Medical Affairs Focus

Thoughts on Global Medical Affairs

Monthly Archives: August 2012

Topic12: Here We Go Again – Oncology Sales Reps and MSLs

Did you see the headlines off this new survey from ZS Associates about sales rep access to oncologists?  The takeaway is that oncologists heavily restrict sales staff access.  Only 39% of oncologists were accessible (by ZS’ definition) to sales staff while the average for other all physicians is closer to 65%.  Take a look at the article here.

For those of us in the oncology space this is not really breaking news but the quantification brings it into focus.   And the article goes on to mention different sales approaches to help overcome this limitation, implying at one point that pharma might re-start the sales arms race and gain access through sheer force of numbers. (I am highly skeptical of this)   We all know when this type of information comes out the next line of reasoning for improving access to oncologists always seems to involve MSLs.

MSLs have access to oncologists, goes the reasoning, and we should use them to “supplement” the limited access of our sales folk.  There was a blog post on this subject in PharmaExec’s blog here that seems to make this case.  In it, the poster cites a study from Industry Standard Research and talks about how MSLs are “…less promotional…” than sales reps and thus more credible.

As MA professionals, we need to nip these arguments in the bud.  While I personally have no issue with taking money that used to go to sales reps and putting it toward MSLs, the justification for doing so cannot be to use MSLs as “scientific sales” or “sales-lite.”  The hard truth is that oncologists are not interested in being marketed to by drug makers.  They are sophisticated physicians with robust knowledge of the scientific state of their therapeutic area, and they don’t need reps to help them make decisions.  What they are interested in is learning and sharing with peers.  And, if we can put MSLs in place that can support that learning and sharing, they will be appreciated and welcome.  But, the minute we try to give MSLs any level of marketing duties, we will simultaneously lose our physician credibility and place the entire MA function in compliance risk.

Instead of seeing the information from ZS as an excuse for pulling MA into marketing, it should be seen as a clarion call for a shift in focus from a customer relationship to an educational and scientific partnership.

MA can have an impact on treatment decisions but not through marketing.  MA’s impact will come from partnering with physicians to ensure they have the scientific facts and support that they need to make informed decisions using their best judgment.

 

What do you think?  Leave your comments below.  And if you are new to the blog, add your email to the list on the right to receive an update when new topics are posted.

Topic11: MSL Team Leadership Challenge

I received a call the other day from an old friend who had taken on a new job.  Her job involved developing the North American MA function for a non-US pharma company.  One of her first tasks was to consolidate and expand the MSL function in the NA. She was very concerned because her budget was fairly limited given the ground she needed to cover with her MSLs.  She wondered whether she could “stretch” her staff by using team leads that have both substantial HCP support and managerial responsibilities.

While practical considerations, especially for very small or very new MSL teams, sometimes dictate the need for MSL Team Leaders to have both substantial HCP support and managerial responsibilities, over time these types of models tend to be unstable.  When Team Leads have substantial HCP responsibilities those responsibilities tend to absorb the time for managing their team.  It is essentially a case of the urgent driving out the important.  In an effort to be responsive, HCP needs tend to trump other requirements, especially requirements that can be put off like team management.  As a result, despite best intents the team suffers from a lack of leadership. And, in cases where the team already has some challenges, like lack of experience or entering a new therapeutic area, this lack of focus can derail the entire MSL effort.

While it is important for the MSL team leads to maintain contact with some very targeted HCPs, it must be a small portion of their workload and their managers need to ensure that they do not lose their focus on their primary responsibility – the leadership of the team.  The important cannot be allowed to be a victim of the urgent.

So what is the magic number where a more-or-less full time team leader is needed?  Putting aside all the caveats that the number varies by TA, product complication, HCP need, etc., I would say the number is between 8 and 12.  Less than 8 it does not make much sense to have a full time-ish team leader.  Over 12 and it too much work for one person.

What has your experience been?  Please leave your thoughts in the comments.  If you are new to the blog, please add your email on the right to receive a notice when new posts occur.

Topic10: MA Reporting Relationships in Small Companies

A reader wrote in to discuss a situation at a small pharma company.  This company was just starting up its MA group and it was not sure where the MA group should report.  The reader was well aware of the issues with having MA report to a commercial leader that we discussed in this post.

The challenge in this situation was that senior management consisted currently of just a CEO and a COO.  While the CEO is a scientist who handles their development efforts, the COO handles all other responsibilities, including   Commercial, Finance, Legal and HR.  The CEO would be the natural choice for managing MA, but given workloads it was not practically feasible.  Could the COO handle the job of managing MA even though they also have some commercial responsibilities without putting the company at risk?

This is a very common situation for young organizations.  There is often very little senior leadership to go around.  Yet, as we mentioned in this post, it is critical to start MA up early to support a product launch that may be over two years away.  In situations where it is not feasible for MA to report to someone purely on the science side and they need to report to someone with commercial responsibilities, my rule of thumb is that the role they report to should have substantial responsibilities outside of commercial and should be measured on results that go beyond just commercial measures.

In the case above, the COO has commercial responsibilities but they also have non-commercial responsibilities as well.  Having MA report to the COO should not be a problem, as long as the COO understands the role of a compliant MA organization and follows the general rule about MA interactions with commercial that were outlined here.  In the end, the Agency looks for actions not reporting relationships, but the reporting relationship do send a clear signal about the priorities of the MA organization.

What has been your experience about MA reporting relationships?  Please leave a comment below.  And if you are new to the blog please sign up for email updates by clicking on 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.

Topic8: Sunshine Act – Preparing KOLs for 2013

We are little over a year (Sept. 30, 2013) away from the date when Department of Health and Human Services (HHS) has committed to having the first round of Sunshine Act data made available to the public via the web.  Allow me to stipulate that we may have more time since the HHS has managed to miss every other deadline they have had with regards to the Sunshine Act.  And, allow me to stipulate that a fully Republican controlled government may actually repeal Obamacare and the Sunshine Act with it.

But, as we head into the 2013 planning season, I think it would be wise to assume this is actually going to happen and thus budget and plan accordingly.

Up to this point, we have discussed the Sunshine Act purely from an administrative point of view – how to collect this data and meet the immediate 2012 requirements.  But, in 2013 this information is going to be made public and we run the risk of losing the trust and support of the very KOLs that we have all invested so much time in developing.

It is critical that your company take a proactive stance on this situation:

  • Reaching out to the KOLs for whom you will be reporting payments
  • Educating them on the law and its reporting requirements
  • Providing them with the same information provided to HHS and an explanation of that information
  • Providing them with some context for this information and how to explain it to others
  • Answering any questions they may have

I will discuss some approaches to this in hopes that it aids in your budget and planning efforts.

The first challenge to overcome in addressing this issue is intra-function coordination.  The data provided HHS includes payments from all company elements, including research, development, medical affairs and commercial.  Therefore, in addressing this to KOLs, a single cross-functional approach needs to be created.

I would suggest a meeting with the other relevant functions to address the corporate approach and name members to a task force.  MA is the logical leader for this given its role as straddling the worlds of products in and out of development.

Once this Task Force is formed, I would suggest the following approach:

  1. Gather a list of those KOLs impacted by the reporting and prioritize if necessary based on KOLs with the biggest numbers
  2. Work with each function reporting to develop standard explanations for the payments made
  3. Develop general metrics such as average payments, ranges of payments, number of KOLs in each range, etc.
  4. Develop individual KOL reports that contain the same information shared with HHS
  5. Develop internal training with information about the Sunshine Act, the general metrics and how the company will explain it to others
  6. Develop materials for KOLs that explain the Sunshine Act, the obligation to report, the expected approach by HHS to share the information, an explanation of the company’s payment types, some bullet points on how the information can be conveyed by the KOLs to others, and the general metrics and a FAQ
  7. Assign KOLs impacted to specific MSLs with targets for discussions before September 2013
  8. Train MSLs
  9. Track the results

This should be a straight forward communication project, but it will be easy to put off as more urgent issues begin to crowd it out in 2013 so it will take consistent leadership to get it done.

What are your plans for supporting the rollout of HHS reporting of the Sunshine Act?  Leave your comments or questions (below) or email me directly (link on the right).

Topic7: Coordinating MA and Commercial

A reader asks:  “Given the importance of consistent communication to the healthcare community, my company is seeking to better coordinate commercial and MA messaging.  What is the best approach for doing this?”

Thanks for the question.   The answer is: Very Carefully!  My sense is that your commercial function is driving this requirement.  I infer this from your question because you use the term “messaging” which is generally a marketing term.  Let’s remember that the purpose of marketing is promotional – promoting the sale and safe use of our products.  Since it is promotional, their communications are limited to on-label information.  If their communications go beyond the label, they are promoting off-label.  We all know this is against the law.

MA is allowed to discuss off label topics only under very specific circumstances – when they receive an unsolicited request.  MA is allowed to have some proactive discussions which are educational and non-promotional about related non-label topics depending on the rules of each organization.  See a detailed discussion of this here.

So, marketing is promotional and MA is non-promotional.  What “messaging” can a promotional and non-promotional functions share?  Conservative organizations would argue that any messaging topics that support the promotional needs of commercial is, by definition, not an acceptable topic for non-promotional MA.  But, many organizations would agree that promotional topics can focus on the product and its competitive positioning; while there can be related non-promotional topics such as the underlying disease state.

Most organizations that allow some coordination between promotional and non-promotional topics understand that this is a risk.  To avoid the risk of MA appearing as a promotional entity, most companies expect the coordination will go one way only:  from MA to commercial.  The theory is that MA is going to be educating the market regardless and the commercial function is just becoming aware of what MA is doing.

Going the other way, from commercial to MA, runs the risk of appearing as though MA is part of the promotional machinery.

So, reader, be careful.  Processes and systems must be put in place to ensure that the coordination is going the right way only.  Otherwise, you run the risk of a future whistleblower pulling out a document showing that MA has become a promotional resource.

For example, there need to be clear firewalls between the way MA is measured and the way commercial is measured on the effectiveness of their communication efforts.  We have discussed MA measurements here.  Commercial measures of effectiveness should be much more related to sales and penetration.

Thanks for the question!

If you have a question, please email me or leave it in the comments!