Medical Affairs Focus

Thoughts on Global Medical Affairs

Topic9: HEOR Studies – Who Should Take the Lead

I was talking with a longtime friend and client the other day and he was describing a situation in his organization.  A tug-of-war of sorts was going on with HEOR studies.  In his business, the amount of funding going into HEOR studies was going up, and although they had typically be run out of the MA shop, there was increasing pressure to move all HEOR studies over to the Access and Reimbursement group.  We had a good discussion on this which I will try to recap here.

Traditionally all post-marketing research has been driven out of MA.  I use the term driven, because in many organizations the actual studies may be managed by a CRO or a clinical development resource.  But the group responsible for identifying the need for the study, budgeting for it, getting approvals to conduct the study and driving the protocol development was almost always MA.  There is a good reason for this, the Medical Director, who typically owns the scientific lifecycle of the compound is in MA and thus should be driving this process.

Now, post-marketing studies is a very large bucket.  It can include additional safety studies, both mandated and not mandated, reformulation studies, label expansion studies, HEOR studies, just to name a few.  And, given the huge range of post-marketing research, it is fairly standard that the Medical Director and MA in general partners with other parts of the organization that have expertise in these areas.

Fast forward to today’s world.  HEOR studies are increasingly critical to the medical and business case that Access and Reimbursement needs to make to payers in order to achieve a beneficial position in their formularies.  Investment in HEOR studies are growing by 0ver 40% in the past few years, as discussed here.  Given their knowledge of the audience, the data that they need and the competitive data that they are likely to have available, no one is in a better position to define the requirements for an HEOR study than the Access and Reimbursement team.

But, does that mean that Access and Reimbursement should be driving the HEOR studies themselves.  My answer remains been no.  Access and Reimbursement should be a defining voice in the development of the protocol, but once that protocol concept has been finalized it becomes an issue of study execution.  This is frankly how it works with most post-marketing studies.  While I can grant that an HEOR study has unique issues, so do many of the targeted post-marketing studies.

Having said all of this, it is also true that I, myself, have set up just such a function for an Access and Reimbursement client.  They had circumstances that made it clear that the MA function was not valuing the need for HEOR research and thus it was not getting done on a timely basis.  This was essentially a political issue but the only way to resolve it in the short-term was the create an dedicated function within Access and Reimbursement.

I am curious to know your experiences in terms of HEOR studies.  Leave me a comment below.  And if you have any question that you would like me to address, please click on the email link to the right.

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