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Accelerate Material Reviews With a Tiered Approach

Material Reviews Need Significant Process Upgrades

Promotional materials developed by pharmaceutical companies are an important source of product information for healthcare professionals (HCPs) and consumers. Pharma companies need to ensure that the information they provide is truthful, not misleading, has a fair balance of benefits versus risks, and complies with the regulatory guidelines. Failing to meet these criteria not only leads to regulatory implications, penalties, and product withdrawals, but also affects patient experience and creates a sense of distrust in HCPs and thereby damaging the company's reputation.

Although content and customer engagement channels have changed significantly in the last 2 decades, the content review and sign-off processes have remained largely unchanged. It is primarily focused on reviewers with similar effort and process steps for reviewing all kinds of content. Consider an analogy when everyone who is using the same airline was offered only a single flight check-in experience? It would not only lead to chaos and poor customer experience, but it would also take up significant airline resources, as the airline could ask passengers with just hand baggage to wait in a queue and get the boarding pass. A typical airline company, on the other hand, offers an expedited experience for passengers with relatively straightforward travel itineraries, while also providing additional support for passengers with more complex needs.

Despite the fact that single drawn-out processes cover all bases, the question remains as to whether it is necessary and can it sustainably scale up. Similarly, we believe that material review processes require a fresh way of thinking because of the following challenges:

Why medical, legal and regulatory process needs fresh thinking?

Limited Medical, Legal, & Regulatory Bandwidth

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Medical, Legal, and Regulatory bandwidth is finite while the quantity and complexity of content is increasing

Opportunity Cost

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Significant business opportunity cost for delayed time to market

These challenges are driven by a perfect storm of factors as follows:

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The post-pandemic way of engaging customers emphasizes digital content and channels, resulting in an increase in the volume of customized and personalized promotional pieces to be reviewed

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The accelerating numbers of product approvals (20 drugs in 2016 vs 53 in 2020) of which a significant percentage are specialty products that require impactful presentation of scientific data and the growing volume of launch materials

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The types of claims extend beyond just summarizing the product label, thereby necessitating extended reviews by internal and external process owners. Hence, different ways of visualizing data and content are required

Factors that demand a new approach to promotional material review

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Increased emphasis on digital content and channels

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Accelerating numbers of product approvals

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Different claim types and ways of visualizing data and content

As the volume of promotional materials continues to rise, pharma companies are struggling to balance the need to get these materials to the market faster, while maintaining efficiency and cost-effectiveness of review processes and ensuring compliance with regulatory requirements.

The tradeoff is that efficiency often takes a hit and, despite this massive expenditure, pharma companies are still receiving warning letters. For instance, in 2020, Office of Prescription Drug Promotion (OPDP) relied more heavily on warning letters and issued 25% more warning letters than in 2019. In addition, the average number of allegations per letter in 2020 increased by a staggering 30% when compared with 2019.

Figure 3: Review teams need to constantly manage & delicate balance of cost and time against compliance

Most pharma leaders have recognized that scaling up manual review capabilities by headcount addition or purely outsourcing staff is not sufficient for balancing these needs. Hence, they are making way for investments in AI/ML-based and technology-based solutions that can transform the review process into an automation-assisted and technology-enabled one. However, technology transformation combined with internal change management has a learning curve and might take substantial time before starting to show tangible benefits. Therefore, there is a need for a more near-term strategy to decongest bottlenecks of the manual review process through process optimization.

A tier-based review is one such process reengineering that enables pharma companies to navigate through most of the current challenges in the review processes. It also enables pharma companies to be future ready by adapting to the automation-based solutions as the best practices in a much more efficient way. The overall approach is based on the fundamental question: "Do all promotional materials created by pharma companies require the same degree of review?". The key aspect of this approach is - identifying ways to effectively segment assets that require more detailed reviews from those that do not, depending on the risk profile of the asset.

Do all promotional materials produced by pharma companies require the same rigor of review?

Promotional Material Review is a Challenging Process

The overall review process demands liaison with a variety of stakeholders such as Brand Managers, Project Managers, Annotators, Proofreaders, Medical Reviewers, Regulatory Reviewers, and Legal and Marketing experts working together to carry out a comprehensive review process. In the current world, most pharma companies follow a traditional approach to review promotional materials where review teams spend countless hours getting together on live meetings and review each asset with equal focus. Our findings also suggest that a majority of the promotional materials are subjected to live review instead of electronic review, and especially a full MLR review (source: TGaS Advisors Virtual How: Level of required MLR review [November 2019], data, n=11)

Majority of asset type below go through a full MLR review (includes all core reviewers-Medical, Legal, and Regulatory)

Figure 4: Live reviews are extensively preferred over electronic reviews despite being uneconomical

(Source: TGaS Advisors Virtual How: Level of required MLR review [November 2019], data, n=11)

Figure 5: Most material go through a full Material Review leading to host of challenges

Surveys and interviews with key medical affairs/commercial functions regarding the material review process also reveals that -

The findings of the survey involving key medical affairs personnel regarding reviews

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Most team members prefer a more strategic role that facilitates impactful stakeholder engagement through dissemination of credible scientific information.

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Considerable review time is spent in correcting routine errors in grammar, style, and referencing. In addition, dealing with a wide disparity of submission quality among multiple vendors is a challenge.

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The review process is not as efficient as it ought to be. Assets are often “gold plated,” even when it may be unnecessary.

A significant amount of time and energy are invested in live-MLR meetings with members from various functions reviewing the content that might not require a rigorous review. Moreover, there exists conflict between multiple groups owning to factors such as:

Typical issues with a live-MLR review process

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Variability in arrival times of marketing submission

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Capabilities of Marketing teams and Agency partners to understand clinical,

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Subjective preference within marketing

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Review team effort, turnaround time, and capabilities

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Unclear roles and responsibilities across members of review committee (RC)

In addition, each phase of the content cycle requires collaboration across multiple teams, whereas reviews done at multiple levels are leading to significant redundancies in the process and delays in releasing promotional material to the market. Our perspective is that a tier-based review can decrease overall review effort, and assets that pose a limited organizational risk can undergo an expedited process through reconfiguring of workflows and roles within the MLR process. The tier-based review will also improve the experience of reviewers by providing them more time to focus on strategic activities.

Furthermore, it would provide reviewers much-needed flexibility on when to review promotional material and allow them to balance review and customerengagement functions. For instance, creating a customer engagement plan is a more judicious use of a medical director’s time than fact-checking a data point paraphrased from a scientific article. Finally, it would also enable them to focus on material that requires more stringent review rather than reviewing every material coming their way.

A tier-based review would reduce countless hours that review teams spend in the live-MLR meetings by streamlining the overall process and engaging stakeholders only when there is a need for a function to review the promotional material.

Defining a Tier-Based Review

In a tier-based approach, each asset is analyzed across a multitude of parameters to define the subsequent workflow for review. The goal is to provide an optimal review experience to all the stakeholders while also ensuring better compliance by focusing more on higher-risk assets and optimizing efforts for lower-risk assets. Consider an analogy of a grocery store with multiple types of checkout counters depending upon the customer type (equivalent to the target audience), kind of goods purchased (equivalent to the type of claims used), payment methods (equivalent to dissemination channels), so on. The following figure describes how the overall customer experience can be improved while ensuring no lapses in the billing process.

Express Check-out

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Approved members

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Items auto-scanned at checkout

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Instant debit from wallet

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In promotional material equivalent, this is Tier 1: least risk due to the use of previously approved content and for use in internal communication

Instant Check-out

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Mix of auto-scanned and manually-scanned items

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Restricted to “n” items

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Instant debit from wallet/card

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In promotional material equivalent, this is Tier 2: medium risk due to promotional material intended for external audience

Normal Check-out

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Large number of manually-scanned items

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Multiple payment options

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May or may not be a member

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In promotional material equivalent, this is Tier 3: highest risk due to the use of new claims and unapproved content

Depending upon the tier of content review, the workflow differs by the number of steps and the number of reviewers required to sign off. For example, assets are classified based on the audience, usage of brand name, use of already-approved content or net-new content, type of product, and so on to identify low, medium, and high-risk assets. Here, the risk is being defined as the regulatory implications of leveraging poor promotional material or distrust created in minds of the target audience (HCPs, patients, etc.) or both. The following are some examples of risks frequently encountered by pharma companies through the promotional material :

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Promotion of a product for uses not consistent with the purposes approved by the regulatory agency. Labeling issues related to uses, dosing/administration, or even patient groups that are not approved by the regulatory agency

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Promotion leading to incorrect interpretation of risks and benefits by HCPs/patients to the extent that a drug is perceived to be more effective/safe than what is supported by its approved label

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With digital promotion increasing rapidly where not only a promotional material is shared but also certain information is collected about the user based on his/her interaction with the material, risk related to data privacy violation could be realized especially if mandatory consent for opt-in is missing

A Tier-Based Review is Especially Necessary Now

The tier-based approach helps to determine the depth of review required for each material along with the number of review cycles and live-MLR meetings required. This is especially relevant in today’s scenario, where there is limited ability to conduct live in-person reviews. In the case where reviews are carried out by live-remote MLR meetings, screen fatigue and employee’s quality of life are gaining more focus today. By simply ensuring the right amount of review for each asset type and keeping a track of risk due to an optimized review process, pharma companies are enabled to drive budget transparency and accountability across the organization and even beyond agency partners. This would also enable pharma companies to be better equipped to deal with the massive uptick in content that they are witnessing due to the significant adoption of digital channels.

A tier-based review differentiates among a variety of promotional materials and classifies these assets based on the level of review required.

Multiple Parameters Define a Tier-Based Review

The tier-based review strategy is based on classifying and segmenting promotional materials and directing them on a risk-appropriate workflow for efficient review. Typical factors considered for segmenting promotional materials and defining their risk profiles are shown in the figure below. For example, promotional material can be prepared for both internal and external stakeholders. Those developed for internal stakeholders, such as corporate communication or training materials, pose minimal risk and can therefore be classified as low-risk materials. These materials can be reviewed electronically by specific members of review teams and the complete life cycle of review may not be required. However, materials meant for external stakeholders, such as promotional material especially for patients, present higher risks of being perceived as misleading and, hence, may require extensive review depending upon factors such as how content is created, the method in which material is used (proactive vs reactive), nature of the material, so on. Similarly, the type of content used (new content vs reusing already approved content) along with the use of brand and product names can also be a criterion for scrutiny. Using some or all of these attributes, promotional materials can be divided into multiple categories or tiers.

Overall, segmenting content and materials based on their risk profile, assigning tier levels, and conducting related review procedures help companies to accelerate and simplify companies’ ability to bring in high-quality, accurate, and impactful information to its internal and external stakeholders.

Typical parameters of a tier-based review

Risk “With” Tier

Audience

Patient = Higher Risk I HCPs = Lower Risk

Use of brand and product names

Branded = Higher Risk I Unbranded = Lower Risk

Content

New Content = Higher Risk I Repurpose Content = Lower Risk

New claims usage

New Claims = Higher Risk I Approved Claims = Lower Risk

Proactive/ reactive use

Proactive = Higher Risk I Reactive = Lower Risk

Intended role of asset

Promotion = Higher Risk I Education = Lower Risk

Presence of IP/trademark and copyright

Product-specific IP = Higher Risk I Product-Nonspecific IP = Lower Risk

A sample framework for a tier-based classification based on the aforementioned parameters is depicted in the figure below

Figure 9: The sample framework for a tier-based review parameters

Here is an example of applying this framework to a specific asset to get a picture of where it fits from a risk-tier perspective. We could apply additional business rules on top of this, for example, as soon as an asset requires opt-in, compliance review is mandatory. Since most of the shaded area below falls into Tier 2 zone, corresponding business rules would apply on who should be reviewing this asset.

Figure 10: Sample visualization of an asset for understanding the tier profile based on parameters

In our experience, some of the business rules applied above could also be automated to get an initial risk profile of the asset, which can then be reviewed for correct tiering. For example, various claims used in promotional material could be scanned through an AI/ML engine and could be parsed against the claims library to validate if they are existing, approved claims with or without verbiage change or completely new claims. Such automation not only enables an initial tiering classification, but can also help reviewers during the actual asset review.

Although the framework above provides broad guidance defining materials as high or low risk based on ranking and weightage, risk should also be taken into account of industry enforcement activities and potential consequences of code infractions in specific markets.

For instance, a recent review of the OPDP enforcement activity over the last 10 years has demonstrated that there has been an increasing focus on patient-directed digital materials rather than traditional HCPdirected materials. The areas of the issue have been around the false or misleading representation of risks and benefits, omission of material facts, and lack of adequate instructions for use. The highest number of citations has been made for the internet-based materials that are primarily patient directed. Regular analysis of culprit areas over time may provide organizations with additional ways to modify risk.

Ways to Implement a Tier-Based Review

Implementing a tier-based review approach could mean a significant amount of change not only in terms of processes, but also in terms of people (and their roles) and support systems that are needed to manage the asset across the review life cycle. What is more important to understand for a lot of companies is that, review teams are formed from a centralized pool (who are mandated with other responsibilities) to bring in diverse capabilities across medical/legal/regulatory aspects for reviewing assets. Since this might not be their core job, any proposed change might require to showcase significant benefit over the status-quo for it to be widely adopted and successful.

Most companies that are trying to do something on these lines have witnessed maximum success when they have gone ahead with one of the following approaches:

1. Big Bang Approach:

In this approach, the most innovative and novel brands, particularly those in large markets were the first to adopt tier-based review followed by established brands. This approach has enabled success for the clients because of the 2 reasons-firstly, it has been able to generate significant delight for the marketing group that relies on the review process, and secondly, it has been able to show significant impact in the short run due to the large size of markets and volumes for which the approach is precisely suggested.

2. Big Market First:

In this approach, all brands (irrespective of the life cycle phase) within 1 or 2 large markets will perform the tier-based review, followed by a market-by-market rollout. Again, this approach seemed to work for 2 key reasons-firstly, it was able to provide the volumes and variety needed to establish and fine-tune the tiering mechanism, and secondly, it gave companies the flexibility to consciously avoid markets where change management was just not worth it.

We also observed that companies going with traditional approaches of small pilots followed by scale took a significant amount of time to adapt to the approach because the benefits were simply not visible on a small pilot scale. Irrespective of the nature of implementation chosen by companies, there were a few changes that were witnessed at varying levels by various internal and external stakeholders who were part of the review process.

Change Management Efforts to Effectively Implement a Tier-Based Review

Regardless of how the tier-based review is implemented, a significant change management effort is required to ensure the desired benefits. However, if implemented correctly, it can be a source of differentiation, and pharma companies can gain a competitive advantage in terms of getting the right information across the right channel in an accelerated manner. It is also worth noting that the change management here goes beyond the traditional realms of continuous communication, implementation of software programs, so on. It necessitates a change in reviewers’ way of working and would need significant training, motivation, and nurturing. Although the changes seen would vary from organization to organization, a brief summary of some must-haves are described below.

Organizational Shifts While Moving to a Tier-Based Review Approach

In many organizations, we find that a marketing operations function owns the process and is responsible for determining whether a submission is complete. In addition, a wide variety of stakeholders are able to submit assets through the MLR process, including brand teams, agencies of record, offshore/low-cost agencies, internal agencies, sales training, and market research. While moving to a tier-based review approach, we believe that the following 3 major organizational shifts must be borne in mind: -

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Focus on Agency Performance Quality In = Quality Out

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Increasing migration from live reviews to offline reviews – reliance on systems and processes

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A shift of sign-off accountability to asset owners-typically brand team members

When review team members (medical, legal, regulatory, and clinical) tend to be company employees, editorial and proofreading functions are outsourced in approximately 70% of the organizations that we work with. The tier-based reviews offer the opportunity to reimagine editorial and coordination functions with the review process.

In order to facilitate the shift in ways of working listed above, we believe that editorial and material coordination functions must become more business-facing as a partner in the process rather than a downstream eventuality.

For instance, current coordination activities of moving jobs through the system can be complemented by a service desk function for marketing teams who are now expected to sign off on low-tier assets. This is a function that is not customary, and for which many marketers are not accustomed to using on a day-to-day basis. In addition, during one of our major engagements, we have objectively found that a major source of rework and additional review cycles within the MLR process is the quality and completeness of review packages at the agency level. For that organization, we recommended the reconfiguration of the coordination role to include agency oversight. The on-ground staff who are directly interacting with assets are best positioned to identify quality culprits and enable quality measures. Marketing teams have limited bandwidth to continually onboard agency teams that are constantly turning over.

While every organization is different in staffing and configuration, we believe the following areas are imperative in facilitating the shifts in ways of working.

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Elevation of current roles to brand or portfolio-centric business-facing roles. This ensures alignment of volume forecasting and business requirements on a rolling basis.

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Creation of fungible coordination and editorial pools that can work across brands and business units to keep the process moving.

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Agency management function is to ensure ongoing QA of submission quality, particularly when final sign-offs will be increasingly borne by asset Creation of fungible coordination owners through agency scorecard.

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Creation of a robust data and analytics owner to continually monitor through performance and quality. Quality includes accuracy of tier determination as well as day-to-day metrics such as accuracy and completeness of review packages.

Change Management for External Teams

Most external teams, especially the Agency of Record, have increased in terms of accountability of content shared for review. External teams would also have to invest in training themselves to learn the new processes and ensure that the team members understand the company-specific tiering structure to avoid the risk of rejection. Other trends/changes in terms of the role played for review depend on the extent of overall process outsourcing. Agencies would also have to understand and have to be trained on the new metrics of quality on which they would be measured against, which would ultimately improve the overall content supply.

Managing Change While Adopting to a Tier-Based Review

Initiatives such as tier-based reviews require a comprehensive change management plan. Creating awareness for change would require the internal and external stakeholders to understand the differences in ways of working as compared to the traditional environment, and they must be equipped with the right tools and training for understanding the new process and accompanying systems. It is also important to understand that creating awareness should not be a one-sided monologue, but a strategic partnership between change agents and the stakeholders to understand diverse perspectives on hindrance to adoption and actively hear suggestions for improving the overall process in subsequent releases.

Periodic surveys including guided and open-ended questions about-(a) systems, roles, and processes, (b) concerns, (c) self-assessment on readiness for change adoption, (d) additional training, and (e) feedback on the overall training and change process can help companies to improve the adoption rate by fineturning their change management approach. From our experience working with companies, we suggest the following as the main findings in driving change management while implementing the tier-based reviews:

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Organization and change agents must own up the critical paths of transition and make it easy for people to adapt to new ways of working

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Drive faster adoption for a large market and realize full value faster

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Technology enhancements need to be aligned to ensure smoother deployment and rollout. For example, the Digital Asset Management System (DAMS) requires provision for alteration or creation of new workflows that enables categorizing the asset by tiers

While communication is the most important component for driving change, practical gaps were seen even in companies adopting all kinds of communication.

In one of our implementations of a tier-based review, where a company was working with a large number of agency partners, we found that despite penalizing agencies for poor tagging of content for tiering, they were just not able to maintain the required inputs for tiering. Further analysis found that the agency partners who were using the downstream resources kept changing continuously and hence required constant training. We partnered with this pharmaceutical company to create training videos and other short-training materials highlighting the tiering mechanism, how the agency played the critical role, and guided on how to fill up response questionnaires for accurate tiering, and so on. This was then taken up by the agency and they were able to provide much better inputs for accurate tiering of assets.

Case in Point: A Top Pharma Company Reduces End-to-End Review Cycle Time by 50%

In one of the tier-based review implementations, it was found that at a steady state, the average turnaround time for a material was reduced by ~50% from 20-45 days to 10-25 days. The traditional process for review, being not tier-based was not only cumbersome, but also led to a poor experience for reviewers who were spending a significant amount of time reviewing promotional material in the liveMLR meetings. These delays impacted product launches and called for a complete revamp of the review process. Investments were made in identifying bottlenecks of the review process, defining new review process, and upgrading technology such as content management systems (integrating asset storage with asset tier-score), mechanisms to track, monitor, and report material review time, and other key performance indexes were defined in a seamless manner.

In addition, specialized roles such as marketing operations-project managers were onboarded and change management was driven by brand teams in collaboration with Medical Affairs leadership.

A significant amount of review and collaboration time was saved as assets were not sent for review to a team (eg, medical team) as there were no new claims and only preapproved claims were used.

Outcomes

All the key metrics were tracked for each job, and despite an overhead in terms of tracking and reporting, outcomes were quite significant. A summary of key outcomes before and after implementation are described in the following table.

Conclusion

Increasing gravitation toward a multichannel and omnichannel customer experience, and a corresponding increase in demand for promotional content will render reviewer-centric approaches obsolete for the type of demand expected (more launches, on-demand content requirements, and complex products). To ensure content reaches the market faster while ensuring compliance with internal and external standards, risk will need to be viewed dynamically at an asset level while keeping in mind the holistic definition of risk. We have already seen examples of similar adoption in pharma companies in terms of Tier-based monitoring in clinical trial site management.

Despite the fact this is an evolving area, this paper covers some pragmatic ideas that have been implemented in some pharmaceutical organizations with good leading indicators. When a lift and shift approach is not working, adoption of a tier-based review approach will require customization based on

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Current review process and overall content maturity

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Necessary change management efforts

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Enabling process and technology

However, a strong and emerging focus in this direction, and a few experiments, can translate into potential benefits and significant process improvements. In our view, tiered review methodologies are a prerequisite in the current maturity model for eventually automating processes in material review supply. Ultimately, innovation in this area will change the narrative of the MLR process from a roadblock to a strategic partner for getting pharmaceutical products to the market faster.