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Topic 45: Medical Affairs Insights – A Key Value Proposition

Overview

On this blog we have discussed the challenges of communicating medical affairs value a number of different times. Specifically, we have addressed the topic here (Topic 6), we have discussed MA value at launch here (Topic 3), and addressed the use of NPS measures in communicating value here (Topic 43).

On subject that we have not addressed is the importance of MA Insights in communicating value to internal stakeholders.

MA has always shared its insights with its internal stakeholders, but in the past the process has been fairly unstructured in the form of MA team members who are working with other functions on specific projects sharing their knowledge. For example, when MA field teams are responsible for helping clinical development identify and initiate sites, they may bring back to the clinical team leadership feedback about the protocol that they learned during their discussions with PIs. Or MA members of cross-functional launch teams may share insights that they gathered doing disease state education that may help commercial colleagues better understand and craft commercial scientific messages.

In the last year or so I have worked with a number of clients that are looking to take these “insight value moments” and make them more frequent by structuring the process for gathering and sharing insights.

Before I share my thoughts on how to best leverage MA insights to drive organizational value, some standard caveats:

  • MA is not a market research organization and must never imply that the insights gathered are anything more than valuable but anecdotal information (the plural of anecdote is not data)
  • MA is not in the business of “taking orders” from other areas for specific insights, but should at least understand what those areas are interested in (see more on this below)
  • MA’s gathering of insights should organically grow from its peer-to-peer scientific interactions, communications and education activities only

Three Elements of Successful Insight Capture and Communication

With that said, I want to share some of the keys to gathering and communicating valuable insights from MA to internal stakeholders.  Three elements are required to successfully provide value through insights:

  1. Awareness of Current Environment and Important Topics
  2. Method for Capturing Insights
  3. Approach for Communicating Valuable Insights

I will review each element in more detail below.

Awareness of Current Environment and Important Topics

MA personnel that interact with HCPs and others in the field are constantly learning new information. However, everything that they learn is not worth their time to document nor the time of internal stakeholders to review. As the saying  goes, if you do not know what you are looking for, you will never find it.

So how do we make MA personnel that interact with others in the field aware of what are potentially valuable insights for their internal stakeholders? We need to educate them on the internal stakeholders’ situation.

Primary internal stakeholders for MA insights are:

  • Clinical Development
  • Commercial
  • Managed Markets

Each internal stakeholder group has different areas of interest. In order to identify that MA has learned something useful to these groups we need to understand their context – we need to know what is important to them.

Clinical Development

Many MA staff already have a good understanding of the priorities and activities of the clinical development function because they have to discuss the organization’s pipeline and development efforts with HCPs.

Types of Insights Sought by Clinical Development:

  • Competing studies in the TA where CD has existing or upcoming studies
  • Current off-label use of existing marketed products
  • Areas of interest about new indications for existing or planned products
  • Feedback and challenges with existing studies or protocols
  • Enthusiasm for future participation in clinical trials

In order to provide this type of insights, the MA staff needs to understand the context of the current clinical development environment. They need to understand the following:

Elements of Clinical Development Context:

  • Detailed pipeline and development strategy for existing products
  • Protocols of ongoing and recruiting studies in their TA
  • Current status of ongoing trials, including challenges being based

Commercial

MA organizations have a firewall with commercial for a reason. MA is non-promotional and therefore cannot be seen taking orders from or executing work on behalf of the commercial organization. However, non-promotional does not have to mean commercially uniformed. As long as the communication is one-way, MA sharing insights it learns to commercial, than MA can provide value to commercial without becoming a promotional organization.

Types of Insights Sought by Commercial:

  • Feedback on commercial launch activities from HCPs
  • New studies from competitors in the organization’s TAs of interest
  • Changes in a competitors approach to communicating with the HCPs
  • New information about competitor’s pipeline
  • Feedback about the scientific messaging in commercial communications

In order to provide this type of insights, the MA staff needs to understand the context of the current commercial environment. They need to understand the following:

Elements of Commercial Context:

  • Product positioning in the TA
  • Product differentiation in the TA
  • Commercial messaging
  • Competitive landscape

Managed Markets

MA organizations have different relationships with managed market organizations based on the company. Some MA groups are tightly integrated with managed markets, with MA staff specialized to support management markets. Other organizations have limited contacts. Regardless of the structure, MA can provide valuable insights to managed markets.

Types of Insights Sought by Managed Markets:

  • Reimbursement concerns expressed by HCPs
  • Changes / surprises encountered by HCPs in reimbursement for company’s products
  • Communications received by HCPs from payers concerning the company’s products or competitor’s products
  • Competitive product reimbursement changes

In order to provide this type of insights, the MA staff needs to understand the context of the current managed market environment. They need to understand the following:

Elements of Managed Market Context:

  • Overall payer environment
  • Payer relationships within the region
  • IDN relationships within the region

Summary of Awareness

With an understanding of the clinical development, commercial and managed markets context, MA personnel can be aware of any insights they may encounter during their dealings with HCPs and be able to highlight those that have the greatest potential for impact on the organization.

As one of my clients put it, we need to shift MA personnel from Medical People to Medical Business People, adding to their knowledge base an awareness of the entire organization’s business.

Method for Capturing Insights

MA insights do not come on a schedule. They can occur whenever MA interacts with an HCP. For that reason, there needs to be an easy, efficient method for capturing insights as they occur. Many organizations leverage their customer relationship management (CRM) systems. Systems like Veeva can be tailored to capture the insights and, with simple drop down lists, at the time of entry they can be coded for internal stakeholder group or groups that may be most interested in the insight.

Leveraging the CRM system has another advantage – visibility. While insights do not come on a set schedule, MA leadership needs to encourage everyone with HCPs interactions to capture insights. The CRM can be used to track who has entered insights in the last period. While I strongly discourage any type of “minimum number of insights” metric, managers should still track who is entering insights and work with any MA team member that interacts with HCPs and fails to capture insights over a significant period of time.

Approach for Communicating Valuable Insights

If MA wants to maximize the impact of its insights, it must communicate them to the internal stakeholders in such a manner that the insights are actionable. Simply providing internal stakeholders with a laundry list of a hundred bullet points of insights, mixing different topics and hoping that they can sort it out to find the needle in the haystack.

Unfortunately this requires the application of judgment, which takes time and attention. However, in return for this effort the MA organization can produce a consistently useful and effective report of competitive intelligence on an ongoing basis. This approach requires the following steps:

  1. All insights are entered into the system (see previous element above) and coded for internal stakeholder group
  2. A single reviewer is selected for each stakeholder group reviews all the insights for that group for a given period and:
    • Identifies key trends
    • Highlights the insights that are potentially most impactful
    • Identifies miscoded insights or insights that may impact more than one stakeholder group
  3. The single reviewer summarizes the results of the for the stakeholder group

Once a summary of the key trends and highlighted insights are developed, the MA reviewer can meet on a periodic basis with a representative of the stakeholder to review the insights and provide context. These insight review sessions can be a very powerful example of how MA drives value into the entire organization.

 

Conclusion

MA is a significant organization investment. Any opportunity for MA to share its value with its key stakeholders helps it to solidify the important role that MA plays in organization success. Providing actionable insights to the organization is a key way that MA can share its value.

 

What is your experience with Insight identification, capture and communication? Leave a comment.

 

 

Topic 44 – Amarin Settlement and What It Means for MA

We have been following the developments in the Amarin off-label communication case for awhile and you can find our posts that provide background here, here, and here.

In brief, Amarin has an FDA-approved indication to market its fish oil supplement as a treatment for very high triglycerides. It conducted a study that showed it lowered the triglycerides in moderately high patients but the FDA declined to approve the label extension because Amarin failed to prove a link to prevention of coronary artery disease. Amarin then informed the FDA that it intended to communicate the triglyceride lowering data to the market and the FDA informed them that it would consider any such communication off-label promotion. Amarin then sued the FDA for unfair restraint. Amarin was granted an injunction against the FDA, which appealed the decision.

In the latest development, the FDA has settled with Amarin, closing down the appeal before a ruling could be made to set clear precedence. In the settlement, which can read about here, the FDA agreed that Amarin could inform doctors of the studies supporting the fact that its product lowered triglycerides in a range of patients as long as the data presented was truthful.  It also set up an “optional” provision in which Amarin can meet bi-annually with the FDA to review the material that they wish to present to ensure that the FDA will find that information truthful and any disagreements from these discussions would be sent to a court to make the final decision.

The FDA’s perceived fear of a precedence setting ruling is not going to go unnoticed. Already another pharma company, Pacira, is suing the FDA under similar circumstances, which you can read about here.

If this case is also settled, expect to see the floodgates open.

It is more than past due time for the FDA to provide clear guidance to industry on the use of truthful, non-misleading communication of scientifically valid data that is not supported by the label. When that guidance is finally offered, it will be a game changer for MA. We believe that most organizations will realize that the safest way to communicate such scientific data will be through the use of peer-to-peer communication driven by medical science liaison-type roles and this will lead to a major expansion of many MSL groups.

We will continue to follow this story. We would love to know what you think. Leave a comment.

Topic 43 – Use of Net Promoter Score Measures to Evaluate MSLs

A couple of my clients have discussed the use of the Net Promoter Score lately so I thought I would address it in my blog.

Quick background:

The concept of the Net Promoter Score was introduced in a Harvard Business Review article in 2003 by Fred Reichheld of Bain & Company. The net promoter score is measured by asking a single question: “How likely are you to recommend the company/product/service to a friend or colleague?” and is usually measured on a 0 to 10 basis. Scores of 9 and 10 are called Promoters, scores of 0 to 6 are Detractors and scores of 7 and 8 are called Passives. The Net Promoter Score is calculated by subtracting the percentage of customers that are Detractors from the percentage of customers that are Promoters.

People like the net promoter score because it is a simple measure of loyalty and when it is paired with an open ended question that asks why the particular score was given, it provides insight into what is important to the customer.

So, does the Net Promoter Score (NPS) provide value to MA? My research has not been able to find a single academic or metric-driven study on the use of NPS in MA specifically related to MSL activity. Common sense says this approach should be helpful but for now anyone using this approach is in experimental mode.

In MA the NPS question is often modified to be:

  • “How likely are you to recommend engaging with [COMPANY X] Medical Science Liaisons to your colleagues or peers?” OR
  • “How likely are you to recommend working with [MSL NAME] from [COMPANY X] to your colleagues?

PRO’s of Using NPS in MA:

  • Brief nature of survey makes it suitable for rapid deployment immediately following MSL interaction to avoid the “blending” affect that occurs when HCPs are asked about MSL performance on a standard survey often weeks after their last interaction
  • Relatively inexpensive to conduct compared to other market research
  • NPS can help gather insights into what an HCP value in an MSL interaction, if open ended questions are employed as well

CONs of Using NPS in MA:

  • Message vs Messenger: When an HCP recommends working or engaging with an MSL is that recommendation based on the quality of the content of the interaction or the interpersonal qualities of the MSL herself or himself?
  • Not comparative: NPS does not give insight into whether HCPs recommend your MSLs any differently than they recommend competitor MSLs. Perhaps HCPs in a particular therapeutic area simply recommend all MSLs the similarly regardless of company.
  • Not clearly actionable: If your NPS drops from one month to the next, what action should be taken? Some insight might be provided by the open ended questions but those responses are often only provided by the most dissatisfied

Given the inherent challenge, it is my opinion that the NPS is still a worthwhile measure, but it needs to be gathered as a part of a broader market research effort to give it the context that can help tease apart the reason for the scores.

The most effective NPS is gathered as soon as possible after the last interaction. In the case of MSLs, a system should be established to seek this guidance directly after a contact has been noted in the company’s contact management system. And, like all market research with HCPs, participation is highly impacted by compensation, so sufficient compensation must be offered to ensure enough participation to make the measure meaningful.

What is your experience with NPS? How do you frame the question? Share your experiences by clicking here.

Topic 42 – The Office-centric MSL

One of my readers asked me an interesting question:

“Are there examples of successful MSL roles that are primarily office-based (minimal travel)?”

Of course I could immediately think of some one-off type of examples like MSLs that focus on supporting other internal teams, like MSLs focused on training, or MSLs focused on providing a clinical development function technical leadership support. But, the simple answer is that I don’t know of any MSL groups that are primarily office-based. If you have experience with this, please leave a comment because my reader would really appreciate it.

Having failed to find a practical example, I nevertheless asked myself if I could imagine such a group existing in the future as a thought experiment. If we take as a given that the role of the MSL is to:

1. Establish relationships with stakeholders (usually thought leaders / key opinion leaders) in order to:

a. Provide the stakeholders with information and education on the disease state
b. Answer unprompted off-label questions about products / pipeline
c. Gather insights from stakeholders to share with the organization

2. Represent their organization in scientific settings like conferences
3. Facilitate efforts to work effectively with the research community
4. Support other scientific needs of the organization externally, like payers

I realize your mileage may vary on this definition, but if we accept it, than is there a future where most of that can be done from a desk?

I think it comes down to how acceptable the use of remote communications like FaceTime or Skype becomes. Today’s reality is that this is rarely done but I believe that this will grow much more common as this type of communication begins to be embedded in our daily interactions. I can imagine a future in 10 years or less where stakeholders express a preference for this type of communication – it is clearly more efficient for a stakeholder to sit at her or his desk and quickly interact with a number of different people than have to do the physical meet and greet with its inevitable open/closing loss of time. However, I think that this change will happen so gradually that we will come to realize that happened only by looking back on the differences.

And even in such a situation, there will still have to be travel for initial introductions which are much more impactful face to face and to conferences/meetings that have not gone virtual.

I just think the MSL job is too fundamentally about human contact to ever be exclusively office-based.

What do you think? Let me know by leaving a comment below.

Topic 38 – FDA Comments on Off-label Dissemination – Did it just tip its hand on upcoming off-label policy?

Have you had the opportunity to follow the Amarin lawsuit against the FDA?  If not, a quick recap:

 Amarin is literally a fish-oil salesman – they have fish-oil pills that are already FDA approved for the treatment of very high levels of triglycerides.  They had conducted clinical trials to expand their label to patients with lower levels of high triglycerides.  The FDA rejected their application.  Amarin decided it wanted to share the results of those studies anyway since they were positive and sued the FDA for the right to share its data on off-label use.

The interesting part comes from the FDA response letter.  Putting aside their primary concern that Amarin failed to work with them before suing them, the letter signed by Janet Woodcock went on to layout the condition in which Amarin (or for that matter any pharam company) can share off-label data.

First, the letter reiterated what we already know and have discussed: the reprint exemption to off label communication – distribute reprints from peer-reviewed journals, avoid some simple issues like highlighting only the “good” passages, and you are in the clear.

But then the letter goes on to say that Amarin can also write up and distribute its own summary of the results of their trial if the write up:

  • Remains factual and does not omit material information or introduce bias
  • Includes full data for each treatment group
  • States that the current label does not approve of the use
  • States that the impact on the off-label use has not been determined
  • Shares data about other, known similar studies that may have different results
  • Any financial or affiliation biases between the firm and the people who conducted the study

They go on to add that to protect against being misleading the company should:

  • Provide a copy of the current Package Insert
  • Provide a copy of any relevant reprints
  • Discuss these topics in an educational or scientific setting and not as a part of a promotional discussion or attached to promotional materials
  • Discussions should be conducted by persons with the appropriate background or training to accurately communicate scientific information

While that is still a lot of hurdles, that is a long way from reprints only.  And while these are NOT an official policy now, I think this is telegraphing what we should expect to see in the upcoming policies.

I particularly like the final bullet point which makes it clear that these topics need to be discussed by roles that sound very much like MSLs.

To speculate, if the FDA were to allow establish this as the policy, it would surely free up MA to proactively share both off label and label supportive information.  That would be a big improvement for some MA organizations that deny all proactive sharing of off-label information.

You can find the letter HERE.  The juicy bits begin on page 8.

What do you think?  Click here to leave a comment.

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.