example, for rare disorders? and (2) when should one stop the treatment? A patient was described as gaining access to expensive medication; however, their condition was fragile and they died a few weeks later: I think it's important if Pharmac has a few loose strings in terms of hospital and severe rare conditions. They are perhaps because of how they are funded, they want a very narrow perspective on those, to try and avoid blow out. They are very emotive issues we don't always know how to best manage people's care (Ph)

High need patients, such as rare disorder patients, received the most sympathy for difficulty in access because of the exclusion criteria. Evidence requirements were described as difficult to attain due to the low patient numbers. Conversely, the PHCO suggested that the supplier needs to produce quality evidence: …where there's some evidence, but not solid or quality evidence:…the company doing the—providing the medication, it behoves on them to do some research in those areas and produce quality data (PHCO)