The Union government’s latest National List of Essential Medicines excludes newer cancer drugs, giving patients little relief from the high cost of treatment, some doctors and activists said.
Four drugs for cancer treatment were added to NLEM 2022, which was released on September 13. With the new inclusions, the NLEM now contains 63 drugs across antineoplastics, hormones and antihormones, and immunosuppressives to treat and support cancer patients and medicines used in palliative care for terminally ill patients.
Yet, oncologists and advocates for the rights of cancer patients say India may have passed up an opportunity to make many cancer treatment, currently priced beyond the reach of the majority of the people, more affordable and accessible.
This is because none of the newer classes of drugs and biologicals that are now available to treat cancer have been included in the list that is periodically prepared to meet the priority healthcare needs of the people.
The National Pharmaceutical Pricing Authority sets ceiling prices for drugs on the list, which are selected considering factors such as disease prevalence and public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness.
Cancer crushes, financially too
According to the National Cancer Registry Programme report for 2021, almost 1.39 million new cancer cases were recorded in India in 2020 and more than 850,000 patients
succumbed to the disease. The burden of the disease in the country grows every year and is projected to reach a total of 29 million in 2025.
While it is widely established that out-of-pocket expenditure is the highest for cancer owing to its chronic nature and expensive treatment, a scientific analysis released last year by researchers associated with the All India Institute of Medical Sciences, Hrishikesh underlined just how bad it is.
The study titled Out-of-Pocket, Catastrophic Health Expenditure and Distress Financing on Non-Communicable Diseases in India: A Systematic Review with Meta-Analysis showed that the percentage of cancer patients facing catastrophic health expenditure was 62.7 percent, which is drastically high.
According to the World Health Organization, health expenditure should be called catastrophic whenever it is 40 percent or more than the capacity to pay.
New cancer drugs in NLEM
The four major drugs included in the NLEM are used in the treatment of cancers of the prostate, blood, lymph node, pancreas and other organs. These medicines are from a list of 42 anti-cancer drugs whose trade margins were fixed by the NPPA a few years ago.
Dr Sachin Marda, senior consultant oncologist with Yashoda Hospitals in Hyderabad, welcomed the development in the backdrop of rising instances of cancers in India.
Dr Aju Mathew, an oncologist and cancer researcher from Kerala, said all four medicines are important anti-cancer medicines for certain types of common malignancies.
“We hope more medicines will be designated as essential medications in subsequent editions of NLEM,” he said.
Oncologist Dr Ravi Mehrotra, who previously headed the Indian Council of Medical Research’s National Institute for Cancer Prevention and Research, called the move a “game-changer in the making.”
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The latest additions will improve the affordability and accessibility of crucial anti-cancer medicines in India, he added.
New cancer therapies
However, the All India Drug Action Network, a patient rights group, expressed disappointment that more of the highly priced, effective treatments for various cancers have not been included.
“This is an area where pharma innovation is the fastest and recognising this, the WHO has in recent years taken steps to expand the cancer section of the global Model Essential Medicines List,” it said in a statement.
AIDAN said the NPPA’s trade margin rationalisation for 42 cancer therapies was neither sufficient nor comprehensive in dealing with the steep costs of cancer medicines and cannot replace direct price controls.
The WHO’s list of essential medicines has 61 anti-cancer drugs, apart from others used in palliative care. More importantly, it includes 10 drugs that are used for targeted therapy in treating cancers – most of them under patent.
“It is important to bring some of the newer drugs, which allow personalised treatment of cancers in patients, under price control as they are ridiculously expensive and just not affordable for 99 percent of the people,” said Malini Aisola of AIDAN.
Dr Shubham Garg, senior surgical oncologist with Fortis Hospital in Noida, pointed out that the previous NLEM came out in 2015 and in the past seven years, a number of new drugs have been added in the treatment formulary of cancer.
“In the latest list, a few anti-cancer drugs have been included but it is just the tip of the iceberg of what can be done to enhance affordability and accessibility of cancer drugs in India and a lot more is required,” he said.
Patent hurdle?
It may be “very unlikely” that promising new immunotherapies or targeted therapy drugs for cancer will be brought under price control, Dr C S Pramesh, director of Tata Memorial Hospital in Mumbai, said several weeks ago in response to a query from Moneycontrol. TMH is considered the top hospital for cancer treatment and research in India.
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“Given the kind of prices there are, drug makers will just probably withdraw from the Indian market,” Pramesh had said.
Almost all new immunotherapy and targeted drugs that have hit the Indian markets over the past few years were developed outside the country and are still under patent.
But AIDAN underlined that the government has explicitly clarified that patent status cannot be the basis to exclude a medicine from the NLEM.
At least four drugs on the list – used in the treatment of multiple drug resistant tuberculosis, Hepatitis C and human immunodeficiency virus (HIV) infection – are still under patent.
“So the government could have brought some anti-cancer drugs, still under patent, too in the new NLEM,” she said.
Sandeep Rathod, a pharma legal expert with JB Chemicals, however, said that while adding patented drugs to the list is a good move, the government should also ensure their availability in India.
According to Aisola, there are tools such as compulsory licensing that can be used to get patented drugs manufactured and distributed to patients locally. Through compulsory licensing, the government may allow other companies to produce a patented drug without the consent of the patent owner.
“These decisions, of course, need to be taken with a context – on a case to case basis for specific drugs,” she said.
Aisola stressed that while for many multinational pharma companies, India may not be a priority market, they do not want to give it a complete miss either. That’s because of the sheer size of the patient pool in the country, she said.
A query seeking comments from the Organisation of Pharmaceutical Producers of India, a network of MNC pharma companies, on the inclusion of new anti-cancer drugs in the NLEM, remained unanswered.
However, OPPI had put out a statement making it clear that it was concerned about the inclusion of some patented drugs in the NLEM.
“NLEM includes four patented medicines for which companies have had robust access mechanisms in place for India,” OPPI director general Vivek Sehgal said in the statement.
“OPPI is concerned with this inclusion of the four patented drugs and the implication it has on value for innovation.”
The Indian Pharmaceutical Alliance, a group of research-oriented drugmakers from India, declined to comment on the issue.
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