Cancer Care News

Community based Cancer Care

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Is this the model to follow?

 

Community oncology clinics are closing or being acquired by hospitals at a swift pace and they are looking hard at the reasons why that’s the case, what makes sense financially and how it impacts the patient. It was argued that the site of care matters a lot and should be kept in the community setting – for the healthcare system in general and also for patients on an individual level. It has been noted that changing the site of care from low-cost physician offices to higher-cost hospital outpatient settings is one of the key cost drivers in cancer care. Reimbursement is much higher when the care is delivered in a hospital outpatient setting, rather than a physician’s office.

When a patient was told that her doctor was becoming part of a hospital system and her appointments would be at a facility 30 miles away she panicked. She was worried about the practical matter of how she would get to her appointments and how much extra time she would be spending in transit. She also worried about losing the close relationship with her clinic staff and how much more it was going to cost in a hospital outpatient setting where copays and out of pocket expenses are much higher. And what about cancers that are physically very painful or patients who are experiencing lots of complications – is asking them to travel long distances to receive care ok?

The medical profession must promote justice in the health care system, including the fair distribution of healthcare resources. Physicians should work actively to eliminate discrimination in health care, whether based on race, gender, socioeconomic status, ethnicity, religion, or any other social category. Patients should be cared for in the place where they will receive the best care at a fair price. They deserve the ability to get care in their community at a price they can afford.

Medical devices in cancer care

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A look into the current situation of the Indian manufacturing capabilities

The total market for diagnostic and medical equipment in India is worth about $3.5 billion and is expanding at an annual rate of 18%. While some “top of the line” Western device companies can sell their triple-A products to private Indian hospitals, most public hospitals will require simpler, portable, easy-to-use and more affordable versions of Western diagnostic and cancer treatment products.

Manufacture of medical electronic equipment forms a negligible part of total electronics production, but there has been a steady increase in the value of its production. In the 15 year period from 1988 to 2003, its value increased 12 fold to Rs. 421.81 crores, at about 18% per annum. [4] The increase in the manufacture of some imaging equipment, such as medical X-ray and ultrasound equipment can be attributed to the manufacture/assembly of these by multinationals such as General Electric (GE) and Siemens, for sale in India and other neighboring countries. GE has partnered with local Indian companies to develop cancer-related services and products. GE and the Indian Institute of Technology Madras’ Healthcare Technology Innovation Center (HTIC) announced a 3-year research and development agreement in January 2014. GE and India’s Max Healthcare announced a partnership in March 2014 to develop cancer treatment protocols and pathways, a training institute and a virtual expert consultation program.

Overall, while manufacturing may seem to be picking up in the country, it is more in the form of subsidiaries, as joint ventures and as part of contract manufacturing. Increasingly, multinationals and other medical device companies from the US are outsourcing several of their activities to India, as a way of reducing costs in manufacturing, R and D, clinical trials and other medical services.

Financial challenges for an Indian Cancer Patient

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According to a July 2011 paper by the Indian Statistical Institute, the average cost of cancer care per patient in a government hospital (the All India Institute of Medical Sciences in New Delhi) amounted to Rs 36,812. And reports suggested that in private hospitals, the cost of cancer treatment ranged between Rs 2 to 8 lakhs.

As of 2015, this cost jumped to between Rs. 2.5 lakhs for a six month treatment with the cheapest generics to Rs. 25 lakhs and more for extensive treatment. Some breast cancer patients, for example, need targeted treatment drugs, which cost around Rs 75,000 for a course; a patient could need up to 17 courses. Similarly, a drug called Avastin – used to treat colon, kidney, lung and gall bladder cancer – can add around Rs 8 lakh to a patient’s bill at around Rs 1 lakh a cycle. ‘Hotspot’ drugs are now used for cancers with detectable and actionable mutations for example Dasatinib, Crizotinib, Osimertinib, Levatinib etc can cost upto 1 lakh rupees per month and need to be taken for indefinite periods. CAR T cell therapy for acute leukaemia costs 360,000 USD per treatment. Immunotherapies like Keytruda fur lung and colon cancer costs Rs. 3 lakhs per dose.

Additionally, procedures cost a fortune because hospitals have to pay a fortune for imported equipment. For example, a linear accelerator, which is used for radiation therapy, costs around Rs 10 crore, plus an import duty of around Rs 1 crore. Similarly, a PET CT scan machine, used to pinpoint the location of cancers, is anywhere between Rs 3 crore and Rs 6 crore. The costliest is a CyberKnife used for radiotherapy which costs around Rs 30 crore.

The cost to treat cancer in India might be cheaper than most developed nations, but it still is heartbreakingly expensive for the average Indian. And the exponential increase in cost that we have seen over the years is set to continue, with statistical analysis showing treatment in 2020 costing anything between 10 lakhs to 50 lakhs and more. Given the state of the middle class in this country and the rising cancer incidence, these costs could potentially bankrupt a large part of our population, driving them below the poverty line.

Cancer Research in India

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Cancer research in India has grown extensively over the last two decades, both in terms of size and impact. Government and state policy makers, scientists and clinicians in India have vigorously supported cancer research from studies to achieve large-scale health outcomes using low-tech solutions to areas of highly advanced cancer science. However, there remain many issues which reveal serious gaps in public policy in India. Most importantly, there is a clear need for setting a strong research agenda across the country. 

Research systems in India need to take into consideration not only modern medicine, but also traditional medicine or what is now referred to as ‘AYUSH’: ayurveda, yoga, unani, sidha and homeopathy. With this inclusion, the research agenda for cancer becomes vast and diverse and the task of delivering cancer research programs becomes more nuanced compared with high-income, developed countries.

Adding to this complexity is the variation in research activity across different states and union territories in India. Worldwide, evidence has shown a correlation between research activity and positive outcomes for patients. However, there are large gaps in research output between states within India. Research programs have to, therefore, take into account the capacity of each state to support research infrastructure, training, and patient care. These gaps can be addressed with greater collaboration between the states and with international stakeholders. Greater engagement with pharmaceutical industries at a regional level, research on repurposing of medicines, and development of novel formulations will also go a long way in improving access to more affordable cancer treatment.

Eminent researchers and medical practitioners have recommended that policy for cancer research and development be embedded within the National Cancer Control Program. This will impact patient outcomes and improve cancer care in India and help achieve important objectives: it will help identify priority areas for research, build academic networks, assess cost effectiveness and impact of research on individual and population outcomes and develop human resources for research.

With the right support, India has the capability to be a world leader in cancer research that delivers cost-effective solutions to deliver affordable cancer care.

Biosimilars in Oncology-way to go?

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The term “biosimilar” refers to a biological product that is highly similar to a licensed biological agent (reference or originator product) with no clinically meaningful differences in terms of safety, purity, or potency. Biological agents or “biologics” are widely used in oncology practice for cancer treatment and for the supportive management of treatment-related side effects.

As biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic, exact versions of the innovator biologic. Biosimilars have the potential to increase access and provide lower-cost options for cancer care as patent protection for some of the most widely used biologics begins to expire. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization strategies that can facilitate their robust clinical development.  As such the Indian guidelines on similar biologics are comparable in many respects to biosimilar guidelines of USA and EU. India has adopted a “sequential approach” (like “stepwise approach” – US and EU) to market biosimilar products.

PROPERTIES GENERICS BIOSIMILARS
SIZE Small Large
MOLECULAR WEIGHT ~150 Daltons ~150,000 Daltons
STRUCTURE Simple and well-defined Complex with potential structural variations
MANUFACTURING Predictable chemical process to make identical copy Specialized biological process to make similar copy
COMPLEXITY Easy to fully characterize Difficult to characterize
STABILITY Relatively stable Sensitive to storage and handling conditions
ADVERSE IMMUNE REACTION Lower potential Higher potential
MANUFACTURING QUALITY TESTS ≤ 50 ≥ 250
APPROVAL REQUIREMENTS Small clinical trials in healthy volunteers Large clinical trials in patients

 

With Biosimilars, not only will patients have more treatment options, but they will also potentially have the ability to get the medications they need for serious disorders at much lower costs than the original biologics. With biosimilars becoming more widely available, consumers can expect the same efficacy, safety and reliability as the original medication at a reduced price.

Drugs

‘Orphan Drugs Act’ a crying need in India

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Orphan drugs are those used in the treatment of rare diseases (orphan diseases), hence the term orphan drugs. These drugs aren’t a lucrative proposition; therefore pharmaceutical companies do not spend a lot on their research and development. Given the challenges inherent in bringing any new medicine to market – which when research failures are accounted for, is estimated to cost over $1 billion per successfully marketed product, it is understandable that in the past, private (and public and voluntary) sector, enterprises often focused their attention on developing and supplying treatments for diseases that affect relatively large numbers of relatively affluent people. Though the percentage of patients suffering from ‘Rare Diseases’ in India is reportedly higher than the world average, unfortunately, even today, such cases get little help from our government.

Access to multi-modal treatment options is inadequate and 40-60% of the facilities and oncologists are concentrated in the top 7-8 metropolitan cities of India hampering equitable access to treatment.

  • Only 40 out of 640 districts in India have Linac installations.
  • India has only 200-250 comprehensive cancer care centers (0.2 per million population in India vs 4.4 per million population in the US), 40% of which are present in eight metropolitan cities and fewer than 15% are government operated.
  • In addition, there is a significant shortage of oncologists in India. India has only one oncologist per 1,600 new cancer patients in India, as against one per 100 and 400 new cancer patients in the US and UK respectively.

The prevalence of cancer in India is expected to increase from an estimated 3.9 million in 2015 to an estimated 7.1 million people by 2020. Real cancer incidence in India is expected to increase by 30-35% over the next five years. This should light a fire under our government and health services and a push for orphan drugs to treat cancer conditions is needed.

Cancer incidence and prevalence is so high, one might believe that it doesn’t come under rare conditions but this needs to be realized that cancer is used as a collective word for all malignant conditions that can affect the human body, and a majority of them fall under the ‘orphan diseases’ category. 1983 signaled the importance of ‘Orphan Drugs’ with the ‘Orphan Drugs Act (ODA) in the U.S. A. A decade after, in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand also have their country-specific ODAs. India must encourage its domestic pharmaceutical industry to get engaged in research to discover drugs for rare diseases by putting an ‘Orphan Drugs Act’ in place, extending financial support, tax exemptions and regulatory concessions like smaller and shorter clinical trials, without further delay.

The Price of Staying Alive with Cancer

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The World Trade Organisation and Big Pharma believe that the intellectual property of the companies must be protected, and came up with Trade-related Aspects of Intellectual Property Rights (TRIPS). In India, all drugs were generics before 2005 because there were no product patents for pharmaceuticals. India became fully TRIPS compliant in 2005 through the introduction of pharmaceutical patents, with legislation that included safeguards to protect public health. Basically, this means that if a company has patented a drug, they have a monopoly on it and there can be no generic forms or cheaper alternatives of the drug. This leads to an exorbitant price hike of the drug, leading to less and less people being able to afford it. Since patents on drugs tend to push prices up, governments, with their duties in mind, must ensure that the introduction of product patents does not jeopardize access to drug to the common people.

In India, the price control along with the amendment of patent laws in early ‘70s resulted in a declining impact on prices and the section 3 (d) amendment led to various patent rejections. Case in point, Novartis filed a suit against the ‘Union of India’ in 2006 for rejecting a patent on their drug Glivec (Imatinib mesylate). After seven long years, a landmark decision by a two-judge bench of the Indian Supreme Court upheld the rejection of the patent application (1602/MAS/1998) filed by Novartis AG for Glivec in 1998 before the Indian Patent Office. Pfizer Inc. said at the time it was, “concerned about the environment for innovation and investment in India.” Another such rejection was when officials withdrew patent protection for an emphysema drug marketed by Germany’s Boehringer Ingelheim GmbH. In 2012, India’s Intellectual Property Appellate Board revoked a Roche Holding AG patent for a hepatitis C drug saying technology involved in the drug’s invention was “obvious” and could be replicated easily.

While the possible price increase in the post WTO regime is highlighted in most of the studies, the non-introduction of new-patented drugs in India due to the weak protection regime is not discussed adequately. One of the advantages of the product patents is that the stronger patents will provide access to the latest inventions in drugs, which the developed world will not shy away from introducing in India.

If the companies wish to continue pushing for stronger product patents, they can bring down production costs by “making in India”. Meanwhile, better insurance coverage and government subsidies will further help bringing down costs of patented drugs.

To the common man, easy access to cheap drugs is the requirement as of today. Due to the low purchasing power being the foremost thought during any expenditure by the average Joe, the patent rights for health care products need to change in India, even if it means that we get newer drugs later than most.