Cardiovascular diseases are a major health concern in India. According to the World Health Organisation (WHO), India accounts for at least one-fifth of the 17.9 million cardiovascular disease-related deaths globally.
The segment is a key focus area for Lupin Digital Health, a wholly-owned subsidiary of Lupin Limited. Last year, Lupin Digital Health launched Lyfe, a Digital Therapeutics (DTx) platform to address the growing burden and challenges of cardiac diseases in India.
Lyfe provides cardiovascular patients who have undergone events like angioplasty, bypass surgery and heart failure a better way to manage and recover from their condition.
Last week, Lyfe received approval as a Class C Medical Device from the Central Drugs Standard Control Organisation (CDSCO). Under LDH, a digital clinic was also launched that combines human intervention of clinicians with technology, thereby enabling easy monitoring and improving adherence to treatment resulting in better patient outcomes.
In an interaction with Financial Express.com, Sidharth Srinivasan, CEO, Lupin Digital Health (LDH) talked about the impact of Lyfe in the last one year, growth of DTx in India, upcoming business growth plans, among others. Excerpts:
How has the digital therapeutics segment evolved over the years and what and how has been the transition?
Digital therapeutics (DTx) is a rapidly evolving field that leverages technology to prevent, treat or manage medical conditions. DTx can be applied across various disease areas, with mental health management being one of the most popular. In fact, more than 25 percent of all start-ups in the therapeutic space are managing mental health through DTx because it can be treated online.
Patients can speak to their psychiatrist or counsellor online for support, which provides anonymity and helps overcome social stigma. DTx has seen a tremendous impact in this area. Similarly, we have also witnessed the importance of DTx in diabetes management. But today where we see the maximum long-term impact of DTx is in managing and treating cardiac issues. Globally, 30% of all deaths in India are attributed to cardiac issues and treatment requires a specialist – a cardiologist. However, cardiac conditions can definitely be prevented or managed. So, that’s the space that Lupin Digital Health is into. In India, we are in the very early days. In India, the market size for DTx is currently around $300 million, but it is expected to increase to around 3.5 billion in the next 5 to 8 years. While diabetes start-ups have had a couple of years to build traction, heart health management is slightly different because doctors must prescribe the treatment for the best patient outcomes. Unlike the diabetes space, DTx companies must work directly with doctors rather than only with patients.
In terms of trends in DTx, AI will create unexpected opportunities where things that were entirely done by people, may be done through technology as well. So, we can expect AI health coaches or AI health counselling, etc., to come in the next few years. For effective adoption of DTx in India, one of the first things that Lupin did was to partner exclusively with the American College of Cardiology. They are the world’s leaders in cardiovascular care and have published extensive guidelines on cardiac rehabilitation and was amongst the first bodies to give a mandatory recommendation for cardiac rehab. So, every cardiac patient must undergo cardiac rehab. Now, the European Society of Cardiology and the Cardiologists here in India have also passed those guidelines. So, it is universally recommended now. The ACC has also created a lot of patient-facing resources, and educational resources that we now translate into multiple Indian languages and make it available. The other thing that we did was we invested in multiple clinical trials as we believe in creating evidence.
We have invested in three trials – first trial which is published is called the eDxENCE post-ACS Study. The second trial called ReStart post-ACS Study, which is under publication. This study showed that in the first 90 days post discharge, patients using the LYFE Cardiac Rehab programme improved their Systolic Blood Pressure by 8 mm. The patients who were not on the program, who followed their traditional approach, their Systolic BP got worse by 6 mm. So, it was 14 mm difference in Systolic BP, more than 6 beats/min difference in heart rate, more than 0.7 percent HbA1C difference. Patients went from 6.5 A1c diabetic to 5.7 non-diabetic. So, huge results. Now we are creating something called a STEP-UP, the single largest heart failure study for DTx.
Can you provide more details on the collaboration with ACC and how it can benefit cardiac patients in India?
As a digital therapeutics company, we knew that partnering with the American College of Cardiology (ACC) would be a game-changer for us. There were three main reasons why we decided to collaborate with them. Firstly, the ACC has been at the forefront of research into digital therapeutics globally. As an association of top cardiologists from around the world, they have conducted extensive research in this field. We were able to leverage their expertise and incorporate it into our programme to create a care protocol pathway. This pathway helps guide healthcare professionals on how to provide the best care for patients with conditions such as atrial fibrillation.
Secondly, the ACC has formed a workgroup of four leading cardiologists, who act as mentors and advisors to us. These are highly respected practitioners who are also fellows of the ACC, making their guidance even more valuable. Dr. Prafulla Kerkar, Sr. Interventional Cardiologist at Asian Heart Hospital, Mumbai who earlier served as HOD of the Cardiac Sciences Department at KEM Hospital, Mumbai; Dr. S. Harikrishnan, Sr. Interventional Cardiologist and HOD, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum; Dr. JPS Sawhney, Sr. Consultant Cardiologist, Chairman – Department of Cardiology and Member, Board of Management at Sir Gangaram hospital, New Delhi and Dr. Aditya Kapoor, Professor and Head, Department of Cardiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow.
Lastly, we have created a certification program for cardiologists to recognize them as digital pioneers. This not only helps educate them about digital therapeutics but also encourages their involvement in developing the programme for the benefit of their patients. This collaboration has helped us reach patients faster and provide customized treatment guidelines for Indian patients who have higher cardiovascular risk than American patients. Adoption of our digital therapeutics solutions has been
significantly faster thanks to this partnership. Ultimately, our goal is to improve patient outcomes, and we believe that our collaboration with the ACC is helping us achieve that.
It’s been one year since you launched LYFE. How has the journey been so far?
The use of digital therapeutics for cardiac rehab has gained significant traction in India, with over 5,000 paying patients, across 280 districts of India, besides several hundred trial/study patients. This large patient pool allows for statistically significant outcomes, which is more than just anecdotal evidence. The concept has earned the trust of over 700 doctors across the country. Lupin Digital Health is now present in over 20 cities and has signed up more than 25 hospitals, with
many more in the pipeline. Signing up hospitals is crucial as most procedures happen there nowadays.
Lupin Digital Health is also conducting trials with insurance companies to demonstrate that digital therapeutics should be covered for cardiac rehab. It’s more cost-effective to pay for everyone’s rehab than to pay for patients’ re-admission. The program has been effective for patients of all ages, ranging from 14 to 92 years old, and from all socio-economic backgrounds. This has given Lupin Digital Health a lot of scale-up potential, and they are excited to continue expanding their reach.
So, for the next financial year, what are your business goals for LYFE and also for Lupin Digital Health?
As a prescription-based platform, LYFE’s primary goal is to gain trust from cardiologists. So far, we have already partnered with over 700 cardiologists, and are aiming to double that number to 1500 to reach more patients and help them manage their heart conditions effectively. LYFE expects to see significant growth in its user base for the next financial year. Currently, the platform has around 5000 patients, but we anticipate this number to increase anywhere between 50,000 to a lakh. Despite competitors in the space, we are confident of LYFE’s growth trajectory, having consistently grown at 40% month on month, which means we’re doubling every two months.
Apart from expanding partnerships and user base, our focus is on improving patient outcomes. Our First-Step module has already invested over 5000 hours in rehabilitating sick patients, and we plan to spend over 50,000 hours counseling these patients in the next year. LYFE is excited to publish the results soon.
Furthermore, LYFE is launching a new product that focuses on early-stage risk factors for heart disease. The goal is to take a preventative approach and help people manage their risk through nutrition, exercise, and other lifestyle changes. This product will make digital therapeutics accessible to the common man and prevent heart issues from arising in the first place.
To achieve this goal, we’re exploring the use of AI and technology to tackle heart conditions for patients. While we currently employ five experts for every patient, we recognize that this level of care may not be affordable for everyone. Therefore, we’re looking for ways to incorporate AI and technology into our platform to make it more accessible and affordable for all.
The global burden of chronic disease is increasing, leading pharmaceutical companies to focus heavily on chronic conditions like cardiovascular diseases. How has the management and treatment landscape evolved, particularly in India?
Heart failure is a major cardiac condition that is unfortunately under-diagnosed. Many people who succumb to heart failure are often misdiagnosed as having died of old age, when in reality it was the heart failure that caused their passing. What’s even more concerning is that heart failure is not just affecting older individuals, but also younger ones in their 30s and 40s.
Thankfully, there have been significant advancements in pharmacological treatments for heart failure. The foundational four drugs have greatly improved outcomes for patients. However, it has been recognized that medicine/treatment alone is not enough. Cardiac rehab has now been identified as the fifth pillar of heart failure management. It’s essential to ensure patients receive proper care and support beyond just medication.
In India, where cost is a major factor, the adoption of innovative drugs increases significantly once they go off-patent. For instance, when the molecule Sacubitril/valsartan went off patent, Lupin brought in products called Valentus and Arnipin, which quickly became market leaders. This allows for the same quality of treatment to be available at a lower cost. However, compliance issues still exist among patients. This is where cardiac rehab comes in. Care managers can provide counselling and support to help patients manage side effects and symptoms, and even arrange for emergency care if needed.
Globally, there is a growing awareness of the importance of cardiac rehab. For instance, in Germany, the government has invested in digital therapeutic trials for heart patients, and cardiac rehab is now paid for by the government. It’s only a matter of time before other countries and insurance companies follow suit and invest in this pragmatic approach to reducing re-admissions and improving patient outcomes.
Recently, Lancet reported on global obesity, highlighting its severity in India. Pharmaceutical companies are intensifying efforts on anti-obesity drugs, with new players entering the market. Discussions around biosimilars are prevalent. Do you believe this presents an opportunity for Lupin Digital Health to offer digital therapeutic solutions for obesity? Given your focus on preventive healthcare, how do you view obesity as a segment?
When a patient joins our program, the first step is clinical goal setting. For Acute Coronary Syndrome (ACS) patients, managing blood pressure and cholesterol levels are primary goals. However, we also take into account secondary goals that are important to the patient. Unsurprisingly, weight loss is the most requested goal among our patients. It’s understandable as people want to look good and feel good about themselves. We work with over 60-65% of our patients on weight loss, but we do it scientifically without resorting to crash diets. Our aim is to achieve a weight loss of anywhere between 0.25-1 kilo a week wherever clinically possible. We focus purely on nutrition and mobility/ exercise, and while there may be pharmacological solutions available, we focus on correcting the root cause through lifestyle modification. Conscious eating plays a big role in this process, and we educate our patients on practical tips. Portion control is also crucial, and we encourage our patients as an example to use a bowl for rice instead of leaving it on the plate.
Weight loss is not just about aesthetics, it’s also a significant cardiac risk factor. Obesity leading to cardiac issues is what we aim to prevent through our program.
LDH has launched a digital clinic. How’s its performance been, and do you plan to open more nationwide?
There are three exciting initiatives that we’ve been working on at our heart failure digital clinics. Firstly, we’re thrilled to report that over 30 percent of our patients are now enrolled in the heart failure clinic, with more than 1500 paying patients and an additional 880 patients signed up for the trial. Our focus on weight management has been particularly successful, as maintaining a healthy weight is crucial for heart failure patients to avoid fluid accumulation in the body. By managing
their weight, blood pressure, and medical protocol compliance, we’ve seen improvements in ejection fractions and overall heart health.
Secondly, we recently launched a new program called First Step, which is designed to be accessible and affordable for all patients. At a starting price of 2000 rupees, patients can access 45 days of cardiac relief, including medication management, diet and exercise guidance, symptom management, and ambulance services. We’ve already seen a great response to this program, with many patients who previously dropped off due to cost concerns now able to continue their care.
Overall, we’re proud to be making a difference in the lives of our patients and helping them achieve optimal heart health. Whether you’re a paying patient or simply interested in learning more about heart health, we’re here to help. With personalized guidance and support from our team of experts, you can take control of your heart health and live your best life.
Lupin Digital Health is a pioneer in digital therapeutics, particularly in cardiac care. With the increasing focus on non-communicable diseases (NCDs), other players are entering this segment. How does Lupin Digital Health compare to competitors, and what opportunities or challenges do you foresee in the next 5 years?
Historically, cardiac rehab in India struggled to gain traction, possibly due to a lack of funding or other reasons. However, instead of focusing on comparisons, we should welcome anyone who wants to collaborate with us. The more people promoting digital therapeutics and cardiac rehab, the better it is for patients in India. To succeed in this space, there are a few things that companies should prioritize. Firstly, invest heavily in information security from day one. This means becoming compliant with all data security rules and obtaining certifications like ISO 27001 and HIPAA compliance.
Secondly, focus on trials, science, and evidence to prove the effectiveness of your product. Investing in evidence-based prescription digital therapeutics is crucial to building trust with patients and healthcare providers. Finally, make sure to have a strong healthcare operations team in place, with experts onboard full-time to drive quality control and ensure focus.
By prioritizing these hygiene, companies can set themselves up for success in the growing sector of digital therapeutics and cardiac rehab in India.
Initially cautious, healthcare providers and tech giants like Facebook and Microsoft are now partnering due to the value of these collaborations. However, public concerns about data privacy persist, fueled by incidents like the AIMS data leak. As new players enter the scene, ensuring robust IT security is crucial. How can we ensure patient data protection as we continue to progress digitally?
As we all know, the Indian government has introduced the Digital Personal Data Protection Act (DPDP) which will provide a clear guideline for Information Security and Patient’s rights. This is great news for those who were unsure about how to proceed in the Indian context. However, there have always been gold standards to follow when it comes to data protection. One such standard is HIPAA compliance, which is the patient protection act in the US. By using this as a guideline, you can ensure that all data is encrypted and that logs are maintained for any access to patient data. It’s important ensure that the systems being used are secure.
If you have the right intentions and are thinking long-term, going the extra mile is worth it. In fact, partnering with hospitals requires even more stringent measures as they are extremely cautious about their data. It’s crucial to take data protection seriously because a single violation under the DPDP Act can result in a punitive fine of up to 250 crores. Combining regulatory enforcement and enlightened self-interest will assure people that their data is safe. So, let’s make sure we are doing everything we can to protect our data and the data of others.