July 27,2024 New Delhi: The World Health Organisation on Saturday called on countries in the South-East Asia Region to urgently scale up efforts to provide universal access to prevention, vaccination, diagnosis, and treatment of viral hepatitis B and C. Despite being preventable and treatable, these chronic infections are increasingly causing serious illness and deaths from liver cancer, cirrhosis, and liver failure in the region, a press release from WHO said. Today, liver cancer is the fourth biggest cause of cancer deaths in the region, and the second most common cause of cancer deaths among men. Almost 75 per cent of liver cirrhosis is due to hepatitis B and C infection, the press release said. In 2022, the region accounted for 70.5 million people living with viral hepatitis B and C. Early testing and treatment can cure hepatitis C and prevent hepatitis B from causing liver cirrhosis and cancer and can help reverse the predictions that liver cancer rates in South-East Asia Region are set to double by 2050 to over 200,000 deaths annually, the WHO release said. “We have the knowledge and tools to prevent, diagnose and treat viral hepatitis, yet people with chronic hepatitis B and C are still waiting to access the services they need. We need to accelerate efforts to deliver equitable services closer to communities, at the primary health care level,” said Saima Wazed, Regional Director WHO South-East Asia on the World Hepatitis Day. The theme this year is ‘It’s time for action’. Globally, hepatitis B and C combined cause 3,500 deaths per day, with 6,000 people newly infected with viral hepatitis each day. An estimated 254 million people are living with hepatitis B and 50 million people are living with hepatitis C, worldwide. Many people remain undiagnosed, and even when diagnosed, the number of people getting services and receiving treatment remains extremely low. In 2022, about 1.3 million people died of viral hepatitis, the same as deaths caused by tuberculosis. Viral hepatitis and tuberculosis were the second leading causes of death among communicable diseases in 2022, after COVID-19. In WHO South-East Asia Region, the coverage of hepatitis B and C testing and treatment remains low. In 2022, only 2.8 per cent people with hepatitis B were diagnosed, and 3.5 per cent of those diagnosed received treatment. Only 26 per cent and 14 per cent of people with hepatitis C were diagnosed and treated, respectively. “We have safe and effective vaccines that can prevent hepatitis B infection. Antiviral drugs are highly effective in controlling and preventing disease progression , managing chronic hepatitis B and curing most cases of hepatitis C. More needs to be done for these life-saving interventions to benefit each person, irrespective of who they are and where they live,” Wazed said. Hepatitis B and C affect the general population and specific populations such as those at higher risk of or with a history of exposure through unsafe blood supplies, unsafe medical injections and other health procedures; newborns and children at risk through mother-to-child transmission of hepatitis B and C, notably in settings with high viral hepatitis prevalence; indigenous populations and mobile and migrant populations from countries with higher prevalence; and key populations, including people who inject drugs, people in prisons and other closed settings and sex workers. It is important to keep the needs of people living with viral hepatitis at the centre of all efforts, and for all stakeholders, including the private sector, to work together at all levels to reverse the current impact on health. Results from several country investment case studies suggest that there is an estimated return on investment of USD 2-3 for every dollar invested in the viral hepatitis response to reverse the increasing mortality and prevent large costs of cancer treatment and care. “Viral hepatitis is a major public health challenge of this decade. With public health approach and leveraging countries’ investments in universal health coverage, elimination of viral hepatitis by 2030 is feasible,” the Regional Director of WHO, said. Source: Healthworld

July 23,2024 New Delhi: Cough syrup samples collected from more than 100 pharma units in the country have failed quality tests, according to a government report, which highlights that some had the same toxins that were found in the cough syrups that were linked to deaths of children in Gambia, Uzbekistan and Cameroon. According to the Central Drugs Standard Control Organisation’s report, the sub-standard batches were declared as “not of standard quality” (NSQ) for parameters such as diethylene glycol (DEG) or ethylene glycol (EG). It flagged it as a “matter of concern”. The report, which was presented in the health ministry, said the batches of cough syrups were declared as NSQ for parameters such as DEG/EG, assay, microbial growth, pH and volume. Out of the 7,087 batches analysed, 353 were declared as NSQ, while nine failed on account of the presence of DEG and EG. The reasons for failure on account of DEG/EG, as per the report, were “unsecured supply chain and failure to test the propylene glycol bulk for DEG/EG, among others”. Various laboratories, including the government-run and the private labs-across the country, have been conducting tests in the aftermath of reports linking India-made cough syrups to 141 child fatalities globally. India-manufactured cough syrups have been under the scanner after the World Health Organisation (WHO) in October 2022 said deaths of about 70 children in Gambia from acute kidney injury (AKI) might be linked to cough and cold syrups made by Indian manufacturers. The CDSCO, with the help of state drug control departments, has been carrying out inspections of the cough syrup manufacturing units and distributors of propylene glycol to map the supply chain. “The manufacturers have been sensitised on the use of pharma-grade propylene glycol,” an official said. In May last year, the Drugs Controller General of India (DCGI) had asked state drug controllers “to give instructions to their state-owned NABL-accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the test report at the earliest”. The Directorate General of Foreign Trade (DGFT) had also made it mandatory for exporters of cough syrups to get them tested at government laboratories and produce a certificate of analysis (CoA), effective last June. An investigation by United States Centres for Disease Control and Prevention and Gambian scientists into the deaths in the small west African country had “strongly suggested” that imported medications contaminated with diethylene glycol (DEG) and ethylene glycol (EG) led to AKI clusters among children. Source: Healthworld

July 25,2024 New Delhi: Union Finance Minister Nirmala Sitharaman presented the Union Budget on Tuesday, announcing customs duty exemptions on three cancer drugs to make them more affordable for patients. Indian Medical Association (IMA) President Dr RV Asokan said that the budget maintains the status quo for health concerns, highlighting the import duty reductions on X-ray components and cancer drugs. “This budget is status quo for health concerns, with only two silver linings: customs duty exemptions on diagnostics and cancer drugs. The economy has moved from USD 3.4 trillion to USD 4 trillion,” said Dr Asokan. “The amount of investment that governments bring out, the total national health expenditure, is around four per cent of the GDP, which works out to 13 lakh crores,” he added. “The investment in health by governments has been stagnant at 1.1 per cent of GDP. Out of this 1.1 per cent, one-third comes from the central government and two-thirds come from state governments. We are a USD 4 trillion economy. 1.1 per cent of the GDP is 3.6 lakh crores. Taking into consideration the inflation and expansion of the economy, the allocation of the health budget has gone down,” he said. “The programmes announced in the previous budget, like HPV vaccination and sickle cell disease intervention, have not been rolled out in the field,” the IMA President noted. Dr Roderico H Ofrin, the World Health Organisation (WHO) Representative to India, also praised the customs duty exemptions on three cancer treatment drugs as a commendable step. Speaking with ANI, Ofrin said, “The significant boost in fund allocation for health, including AYUSH, underscores the government’s commitment to health promotion, disease elimination, and strengthening public healthcare services.” He added, “Additionally, customs duty exemptions on three cancer treatment drugs demonstrate a focused effort to make life-saving treatments more affordable and accessible. These actions are commendable steps towards health for all.” Source: Healthworld

July 12,2024 BioArctic AB’s (publ), a Swedish research-based biopharma company, announced that its partner Eisai receives approval from the Department of Health in Hong Kong for Leqembi (generic name: lecanemab) for treatment of Alzheimer’s disease (AD). Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Hong Kong is the fifth approval following the US, Japan, China and South Korea. Leqembi’s approval in Hong Kong is based on the large global phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. In Hong Kong, 9.3% of people aged 70 years and older are living with dementia, and 32% of those aged 85 years and older, of whom 73.5% are reported to have Alzheimer’s disease. Leqembi selectively binds to soluble amyloid-beta (Aß) aggregates (protofibrils), as well as insoluble Aß aggregates (fibrils) which are a major component of Aß plaques in AD, thereby reducing both Aß protofibrils and Aß plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. BioArctic has no development costs for Leqembi in Alzheimer’s disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalty of 9 percent on global sales. In addition, BioArctic has the right to commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region. Lecanemab (Leqembi) is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab is also approved in the US, Japan, China, and South Korea with the following indications: US: For the treatment of Alzheimer’s disease (AD). It should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. Japan: For slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD. China: For the treatment of MCI due to AD and mild AD dementia. South Korea: For treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD) Lecanemab approvals were based on the large global phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal. Eisai has also submitted applications for approval of lecanemab in 13 countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the US Food and Drug Administration (FDA) in March 2024. The rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the US under Fast Track status in May 2024. Since July 2020 Eisai’s phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the development and commercialization agreement for the antibody Leqembi back-up for Alzheimer’s disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer’s disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales. BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. Source: Pharmabiz

July 17,2024 GSK plc announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will be presenting the largest head-to-head, randomised clinical trial (RCT) of the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared against the 3-drug regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) at the 25th International AIDS Conference in Munich, Germany (22 – 26 July). The presentation is one of 25 abstracts evaluating the company’s portfolio of marketed HIV treatment and prevention options alongside its next-generation pipeline assets. Harmony P. Garges, M.D., chief medical officer at ViiV Healthcare, said: “The exciting findings we’ll be presenting at AIDS 2024 continue to underscore our position as industry leaders in the development of long-acting and 2-drug regimens and our pioneering approaches to both HIV treatment and prevention. People living with HIV continue to tell us they want more treatment options to allow for more personal choice to address needs beyond viral suppression. The breadth of the data we’re announcing, including the head-to-head study between Dovato and Biktarvy, helps individuals better understand those options. We’re proud to be at the forefront of innovative science, driving advancements that have and will continue to transform the future of HIV care and contribute to ending the epidemic.” Key abstracts to be presented at AIDS 2024 by ViiV Healthcare and its study partners will include: Head-to-head study comparing ViiV Healthcare’s oral 2-drug regimen against a commonly prescribed oral 3-drug regimen: The FSG-sponsored PASO-DOBLE head-to-head RCT of the 2-drug regimen Dovato (DTG/3TC) compared with the 3-drug regimen Biktarvy (BIC/FTC/TAF) will be presented as a late breaker abstract. The non-inferiority study assessed virologically suppressed adults on an established treatment regimen and who could benefit from treatment optimisation, who were randomised to switch to treatment with DTG/3TC or BIC/FTC/TAF. Researchers will share 48-week findings on treatment efficacy and safety, as well as changes in weight experienced by participants while taking either regimen. Additional findings for DTG/3TC will include the DYAD study, presenting 48-week findings among virologically suppressed participants with no prior virologic failure who either switched to DTG/3TC or remained on BIC/FTC/TAF; and 96-week findings from the SOUND study, which followed virologically suppressed participants with unknown resistance history who switched from BIC/FTC/TAF to DTG/3TC. Pregnancy data from the HPTN 084 open label extension study for Apretude: New findings will be presented from the HPTN 084 trial that assess the impact of cabotegravir long-acting (LA) for PrEP exposure during pregnancy. The study focuses on maternal, pregnancy, and infant safety outcomes among participants who became pregnant during the open label extension of HPTN 084 and continued with injections of cabotegravir LA for PrEP. New pipeline data from ViiV Healthcare’s third generation INSTI: Researchers will share phase I findings from the first-time-in-human study of VH184, a third-generation integrase inhibitor (INSTI), along with analysis showing potent activity in vitro against multiple INSTI resistant mutations. This is the first data presentation of the company’s next INSTI as a part of its ultra long-acting development strategy. Real-world evidence from long-acting treatment regimen: Findings from several real-world studies of the complete long-acting HIV treatment regimen cabotegravir + rilpivirine long-acting (CAB+RPV LA) will be presented, including the perspectives of people living with HIV 12 months after switching their treatment regimen to CAB+RPV LA from the BEYOND study; effectiveness, participant adherence to injections, and patient reported outcomes from the German cohort of the CARLOS study; and utilisation and effectiveness of CAB+RPV LA among virologically suppressed, treatment-experienced individuals from the COMBINE-2 study. Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato. Source: Pharmabiz

July 10,2024 New Delhi: The CBI has filed a charge sheet against Ram Manohar Lohia Hospital cardiologist Parvatagouda Channappagouda, middlemen and surgical equipment suppliers in connection with the alleged bribery in recommending their stents and other paraphernalia for surgery, officials said Wednesday. In addition to Assistant Professor Parvatagouda, the CBI has also named equipment suppliers Naresh Nagpal of Nagpal Technologies, Abrar Ahmed of Scienmed, sales manager of Biotroniks Akarshan Gulati and his colleague Monika Sinha, and others. In its charge sheet filed before a special CBI court here within 60 days of busting the alleged bribery ring at the RML Hospital, the agency invoked Indian Penal Code section 120-B (criminal conspiracy) and provisions of the Prevention of Corruption Act pertaining to bribery, they said. The CBI busted the ring operating at multiple levels at the hospital on May 9, arresting nine persons, including Parvatagouda. The CBI had also arrested cardiology Professor Ajay Raj, clerks Bhuval Jaiswal and Sanjay Kumar, the hospital’s Cath Lab in-charge Rajnish Kumar, middleman Vikas Kumar, and medical equipment suppliers Naresh Nagpal of Nagpal Technologies, Bharat Singh Dalal of Bharti Medical Technologies, and Abrar Ahmed of Scienmed. The probe into roles of other accused is still ongoing and the agency may file supplementary charge sheets in the case, they said. The CBI FIR had alleged that Parvatagouda was collecting bribes from medical equipment and stent suppliers to recommend their products to the patients under treatment at the government hospital. Parvatagouda had allegedly asked medical suppliers to pay the bribes he was supposed to get as early as possible. On May 2, he asked Nagpal to pay a bribe of Rs 2.48 lakh, which the latter assured him would be done, according to the CBI. The CBI claimed that Parvatagouda also asked Ahmed on April 23 to pay all bribes as soon as possible because he was going on a summer vacation to Europe. The CBI has alleged that Ahmed had earlier made the payment of Rs 1.95 lakh in an account operated by Parvatagouda’s father Basant Gauda in March. He allegedly made a similar demand to another medical supplier Akarshan Gulati, who told the doctor that one of his employees would make the payments. Parvatagouda contacted the employee and asked her to pay Rs 36,000 through UPI and the remaining in cash, the probe agency had said. Source: Healthworld

July 09,2024 India’s pharmaceutical industry is set for significant transformation under the Modi 3.0 government. The sector’s spectacular growth over the past two decades has positioned India as a global leader, often referred to as the “Pharmacy of the World.” Prime Minister Narendra Modi has launched several groundbreaking programs in healthcare, such as Pradhan Mantri Jan Arogya Yojana, Pradhan Mantri Bhartiya Janaushadhi Pariyojana, and the successful COVID-19 vaccination drive. These initiatives have reshaped the pharma landscape, promoting preventive healthcare, robust infrastructure, and innovative technologies. With the government entering its third term, there is an optimistic outlook for further enhancements in quality healthcare through continued reforms and policies aimed at fostering innovation and streamlining regulatory processes. As India builds on its fundamental strengths, focusing on innovation is crucial to propel growth, and increase access to life-saving treatments. To strengthen innovation and research, India needs to improve regulatory policies, particularly around patent and price control, to capitalise on growth opportunities. A strong IPR ecosystem will be critical as pharma companies enhance their efforts to transform the healthcare landscape in India. Global pharma companies with a strong presence in India have partnered with Indian companies, while others are actively collaborating to foster innovations in various therapy areas. A robust IPR framework is essential for these collaborations and future partnerships to thrive. This includes implementing IP training programs, providing access to legal resources, and partnering with educational institutions to enhance IP knowledge. The government has a significant opportunity to incentivise R&D investments through fiscal measures such as deductions on R&D expenses, research-linked incentives for MNCs, and corporate tax concessions. Protecting IP rights is crucial to encourage and recognise innovation and innovators. Rare diseases pose a significant health challenge, affecting a minority of individuals but collectively impacting millions worldwide. Due to the lack of epidemiological data in the country, it has been difficult to estimate the number of persons suffering from these diseases in India. Despite the existence of the National Program for Rare Diseases (NPRD), there is a valuable opportunity for increased involvement and ownership, particularly from state governments. Strengthening infrastructure and ensuring timely patient support, particularly through the establishment of specialised Centers of Excellence (COEs) within state hospitals, is important. These COEs should have multidisciplinary teams to provide comprehensive care for individuals with rare diseases.  Incentives for developing treatments for rare diseases are also crucial. By introducing new sections granting additional incentives for R&D expenditures on rare disease medications, the government can attract substantial investment in this vital area. Furthermore, enhancing the management of rare diseases through more COEs, increased budget allocations, and import duty waivers is essential. Expanding the list of life-saving drugs eligible for GST/import duty exemptions, including all oncology medications, will further improve patient affordability. The need for a comprehensive Over-the-Counter (OTC) policy framework is paramount to creating a regulatory environment that facilitates the availability of safe and effective OTC medications. Such a framework ensures that consumers have access to reliable medications without prescription while protecting them from misleading claims and ensuring proper usage. The country’s pharmaceutical market has long been waiting for a robust regulatory framework for OTC medicines. Such a framework would have enabled and facilitated the creation of a positive list of OTC medicines and ensured their widespread availability across the country, including in remote areas. To achieve this, integrating OTC products into the Drugs, Medical Devices, and Cosmetics Bill (DMDC) and Schedule K of the Drugs and Cosmetics Rules is crucial. This integration will enhance public health by ensuring that all OTC products are properly regulated for safety and efficacy. Additionally, it will mandate accurate labelling of medications, providing patients and consumers with essential information about the products they use, thereby ensuring they make informed choices and use the medications correctly.  Strengthening intellectual property regulations and providing robust support for R&D in the pharmaceutical sector are crucial for India’s continued growth and innovation in healthcare. By fostering a more innovation-friendly environment and offering fiscal incentives, India can attract substantial investment, drive technological advancements, and ensure the development of new and effective treatments. The Modi 3.0 government has a unique opportunity to further transform the healthcare landscape, ensuring better health outcomes for all Indians and positioning the country as a global leader in the pharmaceutical industry. Source: Express Pharma

July 10,2024 Vijayawada: In a major cause for concern, one in four children and adolescents studied in Telugu states have been found to be suffering from impaired kidney functioning (IKF). This is the highest percentage of IKF cases in India. An international research study by a team of health experts from India, the UK and Australia revealed that 29.6 per cent of children and adolescents studied in Andhra Pradesh had IKF, while 19.2 per cent suffer from the renal problem in Telangana. The result of the first of its kind study was published in the recent issue of the health journal, BMC Paediatrics. The researchers were drawn from International Institute for Population Sciences, Mumbai, AIIMS, Bathinda, AIIMS, Jammu, Imperial College London, UK, and University of New South Wales, Sydney. Impaired kidney functioning is an early stage of renal problem indicating that all is not well with the working of the kidneys. Neglect of IKF could lead to major health complications like kidney failure and even death. Telugu states have a history of renal ailments with certain pockets showing a very high incidence of chronic kidney disease . In fact, Uddanam in AP is one of the handful of places in the world where the cause of the high incidence of kidney disease is not known. Even in other places in Telangana and AP the exact reason or aetiology for the kidney disease is not known though health experts have propounded several reasons including polluted water. Amidst this scenario, the BMC Paediatric study has come as a shocker. “The findings indicate the need for follow-up studies utilising internationally accepted methodologies and in accordance with the classification system to assess the prevalence of CKD accurately,” the study suggested. The researchers based their study on the data collected as part of the Comprehensive National Nutrition Survey (CNNS) 2016-18 across the country. They said data from the study provided new information to help develop the national strategy for CKD among children and adolescents. According to the CNNS data adopted by the researchers, serum creatinine (an indicator of kidney functioning) was tested once in 24,690 children and adolescents aged 5-19 years. “Our study presents the first national estimates of IKF in the paediatric population and includes several novel findings. First, there is a high prevalence of IKF among children and adolescents,” the researchers said, adding that there needs to be more such studies at frequent intervals to assess the problem. The estimated IKF prevalence amounts to around 49,000 (cases per million population). Source: Healthworld

July 10,2024 New Delhi: Advancing its efforts in systematically tackling the problem of drug resistance in the country, the national body of healthcare professionals, Indian Medical Association (IMA) announced the formation of National Alliance of Medical Professionals on Antimicrobial Resistance (NAMP-AMR). Uniting on a common platform to strategise against this important health crisis, this initiative brings together leaders and representatives of 52 medical specialty organisations/associations from across the nation, IMA said. Highlighting the severity of the problem Dr Narendra Saini, Chairman of IMA AMR, said, “AMR poses a significant threat to the health of our Nation in 2019, there were 297,000 deaths attributable to AMR and 1,042,500 deaths associated with AMR in our country. The formation of NAMP-AMR by the Indian Medical Association marks the beginning of a concerted National effort to tackle this crisis head-on.” Dr VK Paul from NITI Aayog, describing it as the right step in the right direction has affirmed their commitment to addressing AMR and expressed concern over the potential impact of it on Viksit Bharat, including prosperity, GDP, and various health aspects. “By starting from the basics and strengthening medical education, healthcare professionals can contribute to better healthcare practices and combat AMR,” stated Dr Atul Goel, Director General of Health Services (DGHS). Source: Healthworld

July 10,2024 London: Only one in four U.S. patients prescribed Novo Nordisk’s Wegovy or Ozempic for weight loss were still taking the popular medications two years later, according to an analysis of U.S. pharmacy claims provided to Reuters that also showed a steady decline in use over time. The analysis does not include details about why patients quit. But it does offer a longer view on the real-world experiences of patients taking the drugs than previous research that studied use over a year or less. Evidence that many people may stop using the weight-loss therapies not long after starting is influencing a debate over their cost to patients, employers and government health plans. Wegovy and similar medicines, which belong to a class of drugs known as GLP-1 receptor agonists, can cost more than $1,000 per month, and may require extended use to yield meaningful benefits. Their U.S. prices have drawn fire recently from President Joe Biden and other public officials, who said such drugs could cost the country $411 billion per year if only half of adults with obesity used them. That is $5 billion more than Americans spent on all prescription drugs in 2022. “GLP-1s for all isn’t cost effective,” said Dr. Rekha Kumar, an obesity specialist at New York Presbyterian-Weill Cornell Medical Center and chief medical officer at Found, an online weight-loss program. “People want to provide obesity care to their employees, but they want to do it in a way that doesn’t bankrupt them.” Prime Therapeutics and Magellan Rx Management, a pharmacy benefits manager, reviewed pharmacy and medical claims data for 3,364 people with commercial health plans that cover GLP-1 drugs. They had all received new prescriptions between January and December 2021, and had a diagnosis of obesity or a body mass index of 30 or higher. The PBM excluded patients using the drugs for type 2 diabetes, for which these medicines were originally developed. The mean age of patients included in the analysis was 46.5 and 81 per cent were female. Last year, Prime published data that found 32 per cent of patients were still taking a GLP-1 medicine for weight loss 12 months after their initial prescription. The new data shows that overall, for all the drugs included in the study, only about 15 per cent were still on their medication after two years. For Wegovy, 24.1 per cent of patients persisted with therapy over two years without a gap of 60 days or more, down from 36 per cent who had stayed on the drug for a full year. With Ozempic, which has the same active ingredient as Wegovy – semaglutide – 22.2 per cent of patients kept filling their prescriptions at two years, down from 47.1 per cent who had used it for one year. Older GLP-1 drugs fared worse. At two years, only 7.4 per cent of patients were still taking Novo’s Saxenda, a less effective weight-loss drug that some health plans require patients try before newer GLPs like Wegovy or Eli Lilly’s Zepbound. In the analysis, 45 per cent of patients were taking Ozempic or Wegovy. Others were taking Saxenda or Victoza, which are both liraglutide, Rybelsus, an oral version of semaglutide, or Lilly’s Trulicity (dulaglutide). The analysis also found that 26 per cent of patients switched GLP-1 drugs during therapy, perhaps reflecting shortages or changes in insurance coverage, according to Dr. Patrick Gleason, assistant vice president for health outcomes at Prime/MRx and a co-author of the analysis. Both Novo and Lilly have been unable to keep up with unprecedented demand for the new medicines. Source: Healthworld