The Pharmaceuticals Department (DoP) has turned down Abbott Healthcare’s appeal against the pricing cap set by the National Pharmaceutical Pricing Authority (NPPA) for high blood pressure medication metoprolol in its modified release tablet form.
This decision follows multiple denials by the Department last month, in which it dismissed price revision requests from companies, including AstraZeneca and Lupin, for various strengths of metoprolol modified release tablets.
In their February 10, 2023, application, Abbott argued that other companies had applied the Wholesale Price Index (WPI) based price adjustments from April through July 2022. Abbott claimed that erroneous Price-to-Retailer (PTR) data from Sun Pharma’s 100 mg Prolomet XL 10 and IPCA Laboratories’ 100 mg Revelol XL 15 were used to establish the price, leading to a lower ceiling rate.
Abbott contended that any delay in rolling out revised Maximum Retail Price (MRP) or PTR due to WPI impact shouldn’t be viewed as non-implementation of WPI-based changes. They pointed out that late or absent updates in Pharmatrack’s market data shouldn’t be seen as failing to execute revised MRP. Pack shots provided as documentary proof illustrated price changes.
The company stressed that the September database reflected MRP amendments and that the amended PTR of Rs. 121.43 should have been used, compared to Rs. 112.14, which was considered for Prolomet XL 100 mg. Likewise, the PTR of Rs. 202.88 was preferred instead of Rs. 175.71 by the NPPA for calculating the ceiling price.
According to the NPPA, the drug’s modified release 100 mg tablet wasn’t a scheduled formation until being listed under Schedule I of the Drugs Prices Control Order (DPCO), 2013, on November 11, 2022, making Form II filings irrelevant.
Additionally, Sun Pharma and IPCA Lab hadn’t submitted Form V required for annual pricing updates under Paragraph 20 of the DPCO, 2013, hence, revisions weren’t applied. The authority stated accurate PTR data was retrieved from the database for pricing purposes.
The review authority upheld NPPA’s rationale and decision, dismissing Abbott’s appeal.
It’s noteworthy that AstraZeneca, Lupin, Macleods Pharmaceuticals, Ajanta Pharma, and Primus Remedies had previously filed separate appeals challenging the ceiling rates for different strengths of the drug.
In its review application, AstraZeneca contested that NPPA had set distinct ceiling prices for both 100 mg conventional and 100 mg modified release tablets while equating the prices of modified release 25 mg and 50 mg tablets to their conventional counterparts. It objected to NPPA combining both types for 25 mg and 50 mg tablets and appealed for a reevaluation and removal of ceiling prices for these strengths.
NPPA outlined that their pricing methodology considers only MR data when specified, aligning with the NLEM, 2015. However, when variants aren’t specifically noted, both conventional and MR data is evaluated. This methodology applies likewise to other tablet forms.
The NPPA argued that MR variants, vital to lifesaving medications, shouldn’t be deregulated. For 25 mg and 50 mg strengths, MR tablets hold an 84.86% and 86.46% market share, respectively, reflecting significant MR market dominance. Deregulation could undermine public access as intended by NLEM, 2022.
The review authority confirmed NPPA’s pricing strategy and dismissed the review applications, supporting continued regulation.