Medical Affairs Focus

Thoughts on Global Medical Affairs

Tag Archives: Access and Reimbursement

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.

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Topic 31: Changing Relationship between Medical Affairs and Access & Reimbursement

Note: This is a revised and extended version of a post I first published two years ago. This issue continues to evolve and be an area of focus for many MA Leaders.

Introduction

I received a question about what an optimal relationship should be between MA and Access & Reimbursement in the US. Access & Reimbursement (AR) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers and/or providers. In some organizations this group is known as Managed Markets, Market Access, Payer Relationship, or Contracting. Their primary goal is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.

AR has to make the case for reimbursement of their drug to a payer/providers Pharmacy and Technology Committee (P&T Committee) which is the body that ultimately makes the decision for the payer/provider. In the US, these P&T Committees consider the efficacy and safety of the treatment but they also consider the cost effectiveness of the treatment and its impact on total cost of care for a patient when deciding where to place the treatment on their formularies. The AR function has had to deal with a range of both government and private payers/providers, each with their own formularies.
The AR function in the US has grown in importance as the payers/providers have worked to limit their exposure to treatments they viewed as not cost effective through formulary placements that drive limitations like prior authorizations 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 AR are forcing changes in the way they work with payers, those same pressures are changing the relationship between MA and AR. In the past, MA had a limited role to play in AR. For example, MA may have had a responsibility to train AR Account Managers on the scientific underpinnings of a new treatment, not dissimilarly to how MA may train sales staff. And AR might have occasionally asked an MA resource, typically Field Medical, to provide some scientific support for a formulary presentation. But, in general, these situations were ad hoc and limited.

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

For a P&T Committee to control costs, they must be able to differentiate between treatments. This drives two major scientific 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 like cost effectiveness and total cost of care, and comparator 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 AR.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for P&T Committee 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.
MA which develops and delivers the scientific elements of those presentations need to have a much more robust understanding of their P&T Committee audiences and how to effectively meet their scientific needs. This is leading to two trends in MA:

  1. Much greater degree of training for Field Medical on the role of AR and P&T Committees
    OR
  2. The identification and hiring of full time Field Medical-type roles specifically targeted at supporting AR

Given the importance of AR, 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 Field Medical is prepared to adequately support this need. In addition to training, this will require new measures to be put in place to track Field Medical effectiveness, which I will discuss in a future blog post.

More Specialized Data

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

  • HEOR data should start being gathered in Phase 3B at least, and thus MA HEOR leaders need to engage with clinical development to ensure endpoints are included to begin the generation of HEOR data sets
  • Post-Approval Data Generation Plans, which should be developed by MA to help drive the post-approval study 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 AR 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 AR that they have shifted the leadership of this research to the AR function itself. Whether the HEOR function reports to AR or is developed within MA, the need to ensure that the changing needs of P&T Committees 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 AR as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / AR 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.

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.

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.