An audience of agencies and pharmaceutical companies and others working in market access gathered at The Royal Society of Medicine for the first PM Society Market Access Interest Group event on 12th June 2018.
Market Access Interest Group
The PM Society Market Access Interest Group (MAIG) is made up of members from both industry and agency. It has three core aims: (1) learning and education; (2) celebrating best practice; and, (3) providing an opportunity to exchange ideas and network. Membership of the group is open to anyone with an interest in market access in its broadest sense, but the Society is particularly keen to hear from industry representatives.
Market access survey results Hassan Chaudhury (Health iQ) and Ram Patel (Brainsell) shared key findings from a recent survey the group carried out to assess members’ understanding of market access, challenges and trends, as well as needs and interests.
There were 104 responses (50% pharma, 41% agency and the remainder from CRO or medical devices). A total of 93 replies were received in response to the definition of market access. The average response length was 23 words (ranging from three words to 87 words). The responses were analysed for common words or phrases and the 10 most frequent phrases were used to come up with the following definition: “Ensuring patients receive appropriate treatment at the right time and right price, working with the local/regional NHS and their processes based on value”. While much of the previous definition was validated by the survey new emphasis was placed on processes differentiating the new definition from the old. It appears as though the definition of market access is shifting as the environment changes and the fluid nature may well be useful.
Full discussion of the survey results is available on the PM Society website here.
The survey will be repeated in June 2018 with similar questions and will also include questions as to how to suit needs/demands. Members are encouraged to participate.
Medicines optimisation looks at the value which medicines deliver. It is about ensuring people get the right choice of medicines, at the right time, and are engaged in the process by their clinical team. Four guiding principles of medicines optimisation help to support a patient-focused approach: (1) aim to understand the patient’s experience; (2) evidence-based choice of medicines; (3) ensure medicine use is as safe as possible; and, (4) make medicines optimisation part of routine practice. By focusing on patients and their experiences, the goal of medicines optimisation is to help patients to: improve their outcomes; take their medicines correctly; avoid taking unnecessary medicines; reduce wastage of medicines; and improve medicines safety .
Likened to the parable of the blind men and the elephant, experience and understanding of medicines optimisation can differ between stakeholder; three speakers talked about their perspective: Rob Duncombe (Chief Pharmacist, The Christie NHS Foundation Trust, Manchester), Diar Fattah (Associate Director of Medicines Optimisation, NHS Dartford, Gravesham and Swanley Clinical Commissioning Group [CCG]), and Dr Shirlene Oh (Director of Commerce, Innovation & Capability Development, Imperial College Health Partners).
Optimising the use of cancer medicines: Rob Duncombe
Rob Duncombe talked about medicines optimisation initiatives in place at The Christie NHS Foundation Trust to ensure cancer medicines are used optimally: this involves not only which drugs are used, but also how they are prepared and how and where they are administered. Examples of work to date include:
- dose-banding of chemotherapy as a way of converting an individual patient’s dose to a standard dose in order to reduce wastage of expensive cancer drugs, reduce costs, and increase efficiency, with no impact on the patient outcome;
- introduction of biosimilars into the cancer arena establishing important groundwork to facilitate the introduction of future biosimilars; and
- the introduction of more cost-effective dispensing routes.
In addition, as part of the national NHS England (NHSE) Cancer Vanguard, The Christie pharmacy department has also been instrumental in working with other healthcare providers (The Marsden and University College London Hospital) and industry partners in driving forward innovative ideas to optimise the use of medicines and improve patient care.
Rob moved on to consider next steps in terms of patient experience, evidence base, and safety. He noted that there is a lot more work to be done in terms of fully understanding the patient experience: how information related to that is captured and also how the health service delivers to expectation. Examples of topics to focus on related to cancer treatment included: personalised medicine, optimising treatment in elderly patients; improving delivery methods for chemotherapy; and understanding and managing the complications of newer therapies.
Access to medicines – challenges and opportunities: Diar Fattah
In the second presentation, Diar Fattah discussed the challenges and opportunities associated with access to medicines.
There is strong focus on prevention to prevent spend on avoidable illness by seeing patients more frequently in primary care and promotion of wellbeing; and a move towards whole system thinking (combined budget and holistic thinking). In this respect however, the current set-up often does not facilitate implementation; for example, with different bottom lines healthcare budgets do not encourage primary care spend for secondary care savings. There is a move, however, towards one bottom line with everybody working towards the same goal: achieving best outcomes for patients through more efficient spending.
Diar highlighted the following factors as challenges to access: defining “value” for money: contradicting definitions; cost-effectiveness vs affordability; fragmented structure of disease pathways; many committees; primary vs secondary vs tertiary interface issues; and the impact of Federations.
Variation with regards to the implementation of technology appraisals (TAs), and the need to get smarter. Despite horizon scanning, he highlighted the challenges of finding the funding in a resource constrained system for products with a positive NICE TA. He cited examples of: PCSK9 which has a positive NICE recommendation for the treatment of familial hypercholesterolemia but the uptake of the product has been poor and it has been difficult to identify eligible patients; and novel oral anticoagulants (NOACs), where rivaroxaban had an initially strong entry to market but recent real-world evidence (RWE) demonstrating fewer bleeds with apixaban has seen a shift in the market share demonstrating that RWE plays an important role in terms of longevity.
Market access for high cost therapies innovative and curative therapies. Diar stressed the importance of having early conversations with payers as these products will have a substantial impact on budget and consideration of different approaches to contracting. Citing the example of the Agenzia Italiana del Farmaco (AIFA) assessment of Strimvelis® (GSK) Diar highlighted some solutions to known challenges including; for example, high upfront cost solved with a baseline payment and annual mortgage payments; and, risk share surrounding the uncertainty of effectiveness whereby pay for performance full refund by GSK if a patient requires other treatments after receiving Strimvelis®.
In challenges he commented there are opportunities – new partnerships, innovative contracting. Transparency in terms of communication between stakeholders and early engagement is key.
AHSNs and medicines optimisation: Shirlene Oh
In the final presentation, Shirlene Oh, discussed medicines optimisation from the perspective of the Academic Health Science Networks (AHSNs).
Four AHSN supported medicines optimisation national programmes were highlighted in the presentation. Shirlene presented a case study of the stroke prevention programme to reduce the burden of atrial fibrillation (AF)-related stroke and related mortality. AF can be controlled with drug treatments to prevent further complications, predominantly strokes. Data for outcomes after discharge in people with known AF who are not anticoagulated before their stroke is compelling. Despite this, however, patients with possible undiagnosed AF and those with AF at high risk of stroke who are not anticoagulated are not routinely identified and treated. The AF programme has 3 aims: (1) detect (find more); (2) protect (treat more); and, (3) perfect (treat better). Through collaborative working across the care pathway the programme supports community and primary care to identify those at risk and treat them. You can find out more about the AF toolkit here. The aim is to apply the process that has been used for AF to initiatives in other conditions.
Shirlene highlighted the challenge of trying to retrospectively fit an innovation into the NHS: instead, she stressed the importance of working collaboratively to identify need, and in forming partnerships to identify solutions which in turn help facilitate the adoption of innovations. Shirlene concluded her session by highlighting five lessons learned from work completed to date: (1) take adopters on a journey (commissioner, GP, community pharmacist, nurse, patient); (2) validate in a real-world setting (patient-linked record across settings to make sure understand something about them in the real word); (3) test combinations of innovations to provide solutions; (4) seek longer-term funding (>2 years); and (5) align incentives to provide value for patients, payers, and providers.
Commenting ahead of the panel discussion, Mike Ringe (NHS Engagement Partner [London] and Specialised Commissioning Lead ABPI) added that following the four guiding principles set out in “Medicines Optimisation: Helping patients to make the most of medicines” could facilitate the shift towards a more holistic approach. Moving forward, however, the immediate challenge surround implementation and supporting the introduction of medicines optimisation initiatives / models will be key.
A discussion concluded the session on medicines optimisation with panellists Rob Duncombe, Diar Fattah, Shirlene Oh, and Mike Ringe. Some of the points raised included:
- With the newer high-cost technologies, new challenges will be faced both in terms of commercialisation and how the NHS prepares for their introduction. The panel considered that data will be key: the stronger the data the better. In addition, for the newer therapies high quality real world evidence (RWE) in addition to classical clinical trial data will likely be required. In a potential payment for outcomes model, data and data quality are expected to come under greater scrutiny.
- Regarding the UK's exit from the European Union, the panel were asked to comment what impact they thought this would have on clinical research in the UK. The panel commented that currently the UK is maintaining a competitive position in relation to Europe, according to the Medicines and Healthcare products Regulatory Agency (MHRA) report on clinical trial applications by phase. The panel considered there to be a real risk, however, in terms of supply chains but noted that Industry is preparing and considering contingency plans.
- Putting aside affordability and considering the advancement of technology the panel were asked for their view on what prevents adoption and what might be done to change that? The panel commented that organisational barriers will always be there: changing established behaviour is difficult and organisations need a clear system/s in place to support implementation. Recommendations from the panel were to connect with key stakeholders and to link the innovation to a consequence. The need to support innovation in the NHS has also been recognised by NICE.
- Referencing the Wanless report (2003) which made assumptions about the ability of people to take greater responsibility for their health bringing an estimated saving to the NHS of £30 billion, the panel were asked for their thoughts on the role of the patient in medicines optimisation. In this respect, the panel considered there would be a need for cultural and behaviour change to reverse the expectation that the NHS will “take care” absolving people of the responsibility of looking after own health. Primary prevention; e.g. lifestyle changes was, however, considered key: as a population we do not age healthily. Reference was made to the “Meet MO” videos produced by Wessex AHSN which were produced to encourage and engage patients to book a medicines review with their local pharmacist and GP.
- How often are approaches in other countries taken into consideration in commissioning? In general, do sometimes look to other jurisdictions for learning points but often the question is whether they can be implemented in the UK.
- The current UK landscape was noted as a barrier to incentivising companies to introduce products in the UK, and the panel were asked at what point discussions regarding payment schemes should be initiated. The panel advised to engage as early as possible.
Integrated care systems – evidence for a joined-up approach?
The second half of the agenda opened with a session on integrated care systems (ICSs) introduced by Shirlene Oh. In her presentation Shirlene discussed ICSs and the evidence supporting these models.
Integrated care happens when NHS organisations work together to meet the needs of their local population. Some forms of integrated care involve local authorities and the third sector in working towards these objectives alongside NHS organisations. Research from the Kings Fund has identified three main forms of integrated care: ICSs; integrated care partnerships; and accountable care organisations. An accountable care system is “one in which a group of providers are held jointly accountable for achieving a set of outcomes for a prospectively defined population over a period of time and for an agreed cost” .
Integrated care partnerships include a variety of stakeholders; e.g. commissioners, hospitals, GP Federations, community mental health, and local authorities. Each partner signs up to a particular patient journey. Historically partnerships have focused solely on health without recognising the impact of social determinants on health and wellbeing. Shirlene commented that a person may have many interventions in place in terms of care provision; however, if factors beyond health are not acknowledged the provision often does not meet patient need.
The integrated care model aims to increase health gain. In Berwick et al’s “Triple Aim”, three critical objectives to optimise the provision of healthcare and health system performance: (1) improve the health of the defined population; enhance the patient care experience; and (3) reduce the per capital cost of care. Bodenheimer and Sinsky added a fourth aim to improve the engagement and motivation of the workforce – the so-called “Quadruple Aim”. This fourth factor has a key role in achieving integrated care and achieving the primary goal of the “Triple Aim”.
The World Innovation Summit for Health (WISH) reviewed several international accountable care models (McLellan et al., 2014 ). Some models provide more evidence than others: evidence from centres with a like-for-like population have demonstrated reduced expenditure, increased life expectancy, and improved health outcomes. In order to shift the focus towards population health it will be important to take a broader perspective: a challenge in the current model which supports provider organisations. Five key functional components involved in implementing accountable care were identified: (1) define a specified population for which providers are jointly accountable; (2) determine target outcomes for the specified population – importantly these should be outcomes that matter to people in that population, including resource use; (3) develop and define metrics to help determine whether outcomes are improving; (4) restructure payments and other incentives to align with target outcomes (shared risk); and, (5) coordinated delivery of care within teams, across providers and between providers and patients.
Accountable care reforms are in their early stages, and they involve a broad variety of healthcare organizations, populations, and starting points. In the UK, for example, there are still many jurisdictions which don’t receive funding from NHSE to invest in accountable care models. Investment and support to establish these models is key.
A discussion concluded the session on integrated care with panellists Shirlene Oh, Dr Mateen Jiwani (Medical Director, Enfield CCG), and Mike Ringe. Some discussion points included:
- The challenge of moving to an integrated care approach in the NHS with so many different regulators was noted.
- Dr Jiwani commented that the current system is very fragmented where, contractually, different stakeholders have different aims. The reality is that there is not enough resource to fund everyone in the same way so the resource needs to be shared in an equitable way. With integrated care, stakeholders will share finance and common goals. The vision is right but there is much to do to facilitate implementation.
- Pooling risk such that organisations work towards a common goal, should equal greater accountability in the system.
- Setting budgets could be a challenge as the population needs to be defined before the capita budget can be set—need reference spend for a like population and then some means of understanding likely costs.
Question and answer
The afternoon concluded with a panel discussion chaired by Mr Mark Duman (Director, MD Healthcare Consultants Ltd) and included panellists Mike Ringe, Dr Shirlene Oh, and Dr Mateen Jiwani.
Mark Duman opened the Q&A session mooting the idea that, for patients, market access is not just about health technology assessment or formulary access but about “closing the loop”. He queried why, in an outcomes-based system, more is not done in respect of adherence and compliance. Would programmes whereby targets have to be reached for payments (percentage when clinical outcomes in RWE are aligned with those seen in clinical trials; percentage for setting up a patient support programme; and a percentage for research and development); or where patients are asked to sign a contract committing to take a medicine to best of their ability have a place?
Discussion followed on how to incentivise patients to take their medicines. Ultimately it is about ownership of personal health and how invested someone is to respond to a given incentive. Is incentive to improve outcomes not enough? Could payment work as an incentive? Working on the basis of improving outcomes for patients, adherence is the outcome of a positive experience. One suggestion included flipping the current model in which patients visit a GP or other care provider for a service, to a model where the GP or other care provider enters a patient’s life at a certain part of their journey so the patient hosts (a human centred design). Technology is beginning to change things; for example, video conference GP consultations.
In another discussion point reference was made to companion diagnostics – medical device/s which provide/s information that is essential for the safe and effective use of a corresponding drug or biological product – and whether there is scope for companion support programmes where treatment compliance is known to be particularly bad.
Market access is a means of working with stakeholders to make sure the medicine is in the right place within that health economy. Embedding market access comes back to the need to engage and enable someone to go on a journey with you but the main challenge in achieving this is the lack of continuity of care. The introduction of new models of care is challenging: embedding new models takes time and after a few years decommission and change is not uncommon.
The panel commented that there are examples of where integrated care is a success in the UK but noted that more work needs to be done. Shirlene commented that the AHSN run a quarterly learning lab looking at an ICS in another part of the country to understand where they are and commonalities. In addition, the panel remarked that there are some very good Vanguards to reference.
Ultimately patient-centred care may require a cultural change: to change the mindset of the healthcare provider from “fixing a problem” to “creating a positive experience for the patient to facilitate fixing the problem”; and, to change the mindset of the patient in terms of the way we think about health incentivising awareness for personal health from early years.
The meeting closed and was followed with the opportunity for networking.
If you want to know more or to join the PM Society Market Access Interest Group, please contact Helen Eade at firstname.lastname@example.org