Joint working with the pharmaceutical industry

The NHS and the pharmaceutical industry have pinned their colours squarely to the mast of collaborative working in their joint production of Moving Beyond Sponsorship.

This online tool provides practical advice on joint working and is the culmination of a series of advisory and guidance documents from both sides of the divide. It highlights the importance of mutual trust, with the ultimate aim of improving patient care.

Although not the first example of collaboration, it is hoped that the toolkit will mark an about turn in the culture of cynicism that often surrounds such joint working.

As with other examples of collaborative work, this initiative is most likely to succeed if facilitated and nurtured by a medical communications agency. These agencies “speak the same language” as clinicians and pharmaceutical companies, and understand the professional and regulatory pressures under which both work. The communication channels they provide can make the difference between a strong, worthwhile joint project and one that falls at the starting blocks.

A new culture

The shift in the culture of joint working between the two sectors was welcomed earlier this year in The Lancet, when the editor, Richard Horton, argued that symbiosis, rather than schism, between the NHS and the pharmaceutical industry would provide the best deal for patients. He urged clinicians to stop being dependent on industry, and instead seek to promote relationships based on trust, respect and confidence.

Mr Horton is just one of many commentators to hope the current climate marks a sea change in the relationship between the NHS and the pharmaceutical industry.

NHS professionals are often cynical about the high stakes of the NHS drugs market. Then there are the David and Goliath proportions of the players: on one hand, the cash-strapped primary care organisation, pleased to have a few “sponsored” sandwiches at one of its educational seminars; on the other, the image of the international corporation, with “vested interest” branded on every iota of its largesse.

Many healthcare professionals question why some drugs are so expensive, particularly when marketed to a not-for-profit organisation. In their defence, pharmaceutical companies cite high research and development costs, limited drug patent life and the difficulty of setting a lower basic price for the small UK market, compared with other healthcare marketplaces, including the USA.

Now, with the NHS in its seventh decade, there are encouraging signs that the sellers and buyers in the healthcare marketplace are prepared to put real effort into working together, openly, with probity, and with the clearly stated aim of benefiting all the stakeholders - the NHS, industry and patients.

What is joint working?

The definition of joint working used in Moving Beyond Sponsorship is highly specific (see below), and excludes many worthwhile initiatives that are already in place. This article takes a broader view of collaborative work designed to improve patient access to effective treatments.

Local initiatives

Steps towards joint working have been made around the country, at local level, with agreements reached between commissioners and pharmaceutical companies on, for instance, funding educational schemes and deals to reduce drug acquisition costs.

One good example is the North of England cancer drugs approval group, which spans two strategic health authorities and serves a population of about 3.2 million people.

The group approved the use of sunitinib for the treatment of renal cell cancer in July 2007 under a special deal. The drug is supplied free for the first month, then at a 5 per cent discount. Sunitinib was not made available to NHS patients nationally until early 2009, and the decision could not have been made without a change in the rules governing certain appraisals by the National Institute for Health and Clinical Excellence.

The North of England cancer drugs approval group model of working with industry

• The group was formed in May 2006 to ensure that all patients with cancer in the North East of England and Cumbria receive equitable access to a clinically defined range of cancer medicines.
• The group serves all of the North of England cancer network organisations, encompassing nine acute trusts, five primary care organisations, two strategic health authorities and a population of around 3.2 million.
• It has delegated authority from commissioners across the North East to approve or reject drugs presented for consideration.
• The group meets four to five times a year to consider applications for curative and palliative drugs that are not in the NICE system and/or are ore than six months away from being appraised by NICE.

The North of England cancer drugs approval group has:

• Backing and support from both strategic health authorities
• Expertise and support of the network
• Clinical involvement from oncologists
• Buy-in from primary care organisations to collective decision making to ensure equity for patients
• Strong leadership and close links with NHS senior management

The national picture

Looking at the national picture, it can be argued that the formation of health technology appraisal organisations, notably NICE in 1999, was a key step towards improving patient access to drugs and providing a forum for dialogue between the NHS and the pharmaceutical industry.

In the past two years or so, the scope of that dialogue has been extended to include the possibility of special deals designed to make treatments more affordable to the NHS without an explicit cut in the basic per-unit price.

June 2007 marked the first of these special patient-access deals, when bortezomib was made available for the NHS treatment of multiple myeloma, but the manufacturer agreed to refund the cost for patients who responded marginally or not at all.

Just over a year later, in August 2008, NICE approved ranibizumab as an option for the treatment of wet age-related macular degeneration, on the premise that the manufacturer would meet the cost for treatment that went beyond 14 injections.

Similar deals have followed, extending patient access to treatments that NICE would otherwise consider too expensive, in terms of cost per quality-adjusted life year (QALY).

However, occasional local and national schemes are not enough. They can lead to a perception that patient access is improved for some - potential recipients of the small number of drugs covered by a NICE special deal and those fortunate enough to live in areas where commissioners negotiate with pharmaceutical companies.

The old bugbear of postcode prescribing - which NICE was originally supposed to end - is still looming large. Furthermore, there remains a strong perception that new (expensive) drugs are the preserve of those who can pay for them, or those who have health insurance.

It was in the face of these and other, related challenges, that various key national documents were issued in 2008 and early 2009, notably:

• Improving Access to Medicines for NHS Patients, by national cancer director Mike Richards
• NICE advice on approval of drugs for end of life care
• Guidance on joint working between the NHS and pharmaceutical companies, issued by the NHS and the Association of the British Pharmaceutical Industry
• Moving Beyond Sponsorship: interactive toolkit for joint working between the NHS and the pharmaceutical industry, issued jointly by the Department of Health, the NHS and the ABPI (March 2008)

Mike Richards’ report

Professor Richards’ much-awaited 2008 report on patient access to drugs was triggered by the debate over NHS care for patients who pay for part of their treatment privately. He focused on cancer treatments in particular, but his recommendations are applicable to all new, high-cost medicines that come into the marketplace.

The report included the following recommendations:

• NICE should review its criteria for deciding cost effectiveness limits for patients receiving end of life care.
• The Department of Health should encourage primary care trusts to work collaboratively when making commissioning decisions, citing NECDAG as an example of good practice.
• When making commissioning decisions, it is essential to be transparent and consistent.
• The NHS needs to work with the pharmaceutical industry and to adopt more flexible approaches to pricing of and access to new drugs. 

Professor Richards’ overarching message is that, to improve patients’ access to high-cost medicines, the NHS must look to its own organisation, strengthen its own decision-making processes and work collaboratively with the pharmaceutical industry.

NICE decision on end of life care

In January 2009, NICE advised its appraisal committees that they could consider approving certain treatments for use in patients nearing the end of life, even if the cost per QALY exceeded the current benchmark (£30,000). The criteria for approval are as follows:

• Patient life expectancy should be no more than about 24 months.
• There must be evidence that the treatment is likely to extend life by at least three months, compared with treatments currently available via the NHS.
• There should be no comparable alternative treatment already approved for use via the NHS.
• The treatment will benefit only a small patient population.

One current example of NICE implementing its new end of life care principles, while at the same time collaborating with a pharmaceutical company on a cost-capping deal, is the guidance on the use of lenalidomide in patients with refractory multiple myeloma. In its appraisal, NICE states that lenalidomide fulfils the criteria for approval of end of life care, and approves an offer from the manufacturer to meet the continuing cost of the drug for any patient whose treatment persists beyond 26 cycles (typically two years). The flexibility and joint working practices that have underpinned the lenalidomide decision benefits the following stakeholders:

• Patients - about 2,100 patients in England and Wales have access to a life-extending treatment hitherto unavailable under the NHS.
• The NHS - NICE estimates that 17 per cent of patients eligible for lenalidomide under its criteria will continue to receive the treatment beyond the 26-cycle threshold, when the cost of the drug will be met by the manufacturer.
• The drug company gains an NHS market for its drug.

Government and ABPI guidance

In their recent toolkit for joint working, the NHS, Department of Health and ABPI take pains to explain why the new move towards collaboration is not simply another way of looking at drug company sponsorship of healthcare initiatives. It states that:

• Sponsorship means simply providing funds for a specific event or work programme.
• In joint working, goals are agreed by the NHS organisation and company, in the interests of patients, and shared throughout the project. It requires joint participation in management of the project and open and transparent working.

In its accompanying guidance document, the ABPI stresses that both the NHS organisation and the drug company must make a significant contribution to the project, in terms of, for example, people, other resources, equipment, communication channels or money. There must be no suggestion that the arrangement can be construed as a gift or donation of services.

Many of the collaborative ventures that NHS organisations and drug companies are currently engaged in do not qualify as joint working practices under the toolkit’s definition. These include funding of clinical trials, provision of equipment or nurse support to help administer a specific treatment, sponsorship of meetings and hospitality and educational grants.

Examples of initiatives that may qualify as joint working include:

• Staff training
• Staff or patient education
• Economic analysis
• Pathway redesign
• Guideline implementation
• Audit

The authors of the toolkit guide would be collaborators through the stages of setting up, implementing and monitoring a shared project. They also provide several examples of good practice in joint working, with contact details for individuals from both sides of the NHS/industry divide.

The toolkit acknowledges that, compared with sponsorship, joint working will require a different, more collaborative approach from both parties, based on:

• Shared vision of the aims and outcomes, e.g. reduced morbidity, fewer hospital visits
• Equity, i.e. recognition that each party has a right to have their say, and that there is an interdependent relationship between both of the organisations involved
• Transparency, including sharing of information
• Mutual benefit
• Respect between the organisations

For those who worry that the government/ABPI joint working scheme is based on a rose-tinted view of how the NHS and the pharmaceutical industry regard each other, the toolkit presents the findings of a survey that identifies some of the negative and positive attitudes that staff in the two sectors have towards each other (Table 1). It warns that some of the stereotypical ideas can be unproductive for those intent on joint working, and emphasises the need for mutual respect and recognition of each other’s differences.

Table 1. Preconceptions that NHS and pharmaceutical industry staff have about each other

What can a third party contribute?

Effective communication is probably the biggest challenge for any NHS team and drug company seeking to establish a collaborative venture, whether it comes under the new government/ABPI definition of joint working or owes more to the older concept of sponsorship. A medical communications agency can overcome the hurdles to communication, not least those generated by some of the preconceptions listed in Table 1.

The contributions that a medical education/communications agency can make are many and varied. They include:

• Compilation of market access information, whereby key details about a drug not yet in the NICE appraisal system can be communicated in advance to commissioners, allowing them to consider and plan for its potential impact on, for example, service capacity
• Identification, through facilitated discussion, of opportunities for joint projects likely to benefit all parties
• Organisation and facilitation of educational events
• Production of key documents, reflecting the viewpoints of both parties
• Acting as a neutral arbiter, if needed

To fulfil this role, the agency must:

• Understand the differing needs and attitudes of the NHS organisation and the drug company
• Have a detailed knowledge of the ABPI code, which regulates all promotional and some non-promotional activities undertaken by the pharmaceutical industry, and the professional ethos of NHS staff
• Understand the workings of the NHS and the constraints on health professionals’ time and other resources

Although some healthcare professionals may still be cynical about joint working between the NHS and the pharmaceutical industry, it is clear that collaborative ventures have already helped to improve patient care.

When joint working is contemplated, medical education/communication agencies can bring specialist knowledge and skills to the negotiating table. They already help NHS teams and drug companies forge and maintain effective working relationships, and the role of these agencies is likely to expand as the new joint working initiative takes hold.

NHS North East has shown what can be achieved when a forward-thinking, co-operative approach is taken to working with the pharmaceutical industry. Joint working benefits all stakeholders, but the principal beneficiaries are the patients.