Commissioning Cancer Drugs and Services

Commissioning cancer drugs and services: Looking to the future

12th March 2007, Royal Institute of British Architects, London 

To say that the imposing façade of RIBA headquarters instilled in arriving delegates a sense of trepidation would be pure conjecture; that the conference to which they were arriving would ask more questions than it answered, however, must have been forecast by all 200 who attended.

Convened by the London Cancer New Drugs Group (LCNDG) to discuss the commissioning of cancer drugs and services, the aims of the conference were three-fold:

• To explore how cancer drugs and supportive care could be effectively commissioned alongside cancer services and within the context of the wider commissioning agenda
• To discuss environmental changes that might alter the role of health technology assessment
• To facilitate an understanding of the work of the LCNDG and other health technology appraisal (HTA) bodies amongst stakeholders, including commissioners and the pharmaceutical industry
• Important to note is that delegate participation was integral to the day’s programme and that, although individual speakers are attributed to each of the main topics covered, much of the content of this report originates from contributions from the floor and discussion panel members. Four workshops were also included on the programme, the aims of which were to explore:
• Current and possible future models of commissioning and their strengths and weaknesses
• The financial flows for cancer services and the implications of Payment by Results
• The role of cancer networks in commissioning and the strengths and weaknesses of potential network models to facilitate effective commissioning
• The role of HTA bodies in the assessment of cancer drugs and supportive care and their relationship with commissioners

Conference Speakers

Professor Adrian Newland Chair of the London Cancer New Drugs Group	Dr Rebecca Rosen, co-author of the report 'Future Trend & Challenges for Cancer Services'	Professor Mike Richards, National Cancer Director, Department of Health
Kevin Barton, Chief Executive, Lambeth PCT	Ms Susan Gibbin, Project Consultant working with the National Cancer Action Team

The London Cancer New Drugs Group

“The LCNDG aims to facilitate consistency of approach in London by informing the managed entry of new drugs in cancer treatments and to promote the cost-effective and equitable provision of all medicines used in cancer management.”

Initially set up as a sub-committee of the London Cancer Networks Steering Group to manage the entry of imatinib into the NHS, the LCNDG has evolved into an independent body of professionals with the responsibility of developing recommendations for the managed and uniform entry of new treatments across London. Making the decisions are individuals from the five networks in London plus Bedfordshire and Hertfordshire, representing acute services, public health and commissioners, with specialist support from regional Medicines Information. Observers from Scotland, Northern Ireland and Wales are also welcomed to the meetings.

The group’s recommendations, which are not mandatory, are published at http://www.nelm.nhs.uk and are designed to help PCTs reach decisions on the use of new cancer drugs until such a time as NICE guidance becomes available. The premise is that the lack of NICE guidance cannot be used to prevent prescribing of a drug. Guidance is, importantly, also developed for treatments that are unlikely to be reviewed by NICE and occasionally to provide clarification when NICE guidance is particularly complicated.

While recommendations from the LCNDG are welcome, how widely they are implemented, if at all, was a subject of debate among those at the meeting. The importance of implementing a mechanism for assessment of uptake should not be underestimated. Only through collaboration between PCTs and cancer networks can a systematic response to the managed entry of new drugs across London—and indeed nationwide—be realised. The question remains, however, is the LCNDG model appropriate as the number of new cancer treatments escalates?

There was also a call from the floor for more effort to be made by the LCNDG and similar bodies to provide cost-effectiveness analysis. Once identified for review by the LCNDG, the relative effectiveness of a treatment is assessed, taking into account its effect on survival and quality of life, the strength of the evidence supporting its use and ethical considerations. The likely impact of a drug’s use on resources is also, however, of interest. Indeed, cost-benefit and opportunity-cost calculations are becoming increasingly important within the appraisal process, be it that of the LCNDG, NICE, the SMC or the AWMSG.

According to the Office of Health Economics, between 1992 and 2006, expenditure on prescribing in England trebled to more than £9 billion. While this figure is staggering, it is noteworthy that only an estimated 6% of this total was spent on cancer. Nevertheless, when discussing numbers in excess of £500 million, the forecast global tripling of the cancer drug market by 2010—in part as a result of the predicted launch of molecular therapies—is a huge concern. Indeed, one of the greatest challenges facing cancer services over the next few years is how to manage the entry of new drugs into the NHS without bankrupting the system. This and other challenges facing cancer services are discussed in more detail below.

Future trends and challenges for cancer services

In the 6 years that have followed the introduction of the 10-year NHS Cancer Plan, much has been achieved in the treatment of cancer:

• Waiting times have been substantially reduced, with the vast majority of patients now seen by a specialist within 2 weeks of presentation
• Service capacity has improved both in terms of clinical and diagnostic capability, with a rise in workforce numbers and equipment expansion (CT scanners, linear accelerators etc.)
• Multidisciplinary teams have been established to manage the care of patients with a number of different cancers
• Progress has been made with regard to prevention—the number of people who smoke is falling, the breast cancer screening programme has been extended, the bowel cancer screening programme has been initiated, etc.

This progress has resulted in an overall decrease in mortality (10% in men and 14% in women between 1994 and 2004) despite the continued rise in incidence of cancer (approximately 1.4% per year). Indeed, 5-year survival rates are improving year on year for many cancers, including breast, colon and prostate cancers.

Prevention and early detection statistics, however, indicate that nationwide inequalities in incidence and mortality as well as in helpseeking behaviour remain. Furthermore, access to drugs and treatments differs across the UK, with the phenomenon of postcode prescribing only partially circumvented by NICE guidance. With respect to palliation, a high proportion of people are still dying in hospital despite recent improvements in palliative care services in the community. Finally, the planning and monitoring of cancer services need to be improved, not least to strengthen the baseline knowledge underpinning cancer policy and to be able to better forecast future needs. All of these challenges are compounded by the sheer numbers of people affected by cancer (one in every three people will develop the disease), particularly among the growing elderly population (75% of cancers are diagnosed in those aged older than 60 years).

A further challenge is the evolving nature of cancer, which can now often be considered a chronic illness, with many patients living a long time either in remission or on maintenance therapy. The implications for cancer services of people living with a cancer diagnosis include an increased need for primary care treatment services, processes for review of patients in remission and treatment for those who relapse.

Looking to the future, what trends will emerge? In screening and prevention, initiatives are needed to reduce inequalities in risk factors. Smoking, obesity and alcohol are obvious targets. Clinical management of selected viruses—e.g., human papillomavirus (HPV) and Epstein-Barr virus (EBV)—may become possible. An ovarian cancer screening trial is underway and, with respect to early detection, various technologies are being assessed, including CT colonoscopy and spiral CT for lung cancer.

New drugs and treatments are also being continuously assessed. Curative drugs remain an unlikely prospect, with most options introduced over the next few years more likely to have a marginal, though incremental, impact on survival. With in excess of 2,000 drugs in development, however, nothing is certain. Furthermore, the impact that pharmacogenomics might have on the treatment of cancer is, as yet, unknown. Other treatment strategies that are in the research and development pipeline include computer assisted surgery, radioactive markers for the detection of metastases and combination therapies (surgery/local chemotherapy/radiotherapy).

Finally, policy trends. Within the NHS, independent sector treatment centres, foundation trusts and polyclinics/community based care initiatives are being used to a greater extent now than previously to supply care. Commissioning practice is also changing: PCTs have merged and practice-based commissioning is becoming more widespread. New mechanisms to link commissioners and providers of health care are also being introduced—namely, Payment by Results and increased plurality of providers. In brief, the way the NHS functions is shifting in recognition of:

1. the growing role of the private and voluntary sectors and
2. the call for an increase in specialist care in community settings

Recent reforms are consistent with the aims set out in the 10-year NHS Cancer Plan in that they will help to reduce risk factors for cancer, increase diagnostic capacity and help to integrate care in the community. However, they also conflict with the plan in important ways. Payment by Results incentives, for example, will drive individualistic behaviour, potentially disrupting collaboration between primary, secondary and tertiary care providers.

Before travelling too much further, the scope, cost and benefits of shifting elements of cancer care into community or primary care settings need to be established. Should cancer networks drive commissioning and, if so, how can their ability to do so be enhanced? Finally, an explicit process for policy development and stakeholder engagement needs to be identified. Without strengthening the evidence base for policy and creating payment systems to align incentives, this task will be a difficult one. The research done to inform those writing the Cancer Reform Strategy should provide some answers.

The Cancer Reform Strategy

The aim of the Cancer Reform Strategy is to set cancer care goals for the next 5–10 years, taking into account the changes that have occurred within the NHS and with respect to cancer as a disease since the publication of the Cancer Plan in 2000. Important to note, is that the Cancer Reform Strategy will not replace the Cancer Plan, but build on it. Furthermore, it will link to the End of Life Care Strategy.

Importantly, the key aims of the Cancer Plan remain unchanged. They are to: save lives, improve patients’ experience of care, reduce inequalities and build for the future through education (of the workforce, patients and the public) and research. There is, however, new emphasis on three key areas:

• Choice, quality, equity and value for money
• Prevention and early detection
• Reconfiguration of services—centralisation and decentralisation, where applicable, to improve outcomes and convenience for patients

To develop the Cancer Reform Strategy, an advisory board has been established, comprising chief executives of key charities, senior NHS managers, professionals, patients and senior staff from the Department of Health (DH). These individuals will assess information passed to them by their colleagues, existing advisory groups within the DH (e.g., the National Radiography Advisory Group [NRAG] and National Chemotherapy Advisory Group [NCAG]), industry and six working groups (see Panel 1). A national cancer intelligence group will also be established, probably under the National Cancer Research Institute. Looking to the future, a key question is whether specific data should be routinely collected by cancer teams, hence avoiding the need for a periodic audit. Finally, programmed budgeting now allows, for the first time, analysis of what and where expenditure on cancer services goes, essential when trying to ascertain what treatment protocols/methods are clinically and cost effective.

The aim is to publish the Cancer Reform Strategy in the autumn of this year, so that it can be rolled out in 2008. Whether there will be enough funding to implement change is another question.

Panel 1: Six working groups of the Cancer Reform Strategy and their objectives

Commissioning Cancer Services:

Setting priorities

The aims of commissioning are to:

• Improve health and well being and reduce health inequalities
• Secure access to a comprehensive range of services
• Improve quality, effectiveness and efficiency of services
• Increase choice for patients
• Ensure better experience of care and achieve best value within resources available

These aims are not so different to those outlined in the Cancer Plan. Why, then, do commissioners and providers appear always to be on a collision course?

There is no simple answer to this question, though the most obvious is simply because of differing priorities. Commissioners work across all service areas (from children with disabilities, to renal dialysis, to new drugs), whereas providers often specialise (e.g., in cancer). A commissioner must prioritise spending not only by disease, but also between types of disease (e.g., breast, lung, renal cancer) and treatments within diseases (e.g., surgery, radiotherapy, chemotherapy). Their decisions depend on an understanding of relative need, informed by the evidence base, value for money, patients’ opinions and the perception of need within society.

Providers of cancer care need to understand that cancer drugs represent the biggest cost pressure in commissioning cancer services, and that this pressure is set to increase as the cancer drugs in the R&D pipeline pour into the market over the next few years. So, in a resource-limited system, what is the best way to manage the entry of new drugs?

A legally robust and transparent decision making process needs to be developed, so that tough decisions are equitably made. Patients need to be confident that decisions are being made responsibly. This confidence can be fostered through effective communication. Individuals should be made aware of all of the choices available to them, whether approved by an HTA body, or not. In instances where particular drugs are not recommended for use, healthcare providers and patients need to know why, so that they can make informed personal choices about care. There also needs to be reduced duplication of appraisal of evidence, cost-effective use of, and equal access to, new drugs. A commissioning framework, to encourage communication of best practice between PCTs and to enforce some uniformity, is perhaps warranted. Shared prescribing responsibilities between secondary and primary care should be encouraged too where appropriate.

For many, NICE represents a big step forward in helping to achieve these aims, but is not comprehensive in its appraisal of new drugs and there remains, despite the new fast-track procedure, a time lag between licensing and publication of guidance. How this situation could be ameliorated warrants discussion. Service redesign might also help to increase the overall affordability of drugs. Half of cancer expenditure is on in-patient care—what services could be provided in the community? And should we perhaps be placing greater emphasis on prevention and early diagnosis rather than treatment?

Finally, at what point should treatment be curtailed? Throughout the day, speakers and delegates referred to the marginal benefit associated with some new treatments. However, individual incremental benefits, over drug generations, can add up and translate into large steps forward. Important, therefore, is that NICE and the other HTA bodies continue to assess new options in this context. Whether the current system of QALYs is the most appropriate is a further matter for debate, particularly in view of the fact that treatments are often first referred to the HTA bodies when only licensed later in treatment pathways. In addition, the ethical requirements to allow cross-over of patients in trials makes calculating the cost per QALY problematic. Projection and extrapolation of data forms an increasingly important part of the assessment process in light of the above. How robust can decisions made on these grounds really be? Alternative approaches are, perhaps, needed.

The approval process aside, there certainly appears to be an argument for cancer experts to commission cancer services. With their technical knowledge of the service, cancer networks already effectively influence commissioning. The provider role would, however, need to be rethought before pursuing this option. Practice based commissioning also has a potential part to play in influencing cancer services, facilitating a move towards greater cancer care provision in the community setting. Before any radical changes are made, however, commissioning measures for quality and outcomes are needed, as is a clarification of the information requirements of commissioners. Additionally, the services that can be provided in the community need to be identified and supported by an evidence base. Perhaps these are questions that the working groups of the Cancer Reform Strategy could address?

Ultimately, a systematic and effective approach to the entry of all new cancer technologies is needed. That would be a major step forward. A single body should probably govern this process. That said, the current system across the UK involves numerous groups—e.g., NICE, SMC, AWMSG, LCNDG—which are mutually exclusive, but complement each other, each challenging the other with respect to best practice. The short term overriding goal should not necessarily be to amalgamate these different groups into one, but to streamline their work to avoid duplication of effort, to make decisions consistent to avoid unequal access to treatment, and to ensure adequate professional input to make certain that decisions made are clinically relevant and sound.

Commissioning models for cancer services: Implementing Payment by Results

Healthcare Resource Groups (HRGs) are casemix measures, representing groups of clinically similar treatments and diagnoses, which consume similar levels of healthcare resource. The National Tariff is structured around these to ensure that hospitals are paid according to the complexity of cases treated as well as the total volume (Payment by Results).

In the current financial climate, the challenges facing commissioners include: improved patient experience (safe, responsive and closer to home); managing demand (best health outcomes at best prices); and managing the market (choice and plurality of provider). Payment by Results has been designed, at least in part, to help stakeholders address these challenges. A revised set of HRGs (Version 4) will form the basis of the national tariff from 2008. One of the priorities for version 4 HRGs, including those proposed for chemotherapy, is that they accurately reflect patient care regardless of where it is given.

Chemotherapy HRGs were developed by an expert working group and include two elements: a set of 5 HRGs to reflect the preparation and administration (delivery) of chemotherapy and a second set of 10 HRGs to reflect the costs of procuring chemotherapy drugs and supportive care. Details can be found at http://www.ic.nhs.uk/casemix and at http://www.dh.gov.uk/en/index.htm by following the tabs through Policy and Guidance/Organisation Policy/Finance and Planning/Payment by Results. Reference costs for chemotherapy are being collected over the summer to inform the National Tariff for 2008/09.

There are a number of barriers to the successful implementation of HRGs for chemotherapy, not least inconsistencies in clinical coding by service providers. Commissioners will be particularly interested in the ability of chemotherapy HRGs to facilitate the unbundling of elements of the chemotherapy pathway to avoid expensive trips to the hospital. A number of groups are key to the successful implementation of chemotherapy HRGs, including: service managers, commissioners, cancer networks and the Cancer Network Pharmacists Forum. The National Chemotherapy Advisory Group (NCAG) is developing advice for both commissioners and service providers to guide them in preparing for the new world of Payment by Results in 2008.

Conclusion

This first in a series of meetings was well received. Oversubscription left precious little space for manoeuvre during lunch, when representatives of the UK technology appraisal groups rubbed shoulders with senior pharmaceutical company representatives and bumped into clinical and management directors of UK cancer networks, directors of commissioning of primary care organisations and members of the LCNDG—heady company. The discussion, both during lunch and throughout the rest of day between the podium and the floor and in the workshops provided a fascinating insight into the uncertain nature of commissioning and Payment by Results.

True, the meeting highlighted more issues than it provided solutions to problems, but delegates did not appear to be surprised. The concerns and questions raised (see Panel 2) will be addressed in future meetings and in subsequent issues of Cancer Services Forum—in the meantime, we would be very interested to hear your thoughts at csf@succinctcomms.com.

In the years to come, a lecture-and-listen approach to a meeting on the topic of commissioning cancer drugs and services may work. For now though, debate is de rigueur, albeit hard work.

Panel 2: Issues identified that warrant further discussion

Announcements of future meetings will be made through Cancer Services Forum.

Acknowledgments

The organisers of the conference would like to thank the following companies for their financial support: Amgen, Bayer Healthcare, Bristol-Myers Squibb Pharmaceuticals, Celgene Ltd, Merck Serono, Novartis Oncology, Pfizer Oncology, Roche and sanofi-aventis.