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Communicating value

HTA data must be shaped to meet the needs of different customer groups

A pair of cupped hands holding golden eggsEstablishing and communicating the value of innovation has become the single biggest challenge for pharmaceutical marketers. A decade after the launch of NICE, and with the introduction of the Scottish Medicines Consortium (SMC) and other more localised technology appraisals along the way, Health Technology Appraisals (HTAs) have evolved to become a mechanism through which the value of medicines is assessed. Technologies are evaluated from a clinical and health economic perspective, with the end-game being a value judgement. The result is all-important. HTA has become the X-Factor audition for pharmaceuticals, and if your product cannot demonstrate value, it's unlikely to make it past boot camp. The challenge is that value means different things to different people.

How HTA bodies assess the value of innovation has become the subject of much scrutiny. The recent Kennedy Review, independently commissioned to examine how NICE operates, criticised the organisation (as well as pharma) and made 25 recommendations for change. Appropriately, one of these was the need for NICE to communicate the value of its role to both the public and the industry. The report said: "It [NICE] does not seek energetically to communicate and explain what it does, particularly in high-profile cases. So, it finds itself regarded as blocking patients' access to drugs, rather than holding the ring between conflicting demands."

While Kennedy supported the continued use of approaches such as the incremental cost effectiveness ratio (ICER) and quality adjusted life year (QALY), he said it should also include other health-related benefits in its decision making and that NICE should consult other interested parties and research how to assess the social benefits of an intervention. Significantly, it proposed that pharmaceutical companies should be allowed to attend the first appraisal meeting and take part in the dialogue that leads to HTA decisions.

NICE's response to the Kennedy recommendations is imminent, but the principles of engagement and communication that lie at the heart of proposals to improve the process are unlikely to be contested. Moreover, these principles are synonymous with the challenges facing industry marketers as they develop value propositions to suit their growing customer groups.

Clear distinction
The need to build relationships with, and key messages for, a previously foreign customer group – namely payers – is now widely accepted as an essential component of marketing strategy. Identifying what constitutes value to this and other new customer groups is key and HTA, whether through NICE, SMC or other mechanisms, represents a good opportunity to unlock some of the answers.

It is important to make the distinction between the requirements of an HTA submission and a marketer's objective to develop messages for a diverse customer base. These are two entirely separate initiatives, but the former can be used by marketers to help drive the latter, meaning the value of the HTA process for marketers will long outlive the submission procedure. Marketers' presence may have limited impact on the outcome of an HTA, but it will have major implications for success beyond it.

So what do we know about the HTA process? Moreover, how can we take advantage of it to build value propositions that resonate with all of our key customers?

Defining value
Primarily, understanding the remit of an HTA is critical. An HTA is a rigorous technological assessment of data from both a clinical and a health economic viewpoint. It is not assessed by marketers or indeed by practitioners looking at the 'value' to them as customers. Instead, HTAs are appraised largely by academics and health economists. The values they look for are purely clinical and cost-effectiveness.

The process is not about pulling together 'value propositions' for marketers – these have no place in an HTA submission. However, if properly planned and managed, an HTA can provide a vehicle to ratify your value propositions with key customer groups as you move through the process. The job of the marketer is to pull bits of value out of the data generated for the HTA, which may be appropriate to large numbers of diverse customers. The most crucial aspect is to understand that one message around value will not resonate with all customers and so messages need to be shaped accordingly (box 1).

 

Box 1: An example of different value propositions

Clinical data for a high-cost drug for patients in primary care shows that it can reduce hospitalisation by 35-40 per cent. It successfully gets through an HTA. The marketing team develops a value proposition based around its ability to reduce hospitalisation and presents it to a pharmaceutical advisor (PA). The PA is unimpressed. He is measured by prescribing budget and, since the new drug is 70 per cent more expensive than the treatment he currently uses, he believes the new therapy presents an additional cost. He is not measured on saving money by reducing hospitalisation.

The same value proposition is presented to a commissioner in a PCT, who works alongside the PA. The commissioner notes that the product is more expensive, but is excited by its ability to reduce hospitalisation – which is one of her major priorities. She declares her interest in supporting the product.

Clearly, the value propositions in this example need to be shaped according to the customer. In the case of the PA, it would be more productive to develop a message showing that, although the therapy is more expensive, its ability to reduce hospitalisation will also reduce the possibility of patients being placed on a more expensive treatment when they are discharged – for which the PA currently picks up the cost.

In this case, the same set of data has been shaped to produce two different value propositions.

 

Two teams, one goal
So how should the HTA process be managed? Building the right team, both internally and externally, is key.

Internally, an HTA submission is generally driven by the medical team and health outcomes, with an input from marketing. In the UK affiliate, there may also be involvement from market access departments, with additional advocacy from European and global affiliates. It is important to ensure that the full internal team is appointed as early as possible so that the nature of the submission can gain collective agreement locally, regionally and at an international level.

The appointment of an external team, though equally important, is often overlooked. Yet it is here where marketers can glean the most value. This will normally consist of a programme management team, commonly an independent third party, and a range of customers to help ratify the submission. The programme management team will not manage deadlines, facilitate the process and liaise with the ratification team only, it will also help develop and write the submission document. The programme management team can also play a critical role in finding the right people to help ratify.

The ratification team remains key. This group of people will comprise clinicians, health economists and payers. Their role is to offer counsel in a variety of ways. For example, they may be able to advise around the comparator drug used in the study, the pathway of care or the burden of illness. Does the data being used stack up? Does it make sense and read well, or are certain elements not quite right? From a marketer's perspective, this is vital information that has life far beyond the HTA process.

 

The internal HTA team

• Medical department
• Pre-marketing product manager or new products manager
• Health outcomes team
• Market access team; pricing and reimbursement, guidelines development etc
• International advocates.

 

Five critical steps
Once both internal and external teams are in place, how does the HTA process work? Moreover, where are the opportunities for marketers? NICE is, of course, the best-known HTA model and although its process differs from those applied by SMC and others (which are somewhat shorter and hence quicker), examination of the current NICE submission process provides some clues regarding where marketers can benefit most. The process is split into five stages:
1. NICE issues draft scope
2. Final scope is issued
3. The submission
4. NICE issues an appraisal consultation document (ACD)
5. NICE issues the final appraisal document (FAD).

Within these five stages, there are a number of opportunities for the industry to engage with key customer groups, not only to ratify the significance of the data in the NICE submission, but also, indirectly, to test the value of information that can be used subsequently by marketers. The ratification team should be in place to help review the draft and final scope. While their input with the former may not be significant, the latter provides a chance for them to see the clinical and health economic data that is going to be used and to comment on whether they feel it addresses the scope. What, if any, are the gaps? How can you close them using the data you have? Do you need to get more data, or meta-analysis on competitor data relative to yours? Is your health economic model relevant or, if it has been developed by the global team, has it been based on a different pathway of care to that adopted in the UK?

Their input into the submission, the ACD and the FAD is critical. If you disagree with a final decision, you need to mobilise your ratification teams to review the FAD and consider challenging it through the appeals process. This is also a good opportunity to gain insight into what a negative decision actually means for them. Does a 'no' mean that, at a local level, there is no way to get it funded?

Survival of the fittest
A review of the five critical steps of a NICE submission demonstrates the value of an external ratification process. This value transcends the entire promotional strategy for a therapy and will inform market access decisions beyond HTA approval. For marketers, it shows that HTA is paramount and involvement in the process is essential. Your drug cannot exist without clinical efficacy and health economic data and, just as these are the core values that are assessed by an HTA body, they must also be the core of your product.

Beyond that, value – a judgement individual to each customer group – will radiate from the core into the value propositions that your data supports for patients, prescribing advisors, commissioners, service managers and any other key customers. Establishing these messages is the role of the marketer and, with an effective programme management team in place, the HTA process can help provide the engine to ratify them.

The days of delivering a one-size-fits-all message are over. Because value can be defined in any number of ways, the challenge becomes understanding your customers well enough to discover their own individual definitions.


The Author
Claire Gillis is joint chief executive at WG Consulting
To comment on this article, email pm@pmlive.com

14th October 2009

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