In their assessment of new drugs and medical devices, payers are increasingly looking at economic analyses and health outcomes information to help inform their decisions.
But exactly what kinds of evidence are they using and what criteria are being applied? For manufacturers, the decision-making process is too often like a black box. Payers absorb data from industry and other sources, deliver their verdict, and move on.
Market access managers are keen to understand what kinds of message to present. In this regard, it’s useful to consider some of the reasons why your value presentation might not be effective. A study from researchers based in Canada, Ireland and the UK found several possible explanations:
- Wrong comparator. It might be that trials have been designed for regulatory approval, and have involved comparison with a placebo instead of customary care.
- Evidence not representative of actual use. Clinical trials need to include the populations that are of particular interest to payers.
- Imprecision. There may be too many assumptions, or they may not be explicitly declared. In this case, decision-makers can lose confidence in the result.
- Cost impact and lack of affordability.
- Restricted access. To prevent HCPs from prescribing the drug in situations where the product may not be a valuable enough treatment.
The authors of the study concluded that:
“The key to decision-making among healthcare payers is the provision of appropriate evidence, comparing any new treatment approach to current standard practice, in situations corresponding to real life. When assumptions have to be made, these should be clearly stated with consideration of the impact of varying the assumptions. The impact on budgets should also be considered”.
Shining a light on the process
A separate study from Cerner Research and the National Pharmaceutical Council in the U.S. sought to make the evidence evaluation and formulary decision-making process more transparent.
The researchers note that:
“Although the evidence that is reviewed and the final decisions about a drug are often documented, assumptions and other considerations are not. As a result, various factors that influence the decision-making process might be applied differently. From the perspective of those affected by the decision-making process, there is a need to improve the process in terms of:
- clarity: knowing which factors are influential.
- consistency: understanding whether comparable scenarios are handled in a similar fashion at different times
- transparency: ensuring that those involved in (and perhaps those external to) the decision-making process understand what was decided and why”.
Working with a panel of experts, the study identified key factors associated with formulary access by assessing what level of access would have been given to a product in various hypothetical situations. This was used to create an evidence assessment tool that was then tested in real-world environments.
As might be expected, the study found that “Greater formulary access was associated with greater efficacy, lower costs, fewer safety concerns, and greater evidence certainty.”
Perhaps contrary to expectations, the researchers did not find that a structured evidence assessment was of use in the P&T committees they reviewed.
Given the dynamic and complex nature of the decision-making process undertaken by P&T committees, finding a structured approach that is acceptable in a real-world environment remains elusive.
These findings suggest that there is no silver bullet or ‘one size fits all’ value presentation that payers and decision makers are looking for.
It further underscores the importance of flexibility in value presentation design. Market access managers should look to design flexible tools to ensure that clients have full access to the data they need to see, based on the input criteria they decide, always taking into account that these criteria will vary from one case to another.
Conclusion: our solution to payer diversity
Whether the issue is considered from a national, regional or global perspective, it’s clear that there is a huge diversity of payers and healthcare providers, with disparate concerns and requirements.
As the report’s authors note, it may not be clear the extent to which different factors informed a decision. Factors may include:
- different kinds of data
- subjective preferences
- sufficiency of empirical evidence
- safety of similar available agents
- direct costs
- cost offsets
- total cost of care compared with current care
At BaseCase, we have developed a payer engagement platform specifically with the considerations of flexibility and client-centricity in mind.
The importance of providing information such as budget impact linked to customer-specific inputs is critical. Our clients repeatedly tell us that the most impactful value presentations offer the ability for payers to vary assumptions and tailor results based on the population under consideration.
Our software takes this need into account by enabling market access managers to design customizable, tailored presentations for use on the iPad or other tablet devices, without having to do any programming.
The flexibility of the platform enables global enterprises to quickly develop and distribute payer engagement apps to a global audience, without losing relevance. To the extent that the ‘owner’ of the tool desires, apps can be copied, further modified and adapted by market access teams in each jurisdiction, and at each level - even by the key account managers in the field.
Focus on the message and the medium
When it comes to presenting health economic data, it should not be assumed that the audience is well versed in complex HEOR concepts such as a mixed treatment comparison or cost-utility analysis.
There’s no question then that one of the most important aspects of value communication is the ability to present complex information in a format that’s clear and understandable - another reason why our clients use BaseCase to create tablet presentations:
Value story on iPad
Created using BaseCase Interactive, this app uses a low information density to avoid crowding out the key value messages. Data is presented in a clear and understandable way
Presenting data in this way will ensure that, however opaque the decision-making process may be, you can be assured that the full clinical and economic value proposition for your product is apparent and available for consideration by payers.