Modern technology has transformed our ability to track – and respond to – the core determinants of product success. Today, pharma companies are exploiting that innovation to map a range of commercially critical areas – from the competitor, access and stakeholder landscapes, to prescribing behaviours, channel usage, treatment pathways and the patient experience. However, two of the most important indicators of commercial performance are often poorly monitored: formulary status and subnational clinical guidelines. Intelligence in these areas – both in real-time and over time – can significantly enhance your commercial strategy. It’s an opportunity that, in too many cases, is unfulfilled or overlooked.

Formulary and preferential local guideline positioning are – outside national guidance (where applicable) – the two primary drivers of market access for a brand. If you can achieve both you’ll be optimally positioned for commercial success. Given their importance, it’s surprising that many commercial teams still don’t have good visibility of what’s happening in these crucial areas – and how they connect. In a competitive environment further complicated by the reduction in face-to-face customer engagement, the lack of holistic market intelligence is something organisations need to put right.

The suggestion that pharma should be monitoring formularies or locality guidelines is neither new nor revolutionary, it’s simply a reminder that we need to get the basics right. Formularies and guidelines may not be as exhilarating as a modern-day omnichannel experience, but mapping the former can significantly improve the delivery of the latter. The problem is: few organisations are set up to take advantage of this.

Perhaps it’s no surprise; formularies are complex, variable and ever-changing. They’re a hostage to local policy, local decision-making and local circumstance, and there’s no uniform process for capturing and reporting information. The guidelines landscape is equally complex and nuanced. Mapping change – whether in the UK or EU markets – is incredibly difficult. But it’s not just about mapping, it’s about connecting the dots to understand how everything fits together to shape the market for your brand.
When it comes to mapping the essentials, connectivity is everything. If you can triangulate the three core elements – formulary positioning, guideline positioning and sales – you’ll end up with a GPS that can guide you towards commercial success. What’s more, that new satnav will help drive better decision-making in everything from resource allocation and stakeholder engagement to omnichannel planning and CX strategy. Fundamentally, mapping (and connecting) the basics provides a crucial baseline for commercial decision-making.

Although the benefits of integrated formulary and guidelines intelligence are compelling, common questions and misconceptions remain.

Q: What is more important: formulary listing or inclusion on guidelines?
Companies often want to know whether formulary listing or guideline positioning is more important when it comes to unlocking market access and driving sales. That is the wrong question to ask – each is equally important. The most successful brands achieve both.

Q: Can you quantify how formularies and guidelines contribute to sales?
The formulary and guidelines landscapes are messy, making it difficult to measure the impact successes can have on the bottom line. However, with good intelligence the commercial value of formulary adoption and preferential positioning on locality guidelines becomes apparent: if you get it right, you can potentially double your sales.
A good example of the value of securing both formulary listing and preferential guideline status can be seen in analysis of the launch performance of Trelegy, GSK’s triple therapy for COPD. It has recently been approved by the FDA for asthma too, but our analysis focuses on UK performance.

Example – GSK’s Trelegy: a moment-in-time snapshot
Trelegy launched in the UK for COPD at the end of 2017, with an Evidence Summary from NICE published in June 2018. Figure 1 shows a point-in-time value of formulary and guideline mapping for Trelegy, taken in September 2020. The chart records the number of sales items achieved according to whether the product is available on formulary and/or is optioned/preferred/not in a guideline.

It shows that:
• Where Trelegy is fully available on formulary and an option on the guideline, items sold per month total 87,227. These sales are achieved via 74 PCOs
• Where Trelegy is fully available on formulary and preferred on the guideline, items sold per month total 37,147. These sales are achieved via just 20 PCOs.

As you can see, there are 17 localities where Trelegy is not on formulary but is listed as a preferred option (9) or a general option (8) on a guideline. The sales volumes these localities are generating is not inconsiderable. This is worth noting. It debunks the myth that being on a guideline is a guarantee of formulary availability and highlights the importance of mapping activity. If you can identify the localities in question, you’re better placed to target effort and resources effectively.

Figure 1 certainly underlines the value of being available on formulary and the importance of preferential guideline positioning. However, as a one-dimension moment-in-time snapshot, it doesn’t tell you the full story. Figure 2 triangulates Trelegy’s performance across the three key data points – its availability on formulary, guideline positioning and sales – to visualise activity over time.
Formulary availability is measured using the ValueBase Availability Index (AI), which standardises the various ways formularies classify products into a score that allows companies to compare the availability of products vertically within a formulary and horizontally across different formularies. An AI of 100 represents open access with no restrictions, whatever legend a formulary uses to flag that. A decrease in the index indicates reduced availability; AI of 65 = initiated by a specialist and can be carried on in primary care; 45 = specialist use only; 30 = highly restricted use; 5 = unlisted on formulary; 0 = listed as do not use.

Figure 2 maps Trelegy’s performance during its first two years on the market (in the UK). The first 18-24 months of a product’s life cycle are widely considered to be the ‘launch phase’ and a crucial barometer of a brand’s success.

Figure 2 illustrates the power of triangulating longitudinal data and visualising it over time. At first glance, the sales curve tells a predictable story: that sales volumes increase as availability on formularies grows. However, the devil is in the detail. The chart indicates that the number of PCOs listing Trelegy on formulary with full availability plateaued after a year – reaching 132 in Jan 2019 and only growing by a further 10 in the subsequent 12 months. During the same time, the number of guidelines listing Trelegy (as preferred or option) increased by more than 40% – and sales more than doubled.
The take-home message is clear: brands that achieve both formulary and locality guideline status are optimally positioned for commercial success – with the potential to double their revenues. By mapping activity properly, companies can identify trends and opportunities and flex their commercial strategies accordingly.

Q: Which comes first: the formulary or the guideline?
Although each component can carry equal weight, sequencing your approach is crucial. Strategy should always be determined by where you are in the product life cycle. At launch, formulary adoption simply has to be your first priority: without it you’ll face a huge barrier to sales. Successful formulary listing can quickly open up access to prescribing for patients and open the door to product sales. From there, securing preferential positioning on locality guidelines should be your next goal. This inevitably takes longer; locality guidelines change slowly and influencing them takes time and effort. Success means understanding the local access landscape, mobilising a clinical advocate and aligning your messages with known stakeholder needs.

Q: Does engagement focused on driving guidelines inclusion require different messaging to campaigns designed to secure formulary listing?
No – the messaging doesn’t change, it simply becomes more nuanced. If you’re launching a product, you don’t just need to understand the formulary landscape – you need detailed insight into the whole environment so you can craft your narrative to ensure it speaks in the right currency for each of your stakeholders. Fundamentally you need a value proposition that can flex across all core stakeholders – typically clinicians, patients and payers – with a compelling justification for each group.

Every stakeholder will want the headline view from every angle but, beyond that, they’ll want more information on their priority interests. This means messaging must be nuanced to speak in the following currencies:
• Clinicians: safety, efficacy and clinical outcomes
• Payers: immediate and long-term impact on locality budgets
• Patients: the patient journey, entry and exit criteria for starting/stopping therapy, Quality of Life and patient outcomes.
The clues for understanding the whole access landscape can be found in analysis of formulary/guidelines trends – in real time and over time. That’s why mapping what’s happening in these key areas is so important – it provides a foundation for evidence-based decision-making to drive agile market access and launch strategies.

Q: Where else can formulary and guidelines intelligence contribute?
Formulary and guideline mapping can inform a variety of activities pre- and post-launch. Pre-launch it can provide a crucial lens on the market for your product, unlocking valuable insight into the stakeholder environment, competitor landscape and existing treatment pathways. This, in turn, can help improve forecasting and ensure targets (and rewards) are tangible and realistic.

In the launch phase, the data can help inform critical decisions around customer segmentation and targeting, resourcing, messaging and stakeholder engagement. Furthermore, progressive organisations are increasingly turning to formulary and guidelines intelligence to help shape their omnichannel strategies, combining it with other data sets to automate targeted and personalised customer interactions.

In a world of new ideas and disruptive innovation, driving down old roads like formularies and guidelines is never likely to set pulses racing. But, as primary drivers of market access, knowing what’s happening in these crucial areas could be your gateway to commercial success. Certainly, as pharma companies journey towards a new normal shaped by the global pandemic, the continued reliance on the traditional routes will no longer be enough. You can’t use an old map to explore a new world.
It’s time to reprogramme the satnav and find a better way. Who knows, by effectively mapping formularies and guidelines digitally, you might just discover a new GPS that transforms your commercial strategy.