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.

India’s intellectual protection (IP) protection has been framed in tune with the country’s socio- economic situation. Are there any concern areas and how can they be addressed? 

Intellectual property (IP) protection is essential for fostering innovation and encouraging investment in research and development. While India has made strides in strengthening its IP framework through legislative reforms and enforcement mechanisms, concerns remain regarding the effectiveness of enforcement and the resolution of IP disputes. Continued efforts are needed to enhance IP enforcement, streamline procedures for obtaining and enforcing patents, and address issues such as counterfeiting and piracy.

Stakeholder engagement and dialogue between government bodies, industry players, and IP experts can facilitate the development of balanced and effective IP policies that promote innovation while safeguarding public interests.

Have there been substantial improvements in the ease of doing business in India? 

Improving the ease of doing business is a priority for India’s government, as evidenced by various reforms aimed at simplifying regulatory processes, reducing bureaucratic hurdles, and enhancing transparency.

Despite progress, challenges persist in areas such as obtaining permits, resolving commercial disputes, and navigating tax regulations, which can impact the business environment and investment attractiveness.

Efforts to address these challenges include digitalisation initiatives, regulatory reforms, and capacity-building measures to enhance administrative efficiency and reduce compliance burdens.

Continuous monitoring, evaluation, and stakeholder engagement are essential for identifying bottlenecks, implementing reforms, and fostering a business-friendly environment conducive to sustainable economic growth.

In conclusion, as India continues its journey towards enhancing the ease of doing business and fostering innovation, our recent launches of Tepmetko, Bavencio, and Pergoveris in the country over the last two years is a testament of the government’s commitment to facilitating a conducive environment for pharma growth and healthcare innovation.

Are any of Merck’s oncology medicines due to lose patent protection in the next four to five years? If yes, how is the company strategising for this loss of exclusivity and the price crash that will follow?

The natural progression of pharma innovation often leads to the emergence of generic competition as patents expire. This competition fosters a dynamic marketplace where multiple companies vie to offer cost-effective alternatives, ultimately benefiting patients by providing them with increased access to a diverse range of treatment options.

The prospect of generic competition signifies a step towards a more robust and competitive landscape. This competition incentivises companies to optimise their offerings, driving improvements in efficiency, affordability, and accessibility of medicines.

While this transition may lead to price erosion, it encourages companies to focus on enhancing the quality and efficacy of their medicines to maintain their competitive edge. By ensuring that patients have access to high-quality treatments at competitive prices, Merck remains steadfast in its commitment to meeting the evolving healthcare needs of patients.

In essence, while competition in the pharma industry may initially seem daunting, it ultimately serves as a catalyst for innovation and progress. Through increased competition, patients stand to benefit from a broader range of treatment options that are both effective and affordable, thereby advancing the collective goal of improving healthcare outcomes.

What is Merck India’s approach to cancer treatment and awareness, given the country’s unique demographic and socio-economic profile?

With scientific curiosity and dedication to patients, we strive every day to improve the futures of people living with cancer. Our efforts have led to new standards of care for multiple tumour types, and we are committed to bringing these innovative treatments to as many patients as possible. 

Access and partnerships: Through our determination to maximise the impact of our standard-of-care treatments and pioneer novel medicines, we endeavor to create a world where more cancer patients can become cancer survivors.

Currently, we reach over 50 million patients a year with our healthcare portfolio in low- and middle-income countries (LMICs). One of our key priorities is to expand access to innovative medicine like Erbitux, in LMIC like India

Head and neck cancer is one of the leading causes of mortality in India, contributing to ~30 per cent of overall cancer incidence with a mortality to incidence ratio of 56 per cent. Similarly, ~50,000 new cases of colorectal cancers (CRC) are diagnosed in India with ~31,000 deaths.

As per the Lancet study, ~90 per cent of the avertable cancer deaths were due to non-utilisation/lack of access to healthcare services and rest ~10 per cent due to poor quality of healthcare. We are committed to helping 80 million patients in LMICs by 2030 by going deeper, wider, and faster to enable access in LMICs.

One of our flagship projects is Umeed – a Merck initiative to expand access for H&N and mCRC patients in India.

Overcoming barriers to access for underserved populations and communities in India in a business-integrated and sustainable manner through focused interventions ranging from increasing awareness, prevention and diagnosis of H&N and colorectal cancer; their early signs/symptoms and associated risk factors, in remote areas where access to information and literacy rate is low. Expanding screening coverage and building referral mechanism for early diagnosis and capability building by enhancing knowledge and experience on treatment with targeted therapies. Create platforms for peer-peer exchanges and case-management protocols based on real-world experiences optimising patient outcomes.

We also enhance treatment and quality care by helping reduce financial burden of cancer treatment with patient assistance programme for Erbitux and building integrated care for cancer treatment with counselling support to ensure superior outcomes.

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