- In a “landmark agreement,” the United Kingdom’s (UK) National Health Service (NHS) is set to roll out Orchard Therapeutics’ Libmeldy (atidarsagene autotemcel) for the treatment of metachromatic leukodystrophy (MLD) in babies and children. The single-dose treatment has a reported list price of more than £2.8 million, which would make it the most expensive drug in the world – but it can now be offered to young patients on the NHS in England after the health service negotiated a “significant, confidential discount.”
- The U.S. Food and Drug Administration (FDA) has granted full approval to Moderna’s Spikevax, making it the second vaccine after Pfizer’s Comirnaty to be converted to full approval in the U.S. The mRNA jab is now officially approved for adults 18 and older but has been available under an emergency use authorization (EUA) for adults since December 2020. Spikevax is administered as a primary series of two doses, one month apart.
- The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it will take steps to make a Statutory Instrument (SI) under the Medicines and Medical Devices Act 2021 to provide a legislative framework for the Early Access to Medicines Scheme (EAMS).
The United Kingdom’s (UK) National Health Service (NHS) on Sunday expanded its COVID-19 vaccination program to include vulnerable children aged 5 to 11 years and those who live with immunocompromised individuals. Eligible children include those with diabetes, immunosuppression, learning disabilities and other serious conditions that place them at high risk of contracting COVID-19.
The High Health Authority (HAS) of France has rejected early access authorization (ATU) to Xenothera’s COVID-19 treatment, XAV-19, for the treatment of patients suffering from moderate lung damage due to COVID-19.
Pfizer and BioNTech have initiated a rolling submission to amend the Emergency Use Authorization (EUA) for their COVID-19 vaccine, Comirnaty, to include children aged 6 months through 4 years of age. Their application covers two 3-µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least eight weeks after completion of the second dose are expected in the coming months, at which point Pfizer and BioNTech will seek authorization for a booster in this pediatric population.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for Novavax’s COVID-19 vaccine, Nuvaxovid, for use in people aged 18 and over for a first and second dose.
Sweden has updated its national antimicrobial resistance (AMR) plan, recruiting the help of the relevant authorities, particularly the Swedish Association of the Pharmaceutical Industry (Lif) and organizations set up by the government. Based on the Swedish strategy’s existing seven goals in the work against antibiotic resistance, the updated plan suggests measures including the development of new antibiotics, responsible use and manufacturing and efforts to prevent infections.
A coalition of 29 European cancer organizations, headed up by the European Organization for Research and Treatment of Cancer (EORTC), is urging policymakers in the European Union (EU) to reform EU-wide drug development to reform treatment optimization. The group published a manifesto, which recommends that the appropriate use of treatments is essential for optimizing patients’ health outcomes and preserving public health and healthcare budgets.
The European Union Clinical Trials Information System (CTIS) is now live and will provide a single-entry point for clinical trial application submission, under which sponsors can apply for clinical trial authorization in up to 30 European Economic Area (EEA) countries with a single application.
An official regulation giving the European Medicines Agency (EMA) more power in a crisis situation has been published in the Official Journal of the European Union, cementing the legislation after weeks of preparation. At the end of January, Members of the European Parliament (MEPs) voted 655 to 31, with 8 abstentions, in favor of broadening and reinforcing the EMA’s powers.
NHS England has struck a deal with Roche for early access to Tecentriq (atezolizumab) for the treatment of patients with early-stage non-small-cell lung cancer (NSCLC) whose tumors express the PD-L1 mutation and who have undergone surgery and chemotherapy.
The National Institute for Health and Care Excellence (NICE) has backed AstraZeneca’s Forxiga (dapagliflozin) for treating chronic kidney disease (CKD) in adults.
Finland’s medicines agency (Fimea) has published an assessment on Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of esophageal cancer and gastro-esophageal junction cancer after chemotherapy, radiotherapy and surgery – which is an extension of the indication authorized by the European Commission in July 2021.
Following a review of evidence collected during its stint in the Cancer Drugs Fund (CDF), Bristol-Myers Squibb’s (BMS) immunotherapy duo Opdivo (nivolumab) and Yervoy (ipilimumab) has been recommended for untreated advanced renal cell carcinoma (RCC) in adults, announced the National Institute for Health and Care Excellence (NICE).
The Federal Joint Committee (G-BA) has found AstraZeneca’s Koselugo (selumetinib) to offer non-quantifiable added benefit because the scientific data provided by the company do not allow for quantification.
PRICING & REIMBURSEMENT
Following reconsideration, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has decided to maintain high-cost protection for TNF inhibitors containing adalimumab or etanercept – the International Nonproprietary Names (INN) for Humira and Enbrel.
The Economic Committee on Healthcare Products (CEPS) has delayed a reduction in price for three generic pricing groups (TFR) – fluoxetine, venlafaxine and fluvastatin. The prices of the antidepressant medicines and cholesterol-lowering therapy were meant to go down on February 1, but the Committee has pushed the date back to the 15th of the same month.
At its upcoming meeting, the commission of the Ministry of Health for the formulation of drugs lists will be considering adding nine new medicines to the list of Vital and Essential Drugs (VED), as well as including three new drugs in high-cost nosologies (VZN) program. The drugs suggested for the VED include: teduglutide, lonoctocog alfa, rurioctocog alfa pegol, lanadelumab, dolutegravir and rilpivirine, dolutegravir and lamivudine, atazanavir and ritonavir, paclitaxel and albumin and lorlatinib. On the other hand, it has been proposed that lonoctocog alfa, rurioctocog alfa pegol and carfilzomib should be covered by the VZN.
India’s Prime Minister Narendra Modi wants to subject more medicines to price control, including commonly used yet more expensive medicines such as sitagliptin – branded as “Januvia” by MSD – for diabetes, as well as antibiotic injection meropenem and cefpodoxime. As News 18 reported, the goal is to bring under price control drugs for which the demand is high and customers pay extra out of pocket (OOP). While 399 formulations were listed by an expert committee of the Indian Council of Medical Research (ICMR), the health ministry tapped the Pharmaceutical & Medical Devices Bureau (PMBI) – formerly the Bureau of Pharma PSUs of India (BPPI) – that runs the government’s pharmacy outlets to gather sales data from the past three years for at least 12 molecules covering cardiology, diabetes, anti-bacterials and anti-fungals, and gastroenterology.
The U.S. Food and Drug Administration (FDA) has approved an extension to Janssen and ViiV Healthcare’s Cabenuva (rilpivirine/cabotegravir) to allow dosing every two months for the treatment of HIV-1 in virologically suppressed adults without prior treatment failure or resistance to either component of the regimen.
The European Commission (EC) has granted marketing authorization for Pfizer’s Lorviqua (lorlatinib – branded Lorbrena in the U.S.) for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small-cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
Samsung Bioepis has bagged Health Canada approval for its biosimilar Ontruzant, referencing Roche’s Herceptin (trastuzumab), for the treatment of adults with early or metastatic breast cancer (EBC; MBC) and metastatic gastric cancer (MGC). Organon will take on the commercialization of Ontruzant in Canada.
The Italian Medicines Agency (AIFA) has approved the reimbursement of Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of melanoma, kidney and lung cancers.
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