The entry of generic forms of the proven reno-protective dapagliflozin in the market is expected to improve the pharmacoeconomics of diabetes care in India. The resultant huge price reduction in therapy is expected to benefit the Indian population with diabetes by prevention and reduction in progression of renal and cardiovascular complications of diabetes.

Diabetes exerts an immense economic impact with a major chunk of costs attributed to the late stage complications. One such complication is diabetic nephropathy or chronic kidney disease (CKD) that impacts almost 50% of the diabetes population.¹Diabetic nephropathy is the commonest cause for patient’s progression to end stage kidney disease (ESKD) and initiation of dialysis. Patients with diabetes who develop ESKD have a poor prognosis due to high risk of cardiovascular events, with the mean 5-year survival rates being less than 40%.²

Diabetic nephropathy also exerts an immense mental, physical and economic burden on the patients as well as the caregivers. In a pharmacoeconomic analysis carried out at the nephrology department of a tertiary care hospital in Bengaluru,  the total monthly cost for the management of diabetic nephropathy per patient was estimated to be INR 24,203 with total direct costs of INR 21,013 and the indirect cost per patient of INR 3,189.³ In a country like India,with scarcity of healthcare insurance covers, these costs are usually met by the patients as out-of- pocket expenses  from their savings, further deepening the financial crunch.

Potential and affordable therapeutic options become imperative to prevent or retard the progression of diabetic kidney disease as well as to reduce cardiovascular complications.So far, onlySGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin have emerged as antidiabetics with evidence for potential reno-protective effects in patients with T2DM. Of these, canagliflozin is already approved by US FDA for the treatment of diabetic kidney disease while dapagliflozin and empagliflozin are under a fast track review by the same regulator.  Unlike older antidiabetics like metformin and sulfonylureas that are quite affordable to the people of almost all economic strata, newer molecules like SGLT2 inhibitors face concerns of affordability. Due to their high prices owing to the brand monopolies in the market, they find limited utilization and a majority of the diabetes population therefore  cannot be brought under the umbrella of their benefits. However, now there is a reason for joy for diabetes patients as well as the diabetes healthcare providers as certain dapagliflozin brands go off their exclusivity rights paving the way for  the entry of affordable generics. 

The entry of the generic forms of dapagliflozin has slashed the price of therapy with almost 4-fold reduction in the annual  treatment costs. This brings a positive hope that clinicians will now be encouraged to reap maximum benefits by prescribing dapagliflozin to their diabetes patients. Moreover, this huge price reduction is expected to cover more patients under the umbrella of the evidence-based assured benefits of dapagliflozin and boost medication adherence in those who are already taking it.

References

1. Thomas MC, Cooper ME, Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nat Rev Nephrol. 2016 Feb;12(2):73-81.
2. Pálsson R, Patel UD. Cardiovascular complications of diabetic kidney disease. Adv Chronic Kidney Dis. 2014 May 1;21(3):273-80.
3. Jose JV, Jose M, Devi P, Satish R. Pharmacoeconomic evaluation of diabetic nephropathic patients attending nephrology department in a tertiary care hospital. J Postgrad Med. 2017 Jan;63(1):24-8.