This page has been printed from:
http://www.canserforum.com/print/conference-reports/cancer-commissioningat-a-global-and-a-local-level-london-cancer-new-drugs-g/

Cancer Commissioning—at a global and a local level: London Cancer New Drugs Group Annual Meeting

Conference Coverage

Introduction

Additional private care in practice

Patient-access schemes in cancer care

End-of-life care—the anomalies

Very rare cancers—the challenge

Funding UK cancer services—are there realistic alternatives?

Pan-London approach to prioritising new cancer drugs

Discussion points

Conclusions

 

Introduction

Uncertainty and confusion surrounding the introduction of schemes designed to improve patients’ access to new cancer drugs dominated proceedings at the 2009 London Cancer New Drugs Group (LCNDG) annual meeting, which was attended by more than 150 healthcare professionals and cancer service commissioners.

Other contentious issues included the ambiguity of end-of-life criteria, with which many such schemes are associated, the dilemma of patients having to pay for treatment not sanctioned by the National Institute for Health and Clinical Excellence (NICE), and the growing disquiet over individual funding requests (IFRs).

Adrian Newland (LCNDG Chair and Professor of Haematology, Barts and The London NHS Trust) outlined the main objective of the meeting—to debate the effective commissioning of chemotherapy within the wider context of delivering cancer services in London and elsewhere in the UK. He reported that the total cost of cancer services in the UK is £4.35 billion out of a total NHS budget of about £100 billion. Of that £4.35 billion, only 18% is spent on cancer drugs.

Since 2001, spending in London on NICE-approved cancer drugs has risen from £10 million to £85 million—and although this increase has coincided with an increase in survival from cancer, the UK continues to lag behind the USA and most other European countries. “Despite meeting Government survival targets, we are still not doing as well as we could,” said Professor Newland.

In London itself, there continue to be glaring inequalities of access to cancer care—as judged by mortality rates for all malignancies. Quoting the former Under-Secretary of State for Health, Lord Darzi, Professor Newland said that moving from Chelsea & Westminster to Tower Hamlets, you lose a year of your life with every tube stop.

Meanwhile, the approval process adopted by NICE has inevitably delayed the introduction of new cancer drugs, resulting in an increase in exceptional treatment applications (ETAs). Professor Newland said that one of the main aims of the LCNDG has been to assist the prioritisation and more timely delivery of new cancer therapies across the capital. He commented: “We do not want unrestricted access to new drugs. Their introduction has to be safe and secure.”

Death rates from all cancers have fallen. NHS waiting time targets for access to consultants, diagnosis and initial treatment have been met. “However, inequalities in cancer care are still evident and we need to increase the uptake of both new and existing cancer drugs,” he concluded.

Delegates in the Shaw theatre

 

Additional private care in practice

David Webb (Director of Clinical Pharmacy, London, Eastern and South-East Specialist Pharmacy Services) reported that additional private care had become a thorny issue for the NHS—a visible aspect of the tension between collectivism and individualism. “There has been a great deal of talk, but very little action,” he said.

When Nye Bevan first talked about the spectre of cost creating a barrier between patient and clinician he also talked about the ‘inevitability’ of some patients wanting to buy more than the new NHS was likely to be able to provide. Over six decades later, in 2008, the Department of Health report, ‘Improving access to medicines for NHS patients’ (by Mike Richards) referred to a historic tension between equity and autonomy. “So clearly, little has changed,” said Mr Webb. “This is not a new phenomenon.”

• Professor Richards established four basic principles:
• A framework that would minimise the number of people having to seek additional paid-for therapies
• Greater clarity for those who continue to seek additional care
• Better information highlighting the benefits, toxicities and costs of such care
• Transparency in the fundamental separation of NHS and private care

Mr Webb argued that the notion of ‘top-up’ care should be discouraged when discussing additional private care. With top-up, it would be quite possible for two patients in adjacent beds to receive different care based on their ability to pay. It also suggested that the NHS had reverted to only the most basic provision of care, with everything else having to be paid for.

 

Additional private care in practice contd.

Current NHS guidance (March 2009) encourages patients to explore all reasonable avenues for NHS funding before turning to the additional private care option. “There is no absolute requirement to go down the IFR route, particularly if so-called ‘exceptionality’ is the basis for such an option,” he insisted. In practice, additional private care is judged to be an option only if all other avenues have been exhausted—i.e. no NICE approval, no local PCT agreement, no clinical trial evidence and no IFR criteria.

Feedback from Mr Webb’s approach to the Association of Teaching Hospital Pharmacists has indicated that there is likely to be very little activity on the additional private care front. Indeed, of the 18 teaching hospitals that responded to Mr Webb, 12 had seen no such activity whatsoever.

• NICE guidance seemed to have been helpful in obviating the need for additional private care, but there are still issues surrounding:
• The diagnostic context in which drugs might be prescribed privately
• Safety and clinical governance
• The way in which additional private care costs are handled in NHS hospitals
• For the future—pressure on the NHS to make certain novel drugs available earlier than might otherwise have been the case

In a final warning about the potential impact of the credit crunch, Mr Webb said: “It would be unfortunate if the additional public care given to the banking sector meant that there was a greater reliance of NHS patients paying for additional private care.”

 

Patient-access schemes in cancer care

Scheme assessment

Andy Stainthorpe (Associate Director, Patient Access Scheme Liaison Unit) and Helen Knight (Technical Advisor, Centre for Health Technology Evaluation) entered the LCNDG lions’ den to defend the role of new cancer drug assessment by NICE.

Patient-access schemes (PASs), proposed by pharmaceutical companies, are designed to enable patients to receive access to cost-effective innovative drugs. The PAS Liaison Unit (PASLU) assesses the cost to the NHS of administering such schemes, how robust and plausible they are and whether or not they meet an unmet clinical need.

However, neither PASLU nor NICE is involved in the development of individual PASs. Mr Stainthorpe said that while there was the potential for a number of PAS initiatives, he did not anticipate being trampled in the rush for PAS applications.

Ms Knight maintained that the introduction of PASs would have a minimal impact on NICE technology appraisals. To date, eight such schemes have been appraised, of which four received positive guidance. Three of the four approved schemes also met the supplementary NICE end-of-life criteria.

 

A pharmaceutical industry perspective

Dr Paul Catchpole (Healthcare Management Director, Roche Products Ltd) reported that, based on the limited experience thus far, PASs do appear to be improving patients’ access to innovative drugs, allowing manufacturers to give greater value for money to the NHS while protecting their list prices.

PASLU’s role as gatekeeper would be vital, he emphasised. It would evaluate schemes in a manner that is transparently equitable, with the opportunity of adding further value via feedback to all the stakeholders involved—clinicians, patients, cancer service providers and drug manufacturers. However, without some form of standardisation, there was always the danger that interested parties would be faced with a plethora of different schemes, adding to the cumulative administrative burden.

There was a conundrum in that many new cancer drugs have the potential to be used in multiple tumour indications, whereas NICE has to initiate an appraisal not simply for each drug, but for each drug and for every indication for which its use was proposed. Cost-effectiveness will depend on the indication, so different degrees of commercial consideration are necessary for patient access for the same drug. However, it is not feasible to have 10 different PASs for one drug—a dilemma the Department of Health, NICE, PASLU and the pharmaceutical industry will have to address. The possibility of blended incremental cost-effective ratios (ICERs) had been explored, said Mr Catchpole—as yet, to no avail.

There was emerging evidence, said Dr Catchpole, that patients are willing to pay more for extended life. However, an unintended consequence of the NICE end-of-life criteria was that it favours small populations of patients with rare cancers against the larger populations with common cancers.

Finally, Dr Catchpole argued that efficient local commissioning—whether second-guessing NICE decisions or undertaking independent local evaluations—should minimise the need for independent funding reviews (IFRs). Selection criteria would be essential to avoid duplication of effort, given that the number of local collaborative groups undertaking new cancer drug assessments is growing day by day. It would also be important to establish robust evaluation criteria, making a case for each drug and each indication on the basis of clinical, economic or affordability grounds, unmet need, innovation—or, indeed, a combination of any or all of these factors.

More was said about PASs in the discussion.

 

End-of-life care—the anomalies

Professor Christopher McCabe (Director of the Academic Unit of Health Economics, University of Leeds) said that although many patients at the end of life might not choose chemotherapy just for a survival benefit of 3 months, they would if it improved quality of life (QoL). In one study, it was revealed that the median survival threshold for accepting chemotherapy was 4.5 months for mild toxicity and 9 months for severe toxicity.

He said that the NICE end of life premium raised many concerns:

• Where is the evidence to support the argument that members of the general public value life-extending treatments at the end-of-life more highly than other interventions?
• Why should we value health gain differentially for people with a relatively rare cancer?
• Why are QoL-improving therapies excluded from the NICE end of life premium?

For the pharmaceutical companies, there is now an incentive to prioritise small, rare cancer populations when bringing new drugs to market—and to subcategorise common malignancies as rare cancers with a shared clinical presentation. The process impaired the ability of the NHS to negotiate lower drug prices on the basis of value for money, and would divert resources away from preventive and chronic health care.

“As things stand, new cancer drugs and end-of-life technologies have a distinct advantage compared with other models of cancer care,” said Professor McCabe. Whether that advantage will be maintained in the glare of clinical evidence has yet to be established.

 

Very rare cancers—the challenge

Rod Griffiths (Chair, National Commissioning Group, London) reported that the majority of cancers do not meet National Commissioning Group (NCG) thresholds of rarity. NCG funding is usually restricted to those malignancies affecting 400 patients or fewer in the UK—and in practice, often a lot less.

He was critical of risk-share schemes for the treatment of very rare cancers. “If the patient is still alive after 2 years, the pharmaceutical company offers to pay for the cost of the drug. It sounds like a good deal,” he said. “What they are saying, however, is that if the drug works, the drug company will pay. If it doesn’t work, the NHS will have to pay. The NHS is usually in the business of paying for what does work. It almost creates an incentive for the companies to produce very expensive drugs that don’t work. Meanwhile, surviving patients will sing the praises of their life-saving drug—while those who don’t survive won’t be in a position to say anything at all. We’re between a rock and a hard place.”

Furthermore, said Dr Griffiths, market forces do not work in rare cancers. “If there are too few patients, there will be no valid comparisons between competing therapies, so outcomes are unlikely to improve.” Therefore, NCG validation invariably involves designating a small number of clinicians/service providers for rare cancers to improve the quality of the service offered, often using international comparators as a benchmark. It also has the beneficial effect of speeding up rates of referral to the few specialists capable of managing a rare cancer.

Dr Griffiths reported that some pharmaceutical companies seek to exploit the orphan drug status of therapies for rare cancers—lack of competition might provide a period of additional exclusivity.

 

Very rare cancers—the challenge contd.

Dr Griffiths conceded that some of the costs of developing new drugs for rare cancers may be justified, because research investment has to be recouped from a smaller market. Against that, however, should be set the massive savings on marketing, distribution and post-marketing surveillance.

Loading all the costs on to a particular rare cancer is an artificial accounting trick when the drug concerned might have been developed originally with a number of different cancers in mind. Research costs should be aggregated across the whole of a pharmaceutical company’s drug development programme, he argued. “There’s no transparency—all we get is a price. And that puts PCTs at huge financial disadvantage,” he commented.

Dr Griffiths was also highly critical of the concept of exceptionality—a label that is rarely justified. The concept of exceptionality means different things to different people. A PCT looks at the opportunity cost of one patient against another. Government ministers, on the other hand, always have an eye on the tabloid headlines.

“In practice, the numerator is the cost per case or, more realistically, the cost of providing the service for a rare cancer. The denominator is the entire NHS budget—and against that, almost any cost can be made to seem trivial.”

Dr Griffiths argued for greater consistency and transparency across the whole spectrum of specialist commissioning. Indeed, for the next round of commissioning, we should have a set of core ethical principles made explicit in the process.

He concluded, somewhat provocatively: “The more expensive a service is, the closer the number-needed-to-treat (NNT) to show a survival benefit should be to 1. It makes no sense to fund very expensive treatments that work only occasionally or for very few patients. PCTs must have the confidence that they are not just funding a specialist gravy train.”

 

Funding UK cancer services—are there realistic alternatives?

Nick Bosanquet (Professor of Health Policy, Imperial College, London) cited enormous challenges for cancer service commissioners in getting value for money for patients. Getting more value for the cancer service pound at a local level is a worthy ideal, as is more power for local clinicians and multidisciplinary teams (MDTs). However, central planning has left the NHS with a legacy of soaring costs, while patients have ever-increasing expectations.

Professor Bosanquet reported that although in the next 5 years there will be a 5% rise, at best, in real funding for the NHS, there will be a 20% increase in demand for its services—and a 30% reduction in acute beds in London.

The pressure on resources has never been greater, he said. For example, there are now more than 80,000 people in the UK living with end-stage renal failure, each costing the NHS about £25,000 a year.

“We must move away from current top-down process in terms of health technology assessment,” he commented. “This has developed for negative reasons—mainly to control costs rather than to secure value for money. There is a danger that central planning of medical services will leave very little discretion for local clinicians. Instead, we must encourage greater local planning and delivery of cancer services.”

The Cancer Reform Strategy has already set an agenda for funding an increase in access to local services via a 100,000 reduction in hospital inpatient admissions, although this is clearly not yet happening.

 

Funding UK cancer services—are there realistic alternatives? contd.

The development of 1-year metrics and patient-reported outcomes (focusing on quality of life and side effects) to measure the success or otherwise of local cancer service provision will be crucial. It will mean moving away from 5-year survival data, thereby minimising the variability in cancer survival rates between PCTs.

Despite increases in NHS funding, the National Confidential Enquiry into Patient Outcome and Death has shown that only 35% of cancer patients who died within 30 days of receiving systemic chemotherapy had been receiving a satisfactory standard of care. Better communication within MDTs and between clinicians and patients at a local level could rectify this sorry state of affairs.

Local investment in ‘medium-ticket’ technology and informatics (e.g. greater use of mobile phones, emails and text messaging to facilitate local diagnostic and treatment strategies) should replace use of unreliable and hugely expensive centralised computer systems.

Greater financial flexibility at a local level would enable patients to have access to new cancer drugs, without IFRs, while improved end-of-life palliative care should be a realistic alternative to expensive chemotherapy, for some patients at least.

Perhaps the biggest challenge facing local services will be closer working with GPs to develop strategies for earlier and more accurate diagnosis of cancer. This alone would have a significant beneficial effect on patient outcomes. The challenge was not to spend more money, more quickly—but to spend what money there is more effectively.

 

Pan-London approach to prioritising new cancer drugs

Dr Monica Desai (Public Health Specialist Registrar, London School of Hygiene and Tropical Medicine) outlined details of a stop-gap measure designed to anticipate NICE decisions. The South-East London Cancer Network (SELCN) uses a scoring tool that takes into account the effectiveness of a new cancer drug as well as the strength of the associated clinical evidence.

Effectiveness criteria include magnitude of benefit and quality of life measured against alternative standard therapies and quality-adjusted life years (QALY). The strength of clinical evidence is ranked on the basis of good-quality, randomised clinical trials (RCTs), comparative phase II clinical trial data, non-comparative and unpublished data. Colour-coding is used to identify drugs to be funded once approved by the LCNDG, those that appear to meet NICE end-of-life criteria but which may have cost implications for PCTs, and those that should not be routinely funded.

Dr Desai reported that, on the basis of 50% uptake, the highest scoring drugs would cost the NHS nearly £127,000 per 100,000 of the general population, while those appearing to fit with end-of-life criteria would cost more than £308,000/100,000. Funding of new drugs for rare cancers would cost only £1,604/100,000. She emphasised that the vast majority of SELCN findings with respect to new cancer drugs were subsequently confirmed by NICE rulings.

 

 

 

Pan-London approach to prioritising new cancer drugs contd.

Dr Desai said that although uptake of the scoring system had not been uniform across the region, it had resulted in a 25% decrease overall in the number of independent funding reviews (IFRs). She emphasised, however, that such a scheme is not designed to allow PCTs to pick and choose which drugs to approve or disallow—they are expected to accept the package as a whole.

Dr Andy Mitchell (Medical Director, NHS London) reported that £1 billion is being wasted in London as a direct result of non-compliance with prescribed medication. In turn, this has significant safety implications—6.5% of hospital admissions are related to adverse events, and 9% of incidents are drug-related.

He said that the principal objective of the London New Medicines and Treatment Project (LNMTP) was to improve efficiency by developing collaborative processes for the approval of new drugs, thereby supporting PCTs in their constitutional obligation to give patients the right to:

• Drugs that have been recommended by NICE
• Rational local decisions about other drugs based on a proper consideration of the evidence

The LNMTP also aims to ensure consistent London-wide adoption of policy and commissioning arrangements for decision-making on new drugs, while decommissioning therapies no longer deemed to be appropriate. It is expected that London cancer patients will benefit from the introduction of good-quality recommendations that take account of affordability, and that reduced variation between London PCTs would minimise costs and the number of complaints.

“Rational decision-making will avoid funding for only marginal benefit, and reduce pressures for IFRs,” said Dr Mitchell.

It was not clear, however, whether this centralisation of effort would conflict with the principle of more localised initiatives proposed earlier in the meeting by Professor Bosanquet.

 

Discussion points

David Webb argued that the capacity of the NHS to implement a range of different PAS will soon be reached.

Some of the issues that were discussed included:

• Does a negative NICE ruling give pharmaceutical companies the opportunity to offer the NHS a PAS at a cheaper rate than would otherwise have been the case?
• PASs should not offer the opportunity to distort final NICE guidance
• Does more effective use of the NHS mean that staff should spend more time tracking 1-year survival data or on the administration of PASs?
• On the basis of commercial confidentiality, and due to the complexity of pulling these models together, pharmaceutical companies say it is difficult to reveal the evidence to the NHS upon which they are claiming cost-effectiveness for a new cancer drug
• Why do details of PASs remain confidential during the NICE process?
• Cancer service provider computer systems are not sufficiently sophisticated to administer multiple PASs, thereby denying providers the opportunity to offer patients access to cost-effective drugs
• Does PASLU have a role in evaluating risk-share schemes that operate outside of NICE technology appraisals and for which there are no NICE guidance criteria?
• Why can NICE not sub-contract cancer drug approval decisions to the robust processes already undertaken by local and regional bodies (e.g. the Scottish Medicines Consortium)?
• Does the fact that local health economies are not always able to recoup costs from NICE-approved PASs undermine the validity or integrity of PASLU decisions?

Prof Newland facilitating the discussion

 

Discussion points contd.

Helen Knight pointed out that NICE is only implementing what has been agreed between the Department of Health and the Association of the British Pharmaceutical Industry (ABPI) in the 2009 update to the Pharmaceutical Price Regulation Scheme (PPRS). PASs should not be the norm—they are intended for exceptional cases only. Many new cancer drugs are being approved without the need for PASs. Only if there was no change to NICE guidance following consideration of a PAS application would manufacturers be justified in withholding information they deem to be commercially confidential. NICE always encourages pharmaceutical companies to release as much information as possible to inform the PAS approval process, she added.

Mr Stainthorpe and Ms Knight made it clear that NICE will not provide a standardised PAS or monitor the cost implications for local health economies of new cancer drugs approved within PASs—nor is PASLU currently mandated to assess risk-share schemes outside of its current remit.

Professor McCabe warned of the danger of sub-contracting the legally mandated NICE decision-making process to local or regional bodies. “It is prudent,” he said “to invest whatever resources are required at a national level in order to avoid the potentially catastrophic financial consequences of making a wrong decision.”

Both Dr Catchpole and Professor McCabe said there was a strong case for NICE to audit the cost-effectiveness of PASs on the basis of available evidence.

 

Conclusions

As in previous years, the LCNDG meeting attracted a packed—and voluble—audience eager to discuss and debate contentions topics in cancer care. Patient access to new, expensive drugs was a core theme, and one that emerged at several points on the agenda. There was evident concern that schemes to improve access could also serve, albeit unintentionally, to increase inequality of healthcare. For many delegates, the meeting provided an insight into the gatekeeper role that PASLU is expected to play in the evaluation of PASs.

Delegates looking around the exhibition stands

The day closed with several delegates calling for a follow-up meeting. Details of which will be announced soon in Cancer Services Forum and on the LCNDG website.