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NPPA seeks comments on revision of cancer drugs’ list

The apex drug price regulator has suggested adding 12 medicines used for treatment of various types of cancers such as bone marrow cancer, breast cancer, lung cancer, gastrointestinal cancer and colorectal cancer among others under the NLEM.

The NPPA has sought suggestions from the pharmaceutical industry, health experts and other stakeholders on recommendations of Tata Memorial Centre under the Department of Atomic Energy.

Justifying the revision of the list, a senior NPPA official said, ‘The review of NLEM 2011 is with respect to addition/deletion of oncology drugs is to make life saving drugs affordable to every patient. It’s just a small initiative of NPPA to save the lives.’

According to the official note, the apex regulators has asked for addition of 12 drugs — Tll Trans Retinoic Acid (ATRA), Bendamustine, Rituximab, Lenalidomide, Trastuzumab, Capecitabine, Temozolomide (TMZ), Irinotecan, Erlotinib, palliative and supportive medicines such as Zoledronic acid and hormonal therapy drug Megestrol acetate and Letrozole.

According to NPPA note, Trastuzumab, which is used to cure breast cancer costs, Rs 50,583 for one vial of 440 mg strength. The approximate total cost of treatment for an average sized adult is Rs 8 lakh.

While, for the generic brands, the cost of one vial of same strength is Rs 45,000 and total cost of treatment is Rs 6.75 lakh only.

While, the centre has asked for deletion of three drugs Busulphan, Raloxifene and Danazol from the NLEM list due to their restricted use or not common usage in oncology at present.

‘The recommendations are based on careful review of the list of medications included in the NLEM, taking into consideration factors such as unequivocal proof of benefit versus previous comparator, the number of patients potentially impacted in India and price of the drug to patients and the differential in price between various brands’, NPPA note said.

The note further stated that the NPPA has been assigned with the task of evaluating the impact of NLEM 2011 in making essential and lifesaving drugs both affordable and available to all.

It has also been asked to make necessary recommendations with respect to updating the list of scheduled drugs in order to ensure that all essential and lifesaving drugs of mass consumption are under price control for safeguarding public interest, it added.

‘Comments, if any, on the above draft recommendations for addition/ deletion from NLEM 2011 may be submitted to NPPA within a period of two weeks from the date of the notice,’ NPPA said.

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