Joint working between the industry and the NHS is now more widely encouraged. But success depends on placing patient gain ahead of commercial gain. Roche’s award-winning HER2 testing initiative shows what can be achieved with a proper patient focus.
Earlier this year the UK Government issued new guidance on how the NHS could work in partnership with the pharmaceutical industry and other relevant commercial organisations. This ‘Best Practice Guidance’ was designed to encourage ‘joint working’ between industry and the health service, to deliver efficient and high-quality services that meet the healthcare demands of the 21st Century. Critically, the ongoing objective to build a more patient-focused NHS lay at the heart of the guidelines. For the NHS, the patient is the ultimate customer, and, as the modern business mantra has it, the customer is King. Success, it would seem, depends not only upon achieving a cultural shift in the mindset of traditional NHS/ pharma relations, but more importantly, demonstrating how such partnerships can deliver true rewards where they matter most, with the patient.
Clearly, an underlying principle of all of the latest NHS policy documents through a period of sustained reform is that ‘joint working’ is the future. In reality, for many, it began some time ago. Collectively, the industry has been talking about partnership opportunities for many years and in some cases, companies have moved beyond the theory and actually delivered successful programmes working jointly with an NHS customer-base. To accelerate progress in this area, the ABPI has itself worked in partnership with the Department of Health to develop a toolkit designed to support those involved in joint working projects. Outside of this, however, there remain strong examples of how companies have improved patient care through collaborative working. Such examples are invaluable in providing a benchmark for partnership initiatives designed to deliver sustainable clinical benefits and demonstrable health outcomes for patients.
Perhaps the best example of an initiative that aligned itself with the truest principles of joint working is seen through Roche’s partnerships with the Cancer Networks in the highly emotive area of breast cancer. This article outlines the approach Roche took and the impact its initiative had on the treatment of breast cancer patients in the UK.
The past decade has seen a media frenzy surrounding the revolutionary cancer treatment Herceptin (trastuzumab). Widely acknowledged as the drug that gave birth to ‘postcode prescribing’, Herceptin has been labelled both lifesaving and expensive in equal measure. Unless you’ve spent the past ten years living in an underground cave, you will have heard of Herceptin and will have formed an opinion about its true value. Following Roche’s partnership initiative with the NHS, that value cannot be questioned.
Early opinion on Herceptin was driven by its use as a treatment for metastatic (advanced) breast cancer. Prior to 2005, the drug was licensed only for use in this setting, and there was an absence of any data concerning its use in the adjuvant (earlier) setting. In May 2005, however, data from the HERA trial, which had been testing Herceptin as a treatment for early breast cancer (eBC) since 2001, suggested a major breakthrough for breast cancer. “Normally in HER2 positive breast cancer you fi nd that a high proportion of women will, despite getting surgery, chemotherapy and radiotherapy, relapse within a few years,” said Deb Lancaster, former Senior Brand Manager for Herceptin and now Marketing Manager for Breast Cancer at Roche “The new data showed that, by putting Herceptin into the mix, the relapse rate was reduced by half. When you bear in mind that metastatic breast cancer is not curable, stopping patients from relapsing is a very important treatment goal.”
Currently around 20% of the 41,000 women diagnosed with breast cancer in the UK each year will have tumours that have amplification of the Human Epidermal growth Receptor 2 (HER2) gene, leading to over expression of the HER2 protein. This excess of HER2 means that the tumour is faster growing and more aggressive, leading to a poor prognosis and roughly halving survival in the metastatic (advanced) setting.
Undoubtedly, the evidence generated by the HERA trial promised to revolutionise care for breast cancer patients with HER2 positive disease. However, the challenge for Roche was to identify every patient who may benefit from it. While the funding issues that had previously plagued Herceptin would eventually be helped by NICE guidelines approving its use in eBC in June 2006, the issue of patient throughput and identifying the patients who would benefit from the treatment was a far more pressing challenge for Roche. At the time, the diagnostic process was heavily stacked against the patient. “Working out whether a woman had HER2 positive breast cancer depended upon her undergoing a diagnostic test,” said Deborah. “Unfortunately, because at that stage Herceptin wasn’t being used in early cancer, that test was normally done at relapse. Women being diagnosed for the first time with early breast cancer weren’t being tested. What’s more, the NHS did not have the capacity or the resource to test over 40,000 women each year.”
This underlined the stark reality that many eBC patients could eventually die each year simply because they were not being tested and therefore given the opportunity to receive a treatment that could help them.
Roche realised that, given the scale of the problem and the health service’s undoubted lack of capacity to do anything about it, to help its patients, it needed to help the NHS. It embarked upon a partnership programme with each of the 34 Cancer Networks in the UK, to help set up and implement HER2 testing centres throughout the country. Roche developed individual relationships with each Cancer Network to establish their needs and plan services that delivered their needs. “We looked at various ways of helping,” says Deb. “We assessed each network individually and established what they needed, whether this was staff, funding, testing kits, or a combination of all three. Some networks also had training needs, and we were able to help with this too. Once we’d established their requirements and put together realistic business cases, we drew up individual agreements and set about implementing them.”
To help with the implementation, Roche enlisted the support of Ashfield In2Focus. “We knew that, by operating with each network on an individual basis, we did not have the internal resource to deliver the results we wanted. We needed a team on the ground that could visit the laboratories and ensure not only that everything was being implemented properly, but also to instil the importance of why it was being done.”
Working in partnership with Roche, Ashfield In2Focus built a Regional Implementation Team of six people to manage the implementation of HER2 testing centres across the entire UK Cancer Network. Given the innovative nature of the project, assembling a team with the right skills was itself a challenge. “We weren’t looking for a standard nurse team or a primary care field force, but a unique team that combined experience in an NHS laboratory environment with high quality interpersonal and communication skills,” says Ian Curpen, Project Manager at Ashfield In2Focus. “The team weren’t going to be selling a product, as such, but they were going to be providing a service to the NHS and they needed to be strong enough to challenge and push senior people within the NHS. Their battle was to make sure that patients were getting tested, and to do that they would need to get close enough to customers to ensure that what they were doing was beneficial to patients.”
With every network comprising only one or two testing centres, each team member was responsible for 10-12 testing centres, each with their own specific requirements. These requirements were detailed in the individual agreements Roche had already drawn up with the networks. With these agreements as their blueprint, the NHS and industry, spearheaded by the Regional Implementation Team, collaborated to drive through the implementation.
Collectively, the project had a clear objective: “To increase the level of blanket prospective testing nationally from 31% to 90% by the end of 2006.”
Prospective testing was defined as ‘all newly-diagnosed breast cancers tested for HER2 status by IHC alongside hormone receptor testing – either on core biopsies or excised tumour samples, to fit in with local preference. In addition, all those testing IHC2+ would be retested using FISH/ CISH.’
The implementation process
Despite the early buy-in from the senior figures from each cancer network, as well as support from the very top of government – not least the then Health Secretary Particia Hewitt – full-scale implementation of the programme was not without its challenges. Naturally, a degree of scepticism among NHS professionals as to the commercial motivation behind the initiative was apparent in the early days. Cynics believed that the project was concerned only with ensuring more patients were given Herceptin and that, despite NICE endorsement, funding may again prove an issue. Statistically, with only a fifth of breast cancer patients testing HER2 positive, the feared avalanche of patients requiring Herceptin was never likely to materialise. Shifting that perception was a natural priority. However, Ashfield In2Focus’s Regional Implementation Teams did, of course, encounter additional obstacles along the way.
The team’s main customer contacts largely comprised pathology departments and laboratory staff within hospitals. Whilst the remit was to ensure that lab staff not only agreed with the protocol but were also well-equipped to do the testing and reporting, it became clear that other stakeholders outside of the laboratory environment were restricting the process. “Our job was to make sure the pathologists were carrying out the tests,” says Tasneem Habib, a former member of the Regional Implementation Team and now HER2 Data Manager (South) for the independent body NEQAS (National External Quality Assurance Scheme) for HER2 testing. “However, in some hospitals, oncologists were reluctant to offer the tests to everyone and as a result insufficient tests were being carried out. The lab staff would say that they could only test those they were told to test and it was sometimes necessary to go higher and find out the reasons why people weren’t being referred.”
To overcome this, and to achieve buy-in amongst all the key stakeholders, the Regional Implementation Team enlisted the support of the senior decision-makers involved much earlier in the process. “When the agreements were originally reached, Roche discussions had naturally taken place at the highest level, rather than focusing on the lab staff who would mechanically be doing the testing. It became clear that communication needed to come from the top down,” says Tasneem. “We devised a standard protocol for the Network Directors and Commissioners to customise, sign and distribute to all the relevant parties in their network. This communication outlined the protocol for testing, and which patients it applied to, and this proved to be a vital tool. Once this had been set up and delivered, we knew that if pathologists weren’t clear as to why we were there, we would show them the protocol, authorised by senior management and we would be fine.”
In addition to overseeing implementation, the team was encouraged to build relationships within the hospitals, so that once the set-up was complete and a framework for ongoing testing had been established, team members could still access the testing centres and monitor progress. To help with this, the team performed an audit function, whereby it provided feedback for hospitals on how individual networks were performing and the impact the testing was having on patient care. “This was regarded as extremely beneficial,” says Tasneem. “It helped our customers for budgeting purposes, and gave them the benefit of additional resource to help them make decisions further down the line.”
The audit work was seen as a pivotal part of the initiative for both sides of the partnership. “The plan was to deliver a service to help laboratories across the country not only carry out the testing, but also to audit it,” says Ian Curpen. “What customers chose to do with that data was up to them, but what it did do was help them increase their patient throughput. Of course, what then happened to those patients was decided by the protocols that were already in place.”
So how did the initiative fare? Did it meet its objectives? Well, by the time the project closed at the end of 2006, prospective testing had risen from 31% to 91% in just over a year. “This is incredibly fastmoving by anybody’s standards,” says Deb Lancaster. “The involvement of Ashfi eld In2Focus was very important in ensuring the pull-through and certainly implementation may have drifted without their work.”
Although the set-up programme has now concluded, the project was an unqualifi ed success and the NHS now has a framework from which it is able to continue ongoing screening. “We helped the NHS set up its own screening process,” says Deb. “The analogy would be that rather than give people fi sh, we gave them fi shing rods! That will go on forever. It’s all in place, the setup costs are covered and the NHS is now paying for this itself.”
|“The key thing is not to do a one-size-fitsall approach. Talk to people and try to uncover their individual needs. We did, and it worked.”|
“Partnership initiatives are vital. The NHS is slow and it is difficult for them to set things up without the capacity, resource and capability. Pharma can help. This project shows what can be achieved. And the NHS has welcomed it.”
“To succeed in NHS/ industry partnerships you need a clear patient focus. It’s not about commercial gain, it’s about patients.”
There remain cynics within the NHS who will question the value of joint working with industry, citing a commercial agenda as the sole reason why pharmaceutical companies might engage in such activity. The HER2 testing programme provides powerful evidence against those critics, justifi ably pointing to the increased number of women who will have a better chance of surviving breast cancer due to the partnership initiative between Roche and the NHS. The outcome is unequivocal: “Every single woman with breast cancer will now know early enough that they may have the aggressive form,” says Tasneem Habib. “Before we did this, they wouldn’t know until it was too late.”
The key to the success of all partnership initiatives is, of course, to maintain that patient focus. “Originally, there was fear within the NHS that this project was all about us putting patients on a product,” says Ian Curpen. “In fact, the whole point of it was that we were trying to help patients as much as we could so that by being tested they would at least know what type of cancer they had and it would enable them to be treated in the most appropriate way. Initially, there was a misconception that there may have been a commercial gain from this. However, it was always clear from an industry and an NHS perspective what our joint objectives were: it was all about helping patients.”
The HER2 testing initiative was recently named as the most innovative programme of the year at the 2007 PMEA Awards. It provides a powerful example of the benefits of joint working between the industry and the NHS. What’s more, it worked where it matters most: for patients.
“Now I know that every woman that gets diagnosed with breast cancer in the UK is getting the best chance of survival because she is being tested,” says Deb Lancaster.