There are a number of costs that must be met to conduct non-commercial research. These include:

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1 Cancer Research UK response to NHS England Consultation: Supporting Research in the NHS Part 1: Managing Excess Treatment Costs in Non-commercial Research & Part 2: Further improving commercial clinical research set-up and reporting February 2018 What are Excess Treatment Costs? There are a number of costs that must be met to conduct non-commercial research. These include: 1. Research costs relating to activities that are undertaken to answer the research question. These are met by the research funder. 2. NHS support costs the additional patient care costs that would end once the study has stopped, even if the patient care involved is still provided. These are provided by the NIHR Clinical Research Network, provided that studies meet the eligibility criteria for support. If they do not, then these costs must be met by the study funder or sponsor. 3. NHS treatment costs the costs of patient care incurred if the care/treatment under review became standard care. These are funded by the NHS through normal commissioning arrangements for patient care. When a research study results in care that differs from the standard treatment, or is delivered in a different location from where it would normally be given, the treatment costs usually differ. When the associated treatment costs are more than the standard treatment, they are known as Excess Treatment Costs (ETCs). When they are less, they are known as Excess Treatment Savings (ETSs). For non-commercial research, CCGs (or NHS England for specialised commissioning) currently pay for ETCs. Guidance on attributing the costs of health and social care research studies can be found in the AcoRD guidance. What isn t working? CRUK spends donations on the direct costs of research. This means that we cover research costs and that some of our clinical studies rely on the NHS to pay for support and treatment costs, including ETCs. The current system for dealing with ETCs is inconsistent and inefficient due to variation in ETCs management, with multiple commissioners and providers. This inconsistency has led to delays in setting up studies. This is a concern for CRUK as delays in study set up impacts on the time taken to see the results of the study, and the longer we, as a funder, provide support costs. What s being proposed? NHS England are aware of the issues associated with ETCs and have therefore proposed reforming how ETCs are dealt with. This included a consultation on supporting research in the NHS. CRUK s response to this consultation is detailed below. NHS England proposed three changes to overcome some of the issues with ETCs: 1. Partnering with the 15 Local Clinical Research Networks (LCRNs) to help manage the ETC process on behalf of their local Clinical Commissioning Groups (CCGs) 2. Establishing a more rapid, standardised process for ETCs associated with specialised commissioning, which are the responsibility of NHS England 3. Setting a minimum threshold under which ETCs will need to be absorbed by providers participating in studies. More detail about the options being proposed by NHS England can be found in the Appendix of this response on page 9. 1

2 Consultation questions and responses: Part 1: Managing Excess Treatment Costs in Non-commercial Research 1. Do you agree with the six design principles (capability, consistency, cost neutrality, simplicity, single point of access, transparency) we have used to develop our proposals? Cancer Research UK (CRUK) supports around 250 clinical studies and welcomes the opportunity to respond to NHS England s proposals for overcoming issues with ETCs. As highlighted in the Cancer Strategy for England 1, the inefficient system for dealing with the commissioning of ETCs, with multiple providers and commissioners, has resulted in delays in setting up studies. On some occasions, it has meant that studies are unable to open in certain sites, depriving patients of access to studies. While we welcome interim solutions, such as the 6m fund to support ETCs for Stereotactic Radiotherapy studies, this type of fund is a symptom of a system that doesn t work effectively. We hope that these proposals will create a system that provides a clear and sustainable route of funding for all types of non-commercial study. We have provided some suggested amendments to the proposals to achieve this. CRUK agrees that the capability of sub regional expertise should be exploited, and that a consistent system for the whole country would be a significant improvement. As CRUK works across the UK, we recognise the need for cohesion with the devolved administrations. We welcome simplicity, transparency, and ease in navigating the system through a single point of access. Regarding cost neutrality, we recognise the challenging NHS funding environment and agree that the majority of ETCs should be covered by existing commissioner budgets. However, even with the changes proposed, there may be circumstances where studies provide significant value to the NHS, including those providing long-term savings, but have ETCs exceeding those accommodated through existing, planned budgets. We therefore urge NHS England to consider: The continuation of a funding route at the national level, such as the subvention fund, to support particularly high-cost, high-value research that would substantially exceed existing budgets. A funding route to support ETCs for lower cost studies at the LCRN level, once LCRN budgets have been exceeded (ETCs for these studies may not be high enough to apply for subvention funding). Regarding the second point, at the DH Non-commercial Costing and Attribution Group (NCCAG) event held on 11 th January it was suggested that if the local budgets were exceeded, study recruitment would be slowed or sites would not be permitted to recruit. This is not an acceptable solution as it would prevent patients from accessing studies, which would in turn delay innovative treatments from reaching patients. Delaying studies would also go against initiatives such as the Accelerated Access Review and Life Sciences Industrial Strategy, where the aims are to speed up research and innovation. Additionally, it would transfer costs onto the funders who would be required to support studies for a longer time to accommodate a slower rate of recruitment. 1 Achieving world-class cancer outcomes: A strategy for England, Report on the Independent Cancer Taskforce, July

3 To mitigate against the need for another funding route at the LCRN level, it will be crucial to define the contributions of CCGs to each LCRN, and to set this contribution at a level which does not result in the budgets being exhausted, preventing the progression of research. Consideration should be given to simply retaining the relevant contribution from each CCG, rather than providing for the ETCs, and then undertaking an administrative process to reclaim it. For the proposals outlined to be effective, NHS England must explore ways to embed these requirements in mandates, rather than guidelines. This in particular applies to the minimum threshold under which ETCs will need to be absorbed by providers, since some providers will be unwilling to absorb ETCs regardless of where the threshold may be. Additionally, we would welcome endorsement of NHS England s approach at the senior level, including a letter to service from Simon Stevens and Chris Whitty. 2. Do you agree that ETCs will be better coordinated by LCRNs at sub regional level with a single point of contact rather than managed by CCGs individually? The coordination of ETCs by LCRNs will make it easier for researchers to navigate the process, particularly if there is a single point of contact in each LCRN. However, there is currently a lack of clarity as to how, in practice, the LCRNs will manage the process. Clearly defining this, and ensuring that the training and resources are in place to deliver it, will be critical. Consideration should be given to multi-site studies that take place across more than one LCRN, and to ensuring the process works for studies that have sites in the devolved nations. Effective coordination between the LCRNs is vital to ensuring the process can be made as streamlined and efficient as possible. To make this process more efficient, we suggest that the study sponsor only needs to apply to a single lead LCRN, whose coordinated response and decision is upheld by all the LCRNs involved in the study. Coordination by LCRNs will also allow for the collection of data, which has not been complete or consistent to date. Excess treatment savings (ETSs) should be captured as well as ETCs, as ETCs alone are not representative of the true costs. The capturing of ETSs would also help to incentivise research and engage commissioners by demonstrating that research is not simply a resource drain but can deliver savings both while it is ongoing and in the future. One such example includes the CRUK funded radiotherapy study, Conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer (CHHiP). This study proved that fewer fractions of radiotherapy in higher doses improved the treatment outcomes for prostate cancer patients. This is cost saving in the long-term, since the course of radiotherapy would be shorter than the previous standard treatment. 3. Do you agree that pooling risk across the 15 LCRNs to manage annual variation in ETCs would be an appropriate approach? Pooling risk across the 15 LCRNs would ensure that no region is overburdened by taking on a study with higher ETCs. It would ensure that regions are not discouraged from taking on studies due to concerns that their ETCs fund will be exhausted. It will also help to ensure a better balance between studies with higher and lower ETCs, as regions will be less inclined to make trade-offs. Ultimately, all CCGs will see improved patient care if the results of studies are successful, so it would seem appropriate that risk is pooled across LCRNs. 3

4 There is a wide geographical distribution of NHS Trusts and variability in level of research activity, with some individual LCRNs having a higher number of research active Trusts than others. We would welcome clarity on whether the pre-defined annual funding for each LCRN reflects this variation. 4. Will the proposals outlined work for both single site and multi-site studies? No. It is not clear from the proposals how multi-site studies would be handled. At the DH NCCAG meeting on 11 th January, it was suggested that the lead LCRN for the study would coordinate the process across all LCRNs involved in the study. We would support this approach, that a lead LCRN coordinate a response, and the decision is upheld by all the LCRNs involved in the study. This approach would ensure consistency and be more efficient than each LCRN undertaking their own processes. The current, inconsistent approach is reflected in some CRUK supported studies such as the case below, which has experienced various levels of support from NIHR regions when managing ETCs across the country. In some areas, study teams directly apply to individual CCGs and some networks are unclear of the responsibility, making the process disjointed and difficult to navigate. CASE STUDY: The Barrett s ESophagus Trial 3 (BEST3): A Trial of new GP-based test for patients with heartburn symptoms The BEST3 trial is supported by CRUK along with the MRC Cancer Unit at the University of Cambridge, Queen Mary University of London and Cambridge University Hospitals NHS Foundation Trust. The trial is assessing whether a newly developed test for patients with acid reflux symptoms will be effective in increasing the detection of Barrett s oesophagus, a condition that increases the risk of developing oesophageal cancer. The trial involves both primary and secondary care, including up to 150 GP surgeries and 15 hospitals across the UK. This scale of primary and secondary care services is spread over a large geographical area and required separate negotiations of ETCs with a number of CCGs and LCRNs. Although there were no CCGs in which ETCs were not funded in some way, the inconsistency in approach from one CCG to another meant that delays were experienced in some areas, while in other areas dealing with the ETCs was simpler. For example, some hospitals involved in the trial would simply absorb the ETCs, while others would have to make formal applications. Navigating the process was so resource intensive, it was diverting the project manager from other crucial operational tasks, causing disruption and resulting in more inefficiencies in the trial. Even where the lead network did well in managing the ETCs, the re-costing necessary for the other networks meant delays were experienced for weeks and even months in some cases. Identifying the main point of contact was one difficulty experienced across many CCGs when managing the ETCs. In some instances, when interacting with the networks for primary care, the researchers were not given any guidance. Often, once the point of contact was established, no further complications were experienced. A more streamlined process with a single point of contact may increase the efficiency in cases such as these. We would welcome a consistent, transparent and efficient application process to minimise inefficiencies such as this example. 4

5 It is essential that clarity is given on how this process would work for multi-site studies to prevent delays in cases such as the example above. 5. Do you agree with the proposal to strengthen the process for specialised services? We agree with the proposal to create a rapid, standardised process for ETCs associated with specialised commissioning. Additionally, we value the expertise provided throughout the specialised commissioning process in ensuring that national strategic priorities, such as the radiotherapy portfolio of studies, are being met. However, it is not clear why a separate route for accessing specialised commissioning is necessary, rather than having a single process through the LCRN model. To ensure a rapid, standardised process, we suggest that NHS England consider contributing specialised commissioning funds to the LCRN fund, rather than providing a separate funding, and access route, for specialised commissioning. A single process managed through a single route by the LCRN would be preferable, as it can sometimes be difficult to ascertain whether a future treatment would fall under specialised commissioning and therefore to attribute it to the specialised commissioning route. Additionally, some studies involve both specialised and non-specialised commissioning, meaning that two separate processes would have to be followed and two separate streams of funding accessed. If a separate process for specialised commissioning is adopted, it must be aligned as closely as possible to the LCRN process and ideally channelled through the same route so that there remains a single point of contact regardless of whether the study involves ETCs relating to specialised commissioning or not. 6. Do you agree that applications that fall below the proposed minimum threshold would not be considered by NHS England? A minimum threshold for consideration by NHS England would seem to be a pragmatic approach to balance the scale of the ETCs with the burden of undertaking the administrative process for studies with small ETCs. 7. Are there any additional comments to add to the specialised services proposals? CRUK would welcome clarity on what is meant by We will also ensure early engagement between NIHR and specialised commissioners in the funding process, allowing high cost/low value proposals to be challenged and potentially rejected earlier in the process and about how this process will work in practice. From the DH NCCAG meeting on 11 th January, it is understood that for studies where the ETCs exceed a certain threshold (regardless of any ETSs), the value of the study to the NHS will be considered by a Commissioner Panel. The panel will determine whether the ETCs should be covered. We would welcome clarity on this aspect of the proposals to enable respondents to express a wellconsidered and valuable view. If this proposal is taken forward, the following must be carefully considered: The threshold for referral to the panel must be sufficiently high to ensure that a high volume of studies do not need to go down this route. 5

6 Whether the threshold relates to the overall ETCs for a study or the ETCs which would be incurred by a single provider. If risk is pooled across LCRNs then overall ETCs would seem to be the more appropriate option. ETSs should be considered when determining which studies exceed the threshold so that only those which truly represent a high cost to the NHS are referred. This would reduce the administrative burden for the studies that would not exceed the threshold if treatment savings are taken into account. If ETSs are captured for studies by the LCRN as described above, this would be a straightforward determination. The membership of the panel should be made up of commissioners and other relevant stakeholders with an interest in and ability in determining the value of a study. Crucially, this should include patient representatives and stakeholders with knowledge of national strategic priorities. The information required for the panel to reach a decision. The criteria through which the panel would reach a decision. These should be defined in consultation with other relevant stakeholders and patient representatives, and should be clear and transparent. The reasons for rejecting a study should also be clearly stated. The process and timeframes associated with review by the panel. This must not slow down the opening of studies, and it would strongly be preferable for the panel to reach a decision either before or alongside consideration of an application by a funder. The panel would therefore need to consider applications on a regular basis to accommodate application timeframes of different funders. 8. Please rank the options outlined for setting minimum ETC threshold for CCG funding in Table 1 (see appendix) in order of preference with your preferred option first and your least preferred last. Refer to section 3.3 of the consultation document. Option 2: Total (cumulative) ETC per Trust, per financial year, based on Trust income which would be banded to offer stability around the threshold year on year. 3: ETC per Trust, per financial year, fixed sum. 4: ETC per study per Trust (over lifetime of the study). 1: ETC per patient, per financial year for Trust. 9. Why do you think your preferred option is the best one? Of this list, our preference is for option 2. However, we believe it could be optimised by combining with aspects of option 3. We have therefore outlined the rationale and necessary amendments to create a better solution in our answer to question 10. Of these, option 2 would seem to account for the different capacities of different Trusts to absorb ETCs. This option would also ensure that Trusts are not discouraged from taking on certain studies, something which is vital to ensuring no study is disadvantaged. However, it would be important to ensure that the LCRNs have oversight of when a Trust has reached their threshold and to manage the process of following the correct route. This would ensure that delays are not incurred by uncertainty as to which route is required. Option 1 would potentially discourage Trusts from taking on high volume, low ETC studies that may have a significant overall impact on budget. Options 3 and 4 would discourage Trusts from taking on studies falling below the threshold. 6

7 Overall, it is vital to set the threshold at a reasonable level that is both manageable for the Trust, while also ensuring that it isn t rapidly exhausted, as to do so would make it ineffective as a process. Provision is made within the tariff for ETCs, and providers will also benefit from ETSs, hence it would seem reasonable to expect a certain level of ETCs to be absorbed within recourse to LCRN pots. It is vital that providers are incentivised to absorb ETCs under the minimum threshold, whatever that may be. CRUK is aware that there is variation in approach to supporting ETCs, and some providers may be unwilling to absorb ETCs regardless of the threshold. We would therefore welcome clarity on how NHS England will ensure there is consistency in approach, and that all providers absorb ETCs under the minimum threshold to encourage research in all parts of the country. 10. Are there any other ways to set thresholds that would work better than those presented? Yes/No One possible disadvantage of Option 2 is that one study with high ETCs could exceed the threshold, with studies with low ETCs that follow then having to go through the LCRN process. This could be avoided by adopting a mixed model whereby there is maximum overall threshold for each Trust (option 2) but also a threshold per study per year (option 3). Above this threshold, a study must apply to the central LCRN pot even if the overall Trust budget hasn t been exceeded. This way, one study doesn t result in several Trusts breaching their thresholds early in the financial year. The level at which these thresholds are set would be critical to making the process work so some modelling work could be carried out to facilitate setting of effective thresholds. 11. Do you think there should be a nominal payment cap for primary care to discourage applications for ETCs where the cost of processing will significantly out-weigh the cost of the ETCs? A nominal payment cap for primary care would not be necessary if the LCRNs are fully managing in the process. Part 2: Further improving commercial clinical research set-up and reporting 1. Which do you think is the best option for costing NHS provider participation in commercial research? Option 1/2/3 (see appendix) Option 1: National, binding coordination of contract values Option 2: First/lead site setting of contract values with MFF adjustment Option 3: Alternative options Option If you have selected Option 3, what is your proposal and how does it meet the design criteria outlined? For example; capability, consistency, transparency, speed and simplicity, single point of access and continuous improvement. N/A 3. Why do you think the option you have selected is the best one? 7

8 Option 1 would bring transparency, simplicity and fairness to the costing process. It will be crucial that the decision is binding and Trusts agree and opt to participate or decline to participate without negotiation. Option 2 would not work due to its similarity to the current mechanism for costing non-commercial studies, which has not proved successful. It is likely that there would be uncontrolled variations between Trusts, thus making it difficult to insist that the costings be binding. In addition, it would not remedy the disagreements between Trusts on costs, regardless of the costs being calculated by the lead Trust. 4. Do you agree that we should reaffirm, through the NHS Standard Contract, the requirement for NHS providers to report and publish a standard dataset for performance in clinical research initiation and delivery? 5. Are there any additional steps that you think would be helpful on the part of commercial research sponsors and/or their representatives? Although CRUK is a non-commercial representative, we are supportive of all studies that can speed up the process of assessing life-saving interventions for cancer patients. This includes both noncommercial and commercial studies. Within CRUK, our Commercial Partnerships team offers unique opportunities to industry partners to develop and commercialise new discoveries in cancer research. As such, it is important for all representatives to be kept informed about the changes to improving commercial set-up and reporting. 6. Do you agree with our proposed wording for a future National Variation to the NHS Standard Contract? As non-commercial representatives, we have little to comment here. We would welcome any educational activity to broaden understanding, particularly around issues where there is a difference over how the contract is interpreted and regulated. About Us Cancer Research UK is the world s largest independent cancer charity dedicated to saving lives through research. It supports research into all aspects of cancer and this is achieved through the work of over 4,000 scientists, doctors and nurses. In 2016/17, we spent 432 million on research institutes, hospitals and universities across the UK. We receive no funding from the Government for our research and are dependent on fundraising with the public. Cancer Research UK wants to accelerate progress so that three in four people survive their cancer for 10 years or more by For further information please contact Angel Yiangou, Policy Adviser on Angeliki.Yiangou@cancer.org.uk or

9 Appendix Table 1: Options for setting minimum ETC threshold for CCG funding as proposed by NHS England in the consultation Option Limit calculation 1 ETC per patient, per financial year for Trust. 2 Total (cumulative) ETC per Trust, per financial year, based on Trust income which would be banded to offer stability around the threshold year on year. 3 ETC per Trust, per financial year, fixed sum. 4 ETC per study per Trust (over lifetime of the study). Example limit Potential Implications Benefits Risks 60 Applications for ETCs worth less than 60 per patient per financial year for Trusts are not accepted. Costs must be absorbed by the participating Trusts. Variable Trusts required to absorb the first X,000 ETCs per financial year. this amount would vary based on Trust income, This could be up to a maximum per Trust per year. 10,000 Trusts required to absorb the first 10,000 of ETCs per financial year before being eligible for separate funding. The threshold would be the same for all Trusts. This could be up to a maximum per year. 2,000 Trusts are expected to absorb ETCs for studies where the total ETC per Recognises that costs per patient may be low. Allows variable investment based on Trust income which may be more equitable. Clarity in process. Clarity in process. Studies with high volumes would incur high costs that Trusts must absorb. Could be seen as an inconsistent approach as varies by Trust, Different implications across different Trusts. Equal costs applied to all Trusts, which may be unaffordable for some and may be significantly less than some Trusts absorb currently. Equal cost pressure applied to all Trusts, which may be 9

10 Proposal options for improving clinical research set-up and reporting as outline by NHS England in the consultation Option #1 National, binding coordination of contract values The simplest option would be to establish a single process for assessing and determining contract values for commercial contract studies16, regardless of NIHR Portfolio status. This would be delivered through a new coordination and pricing function, hosted by the National Institute for Health Research. Expert assessors would apply a standard costing methodology, to make a fair and binding determination of prices. In spring 2018, NIHR would consult on its updated methodology. In broad terms, it is envisaged that NIHR CRN would allocate a National Coordinator for each clinical research proposal17, with defined minimum standards of training/experience. The National Coordinator would liaise with the commercial research sponsor on behalf of all interested providers to establish a single contract value for the clinical research study. This coordinator would be responsible for: Supporting the commercial Sponsor in understanding the NHS study set-up process and costing methodology as necessary; Ensuring clinical staff input as required; Negotiating with the Sponsor prior to, or in parallel with, submission of the study for HRA Approval, to ensure all activities are appropriately costed to secure an accurate and transparent level of cost recovery, and defined element of capacity building Making a binding an fair determination of contract values, leaving only appropriate adjustments for market forces (Market Forces Factor) and/or specialist facilities (for example Clinical Research Facility) for individual sites Maintaining responsibility throughout the study life cycle including review of any study amendments with potential impact on the cost. Escalating unresolved issues in a timely manner including to the NIHR CRN Coordinating Centre, as required Also, under this option: The existing CRN Industry Costing Group would provide a governance group for ongoing review of the NIHR industry costing template, providing reassurance to industry that the implementation of the model will not result in unwarranted price inflation, and to providers that implementation will broadly reflect actual costs incurred. NHS England would support ongoing review and development of current costing schedule within the NIHR CRN Industry Costing template to maintain up-to-date, robust baseline values for all departments involved in research activities and credibility of the template. Providers would be required to accept the stipulated contract value without further negotiation. Where an NHS Organisation may work with their Clinical Research Facility or a Higher Education Institution to participate in a study, the internal distribution of income of the single contract value negotiated should be based on a pre-agreed Memorandum of Understanding outlining principles and expectations for distribution. NIHR would establish regular audits to assess any variation in costs across departments involved in research activities and identify issues impacting single agreement, providing 10

11 reassurance that the model does not significantly disadvantage any specific or individual providers. Option #2 First/lead site setting of contract values, with MFF adjustment An alternative option would be to require trusts to operate a lead provider model, whereby the approach taken for the first site becomes binding for all subsequent participating providers, with MFF adjustment. This would be simple, but it risks gaming and inconsistent approaches across similar trials. Option #3 - Alternative options We are also open to alternative options, that meet the design criteria outlined earlier, ie capability, consistency, transparency, speed and simplicity, single point of access and continuous improvement (ii) requiring providers to use a standard research contract; We propose to require all providers (and, by extension, sponsors) to use updated, model contract terms and conditions, developed in partnership by the ABPI, HRA and other NHS partners. The relevant updated model clinical trial/ investigation agreements and the associated guidance will be published by the HRA on the IRAS website. The model agreements will be reviewed periodically on a UK-wide basis with the relevant industry groups. (iii) publishing a common, simple set of performance data on research initiation and delivery. We propose to require all providers to comply with reporting guidance issued by the HRA, NIHR, DH and/or NHSE. Initially, this would codify existing requirements. However, in due course this would be updated to reflect the outcome of discussions currently underway to determine more effective and streamlined ways to generate, report and publish collective clinical research performance data and to ensure that the data is transparent, accessible and helpful for all, including to inform appropriate site selection. 11