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

July 11,2024 Mumbai: Swiss biotech giant Roche has sued Zydus, claiming the Indian drug maker infringed on their patents numbered IN 268632 and IN 464646. This lawsuit involves allegations of Perjeta’s (Pertuzumab) patent infringement, specifically targeting the ‘formulation’ and ‘process’ associated with an innovator’s ‘Reference Biologic Product’. Roche contends that their suit patents are on the verge of being infringed upon by Zydus through the development of a ‘similar biologic product’. However, Dr Abhishek Manu Singhvi, Senior Counsel representing Zydus, pointed out that Roche does not have a patent registered for Pertuzumab in India. Earlier, Roche had alleged that clinical trials conducted by Zydus for Sigrima (Perjeta’s biosimilar) might have been dubious as Zydus had procured Perjeta from an unofficial supply chain, potentially compromising the biologic’s nature. Zydus refuted the allegations, stating that all reference medicinal products were carefully tested before being submitted for clinical trials. The company also confirmed that all necessary study protocols and regulations in India were followed, with results submitted to the relevant authorities. Interacting with ETPharma, an expert in the know-how of the ongoing legal battle based on anonymity highlighted that in terms of affordability and accessibility, the annual cost of Perjeta is Rs 47.6 lakh, which will be reduced to Rs 13.5 lakh with Sigrima—almost one-fourth of the cost. Within a week of its launch, over 200 patients were prescribed Sigrima. For patients needing both trastuzumab and pertuzumab, costs could reach Rs 80 lakh. Refuting the cost of trastuzumab and pertuzumab combination, Roche’s spokesperson confirmed, “With PHESGO (which is the world’s first fixed-dose combination of pertuzumab and trastuzumab), the price is practically the same as what it is for pertuzumab alone. Also note that PHESGO is a subcutaneous injection, reducing hospital time by over 90 per cent. Patients don’t need any hospitalisation like in an intravenous procedure. The interim injunction issued by the Delhi High Court on July 9, 2024, is based on significant concerns raised by Roche’s senior counsel. It was brought to the court’s attention that, amidst ongoing deliberations on the grant of an interim injunction [in IA 4196/2024], Zydus launched Sigrima, a biologic similar to Roche’s Perjeta, which comprises Pertuzumab. The senior counsel also noted that Zydus entered into a commercial licencing arrangement with Dr Reddy’s Laboratories for co-marketing their Sigrima product in India. Under such circumstances, Roche sought injunctive relief against the sale and distribution of Sigrima through an application under Order XXXIX Rules 1 and 2, claiming it infringes the patents numbered IN 268632 and IN 464646. Roche’s senior counsel emphasised that during hearings on I.A. 4196/2024, conducted on February 23, April 4, April 24, and May 13, 2024, concerns were repeatedly voiced regarding the potential launch of the impugned product by Zydus. Considering fairness, equity, and the balance of convenience, the Court found compelling reasons to issue an injunction. Accordingly, until the next date of hearing, Zydus is restrained from marketing/selling Sigrima. It should be noted that Roche has been entangled in various legal battles with Reliance Life Sciences, Biocon, Mylan, and Zydus over the approval and launch of another breast cancer drug, Vivitra (trastuzumab). The expert also highlighted, “There is no product patent in India for pertuzumab, as Roche never applied for it. Roche has a formulation patent, which Zydus has not infringed in any manner. Roche is deploying this tactic to delay the launch of biosimilars in India and thereby delay the affordability and accessibility that a biosimilar brings to Indian patients.” He continued, “Scientifically, Roche cannot fight the case based on their patents; Indian authorities have been smart enough to prevent the ever-greening of patents. Hence, these additional barriers are created to prevent the availability of biosimilars.” The expert mentioned that over 100,000 patients have benefited from Zydus’s Ujvira (trastuzumab) since its launch, highlighting that 300 patients are enrolled every month for Ujvira, whereas Kadcyla only enrols 30 patients each month on average, increasing access tenfold. The expert noted that Perjeta served 2,000 patients last year, while Sigrima could serve 12,000 patients this year. When trastuzumab and pertuzumab are administered together, it is very expensive, which can be reduced by the launch of a biosimilar. A metastatic breast cancer patient can gain 16 months of additional life. The delay in the product launch will prevent thousands of patients from gaining access to these 16 months. In terms of affordability and accessibility, the expert explained that the annual cost of Perjeta is Rs 47.6 lakh, which will be reduced to Rs 13.5 lakh with Sigrima—almost one-fourth of the cost. Within a week of its launch, over 200 patients have been prescribed Sigrima. For patients needing both trastuzumab and pertuzumab, costs could reach Rs 80 lakh. The expert questioned how many patients in India can afford this, highlighting that the safety and efficacy of Ujvira and Kadcyla were comparable. Roche has been involved in several legal battles in India over the years. The expert expressed that this is done to prevent the launch of biosimilars, as their launch would hurt Roche’s market share. As long as it serves their commercial interests, they remain in the Indian market; when it no longer serves their interests, they exit. Such a scenario impacts patients the most, who are in dire need of more affordable and accessible alternatives. Legal battles like these once again raise the question: What about patient centricity? Are all innovator pharma companies only interested in higher profit margins? Source: Pharma

July 09,2024 New Delhi: The government is actively considering doubling the beneficiary base under its flagship Ayushman Bharat health insurance scheme over the next three years, with all those aged above 70 years to be brought under its ambit to begin with, and also increase the insurance coverage to Rs 10 lakh per year. The proposals, if given a go ahead, would entail an additional expenditure of Rs 12,076 crore per annum for the exchequer as per estimates prepared by the National Health Authority, official sources told PTI. “Discussions are happening to double the beneficiary base under the AB-PMJAY over the next three years, which, if implemented, will cover more than two-third population of the country with health cover, the sources said while noting that medical expenditure is one of the biggest reasons that push families to indebtedness. “Deliberations are also underway over finalising a proposal to double the limit of the coverage amount from the existing Rs 5 lakh to Rs 10 lakh,” they said. These proposals or some parts of it are expected to be announced in the Union Budget to be presented later this month. In the interim Budget 2024, the government increased the allocation for the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), which provides health cover of Rs 5 lakh per family per year for secondary and tertiary care hospitalisation to 12 crore families, to Rs 7,200 crore while Rs 646 crore was assigned for the Ayushman Bharat Health Infrastructure Mission (PM-ABHIM). President Droupadi Murmu, in her address to the joint sitting of Parliament on June 27, had said all the elderly above 70 years of age will also be covered and get the benefit of free treatment under the Ayushman Bharat Yojana now. Those above 70 years of age add up to around 4-5 crore more beneficiaries being covered under the scheme, another source said. The limit of Rs 5 lakh for AB-PMJAY was fixed in 2018. Doubling the cover amount is aimed to cater for inflation and provide relief to families in case of high-cost treatments such as transplants, cancer etc. The NITI Aayog, in its report titled ‘Health Insurance for India’s Missing Middle’ published in October 2021, suggested extending the scheme. It had stated that about 30 percent of the population is devoid of health insurance, highlighting the gaps in the health insurance coverage across the Indian population. The AB-PMJAY flagship scheme towards Universal Health Coverage, and state government extension schemes provides comprehensive hospitalisation cover to the bottom 50 per cent of the population. Around 20 per cent of the population is covered through social health insurance, and private voluntary health insurance primarily designed for high-income groups. The remaining 30 per cent of the population is devoid of health insurance, the actual uncovered population is higher due to existing coverage gaps in PMJAY and overlap between schemes. This uncovered population is termed as the missing middle, the report stated. The missing middle is not a monolith – it contains multiple groups across all expenditure quintiles. The missing middle predominantly constitutes the self-employed (agriculture and non-agriculture) informal sector in rural areas, and a broad array of occupations — informal, semi-formal, and formal — in urban areas, the report said. The report highlighted the need for designing a low-cost comprehensive health insurance product for the missing middle. It primarily recognises the policy issue of low financial protection for health for the missing middle segment and highlights health insurance as a potential pathway in addressing that. Source: Healthworld

July 09,2024 New Delhi: Maharashtra Minister Uday Samant on Tuesday said the state government has drafted a law to crack down on bogus pathology labs, which will provide punishment to violators. During the Question Hour in the state assembly, Samant, the higher and technical education minister, said the proposed law would entail proper rules and regulations, and flying squads would be formed to check violations. Unregistered pathology laboratories will not be allowed to operate, he said. The issue concerns the urban development, public health and medical education departments, Samant said. BJP MLA Ashish Shelar said bogus pathology labs were looting money and playing with people’s lives. Several collection centres that have come up over the years should be registered, he said, demanding criminal cases against violators. NCP (SP) legislator Rajesh Tope said the Nursing Home Act should be amended if the state government can’t implement the new law soon. To this, the minister said the draft of the new law was ready, and if needed, the Nursing Home Act would also be amended. Yogesh Sagar of the BJP said pathology forms a base for any surgery, and the poor end up going to bogus labs for testing. Shiv Sena (UBT) MLA Ajay Choudhary claimed that bogus pathology labs work in connivance with government hospitals. The discussion took place on a question by BJP legislator Sunil Rane, who sought data about the number of pathology labs in Mumbai. He expressed surprise at the government’s reply that under existing rules of the Mumbai Municipal Corporation Act 1888, there was no provision for registration of pathology labs. Fire NOC, certification from the National Accreditation Board for Testing and Calibration Laboratories, certification for good clinical practices, and registration for bio-medical waste disposal are required, he said. The minister said the Maharashtra Paramedical Council had authorised 7,085 candidates to operate pathology labs since 2019, and of these, 182 were in Mumbai. There were 197 labs in civic-run hospitals in Mumbai, he added. Source: Healthworld