An IQIVIA event titled, “RWE in 2024: Recognizing opportunity and demonstrating value with confidence,” held on October 25-26, 2023, made several interesting observations such as:

• The future of healthcare is being reshaped and RWE is playing an increasing role in revolutionizing patient care, drug development, and healthcare policy.
• Generative AI and new technologies create new opportunities and ways of working, increasing acceptance of RWE by regulators and payers, and ever-evolving and diverse patient needs.

In recent days, post-launch of a new product, several drug companies, although more globally and some locally, are using Real-World Evidence (RWE) to showcase how their product is providing value - not just clinically and economically, but also from a humanitarian perspective, in a real-life situation. Besides, RWE is also increasingly being used to improve product detailing outcomes, taking a quantum leap in enhancing brand awareness among prescribers.

Thus, while exploring the emerging space of RWE, I shall focus in this article on the increasing importance of leveraging this area for greater effectiveness of pharmaceutical marketing strategies, especially in India. To be on the same page with my readers, let me start with a quick recap of what I really mean, as I use this terminology.

RWE – A quick recap:

As I talk about “using Real-World Evidence (RWE) in pharmaceutical marketing,” I mean ‘leveraging Real-World Data (RWD)’ to gain insights that inform and shape marketing strategies for pharmaceutical products. Obviously, this could raise a pertinent question – why RWE is gaining ground in drug marketing now.

Why is RWE gaining ground in recent pharmaceutical marketing globally?

The growing popularity of RWE in recent drug marketing, globally, can be attributed to several key factors, as flagged in various studies. Some of these include:

1.  Addressing limitations of clinical trials: While clinical trials provide valuable insights, they often have limitations. RWE complements clinical trials by offering insights into how drugs perform in the real world, addressing these limitations.

2.  Evolving regulatory landscape: Top regulatory agencies of the world like the US FDA and EMA are now recognizing the value of RWE. This incentivizes drug companies to embrace RWE for marketing purposes.

3.  Advancements in data analytics: Sophisticated data analytics techniques and tools are enabling researchers to extract meaningful insights from complex RWE datasets. This allows for more robust and reliable evidence generation, enabling marketers to create more effective sales and marketing strategies. In one of my articles -‘Data-giri’: Critical For A Rewarding New Product Launch, written on December 24, 2018, I deliberated on this area. 

4.   Precision medicine: The rise of precision medicine necessitates understanding how drugs work in specific patient subgroups. RWE can identify these subgroups and their responses to treatment, facilitating targeted marketing campaigns.

5. Transparency and Patient-Centricity: Patients and healthcare professionals increasingly demand transparency and real-world evidence to support treatment decisions. RWE demonstrates a commitment to transparency and provides evidence grounded in real-world settings, fostering trust and confidence. 

As data analytics capabilities continue to advance and regulations evolve, we can expect RWE to play a more prominent role in shaping future pharmaceutical marketing strategies. 

Real-Life Advantages of using Real-World Evidence (RWE) in Indian pharmaceutical marketing:

A.   Increased relevance and credibility, including more accurate measuring of cost-effectiveness.

B.   Improved decision-making, enabling more targeted marketing campaigns and improved resource allocation.

C.   Added regulatory benefits, as it can provide additional evidence to support claims of effectiveness and safety, potentially influencing regulatory decisions and gaining new indications for existing drugs.

D.   Help become more patient-centric, as utilization of RWE findings enhance quality of communication with patients and healthcare professionals – fostering trust and transparency. RWE can also help identify areas where current treatments are inadequate, prompting research and development efforts towards better solutions.

Challenges to consider:

• Data quality and access: Ensuring data quality and ethical access to patient data remains a challenge in India.
• Data analysis expertise: Utilizing complex RWE data effectively requires skilled data analysts and statisticians.
• Regulatory framework: The regulatory framework in India for RWE is still evolving, requiring careful navigation.

Despite these challenges, the potential benefits of RWE for Indian pharmaceutical marketing appear to be significant. By overcoming these hurdles and embracing RWE with collective advocacy, when required – pharmaceutical companies can gain valuable insights, improve decision-making, and ultimately serve patients better.

Some recent international examples of RWE in pharmaceutical marketing:

Here are some recent international examples of how pharmaceutical companies are using real-world evidence (RWE) in their marketing strategies:

1. Novartis:

• Campaign: Leveraged RWE from a large observational study to demonstrate the effectiveness of their drug Entresto in reducing heart failure hospitalizations in real-world patients compared to other standard treatments. This evidence supported claims beyond the initial clinical trials and resonated with healthcare professionals.
• Results: The campaign helped increase market share for Entresto and positioned it as a more effective option for managing heart failure.

2. AstraZeneca:

• Campaign: Utilized RWE from claims data to identify specific patient sub-populations most likely to benefit from their oncology drug Tagrisso. They then targeted these segments with personalized marketing messages highlighting the drug’s effectiveness in their specific situation.
• Results: This data-driven approach led to a significant increase in prescriptions for Tagrisso among the targeted patient groups.

3. Sanofi:

• Campaign: Analyzed RWD from multiple sources to understand the real-world disease burden and treatment patterns for diabetes in different regions. This information informed their marketing strategy by tailoring messaging and product offerings to specific regional needs and patient populations.
• Results: This data-driven approach enabled Sanofi to develop more relevant and targeted marketing campaigns, potentially increasing market share in key regions.

4. Roche:

• Campaign: Used RWE from registries and claims data to track the long-term safety and effectiveness of their cancer drug, Avastin, in real-world patients. This ongoing monitoring allowed them to proactively address potential safety concerns and update their marketing messages accordingly.
• Results: By demonstrating transparency and commitment to patient safety, Roche maintained trust and confidence in Avastin, even after initial safety concerns emerged in clinical trials.

The above examples possibly showcase how RWE can be used for various marketing objectives, including:

• Demonstrating real-world effectiveness beyond clinical trials
• Targeting specific patient segments for personalized marketing
• Building trust and confidence through safety monitoring
• Tailoring marketing strategies to regional needs

Nevertheless, it’s important to note that these are just a few examples, and the specific ways RWE is used in marketing will vary depending on the company, drug, and market conditions. Be that as it may, these examples illustrate the growing trend and potential of RWE as a valuable tool for pharmaceutical marketing strategies.

Some Indian examples of RWE in pharmaceutical marketing:

While specific examples from current marketing campaigns might be limited, the Indian pharmaceutical industry, as I fathom, is actively exploring the potential of RWE, and we can expect its impact on marketing strategies to grow in the future.

That said, from publicly available data, I can offer some general examples that demonstrate the growing interest and potential applications of RWE in the Indian drug industry:

1. Sun Pharma:

• Partnered with IQVIA to leverage real-world data for clinical research and potentially future marketing insights.
• Developed a real-world data platform aimed at understanding treatment patterns and patient outcomes, which could inform future marketing strategies.

2. Cipla:

• Collaborated with Pharm Easy to analyze anonymized prescription data, potentially generating insights for targeted marketing campaigns.
• Invested in building data analytics capabilities, suggesting an intent to utilize RWD for various purposes, including marketing.

3. Dr. Reddy’s Laboratories:

• Partnered with Apollo Hospitals to create a real-world data platform focusing on disease registries and patient outcomes, paving the way for future RWE -   based marketing strategies.
• Established a dedicated data science team, indicating an interest in leveraging RWD for various applications, potentially including marketing.

4. Torrent Pharmaceuticals:

• Entered a strategic partnership with IQVIA to utilize real-world data for market research and potentially inform future marketing decisions.
• Invested in building data analytics capabilities, suggesting an intent to utilize RWD for various purposes, including marketing.

5. Lupin:

• Partnered with Pfizer to analyze real-world data on the effectiveness of their co-developed tuberculosis treatment, which could potentially inform future marketing efforts.
• Invested in digital health initiatives, which can generate real-world data that could be utilized for future marketing strategies.

It’s important to remember that these are just examples of companies investing in RWD and RWE, and not necessarily evidence of direct use in current marketing campaigns. Nonetheless, they showcase the growing trend and potential for future applications in the Indian pharma industry.

Recently reported couple of other developments and initiatives in India:

• The Indian Society for Clinical Research (ISCR) released a white paper in 2022 outlining recommendations for implementing RWE in India, highlighting its potential for drug development, regulatory submissions, and post-marketing surveillance.
• The IQVIA Institute for Human Data Science India was established in 2023 with the aim of advancing capabilities leveraging real-world data and analytics in the Indian healthcare ecosystem.

Conclusion:

In a recent publication named, ‘Real-world evidence comes of age for pharma’ - the global consulting company - PwC, has also reaffirmed the critical need to understand how medicine performs in the real world. The authors highlighted, RWE has the potential to transform the pharmaceuticals business – from driving increased efficiency and cost savings in drug development, to helping identify new patient populations for marketed drugs. This can, in turn, translate into higher profitability and shareholder returns, while driving value growth. The big challenge for industry leaders now is learning how to leverage RWE as a sustainable competitive advantage in a landscape that has changed dramatically over the past few years.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.