Why in News
  • Keytruda (pembrolizumab) has gained attention due to:
    • Rising cancer burden in India
    • High treatment cost and accessibility issues
    • Emergence of a counterfeit drug market
  • It is one of the most widely used and highest-selling cancer drugs globally
  • The issue highlights the challenges of Advanced medical technology vs affordability in India
KEYTRUDA (PEMBROLIZUMAB) & INDIA’S CANCER TREATMENT LANDSCAPE explained for UPSC

WHAT IS KEYTRUDA?

  • Keytruda is the brand name of:
    • Pembrolizumab, a cancer drug
  • Manufactured by:
    • Merck & Co
  • It belongs to:
    • Immunotherapy drugs, specifically checkpoint inhibitors

MECHANISM OF ACTION

  • The human body uses T-cells to identify and destroy harmful cells
  • Cancer cells escape detection by:
    • Using PD-L1 proteins to deactivate T-cells
  • Keytruda works by:
    • Binding to PD-1 receptors on T-cells
    • Blocking interaction with PD-L1 on cancer cells
Result:
  • T-cells are reactivated
  • Immune system starts attacking cancer cells effectively

WHAT IS IMMUNOTHERAPY?

  • Immunotherapy is a treatment approach where:
    • The body’s own immune system is used to fight disease
Comparison with Traditional Treatments Chemotherapy and Radiotherapy
  • Directly kill:
    • Cancer cells
    • Also damage healthy cells
  • Side effects:
    • Hair loss, fatigue, immune suppression
Immunotherapy
  • Works indirectly by:
    • Activating immune response
  • Advantages:
    • More target-specific
    • Fewer side effects
    • Effective in advanced cancers
  • Limitations:
    • Expensive
    • Not effective for all patients

TYPES OF IMMUNOTHERAPY

(A) Checkpoint Inhibitors
  • Example:
    • Keytruda
  • Function:
    • Remove “brakes” on immune system
(B) Monoclonal Antibodies
  • Lab-made molecules targeting:
    • Specific cancer proteins
  • Keytruda belongs to this category
(C) CAR-T Cell Therapy
  • Process:
    • Patient’s T-cells extracted
    • Genetically modified
    • Reintroduced to attack cancer
  • Indian example:
    • NexCar 19 (indigenous CAR-T therapy)
(D) mRNA Cancer Vaccines
  • Purpose:
    • Prevent recurrence of cancer
  • Work by:
    • Training immune system to detect neoantigens (cancer markers)

MEDICAL USES OF KEYTRUDA

  • Approved for treatment of:
    • Lung cancer
    • Cervical cancer
    • Kidney cancer
    • Breast cancer
  • Initially approved:
    • 2014 by US FDA
  • Has shown:
    • Tumour shrinkage
    • Complete disappearance in some advanced cases

GLOBAL IMPORTANCE

  • Keytruda is:
    • World’s best-selling drug
  • Revenue:
    • Around $29.5 billion in 2024
  • Accounts for:
    • Nearly half of Merck’s revenue

AVAILABILITY IN INDIA

  • Available in Tertiary care hospitals
  • Similar immunotherapy drugs available:
    • Trastuzumab
    • Nivolumab
Access Channels
  • Direct purchase from hospitals
  • Patient Access Programme
  • Government schemes: CGHS
  • Insurance:
    • Limited coverage under general insurance
    • Better coverage under specialised cancer policies

COST OF TREATMENT

  • Standard dosage:
    • 200 mg every 3 weeks
  • Price:
    • ₹1.5 lakh per 100 mg vial
  • Monthly cost:
    • Around ₹3 lakh or more
Patient Access Programme
  • Structure:
    • Buy 5 vials ? Get 30 free
  • Approximate cost:
    • Around ₹10 lakh initially
  • Eligibility:
    • Income/sum insured below ₹25 lakh
This programme improves partial affordability

WHY IS KEYTRUDA EXPENSIVE?

(A) Complex Production
  • Monoclonal antibodies require:
    • Advanced biotechnology
    • High production cost
(B) Patent Protection
  • Patent valid till:
    • 2028
  • Prevents:
    • Cheap generic versions
Future Possibility
  • After patent expiry:
    • Costs may reduce by up to 70%

CANCER BURDEN IN INDIA

KEYTRUDA (PEMBROLIZUMAB) & INDIA’S CANCER TREATMENT LANDSCAPE explained for UPSC
  • Increasing trend:
    • 1990: 84.8 per 100,000
    • 2023: 107.2 per 100,000
Current Data
  • 2022:
    • 13 lakh cases
Future Projection By 2045:
  • 56 lakh cases
Indicates urgent need for:
  • Advanced cancer treatments

GOVERNMENT INITIATIVES

  • Government removed:
    • Basic customs duty on Keytruda
  • Announced by:
    • Nirmala Sitharaman
  • Included in:
    • 36 life-saving drugs exempted
Objective:
  • Improve access and affordability

COUNTERFEIT DRUG ISSUE

  • Investigation revealed rise in fake Keytruda market
Reasons
  • High cost
  • Limited access
Key Concerns
  • Fake drugs sold in Original packaging
  • Difficult to detect Even by experts
  • Possible involvement of Hospital staff
Risks
  • Treatment failure
  • Health complications
  • Loss of trust in healthcare system
Prevention Measures
  • Purchase only from:
    • Hospital pharmacies
  • Use:
    • Official patient access programme

CHALLENGES

  • High cost limits access
  • Limited insurance coverage
  • Regulatory gaps in drug supply
  • Technology-intensive treatments