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 36 - Off-Label Promotion Prosecution is Changing – and Medical Affairs Should Benefit

Normal disclaimer: I am not a lawyer just a lay observer.

I was at the 3^rd Annual World Congress Summit on the Evolving Role of Medical Affairs.  As in the last two years, one of the highlights is the presentation by a representative of the OIG and US States Attorney on Off-Label Promotion.

Usually this is an opportunity for them to remind us that pharma is not allowed to promote off label, trot out examples of people who were prosecuted for off-label promotions (which are almost exclusively Sales and Marketing examples, not MA examples) and then encourage us to snitch on our organizations if we think we see this behavior.

 

But this year was different.  This year we were all introduced to an important new term – Off-label Plus.  What does Off-label Plus mean?  It’s how they refer to cases that they are willing to prosecute.  In light of the Caronia ruling (an overview of which you can find here, with subsequent commentary here and here), they are no longer willing to base cases on simply promoting off label (assuming the test laid out in Caronia that the off-label information presented is from a credible, unbiased source, like a “real” journal, and the presentation is not misleading).  Instead, they are only willing to go after cases where there is Off-Label Plus something else, like Kickbacks or Fraud of some type. 

In my opinion this is huge for medical affairs – most medical affairs organizations are unwilling to proactively share even an article published in the NEJM if it is off-label out of fear of being accused of promoting off-label.  Instead we wait to be asked, since responding to a question is not promotion.  I think the fear of promotion is now unjustified.

The simple reality is that even before Caronia no medical affairs employee has ever been prosecuted for simply providing accurate, non-misleading off-label information.  Caronia  was a sales guy, not medical affairs. The only example that the prosecutor could cite of an MA employee being prosecuted was a device company where the medical affairs lead used speaking fees as a kick backs.   Now that Caronia is out there, I think the risk is even lower. 

Just like our treatments, all of medical affairs is a risk / benefit.  If we wanted zero risk, we would not have medical affairs or sales or marketing for that matter.  Instead we reduce our risks through the use of strong processes and a compliance function to ensure those processes remain in place.  It is my assertion that providing credible, non-misleading peer-reviewed published off-label data pro-actively is no longer a major risk, assuming there are procedures in place to avoid all the other “Plus” activities. 

I don’t expect this to change overnight, but some organizations are going to start operating this way and when the sky does not fall, all medical affairs organizations will be operating this way – my guess is within 5 years.  And this is all for the best – its good for HCPs because they will have the latest information, its good for patients because their HCPs will be well informed and its good for medical affairs because it allows us to do our jobs even better than today.

What do you think?  Leave a comment by clicking here.

Topic 33: Significant Risk of Naming / Shaming in Clinical Trial Results Reporting

The Challenge

We have talked a lot about big data on this blog, and that’s because it’s a game changer.  

As evidence, did you see this article in the NEJM?  It’s a research analysis in which they pulled the entire ClinicalTrials.gov database and analyzed it to determine who has been publishing summarized clinical trials results as required by FDAAA from 2007.   This analysis was done by cardiologists at Duke, and what got the headlines was that only 38% of completed studies had their data posted as required by the law.

However, dig a little deeper and with more of our focus and you can learn some interesting things about the biopharma industry.  Of all the 13,300 (all numbers rough for discussion purposes) completed clinical trials analyzed, 66% were industry sponsored or roughly 8700 trials.  Only 5100 of the 13,300 completed clinical trials reported any results, and of 3600 of those 5100 reporting trials, or 71%, were industry trials.  So, in a world of terrible compliance, industry was punching above its weight.  That still leaves some 5100 industry trials with not results posted despite the law.

BUT, you say, isn’t there some exception for holding back results until after FDA approval/rejection.  Yes, a company can file a certificate which allows it to delay posting results in that circumstances.  Of the 5100 completed industry trials missing data only 2000  certificates were filed – leaving 3100 or 36% of all industry trials unreported or uncertified per the law.

This is where big data and company reputation risk raises its ugly head.  There are big data sources already out there that read all the data from ClinicalTrials.gov.  With today’s big data tools it is a straight forward exercise to determine which industry company sponsored which trial and whether it reported/certified per the law.  They will also know which products have failed to report/certify if the products are approved. It is not long from now that some reporter will put this together and produce a list of the “best and worst biopharma companies for publishing results” – some uncharitable media outlets (and which ones are charitable to biopharma) may even imply sinister intent at “denying their legal obligation to share this data – what are they hiding.” 

Implications for Medical Affairs and Clinical Development

There is a unique opportunity to head this potential distraction off at the pass.  We don’t want our MA field team’s spending time justifying why the company is not posting data. 

While maintaining ClinicalTrials.gov is generally the responsibility of the CD in most organizations, MA has a strong vested interest to ensuring that the company is bullet proof in this area. MA and CD need to collaborate to make sure that data is posted or the certificates are filed.  A process audit to confirm that the processes are in place and are working, as well as verifying that the company does not have any missing posting or filings, is a small bit of work that can save a huge amount of distraction for the entire organization in the future.

What has been your experience in this area? To leave a comment click HERE and scroll to the bottom.

Topic 31: Changing Relationship between Medical Affairs and Access and 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.