Why packing a suitcase is like developing a value story
And what you should prioritise including in it.
In T-minus one month, my family is relocating abroad. Eek!
We’ll be living out of a suitcase for the first few months until our luggage makes its way across the Mediterranean Sea.
It’s a bit of a daunting prospect but with a good dose of strategy and prioritization during the packing process (and treating the kids to some new toys), I’m sure we’ll make it work.
In the same way that you can only fit so much stuff into a suitcase, a Pharma Company can only fit so much content into a Value Story, and a good deal of prioritization is needed to make a clear, compelling, and concise value proposition for payers.
So what do you pack into your value story?
Disease Burden and Unmet Need
If you’re not going on a trip, then you don’t need to pack.
Similarly, if you’re not addressing an unmet medical need, does the payer really need to cover/reimburse your product? What benefits are you delivering if your product is not differentiated from the standard of care?
The unmet need(s) your product addresses is similar to your suitcase:
Identifying a clear unmet clinical, economic or humanistic need is the starting point of value story development, similar to a suitcase being the starting point to the packing process
It holds everything together. Every component of the value story should link back to the unmet need(s) your product addresses.
Make sure you invest in a robust suitcase - it needs to provide support and structure for the whole journey through the value story.
And why not choose a brightly coloured suitcase for your trip since the intent of the unmet need section of a value story is to grab the payer’s attention on why it matters.
Target Patient Population
Your target destination is stated on your travel ticket in the same way that your target patient population is defined by your regulatory label. Don’t go anywhere else – you haven’t got the ticket to get you past the gate, nor the evidence to have a substantiated story to tell.
Also, be careful and strategic when considering how you will travel to your destination - or position your product. Just as you have multiple routes to choose from, the payer might have multiple patient population reimbursement/coverage scenarios to consider.
Clinical Value: The Pivotal Trial Data
Pivotal trial outcomes should be a core component of any value story and, hopefully, they’re also an opportunity to show differentiation from your competitors.
You can liken them to packing your underwear! It should be one of the first things you pack. Forget it and you’ve made a significant faux pas.
And it’s not just about remembering the underwear, it’s also about choosing the right ones. Enter your inner Bridget Jones!
Payers are not willing to accept outcomes of any type. They may challenge a value story built off evidence from surrogate or composite endpoints if they are not validated or patient-relevant, or if the time horizon over which an endpoint was measured is not considered appropriate.
The difficulty is that many value stories are developed once clinical trials are underway and it’s too late to change the trial endpoints…but you’ll still have to report them.
The solution? You have to pack both the “sexy knickers and granny pants” and a good objection handler too!
Clinical Value: Long-Term Efficacy Data
Packing for long trips requires some changes of clothes. You don’t want to live in the same outfit for weeks on end, in the same way, payers aren’t interested in outcomes at just one point in time. Show them the full-time horizon of your efficacy outcomes – both the short and long term.
And remember, if your therapy requires chronic use or is a one-shot ATMP, payers will want to see evidence of sustained benefit, to justify the total cost of therapy.
Clinical Value: Safety Data
Safety data is like packing appropriate footwear.
Payers want to know your product’s tolerability and safety profile is acceptable and any major risks should be adequately highlighted.
Regulatory approval indicates that your product has an acceptable benefit-risk ratio, hence it is often sufficient to provide a high-level safety summary with extra detail in an appendix if needed.
Payer Relevant data
If you’re off on a summer holiday, you’re probably not planning to pack thermals, jumpers, or coats. Most likely they won’t leave your suitcase but will take up precious space.
In the same way that we adapt our packing list to the climate and environment we’re traveling to, a value story needs to be adapted to the payer we are speaking to.
Is the data included applicable to the population and healthcare system they manage? If the answer is no, it might be better to exclude it.
Differences in demographics, healthcare costs and spending, and disease management need to be considered as value stories are adapted for local delivery. If it’s not relevant it won’t be used in their assessment, and you’ve wasted precious real estate.
Economic Value
New medicines come at a cost. So do holidays.
The price of staying in a tropical beach-side villa may be accepting a few mosquito bites and high UV levels. So be prepared and don’t forget to pack your insect repellent and SPF!
The price of gaining reimbursement for a new therapy may be handling a few cost-related payer objections along the way.
Avoid the bites and burns with these types of economic evidence that demonstrate the cost impact of a new intervention, including:
Cost-effectiveness analysis
Budget impact analysis
Resource utilization impact
Competitor comparisons
Please note that unless your product solely addresses an unmet economic need, the economic value section of the value story is not the reason your product will be reimbursed!
Patient Value
Some types of patient data are a bit like miscellaneous packing items that might improve the quality of your trip… a book to read or a favourite toy.
They are essential packing items for some, and less important for others.
Why? Patient value data is not factored heavily into some payer’s decision-making. If you’re talking to payers in the UK, Germany, and Sweden then it’s essential data to include, but in other countries, it should be streamlined or deprioritized.
Examples of patient value data (quantitative and qualitative) include:
Quality of life improvements (e.g QoL measures from validated instruments such as EQ-5D and SF-36) which should patient benefits
Activities of daily living such as work/school attendance, mobility, and social interactions
Caregiver impacts such as reduced caregiver time and improved caregiver quality of life.
Presentation
Can you guess this one? I’d liken it to toiletries. You want to be clean and well-presented while traveling, in the same way, a value story should be polished and refined in its presentation.
A value story needs clarity and conciseness. Its messages and data should be neatly presented in a visually appealing, easy-to-digest format.
No font size 10 unless you’re a footnote!
Value Proposition
Sometimes you won’t have time to run through the full value story to a payer but it would be great to have 1-2 sentences that open the door to further discussions. The value proposition can be your passport to longer, in-depth discussions on a new product with payers.
Conclusion
Start with the unmet need then show how your product addresses that need, leveraging clinical, economic, and patient value data where relevant to substantiate your claims. Throughout you should demonstrate differentiation to highlight the need for your product, all the while ensuring messages and data are clearly presented. And when it comes to local delivery, ensure your messages and data are relevant, adapted or deprioritized as needed.
Hopefully, with this checklist and tips, the development of a new value story will be plain sailing. Bon voyage!
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Cover photo credit: Photo by Arnel Hasanovic on Unsplash