Thoughts on Global Medical Affairs
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:
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:
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:
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.
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:
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:
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:
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:
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:
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:
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:
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.
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.
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.
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:
PRO’s of Using NPS in MA:
CONs of Using NPS in MA:
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.
A number of my friends in MA leadership have been debating the implications of the Amarin case for MA overall. Spoiler alert – I think it will prove to be another avenue for MA to add value and I will share my rationale below.
In case you have not been reading up on this case, you can see my brief discussion and some links to other sources of information on this blog post. When discussing the Amarin case it is critical to understand the context – this case was decided by a federal district judge in Manhattan for the Southern District of New York – so obviously this ruling does not set national standards. However, the Southern District court is one of the most influential and active courts in the US and it has a history of leading the nation.
Assuming that this ruling becomes the precedent for either other cases in other districts or even national cases, the question is if/when pharmaceutical companies have the flexibility to promote off-label data (with all the fair/balanced caveats) – what are the implications for MA?
So let’s go on a trip to a speculative future in which the ability to share off-label data with HCPs on proactive basis becomes accepted in the US. In this future, I would fully expect that the FDA decides to put guardrails around this freedom. Their rationale will be simple – there is high risk to patients if HCPs make decisions based on off-label information which have not run the full risk/benefit analysis of a product with an approved NDA. What would these regulations look like? We can get a good view from FDA’s response to Amarin (which we covered in detail here) the summary of which is that this education would need to be fair and balanced and, among many other things:
That would clearly call for a role similar to the MSL or field force role of today’s MA. But would that role need to be in MA, or more provocatively, would MA need to be a separate entity from commercial.
Those you that have been around the industry long enough remember when MA was sometimes a function of commercial, often called Scientific Sales. Driven by increasing FDA and EMA scrutiny primarily concerning off-label promotion and a desire to be seen as a voice of science instead of promotion, MA as an independent, non-promoting entity became the standard.
In our speculative future the US has loosened the off-label promotion rules, but the EMA has not and the need for an independent voice for science has not decreased so I do not foresee an effort to move MA back under commercial. Frankly that ship has already sailed since so many other functions that MA serves also benefit from it being independent from commercial.
So if MA is likely to remain independent would the MSL role remain in MA? I think that they would, not only due to inertia (although you can never over-estimate the power of inertia in pharma) but also because keeping the MSL role in MA would improve the case that the information presented was fair/balanced and not tainted by promotional messages.
Following my logic stream, MSLs would gain a new capability (ability to pro-actively share off-label data) while remaining in an MA function independent from commercial – so a net improvement to the value that MSLs and MA overall brings to the company. That can only be a good thing for MA leaders.
That was quite a bit of speculation – what is your opinion? Please click here to leave a comment.
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:
They go on to add that to protect against being misleading the company should:
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.
Have you seen the new FDA guidance about disclosing risk in consumer-directed print advertising that came out in February? (You can see it here) Unless you are a gluten for FDA guidance-reading punishment, my guess is that you skipped this one since it seems to be commercially focused.
BUT, there is actually something that MA should be aware of and perhaps an opportunity to add some value to our commercial brethren. The focus of the guidance is straight forward – under current law print advertising has to also disclose risks, and the safest approach for disclosing that risk is to publish the full package insert (PI) along with the print ad. As we know PIs are a tough read normally, but when shrunk down to fit in a magazine they are almost unreadable and certainly mostly incomprehensible to the very audience they are supposed to be protecting – consumers.
This has not been lost on the FDA and the guidance linked to above was entirely focused on resolving this issue.
In an FDA survey, few respondents reported reading half or more of the brief summary presented in the traditional format. Of those who read at least some of the brief summary, 55 percent described it as hard to read. Over 40 percent of respondents in the survey reported they do not usually read any of the brief summary in direct-to-consumer prescription drug print advertisements.
The FDA realizes that the full PI is aimed at medical professionals and full of details that the vast majority of consumers don’t care about like clinical pharmacology or chemistry. So the FDA is suggesting that manufactures should have the flexibility to replace the PI with something they are now calling “consumer brief summary.”
What is a consumer brief summary? Per the guidance it is an explanation written in consumer-friendly language (ie. drowsiness not somnolence) that includes:
And this is where Medical Affairs comes into play. Now our commercial colleagues and their agencies are going to be needing to develop information that includes medical judgement, like:
These questions are great ones for Medical Affairs to either provide guidance, answer directly or gather information from practitioners during their interactions to answer these questions and others. Given the proper but strong firewalls between MA and commercial, this new guidance provides a value-added opportunity for MA to provide some guidance to commercial.
MA leaders may wish to discuss this topic with their commercial colleagues.
Do you have any thoughts on the new guidance? Leave them in the comments by clicking HERE and scrolling down to the comment box.
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.
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:
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:
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:
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.
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.
“The era of Big Data is here!” That may be true but what does that mean for Medical Affairs? As in all of biopharma, MA is comfortable working with data. So much of our work revolves around discussing data and the implications of data that many people may think that we were already living in the era of Big Data.
But for most MA organizations, the data sets we have focused on are purpose generated – either our own data or data from similarly-scaled studies conducted by others. Big Data refers to something different. I like the differentiation that SAS uses when comparing Big Data to the past data sets. They break it down to four “V”s and a C:
This is not your grandfather’s data sets. What are some examples of Big Data as relevant to biopharma and MA:
Contained within these and many Big Data sources are key tools for MA:
But, none of these benefits can be achieved unless the question is asked and the data is analyzed. I would suggest that effective MA organizations of the future will need to have the capacity to ask and answer these types of questions.
In order to do so, MA organizations will either need to build or have access to increased levels of biostatistical and epidemiological resources. And these resources need to have skills directly related to Big Data. The characteristics that differentiate Big Data from existing data sets also means that many existing biostats and epi staff do not have the expertise or confidence working with these large, external data sets. MA organizations need to ensure that people with exactly these skills sets are available within their organizations or from outside vendors and that these resources have the capacity to support MA.
Then, MA needs to improve its overall level of confidence defining Big Data questions, conducting Big Data analysis, and discussing the results with others. Given the difference in the source of this type of data, the way this data is presented and discussed must be different too. Everyone in MA, but especially the MSLs, must become more comfortable understanding the nuance of this type of data analysis and discussing both the strengths and weaknesses of working with Big Data.
The era of Big Data is here. MA has a long history of effectively using data and explaining data in support of its organization. MA leaders must investigate and embrace Big Data to take advantage of all the tools available today. The questions unasked are always the questions unanswered.
What is your experience with Big Data? Please leave a comment.
As most of you know, the Caronia Ruling by the Second Circuit Court of Appeals found that a pharma rep was within his 1st Amendment rights to discuss off label use of his company’s drugs, assuming that those discussions were truthful. This went off like a rifle shot within the pharma world with all sorts of discussions, you can read some of them here, here and here.
It is very likely that this ruling will be appealed to the full Second Circuit, and/or directly to the Supreme Court. But there are reasons to believe that the Supremes may be open this interpretation given their past rulings on similar subjects. Regardless, until this is settled it only applies to the Second Circuit so unless you are a pharma company only doing business in the Second Circuit in and around New York, you can’t make much change.
BUT, what if this becomes the new law of the land? What does it mean for Medical Affairs? That’s what I want to explore in this blog post.
The most obvious impact it has is on all the current focus we place on “proactivity”. I have discussed this topic in detail here, here, and here. I bemoaned the unclear state of the current regs here. Now we are imagining a world where the issue of proactivity has to be seen in a completely different light. MA avoided proactively discussing off-label data on our products because proactivity implied promotion and it is (or in our scenario was) illegal to promote off label. Under this scenario that thinking would be wrong. Replaced, potentially, with a focus on “truthfulness”.
Now, for MA at least, this is an expectation we are more than willing to meet. In the past MA has typically thought of any peer reviewed study as truthful but some of the commentators are suggesting that the definition might become the same one that they use for the FTC. The FTC definition id focused on “…competent, reliable scientific evidence supporting the claims you are making…” so it may not require a peer reviewed journal publication. The one caveat, however, is that if you conduct a test and find that the content being shared is misleading to 20% or more of the targeted consumers, than it is not considered truthful. In general, then, although peer reviewed journals would not be a requirement, it would represent a fairly safe harbor to avoid the risk of sounding misleading.
So, in the future world we are imagining, our field force of MSLs would be free to go out to HCPs armed with peer reviewed journal articles, and introduce the HCP to that article and then proceed to have a scientific exchange about the results, assuming they stick to findings documented in that or other peer reviewed articles.
Scientifically speaking, this frees MSLs to have very wide ranging discussions with HCPs at their initiation and allows for much greater control over the type of discussions that we have with the HCPs. It will allow MSLs to show much greater value to the organization by allowing the targeting of discussions that are the most meaningful to our products. And if you think is hard to hire MSLs today, watch out. With that increase in value will come greater investment in both MSLs and in Investigator Initiated Studies and P4 studies that will now be seen as more valuable as well.
What do you think? Do you think it we will see the end of proactivity restrictions in the next three years? Leave your comments above.
I was talking with a friend the other day who is charged with running the medical information (MI) function for their small pharma company. Currently they outsource the MI function and she was wondering if it made sense to bring the function in-house of keep the current arrangement. We discussed how effectively the outsourced MI function works with the current MA group, including the MSL field force, and the answer is that they have some formal links but rarely talk. We talked some more and reached some conclusions, but I thought this might be a good topic for a post.
MI is both a regulatory mandated function, and a critical component in achieving MA’s educational and public outreach goals. It is possible to structure and run the MI function merely to meet the regulatory requirements but that would represent a significant waste of an opportunity.
From a regulatory perspective, the MI function needs to be structured to answer calls from both patients and healthcare professionals (HCPs), differentiate between inquires and pharmacovigilance calls and route the calls appropriately, answer questions directly when appropriate, distribute accurate and approved materials to appropriate audiences, and develop outgoing medical communications on important issues (Dear Doctor letters). It needs to be staffed by people with appropriate qualifications to answer medical and technical questions about the use of company’s products.
But, some organizations gain much more benefit from their investment in MI. For one thing, MI is often the first sign that a problem is occurring relating to our products or issues are being raised concerning the scientific underpinnings of our products. Spikes in the type and content of questions help provide a Zeitgeist view of the needs for education in the HCP community. But, this only works if MA listens. There must be processes and systems in place to ensure that MI is coding their contacts in a manner that allows for analysis and reporting in place to ensure that the information is summarized on a timely basis. Finally, clear responsibilities need to be established for who will review and respond to this information.
Other organizations utilize the MI resources to more effectively partner with the MSL field force. MI and MSL groups tend to talk with related but mutually exclusive audiences. Given the limitations on MSL time, they need to focus that time on those HCPs that can offer the greatest impact on the medical community, the so-called Key Opinion Leaders (KOLs). Based on research I have seen in the past, it is very rare for a KOL to call MI. They tend to expect the answers to come to them through MSLs or research on the internet. Non-KOL HCPs tend to call MI. Given that, the opportunities for MSLs and MI to interact is not in terms of serving the same HCPs but instead in terms of “having each other’s backs.” Often when MSLs are interacting with HCPs, they need to provide those HCPs with additional information and support. MI is well suited to provide that information and support. And, when MI is answering questions for HCPs they encounter situations that require more in-depth support, and MSLs are well positioned to provide it.
Establishing a strong partnership between MI and MSL groups brings value to both sides, yet it is not as common as you might expect. Sometimes it’s due to organization structure – the two groups have unrelated reporting relationships and thus lack incentive to interact. Other times it’s due to a difference in philosophy, where one of the two groups does not see value in interacting with the other. Regardless, there is value in establishing this relationship, but it needs to be clearly structured and actively managed to avoid either group “dumping” on the other.
This leads back to the discussion of outsourcing MI. To really gain value from MI, it needs to tie in easily with the rest of the MA organization. It may be possible to pull that off with an outsourcer, but its unlikely. For that reason, I suggest that insourcing MI brings more value to the organization.
My final thought on MI relates to technology. A call does not have to be a phone call. Web chats are significantly more efficient to manage and allow for careful scripting of responses. Providing this service on an after-hours basis may allow more of those KOLs discussed earlier to actually connect. And, I have yet to see a company develop an MI app, but I think we can’t be too far from having one – just tap the icon and link directly to an MI chat or other dialog.
What has been your experience with MI and how it relates to other function in MA? Please leave your comments below. And if this is your first time on the blog, please sign up on the right to receive email updates of the latest posts – don’t worry its spam free.
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.