• 1.

    Heerspink HJL, et al.. DAPA-CKD Trial Committees and Investigators. Dapagliflozin in patients with chronic kidney disease. N Engl J Med 2020; 383:14361446. doi: 10.1056/NEJMoa2024816

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  • 2.

    Legendre CM, et al.. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med 2013; 368:21692181. doi: 10.1056/NEJMoa1208981

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3.

    Vincenti F, et al.. Belatacept and long-term outcomes in kidney transplantation. N Engl J Med 2016; 374:333343. doi: 10.1056/NEJMoa1506027. Erratum in: N Engl J Med 2016; 374:698.

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Acquiring Novel Agents for Kidney Disease in India: A Pipe Dream or Science Fiction?

  • 1 Mayuri Trivedi, DM, is Assistant Professor, Nephrology Services, Department of Medicine, LTMGH, and consultant nephrologist and transplant physician, Hinduja Healthcare Surgical and S L Raheja Fortis Hospital, Mumbai, India.
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Recently, the world of nephrology rejoiced at another “positive” trial in nephrology: Dapagliflozin in Patients with Chronic Kidney Disease (DAPA-CKD) (1). But in India and other nations in the South Asian subcontinent we also are deeply concerned by the fact that the sodium glucose cotransporter-2 inhibitors (SGLT2i) are scarcely available and, when they are, place a huge financial burden on our patients who manage to procure them. Dapagliflozin costs the US dollar equivalent of $0.89 for a 10-mg tablet in India (compared to one 75-mg tablet of aspirin [ASA] at $0.038 and one 10-mg tablet of atorvastatin 10 mg at $0.12), and the costs of drugs are not covered by the insurance companies.

On second thought, at least this drug is available, albeit not as freely as we would want. An expanding list of drugs seems to have lost “novel” status in the Western world, but physicians in the South Asian subcontinent have not had the pleasure of experiencing the magic of these drugs in their patients. Many might not be aware that drugs such as patiromer and sodium zirconium cyclosilicate, which were approved for use in the United States in 2015 and 2018, respectively, remain unavailable in India. Eculizumab, an anti-C5 monoclonal antibody, which was approved in 2007 by the US Food and Drug Administration as a game changer in patients with atypical hemolytic uremic syndrome (2), is still available only through a restricted access program in India as a research molecule. The BENEFIT trial clearly showed better patient and graft survival after kidney transplantation, with higher rates of estimated GFR for belatacept in a 7-year follow-up study published in 2016 (3). Although centers in India were part of this multicenter trial, this drug remains unavailable in India as of today.

The lists of medications that promise to mitigate some of the kidney maladies continue to remain a clinician’s dream in India despite comparable rates of kidney disease burden globally. This glaring disparity in the distribution of resources, including the newer drugs in the nephrologist’s tool kit, seems to significantly contribute to the abysmal outcomes for kidney diseases in India and other nations in the South Asian subcontinent. The delivery of healthcare in India, including kidney disease healthcare, rests on the shoulders of an overburdened public sector infrastructure and a large, yet expensive, private sector. More often than not, patients end up paying for the drugs and for disposables personally, inasmuch as insurance schemes and government health policies are restricted in their outreach and their benefits. Integral to providing holistic kidney disease care is ensuring the availability of all recent and novel drugs that are proving to reduce morbidity and mortality in our patients. Perhaps nephrologists in the Western world can help change this situation. Table 1 lists potential ideas on how this can be achieved.

Table 1.

Possible solutions for easing the procurement of novel nephrology drugs in South Asia

1. Development of generic brands of novel drugs produced locally in each country
2. Innovative insurance schemes targeted at specific diseases that collect regular small amounts per person per month to provide the required high-budget drugs
3. Government-aided schemes for specific drugs
4. Dedicated nongovernmental organizations or groups that may help in crowd-funding for specific drugs
5. Rational, transparent, and protocol-based process of approval of newer drugs in India that is patient-centric and without bureaucratic hurdles
6. Group efforts by relevant nephrology societies with adequate representation to urge government bodies to hasten procurement and availability of life-saving drugs

Until we overcome this deep abyss in the South Asian subcontinent, we will continue to regard these novel kidney drugs as part of science fiction. Many of us identify well with this quote by the American author Ray Bradbury: “I have never listened to anyone who criticized my taste in space travel, sideshows, or gorillas. When this occurs, I pack up my dinosaurs and leave the room.”

References

  • 1.

    Heerspink HJL, et al.. DAPA-CKD Trial Committees and Investigators. Dapagliflozin in patients with chronic kidney disease. N Engl J Med 2020; 383:14361446. doi: 10.1056/NEJMoa2024816

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2.

    Legendre CM, et al.. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med 2013; 368:21692181. doi: 10.1056/NEJMoa1208981

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3.

    Vincenti F, et al.. Belatacept and long-term outcomes in kidney transplantation. N Engl J Med 2016; 374:333343. doi: 10.1056/NEJMoa1506027. Erratum in: N Engl J Med 2016; 374:698.

    • Crossref
    • Search Google Scholar
    • Export Citation
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