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The expert panel which advices the National Pharmaceutical Pricing Authority (NPPA) has recommended retail price fixation of various anti-diabetes formulations comprising dapagliflozin, sitagliptin, and vildagliptin in various dosages, strengths and delivery models, using the methodology of 50 per cent reduction on the price of the patented components, which have now gone off patent.
The Multi Disciplinary Committee (MDC) of Experts for NPPA has recommended the retail price of fixed dose combinations (FDCs) of dapagliflozin, sitagliptin and metformin tablet against three applications filed by Sun Pharma Laboratories and Mankind Pharma Ltd, which manufacture the products through Exemed Pharmaceuticals.
The Authority said that the retail price of these FDCs has been attempted in line with the principles adopted last year, which is reduction of 50 per cent from the patented component (dapagliflozin and sitagliptin) and then adding the ceiling price of the scheduled components as applicable six month earlier from the date of application.
Further, it calculated a reduction of 20 percent of the lower of the three components - the price arrived for the two patent components after 50 per cent reduction and the ceiling price of metformin - in line with the recommendation of the Pronab Sen Committee that has also been provided while fixing the price.
It may be noted that the methodology was decided in a meeting held on March 24, 2022 based on the recommendation of the Committee of Experts in a meeting held on March 14, 2022 for calculation of retail price of the FDC which has a component which has become or is on the verge of becoming off-patent.
The methodology was developed considering that if the retail price is calculated based on six month prior market data, the price of the patented period would be taken into consideration and the benefit of price reduction due to medicines which become off-patent would not pass on to the consumers.
Considering the issue related to fixing of the retail price of an FDC with sitagliptin as a component, the MDC on March 14, 2022, recommended, "The Committee deliberated upon the matter in detail and is of the opinion that the price of drugs be reduced in respect of the drugs which has become/on the verge of becoming off-patent so as to pass the benefit of price reduction to the consumers and that a reduction of 50 per cent to be allowed on the patented component of FDCs (i.e sitagliptin) to arrive at the retail price".
The methodology has been followed by the MDC for the other FDCs which have one of the components recently went off patent, since then.
Similarly, in its latest meeting, the MDC recommended retail price fixation for the FDCs comprising dapagliflozin, vildagliptin and metformin as sustained release tablets, against 18 applications it has received from various companies. The Committee noted that the components dapagliflozin and vildagliptin of the FDCs were patented and the patent expired on October 2, 2020 and December 9, 2019 respectively.
The retail prices fixed for the combinations marketed by Exemed Pharmaceuticals and marketed by Eris Lifesciences, Intas Pharmaceuticals, USV Pvt Ltd, Zydus Healthcare Ltd, Cipla Ltd, Micro Labs Ltd, Lupin Ltd, Emcure Pharmaceuticals, Lupin Ltd, and Abbott Healthcare Pvt Ltd.
Besides, it has also recommended retail price fixation for FDCs of dapagliflozin and teneligliptin tablet against two applications - an FDC of dapagliflozin 5 mg and teneligliptin hydrobromide hydrate IP equivalent to teneligliptin 20 mg and another of dapagliflozin 10 mg and teneligliptin hydrobromide hydrate IP equivalent to teneligliptin 20 mg, both manufactured by Ravenbhel Healthcare for Mankind Pharma Ltd.
The Committee meeting also recommended retail price for the FDC of sitagliptin 100 mg and metformin 500 mg (extended release) tablet, in which the patent of sitagliptin was expired by July, 6, 2022, under the same methodology. It has fixed the retail price based on two applications - one filed by Pure and Care Healthcare as manufacturer and Abbott Healthcare as marketer and another filed by Ravenbhel Healthcare Ltd as manufacturer and Lupin Ltd as marketer.
It may be noted that after arriving at the decision to reduce the price by 50 per cent of the patented compound which has expired the patent exclusivity, the MDC in April, 2022, has said that it is looking at whether the benchmark of the 50 per cent reduction may be examined on case-to-case basis by the Committee for medicines which has become or is on the verge of becoming off patent.
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