NEW DELHI – India's leading cancer treatment hospital has requested the country's drug pricing regulator to delete three cancer drugs from its national list of essential medicines (NLEM), and instead add a dozen others. The regulator has put up the list in the public domain for feedback, before taking a decision.
The public-funded Tata Memorial Hospital, Mumbai, which recommended the revised list to the National Pharmaceutical Pricing Authority (NPPA), is India's leading cancer specialty hospital that treats thousands of patients daily, offering almost free treatment to the very poor patients.
NPPA recently invited comments on Tata Memorial's recommendations for the NLEM that attempts to make highly expensive essential medicines affordable by fixing a price cap.
The drugs suggested for deletion from NLEM include cytotoxic medicine Busulphan, which has restricted use, mainly as part of a conditioning regimen before autologous stem cell transplants, and Raloxifene and Danazol, which are rarely, if ever, used in India, for hormonal treatment in postmenopausal women to prevent breast cancer.
The hospital has suggested adding 12 drugs to the list, including nine cytotoxic and targeted drugs, one used for palliative support and care and two used for hormonal therapy. Those, in combination with chemotherapy, have helped improve treatment outcomes in a range of cancers in Indian patients, which justifies their inclusion in the NLEM, the hospital explained.
The cytotoxic drugs include all trans retinoic acid, or ATRA, which has improved treatment outcome in patients with acute promyelocytic leukemia, a form of bone marrow cancer; Bendamustine, used for treating non-Hodgkins lymphoma, which affects white blood cells; and Rituxan (rituximab, Biogen Idec Inc. and Roche AG), a monoclonal antibody-based drug used to treat lymphomas.
The others are Revlimid (lenalidomide, Celgene Corp.), a drug used in a wide range of cancers to improve the immune system and prevent formation of blood vessels; it also reduces transfusion requirements in more than three-quarters of patients; Herceptin (trastuzumab, Roche AG), which is used to treat breast cancer; Xeloda (capecitabine, Roche AG), which is used for gastrointestinal cancers; temozolomide for malignant brain tumors; irinotecan for second-line recurring cancers; and Tarceva (erlotinib, Roche AG and Astellas Pharma Inc.) for lung cancer.
The others in the list are zoledronic acid used for palliative and supportive care and two drugs used in hormonal therapy, megestrol acetate and letrozole in breast cancer.
Analysts working on access to affordable medicines and public health issues in India welcomed the NPPA's opening of the Tata Memorial Hospital's suggestions for public comments. "It is a progressive step as it is for the first time that a developing, or any, country has put biological pharmaceuticals in a national list for essential medicines," Leena Menghaney, a public health lawyer involved in several high-profile legal cases on drugs patents, said.
Ranjana Smetacek, director general of the Organisation of Pharmaceutical Producers of India (OPPI) observed: "An expert committee is following a robust and inclusive process, reaching out to various stakeholders across the nation. Two of six planned consultations have been completed in Mumbai and Hyderabad, respectively, while others are scheduled in Kolkata, Guwahati and so on. It is important to recognize that revision of the NLEM is still under way, and it would be premature to surmise or speculate about any suggested inclusions, before the process is complete."
MARKET GROWING DESPITE PRICES
The high prices of cancer drugs continues to be a contentious issue in India and elsewhere. India made global headlines in 2013 when its Supreme Court rejected Swiss pharma giant Novartis AG's appeal against an Indian patent court that rejected Novartis's application for a patent for cancer drug Gleevec (imatinib).
In May 2103, Blood published a joint editorial by 100 U.S. specialists treating chronic myeloid leukemia (CML), which argued for more affordable cancer drugs. Their editorial pointed out the "spiralling prices of cancer drugs in general." The specialists wrote that they believe that the current prices of CML drugs "are too high, are unsustainable, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our [U.S.] national health care systems."
"Of the 12 drugs approved by the FDA for various cancer indications in 2012, 11 were priced above $100,000 per year. Cancer drug prices have almost doubled from a decade ago, from an average of $5,000 per month to more than 10,000 per month," the doctors added.
High prices notwithstanding, some market analysts, meanwhile, predict a sustained growth for India's cancer drugs market.
A May 2013 report by Frost and Sullivan said the oncology market in India is estimated to grow to $619 million by 2017, at a compounded annual growth rate of 15.46 percent. It said biologics and targeted therapy drugs are poised to grow at a faster rate than chemotherapy drugs.
A report, titled "Oncology Market in India to 2017" by GBI Research, said the overall market for five indications – breast cancer, colorectal cancer, prostate cancer, lung cancer and non-Hodgkin's lymphoma – was at $153.4 million in 2009. It is expected to grow at a compound annual growth rate of 11.3 percent for the next eight years and will reach $361.9 million.
The GBI report identified India's large population base and increasing incidence rate, along with government support as the major drivers. But those are outnumbered by constraints that include pricing and patent issues, absence of health policies that cover cancer and reimbursement of treatment costs.