NAVLIN Brief
Australia is grappling with major shortages of more than 300 drugs, a number that is expected to soon top 400. Among the indications impacted by the shortage are contraception, depression, diabetes, hormone replacement therapy, nausea, and stroke. To fulfill some of the shortages, Australia’s federal government recently signed a supply guarantee contract agreement requiring drug makers to keep a reserve of at least four- or six-months’ worth of select medicines covered by the Pharmaceutical Benefits Scheme (PBS). The requirements, which begin in July 2023, are paired with price increases for as many as 900 products.
Colombia’s Health Ministry (MINSALUD) has published a draft of the Institute of Health Technology Assessment’s (IETS) methodology for setting the maximum sale prices of new medicines, considering its own therapeutic evaluations.
The National Association of the Spanish pharmaceutical industry (Farmaindustria) has put forward a new set of measures it believes will help ensure patient access to new medicines, and “reverse the deterioration in the indicators of access to innovation” in Spain.
The Details
Covid-19
The European Commission has announced that it has signed a contract with Gilead Sciences for the procurement of up to 2,250,000 vials of Veklury (remdesivir), the company’s COVID-19 antiviral. The agreement covers purchases of Veklury for the next year and has the option to be extended for an additional six months. Veklury is the only antiviral indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen in the European Union (EU) and European Economic Area (EEA).
The European Commission has amended its existing Advance Purchase Agreement (APA) with Valneva, significantly reducing the number of doses purchased from 27 million in 2022 to just 1.25 million. The amendment also proposes a further, optional 1.25 million doses, whereas the original contract was signed for a total of up to 60 million doses of VLA2001 over the course of two years.
Through a joint venture with majority-owned TSB Therapeutics, Brii Biosciences is partnering with China Resources Pharmaceutical Group (CR Pharma) to advance stockpiling, channel distribution, and hospital access to COVID-19 therapeutic, amubarvimab/romlusevimab in China.
Emergency approval for a COVID-19 antiviral pill developed by Shionogi & Co. was delayed by a panel from Japan’s health ministry until more clinical data is available. The Japanese government has already agreed to purchase roughly one million doses of the antiviral once approval is granted, and Shionogi plans on producing as many as 10 million doses of the drug per annum.
The Union Health Ministry has asked Global Alliance for Vaccines and Immunization (GAVI) to supply five crores (50 million) of the allocated ten crores (100 million) doses of Covishield to India under the COVAX facility free of cost, Indian business media sources said. According to the business media sources, the Serum Institute of India (SII) has stated that if these 100 million free doses of Covishield are not taken by the Indian Government timely, it will lead to wastage of the life-saving vaccines amid the pandemic outbreak.
Policy
Australia is grappling with major shortages of more than 300 drugs, a number that is expected to soon top 400. Among the indications impacted by the shortage are contraception, depression, diabetes, hormone replacement therapy, nausea, and stroke. To fulfill some of the shortages, Australia’s federal government recently signed a supply guarantee contract agreement requiring drug makers to keep a reserve of at least four- or six-months’ worth of select medicines covered by the Pharmaceutical Benefits Scheme (PBS). The requirements, which begin in July 2023, are paired with price increases for as many as 900 products.
The National Association of the Spanish pharmaceutical industry (Farmaindustria) has put forward a new set of measures it believes will help ensure patient access to new medicines, and “reverse the deterioration in the indicators of access to innovation” in Spain.
Similarly, the Spanish Association of Generic Medicines (AESEG) has published a document of proposals for a new regulatory framework for value-added medicines. The proposals include a series of action proposals aimed at establishing a new regulatory framework for value-added medicines (VAM), analyzing the regulatory options for this type of drug. The document was prepared by a group of experts with the purpose of “debating and reflecting on” the VAM concept and how these medicines are perceived by the different agents that make up the National Health System (SNS), as well as their process of evaluation and reimbursement, as well as the possibility of establishing specific regulations for this group of drugs.
The Japan Pharmaceutical Association’s “Basic Policy for Economic and Financial Management and Reform 2022” bill has been approved by the government’s Cabinet. Notably, for the pharmaceutical industry, the bill wants to use Japan’s learnings from COVID-19 and “seek to respond to emergencies such as new infectious diseases.”
The Ministry of Health has a list of 122 generics it deemed as priority drugs, which the ministry must now ensure are supported with studies demonstrating they are equally as effective as their respective originator counterparts. In Costa Rica, doctors can prescribe generics that have been cleared for marketing but lack studies confirming their efficacy is commensurate to that of the branded versions.
The Ministry of Health (MoH) has announced its key plans as part of the country’s Recovery and Resilience Mechanism Plan, to help move towards a “sustainable, human-centered, comprehensive, high-quality and understandable health care system” via “far-sighted” changes that could help facilitate an integrated approach in health care. The proposed changes to the system are backed by funding of around EUR 830,000, of which EUR 700,000 is from the Recovery Fund, while almost EUR 130,000 is from the state budget intended to cover value-added tax.
The Health Department has distributed drugs for Spinal Muscular Atrophy (SMA) free of cost to 14 children with the rare disease, Kerala Health Minister, Veena George, has said in a statement, Indian Daily THE HINDU reported. The only drug available in India for SMA is Evrysdi (risdiplam). Through crowdfunding and government contribution, the government provided the drug, which costs ₹6 lakh ($7,500) per vial, to 14 children.
HTA
After recommending another 11 medicines for approval at its July 2022 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has adopted positive opinions for 58 medicines to date.
The Zorginstituut has issued a positive opinion for reimbursement of Opdivo (nivolumab) from the basic package for the treatment of patients who have a tumor with a rare abnormality (dMMR or MSI) and for whom no other treatment is available.
The National Healthcare Institute (Zorginstituut) has advised the Netherlands’ Minister of Health, Welfare and Sport (VWS) to only reimburse Roche’s Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA) if the company agrees to reduce the price “significantly”. In the interim, the minister has placed the therapy in the Netherlands’ lock for expensive medicines.
The Package Advisory Committee (ACP) has advised the Zorginstituut not to include Trodelvy (sacituzumab govitecan) under basic insurance for the treatment of some unresectable or metastatic triple-negative breast cancer (mTNBC) patients, unless it receives a price reduction of at least 75%.
EUnetHTA 21 has opened the public consultation for D7.1 – it is deliverable on guidance on interaction between the Health Technology Developer and HTA, which will now be open for comment until midnight on August 19. In a release, it explained that the objectives of this deliverable are to produce practical guidance for HTA/HTD interaction, by defining objectives and extent of interaction between HTA agencies and HTD for JCA/CA and JSC.
Pricing & Reimbursement
Colombia’s Health Ministry (MINSALUD) has published a draft of the Institute of Health Technology Assessment’s (IETS) methodology for setting the maximum sale prices of new medicines, considering its own therapeutic evaluations.
After garnering South Korea MFDS approval in May 2021 to treat SMA type 1, Novartis’ Zolgensma has been given a price of KRW 1,981,726,933 and will be part of a performance-based risk-sharing agreement (RSA) for the next five years, which is set to kick off this August. During the first year of the RSA, 14 patients are set to receive the gene therapy, of whom seven have already been administered Biogen’s Spinraza, and South Korea will re-evaluate the reimbursement standard for Zolgensma in four years based on its efficacy.
A new report, published by the World Health Organization (WHO), has found that Bulgaria has a high incidence of catastrophic health spending compared to other European countries. According to findings presented at the Bulgarian parliament, one in five households incurred out-of-pocket payments that exceeded their capacity to pay for health care by at least 40%.
Gavi, the Vaccine Alliance, has opened a process for countries to apply for funding and support the rollout of the world’s first malaria vaccine. This first application window, which closes on 13 September, will be limited to the three countries that have taken part in the vaccine’s multi-year pilot program: Kenya, Ghana and Malawi. In the future, a second window will open, which will then be open to other countries with moderate to high transmission rates.
Spain’s drug pricing commission, CIPM, fixed prices for Bayer’s Xarelto (rivaroxaban), Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), and BMS’s Eliquis (apixaban), all of which are used to prevent strokes and prevent and treat venous thromboembolism. The price cuts initiated by CIMP were supported by Article 96.2, which allows adjustments to the prices of medicines due to changes in economic, technical, or health standards, considering the availability of therapeutic alternatives at a lower cost.
Canada’s government has inked a four-year agreement with GlaxoSmithKline (GSK) to ready itself for the possibility of a sustained influenza pandemic, announced the Public Health Agency of Canada. In the event of an influenza pandemic, the contract can trigger the procurement of 80 million doses of influenza vaccine. Further, on an annual basis, GSK is expected to supply at least 4 million doses of seasonal influenza vaccine to publicly funded vaccination programs, with first deliveries planned for September and October 2022.
Drug Approval
EMA has given Junshi’s toripalimab Orphan Drug status for the treatment of nasopharyngeal carcinoma (NPC), a less-common cancer in Europe for which there are emerging novel therapies, but none yet approved, according to Junshi Chief Medical Officer, Dr. Patricia Keegan.
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Byondis B.V.’s investigational next-generation anti-HER2 antibody-drug conjugate (ADC) SYD985 (trastuzumab duocarmazine) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
The European Medicines Agency (EMA) has adopted a positive opinion on Bavarian Nordic’s smallpox vaccine for preventative use against monkeypox.
The European Commission has approved PTC Therapeutics’ Upstaza (eladocagene exuparvovec) as a treatment for aromatic L-amino acid decarboxylase (AADC) deficiency for patients 18 months and older. The disease-modifying treatment is both the first treatment for this indication and the first marketed gene therapy directly infused into the brain.
The European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for natalizumab, a proposed biosimilar to Tysabri. The application, from Polpharma biologics, is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine Tysabri, submitted for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS).
其他
Amazon will be acquiring primary care company One Medical for a total of $3.9 billion, signaling Amazon’s next advancement into the healthcare space. One Medical CEO Amir Dan Rubin commented, “There is an immense opportunity to make the health care experience more accessible, affordable, and even enjoyable for patients, providers, and payers. Amazon’s joint healthcare venture with Berkshire Hathaway and JP Morgan ended in February 2021, however, Amazon began rolling out Amazon Care the following month in all 50 United States for its employees.
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