New Delhi: The Multi Disciplinary Committee (MDC) of Experts, which advises the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has recommended to fix the retail price of Sanofi’s anti-diabetes drug combination Soliqua at the price applied by the company.
The company applied for retail price fixation of a combination of insulin glargine 100 U and lixisenatide 0.05 mg and insulin glargine 100 U and lixisenatide 0.33 mg, at Rs. 587.30 per ml excluding Goods and Services Tax (GST).
The recommendation follows a meeting with the representatives of Sanofi India, in which the company informed the experts that it has discontinued lixisenatide in India and globally purely on commercial reasons. It informed that there is no safety or efficacy concern of the single molecule and the company proposes to launch the FDC of lixisenatide and insulin glargine and lixisenatide is recommended to be used along with insulin glargine.
The Committee in its earlier meeting noted that insulin glargine 100 IU is a schedule formulation and its present applicable ceiling price is Rs. 181.45 per ml.
Further, lixinsenatide is a non-scheduled formulation and is a product of Sanofi Group which has limited sales according to data from Pharmatrac, a product from market intelligence firm PharmaTrac AWACS which is relied on by the Authority for price fixation, in the last three years. Its retail price as on November 2022, six months prior to the date of application, was Rs. 1,212 per ml excluding GST, and is same for 0.02 mg and 0.01 mg irrespective of strength.
According to the MDC’s calculation, the retail price of lixisenatide 0.05 mg and 0.033 mg were calculated at Rs. 1,212 per ml, and the price of insulin glargine 100 IU is Rs. 181.45 per ml. After reducing 20 per cent of the lower of both these prices as per the methodology, the worked out retail price is Rs. 1,357.16 for both the formulations it has applied for. However, with the claimed retail price being Rs. 587.30 per ml, the MDC recommended the claimed retail price for price fixation.
As reported earlier, according to data from Pharmatrac, the company has sold seven units of lixinsenatide 10 mcg between September, 2020 to August, 2021 for a total value of Rs. 22,000 and six units between September, 2021 and August, 2022 for a total of Rs. 19,000 while for the year September, 2022 to August, 2023 no sales has been reported.
For lixisenatide 20 mcg, between September, 2020 and August, 2021 the company sold 620 units for a total value of Rs. 19.43 lakh, and between September, 2021 and August, 2022, a total of 210 units for Rs. 6.58 lakh. The data shows there were no sales of this formulation also between September, 2022 and August, 2023.
Soliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without
sodium-glucose co-transporter-2 (SGLT-2) inhibitors.
Sanofi India, in March, 2023 announced that it has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for the diabetes drug Soliqua in pre-filled pen.
“Soliqua is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes who are insufficiently controlled on oral or injectable therapies. It comes in once daily dosing of pre-filled pens in fixed-ratio combination (10-40 and 30-60) of insulin glargine and lixisenatide,” said the company during the time.
