- Hubertus Cranz, Managing Director of the Federal Association of Drug Manufacturers (BAH), has expressed concern over the newly proposed cost-containment measures in Germany.In an interview with Ärtze Zeitung, Cranz suggested that the proposals endanger the supply of medicines and Germany as a pharmaceutical location. “It is particularly problematic that almost a tripling of the manufacturer’s discount is planned for 2023. Many of our companies have neither the financial reserves nor other savings to be able to cope with this. In addition, there are the generally higher burdens, such as increased energy, logistics and procurement costs.”
- The European Medicines Agency (EMA) has initiated a rolling review of HIPRA Human Health S.L.U.’s COVID-19 vaccine, known as PHH-1V, as well as beginning a review of Sanofi & GlaxoSmithKline’s COVID-19 vaccine, according to the Agency’s COVID-19 update portal.
- For its FY2023 budget, the U.S. Food and Drug Administration (FDA) is requesting $8.4 billion, about a 34% increase from 2022. FDA Commissioner Robert M. Califf, M.D., said, “The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities.” Funding has been requested for future pandemic preparedness initiatives, modernizing technology and platforms, and research and review of new cancer drugs as part of the Cancer Moonshot initiative.
The European Medicines Agency (EMA) has started a review of Sanofi & GlaxoSmithKline’s COVID-19 vaccine, according to the Agency’s COVID-19 update portal. The committee for human medicinal products (CHMP) began evaluating the application for a conditional marketing authorization of Sanofi’s COVID-19 vaccine, dubbed Vidprevtyn, on March 30.
A group of EU-27 health ministers have called for a coordinated second booster approach for people over the age of 60 to boost immunity in the absence of vaccines that specifically protect against the omicron variant. At the EU-27 Employment, Social Policy, Health and Consumer Affairs Council (Health) gathering, Germany and Italy were at the forefront in advocating a unified position in terms of both timing and segments of the population to which the fourth shot should be administered. “I urge a common position of EU countries, agencies, and the European Commission on the fourth dose,” Italy’s Health Minister Roberto Speranza said, adding that “inconsistent choices in the various European countries only end up confusing people and do not help the vaccination campaign.”
The European Medicines Agency (EMA) has initiated a rolling review of HIPRA Human Health S.L.U.’s COVID-19 vaccine, known as PHH-1V. The vaccine is currently in development as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine; it contains two versions of part of the spike protein that have been produced in the laboratory.
The U.S. Food and Drug Administration (FDA) has authorized a second booster of either Pfizer and BioNTech’s Comirnaty or Moderna’s Spikevax for older people and certain immunocompromised individuals at greater risk of COVID-19. The Emergency Use Authorization (EUA) for Comirnaty and Spikevax has been updated to allow a second booster for those aged 50 years and older four months after the first booster, while the EUA for Comirnaty allows another booster for those aged 12 years and older who are immunocompromised, also four months after the first booster.
The RECOVERY Trial, the world’s largest study investigating potential treatments for severe COVID-19, has announced it will begin testing the antiviral treatment Paxlovid across hospitals in the UK, which has already approved the drug for early-stage treatment. Sir Peter Horby, Professor at the University of Oxford and Joint Chief Investigator for the RECOVERY Trial, said: “Two years into the pandemic, we are still lacking effective antiviral drugs for patients with severe COVID-19. Paxlovid is a promising oral antiviral drug, but we don’t know if it can improve the survival of patients with severe COVID-19. By testing Paxlovid in RECOVERY, we will find out”.
For its FY2023 budget, the U.S. Food and Drug Administration (FDA) is requesting $8.4 billion, about a 34% increase from 2022. FDA Commissioner Robert M. Califf, M.D., said, “The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities.” Funding has been requested for future pandemic preparedness initiatives, modernizing technology and platforms, and research and review of new cancer drugs as part of the Cancer Moonshot initiative.
Recently, the German Federal Ministry of health published a draft law on the financial stabilization of the statutory health insurance (GKV-Finanzstabilisierungsgesetz), proposing a number of new measures, including an increased mandatory discount on patented drugs from 2023 and a new restriction in the current “orphan privilege” rule. Dr. Hubertus Cranz, Managing Director of the Federal Association of Drug Manufacturers (BAH), has expressed concern over the newly proposed cost-containment measures in Germany. In an interview with Ärtze Zeitung, Cranz suggested that the proposals endanger the supply of medicines and Germany as a pharmaceutical location. “It is particularly problematic that almost a tripling of the manufacturer’s discount is planned for 2023. Many of our companies have neither the financial reserves nor other savings to be able to cope with this. In addition, there are the generally higher burdens, such as increased energy, logistics and procurement costs.”
The Finnish Medicines Agency (Fimea) has announced that the Act amending the Medicines Act will come into force from April 1, enabling price competition for self-medication medicines. In addition, Fimea noted that the government Decrees on the Amendment of the Medicines Decree and the Pharmaceutical Price Regulation will also come into force from April 1. According to Fimea, following the amendment, self-medication medicines will have a maximum and minimum price according to the pharmaceutical rate, which in turn should enable price competition and allow citizens to obtain drugs more cheaply than before.
The High Health Authority (HAS) of France has granted early access to Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with Kaldeco (ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 to 11 years old who have at least one F508del mutation in the CF transmembrane conductance regulator (CFTR) gene.
In its appraisal consultation, the National Institute for Health and Care Excellence (NICE) has turned down Amarin’s Vazkepa (icosapent ethyl) for reducing the risk of cardiovascular events in adults who have a high cardiovascular risk with raised triglycerides, are taking statins and have established cardiovascular risk or diabetes and at least one other cardiovascular risk factor.
In a recent editorial published in the European Journal of Health Economics, Michael Drummond from the Centre for Health Economics, University of York; and Rosanna Tarricone and Aleksandra Torbica, both of CERGAS, SDA Bocconi School of Management, Milan, argued that there are several issues that need to be addressed before the implementation of joint European health technology assessments (HTA). The European Commission (EC) proposal for the regulation of HTA was adopted by the European Union on 15 December 2021 and entered into force on 11 January 2022, but the authors stress that a “common approach” needs to be agreed upon before any joint assessments can be undertaken. Writing for the audience of the Coordination Group that will be in charge of the process, the group of experts highlighted a number of key issues to iron out to make the EU-centralized HTA work, such as differences in the current standard of care and the lack of randomized clinical studies.
PRICING & REIMBURSEMENT
Amarin has secured reimbursement of Vazkepa (icosapent ethyl) in Sweden, marking the first national reimbursement of the drug in a European country since it was approved by the European Commission in March 2021. The Swedish Dental and Pharmaceutical Benefits Agency (TLV) confirmed reimbursement for Vazkepa for use as treatment of statin-treated patients with established cardiovascular disease (eCVD) and elevated triglycerides (≥ 150 mg/dl [≥ 1.7 mmol/l]), at a price of SEK 1,640 per month.
The National Authority for Medicines and Health Products (INFARMED) has approved Bristol Myers Squibb’s Opdivo (nivolumab) to be used in hospitals for the treatment of adult patients with refractory or relapsing classical Hodgkin’s lymphoma following autologous hematopoietic progenitor transplantation (APT) and treatment with brentuximab vedotin, as monotherapy, and in combination with ipilimumab for the first-line treatment of adult patients with intermediate/high-risk advanced renal cell carcinoma, clear cell histology.
The U.S. Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through status for Heron’s Zynrelef (bupivacaine and meloxicam) extended-release solution, meaning the drug has become the sole local anaesthetic available for separate reimbursement in the treatment of hospital outpatients. Beginning on April 1, the treatment will be reimbursed for three years outside the surgical bundle payment at Average Sales Price (ASP) +6% in both the HOPD and ASC settings.
The Italian Medicines Agency (AIFA) has published its list of medicines that met the criteria of full or conditioned therapeutic innovativeness in the opinion of the Technical-Scientific Commission (CTS) in March. When added to the list, innovative drugs must be made immediately available to patients, even without formal inclusion in the regional hospital therapeutic formulas. In March, Bavencio (avelumab), Lynparza (olaparib) and Tecartus (CD3 + autologous transduced anti-CD19 cells) were added to the list.
The Australian Government is committing funding to the country’s healthcare system through a record $132 billion in 2022–23, increasing to $140 billion in 2025–26, amounting to a total commitment of $537 billion over the next four years. Under the designated funding, $45.5 billion will be allocated over four years to access more affordable medicines through the Pharmaceutical Benefits Scheme (PBS), and more than $2.4 billion of this budget will be used to add “vital new medicines” to the PBS.
The Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved a second indication to Gilead’s Jyseleca (filgotinib), a once-daily, oral JAK1 preferential inhibitor, for the treatment of patients with moderate to severe active ulcerative colitis (UC).
The European Medicines Agency (EMA) has commenced a review of CSL Behring’s haemophilia B gene therapy candidate, etranacogene dezaparvovec (EtranaDez). The EMA’s approval of CSL’s marketing authorization application (MAA) for EtranaDez is supported by the phase 3 HOPE-B study, which showed the drug to have a durable and sustained therapeutic effect after a single infusion.
The EMA has granted Orphan Medical Product Designation to Autolus Therapeutics’ obe-cel for the treatment of acute lymphoblastic leukaemia (ALL) patients.
Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has placed Pfizer’s Lorviqua (lorlatinib) in high-cost protection with general subsidy. The drug is used to treat adults with non-small-cell lung cancer (NSCLC) when the disease is advanced and ALK-positive.
The U.S. Food and Drug Administration (FDA) has approved an extension of indication for Viiv & Janssen’s HIV drug, Cabenuva (cabotegravir and rilpivirinet), to include virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg.
ViiV Healthcare has bagged FDA approval for its New Drug Application (NDA) for a dispersible tablet formulation of fixed-dose combination abacavir, dolutegravir and lamivudine for treating children weighing 10 kgs < 25 kgs with HIV-1.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded Nurix Therapeutics an Innovation Passport for its NX-1607, an oral bioavailable inhibitor of CBL-B for immuno-oncology indications, including a range of solid tumour types, under the UK’s Innovative Licensing and Access Pathway (ILAP).
The European Commission (EC) has approved an extension of the current indication of Blueprint Medicine’s orphan drug Ayvakyt (avapritinib) to include monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.
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