Challenges in Accessing Keytruda in India

Keytruda, the brand name of Pembrolizumab, is a globally recognized immunotherapy drug by Merck & Co. However, its accessibility in India is fraught with financial, logistical, and regulatory challenges, making it difficult for most patients to procure.

Case Studies: Ekta and Ajit

Ekta’s experience highlights the difficulty in accessing Keytruda due to intricate processes for getting drug doses, despite the Kiran Patient Access Programme. Ajit's path was slightly easier due to his cancer insurance policy.

Keytruda's Global and Indian Context

• Global Approval: Keytruda is approved for multiple cancers worldwide and was the best-selling drug with sales of USD 29.5 billion in 2024.
• India’s Accessibility: Despite its effectiveness, Keytruda remains largely inaccessible in India due to high costs and complex programme requirements.

Process and Structural Barriers

• High Initial Cost: Patients must purchase five vials at a cost of nearly Rs 10 lakh to join the programme, making it unaffordable for many.
• Complex Documentation: Each dose requires extensive paperwork, including a signed and stamped OPD card and infusion forms, leading to delays.
• Limited Information: Patients rely solely on physician guidance for programme information, leading to potential exploitation and misinformation.
• Income Cap: The programme excludes those with annual income over Rs 25 lakh, despite the drug's high cost per dose.
• Scarcity of Specialists: Only registered medical oncologists and haematologists can prescribe Keytruda, with specialists concentrated in major cities.

Statistics and Study Findings

• Health Insurance Coverage: Only 20% of Indians have health insurance, and most policies do not cover costly treatments like immunotherapy.
• Access Percentage: Less than 2% of patients eligible for Keytruda can access the drug, with financial constraints being a significant barrier.
• Oncologist Availability: An estimated 1,500 oncologists in India treat about 677 new patients annually, indicating a shortage of specialists.

Regulatory Delays and Programme Protocols

• Regulatory Delays: There is a lag between US FDA approvals and India’s Central Drugs Standards Control Organisation approvals, delaying access for new indications.
• Access Protocol: The prescription process involves registration with the Kiran programme, requiring a caregiver for each dose collection and strict document verification.

The investigation by The Indian Express and ICIJ underscores the pressing need for improved access to life-saving drugs like Keytruda in India, highlighting the financial and procedural barriers that patients face.