After Cipla, Glenmark Digihaler secures NPPA nod for separate price; Details

New Delhi: The National Pharmaceuticals Pricing Authority (NPPA) recently approved the price for the digital dose counter brand ’Digihaler’ manufactured by Mumbai-based Glenmark Pharmaceuticals at Rs. 44.70 (excluding GST) on the ceiling price of the MDI Digital Inhalation (Inhalation having digital dose counter).

The approval was based on the recommendations of the Multidisciplinary Committee of Experts after the company moved an application for a separate price of “Budesonite+ Formeterol MDI Digital Inhalation under the brand “Digihaler”.

The company had launched Digital dose inhaler or ‘Digihaler’ in 2016 to enable asthma and Chronic Obstructive Pulmonary Disease (COPD) patients to track the number of doses that have been consumed. Priced in the range of Rs.300 to Rs.450, the Digihaler comes with a small screen which displays the number of puffs remaining, discounting from 120, the typical number of medicine puffs a standard inhaler offers.

Seeking a separate price for the first digital dose inhaler-Digihaler, the company submitted an application with NPPA. The application was placed before the Multidisciplinary Committee of Experts in its 14th meeting dated 04.12.2019. Two Pharmacoeconomic experts were co-opted in the Committee. The Committee noted that a separate price could be considered to promote incremental innovation. Accordingly, it recommended a special price of ‘digital dose counter’ under the brand “Digihaler” for Glenmark Pharmaceuticals Ltd under para 11(3) of DPCO 2013.

"NPPA supports incremental innovations that could increase the therapeutic value and effectiveness of a drug. It was noted with satisfaction that two Pharmacoeconomics experts had been co-opted in the Multidisciplinary Committee of Experts, " states the minutes of the meeting.

The Authority accepted the recommendation of Multidisciplinary Committee of experts under para 11(3&4) of DPCO 2013 that in case the incremental innovation is not supported by a published journal, well-designed study, adequate trial, conclusive clinical data, then an incremental price increase up to 15% be allowed and in case, the incremental innovation is supported by published journal, well-designed study, adequate trial, conclusive clinical data, then an incremental price increase up to 20% be allowed.

Accordingly, the NPPA approved the price for the digital dose counter brand ’Digihaler’ of Glenmark at Rs. 44.70 (excluding GST) on the ceiling price of the MDI Digital Inhalation (Inhalation having digital dose counter) having the formulation (a) Budesonide 100mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (c) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI, based on the recommendations of the Multidisciplinary Committee of Experts.

The Authority also decided that the additional price of Rs. 44.70 (excluding GST) on the applicable ceiling price of the MDI Digital Inhalation (Inhalation having digital dose counter) brand “Digihaler” of Glenmark would remain fixed irrespective of the subsequent change in ceiling prices of the Inhalation having the formulation (a) Budesonide 100mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (c) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI.