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Published on 9 February 2012

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Clinical and financial risks with patient access schemes

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Calum Polwart, MRPharmS, SPres, IPres, MSc

Pharmacy Clinical Team Manager and Network Pharmacist, County Durham and Darlington NHS Foundation Trust

Leela Barham, BSc (Hons) Econ, MSc Health Econ

Independent Health Economist

David Thomson, MRPharmS, ClinDip

Lead Pharmacist, Yorkshire Cancer Network

Steve Williamson, MRPharmS (IPresc), MSc, FFCP

Consultant Pharmacist in Cancer Services,

Northumbria Healthcare NHS Foundation Trust

Patient access schemes (PASs) allow drug companies to offer discounts or rebates to reduce the transaction price of a drug to the UK’s National Health Service (NHS). They are seen as a way of improving access to new medicines for NHS patients that would otherwise be deemed too expensive or not cost effective by the National Institute for Health and Clinical Excellence (NICE).

In England, NICE provides recommendations that determine whether the NHS will reimburse a treatment. Patients receive their medications in hospital provider trusts, which are then reimbursed by the patient’s local primary care trust (PCT). The commissioning arrangements are set to change in the next two years, following a review of government policy on the NHS, with the publication of a White Paper, ‘Equity and excellence: liberating the NHS’.1 Changes to primary legislation will be made that will put great emphasis on empowering health professionals, reducing bureaucracy and improving access to medicines for patients. In future, the English Consortiums of Primary Care Doctors (primarily General Practitioners and other clinical members of the primary care team) will be responsible for commissioning, and paying for, care delivered by all providers of healthcare. Finally there is ongoing debate on the future of PAS after April 2014 when the UK government plans to introduce Value Based Pricing (VBP) as a new system of reimbursement. In their response to initial consultation, the Department of Health stated: “We have not ruled out the possibilitythat there may be a role for some type of ‘PAS’ arrangements in the new system.”

Background

The first oncology PAS scheme to be widely adopted in the UK came in October 2007, when NICE announced that it intended to approve bortezomib (Velcade™) for the treatment of multiple myeloma under a PAS. In the scheme, the manufacturer agreed to refund the cost of the treatment after four cycles of chemotherapy (16 doses) if the patient failed to achieve at least a partial response to treatment.2 This scheme opened the way for other similar strategies to be introduced to enable these high-cost treatments to proceed through the economic assessments required by NICE.

All PASs require some degree of administrative process in order to claim back the costs of treatment (although they are increasingly becoming simpler with time). In the melee of a busy clinical service delivering an ever increasing volume of chemotherapy, it is very easy for a non-essential piece of administration to be left incomplete and as a result the relevant free stock or refund not being claimed. Generally, the responsibility for making such claims has fallen to the pharmacy departments, although some organisations have placed responsibility with clinical teams. While the administration required to deal with a single patient claim is relatively minimal – usually a single page form sent by fax, followed by free stock or a refund for the treatment costs – the cumulative effect of multiple schemes for multiple indications is increasing.

Research conducted by the UK Cancer Network Pharmacist Forum (CNPF),3 which was summarised in Lancet Oncology,4 highlighted some inefficiencies in how these schemes are being operated. A major reason identified was the lack of NHS resources to manage them. The research did not estimate how effectively these schemes were actually being conducted across the whole healthcare system; however, only 47% of respondents to the CNPF study were able to say that the relevant costs were refunded to the appropriate funding PCT. The CNPF report also assessed if there was capacity to accommodate further PASs; 73% of respondents felt they had no capacity to take on further schemes, with over 80% of respondents reporting that PASs should not be introduced unless they were adequately resourced to manage them. In summary, the research found that PAS schemes are a time-consuming and bureaucratic system of paying for cancer medicines. Communication between doctors managing treatment and pharmacists managing the scheme was the key to success. The researchers found that, with bortezomib, every claim that was missed due to inadequate communication resulted in a loss of £12,000 (about €19,000).

In 2002, the Department of Health established an access scheme for multiple sclerosis medicines, in which it agreed to reduce the cost of treatment if subsequent evidence demonstrated that the effectiveness of the treatment was not as good as predicted. A series of articles has recently been published in the British Medical Journal5 highlighting the fact that, seven years on from the development of the scheme, the clinical outcomes expected have not been achieved even though the treatment costs have not been reduced. The potential additional expenditure on medicines to the NHS for this scheme alone has been estimated at £50m (€ 60·6) a year. There is a risk that, if current and future PASs are not efficiently managed, they, too, could fail to produce the anticipated savings and other benefits.

Given these problems, an obvious question that most health professionals in the UK ask is, “Why can’t the drugs be priced appropriately for the UK market?” The answer from the pharmaceutical industry is their need to operate in a global market; the UK list price affects the price in many other countries (the UK Office of Fair Trading has estimated that countries referencing the UK list price account for around 25% of global pharmaceutical sales).6 In the UK, PAS schemes seemed to have been widely accepted by the pharmaceutical industry who acknowledge that “risk-sharing plans may become a staple feature of the market in the future”.7

Patient access schemes in use

There are many examples of patient access schemes that have been used or put forward during the NICE process in recent years (see Table 1). The design of each of these schemes varies widely from the first cycle of treatment being free, to refunds for lack of effect, through to ongoing continuation costs being met beyond a certain threshold. This varied approach further adds to the complexity of managing these schemes, as does the inability of current hospital pharmacy computer systems to handle the arrangements. However, since 2009 the administrative costs of PASs have been subject to scrutiny by the Patient Access Scheme Liaison Unit (PASLU), a new unit within NICE.8 All PASs being put forward during NICE processes must be assessed by PASLU, including estimates of their administration costs to the NHS.

The financial risk with failure to claim through the schemes is variable, as is the complexity of making an individual claim. In some cases, particularly schemes that supply free drugs after a period of treatment (for example, lenalidomide and trabectedin), the nature of the scheme makes it extremely difficult to predict the associated financial risk because the risk could range from a single missed claim to many missed claims for the remainder of that patient’s treatment.

Some schemes do not apply to all patients or all clinical indications for the particular drug. This makes claiming a challenge. For example, in the case of the Velcade Response Scheme, NICE estimated it would be necessary to identify almost 785 patients receiving treatment to locate the 377 patients eligible for a refund. In some cases (for example, lenalidomide) it is necessary to track every patient at every cycle and document this with the company, even if the patient will never reach the criteria for ‘free’ drug under the scheme (such as cycle 26 for lenalidomide).

There are other access schemes outside the scope of cancer. The largest of these schemes is a NICE-approved scheme for ranibizumab (Lucentis™) for age-related macular degeneration. Under this scheme, the NHS carries the cost of the first 14 injections and the manufacturer takes over the cost after this.

The cost of a single injection is £761·20 (€921·44), and NICE estimates that on average patients receive 14 injections over their lifetime. Therefore, a hospital serving a population of 300,000 would expect to be giving 1778 injections per year (34 injections per week). It can be simply estimated that staff managing the scheme would need to work 17 hours per week (approximately 30 minutes per dose administered for 1778 doses in a year, equals 899 hours per year of 17 per week). This represents the worst case as hopefully there will be some economies of scale.

Two further non-cancer PASs have been introduced recently, following NICE technology appraisals. Ustekinumab9 (a treatment for psoriasis) has been introduced through a scheme that will ensure patients who require more than 45mg as a single dose will receive the additional 45mg vial cost free of charge. NICE has not estimated how many patients this will affect. In addition, NICE has introduced a further treatment for rheumatoid arthritis10 that has a PAS, providing 12 weeks (10 doses) of certolizumab free of charge to all patients (equivalent to ~ £2500 or €3900). The NICE Technology Appraisal failed to identify any resource impact associated with certolizumab because the drug is a like-for-like replacement of another. However, the alternative drugs do not require the use of a PAS.

Future access schemes

In October 2010, we undertook a Horizon Scanning exercise of forthcoming new cancer medicines that identified 14 new cancer indications, which are likely to be accompanied by a PAS. This would double the current number of schemes. While the details of these schemes are unknown, it is possible that at least an additional 0.5 whole-time equivalent of staff resource would be needed to manage their impact per one million population.

One scheme approved by NICE (gefitinib – Iressa™) in July 2010 introduced another new model, which included a ‘single lifetime price for a patient’. Patients starting on gefitinib will be eligible to receive their drug for as long as it is clinically indicated to treat non-small cell lung cancer for a one-off cost of £12,200 (€19,000), rather than the conventional monthly cost of around £2500 (€3900). This additional one-off fee will be charged on the patient’s third cycle of treatment, and patients who don’t reach cycle three will have no charge applied.

Time required to administer schemes

Accurate estimates of the administrative impact of these schemes are difficult to establish. The CNPF study asked respondents to estimate the time required for each of the four schemes it reviewed. Times vary per scheme and across organisations nationally, with a mean time per episode of care of 19 minutes for sunitinib and 37.5 minutes for bortezomib.

In Scotland, the Scottish Medicines Consortium has been slower to adopt PASs and has established an advisory group (Patient Access Scheme Assessment Group (PASAG), NHS National Services Scotland). PASAG has developed a model for assessing the impact of these schemes. It is likely that the bulk of the administrative processes could be undertaken by a relatively low-grade member of the pharmacy support staff, for example a technician or administrator.

There are four main models of PAS currently in use. Table 2 outlines how each of these schemes operates in a simplified manner. (The newest scheme for gefitinib is a hybrid of free start and free ongoing). One of the recommendations of CNPF research was the development of a set of consensus templates that describe the high-level process and time required for different types of PAS. We believe that, to optimally manage these schemes, all patients starting on a treatment that includes a PAS should be registered either on a national or local database and then tracked throughout treatment. Standardised estimates of staff time required at each stage of the process should be agreed for each of the main models.

Conclusion

It can only be good news for patients that the pharmaceutical industry and the NHS have worked together to find new ways of making innovative medicines affordable in the UK. Not being able to access a medicine that will help treat their cancer can be very distressing for patients and for this reason PASs definitely help our patients and clinicians. However, the variety and complexity of these schemes is clearly a concern for clinicians and those administering hospital finances. Clinical staff are having to spend time manually tracking patients, retrospectively adjusting stock control systems and ensuring that financial systems account for the cost of the drug. In order to make PASs work, the NHS is faced with having to spend money on administrative duties at exactly the time when we are trying to move towards a more streamlined clinically led healthcare system.

The future of PAS Under Value Based Pricing is not clear but, given the issues we and others have found with the use of PAS, we would strongly advise that the value in value-based pricing is not proposed to be achieved via PAS.

References

1. Department of Health. Equity and excellence: liberating the NHS. 12 July 2010: ISBN: 9780101788120.

2. National Institute of Health and Clinical Excellence (NICE). Technology Appraisal 129: bortezomib for relapsed multiple myeloma. October 2007. http://guidance.nice.org.uk/TA129 (Last accessed 6 January 2012).

3. Williamson S. A report into the uptake of Patient Access Schemes (PAS) in the NHS 2009. (Available from: http://bopawebsite.org/tiki-download_file.php?fileId=626)

4. Williamson S. Patient access schemes for high-cost cancer medicines. Lancet Oncology 2010;11:111–12.

5. Raftery J. Multiple sclerosis risk sharing scheme: a costly failure. BMJ 2010;340:c1672.

6. OFT The Pharmaceutical Price Regulation Scheme: a market study, 2007. http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885.pdf.

7. Cook J P et al. Current opinion: pharmaceutical risk-sharing agreements. Pharmacoeconomics 2008;26:551–56.

8. Patient access schemes liaison unit. NHS. www.nice.org.uk/aboutnice/howwework/paslu/patientaccessschemesliaisonunit.jsp (Last accessed 6 January 2012).

9. National Institute of Health and Clinical Excellence (NICE). Technology Appraisal 180: Ustekinumab for the treatment of adults with moderate to severe psoriasis. 2010. http://guidance.nice.org.uk/TA180 (Last accessed 6 January 2012).

10. National Institute of Health and Clinical Excellence (NICE):.Technology Appraisal 186: Rheumatoid arthritis – Certolizumab pegol. 2010. http://guidance.nice.org.uk/TA186 (Last accessed 6 January 2012).



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