The National Pharmaceutical Pricing Authority (NPPA) proposes to bring several drugs belonging to the oncology segment under the National List of Essential Medicines (NLEM) in the forthcoming revision of the NLEM being undertaken by the union health ministry to make these now costly drugs within the reach of common people of the country.
The drugs recommended to be added to the NLEM include All Trans Retinoic Acid (ATRA) for the treatment of acute promyelocytic leukaemia (APL); Non-Hodgkins lymphoma (NHL) drug Bendamustine; Rituximab, a monoclonal antibody against CD 20 antigen; Lenalidomide, an immunomodulatory and antiangiogenic drug, which is being used in wide range of cancers like multiple myeloma; Breast cancer drug Trastuzumab; Capecitabine, indicated in gastrointestinal cancers, including stomach and colorectal cancers; Temozolomide (TMZ), a novel alkylating agent used in management of malignant gliomas; Irinotecan, a camptothecin derivative, used in various cancers such as colorectal, gliomas, glioblastomas, esophageal, stomach, cervical, ovarian, lung and mesothelioma; and Lung cancer drug Erlotinib.
The NPPA also proposes to bring some palliative and supportive medicines such as Zoledronic acid, Megestrol acetate and Letrozole under the NLEM to make them affordable to common people in the country.
The NPPA was earlier assigned with the task of evaluating the impact of NLEM 2011 in making essential and lifesaving drugs both affordable and available to all, and for making 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.
As part of the ongoing consultative study process, the NPPA now invited comments and suggestions from all stakeholders, including pharmaceutical industry and consumer organisations, on the recommendations received from the Tata Memorial Centre (Mumbai) under the Department of Atomic Energy, Government of India regarding addition/deletion of drugs relating to oncology in the NLEM 2011, before making its own recommendations in this regard to the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and the Core Committee on Revision of NLEM 2011 set up by the Ministry of Health & Family Welfare.
The recommendations are based on a careful review of the list of medications included in the NLEM taking into consideration the factors like Unequivocal proof of benefit versus previous comparator. Improvement in overall survival (OS) is ranked highest followed by disease-free and progression-free survivals (PFS) in the adjuvant and metastatic settings, respectively; Higher priority to drugs that have the potential to cure a fraction of patients versus those that have been proven to only prolong lives in metastatic setting; The number of patients potentially impacted in India based on data from population based cancer registries of the National Cancer Registry Programme; The non-availability of alternative medications of the same or other pharmacological class that can act as a reasonable ‘substitute’; and Price of the drug to patients and the differential in price between various brands.
The drugs recommended for deletion from NLEM include Busulphan, Raloxifene and Danazol which are not used commonly in oncology at present.