Amid the rising prevalence of non-communicable diseases (NCDs), cancer continues to be one of the major causes of death globally. The International Agency for Research on Cancer’s GLOBOCAN project estimates that compared to 2012 when almost one million cases were reported, the burden will almost double in 2035 to a projected 1.7 million, and the number of cancer-related deaths will increase from 0.68 to 1.2 million.
Earlier this month, a parliamentary panel asked the Centre to provide free cancer treatment to middle-class households through a government-funded health insurance scheme and to cap cancer diagnostics and treatment services in government and private hospitals.
The panel, in a report on cancer management in the country and tabled in Parliament, asked the health ministry to include middle-class households among the beneficiaries of the Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PMJAY) for cancer treatment.
It is noteworthy that the diagnosis of cancer comes with the burden of economical implications as the major proportion of out-of-pocket healthcare expenditure is borne by patients. Over the years, pharmaceutical companies across the world have developed numerous anti-cancer drugs to combat one of the world’s deadliest diseases.
As these branded drugs are usually extremely costly and which makes them inaccessible and unaffordable, especially to the deprived section. Once the patent expires, other pharma companies can start producing and selling the generic version of the drug and this brings down the cost of the drug.
However, several industry experts told Financial Express.com that there is a lack of generic options for these expensive branded drugs, especially targeted immunotherapies.
‘Generic Anti-Cancer Drugs–Need of the hour’
According to Dr. Parth Sharma, a public health physician and researcher, The Lancet Citizens’ Commission on Reimagining India’s Health System, currently, there are generic options available for chemotherapy agents which have helped in cutting down the cost but options for immunotherapies or targeted therapy are still low.
“The lack of generic options in immunotherapy or targeted therapy agents is the issue. Few pharma companies have control over these drugs which makes them unaffordable. The generic version of a drug called Trastuzumab, used for a type of breast cancer, helped in reducing the cost of the vial from nearly 60,000 to just 20,000,” Dr. Sharma told Financial Express.com.
Several studies around the globe have proved that the disease outcome is the same irrespective of whether the patient received the ‘original’ molecule or the biosimilar (generic) one.
“India being the ‘pharmacy of the world’ has the potential to generate more of such generic drugs. With better political and research support that could be possible,” Dr. Sharma added.
According to the PM Jan Aushadi Yojana annual report (2021-22), India is the largest supplier of generic medicines with a 20 per cent share in the global supply by manufacturing 60000 different generic brands across 60 therapeutic categories.
“This list could be expanded to include more cancer drugs considering it is one of the leading causes of death in the country,” he added.
According to a 2021 study published in the Cureus Journal, except for methotrexate (2.5 mg tablet), the cost of anticancer branded drugs was more than their generic counterparts sold through Jan Aushadhi pharmacies.
The study also highlighted that replacing generic anticancer drugs can result in substantial cost savings and benefit the patient requiring curative chemotherapy for breast cancer.
A drug audit suggests that, in India, almost 80 per cent of all drugs are marketed as branded molecules and are more expensive than their unbranded generic counterparts.
“Historically, cancer medicines have been sold through a separate channel called ’super specialty’ with very few distributors cornering the majority of the market. The pharma companies themselves have driven opaqueness by not allowing mass distribution of the medicines and going directly to customers through selected ‘monopoly’ partners. This has ensured that prices remained high and opaque (b) availability to most Indians was poor given limited reach (c ) no incentive for others to come given the lack of distribution,” Amit Choudhary, Co-founder and CEO, Dawaa Dost told Financial Express.com.
Choudhary also pointed out that in the last couple of years, we are seeing a few companies take the lead in terms of launching generics and finding new ways to distribute their products through traditional pharmacies.
“The critical thing that needs to be done is to break this restrictive distribution behavior and ensure that medicines are both affordable and accessible,” he added.
Anti-Cancer Drugs that should have Generic options soon
According to Choudhary, several branded anti-cancer drugs still do not have a generic alternative in India.
“For example, Pomalidomide (brand name Pomalyst) marketed by Celgene is used for the treatment of a type of bone cancer, Carfilzomib (brand name Kyprolis) marketed by Onyx Pharmaceuticals, used for the treatment of a type of blood cancer, Alemtuzumab, and Clofabine, by Genzyme which is used for a type of blood cancer, Regorafenib, marketed by Bayer Healthcare, and Panitumumba (brand name Vectibix) manufactured by Amgen for colorectal cancers and Pertuzumuab (brand name Perjeta) and Ado-trastuzumab emtansine (brand name Kadcyla) marketed by Roche as Kadcyla which is used for the treatment of breast cancer,” Choudhary told Financial Express.com.
Meanwhile, Dr. Sharma pointed out that most chemotherapy drugs have generic options. However, immunotherapy and targeted therapy still lack generic options.
“Generic molecules for drugs like Nivolumab sold as Opdyta (used for head and neck cancers among other cancers), Pertuzumab – sold as Perjeta by Roche (used for breast cancer), and various oral cancer drugs like Osimertinib (used for lung cancer) would help in improving cancer care as these drugs have been proven to be very effective and they are used for the treatment of the common cancers – breast, lung, oral,” he told Financial Express.com.
Status of Generic Anti-Cancer Drugs in India
According to a report by GlobalData, a data and analytics company, last year, the approval of generic alternatives for branded oncology medications could improve affordability, access, and adherence to treatment in India.
As per GlobalData’s data, there are currently 1,351 generic drugs available in India for the treatment of various cancers as of 26 February 2021. The data also revealed that most of these generic drugs are for haematological malignancies, such as blood cancer (606) and leukaemia (428).
In 2008, the government of India launched the Jan Aushadhi scheme, a public medicine scheme of making generic medicines available at affordable prices in select designated pharmacy stores termed as “Jan Aushadhi Kendra”.
According to a 2021 study published in Cureus journal, the cost of Jan Aushadhi generic drugs was significantly less in the case of the most important cytotoxic drugs like paclitaxel, docetaxel, doxorubicin, carboplatin, cisplatin, gemcitabine, oxaliplatin, capecitabine, and etoposide that are used either alone or in combination to treat different cancers.
However, other essential generic anti-cancer drugs like 5-Fluorouracil, Irinotecan, and Gemcitabine are not available on Jan Aushadhi’s online portal as checked by Financial Express.com on 19 December 2022.
‘Expensive cancer diagnosis and treatments’
Several studies point out that out-of-pocket expenditure for cancer treatment is the highest for any ailment in India. It is noteworthy, non-affordability and limited access to basic treatment account for a higher cancer mortality rate in India.
“While estimates indicate India’s reported cancer incidence in 2022 to be 19 to 20 lakhs, the real incidence can be 1.5 to 3 times higher than the reported cases. There are several challenges faced by cancer patients that come in the way of reducing the cancer burden in India. According to a recent study conducted by the Tata Memorial Centre, less than 3 percent of cancer patients in India have access to immunotherapy treatment, mainly due to exorbitant costs,” Choudhary told Financial Express.com.
According to Choudhary, immunotherapy is a relatively new treatment option for specific cancer cases that can dramatically improve survival and quality of life for many patients but a full dose of treatment costs nearly Rs 2.5 lakh to 5 lakh every month.
“The cost of these drugs is enormous and, unfortunately, there is a lack of fair pricing guidelines and costs are kept similar across the globe so there is limited support for patients from low and middle-income countries (LMIC) such as India,” he added.
According to a 2022 study published in the Global Oncology Journal, high-priority cancer medicines identified by Indian oncologists are generic chemotherapy agents that provide substantial improvements in survival and are already included in WHO EML.
However, access to these treatments remains limited by the major financial burdens experienced by patients. Moreover, the majority of recent blockbuster medicines in oncology are not considered a high priority by oncologists in India.
“Cancer care, even though much better than before, still remains inaccessible and unaffordable for most of the population. The COVID pandemic too had a huge impact on cancer care in India. Post-COVID we noticed a lot of patients with cancers in the last stage. The financial impact of COVID made cancer care even more unaffordable,” Dr. Sharma said.
Although chemotherapy is beneficial, it is expensive and incurs a huge financial burden on the patient and their family.
“Affordability is the initial barrier. And in my personal experience money in cancer care makes all the difference. For example, the cost of the basic chemotherapy for oral cancer would come to around 8-10k per cycle if there are no complications. However, it is proven that adding immunotherapy to the chemotherapy regimen gives great results – shrinks the tumor and even makes inoperable tumors operable sometimes. But the cost of the most commonly used agent, Nivolumab, is around Rs 1 lakh per vial,” Dr. Sharma told Financial Express.com.
How Cancer Diagnosis and Treatment has advanced in India over the years?
Globally, cancer treatment is very structured and clearly defined with proper guidelines to be strictly adhered to by the treating physician/s. According to Dr. Sharma, cancer care has significantly improved in India over the years.
“Breast cancer which was a deadly disease a couple of decades ago can now even be cured if identified at an early stage. Even in the late stage of the disease, there are multiple lines of therapy available that help the patient in living with the disease. Cancer is now more like any other chronic disease, for example, diabetes or hypertension. With multiple treatment options available for most cancers, people now live with diseases just like diabetes or hypertension,” Dr. Sharma told Financial Express.com.
He also pointed out that diagnostics have improved too with the advent of molecular and genetic testing which help in understanding the disease at a much deeper level. However, these facilities are available only in a few major cities in the country.
Earlier this year, the central government made 34 new additions to the National List of Essential Medicines with an aim to reduce “patients’ out-of-pocket expenditure”.
Several anti-cancer drugs, antibiotics and vaccines will now become more affordable as they are among 34 new additions. Four major anti-cancer drugs – Bendamustine Hydrochloride, Irinotecan HCI Trihydrate, Lenalidomide and Leuprolide acetate which are effective in various types of cancers and psychotherapeutic medicines, Nicotine Replacement Therapy and Buprenorphine, have been added to the list.