Latest News — Page 88

The South Africa Health Products Regulatory Authority (SAHPRA) has announced the successful completion of the second cohort of graduates who participated in a 12-week course for Clinical Assessors within African Regulatory Agencies. The course was developed to address the skills gap in regulatory sciences in Africa and was attended by participants from five regulatory agencies. The course was accredited by The University of Witwatersrand and was developed in collaboration with Pharmacometrics Africa and The Department of Pharmacy and Pharmacology at […]

Researchers examined immediate availability, pricing, and counseling aspects of oral emergency contraception in Berlin pharmacies. Results included: ✅ Ulipristal acetate prices ranged from €15.95 to €42.95 (median €35.00) ✅ Levonorgestrel prices ranged from €10.60 to €32.49 (median €22.00) Great access, but high price ranges pose challenges. A comparison app could help minimize costs. Pharmacy staff training is essential for providing “adequate” counseling.

Acino has collaborated with Janssen, the Pharmaceutical Company of Johnson & Johnson in South Africa, to enhance patient access to several medicines. Acino will now market and sell several of their products, focusing on pain, CNS (Central Nervous System) and Infectiology therapeutic areas in South Africa.

SFDA hosts their 1st meeting of Arab Authorities Controlling Medicines, promoting Arab integration in the field of medicines control and legislation. Topics discussed included registration procedures, monitoring safety and quality, and the role of medicines control labs. Coordination and alignment with legal and regulatory requirements for medicines are key to facilitating availability and lowering costs for patients.

Clinical trials show that using voclosporin with mycophenolate mofetil is more effective at stopping lupus nephritis from getting worse than mycophenolate mofetil alone. This option is recommended for treating active class 3 to 5 lupus nephritis in adults. The cost-effectiveness estimates are within what NICE considers acceptable for NHS resources.

Reimbursement is still dependent on authorisation and benefit limits. Some drugs included: ANTIHEMORRHAGICS Hemlibra CARDIOVASCULAR SYSTEM Volibris DERMATOLOGICALS Dupixent ANTIVIRALS FOR SYSTEMIC USE Epclusa ANTINEOPLASTIC AGENTS Blitzima and Ristova (Rituximab) Plegridy IMMUNOSUPPRESSANTS Myelenea and Filengia (Fingolimod) Unamity Tremfya DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xolair

This study discusses the importance of embedding equity in global health research and describes lessons learned from piloting the 8Quity tool for assessing equity considerations in research practices. The tool comprises eight domains of equity and provides practical resources for each stage of the research process. While tools like 8Quity are helpful, broader societal changes are needed to ensure equity in the research enterprise. However, researchers can play a role in promoting equity by setting intentions and accountabilities within their […]

Addressing Concerns for Successful Implementation of National Health Insurance in South Africa: Perspectives from Policymakers and the Role of Pharmacists in Primary Healthcare Re-engineering In this study, policymakers in South Africa were interviewed to gain insights into their perspectives on the implementation of National Health Insurance (NHI) and the role of pharmacists in primary healthcare (PHC) re-engineering. The study identified several concerns that could compromise the efficient functionality of NHI and attaining universal healthcare (UHC). These concerns included the need […]

The WHO Science Division conducted a horizon scan exercise to identify new and emerging innovations in science and technology that could significantly impact global health in the future. The article invites readers to consider the innovations from a public health perspective and to assess their potential benefits and risks.

Investments in health management capacity are important, but improving the environment in which managers operate is equally critical to achieving Sustainable Development Goal targets for health. A political economy analysis conducted in Kenya, Malawi, and Uganda revealed that while decentralization should improve PHC, it has been accompanied by thick bureaucracy, underfunded budgets, weak accountability, and insufficient public administration capacity. The emergence of COVID-19 has highlighted these challenges and underscored the need to address the disconnection between the vision for decentralization […]

The Institute for Clinical and Economic Review (ICER), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the UK’s National Institute for Health and Care Excellence (NICE) have announced changes to the way confidential information about health technologies is handled. The aim is to streamline processes and increase transparency while balancing the need to protect confidential information. The three organizations have been working together to create a more consistent approach to handling clinical data. ICER has updated its […]

Medical schemes in South Africa are prioritizing mental health as a key component of managed care services. In 2019 CMS published a PMB definition guidelines for mental health emergencies. “It is still concerning that beneficiaries of medical schemes attracted copayments as high as five (5%) for services such as a psychiatry benefit. Prior studies have also found that medical scheme members affected by mental illness and in most cases were discriminated against by funders. There needs to be a concerted […]

The Institute for Clinical and Economic Review has released a report on lecanemab, an anti-amyloid monoclonal antibody approved by the FDA for the treatment of Alzheimer’s disease. The report found that while lecanemab showed a statistically significant 27% slowing of cognitive decline compared to placebo, there are concerns about the potential harm from amyloid-related imaging abnormalities. The report also found that lecanemab’s annual price of $26,500 exceeds commonly used cost-effectiveness thresholds, and recommended efforts to achieve affordability and access. The […]

Update on the HTA Coordination Group subgroup meetings held on April 25 and 26. Their collective efforts will surely shape the HTA landscape in the long run.

Passive immunization through monoclonal antibodies (mAbs) could potentially provide immediate protection against malaria. To guide the development of urgently needed health products, WHO has published preferred product characteristics (PPCs) for mAbs in malaria prevention. These PPCs aim to reduce morbidity and mortality in infants and children due to Plasmodium falciparum, and highlight the preferred characteristics and clinical development considerations for mAbs in this area. This is an exciting development alongside the development of new malaria vaccines and chemoprevention drugs.

Tezepelumab as an add-on maintenance treatment is recommended as an option for severe asthma in people 12 years and over, when treatment with high-dose inhaled corticosteroids plus another maintenance treatment has failed. It is recommended only if people: Have had 3 or more exacerbations in the previous year, or Are having maintenance oral corticosteroids. Tezepelumab should be discontinued if the rate of severe asthma exacerbations, or the maintenance oral corticosteroid dose, have not been reduced by at least 50% at […]