New Delhi: As the top-selling diabetes drug sitagliptin will lose its patent protection, many pharmaceutical companies are expected to launch the generic version of Merck, Sharp & Dohme (MSD) Januvia (brand name of sitagliptin) in the domestic market. The news is a huge relief for type 2 diabetes patients in India as it is expected to reduce the cost of the drug significantly.
According to 2019 estimates, 77 million people suffered from diabetes in India, which is expected to reach over 134 million by 2045. Diabetes was the ninth leading cause of death with around 1.5 million deaths directly caused by the disease in 2019.
ETHealthworld spoke to diabetes experts about the impact of price cuts on diabetes management for Indian patients.
“When a drug is off-patent and becomes available in a generic form, the price of the drug drops sharply, sometimes by more than 50-70%,” said Dr. V Mohan, Chairman and Chief Diabetologist , Dr. Mohan’s Diabetes Specialties Center and Director, Madras Diabetes Research Foundation.
Elaborating on the use and effectiveness of the drug, he added, “Sitagliptin is not a new drug and has been present in the Indian market for over 10 years. It belongs to a group of medicines called ‘DPP4 inhibitors’. These drugs are very safe because they do not produce severe hypoglycemia. There are also very few contraindications to the use of sitagliptin. Our studies and those of others have shown that DPP4 in general, and sitagliptin in particular, works very well in Indians and Asians, perhaps because we have a greater degree of insulin deficiency. Sitagliptin is already a good medicine, if it becomes more affordable, certainly many more people will benefit from it.
Speaking along similar lines, Dr Anoop Misra, President of the Fortis-C-DOC Center of Excellence for Diabetes, Metabolic Diseases and Endocrinology, said: “Sitagliptin is one of the first DPP-4 class inhibitors introduced in India. This drug has an excellent mechanism of action and benefits a variety of diabetes patients and continues to be one of the blockbuster drugs. It is without significant side effects and has a reliable hypoglycemic effect. Due to the minimal risk of hypoglycemia with this drug, it can be used with confidence in elderly patients. Sitagliptin has been extensively researched in diabetes.
Given this fact, Dr. Misra believes that many physicians will start using sitagliptin due to its low price and proven effectiveness. He estimates that around 20% of patients will be switched to a cheaper version of sitagliptin.
How Sitagliptin Works
Sitagliptin is a medicine used in patients with type 2 diabetes, a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot use the insulin it produces effectively . Hyperglycemia, or high blood sugar, is a common effect of uncontrolled diabetes and, over time, causes serious damage to many body systems.
“JANUVIA is indicated, in addition to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus,” Merck’s website states.
This means that sitagliptin is used with an appropriate diet and exercise program to control high blood sugar; However, lifestyle modification remains one of the major challenges in diabetes management in India.
Dietary indiscretions or lack of exercise are major causes of uncontrolled diabetes in India, says Dr. V Mohan. Highlighting the reasons for the huge burden of uncontrolled diabetes, he said, “In India, excessive consumption of carbohydrates is very common and nearly 65-75% of the diet in different parts of the country comes from carbohydrates. Since carbohydrates, especially refined carbohydrates like highly polished white rice and refined wheat easily convert to glucose, this elevates blood sugar levels and makes it difficult to control diabetes. Lack of exercise, sleep, and stress are still other reasons. Sometimes people don’t take their medications regularly. Most importantly, regular follow-up with the doctor is the secret to good diabetes control.”
Every patient needs a change in the dose of drugs or a combination because with age, drugs lose their effectiveness, Dr. Misra informs. “Failure to adhere to diet, exercise and medication is very common. An additional major barrier is increased weight in individuals, which hampers blood sugar control,” he added.
Uncontrolled diabetes directly or indirectly affects many organs in the body, which further impacts quality of life. This can lead to acute complications such as infections, fatigue, excessive urination, thirst, and sores that don’t heal. In the long term, it can damage blood vessels, which can affect the eyes, kidneys, heart, feet and nerves. The presence of diabetes and obesity also increases the risk of cancer.
“Lack of diabetes knowledge, self-management practices, cultural practices, insufficient counselling, lack of counseling guidelines and protocols, and financial issues further compound the problem of uncontrolled diabetes,” said Dr. Navneet Agarwal, SVP and Head of Care Programs, BeatO- an app-based digital platform that provides diabetes care programs.
Role of digital technologies in diabetes management
Technology is an integral part of diabetes care with the introduction of new products in blood glucose monitoring systems, treatment devices and app-based medical advice. The global Diabetes Care Devices Market size was valued at USD 20 Billion in 2020 and is projected to reach USD 38.3 Billion by 2030, growing at a CAGR of 6.6% from 2021 to 2030, said Allied Market Research.
Informing how technology is playing a big role in diabetes management, Dr. V Mohan, said, “Teleconsultations are now possible for patients in very remote areas. Through the use of continuous blood glucose monitoring sensors placed on the arm, one can get an idea about the blood sugar levels throughout the day. This also avoids unnecessary needle sticks and thus the pain is also reduced. Retinal cameras which were previously unaffordable, are now made in India and have become inexpensive and hence affordable for the majority of patients. Various diabetes apps are also used today which helps to connect with the patient and helps to keep sugars under good control and also to try to prevent or reverse diabetes in those who are in the early stages .”
Emphasizing that digital technologies allow patients to track, monitor and manage their condition with easy, convenient and personalized access, Dr Navneet Agarwal, said: “Digital technology can help diabetes management in many ways. She helps patients with remote sugar monitoring options. making home care more efficient and reducing the need to go to a lab or a doctor just to check sugar levels. Additionally, virtual care from doctors, diabetes educators, and AI-powered insights can help people make changes to their diet, lifestyle, and diet in real time. Studies show that digital monitoring supported by real-time, personalized care can effectively reduce incidents of hypoglycemia and improve blood sugar levels. Today, digital tools are making it easier to manage diabetes even in rural areas, thanks to widespread connectivity and pan-India penetration of mobile phones.”
Experts have emphasized strict adherence to medications, healthy eating habits, daily exercise and routine testing to effectively control blood sugar in people with type 2 diabetes. All aspects are imperative considering the number at which the burden of disease increases to become the greatest global health emergency.