Breaking Barriers: How to Effectively Unlock Market Access for Cell & Gene Therapy in India

By providing patients with genetic diseases with potentially curative treatments, Cell & Gene Therapies (CGT) will revolutionise healthcare. Cell and Gene therapies that have recently received approval are demonstrating great promise for prolonging or improving patient lives. The science is complicated, treatments are expensive, the supply chain is unreliable, and the regulatory pathway is more complicated than that of conventional therapies.

In order to guarantee that patients who could benefit from these Cell and Gene therapies have timely access, the approach to market access needs to be completely rethought. There is a genuine worry that the significant upfront cost of these pricey therapies will place an excessive burden on the healthcare system. It is crucial to assess the long-term clinical and cost-effectiveness tradeoffs linked to these therapies because the lifetime cost of treating many genetic conditions is significantly higher than the upfront cost of these gene therapies. In order to collaborate with providers, payers, and policymakers to maximise market access to these therapies, manufacturers must investigate new commercialization models as the sector expands.

But in order for CGT to succeed in India, a thorough market access strategy that takes into account the specific difficulties and opportunities in this developing market must be created. The main facets of market access for CGT in India are examined in this article, including payers and reimbursement, Ayushman Bharat's function, disease adoption, policy advocacy, and patient channelling.

Payers & Reimbursement: Navigating the Complex Landscape

One of the main challenges in securing market access for CGT in India is the complex landscape of payers and reimbursement systems. India has a mixed healthcare financing system, where both public and private sectors play a significant role. The public sector primarily consists of the Central and State Government Health Insurance schemes, while the private sector includes various private health insurance companies and employer-based insurance programs.

Public Payers: The Role of Ayushman Bharat

Ayushman Bharat, also known as the National Health Protection Scheme (NHPS), is an ambitious healthcare initiative launched by the Government of India in 2018. It aims to provide health insurance coverage for over 100 million economically vulnerable families, covering hospitalization expenses up to INR 5 lakhs (approximately USD 6,500) per family per year.

For CGT manufacturers, engaging with Ayushman Bharat can be a strategic step in gaining market access in India. By demonstrating the value of their therapies to public payers, manufacturers can potentially secure reimbursement for their products under the scheme, thereby expanding access to a vast patient population.

However, it is crucial to note that the inclusion of CGT under Ayushman Bharat would require a thorough evaluation of their cost-effectiveness and clinical benefits. Manufacturers must present robust evidence of the long-term therapeutic value of their products, considering the high upfront costs associated with CGT.

Private Payers: Overcoming the Affordability Barrier

While the private insurance sector offers significant opportunities for market access, the high costs of CGT pose a significant barrier to their inclusion in private insurance plans. Manufacturers must explore innovative pricing and reimbursement models, such as outcome-based agreements or installment-based payments, to address the affordability concerns of private payers.

Moreover, engaging in early and transparent dialogue with private payers can help manufacturers understand the specific requirements and expectations of the Indian market. This can facilitate a smoother market access process and enable manufacturers to design tailored value propositions and pricing strategies for their CGT products.

Disease Adoption: Focusing on High-Value Opportunities

To maximize the impact of CGT in India, manufacturers must prioritize diseases with a high prevalence and significant unmet medical needs. By targeting diseases with a high burden, CGT developers can demonstrate the value of their therapies to both payers and patients, thereby enhancing market adoption.

In India, some of the high-value opportunities for CGT include rare genetic disorders, such as spinal muscular atrophy (SMA) and thalassemia, as well as prevalent chronic conditions like cancer and diabetes. Focusing on these disease areas can help manufacturers establish a strong market presence and drive the adoption of CGT in India.

Policy Advocacy: Shaping the Regulatory Environment

The regulatory environment for CGT in India is still evolving, with the Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR) taking the lead in developing guidelines for the approval and monitoring of CGT products.

Manufacturers must actively engage in policy advocacy to shape the regulatory landscape for CGT in India. By participating in consultations, workshops, and conferences, they can contribute to the development of guidelines that are supportive of CGT innovation and market access.

Additionally, manufacturers should collaborate with local and global stakeholders, such as patient advocacy groups, academic institutions, and industry associations, to build a strong advocacy ecosystem for CGT in India. This can help in creating awareness about the potential benefits of CGT and facilitate a conducive policy environment for their adoption.

Patient Channeling: Ensuring Access to the Right Patients

Ensuring that CGT reaches the right patients at the right time is a critical aspect of market access in India. Manufacturers must develop effective patient channeling strategies to identify and connect with eligible patients who may benefit from their therapies.

Newborn Screening and Genetic Testing

Newborn screening and genetic testing programs can play a vital role in the early identification of patients eligible for CGT. By collaborating with healthcare providers and diagnostic laboratories, manufacturers can promote the adoption of such testing programs, which can help in the timely diagnosis and treatment of patients with genetic disorders.

Patient Registries and Networks

Establishing patient registries and networks can help manufacturers track and identify patients with specific conditions who may be eligible for CGT. These registries can also serve as a valuable resource for generating real-world evidence on the safety, efficacy, and long-term outcomes of CGT, which can further support market access efforts.

Collaborating with Healthcare Providers and Centers of Excellence

Manufacturers must also collaborate with healthcare providers and establish partnerships with Centers of Excellence (CoE) that specialize in the diagnosis and treatment of target diseases. CoEs can act as hubs for the delivery of CGT, ensuring that patients receive the best possible care and support throughout their treatment journey.