PSM News

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

July 10,2024 New Delhi: Concerns raised by the Indian Medical Association on Bharatiya Nyaya Sanhita are unsubstantial and there is no change in punishment for causing death by negligence under it, official sources said Tuesday. The clarifications came amid some media reports stating that the IMA will hold protests against section 106(1) of BNS, the new criminal law. The section states that death by negligence caused by a registered medical practitioner while performing a medical procedure shall be punishable for two years with a fine, the sources said. “It is clarified that causing death by negligence by any person (including medical practitioners) was punishable with imprisonment up to two years or fine under section 304A of Indian Penal Code (IPC). When the Bill to replace IPC with the Bharatiya Nyaya Sanhita, 2023 (BNS) was introduced in Lok Sabha in December, 2023, the death caused by negligence was made punishable with imprisonment up to five years and fine under section 106(1) of BNS, 2023,” an official source said. The representations were received from medical practitioners and the said section 106(1) of BNS, 2023 was amended to provide that if such act of negligence is committed by registered medical practitioners while performing medical procedure, they shall be punished with imprisonment up to two years and fine. “It may be seen that the punishment for causing death by negligence by medical practitioners is imprisonment up to two years even now,” the source stated. The IMA recently wrote to Prime Minister Narendra Modi highlighting there is no criminal intent (mens rea) on the part of the doctor while treating a patient and there is no negligence to attract criminal prosecution and demanded that an investigating officer should invoke the protective provision under Section 26 of the BNS in cases of alleged criminal medical negligence. “Union Home Minister Amit Shah ji acknowledged on the floor of Parliament that death during treatment is not murder. The new BNS legislation brought up by your government reflects on this aspect in section 26. “The IMA kindly requests the government that the investigating officer invoke this provision in cases of alleged medical negligence. In the rarest of rare cases which might be considered as recklessness the investigating officer may prefer the case to an expert committee for opinion,” the IMA said in the letter sent recently. IMA president Dr R V Asokan said Section 26 of the BNS clearly states that doctors fall outside the purview of criminal law and demanded that the provision under Section 106(1) should be deleted so that doctors are exempted from criminal prosecution. “Presently, police charge doctors under Section 106(1) in cases of alleged criminal medical negligence and do not follow the provision of Section 26. A crime necessarily has to have a criminal intent. “In the absence of mens rea, doctors can be held responsible only in civil law (Law of Torts). Accordingly the IMA is committed to work towards exempting the doctors from criminal prosecution,” Dr Asokan said. The IMA in its letter to the prime minister also highlighted that doctors of the country, however, are passing through difficult times in practising the profession and that there is an ambience of fear and mistrust in hospitals. The violence on doctors and hospitals has reached epidemic proportions and is a “national shame”, it said. “Your government had initiated a Bill on violence on doctors and hospitals. It was even put up for public comments. “However, the Bill is yet to be introduced in Parliament. Your government also protected the doctors during the mindless violence during COVID by amending the Epidemic Diseases Act of 1897. “A central law in statute on attacks on doctors and hospitals will be a deterrent and would strengthen the lame duck state legislations in 23 states. Hardly any conviction has happened inspite of numerous violent incidents,” the IMA’s letter stated. Source: Healthworld

July 10,2024 New Delhi: India’s drug regulatory authority will take action against pharma companies that have failed to implement barcodes or QR codes on top 300 medicine brands. The drug regulator is also considering setting up a joint task force for fighting the menace of spurious and adulterated drugs in the country, people in the know told ET. In a recent meeting the drug regulator has asked states for “strict implementation” of barcodes. In a bid to weed out spurious drugs, the regulator had made it mandatory for the companies to have a barcode on its label so that information such as manufacturing licence and batch number can be accessed upon scanning. The top 300 brands of drugs included widely used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets. “The move was to ensure authenticity of drugs and enable tracing,” added the person. The brands identified by the National Pharmaceutical Pricing Authority (NPPA) include Dolo, Saridon Fabiflu, Ecosprin, Limcee, Sumo, Calpol, Corex syrup, Unwanted 72 and Thyronorm. They were shortlisted on the basis of their moving annual turnover value as per data from market research firm Pharmatrac. Prior to this, the health ministry had asked the department of pharmaceuticals (DoP) to shortlist top 300 drugs so that necessary amendments can be made in the drug rules for its implementation. Source: Pharma

July 10,2024 New Delhi: Nearly one in every two prescriptions issued by doctors from top govt hospitals, including AIIMS and Safdarjung, have been found to deviate from standard treatment guidelines in a study published in the Indian Journal of Medical Research. While most deviations are ‘acceptable’ as they don’t pose any threat to patient’s life, the study showed that at least 10 per cent of prescriptions had deviations that were ‘unacceptable’ as they could result in a drug interaction, lack of response, increased cost, preventable adverse drug reaction and/or antimicrobial resistance. Sample this: A patient suffering from anal fissure or tear in the inner lining of anus was prescribed two antibiotics when standard treatment guidelines suggest treatment of anal fissure in topical therapy unless it is secondary to other systemic diseases. The IJMR study said unnecessary prescription of antibiotics in such a case increases the risk of antibiotic resistance, adverse drug reactions and the cost of treatment; thus, putting the prescription in the category of unacceptable deviation. An acceptable deviation would include incomplete prescriptions with respect to formulation, dose, duration and frequency. In the study, researchers analysed 4,838 prescriptions issued by doctors posted at the outpatient departments of tertiary care hospitals across the country where the 13 Indian Council of Medical Research Rational Use of Medicine Centres are located. All prescribers were post-graduates in their respective disciplines & on average were in practice for four to 18 years. Researchers found OPDs having maximum deviations was community medicine, followed by ENT & paediatrics. “It’s possible that deviations in community medicine were more as such OPDs are run by junior docs,” the study stated. Source: Healthworld

July 04,2024 Jind: In an ongoing deadlock over pending payments, private hospitals in Haryana have stopped admitting patients under the Ayushman Bharat and Chirayu Haryana schemes. The Indian Medical Association (IMA) has called for the protest, affecting nearly 700 private hospitals across the state which refused treatment of patients. Notably, private doctors claimed that several private hospitals are empanelled under the central government’s Ayushman Bharat and state government’s Chirayu Haryana schemes. The schemes provide cashless treatment to beneficiaries, with the government clearing the dues of private hospitals. However, the state government has not released payments worth over ₹225 crore, prompting the protest statewide, said doctors. The move has left several patients in need of treatment under the schemes in a difficult situation. Gauri, Rampal, Vicky and many other patients who reached private hospitals in Jind district were forced to return as doctors refused to treat them. Shamser Singh, a native of Chhatar village of Uchana Kalan town said that “my treatment was going on in a private hospital in the city. Doctors have fixed my appointment today for conducting back bones’ operation but they refused citing payment issues. It’s up to government and private hospitals to settle down the issue but patients should not be harassed. We don’t know where to go now,” he said while expressing his Reportedly, nearly 74.33 lakh beneficiaries are covered under the Chirayu scheme in Haryana and 28.89 lakh beneficiaries are covered under the Ayushman scheme in the state. Each family gets health coverage of up to ₹5 lakh per year for secondary and tertiary care hospitalisation under the schemes. Talking to TOI, Dr Gopal Goyal said that patients who are being denied for treatment in private hospitals are being looked after in government hospitals. “We have asked our teams to speed up the process to treat such patients as per requirements,” he added. On being contacted Dr Ajay Mahajan, IMA state president, said that “today we held a meeting with Sudhir Rajpal, ACS health who assured us to clear our pending payment till July 15. We will wait as per the assurance given by him and action would be taken accordingly. We would start treatment once we get minutes of a meeting held with ACS, said IMA state president. Source: Healthworld

July 03,2024 Mumbai: Wockhardt Hospitals, Mumbai Central, has successfully completed 200 minimally invasive joint replacement surgeries utilising cutting-edge Makoplasty robotic techniques from its launch in October 2024. A substantial contribution to this milestone has been made by Dr Mudit Khanna, Senior Orthopaedic Consultant & Joint Replacement Surgeon, Wockhardt Hospitals, Mumbai Central, who has individually completed 100 of these procedures within a span of few months since its launch. The integration of the Mako Smart Robotic system has revolutionised the way complex joint replacement procedures are performed. The system is capable of performing hip replacements, partial knee replacements, and total knee replacements. The robotic system uses CT-guided pre-planning for accurate assessments and haptic technology to ensure safety, allowing for surgeries with unparalleled accuracy. This results in reduced operative time, minimised tissue damage, and faster recovery for patients. Dr Virendra Chauhan, Centre Head, Wockhardt Hospitals, Mumbai Central, stated, “A team of orthopaedicians trained in Mako robotic knee and hip replacement surgery has contributed to achieve the milestone of 200 plus robotic surgeries. We are immensely proud of Dr Khanna’s contributions and our team’s collective efforts in reaching this achievement.” Dr Khanna, sharing his thoughts on the accomplishment, said, “Reaching the milestone of 100 surgeries is just the first step in utilising the transformative power of technology in modern healthcare. Makoplasty has allowed us to redefine what’s possible in orthopaedics, enabling us to deliver better outcomes and improve the quality of life for our patients.” The hospital looks forward to the continued impact of its ground-breaking work in orthopaedic surgery. Source: Healthworld

July 06,2024 Thiruvananthapuram: Kerala’s first paediatric liver transplantation was done in Government Medical College Hospital in Kottayam district. The surgery was performed on a five-year-old child suffering from liver-related ailments, Health Minister Veena George said here in a statement on Saturday. “The child’s 25-year-old mother donated her liver. It is the first paediatric liver transplantation in the state,” she said. Paediatric liver transplantations are very rare in government hospitals, she said, adding that live surgery is a very complicated procedure. An expert tream, led by Dr R S Sindhu, head of the surgical gastro department of the hospital, carried out the complicated operation, she said. George also congratulated the doctor and her team for conducting the rare surgery. Kottayam Medical College has begun liver transplantation in the government sector for the first time in the southern state in February 2022, the statement added. Source: Healthworld