PM Society Market Access Interest Group Meeting Highlights
- Meindert Boysen, programme director technology appraisals, NICE
- David Thorne, chief executive, Newcastle West CCG
- Eric Low OBE, chief executive, Myeloma UK
- Anne-Toni Rodgers, director, global pricing and market access, AstraZeneca
Chaired by Dr Beverly Barr, PM Society Market Access Lead (Director Zaicom International) and Andy Cowper, Health Policy Insight.
Dr Beverly Barr, Market Access Lead, PM Society introduced the meeting by highlighting that while everyone recognises the importance and challenges of market access, there is no single solution for or definition of, market access. She stated that this was hardly surprising as every stakeholder, whether industry, NHS, NICE or patient, defines market access from their own perspective. None the less all stakeholders want to achieve the common goal of timely patient access. The meeting programme was therefore designed to take into account the differing views of each stakeholder group involved in market access and to promote debate.
Andy Cowper summarised the new NHS situation for the audience and the impact of the Health & Social bill, apparently set to 'liberate the NHS'.
He observed that the NHS Commissioning Board is the biggest quango ever, costing four billion pounds a year and spending 20 billion pounds of NHS money annually.
In England, 10 regional bodies will become 31, while 150 statutory commissioning organisations will be replaced by (approximately 211) Clinical Commissioning Groups (CCGs), led by clinicians who have been elected by their peers. Every GP practice will be required to be a member of a CCG, which will be responsible for commissioning local health services, including emergency and out of hours care.
The NHS Commissioning Board (NHS CB) was set up in October 2012 and is independent of the government. The Board's main aim is to improve the health outcomes for people in the UK and it is also responsible for authorising CCGs. Authorisation is the process which will test that a CCG has the capability of delivering its new commissioning role against criteria including clinical quality, commissioning, finance, governance, organisational development and engagement. A deadline of 1 April 2013 has been set for authorisation, although not all CCGs are expected to be able to meet this.
Twenty five new Commissioning Support Units (CSUs) are intended to support the CCGs through authorisation and to help them deliver their responsibilities. They are tasked with 'using available expertise to help with the safe transfer of responsibilities within the NHS commissioning system during the process of transition'.
Although the NHS budget is protected in real terms by the government it is well recognised that with costs rising at around four per cent a year there is a gap in the healthcare budget. This is sometimes known as 'the Nicholson challenge' (after NHS CEO 2006-2012 Sir David Nicholson, who has mandated efficiency savings) or the 'QIPP Challenge'. In order to meet this challenge, the NHS needs to make significant annual productivity and efficiency gains.
The National Picture
Meindert Boysen, programme director technology appraisals, NICE
Meindart Boysen called for early engagement by all parties, citing this and information sharing, without needing to compromise the commercial agenda, as the key to successful market access. "When things are uncertain at NICE we tend to say no, even though the committees like to say yes! What we need is information." A key plea in his presentation was that companies should work through UK PharmaScan, as soon as possible, to help inform NICE about new products.
Boysen discussed the various possible definitions for value-based pricing and highlighted the issues regarding different perspectives on this. However, he explained, a key feature of value-based pricing is that there will be a cost effectiveness threshold. He questioned whether NICE should look to increase the number of positive health technology appraisals, suggesting that this is probably not the right approach. Boysen also warned of the danger of creating a system that needs endless conversations with multiple stakeholders, particularly when the time to complete a NICE appraisal has now been reduced to a matter of months. Otherwise, he observed, the NHS will simply hold back funding until NICE has commented. He advocated getting the technology assessment groups more involved in the conversation, reiterating the need for early industry/NICE discussion, but said that the quality adjusted life year (QALY) will remain and explained that much of value-based pricing depends on the QALY.
The other 'elephant in the room', Boysen commented, is the regulator and he questioned whether they are starting to encroach on NICE territory in the UK as they begin to monitor effectiveness.
Describing the changing role of NICE, Boysen explained that he had seen the organisation grow from 80 to 180 people and said that in market access terms there are many potential points of contact with NICE, which should be used more by industry. In addition to PharmaScan, NICE now manages and will influence documentation published by the Medicines Prescribing Centre and the British National Formulary (BNF) is also under contract to them. All of these will help doctors to understand more about medicines.
At the same time, it is an uncertain time for NICE because from 1 April 2013, it will no longer be an NHS body, but a non-departmental government body. Boysen commented: "This is a defining time for NICE as well as for industry." There is a different emphasis on NICE's work and the organisation will now be established in legislation and so cannot easily be abolished without changing the law''. Boysen concluded that From April 2013, it will be the CCGs that are the main customers of NICE and as such there are questions around whether they should be involved in the selection of health technology appraisal topics.
Also on 1 April 2013, the NICE board will stand down and a new chairman will be appointed. Since the meeting, it has been announced that this will be Professor David Haslam, immediate Past President of the British Medical Association and President of the Royal College of General Practitioners from 2006-09. It remains to be seen how this new influence might affect NICE policy. However, the funding direction for CCGs, as with PCTs will still come from the Secretary of State, based on NICE recommendations. NICE will continue to require that all its technology appraisals are automatically incorporated into relevant NHS formularies and will establish a NICE Implementation Collaborative to support prompt implementation of guidance.
NICE will continue to require that all its technology appraisals are automatically incorporated into relevant NHS formularies and will establish a NICE Implementation Collaborative to support prompt implementation of guidance.
The Local Picture
David Thorne, chief executive, Newcastle West CCG
David Thorne talked about the various contact points for pharma within the new NHS. He highlighted the need for pharma to understand local demands rather than coming in with a 'one size fits all' solution, in essence following the consumer marketing model where the approach is driven by demand and the agenda of the people who use the products.
"Commissioning is misunderstood," Thorne explained. "The whole point of the health service is actually to look at a population's health needs, note national priorities from the Department of Health – for example in vaccinations – and to find ways to meet those needs."
He gave the example of his CCG where life expectancy is only 67 - the same as that of a developing country - and which has the highest rate of binge drinking of any CCG. Over one third of ladies admitted to hospital to deliver a baby had smoked that day. "For an inner city area in the UK, this is a reality," commented Thorne. "But I don't often see an understanding or awareness of this from pharma – the cars they drive, the clothes they wear… there is a cultural mismatch."
Thorne advised that there are opportunities everywhere. On one hand, the CCG will need to care for a sick 46 year old male who smokes, has diabetes and heart disease and costs £4,000 if he is admitted for three days (over double the annual 'per patient' budget). On the other hand the CCG must find ways to work children, to stop them getting into this position. The questions are always how do you manage and prioritise these situations and needs in the context of limited budgets? For the CCGs, he explained that maintaining public confidence in the NHS is critical. He also observed that the new NHS will continue to be a centralised controlled structure, but that even so, companies should look to work with all the players in the field including CCGs, Commissioning Support Units, the Local Area Teams, the Health & Wellbeing Boards and the Trusts. Thorne recommended that QOFs, and addressing quality and productivity offer huge opportunities, but questioned how many company representatives have the flexibility to identify and meet an area's needs. He also flagged how industry is so much more experienced than the NHS in training and management and suggested that they could offer something here to CCGs. Importantly, Thorne suggested that pharma can bring together primary and secondary care to work collaboratively, in a way that might otherwise not happen and that in so doing, all might benefit from the one 'set' of money within the NHS system.
- Transition capacity and capability
- Organisational development and networking
- Business intelligence
- Management support, management systems and project management
- Education and training
- Facilitating integrated care
- QIPP and cost efficacy are fundamental
- transferable positive practice
- collaboration across sectors of health care
- speak our language and know our whiteboard
- Respond! Nb Ramadan and diabetes
"See the person and you’ve seen the company" it is all about you
The Patient Picture
Eric Low OBE, chief executive, Myeloma UK
Eric Low OBE opened with a comment that unlike ten years ago when patients might have been associated with emotion and anger, now they are increasingly important partners who recognise the multitude of problems in securing market access. In reviewing key considerations in the patient perspective he explained that it is critical to recognise that patients are individuals and that different patients want different things, in different circumstances. Many opt for choice where possible and some like to be part of the decision-making process, while others defer to the clinicians. Furthermore, it is difficult to calculate the value of a drug for a given patient. "Is the value of a drug to the patient the same as industry or NICE?" asked Low. He explained: "We may never know because we are asking the questions of the wrong people, asking members of the public to hypothesis about how they might feel in a certain disease state rather than talking to the patients."
Low added that a further problem is that often the value of a given therapy will be considered in isolation from other treatments, yet this is rarely the way it will be used in real life. The way a drug it is delivered – in terms of setting and convenience to the patient – and if/ how there are side effects to be managed are also important factors in its evaluation. Sadly, in many cases it is simply price that takes precedence.
Ultimately, it is important to weigh up the patient experience in all aspects of a treatment. The equation of product risk or side effects versus benefit will balance differently according to the individual patient. In an ideal world, clinicians should be aiming to identify what it is a particular patient wants and to deliver treatments or care to help them achieve that. However, this makes placing a value on a given treatment difficult and there is still much work to be done on this, particularly around the impact of treatments on patients.
Low also warned of the need for transparency by pharma over the way drug prices are set. He questioned whether the £50-80,000 price tags for certain treatments can be justified when they deliver such small, incremental benefits, extending life for only a matter of months. He commented how unfair it seems and suggested that the day may soon come when patients stop knocking on NICE's door claiming injustice and turn their attack on the pharmaceutical companies. "Can you tell me how you price drugs?" Low asked, questioning if the industry will have a robust justification for the level at which prices are set and demanding greater transparency.
As a representative for the patient perspective, Low explained: "We are trying to put systems in place to arrive at a point that allows us all to achieve our objectives. We need pricing transparency, otherwise you can no longer rely on patient advocacy," he warned.
When considering NICE appraisals, Low stated that they are only as good as the available data and encouraged the industry to consider developing additional evidence alongside the commercial data demanded by the regulators, which might include local- and real life data. The data from MRC studies, for example, could be far more valuable to the clinician than clinical trial data and there needs to be a way for this to be incorporated into the NICE appraisal process.
His take-home message also highlighted the need for early engagement with patient organisations and other agencies such as NICE, saying: "You have everything to lose and nothing to gain."
He commented on how decision making needs to return to the clinic for innovation to really triumph and suggested that commissioning as it stands stifles innovation. Doctors must be rewarded better for innovation and for offering patients the best possible option, possibly linking back to the lab to achieve this. Value-based pricing may not be the mechanism to achieve this.
Finally, Low bemoaned a system which takes so long to make an individual policy decision that the patient who could have lived a further four years is already dead. He warned that the Cancer Drugs Fund stifles innovation and excellence, commenting that it is evidence that the system doesn't work. "Rather than introduce the policy of value-based pricing (VBP), why not evolve the NICE system?" Low asked. "Let's work out what it is that NICE is not capturing or doing well that we think VBP might solve and evolve NICE, which already has 12 years of experience. In the meantime, a competitive environment that promotes innovation is the way forward, he concluded.
CONSIDER AS BOX OUT: Myeloma UK is working on a way forward. They have removed the silos and sit at a virtual table with NICE, clinicians DH, SMC and the industry all working together. Their solution is disease-specific, but they are looking at something that works in 3/10 patients and trying to identify what the criteria are that makes it work in these particular individuals.
There is a need to be more sophisticated in how the value of drugs is assessed and NICE can do that. However, it is also important to marry this up to the limitations of inputs to NICE? Myeloma UK is therefore advocating disease-specific, whole pathway modelling - in a way which can reflect clinical heterogeneity. Low commented: "If we can get the economics right we can create a pathway that can be commissioned at national level, and then let's do something really novel! Let's collect performance data against a set of KPIs and report back!"
Although myeloma is a small disease area, Low believes there is potential to upscale such a model to other disease areas.
A Pharma Perspective
Anne-Toni Rodgers, director, global pricing and market access, AstraZeneca
Anne-Toni Rodgers opened her presentation – representing her personal views – by stating that future-proofing with the NHS for pharma is about understanding the environment and the customers. She defined market access in the same way as she had back in 1999 when she held a role at NICE, as 'patients having access to products and services when and where they need them and that in turn that the products and services are fairly priced and reimbursed'. And that is what the NHS is trying to do now. It and pharma are on the same side. However, she highlighted the need for trust, warning that there is a phenomenal lack of trust between the public and the private sector and a sense that every penny that goes to shareholders could have been spent on patient care.
She encouraged pharma to take a different approach today, suggesting "Never be afraid to draw a conclusion/ make a decision, because others won't. If you can see something that can be seized and driven, take it forward!"
Rodgers called for the champions that are needed in periods of change, when so many others are scared. And in that context, she welcomed the current NHS reforms as a way of driving positive change and suggested that companies should come forward and work in partnership to engage with the NHS. Austerity is here to stay, she said, underpinning her arguments with data. She outlined how the UK is heading down the decentralised route for market access. Customers are fragmented and a special field force is needed as well as broader thinking, such as talking to the Health & Wellbeing boards.
Citing the current funding crisis in the NHS, Rodgers presented a model demonstrating how easy it would be to make 81-87% funding economies in the NHS.
"We need to look at how the people in the private sector drive change," she commented. "The smart NHS providers will be mapping patient treatment pathways and investing in this or that, for example smoking cessation. Pharma needs to do the same – to look at relevant pathways in the context of the care that patients are receiving so that they can identify how they can contribute."
"So, if you know that your pill causes constipation, go back to the CCG and package it with a constipation treatment and say we'll pay for that at the same time," Rodgers explained.
The solution for driving NHS efficiencies is about redesigning care across care pathways.
Opportunities for the industry in market access might come from a number of avenues including new customers such as the Health & Wellbeing Boards, co-payment/ personal health budgets, patient access schemes, joint-working, non-clinical prescribing and the National Service Frameworks (NSF) and local health promotion/ disease prevention programmes.
Rodgers also cited QOF, the Quality Outcomes Framework, as a key opportunity for industry, with 150 new measures to be introduced over the next five years against which GPs will receive their funding. She challenged the audience: "As a pharmaceutical company, if you don't know what your customer is doing, how can you meet the change?"
"Meeting the needs of the future NHS, requires a step change," Rodgers explained. It's not just the things that people think about, not just the product. The key will be strategic solutions and partnerships – transparency – not just pills. Data must be comparative not absolute and tailored to local needs, pathways and clinical indications.
It is about standards of care and social care will say it's about early interventions, alternative therapies and outcomes pricing, relevant to NHS pricing. So, there will be negotiations about differentiation relative to standard of care instead of innovation alone. There will be fewer 'me toos' and block busters and more outcomes pricing relevant to the NHS, with the possibility of different prices for different indications.
Importantly, it is about payers as customers, not 'hurdles' and there will be a whole range of different customers demanding new, sometimes non-clinical ways of communication.
"Trust is the fundamental thing pharma needs to engender in its market access [initiatives]. Unless it wins this trust, market access will still be a technicality.
Summing up, Rodgers said that the key challenges and opportunities can be seen as the same thing: "For some these will be opportunities and for others challenges. However, it is what your attitude is to these things that will make things happen. It is how you view them that will determine your success." The conclusion is that the pharma role in delivering market access is as it always was: right product, right patient, right place, at the right price and this means the right data, right customer, right message and the right time.
In addition, she concluded: "Trust is the fundamental thing pharma needs to engender in its market access [initiatives]. Unless it wins this trust, market access will still be a technicality.
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