The main reason why cancer is so serious a disease, is the ability of the malignant cells to spread in the body, both locally by moving into nearby normal tissue, and regionally to nearby lymph nodes, tissues, or organs, affecting even the distant parts of the body. When this happens, doctors term it as metastatic or stage IV (four) cancer.
Although most patients with metastatic tumors would eventually die of cancer, the treatment with various types of anticancer drugs, could help prolong life, in varying degree. No wonder, many new anticancer drugs now obtain regulatory approval based on their effectiveness on metastatic cancer patients. Consequently, it has now become almost a routine to administer newer anticancer drugs to patients with early stage of disease, after they have undergone surgery or radiotherapy.
But, these lifesaving drugs are expensive – very expensive! For example, a newer anticancer treatment is often priced at US$ 100,000 or more per patient, which, obviously, a large majority of the population can’t just afford.
Are these new drugs cost-effective?
To put in simple words, cost effectiveness of a drug is generally ‘expressed in terms of a ratio where the denominator is a gain in health from a measure (years of life, premature births averted, sight-years gained) and the numerator is the cost associated with the health gain.’
From this perspective, a January 2015 research study titled, “Pricing In The Market For Anticancer Drugs”, published by the National Bureau Of Economic Research of the United States observed that anticancer drugs like bevacizumab (US$ 50,000 per treatment episode) and ipilimumab (US$120,000 per episode) have fueled the perception that the launch prices of anticancer drugs are fast increasing over time.
To evaluate the pricing trend of these drugs, the researchers used an original dataset of 58 anticancer drugs, approved between 1995 and 2013, and found that launch-prices, adjusted for inflation and drugs’ survival benefits, increased by 10 percent, or about US$ 8,500, per year. This study was restricted to drugs administered with the primary intent of extending survival time for cancer patients and drugs for which survival benefits have been estimated in trials or modeling studies. The researchers did not consider drugs administered to treat pain or drugs that are administered to alleviate the side effects of cancer treatments.
The paper concluded, as compared to the older ones, newer anticancer treatments, generally, are less cost-effective. Despite this fact, the prices of these drugs are rising faster than their overall effectiveness.
How much do these drugs cost to prolong a year of life for cancer patients?
Another paper, titled “Cancer Drugs Aren’t As Cost-Effective As They Used To Be”, published in the Forbes magazine on September 30, 2015, expressed serious concern on the declining cost-effectiveness of new anticancer drugs. The author termed this trend as unacceptable, and more disturbing when providing just a year of life to cancer patients costs around US$ 350,000 to even US$ 800,000. High prices should reflect large benefits, and we need to demand value out of medical interventions – he recommended.
Do the claims of efficacy also reflect the real-world effectiveness?
Providing an answer to this question, a very recent article titled, “Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines”, published in the well reputed medical journal ‘JAMA Oncology’ on December 29, 2016, concluded as follows:
“Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.”
As stated above, this conclusion was drawn by the researchers after a detail study on the overall survival, quality of life, and safety benefits of recently licensed cancer medicines, as there was a dearth of evidence on the impact of newly licensed cancer medicines.
The authors analyzed in detail health technology assessment reports of 62 cancer drugs approved in the United States and Europe between 2003 and 2013, and found that these were associated with increased overall survival by an average of 3.43 months between 2003 and 2013. Following is a summary of the detail findings:
- 43 percent increased overall survival by 3 months or longer
- 11 percent by less than 3 months
- 30 percent was not associated with any increase in overall survival, which means almost one third of these drugs lacked evidence to suggest their increased survival rate when compared to alternative treatments
- Most new cancer drugs, though improved quality of life, were associated with reduced patient safety
The researchers expect this study to support clinical practice, and promote value-based decision-making in the cancer drug treatment, besides assessing their cost-effectiveness.
Some overseas Cancer Institutes protested:
In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced through ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug at that time, from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut the price of Zaltrap by half.
Unlike India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.
In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of these drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom.
Was it a tongue-in-cheek action from India?
On March 9, 2012, India did send a signal to global pharma players on its apparent unhappiness of astronomical pricing of patented new cancer drugs in the country. The then Indian Patent Controller General, on that day, issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.
However, nothing has changed significantly since then on the ground for cancer drugs in the country. Hence, many construe the above action of the Government no more than mere tokenism.
In this context, it won’t be out of place recapitulating an article, published in a global business magazine on December 5, 2013 that quoted Marijn Dekkers, the then CEO of Bayer AG as follows:
“Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India, but for Western Patients that can afford it.”
Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.
VBP concept is gaining ground:
The concept of ‘Value-Based Pricing (VBP)’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.
Cost of incremental value that a product delivers over the existing ones, is of key significance, and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.
Intriguingly, in India, public health related issues, however pressing these are, still do not seem to arrest much attention of the government to provide significant relief to a large majority of population in the country.
Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life-saving drugs, such as, for cancer.
Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is mainly because their prices are disconnected from the actual therapeutic value of products.
Currently, a sizable number of poor and even middle-income patients, who spend their entire life’s saving for treatment of a disease like cancer, have been virtually priced out of the patented new cancer drugs market.
The plight of such patients is worse in India, and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.