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 40: BREAKING: Court Rules FDA Cannot Prevent Truthful Off-label Promotion

In a court case that may have huge implications for pharma, a federal district judge in Manhattan ruled that the FDA cannot prevent a company from conducting off-label promotion if the promotion is truthful and scientifically accurate.

This ruling stems from the Amarin case that we discussed HERE.  In that case, Amarin argued that the precedent set by the Caronia case (which we discussed HERE) allowed them to promote off-label if the information shared was truthful and not misleading.  The FDA argued that the Caronia ruling was specific to those circumstances only and did not apply to Amarin.  Judge Engelmayer wrote in today’s ruling that “…A fair reading of that decision refutes the F.D.A.’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.”

While this only currently applies to the circuit in question, it is a clear precedent that will need to be addressed if the FDA intends to retain its current regulatory approach to off-label promotion.  The FDA has not stated whether it intends to appeal but it did not appeal the Caronia ruling, a decision some pundits felt was made to avoid having a broader precedent set for allowing truthful off-label promotion.

This is an ongoing story but it could have some major implications for pharma and medical affairs.  Stay tuned to this space for more developments as they occur.

You can read an article about the verdict HERE.

Any comments or thoughts on today’s news?  Click here to share them.

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 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.