Uptake of treatments approved by NICE and NHS England can sometimes be slower than expected, which is frustrating for clinicians, patients, and industry. What are the roadblocks? What can be done to overcome them? Our roundtable panel discusses the issues.
The process of getting new, expensive, and highly specialised treatments to patients will always be slightly convoluted and involve significant effort for healthcare professionals and industry. The various processes have been in a state of constant change for the last decade, making it even harder for those involved to navigate the system. Increasing numbers of new treatments being approved adds to the problem.
Specialised Commissioning asked a panel of experts to identify the key practical issues facing them, and suggest ways of resolving them now and in the future. The senior professionals who participated in this discussion were chosen to reflect the diversity of expertise involved, including NHS England, clinical and finance leads, pharmacy, and patient groups.
Evaluation of medicines by NICE and NHS England
Jayne Spink started the discussion by sharing her concerns about the speed with which medicines are evaluated post-licence, which causes significant barriers for orphan medicinal products (OMPs); there are no fewer than 15 different ways in which OMPs are evaluated for the possibility of routine prescribing in the NHS, and only half of all OMPs with a licence are routinely available in England.
Peter Clark contrasted this with the situation in cancer, commenting that there are only two routes available to get cancer drugs into play in England: NICE’s technology appraisal (TA) system and the NHS England policy prioritisation process. However, he added that the NHS England policy prioritisation process can sometimes be too long and difficult to navigate.
… the NHS England policy prioritisation process can sometimes be too long and difficult to navigate.
Alastair Whitington added that with NICE planning to do a significantly greater number of assessments, something will need to be done in terms of prioritisation to prevent a logjam for NHS England.
Peter Clark said that there is a need for the appraisal process to reflect off-label use, because formal licensing will not keep pace with potential clinical applications due to the growth of targeted treatments and the advent of genomics. NICE has been in discussion with NHS England about this, with cancer the likely starting point, it being the therapy area with the greatest need.
Jayne Spink said that although the NICE process is very transparent, the NHS England prioritisation process is ‘completely opaque’. Consequently, patient groups do not have a good understanding about why some drugs are, for example, priority level five initially, but in later rounds of the process become priority level two. There does not seem to be a space within the NHS England prioritisation process for evaluating and taking into account evidence submitted by patient groups and advocates, which there is in the NICE appraisal process.
Alastair Whitington commented that NICE and NHS England need to work more closely together to achieve a single unified system and transparency.
Concerns about testing and lack of real-world data
Robert Glynne-Jones outlined some concerns about testing. Due to lack of capacity in pathology departments and unclear funding routes, there are delays in trusts being able to offer new tests following NICE endorsement. This has caused delays in the initiation of some new drugs where testing is required. Confusion around pathology testing has also caused delays; it is sometimes unclear who is responsible for testing, or who commissions it.
Confusion around pathology testing has also caused delays …
Robert Glynne-Jones also mentioned that despite the creation of the Systemic Anti-Cancer Therapy (SACT) database,1 there is a lack of robust audit data on how new technologies are working in the real world outside of academic research.
Jacky Turner offered insights into the issues faced by pharmacy departments. With five or six new NICE approvals coming through each week compared with one or two per month a couple of years ago, the workload for people on the ground at trust level is increasing. Pharmacy used to implement prescribing of newly approved cancer drugs through whichever pathway worked locally, whereas now implementation is often led by the oncology pharmacy team and lead cancer clinician, and the workload across the board in terms of getting newly approved drugs has massively increased. Substantial amounts of paperwork must be in place before the implementation of new cancer drugs, including local and national governance processes, data collection, funding submissions etc. All of these additional processes add to delays in implementing newly approved drugs.
There have also been issues related to communications from NHS England to trusts, which have further delayed the process of implementation. Some trusts have had to invest in personnel with a pharmacy background rather than an accounting or data-management background because these individuals have a better understanding of the appropriate flow of paperwork and money. All the different funding streams that must be dealt with, in addition to numerous new drugs and new indications, add to the complexity and volume of work for pharmacy.
Costs associated with service delivery
Alastair Whitington said that when the Cancer Drugs Fund (CDF) originally came into operation, it funded the acquisition cost of a drug, but not costs associated with the service delivery of that drug. He asked whether tariffs have now been adjusted to cover this.
Peter Clark responded that drug and delivery costs are now covered for all routinely commissioned or CDF-recommended cancer drugs, and manufacturers now also have to include the costs of diagnostic processes in technology appraisals. He added that this was going to become a very fast-moving field, with horizon scanning by NICE and NHS England identifying genetic tests likely to be needed in future.
Financial challenges involved in delivery
Patrick McGinley agreed that the need to improve patient flow, the number of drugs being approved, and the complexity of the approval process is challenging. He added that delays are a reflection of the fact that there is not enough funding in the system to enact change; new approvals have an impact both on commissioners, who are responsible for funding the drug only in the approved indication, and providers, who must make changes to funding and provision to enable and monitor correct prescribing.
… delays are a reflection of the fact that there is not enough funding in the system to enact change
Blueteq CDF requests inevitably slow down implementation because providing detail on the relevant form tends to be dependent on individuals within the system. The rise in the number of newly approved drugs equates to an increase in the time required for Blueteq requests over and above that necessary 2–3 years ago, which should be supported. Improvements in flow in one aspect of a pathway almost invariably result in pressures downstream. The key issue is that funding is increasingly not in the hands of accountants or administrators, which can be viewed positively, but it means that pharmacists are using valuable pharmacy resources to provide these data.
More cancer drug approvals
Peter Clark appreciated that the system is stretched by a proportion of approvals approaching 85% and an increasing cancer drug pipeline, with NICE appraising 40 new cancer indications in 2019.
Regarding Blueteq, he said that registration enables NHS England to monitor the uptake and speed of uptake for every new cancer drug. Nationally, every audit for every drug with a potentially high level of use has shown plateau use within 3 months of approval. However, plateau use is not reached within 3 months of approval in the case of drugs linked with the introduction of a molecular diagnostic, which always take more time to implement. He added that the speed of uptake of new cancer drugs is an incredible testament to everyone involved—commissioners, providers, oncologists, pharmacists, and nurses.
Jayne Spink explained the situation for rare diseases. Because there is no centralised service specification for a good proportion of rare diseases, patients may or may not be seen at a specialised centre designated for prescribing. The barrier to accessing a drug with a positive approval is a patient flow issue in terms of accessing the appropriate prescribing centre rather than a money issue.
Alastair Whitington said that in the past, the number of chemotherapy cycles undertaken by patients in trials was not necessarily reflected in the real-life setting, with some patients only going through 30–40% of expected cycles. He asked whether there is greater consistency between expectations and what patients are receiving, and if the SACT database shows that this is still an issue?
Peter Clark responded that no‑one expected real-world practice to exactly mirror the experience in clinical trial settings. Trials include specialised groups of patients, and also usually have clear rules for stopping treatments, including the first sign of resistance‑driven progression, whereas clinicians often continue drugs—particularly immunomodulatory imide drugs—in clinical practice while the patient still derives benefit.
He added that the CDF invested heavily in the SACT database to get CDF outcomes, and SACT data are expected to be as accurate and pristine as real-world data can be. In a year, there should be good data on CDF treatment durations in clinical trials and real-life situations.
Aseptic unit capacity
Jacky Turner said that because pharmaceutical companies are working well with NICE and getting their portfolios and data to NICE in a timely manner, the front-end element is working.
However, if 40 new drugs are going to be approved this year, this is another drug per week that pharmacists must add to the prescribing system, update an existing record for, or manufacture within the aseptic unit. Early access medicines schemes and compassionate‑use programmes are also adding to these pressures, particularly because they must be implemented within 30 days rather than 90 days. The income that trusts are now getting to introduce drugs through a proper process should be tailored towards the people who are doing that work. In one large trust, the number of items that the aseptic unit was making increased by 16% last year, so they needed to invest in more staff to manufacture the injections. This was outsourced, as is the case for many trusts, but external providers and companies are themselves struggling to meet demand, leading to other capacity pressures. The whole process of outsourcing needs to be stabilised, with better horizon planning and investment in future capacity.
The whole process of outsourcing needs to be stabilised, with better horizon planning …
A whole-system approach is needed, to anticipate and provide capacity before a situation similar to the homecare crisis arises, in which different homecare companies began to develop problems and could not maintain adequate homecare delivery.
Patrick McGinley agreed that the overall flow of approvals has improved significantly in the past 2–3 years, which has resulted in pressures related to capacity within the system. He said that we were at a point where we either expand aseptic units or buy in from a market that does not have the capacity to provide what is needed. With providers, commissioners, NICE, and pharmacy working together more closely, we should be able to understand future capacity for all stakeholders within the limits of confidentiality and commercial secrecy.
If the flow of approvals is improving, but the process is limited by what can be obtained and produced at the front line, capacity needs to be taken into consideration during appraisals. Approvals should therefore take into account and provide guidance on capacity and required resources, recognising that a specified prescribing centre may not be able to expand to the capacity required to deliver a newly approved drug.
In addition, confirmation of the ability of pharmaceutical companies to supply the volumes required to all trusts will be helpful.
Jacky Turner added that a review of aseptic services published by NHS Improvement in 2018 concluded that NHS aseptic facilities in England need to transform to deliver a future-ready, resilient, high-quality, safe, and efficient service.2
Patrick McGinley agreed that this aseptic services review is a useful resource for NICE appraisals and NHS England reviews because it identifies not only the location of units, but also their capacity to increase throughput.
Deals and pricing
Alastair Whitington asked whether the closer relationship between NICE and pharmaceutical companies in terms of planning at the start of the process, and during negotiations, has helped to resolve problems further down the line because pricing deals are more straightforward.
Peter Clark responded that deals are more straightforward, and that pharmaceutical companies are pricing much more responsibly for a variety of reasons, including recognising that routine commissioning is the only way they can be sure of funding, and that this requires approval from NICE. Both of these facts explain why NICE approvals have increased in number so dramatically over the past 2 years.
Robert Glynne-Jones raised the issue of information about new medicines. He said that in his non-teaching clinical setting, he receives an email from management on the day a drug is going to be approved by NICE to flag that it is now eligible for use, and this is often the first time he hears about the availability of a new drug for use within the NHS.
There is no formal system to identify barriers or issues for implementation, and it is left up to the clinical lead to ensure implementation, which, in some cases, can lead to delays of months, even up to a year, between approval and implementation in practice.
There is no formal system to identify barriers or issues for implementation …
Peter Clark said that the cascade system from commissioning hubs down to clinicians and pharmacists is variable, so it is good to hear that some circulars are received on the day a drug is approved. The fact that NHS England has 90 days to fund a drug after a positive TA does, in itself, act as a pre-warning system with respect to non-cancer drugs. However, the CDF routinely provides funding to cover the 5-month gap after NICE recommends a cancer drug and, in providing the opportunity for that funding, the CDF is effectively putting pressure on the provision system. Advanced warning cannot be given because, in effect, the first warning is when NICE issues its final appraisal determination. The only warning is given to commissioners, who need to line everything up in terms of provision.
Robert Glynne-Jones pointed out that there is no provision to assess any issues that would make it difficult to introduce a drug within the trust. The lead is expected to implement the CDF’s decision and, in some cases, particularly for rare cancers, the clinical lead is unclear and the trust’s chemotherapy lead is not always willing to take on that responsibility.
Jacky Turner said that in some of the larger trusts, the chemotherapy lead takes on this role, and monthly meetings are held to discuss the clinical, resourcing, training, and financial implications of newly approved drugs and drugs that are likely to be approved in future.
However, some trusts may not have a system set up to deal with new chemotherapy drug approvals. It also depends on the lines of communication between a trust and NHS England: some larger trusts in London have direct communication with NHS England, and even have staff working across both settings, which helps with flow and implementation.
The final word
Peter Clark said that key issues remain with respect to the contributions of industry and NICE given the accelerating pipeline for cancer. Capacity is the biggest concern because many of the new drugs do not replace but rather displace existing treatment options, and the system—whether the commissioner’s office, the provider’s office, or the clinic—may not be able to cope with the influx of new drugs. For every audit of how fast the latest drugs are implemented, a plateau is expected, but so far the speed of implementation is not slowing down. He added that we can only pay tribute to those involved, but there will come a time when people on the ground cannot keep pace with the drugs pipeline.
Editor’s note: This is a summary of the roundtable discussion held in January 2019. A full report will be available to download later in 2019.
- National Cancer Registration and Analysis Service. Systemic anti-cancer therapy chemotherapy dataset. www.chemodataset.nhs.uk/home (accessed 9 May 2019)
- NHS Improvement. Pharmacy aseptic services review: summary of key findings. Specialist Pharmacy Service, 2018. Available at: www.sps.nhs.uk/wp-content/uploads/2018/04/NHSI-Aseptic-Summary-and-Findings_280318.pdf