- The European Parliament has adopted new legislation that ensures the continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta, following Brexit. The rules will govern Northern Ireland indefinitely, but Malta, Cyprus and Ireland will benefit from certain derogations for only a three-year period. Following the decision from the Parliament, medicines approved or manufactured in Great Britain will be able to flow uninterrupted to Northern Ireland, as the vote has given new formal status to temporary legislation linked to complexities created by Brexit.
- The National Institute for Health and Care Excellence (NICE) has issued an appraisal consultation document rejecting coverage of Gilead’s Trodelvy (sacituzumab govitecan) for the treatment of unresectable triple-negative locally advanced or metastatic breast cancer in adults after two or more systemic therapies, at least one of which was for advanced disease. As per the published document, the list price of Trodelvy is £793.00 per 180 mg vial, but the company has a commercial arrangement with the NHS that would have applied if the technology had been recommended.
- From April 1, the prices of more than 800 essential medicines, including over-the-counter (OTC) drugs for pain and antibiotics, have increased by 10.76% in India. The price increase applies to many commonly used drugs for hypertension, infections, heart disease and skin conditions, as well as insulin, multi-vitamins, steroids for COVID-19 and contraceptives.
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application (sBLA) for Actemra (tocilizumab), granting the therapy Priority Review for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
As of April 4, the UK National Health Service (NHS) has begun vaccinating all eligible children 5 to 11. According to the organization, approximately five million children in this age group are eligible for a full course – two doses – of the vaccine, now that the Joint Committee on Vaccination and Immunization (JCVI) guidance has been updated to include all children, not just those who are immunocompromised.
The World Health Organization (WHO) has announced that it has suspended United Nations (U.N.) deliveries of Covaxin (BBV152) due to deficiencies uncovered in a facility inspection. Produced by India’s Bharat Biotech, COVID-19 Vaccine Covaxin is a whole virion inactivated SARS-CoV-2-based vaccine against COVID-19. In a statement, the WHO said: “The suspension is in response to the outcome of a WHO inspection on 14–22 March 2022, and they need to conduct process and facility upgrades to address recently identified deficiencies in good manufacturing practices (GMP)”.
The U.S. Congress has agreed to a deal to provide $10 billion in funding for urgent COVID-19 needs and therapeutics that was introduced by Senate Majority Leader Chuck Schumer (D-NY) and Senator Mitt Romney (R-UT). Romney stated: “Today’s agreement [repurposes] $10 billion to provide needed domestic COVID health response tools. Half of the funding will be used for the development and purchase of therapeutics, potentially eliminating the need for future vaccine and mask mandates”. Of the $9.25 billion specifically for the Biomedical Advanced Research and Development Authority (BARDA), no less than $5 billion should be for R&D, manufacturing, producing, purchasing and administrating therapeutics, and $750 million is for research and clinical trials for emerging coronavirus variants and supporting sustainable and expanded vaccine manufacturing capacity.
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency’s (EMA) COVID-19 task force (ETF) have advised that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines, such as Pfizer’s Comirnaty or Moderna’s Spikevax, in the general population. However, both agencies agreed that a fourth dose (or second booster) can be given to adults 80 years old or over after reviewing data on the higher risk of severe COVID-19 in this age group and the protection provided by a fourth dose.
The U.S. Food and Drug Administration (FDA) rescinded the emergency use authorization for GlaxoSmithKline and Vir Biotechnology’s antibody therapy, sotrovimab, now that most U.S. COVID-19 cases are driven by the omicron BA.2 sub-variant. The dose level of sotrovimab authorized by the FDA is not known to be effective against this sub-variant, but GSK recently announced it is evaluating a higher dose.
The African Union and the COVAX facility have both turned down options to acquire more batches of Moderna’s COVID-19 vaccine now that the pandemic appears to be letting up. The African Union turned down 60 million doses for delivery in the second quarter of this year, while the COVAX facility declined purchase options for both the third and fourth quarters, each representing 166 million doses.
The European Parliament has adopted new legislation that ensures the continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta, following Brexit. The rules will govern Northern Ireland indefinitely, but Malta, Cyprus and Ireland will benefit from certain derogations for only a three-year period. Following the decision from the Parliament, medicines approved or manufactured in Great Britain will be able to flow uninterrupted to Northern Ireland, as the vote has given new formal status to temporary legislation linked to complexities created by Brexit. The Commission believes that this legislation will give operators more time to adapt, as “work on a long-term permanent solution is ongoing in the context of the EU’s Pharmaceutical Strategy”. Now that it has been passed, the new legislation applies retroactively from 1 January 2022 and will come into force as a matter of urgency.
Unlike more-stable numbers from the FDA and EMA, the tally of new medicines reported to the Patented Medicine Prices Review Board (PMPRB) continues to slow each year, with 108 reported in 2018, 81 reported in 2019 and 79 reported in 2020. The total number of patented medicines on the Canadian market is also dwindling, with 1,403 in 2018, 1,364 in 2019 and 1,289 in 2020. Meanwhile, R&D expenditures were stable across 2018 and 2019, totalling $892.6M and $893.2M respectively, but tumbled to $823M in 2020. Due to initiatives taken by a scattering of Canadian payers, the uptake of biosimilars is on the rise, and a sudden spike in generic drug sales after comparatively sleepy rates since 2010 is partially attributed to price-setting policies introduced by the pan-Canadian Pharmaceutical Alliance (pCPA) and provincial governments.
The WHO said the agencies in Egypt and Nigeria “have been found to function well” and they may soon join Ghana and Tanzania to become transitional WHO-Listed Authorities. Using its Global Benchmarking Tool, the WHO determined that Egypt’s regulation of domestic and imported vaccines and Nigeria’s regulation of medicines and imported vaccines have reached “maturity level 3”.
The Government of Peru has adopted the National Cancer Law (Decree 004-2022-SA), which will offer free universal health care to cancer patients. All patients, including foreigners with a cancer diagnosis, will be provided cancer care through the SIS, and every two years the Ministry of Health (MINSA) will update the list of complementary cancer products that also includes maximum cost thresholds for the treatment of cancer.
The National Institute for Health and Care Excellence (NICE) has issued an appraisal consultation document rejecting coverage of Gilead’s Trodelvy (sacituzumab govitecan) for the treatment of unresectable triple-negative locally advanced or metastatic breast cancer in adults after two or more systemic therapies, at least one of which was for advanced disease. According to the document, clinical trial evidence showed that Trodelvy increases how long people have before their disease gets worse and how long they live compared with chemotherapy; however, at its current price, NICE determined that cost-effectiveness estimates for Trodelvy are “higher than what NICE usually considers an acceptable use of NHS resources”. As per the published document, the list price of Trodelvy is £793.00 per 180 mg vial, but the company has a commercial arrangement with the NHS that would have applied if the technology had been recommended.
The High Health Authority (HAS) of France has granted an early access scheme (ATU) to AstraZeneca and Merck’s Lynparza (Olaparib) as adjuvant treatment for early-stage breast cancer. According to a release, the ATU covers Lynparza for high-risk, early-stage HER2- negative breast cancer with a BRCA1/2 mutation in patients who have received prior neoadjuvant or adjuvant chemotherapy.
HAS has also begun a new early access scheme (ATU) for Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), to treat first-line oesophageal cancer.
The Institute for Quality and Efficiency in Health Care (IQWiG) has determined that Biogen’s Vumerity (diroximel fumarate) offers “no added benefit” to treat adults with relapsing-remitting multiple sclerosis (RRMS) because of missing data.
PRICING & REIMBURSEMENT
The National Institute for Health and Care Excellence (NICE) has recommended Merck’s Bavencio (avelumab) as maintenance treatment for adults with locally advanced or metastatic urothelial cancer (UC) that has not gotten worse after platinum-based chemotherapy.
NICE has recommended Alexion Pharma, AstraZeneca’s (AZ) Rare Disease group, Koselugo (selumetinib) for treating symptomatic and inoperable plexiform neurofibromas (PN) associated with type 1 neurofibromatosis (NF1) in children aged three and over.
At its latest meeting, the Agency for Health Technology Assessment and Tariff System’s (AOTMiT) Transparency Council (TC) assessed coverage of Dr. Falk Pharma’s Jorveza (budesonide), Laboratorios’ Buccolam (midazolam) and Roche’s Tecentriq (atezolizumab) for the treatment eosinophilic esophagitis, convulsive seizures and breast cancer, respectively.
The Italian Medicines Agency (AIFA) has added Sarclisa (isatuximab) and Oxlumo (lumasiran) to its innovative medicines list, following the publication of Official Gazette no. 79. According to the documents published by AIFA, Oxlumo will be available at an ex-factory price of EUR 67,904.11 and retail price of EUR 112,068.95 for one vial with a mandatory discount applied to the ex-factory price.
The Finnish Medicines Agency (Fimea) has launched new therapeutic and financial assessments for Janssen and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
From April 1, the prices of more than 800 essential medicines, including over-the-counter (OTC) drugs for pain and antibiotics, have increased by 10.76% in India. The price increase applies to many commonly used drugs for hypertension, infections, heart disease and skin conditions, as well as insulin, multi-vitamins, steroids for COVID-19 and contraceptives.
The UK has granted early access to Novartis’s targeted radioligand therapy, Lutetium (Lu-PSMA-617), for the treatment of adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The Brazilian Health Regulatory Agency (ANVISA) has approved Carvykti (ciltacabtagene autoleucel) from Janssen and Legend Biotech for the treatment of patients with relapsed or refractory multiple myeloma (MM) who have not responded to previous treatment with immunomodulatory agents, proteasome inhibitors or monoclonal antibodies.
The European Commission (EC) has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.
The EC has also approved Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in three indications. The company said the EC has approved Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC) with tumour cell PD-L1 expression, equal to or more than 1%. The approval is based on phase 3 results from the CHECKMATE-648 trial. Also, based on the same results, the Commission approved Opdivo plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumour cell PD-L1 expression equal to or more than 1%.
Additionally, the EC has approved Kimmtrak (tebentafusp) for the treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma (mUM).
Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving Johnson & Johnson’s (J&J) fully human, bispecific antibody Rybrevant (amivantamab) for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with FGR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Vijoice (alpelisib) for the treatment of severe PIK3CA-Related Overgrowth Spectrum (PROS), announced Novartis.
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