Article Category: Clinical Practice
Published Online: Jun 17, 2020
Page range: 59 - 69
DOI: https://doi.org/10.17225/jhp00156
Keywords
© 2020 Debra Pollard et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.
Focusing on the introduction of NovoEight, a survey of haemophilia nurse specialists on their experience of managing factor product switches reveals the hidden workload involved
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Haemophilia is characterised by a deficiency of coagulation factor VIII or IX in haemophilia A and B respectively. In the UK, following the introduction of a national policy [1], most people with haemophilia are treated with replacement clotting factor concentrates produced by recombinant technologies. The widespread adoption of factor VIII and IX prophylaxis and increasing usage over recent decades has led to haemophilia being considered an expensive condition to treat [2]. This has resulted in increasing levels of administrative scrutiny from payers and attempts to procure clotting factor concentrates more efficiently and collectively. Since 2004, there has been a national tender system for the purchasing of clotting factor concentrates managed by the Commercial Medicines Unit, a part of NHS England. Over time, this has led to significant savings in the National Health Service (NHS) budget [3].
The tendering process for factor concentrates now operates through a system whereby companies bid for volumes of the market every three years. Following each new contract, haemophilia centres must commit to using certain volumes of particular products. Consequently, some patients have to switch product in a timeframe that allows the target volumes to be reached within a year of contract award.
Tender-mandated factor switches are associated with an additional workload that involves:
Ensuring product is stocked by hospitals Liaising with data managers Identifying and informing patients Updating patient prescriptions for both in-hospital usage and home delivery of clotting factor concentrates Liaising with home delivery companies around stock management and to limit product wastage Managing pharmacokinetic assessments and inhibitor screens, if required Counselling and educating patients and families.
Inevitably, much of the work of managing the process of switching products falls to specialist haemophilia nurses [4]. However, there has been little in the way of formal assessment of the additional workload that tender-mandated factor switches impose on haemophilia nurses, or the hidden cost that this incurs. The recent (spring 2018) introduction of turoctocog alfa (NovoEight®; Novo Nordisk), and the loss of other regularly used products, offered the opportunity to gain valuable insights into the role of the specialist haemophilia nurse in switching factor products on a relatively large scale.
In advance of the 2018 tender-mandated switch, a roundtable discussion meeting of experienced haemophilia nurse specialists was held focusing on the management of product switches in light of the pending national recombinant factor VIII tender. This was organised and funded by Novo Nordisk, although the discussions and output were not product-specific. Following that meeting, the participants developed a practical guide primarily for new nursing staff who had not previously experienced a significant product switch (Table 1). This, together with sample templates of a checklist and a patient letter, were shared with nurses via the Haemnet website (
Practical guide to switching factor concentrate post-tender
| Knowledge of products | |
| Draw up list of potential patients to switch Highusers On a product that will no longer be available e.g. Helixate On a plasma-derived product and due to switch to recombinant Pendingsurgery Under 50 exposure days Children and parents new to managing home treatment Likely anxiety e.g. extreme worry about treatment safety and the consequences of changing treatment – often with family history of transfusion transmitted disease or inhibitors. Communication issues e.g. learning difficulties, language | |
| Agree list of propose patients | |
Subsequently, we undertook a series of semi-structured telephone interviews with 12 senior representatives from haemophilia centres across the UK. Interviews focused on the experience of managing product switches following the recent national recombinant factor VIII tender, with a particular focus on the introduction of NovoEight as this was new to the UK market. All interviews were conducted in July/August 2018. Healthcare provider research in the UK does not require ethical approval, however verbal consent was taken from participants.
Interviews were conducted with 11 senior haemophilia nurses and one operational services manager from haemophilia centres across the UK. Collectively, participants claimed experience of switching products for approximately 190 people with haemophilia to NovoEight (Table 2). Three of the nurses were from paediatric-only centres. While all nurses had experienced the occasional need to change a patient's product for clinical reasons, for most nurses, this was their third experience of a mass tender-mandated factor switch; two had experienced just two previous contract switches.
Patient selection (‘p’ indicates nurse in a paediatric centre)
| HNS1p | Doctor/Nurse | Routine visit | High users | Presence of an inhibitor | 0 |
| HNS2p | MDT | Routine visit | Product withdrawal | Presence of an inhibitor | 0 |
| HNS3 | MDT | Routine visit | High users | None | 0 |
| HNS4 | MDT | Routine visit | High users | History of an inhibitor | 0 |
| HNS5 | MDT | Routine visit | Volume target (ReFacto FuseNGos patients) | Presence of an inhibitor | 0 |
| HNS6 | Nurse | Routine visit | High users | None | 0 |
| HNS7 | MDT | Routine visit | High users | Those pending surgery | 1 who was new to prophylaxis |
| HNS8p | MDT | Routine visit | High users | <50 exposure days | 2 inhibitor concern |
| HNS9 | Doctor/Nurse | Routine visit | High users | Patients who had switched too often | 2 inhibitor concern |
| HNS10 | MDT | Letter (unless due in clinic) | Product withdrawal | <50 exposure days | 0 |
| HNS11 | Nurse | Letter/phone call | High users | Presence of an inhibitor | 0 |
| HNS12 | Doctor | Routine visit | Product withdrawal | Presence of an inhibitor | 0 |
When asked who decided which patients should switch product, most said it was a multidisciplinary team decision or one made by the doctor and a nurse; two nurses said it was a nurse-only decision (albeit with approval of the centre doctor) and in one case it was a doctor-only decision (Table 2).
Most patients were told that they would switch product at a routine clinic visit; specific letters or phone calls were only made if the patient was not due for a routine clinic review during the time period in which the switch had to be made.
Patients themselves appeared to be relatively uninvolved in the decision; they were not consulted.
By far the most common reason for not switching a patient's product was a previous history of an inhibitor (mentioned by 75% of nurses). Difficulties in regard to communication (e.g. learning or language difficulties) were also cited by several nurses.
There was no official guidance from the UK Haemophilia Centre Doctors’ Organisation (UKHCDO) with regard to which patients should have their product switched. Unlike the earlier introduction of extended half-life products, this switch required no pharmacokinetic monitoring [5], and was seen as a relatively straightforward ‘like-for-like’ factor VIII switch. When asked about the criteria used in the decision-making process, decisions appeared to have been based on the imperative to meet volume targets, resulting in two principal target groups:
Patients on products due to be withdrawn from the UK market
High volume users
Within this, however, some specific considerations could be identified. For instance, one paediatric nurse saw the switch as an opportunity to reduce infusion volumes in one patient, or for those thought to be not responding to their current treatment. One centre specifically targeted NovoEight to new mild and moderate patients. But all nurses tended to consider the nature of the individual patient and whether they would cope well with a switch. This also included thinking about the needs of carers:
Most nurses admitted they would not consider those patients they thought were unlikely to agree to switching, or those in whom a product switch might provoke anxiety. As a result, only three nurses said patients had refused to switch to the new product. In five patients, this was due to the fear of an inhibitor, while the sixth was a patient new to prophylaxis who was unwilling to make a further change so soon.
For nurses, the additional workload involved in a tender-mandated product switch begins very early.
There is a considerable effort involved in ensuring a new named product is on the hospital drugs and therapeutics prescribing formulary, and this can add to the difficulty of achieving switches in a timely way and meeting target volumes. All nurses agreed that tender-mandated switching resulted in a significant extra workload, principally for the nurse and data management teams. However, attempts to quantify this additional workload were difficult: most nurses felt the workload was simply absorbed (Table 3).
Workload associated with switching
| HNS1p | 3 | 0 | Nurse | Assessed by phone | Minimal (low patient numbers) | ||
| HNS2p | 3 | On 1 patient | Comparable | Usual 6 months | Nurse | Instruct patient | Minimal (low numbers) |
| HNS3 | 15 | On 1 patient | Improved | Usual 6 months | Nurse | 1 day per week for 4 months | |
| HNS4 | 30 | 0 | Usual 6 months | Nurse | Instruct patient | 1 day followed by bulk switch | |
| HNS5 | 6 | 0 | Only for severe patients | Nurse | Minimal if well planned | ||
| HNS6 | ~10 | 0 | Usual 6 months | Nurse | 1–2 days | ||
| HNS7 | ~40 | 0 | Usual 6 months | Nurse | Trust | 3–4 days | |
| HNS8p | 10 | 0 | Usual 6 months | Nurse | Home delivery company | Minimal (absorbed into general workload) | |
| HNS9 | 18 | Only where practical | Comparable | Prior to switch and FU | Nurse | Substantial but absorbed into general workload across the team | |
| HNS10 | 8 | 0 | Usual 6 months | Nurse | Trust and Haemtrack | 3 days | |
| HNS11 | ~20 | 0 | Usual 6 months | Nurse | |||
| HNS12 | ~25 | Yes | Comparable | 6–12 doses | Doctor | Trust | 2–3 days |
For those who were independent prescribers, the workload was probably greater, but easier in the sense of not having to liaise with others who may not always be available. In the main, the present switch did not require centres to change home delivery companies, but where it did this would have added significantly to the workload due to additional paperwork.
One practical challenge is ensuring that the patient uses all of his old product before the switch. All of the nurses advised their patients either by letter, phone or in person (where this coincided with a routine visit) to use up all of their old product, but responsibility for this was primarily down to the patients. For some nurses this meant rescheduling appointments.
With no official UKHCDO guidance about pharmacokinetic or inhibitor testing regarding this particular switch, eight of the 12 participants did not undertake any additional pharmacokinetic assessment, but four did so on at least some patients, usually where these were due as part of a routine visit. Similarly, preand post-switch inhibitor screens were not undertaken outside of the patient's routine six-month visits.
Given the additional impact upon workload, most of the nurses agreed that patients should be switched no more than every three years:
Haemophilia is an expensive condition to treat. The average adult with severe haemophilia A in the UK used 250,000 IU of factor VIII in 2011/2012, at an annual cost in excess of £100,000 [3]. The cost has led to growing scrutiny over treatment as well as pressure to procure clotting factor concentrates more efficiently. In the UK, clotting factor products are purchased centrally for use within the NHS in a system by which pharmaceutical companies bid for volumes of the market every three years. This has resulted in substantial cost savings at a central level. However, it takes no account of the hidden workload cost of switching patients’ treatment from one clotting factor to another or additional blood test costs where these are performed.
The key stages in product switching begin with identifying the patients, followed by:
In addition, most factor in the UK is now delivered to patients by third-party home delivery companies who operate contracts with specific pharmaceutical companies. This could potentially impact upon the patients likely to be targeted for switching.
For most nurses, however, the additional workload proved very difficult to quantify:
Based on the 2017/18 pay rate for a Band 7 haemophilia nurse in the UK (£31,696 to £41,787 basic national salary without regional ‘uplifts’ and additional employer costs), and assuming an additional workload associated with this product switch of one to three days, the nursing cost alone would be in the region of £365 to £481 per centre.
That the impetus for product switches is principally financial is recognised by both nurses and patients:
As financial pressure on healthcare services continues, product switches are likely to continue to be a routine aspect of the haemophilia nurse's role. It will be important to ensure that this does not conflict with the nurse's role as principal advocate for the patient. Switching patients’ factor products has the potential to cause conflict. In a recent assessment of patients whose treatment was switched to extended half-life factors, we found that for patients, product switches could be disruptive: if not handled and communicated appropriately, switching could affect relationships with health care professionals as well as their confidence in treatment [6]. The current study suggests that nurses are, in the main, sensitive to patients’ concerns.
The comment relating to the device was echoed by other nurses, who had used the ‘opportunity’ of the switch to avoid using a product-linked administration device that had proven unpopular with patients and nurses, principally because it involved vial-to-vial transfer. The new product is administered by means of pre-filled diluent syringe (MixPro®), which has previously been evaluated among patient/carer users and nurses [7]. It was described as being user-friendly, simple and quick; its compactness and portability were highlighted as advantages for storage and travel.
Perhaps the major reason for patients refusing to switch products, and for nurses feeling reluctant to switch patients’ products, was the fear of the risk of an inhibitor.
Such fears are based on early studies suggesting that particular products (e.g. recombinant vs. plasma-derived and full length vs. B-domain modified) may be associated with increased risk. However, current evidence does not suggest that switching products significantly influences inhibitor development, although there is a need for regular inhibitor testing [8,9]. There is a need for nurse educators to reinforce these messages and for nurse specialists to ensure better understanding among patients and families.
However, the very fact of a tender perhaps results in a limited range of product choices. This poses a conflict with the current NHS agenda around ‘choice’, as set out in the Department of Health's Choice Framework, first published in April 2016 [10]. This document set out a goal of “significantly improving patient choice by 2020 and in doing so, empowering patients to shape and manage their own health and care.” It is, therefore, a concern that:
From a purely practical viewpoint, there is no doubt that clotting factor switching becomes easier with experience.
Nevertheless, the process could be made easier for health care professionals. Asked for practical suggestions regarding how to make switching process easier for health care professionals, nurses’ comments suggested a strong role for contact with and support from other nurses:
However, there is a need for commissioners to recognise that the current climate of innovation may not sit easily with a target-based tender. As one nurse participant noted:
One unforeseen consequence of the tender-based system is that haemophilia nurses find themselves under increasing pressure from pharmaceutical companies ‘encouraging’ switches to their product.
Clearly, such pressure on health care professionals is unacceptable. It is the responsibility of medical and nursing educators and leaders to ensure that all centre staff involved in delivering product switches understand the commercial reasons behind such approaches.
Switching patients’ treatment from one clotting factor to another saves money for the health service but is not a cost-free exercise for treatment centres, which have no additional resources allocated for the tasks involved. It is associated with an additional workload, which falls principally to the haemophilia specialist nurse and data management teams. For the process described in this study, there was no national guidance on which patients should have their product switched, and many nurses described decision-making based on their knowledge of individual patients, either alone or, more often, as part of the multidisciplinary team.
Standardised guides to switching, including template letters, were well received and acknowledged as making the overall process easier