Medical Affairs Focus

Thoughts on Global Medical Affairs

Topic5: Relationship between MA and Managed Markets

Introduction

I received a question about what an optimal relationship should be between MA and Managed Markets in the US.  Managed Markets (MM) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers.  In some organization this group is known as Reimbursement, Access, Market Access, Payer Relationship, or Pricing.  The primary challenge is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.  In the US, the MM function has had to deal with a range of both government and private payers, each with their own formularies.

The MM function in the US has grown in importance as the payers have worked to limit their exposure to potentially expensive treatments through formulary placements that drive limitations and co-payments for the patients.  Even specialty areas like oncology, which used to have very few restrictions, are now seeing greater control exerted by the payers.

Defining a New Relationship

Just as the pressures on MM are forcing changes in the way they work with payers, those same pressures are changing the relationship between MM and MA.  In the past, MA had a limited role to play in MM.  For example, MM might occasionally ask an MA resource, typically an MSL, to provide some scientific support for a formulary presentation.  But, in general, these situations were ad hoc and limited.

However, now that MM’s success more directly drives the success of the pharma company and thus their importance has grown, the relationship between MM and MA is changing.

For a formulary committee to control costs, they must be able to differentiate between more and less effective treatments, including the total cost of treatment.  This drives two major needs:

  1. The formulary committee needs a more robust scientific understanding of the drug’s properties, its known efficacy, its known risks and its place in the overall therapeutic area’s treatment options
  2. The formulary committee is demanding more specialized data, specifically health economics and outcomes research (HEOR) data, to allow them to understand the full impact of the drug’s use

Both of these ramped up requirements have direct impact on MA’s relationship with MM.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for formulary presentations is growing from a part of the presentation to the core of the presentation.  And with that growth comes the need for greater specialization by the presenters.

As the importance of the scientific presentations to formularies grows, the developer of those presentations and the presenters need to have a much more robust understanding of their audiences and how to effectively meet their needs.  This is leading to two trends in MA:

  • Much greater degree of training for MSLs on the role of MM and formularies  

OR

  • The identification and hiring of full time MSL-type roles specifically targeted at supporting MM                                                                 

Given the importance of MM, supporting their needs can no longer be seen by MA as a side responsibility.  Instead, it needs to be a core responsibility and an investment in training or personnel is needed to ensure that that the field force of MSLs is prepared to adequately support this need.

More Specialized Data

MA has typically taken the lead in developing data post-approval.  And while HEOR has always been an part of generating that post-approval data, its importance has grown significantly.  The increased demand for HEOR data has a number of implications:

  • Data Generation Plans, which should be developed by MA to help drive the post-approval data efforts, must give greater consideration to the HEOR needs
  • The priority given to Investigator Initiated Studies that cover HEO subjects may need to increase
  • The need for specialized MA resources dedicated to developing and managing HEOR may need to increase, with new dedicated positions developed
  • Processes for ensuring that the input of MM is gathered in the development of HEOR protocols should be re-examined to ensure that the results will meet the demands of the key formulary committees

In some companies have decided that HEOR is so important to MM that they have shifted the leadership of this research to the MM function itself.  Whether the HEOR function reports to MM or is developed within MA, the need to ensure that the needs of MM are addressed has become a major priority for post-approval research.

Closing Thoughts

MA’s role as the owner of scientific education and communication for post-approval drugs is a critical element in today’s formulary-driven environment.  MA needs to be an active partner to MM as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / MM partnership?  Leave your comments below.

If you have a topic you would like me to cover, please email me from the link to the right.

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