Access plan ties cancer patients in red tape and Rs 10-lakh upfront, Pg1

Key Highlights:

• Access to Keytruda, a crucial immunotherapy drug, in India is hindered by financial, logistical, and regulatory obstacles, despite the existence of a patient assistance program.
• The Kiran Patient Access Program requires patients to initially purchase approximately Rs 10 lakh worth of the drug before accessing free doses, creating a significant financial barrier.
• Only an estimated 2% of Indian patients who require Keytruda can access it, with financial constraints being the primary reason.
• The drug can only be prescribed through the Kiran program by registered medical oncologists or haematologists, limiting access in rural areas where specialists are scarce.

Detailed Insights:

• The Kiran Patient Access Program provides one free 100 mg vial of Keytruda alongside one purchased vial for the first five infusions, after which patients can access 25 more vials for free, but only after the initial purchase.
• Patients face logistical challenges, including repeated document verification and the requirement of a registered caregiver's presence at each infusion, adding to the difficulty of accessing the drug.
• Limited information about the Kiran program can lead to exploitation, with some individuals offering counterfeit drugs at lower costs.
• Even patients with health insurance may find it difficult to qualify for the program due to eligibility criteria based on annual income or sum insured.
• A significant delay between US FDA approval and approval by India’s Central Drugs Standards Control Organisation further restricts access to Keytruda for certain indications.

Key Concepts Involved:

• Immunotherapy: A type of cancer treatment that helps the immune system fight cancer.
• Patient Access Program: Initiatives by pharmaceutical companies to provide medications to patients at a reduced cost or for free.
• Medical Oncologist: A doctor who specializes in diagnosing and treating cancer with chemotherapy, hormone therapy, immunotherapy, and other targeted therapies.