Our aim is to tailor our oncology portfolio to address the most pressing needs in India

What are the therapeutic focus areas of Merck’s Oncology division? Do they match the unmet medical need in India for oncology treatment? 

WHO states that cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths and is set to increase. This drives us at Merck to develop innovations that matter most to people living with cancer.

Merck’s oncology division is committed to addressing critical unmet medical needs globally, including in India. We prioritise innovation in areas such as immuno-oncology, precision medicine, and targeted therapies. Our goal is to develop treatments that not only extend survival but also improve patients’ quality of life.

With the rising burden of cancer in India, there is a definite need to increase efforts towards awareness about early diagnosis and treatment options. Merck Healthcare in India has been instrumental in bringing globally acclaimed, time-tested, precision-led medical treatment to Indian patients for several years. Our portfolio of therapy includes treatment options for head and neck cancer, colorectal cancer, bladder cancer and lung cancer. 

In evaluating the alignment of our therapeutic focus with the unmet medical needs in India, it’s essential to consider the unique characteristics of the Indian healthcare landscape. While significant progress has been made in oncology care, challenges such as access to advanced treatments, affordability, and infrastructure limitations persist.

To ensure our efforts resonate with the Indian context, we collaborate closely with healthcare stakeholders, including physicians, patient advocacy groups, and regulatory authorities. Through these partnerships, we gain insights into the specific challenges facing Indian patients and healthcare providers.

Ultimately, our aim is to tailor our oncology portfolio to address the most pressing needs in India while upholding the highest standards of scientific excellence and patient care. By leveraging our global expertise and local insights, we strive to make meaningful contributions to the fight against cancer in India and beyond.

As India is a price-sensitive market and most of healthcare needs are out-of-pocket rather than covered by insurance, what are the market access and affordability strategies that Merck has incorporated to stay ahead in the oncology segment?

Merck ranks fifth among the 20 largest pharma companies worldwide based on initiatives to advance global access to medicines in LMICs, improving from eighth place in the 2021 ATM Index. 

More than 30 per cent of India’s population lacks financial protection for health, often termed the ‘missing middle.’ This segment falls between government-subsidised schemes and private insurance coverage, highlighting a critical gap in access to healthcare.

To address this challenge, Merck is committed to partnering with the government and related associations to foster impactful patient outcomes through sustainable access solutions. Our philosophy of “As One for Patients” underscores our dedication to developing non-commercial initiatives that strengthen healthcare systems and enhance patient access programs.

Aligning with the government’s vision of universal healthcare, Merck Healthcare in India has pioneered the National Payers Partnership programme on cancer care. This innovative initiative collaborates with national payers such as the Employees State Insurance Corporation (ESIC) and the Ministry of Railways to facilitate access pathways for cancer therapies.

Additionally, we collaborate closely with state governments and other stakeholders to implement innovative, differential pricing schemes tailored to local market dynamics. These segmentation-based pricing strategies align with governmental programmes and prioritise affordability without compromising sustainability.

Patient access programmes are integral to Merck’s approach, providing financial assistance to qualified patients in accordance with applicable local regulations. Through these initiatives, we ensure that patients who cannot afford our medications still have access to life-saving treatments.

Recognising the potential of digital healthcare, we are actively exploring partnerships to leverage telemedicine and e-health solutions. Given India’s extensive smartphone penetration and improving mobile connectivity, these digital platforms offer promising avenues for expanding access to healthcare services.

Name one or two recent groundbreaking innovations and collaborations by Merck in the field of cancer care. What is the time lag between their global and India launch? 

One recent groundbreaking innovation by Merck in cancer care is the development of immuno-oncology therapies. These therapies, such as avelumab (Bavencio), focus on harnessing the power of the immune system to combat cancer. Avelumab, for example, is a monoclonal antibody approved for the treatment of various types of cancer, including metastatic Merkel cell carcinoma and advanced urothelial carcinoma.

Additionally, Merck collaborates with leading academic institutions, biotechnology companies, and research organisations to advance personalised medicine approaches in oncology. By identifying biomarkers and developing targeted therapies tailored to individual patients’ genetic profiles, Merck aims to improve treatment efficacy and reduce adverse effects.

Regarding the time lag between global and India launches of such innovations, it can vary based on regulatory approval processes, market access considerations, and healthcare infrastructure readiness. Merck endeavours to minimise this time gap by working closely with regulatory authorities and healthcare stakeholders in India to expedite access to innovative cancer treatments for patients.

How has India’s clinical trials ecosystem evolved in terms of regulations, approvals etc?  

India is a preferred destination for global clinical trials due to a high unmet need, with some of the highest disease burden globally, a heterogeneous patient pool, cost competitiveness, a skilled human resource and FDA audited sites, as well as rising costs in developed markets. Cost of clinical trials in India is 40-60 per cent lower than developed markets.  

However, challenges such as regulatory complexities, lengthy approval processes, and varying ethical standards across different states have been reported, impacting the efficiency and timeline of clinical trials.

Efforts are underway to streamline the regulatory framework for clinical trials, with initiatives aimed at harmonising guidelines, enhancing transparency, and expediting approval processes.

Collaborative efforts between government agencies, industry stakeholders, and research institutions are crucial for addressing these challenges and promoting a conducive environment for clinical research in India.

We continue to sustain dialogue and involvement of our key countries in all future clinical trials and seek support to ensure that countries like Taiwan, Korea, and India, where local patient inclusion in global studies is a key regulatory requirement for product registration, are always included in global clinical development programs.

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