Topic 41: The Implications of Amarin. Is It “Good” for MA?

A number of my friends in MA leadership have been debating the implications of the Amarin case for MA overall. Spoiler alert – I think it will prove to be another avenue for MA to add value and I will share my rationale below.

In case you have not been reading up on this case, you can see my brief discussion and some links to other sources of information on this blog post. When discussing the Amarin case it is critical to understand the context – this case was decided by a federal district judge in Manhattan for the Southern District of New York – so obviously this ruling does not set national standards.  However, the Southern District court is one of the most influential and active courts in the US and it has a history of leading the nation.

Assuming that this ruling becomes the precedent for either other cases in other districts or even national cases, the question is if/when pharmaceutical companies have the flexibility to promote off-label data (with all the fair/balanced caveats) – what are the implications for MA?

So let’s go on a trip to a speculative future in which the ability to share off-label data with HCPs on proactive basis becomes accepted in the US.  In this future, I would fully expect that the FDA decides to put guardrails around this freedom.  Their rationale will be simple – there is high risk to patients if HCPs make decisions based on off-label information which have not run the full risk/benefit analysis of a product with an approved NDA.  What would these regulations look like?  We can get a good view from FDA’s response to Amarin (which we covered indetail here) the summary of which is that this education would need to be fair and balanced and, among many other things:

• Discussions should be conducted by persons with the appropriate background or training to accurately communicate scientific information

That would clearly call for a role similar to the MSL or field force role of today’s MA. But would that role need to be in MA, or more provocatively, would MA need to be a separate entity from commercial.  

Those you that have been around the industry long enough remember when MA was sometimes a function of commercial, often called Scientific Sales. Driven by increasing FDA and EMA scrutiny primarily concerning off-label promotion and a desire to be seen as a voice of science instead of promotion, MA as an independent, non-promoting entity became the standard. 

In our speculative future the US has loosened the off-label promotion rules, but the EMA has not and the need for an independent voice for science has not decreased so I do not foresee an effort to move MA back under commercial. Frankly that ship has already sailed since so many other functions that MA serves also benefit from it being independent from commercial.

So if MA is likely to remain independent would the MSL role remain in MA? I think that they would, not only due to inertia (although you can never over-estimate the power of inertia in pharma) but also because keeping the MSL role in MA would improve the case that the information presented was fair/balanced and not tainted by promotional messages.

Following my logic stream, MSLs would gain a new capability (ability to pro-actively share off-label data) while remaining in an MA function independent from commercial – so a net improvement to the value that MSLs and MA overall brings to the company. That can only be a good thing for MA leaders.

That was quite a bit of speculation – what is your opinion?  Please click here to leave a comment.

Topic 37: Medical Affairs and the Integrated Payer / Provider Model

For a while we have been discussing the need for a specialized medical affairs function focused on Payers – we discussed it here.

But what about Accountable Care Organizations (ACOs) or other integrated payer / provider models, where the provider owns both the cost and the outcomes of their work.  This type of model is becoming more and more prevalent, yet most MA organization have not flexed to directly engage with these types of organizations. 

The needs for these organization are not a match for current MSL field organizations focused on HCPs and, while payer oriented organizations may be better suited, they are not a perfect match either.

Like payers, these groups are interested in population-level information.  And, like payers, they care about total cost of care.  But like HCPs they also place a greater emphasis on understanding treatments in the context of the overall disease progression and methodologies for approaches for ensuring improved outcomes with existing treatments.

I suggest that MA organizations are going to need to develop groups that directly target these ACOs.  These will be teams that understand population health and quality metrics.

And MA is going to need to collect this population data directly.  

 One thing that seems clear is that HEOR secondary endpoints gathered during P3 simply lack credibility with these audiences since they know the P3 had inclusion/exclusion criteria that did not model their patient population.  Real world data and post marketing studies, already important for payers, is going to be equally important for these ACOs.

MA is going to need to come to them with models of costs and outcomes and budget impact, then partner with them to validate the model and gather relevant data about treatment approaches which produce the best results for the least costs.  

What do you think?  Leave a comment by clicking here.

Topic 35: Trends in Data Sciences for Medical Affairs

Data has always been the backbone of medical affairs.  Understanding the data that underlies the company’s products and the products of the competition and understanding the prevalence and treatment data available about the disease state has always been a requirement.  And, being able to summarize and explain the meaning of the data is one of the greatest values that MA brings to the organization.

But as a generator of data analysis and manager of data, most MA organizations have been passengers not drivers.  Most data sets are being generated by clinical development and analyzed by statistical staff within the clinical function.  Even after the product is on the market and the data generation turns from a clinical responsibility to a medical responsibility, most MA organizations still rely on these resources or the resources of outsourcers to define, manage and analyze their data.

However, as MA groups grow more sophisticated in their use of data, and as real world data sets available for analysis continue to increase in size and importance, it may become in the best interest of MA to begin developing some data science capability of their own.

MA Stats

Some MA organization already have their own stats staff or stats staff assigned to them but working in clinical, but in my experience this is still the exception not the rule.  Instead, most organization rely on stats people internally who are not primarily focused on MA or on outsourced stats resources.  There are a number of challenges with this environment.  First, for the internally loaned people, most of them are not that familiar with what MA does and they are also usually not familiar with using real world data sets.  Leveraging them requires bringing them up the learning curve, sometimes at the expense of time and effectiveness of the analysis. 

Relying on to a large degree on outside statistical help is also very problematic.  In these outsourcing situations, the cost can be high and the learning curve that you are paying for becomes the property of the outsourcer to resell to your competition.  Additionally, when a non-stats person hires and manages a stats outsourcer, it is very difficult for them to understand if they are getting the best thinking out of the outsourcer and suggest other alternate directions if they feel the outsourcer is taking a less than optimal path.  It is this very difficulty that led many clinical organizations, even virtual clinical organizations, to realize that they always needed some stats capability in-house, even if it was simply to manage the outsourcers.  Finally, working with outsourcers makes it very difficult to answer quick, smaller “what if” questions that always seem to come up after the main analysis is complete.

Given the importance of these analysis for MA and the need to be flexible, I believe that more and more MA organizations will realize that they need their own stats capability on the MA team – focused full time on the data sets and analyses that are most relevant to the post-marketing world.

MA Data Managers

While some MA organizations already have stats, I have yet to see one that has their own data management function.  Nevertheless, I am going to suggest that this will be less rare in the future.  Data managers are responsible for the “care and feeding” of the databases that the stats team analyzes.  A common function on clinical. 

As medical affairs becomes more data sophisticated and as cutting edge groups decide to build huge repositories of real world data to perform ongoing analysis, the need for professional MA focused data managers will grow.  These data managers will be more focused on the collating and cleaning of external data then their clinical counterparts and that is why I think the need for an MA specialist group will take hold.

What do you think?  Does your MA team have its own stats function today?  Is data sciences in the plans for the future? If you would like to leavea comment, click here and scroll down.