GETTING MORE OUT OF YOUR ANALOGUE ASSESSMENTS WITH NURO
‘What pricing opportunities do I have when launching in a highly genericised landscape?’
‘What does differentiation look like in a crowded market place?’
‘If my clinical comparator is off label, how do I support a trial design that is acceptable to payers?’
These can be difficult questions to tackle. Often, the first place to look for answers are analogues, i.e. what other products faced a similar situation and what can we learn from them? Finding good analogues (or even no analogues!) can go a long way in better informing your market access strategy and in developing stronger business cases internally.
Below, I’ve put together some considerations and best practices we apply ourselves while conducting analogue assessments.
Create a robust set of matching criteria
Before embarking on any assessment the first step is to make a thorough list of criteria that characterise your situation. Defining criteria by ‘product/disease characteristics’ and ‘launch environment’ can often be a good place to start.
Define product/disease characteristics
- Therapy area(s)
- Incremental clinical benefit demonstrated (efficacy, safety, QoL)
- Molecule type (small molecule, biologic, ATMP)
- Acute or chronic treatment
- Orphan designation
- Route of administration
- Adult/paediatric use
Define the launch environment
- Size of target population
- Number of other indicated products
- Availability of generic price benchmarks
- Launch indication or follow-on indication
- Parallel or sequential launch of indication
- Competitors using active comparator or placebo in clinical trials
- Off-label/on-label comparators
The list above is not comprehensive
You may choose to apply a very broad matching criteria (e.g. products with orphan designation regardless of therapy area) or be very specific (e.g. products that are small molecule, oncology, oral-only, launched in at least two indications simultaneously, having used active comparators in pivotal trials)
Either way, this sets up the basis of your analogue search. The next step is to apply this criteria to a reference data set. To make the best business case for your assessment, use either the EMA or FDA drug databases (or both) as your starting point.
Be comprehensive and systematic in applying the criteria
It’s important to take a comprehensive approach (e.g. start with all EMA or FDA approved products) to avoid cherry-picking only those analogues you are already aware of. It’s equally important to be systematic in applying the matching criteria to ensure repeatability of the exercise and build defendable business cases.
In taking this approach, what you normally get is a ‘funnel’ that starts with a very large dataset and ends with a manageable shortlist of analogues for you to deep-dive into. For instance, let’s imagine you’re looking for examples of non-orphan biologic products in selected therapy areas that achieved an ASMR III or higher having submitted only placebo controlled pivotal studies. Your analogue selection funnel might look something like this:
Be aware of the limitations: think directional insights
It’s tempting to look to analogues to answer all your questions. More often than not they’re there to shine light on some, often critical, aspects and to reduce that cloud of uncertainty surrounding your business objectives. After all, you’re bringing a new product to market with characteristics that are unique to it. But despite their limitations, analogues can be a source of great insights that support a better understanding of your product’s price and access opportunities. The exercise also gives you valuable arguments in situations such as when leadership expects a price you know will be difficult to achieve or perhaps in convincing the clinical team about the importance of ‘hard endpoints’ in payer negotiations.
Having done several projects where finding analogues have generated critical insights, we recently launched a digital solution called Nuro that helps identify analogues for your products rapidly. The hypothetical funnel I created above, for instance, can be built and relevant analogues identified in a matter of minutes using Nuro.
About the author
Ahmed Edathodu
Founding Director at Access Infinity
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