It’s no secret that the landscape for market access and pricing professionals is ever-changing. Today the role of the function has evolved to be a critical link between R&D, medical and commercial functions. It’s providing the foundation for clarity in evidence expectations, willingness to pay and market needs, all while communicating and connecting pharma’s other functions.
Within this challenging environment, data-driven decision making is fundamental to overall business success. Enter, analogue analysis – the process of looking at past products’ performance to guide strategy and planning for current and future brands
An “analogue” is essentially a brand in a similar situation to your own. No brand is entirely the same as another, but it can have many of the same characteristics. Analysing these analogue brands can provide critical insight for our own brands, as they have already navigated through similar waters.
Why is analogue analysis beneficial?
When we predict the price and health technology assessment (HTA) outcomes of pharmaceutical brands, we base many of our assumptions on previously approved drugs – otherwise known as analogues. This competitor analysis in the pharmaceutical industry is essential for benchmarking price and informing product launch strategies.
In market access, we have time pressures to answer a range of complex questions. We need to know how to produce more accurate analyses and provide evidence to support a product launch strategy. From TPP profile definition through to price estimation, we need to speed up analysis to present the best business cases for early asset investment decision committees.
Important considerations for analogue analysis
When searching for analogues, we might look at defining characteristics such as:
- Product and disease characteristics
- Considerations for the launch environment
- Broad or specific product launches.
We also need to ask ourselves some key questions. For example, what pricing opportunities are there in a highly genericised landscape? Does our product have an orphan indication? What does differentiation look like in a crowded marketplace? How can we support a trial design acceptable to payers if our comparator is off label?
TPP versus aspiration-led approaches
Analogues are selected using one of two approaches. One involves starting with what you have and using your existing TPP to identify analogues. Another is more aspirational, defining outcomes you wish to achieve and identifying analogues that achieved those outcomes.
The TPP-led approach
In this approach, analogues are selected based on how well they match to the target product profile (TPP) for the brand.
This approach works well when the TPP is available, however, it can be long and iterative, as many different TPP variations are introduced. It is also difficult for market access teams to influence clinical programmes and medical strategies to shape the TPPs.
Aspirational pricing and market access approach
This approach is based on a target price, and HTA outcomes that are expected to achieve the price. We need evidence to reach the desired HTA outcomes, which we can achieve by reverse engineering the TPP.
This makes it possible to guide research and development teams on trial designs and optimal products, but it may be far from reality. Whatever the findings, adequate risk analysis in the pharmaceutical industry is paramount, so whatever is identified must be robust.
Best practices for analogue analysis
Many teams face challenges, whichever approach is followed. Analogue identification is frequently restricted by limitations on yours and your team’s knowledge. Up to eight in ten analogues are selected based on team members’ personal knowledge, rather than being identified in a systematic manner.
At Access Infinity, we have developed Nuro to help you identify analogues, and get the best out of your analogue assessments. We generally advise this approach to get the best results:
Step 1: Define product or disease characteristics
This may include therapy areas, clinical benefits, molecule types, acute or chronic treatments, orphan drug indication, route of administration, and adult or child use.
Step 2: Define the launch environment
This may include size of target population, number of indicated products, availability of price benchmarks, competitor activity and off-label/on-label comparators.
Step 3: Apply criteria comprehensively and systematically
Bearing in mind that the above factors are not exhaustive, we need to take a comprehensive approach. This means starting with all EMA or FDA approved products. We need to be systematic when applying matchability of criteria. This will ensure repeatability, making for better business cases.
Step 4: Create the funnel
With these steps, we can then create our own funnels, for example, filtering out other therapy areas and focusing on auto-immune disorders. But we also need to be aware of the limitations, and draw on our own experience in addition to existing data. Generally, nine in ten analogues start with the disease, but we cannot simply create a funnel in any order.
As pharmaceuticals become more expensive and competitive, we need faster, more reliable methods to benchmark pricing and assist product launches. Technology such as Nuro helps us to see all the essential data in one dashboard, which we can augment with our own experience.
No single method is the ‘correct’ one for getting a product to market effectively, as there are so many variables. What we can do is refine our strategies by looking at historical data and grouping by key characteristics. In future, this will help us satisfy HTA outcomes faster and create competitive price benchmarks.
You can also hear our Founding Director Shri Rao Mukku talk more about analogue analysis in this webinar recording: https://accessinfinity.com/webinar/analogue-analysis-dos-and-donts/