With the number of living mesothelioma claimants making claims for experimental immunotherapy on the rise, claimants and their solicitors are exploring alternative mechanisms to enhance their prospects of recovery, despite serious questions around whether or not the suitability of the treatment has been established.
In a recent but unreported first instance case, leading counsel for the claimant, Michael Rawlinson QC, successfully argued for a Periodical Payment Order (PPOs) (pursuant to the Damages Act 1996 and Civil procedure Rule 41.7), the terms of which, were encapsulated under what Mr Rawlinson QC is seeking to call a “Scott” Order (not to be confused with “Scott” schedules, which are used to encapsulate late volumes of information).
“Scott” demonstrates what Mr Rawlinson QC seeks to present as an alternative approach to securing future treatment costs. The Order in that case provides for an annual payment of £130,000 payable in four equal instalments, to be triggered once the treating oncologist approves the commencement of immunotherapy. In order to administer this fund Mr Rawlinson QC suggests the creation, administration and funding of a trust (a financial device for holding and controlling assets and money on another person’s behalf).
It is not only the costs of immunotherapy which are pursued, but also the costs of chemotherapy treatment where the recommended drugs are unavailable on the NHS.
This article examines the creation of PPOs, the issues of PPO’s in mesothelioma cases and explores a number of discussion points for defendants and insurers faced with these claims. Before doing so, we assess the current status of immunotherapy treatment, its effectiveness, cost and the degree of support amongst leading medico-legal experts.
The number of clinical trials and studies into new immunotherapy treatments for mesothelioma continues to expand. According to the US National Institute of Health, there are 137 active clinical trials and studies of which eight are taking place in the UK, with one exploring further the use of ‘Pembrolizumab’, a treatment discussed in more detail below. There exists a range of immunotherapy treatments available privately, or otherwise still in trial phase. Examples include Nivolumab, Ipilimumab and Tremelimumab, none of which are NICE (The National Institute for Health and Care Excellence) approved for use by the NHS.
For the purpose of this update, our focus is on the drug treatment Pembrolizumab, which is the most frequently claimed treatment type. Pembrolizumab is approved by NICE for use on the NHS in the treatment of skin and non-small cell lung cancer, but is yet to be approved for treating mesothelioma.
As with other immunotherapy treatments, Pembrolizumab or, “Keytruda” to use its brand name, is aimed at reducing/halting tumour growth and prolonging life expectancy. The drug works as a ‘checkpoint inhibitor’, blocking the PD1 protein on the surface of certain immune cells called T cells, enabling the T cells to eliminate cancer cells. Costs range from £4,800-£7,000 per dose and counting, with recent increases most probably due to an upturn in demand.
The number of cycles range from anything between 2-6 doses on average, before a PET-CT scan is undertaken, measuring mesothelioma activity and assessing the drug’s effectiveness. The total costs might typically range from £30,000 to in excess of £100,000.
Oncologist Dr Jeremy Steele, a key supporter of the treatment, points to the positive results in the trial “Keytruda – 028”, where 76% of patients “derived clinical benefit” (out of 25 in total). However, the drug is not suitable for all claimants who have developed mesothelioma, and there are a number of qualifying conditions such as:
Possessing a suitable medical history/genetic factors.
Capturing the tumour at a stage where immunotherapy might have a positive effect.
The absence of certain co-morbidities and,
The claimant’s fitness to withstand the treatment and what benefit he/she is likely to derive from it.
There is one additional qualifying factor which is causing tension between claimant and defendant’s experts, principally chest physicians. In a recent BLM case the issue arose as to whether the expression marker PD-L1 must be present in at least 1% of tumour cells, before it can be said that it is likely to be of benefit and therefore reasonable to proceed with treatment. The issue has not been fully tested but, that case highlights some key points for consideration amongst defendants, insurers and paymasters alike:
Is the decision to offer Pembrolizumab (or other immunotherapy or chemotherapy treatment) reasonable? In practical terms, is there a realistic prospect of prolonging or improving quality of life when balanced against the estimated cost of the treatment?
Does the claimant meet the qualifying criteria?
What control measures can be exercised over the duration of the treatment including but not limited to, frequent PET/CT scans to assess the present status of the tumour and effectiveness of the treatment?
Despite the results of the (small) study referred above, it is fair to say that evidence as to the efficacy of immunotherapy treatment and Pembrolizumab in particular, is limited and uncertain. This is the case, even though some Oncologists/Chest Physicians instructed by defendants have, where the criterion is met, agree the decision to offer treatment is or was, reasonable. In one instance, the use of Pembrolizumab was thought to have had a positive impact, at least initially, but within three months of the first cycle, symptomatic deterioration had occurred and treatment was discontinued.
However, even in the light of such uncertainty, defendants and their insurers face a difficult task resisting claims when the criteria for allowance (or not as the case maybe), is the broad test of reasonableness. This is particularly so, given the terminal nature of the disease involved.
Nevertheless, while Pembrolizumab and other treatments remain unavailable on the NHS and claims continue to be presented, the prospect of challenge by defendants and insurers as to what constitutes ‘reasonable’ is inevitable, even if there is a dearth of case law on the point. This also highlights the importance of implementing an effective strategy early, during the pre-litigation stage.
The “Scott” Order and PPOs
A Scott Order, it is claimed, strikes a much needed balance between compensation tailored to reflect the claimant’s requirements, whilst offering protection to insurers that any final outlay will only reflect the number of treatments received.
The principle terms of the Scott Order propose:
Payment of the future cost of immunotherapy even if at the time of agreement, the parties do not know if the claimant will in fact require immunotherapy.
An agreement to fund future treatment without “medical oversight” by the defendant or its insurers.
Any changes in the nature of the treatment, frequency and cost to be notified by defendants and their insurers and adjustments made – but there is no basis to challenge the change of immunotherapy type, only the cost of it.
Payments to be made upfront to a Personal Injury Trust, the reasonable costs of which will also be paid by the defendants, in addition to the costs relating to scanning and the claimant’s out of pocket expenses.
The court has a fairly wide discretion when deciding whether or not to make PPOs. Under CPR Part 41.7, when deciding to make an Order under Section 2(1)(a) of the Damages Act 1996, “the court should have regard to all the circumstances of the case and in particular the award which best meets the claimant’s needs”. Briefly and for ease of reference, the requisite detail can be found under:
Section 2 of the Damages Act 1996.
Section 100 of the Courts Act 2003.
Section 2 of the Damages (Variation of Periodical Payments) Order 2005 and, CPR 1.6, 41.7, 41.8 and the practice directions thereto.
Whilst the court has a wide discretion (CPR 41.7), when applying the factors to which it must have regard (Practice Direction 41B), a number of questions arise as to whether a PPO in the terms advanced under Scott would be suitable and CPR compliant:
Under Part 41.8 re: form and content requirements of the PPO, the annual amount awarded must be defined as well as how each payment is to be made during the year. Whilst “Scott” Orders propose an annual payment of £130,000 divided into four quarterly instalments of £32,500, there is considerable uncertainty as to the fact that the claimant may undergo treatment as well as the duration and cost of it. As such, it is difficult to see how Part 41.8 can be complied with.
Further, it is questionable whether a PPO can be made when the date for commencement and conclusion is unclear. In AA v CC (2013) EWHC 3679, Swift J held that “the court does not have the power to make an order for periodical payments which would start and end on a date which was uncertain”. As set out above, the Scott order proposes the first instalment of £32,500 is payable on the “trigger date”, but that date is not clear.
There are other concerns namely, the creation and cost of the administration of a Trust, in addition to the submissions of sizeable upfront payments which may or may not be required.
Where there is problems with the form of treatment proposed, resisting a claim for the costs of treating mesothelioma is challenging but, there is a concern that if a “Scott” type PPO Order prevails as an alternative form of resolution, the costs of not only the treatment itself but, the additional legal/trustee costs involved would fall beyond the bounds of reasonableness, when balanced against the likely benefit/effectiveness of the proposed treatment.
For defendants and their insurers, this and other challenges including criteria for suitability, proportionality and CPR compliance are available in varying degrees. However, implementing an effective strategy at the earliest possible stage could be vital in exercising some degree of control and potentially avoiding a “Scott” Order. In that regard, we close on some key points for consideration:
Where liability is not in dispute, consider an early, enhanced interim payment subject to confirmation of initial evidence from expert clinical and oncologists/chest physicians as to the suitability, duration and cost. A similar tactic worked in a recent case before Master Thornett in the Senior Courts, when a request for a preliminary hearing to consider a “Scott” Order was resisted.
Explore whether an agreed criterion for the provision of immunotherapy can be agreed including suitability, duration and cost. Outside the scope of an individual case, share knowledge to establish in which case immunotherapy will assist. Consider instruction of a medico-legal expert if there was or is an issue over the requirement for minimal PD-L1 expression.
Early disclosure of medical records to assess the current status and progression of the tumour, and proposed future treatment plan are important. A review may also help identify what chemotherapy treatment has been provided and the response.