Tuesday, July 2, 2013

Pioglitazone ban will spiral treatment cost for diabetes patients

With the DCGI imposing a  ban on pioglitazone, the problem for the diabetes patients in India, is that there are no cost effective treatment alternatives.. Alternative treatment options which could be a DPP-IV inhibitor, GLP-1 or an insulin are all several fold expensive than a  pioglitazone pill. With the pioglitazone market worth about INR 700 crores in India and assuming INR 1000 as the annual cost of treatment, there are about 7 million patients that would have to be shifted to alternative treatment. In absence of a medical insurance system, this may also lead to many diabetes patients skipping treatment for affordability reasons and thus not adhering to their HbA1C goal.

Besides the cost, efficacy will also be an issue ? 

DPP-IV's which is one of the oral alternative is not as efficacious as pioglitazone and hence besides the cost, patients may also not be able to reach their treatment goals. Pioglitazone has a unique mechanism and acts by improving insulin sensitivity, while others act by promoting the release of insulin in response to glucose. Because of its unique mechanism, pioglitazone offers a more synergistic action.

Should the DCGI follow USFDA / EMA footsteps

Unlike in the France, the USFDA and EMA’s  have not imposed a ban on piogltiazone. The USFDA and EMA have updated pioglitazone label, as they still believe the risk-reward profile of actos is favorable. The USFDA and EMA have concluded that pioglitazone should not be used for patients with active bladder cancer or who have a history of bladder cancer.

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