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Need of the hour

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Making cancer care affordable is an urgent need in Indian healthcare and ensuring access to easy and cost-effective drugs can be pivotal in achieving this objective

Ohh No! Which stage? Will it be cured? How much will be spent to completely cure the disease? These are some of the questions which plays in one’s mind when diagnosed with cancer. The dreaded disease not only affects the sufferer mentally and physically but also financially.

In India, the incidence of cancer is growing and has spread its tentacles. The disease has not restricted itself only to the poor, it has affected the rich as well.

There are instances where celebrities like Manisha Koirala (ovarian cancer), Yuvraj Singh (Stage 1 Cancer), Lisa Ray (multiple myeloma), Anurag Basu (blood cancer) and Mumtaz (breast cancer), have successfully conquered the battle against cancer and are now leading a normal life. Most of them opted to go abroad and get cured. However, this is not the case for all.  Not everyone can afford these privileges. Having no option, poor patients are sometimes forced to sell off everything to get cured as the treatment is often costly. Often, the patients succumb to the disease despite the family members trying to give their best.

Cancer drugs are a major compnent in cancer treatment. The cancer drug market in India is valued at Rs 2500 crores and is growing at 15-18 per cent annually. So, what efforts has the Indian government taken for the cancer drug market?

Need for a revision in the NLEM list

Dr YK Gupta

Dr YK Gupta, Professor and Head, Department of Pharmacology, President, Indian Society of Nanomedicine, National Scientific Co-ordinator, Pharmacovigilance Programme of India, on being asked about the efforts been taken by the government, informs, “The government is struggling to make expensive anti-cancer medications affordable for patients. Monumental advances in healthcare have been done, yet access to affordable anti-cancer medicines
remains a major issue. This requires a multi-pronged approach.”

Elaborating on the steps already taken by the government, Gupta briefs, “The National List of Essential Medicine (NLEM) 2015 was prepared under the chairmanship of VM Katoch and myself. The list was drafted after an extensive national wide consultation process. It is a dynamic list and now needs revision after a gap of three years to keep it contemporary.”

Bhupinder Singh, Chairman, NPPA, in an address at IDMA’s 56th Annual Day in Mumbai, indicated about adding more life saving drugs to the existing NLEM list. He also informed that in future, the price regime is likely to be more strict and the government intends to bring in more changes to the existing NLEM list.

Due to government’s intervention, many cancer medicines are already covered in the NLEM list and cost of treatment has reduced significantly during the last 8-10 years.

Dr Sanjit Lamba

Dr Sanjit Lamba, MD, Eisai Pharmaceuticals, points out, “In the last few years, the cost of cancer treatment has reduced to a considerable extent. While launching products, originator pharma companies evaluates the affordability of the targeted population. Anti-cancer medication in India is five to six times less costly than in the US and other western countries. Cost of basic cancer care treatments has lowered on account of availability of lower priced generic versions and price regulations like the NLEM by the government bodies.”

However, Mohandas K Mallath, Senior Consultant, Department of Digestive Diseases, Tata Medical Center offers a counterview and says, “Cost of cancer care has actually increased in the last decade. The reason being patients opting for better treatments such as advanced scans, pathology, surgery, radiotherapy and chemotherapy. The cost of many cancer chemotherapy drugs has reduced but that is the only part of the whole treatment.”

Cost drivers of cancer treatment

Gupta and Bhupinder Singh have already spoken on the price revision in the NLEM list, however, will adding more cancer drugs to this list really help reduce the cost of cancer treatment? What are the other aspects as well which will contribute significantly in increasing the cost of cancer treatments?

Lamba informs, “In India, the cost of cancer care appears to be very high. The biggest challenge is delayed diagnosis which leads to requirement of prolonged therapy with multiple modalities like multiple rounds of chemotherapy or radiotherapy. It also includes the cost of the diagnosis tests, biopsies, surgeries, etc., which collectively drives the costs. The later the stage of diagnosis, higher is the cost of treatment.”

Mohandas K Mallath

Stressing on early diagnosis, Mallath says, “Most cancers in India are diagnosed in locally advanced or metastatic stages and hence need more diagnostic tests and more than one modality for treatment such as surgery, radiotherapy and chemotherapy or targeted therapy. This multi-modal treatment is expensive.”

He continues, “Newer treatments like robotic surgery, SBRT and IGRT radiotherapy and many targeted therapies are very costly because they are imported from developed countries.”

Dr Pradeep Mahajan, Regenerative Medicine Researcher, Adigos Stem Cells explains, “Cancer requires immediate attention and unlike other conditions does not have alternative or optional therapies. For e.g., chemotherapy and radiotherapy are mandatory in most cases. Families therefore tend to overlook treatment costs while deciding over life of the affected individual. Having said that, it must also be understood that the availability of generic drugs at government centres have increased thereby bringing down the cost of treatment for patients.”

Dr Pradeep Mahajan

Mahajan rightly pointed out the need for generic drugs at government centres. The government has already taken a step in this direction and has opened several Jan Aushadhi stores across the country and there are plans to start many more in the coming years.

However, to accomplish the government’s vision successfully, do pharma companies have enough cancer medicines?

Availability of cancer medicines

The standard drugs required for various forms of cancer (cisplatin, epirubicin, methotrexate, vincristine, chlorambucil etc.) are available in either generic or branded forms. R&D wings of large Indian pharma firms are striving to ensure adequate anti-cancer drugs in their product pipeline with an aim to meet the ever increasing demands.

In the past five years, around 70 new oncology treatments have been launched and are being used to treat over 20 different types of tumour. Many more such drugs are in the pipeline at various stages of clinical trials. In all ~77 companies, inclusive of MNC’s and domestic entities, operate in the market. There are ~140 molecules in the cancer market with ~1337 brands. Most of the MNCs are present in the market with their innovator products while the domestic companies generally are present with the generic versions.

Singh informs about Eisai Pharma’s product basket and says, “In the oncology space, our in-house research brand- Halaven, which is indicated in mBC, was recently approved in India for soft tissue sarcome (STS) as well. Recently, we have launched an in-house innovator research molecule- Lenvatinib (Lenvima) indicated in a niche indication of Differentiated Thyroid Cancer (DTC). Lenvima is currently indicated for DTC. The molecule is also under study for hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC), which will ensure meaningful survival for patients.”

Singh further says, “Eisai globally has around six molecules in its pipeline being developed in-house, which are currently at different stages of development. In addition, globally, we have also collaborated with other innovator for development of newer molecules in cancer segment.”

The Siege of Cancer

According to the National Cancer Registry and reports from the Indian Council of Medical Research (ICMR), breast cancer accounts for 27 per cent of all cancers while 22.9 per cent women suffer from cervical cancer. Similarly, oral cancer is the most prevalent cancer in Indian males. This type of cancer is primarily attributed to consumption of tobacco and smoking. In case of females, breast, cervix and ovary cancers are more prevalent.

Alongwith tobacco,sexually transmitted diseases (syphilis, human papilloma virus etc.), infections and weakened immune status are also causes of the different types of cancers. There has been a significant rise in oral, lung, stomach, prostate and colorectal cancer among male population while the female population is showing increased rates of uterine/ ovarian, breast and cervix cancers. These cancers account for almost 50 per cent of all deaths in our country.

There are more than 120 types of cancer and related hereditary syndromes and many of these cancer cases are due to lifestyle changes. The prevalence of these cancer cases have been attributed largely to urbanisation.

Other pharma companies too have been ramping up their portfolio of oncology drugs. Among the newsmakers are Sun Pharma, which has acquired the skin cancer drug Odomzo from Novartis.

The cancer drug market in India is a very niche segment as compared to the pharma market consisting of acute and other chronic therapies. Underlining the need for newer class of treatment methods, Mahajan stresses, “Research on newer therapeutic modalities to treat cancer will aid in reducing burden on the existing conventional forms of therapy. Specific cancer targeted therapy, hormone therapy, immunotherapy etc. are now garnering attention owing to utilisation of biological molecules, thus being safe and effective treatment modalities.”

The newest category of cancer drugs are immunotherapy agents that act directly on the immune system, by antagonising cancer cells. Some examples are Nivolumab and Pembrolizumab, which were launched in India six months back for lung cancer and melanoma.

Mallath also recommends that along with research there is a need to prevent people from consuming tobacco because tobacco-related cancers (oral, lung etc.) have been projected to increase by 30 per cent by the year 2020 amongst the Indian male population. He suggests, “We need to do more research with old drugs as well as discover new ones. We need to prevent cancer by tobacco control, vaccinations, improvement of general diet of the population and creation of places for improving physical activity and fitness. This will help reduce deaths from many diseases that are more common than cancer including heart disease and diabetes.”

Learnings from HIV management

“If we look back at the start of the millennium, India broke the worldwide stranglehold of high cost anti-retro viral therapy drugs by supplying generic anti-retro viral drugs (ARV) at low cost to the HIV-AIDS epidemic stricken African nations. Since then, India has been a major supplier of ARVs across the world. Today, India is at the brink of another such revolution, this time in terms of cancer drug therapy. New alternative therapies that are gradually shifting focus from chemotherapy to specific cancer targeted therapy, immunotherapy and hormone therapies drive the Indian oncology drug market,” informs Mahajan.

What are the other steps needs to be taken to prevent cancer?

Conquering cancer

Mahajan suggests, “The first step should always aim towards prevention and creating awareness amongst masses to ensure early diagnosis and prompt treatment. Improving public health education is important, as is introduction of programmes to curb tobacco use and promote healthy living.”

Prof Gupta says, “Access to affordable quality medicines is a global challenge and more critical in developing socio-economy country like India.” However, the cost of cancer treatments can be brought down if the disease can be diagnosed at an early stage, since, we have better diagnostic modalities that facilitate early screening, diagnosis and prompt treatment planning of various cancers.”

Commenting from a treatment perspective, Singh asserts, “ Availability of biosimilars, MAbs and TKIs along with generics have also helped in driving the costs lower.”

Providing financial assistance

Cost of many cancer chemotherapy drugs have reduced but that is the only part of the whole treatment. What can be done to provide financial assistance to cancer patients?

Due to inadequate cancer care system, patients and families have to pay most of the treatment cost from out-of-pocket, which results in drop outs due to bankruptcy and loans. Singh believes that with respect to pharma companies, initiatives should be taken to ensure that the products should be priced in such a way that the common masses can afford it. He remarks, “Alternately, tiered pricing programmes, based on the income group segmentation, should be focussed upon to increase access to medicine. In line with our human health care (hhc) philosophy, Eisai
constantly strives to bring in the market the products that address the unmet medical needs.”

As the awareness of the disease is increasing among people, many are opting for insurance schemes. From the perspective of pharma companies as well, the companies are proactively introducing differential or tiered pricing programme to ensure that their products are affordable.

Mahajan says, “Health insurance plays a key role in healthcare delivery. At present, only one-fifth of the Indian population has healthcare insurance, of which cancer cover is even lower. In most cases, critical illnesses and medications do not fall under the cover of insurance policies. It may be beneficial to include cancer and other high-risk disease medications under insurance schemes which will enhance accessibility to the otherwise financially compromised sections of the society.

India needs strong funding from both public and private sectors to launch cancer care products which address end-to-end cancer treatment expenditure.”

He further continues, “Government policies or public-private partnership schemes must be announced to ensure that insurance is available to every individual irrespective of social status.

There are several schemes/ initiatives run by the government like Rashtriya Swasthya Bima Yojna (RSBY), Vajpayee Arogyashree Scheme, etc. to ensure that people suffering from cancer take the insurance benefits. In addition, the government is setting up hospitals across the states in India to cater to the population who are below the poverty line.

Singh feels, “Government should also take initiatives to ensure that cost of cancer care is optimised. Both at the state and central government levels, a structured assessment of existing healthcare policies for delivery of affordable cancer care is needed.”

Many public private partnerships have also come up, which help to address the concern of access. Noticeable increase in the number of cancer specialists have helped to diagnosis the disease at a nascent stage, which leads to early detection and treatment of cancer.

Prof Gupta suggests, “Government needs to ensure that the price of these medicines are within the affordable range, there is subsidy and should be made available from government supply where they are not covered by some insurance policies. These medicines are those which will take care of most cancers in the country. The major thrust should be to bring these medicines under check and ensure their affordability.”

“Setting up of cancer institutes in tier II and tier III cities will go a long way in addressing the need of patients. Ensuring compulsory practice by professionals for a pre-determined tenure in these cities, will help to improve the infrastructure in non-metro region of the country. In addition to initiatives like NLEM which keep the price of medicines in check, the government should also take initiatives to ensure that fees of procedures like surgeries and radiation sessions, are kept a close eye on to ensure a more holistic approach towards making a therapy available and affordable.”

He further reaffirms, “To bring down the cost, committees have suggested compulsory licensing of cancer drugs. This will allow pharma companies to make generic versions of patented medicines at lower costs. As an example, recently, Natco Pharma acquired the Indian Patent Office rights to manufacture generic version of a drug used to treat certain types of renal and liver cancers. This brought down the manufacturing cost to less than five per cent of the branded version.”

Regulatory bodies too need to bring changes in speeding up the regulatory process.

Need faster regulatory process

In India, pharma companies are asking the regulatory bodies to speed up the approval process, which will improve accessibility and also affordability. Prof Gupta highlights, “Regulatory approval of such drugs should not be conventional longer phase III trials of thousands of patients. Some time an anticancer drug is developed for one indication but later with bridging studies gets approval for another indication. In such cases simply because of increased market size the price can be reduced voluntarily.”

Singh says, “Early detection will in turn help to increase the number of screenings, leading to increased diagnosis and lower cots.”

Singh says, “At a preliminary level, it is assumed that anti-cancer medications are priced very high. However, on a closer look, this doesn’t seem to be the case. Anti-cancer medications are multi-times less costly as compared to the western countries.

The government along with private stakeholders need to take proactive steps to ensure that people suffering from cancer gets the right treatment and are insured. The government needs to invest more in creating centres like Tata Memorial. A number of initiatives should be taken by each and every stakeholder of the community to ensure that cancer care becomes affordable and accessible. The first and foremost step is to increase awareness of the disease so that the population in general becomes more aware about the disease, which will help a long way in early detection of the disease. Along with creating awareness, pharma companies too need to analyse about the affordability before launching a product in India.

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