Tirzepatide

New Delhi: With the World Health Organisation (WHO) endorsing GLP-1 receptor agonists as essential medicines for diabetes, patient advocacy groups in India push for their inclusion in the National List of Essential Medicines (NLEM) to break price barriers and expand access. The global health body in its 24th Model List of Essential Medicines, under the has enlisted Semaglutide —a blockbuster GLP-1 molecule —along with its other alternatives including Dulaglutide, Liraglutide and Tirzepatide. “The Expert Committee observed that, Glucagon-like peptide-1 (GLP-1) receptor agonists can help people with type 2 diabetes – especially those who also have heart or kidney disease – by improving blood sugar control, reducing the risk of heart and kidney complications, supporting weight loss, and even lowering the risk of early death, WHO said in its official release. Notably, several patient advocacy groups from India were among the first in the world to approach the WHO in 2024, seeking the inclusion of GLP-1 drugs for diabetes in the organization’s Essential Medicines List (EML). Speaking to ETPharma, Leena Menghaney, a patient advocate and Lawyer, Public Health, Pharmaceuticals & Access, called the move as a “much needed step” citing that type-2 diabetes patients also need access to insulin-sparing regimens and these medicines that have been demonstrated to reduce mortality. Menghaney further urged the inclusion of these therapies in India’s National List of Essential Medicines (NLEM) to unlock “government procurement, price caps and ensure wider access for patients.” “The inclusion in the essential medicines list is very important, as the National List acts as a guiding document for State governments in procuring and distributing medicines at public health facilities,” she added. One of the key reasons patient advocates cite for preferring GLP-1 therapies, beyond clinical benefits, is their convenience—as these drugs are administered once weekly, unlike insulin, which requires daily injections. Additionally, existing formulations come in prefilled pens, making administration easier and more convenient for patients. “We call on the Government of India to urgently make GLP-1 receptor agonists, particularly in pre-filled syringe formulations, available to diabetes patients who need them most," said Deeksha Dev, another patient advocate associated with the Alignia Wellness Foundation. The National List of Essential Medicines (NLEM) includes 384 therapies (as of the last revision in 2022) and are in “general obligation of the health administrators to ensure abundant availability of these drugs in the country.” Under the provision of the Drugs Price Control Order of 2013, India’s drug price controller National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices of the listed medicines. Notably, the listed medicines (WHO model list) includes drugs which are under patent protection and commands over at least 95 per cent of the market share. According to Menghaney, while there is no obligation to include only off-patent drugs, the demand for adding Semaglutide gains added significance with its impending loss of exclusivity, which is expected to trigger a surge of generics and a significant price drop. “The EML committee can add off-patent therapies such as semaglutide and liraglutide to the list, allowing the health system to benefit from the anticipated price reductions with generic alternatives,” She added. Besides inclusion in the essential list, Menghaney also highlighted that, along the lines of the National Viral Hepatitis Control Program (NVHCP), the Union Health Ministry could negotiate prices for these therapies on behalf of state governments, which could then offer the drugs free of cost to patients, depending on their budgets. First championed by Danish drugmaker Novo Nordisk, the Glucagon-like-peptide-1 receptor agonist (GLP-1 receptor agonist) is a newer class of drugs indicated to treat type-2 diabetes in uncontrolled traditional therapies like metformin. Marketed under the brand name Ozempic for Type–2 diabetes and Wegovy for weight-loss, Semaglutide stands as Nordisk’s crown jewel, with cumulative net sales of over $25 billion in 2024. In India, according to PharmaTrac data as of August this year, Semaglutide has a market size of Rs 421 crore and its injectable brand Wegovy reported total sales of Rs 19 crore since its launch in June. Liraglutide, also marketed by Novo Nordisk for both type-2 diabetes and weight loss indication, has lost its patent exclusivity and several domestic drugmakers including Glenmark’s–Lirafit , Eris Lifesciences–Erly Prefilled Pen are in distribution channels since last year. Meanwhile the two brands listed by WHO include Tirzepatide and Dulaglutide marketed by its arch rival and US pharma giant Eli Lilly. ETPharma earlier reported that several Indian drugmakers such as Zydus, Lupin, and Alkem, are developing their own generic versions of GLP-1 therapies, with potential launches expected in the first wave. Whereas, Bengaluru-based Biocon expects its brand to enter by 2027, indicating that regulatory pathways for these treatments are relatively more stringent over other drugs. Several estimates peggs the generic competition to bring a major price relief for patients, with the drug monthly dosage cost will go as low as up to Rs 4,000 down from the current range of Rs 14,000-Rs 25,000 depending on the brand. By Abhijeet Singh ,

For the first time, the World Health Organization has added GLP-1s and GLP-1/GIP dual agonists to its registry of essential medicines that should be available “at all times” in functioning health systems. The decision could make products like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro more widely available around the world, as the WHO’s list is used as a tool for countries identifying their own medicine priorities. Insurers may also use the list when making reimbursement decisions. The updated registry names Novo Nordisk’s semaglutide, and specifies Novo’s liraglutide and Eli Lilly’s dulaglutide and tirzepatide as therapeutic alternatives. The WHO said its decision “applies specifically to people with multiple comorbidities — Type 2 diabetes, heart or kidney disease and obesity.” “While newer studies in people with obesity alone are also showing positive results, the Expert Committee decided on a stepwise approach — starting with the patients where the evidence is most compelling and the potential public health impact is greatest,” the agency said in a statement to Endpoints News. The essential medicines list is updated every two years by an expert committee. The committee previously considered applications to include GLP-1s for the treatment of diabetes in 2017, 2021 and 2023. This time around, the WHO said in its executive summary that the committee “recognized that diabetes and obesity currently represent two major global health challenges, with both conditions reaching epidemic proportions across diverse populations and regions.” The United Nations agency estimated that more than 1 billion people worldwide are currently affected by obesity, and projected that more than 1.3 billion will be living with diabetes by 2050. It called for increased access to products like semaglutide and tirzepatide, noting that high prices are inhibitory. “Prioritizing those who would benefit most, encouraging generic competition to drive down prices and making these treatments available in primary care – especially in underserved areas – are key to expanding access and improving health outcomes,” the WHO said in a press release.