- In an email to EVERSANA’s Tender department, the pharmaceutical procurement service for the five regional authorities in Denmark (Amgros) clarified that as of April 1, 2022, it will no longer be publishing the prices of “new expensive hospital pharmaceuticals and biologicals.” The agency explained, “The new agreements that started from 1 April 2022 are with non-public prices. Therefore, the prices are not available.”
- The National Institute for Health Care and Excellence (NICE) has recommended AstraZeneca’s Imfinzi (durvalumab) as an option for treating non-small-cell lung cancer (NSCLC) in adults who have PD-L1 of 1% or more for routine use in the National Health System (NHS).
- The Federal Joint Committee (G-BA) has given Gilead’s Trodelvy (sacituzumab govitecan) a rating of “significant additional benefit” for the treatment of unresectable or metastatic triple-negative breast cancer (mTNBC) patients who have previously received two or more systemic therapies, including at least one for advanced disease. It is so rare for the G-BA to hand out a rating of this caliber that this is only the 9th time it has happened in the history of the group’s assessments.
Spain’s President, Pedro Sánchez, has announced he will earmark approximately EUR 300 million to donate COVID-19 vaccines and fund health projects worldwide. Speaking at the second Global COVID-19 Summit, Sánchez warned “that while the worst of the pandemic may be behind us, it is not yet over and there are lessons to be learned for future health crises. Global health is a public good, no one would question that now, so we must act accordingly.” According to a release, Sánchez plans to allocate almost EUR 200 million for the donation of an additional 30 million COVID vaccines, through COVAX and bilaterally, which will be added to the 70 million doses already delivered.
Pfizer and BioNTech announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine. According to the EC, the amendment is part of an ongoing process whereby the Commission and Member States are working closely with the EU’s vaccine suppliers to address the evolving pandemic needs. Pfizer stated that doses scheduled for delivery in June through August 2022 will now be delivered in September through Q4 2022.
The U.S. Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, to include a booster dose for children ages 5 through 11 at least five months after their primary vaccination with Comirnaty.
Valneva announced it successfully submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its COVID-19 whole-virus, inactivated vaccine candidate, VLA2001.
The World Health Organization (WHO) announced it has issued an emergency use listing (EUL) for CanSino’s Convidecia for the prevention of COVID-19. The listing indicates that the WHO reviewed data on the safety, quality and efficacy of the vaccine in order for it to be cleared for supply through the COVAX facility, and for regulatory bodies around the world to expedite their own approval processes.
AstraZeneca announced it has acquired the global rights to RQ Biotechnology’s early-stage monoclonal antibodies (mAbs) targeting SARS-CoV-2. The terms of the newly inked deal enable AstraZeneca to develop, manufacture and commercialize the mAbs for use against COVID-19.
Speaking at a Webinar hosted by the European Observatory on Health Systems and Policies, Malta’s Health Minister Chris Fearne called for a “fair deal” across Europe when dealing with pharmaceutical purchasing, urging member states to focus on price transparency. Fearne supported the idea of sharing prices across countries to ensure that each country pays no more than it should, noting: “Price transparency and the process of setting prices are crucial. We found we could not negotiate unless we knew each other’s prices.” Malta is already part of the Valletta Declaration scheme, under which Malta, Portugal, Spain, Italy, Cyprus, Greece, Slovenia, Croatia, Romania, and Ireland share information related to drug pricing, but Fearne argued that the group needs more “structure,” before suggesting the need for a Europe-wide mechanism.
The Pharmaceutical Management Agency (PHARMAC) of New Zealand has announced it is receiving a budget increase of NZD 191 million over the next two years, specifically NZD 71 million for 2022/2023 and NZD 120 million for 2023/2024. With this funding boost, which agency Chief Executive Fitt called “the biggest we’ve had since we were formed almost 30 years ago,” PHARMAC now has a budget of NZD 1.186 billion this year and a budget of NZD 1.245 billion for next year.
Japan’s Upper House, the House of Councillors, has enacted a bill to amend the existing Pharmaceuticals and Medical Devices (PMD) Law, under which Japan would embrace the introduction of an official emergency approval scheme. Following the approval from the House, the draft bill is likely to be implemented by the end of May.
The Therapeutics Goods Administration (TGA) of Australia has issued a joint statement with various Australian medical societies and Novo Nordisk calling for type 2 diabetics to have prioritized use of Ozempic (semaglutide) amid a shortage of the drug. According to TGA, the shortage of both strengths of Ozempic has been caused by an “unexpected” increased demand for the drug for obesity management.
The Federal Joint Committee (G-BA) has given Gilead’s Trodelvy (sacituzumab govitecan) a rating of “significant additional benefit” for the treatment of unresectable or metastatic triple-negative breast cancer (mTNBC) patients who have previously received two or more systemic therapies, including at least one for advanced disease. It is so rare for the G-BA to hand out a rating of this caliber that this is only the 9th time it has happened in the history of the group’s assessments.
The Italian Medicines Agency (AIFA) has announced that, following the publication of the AIFA Determination in the Official Gazette no. 115, Erleada (apalutamide) has been approved under Italy’s National Health (SSN) monitoring scheme. According to a release on AIFA’s website, the drug is set to be reimbursed for the treatment of hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), for adult men diagnosed with low-volume or high-volume disease and not suitable for treatment with docetaxel. As seen in an agency document, Erleada has an ex-factory price (excluding VAT) of EUR 3,593.07 and a retail price of EUR 5,930.00.
The National Institute for Health Care and Excellence (NICE) has recommended AstraZeneca’s Imfinzi (durvalumab) as an option for treating non-small-cell lung cancer (NSCLC) in adults who have PD-L1 of 1% or more for routine use in the National Health System (NHS). The technology appraisal committee noted there were limited treatment options for people with locally advanced unresectable NSCLC and the clinical evidence showed that Imfinzi increases survival time for patients and the time it takes for cancer to progress. According to the NICE document, the list price of Imfinzi is £2,466 per 500 mg per 10 ml infusion vial.
The High Health Authority of France (HAS) has recommended an indication extension for Repatha (evolocumab), suggesting it should be used for children and adolescents from 10 years of age with heterozygous familial hypercholesterolemia (HeFH), insufficiently controlled (LDL-c > 1.30 g/L) by a maximum tolerated oral treatment, in addition to a controlled diet.
PRICING & REIMBURSEMENT
In an email to EVERSANA’s Tender department, the pharmaceutical procurement service for the five regional authorities in Denmark (Amgros) clarified that as of April 1, 2022, it will no longer be publishing the prices of “new expensive hospital pharmaceuticals and biologicals.” The agency explained, “The new agreements that started from 1 April 2022 are with non-public prices. Therefore, the prices are not available.” Amgros elaborated, “Whether a price is public or not from Amgros depends on a specific assessment depending on the market, the competition, the type of drug and input from external stakeholders, medicinal suppliers and hospital pharmacies, etc.”
The Department of Health and Social Care (DHSC) in England has announced that the cost of NHS prescriptions will be frozen for the first time in over a decade, to help “ease the cost of living.” Charges for prescriptions in England typically increase in line with the inflation rate of the country; however, to help ensure that people can still access necessary medication the prescription costs will remain at £9.35 for a single charge or £30.25 for a 3-month prescription prepayment certificate (PPC), as costs of living elsewhere continue to rise rapidly.
The Health Insurance Review and Assessment Service (HIRA) of South Korea has published the results of its cancer drugs committee meeting, which deliberated on the reimbursement status of cancer medicines. HIRA decided to expand the insurance listing for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) to include the treatment of patients from one year with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), in combination with chemotherapy.
The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has released a health economic assessment of GlaxoSmithKline’s monoclonal antibody Xevudy (sotrovimab).To come to its decision, TLV assessed data from the COMET-ICE clinical trial, which showed that Xevudy reduces the risk of developing severe COVID-19 disease. The Agency says that according to its scenario analyses, the cost per quality-adjusted life-year (QALY) gained amounts to approximately SEK 361,000 over a lifetime perspective.
The three major pharma lobbies of Japan met for the first time to discuss Japan’s upcoming re-pricing policies. The groups called for a more “transparent” and “predictable” system, to incentivize companies that are more research-focused. According to one group, the environment in Japan is “losing its attractiveness” and the changes could risk the return of “drug lag,” harking back to a period 20 years ago when therapies would often take four years to be put on the market in Japan.
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) once-weekly injection, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Eli Lilly’s new GIP and GLP-1 receptor agonist, the only such product to win FDA approval, will launch on the U.S. market within weeks in six different doses ranging from 2.5 to 15 mg for use in an auto-injector pen.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Roche’s Vabysmo (faricimab) for the treatment of progressive eye diseases, wet age-related macular degeneration (wet AMD) and visual impairment due to diabetic macular edema (DME). The treatment was the first approved by the MHRA through the Access Consortium initiative, a collaboration of regulatory agencies from the UK, Australia, Canada, Singapore, and Switzerland. Sajid Javid, Health and Social Care Secretary said, “Now we have left the EU, the UK is free to team up with other world-leading regulators to speed up the approval process for medicines, while maintaining the highest safety standards – and this is a great example of UK patients getting quicker access to cutting-edge treatments.”
Health Canada has approved Alnylam’s Oxlumo (lumasiran) injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a license for Teva’s Ongavia (ranibizumab), a biosimilar to Lucentis, for the treatment of neovascular (wet) age-related macular degeneration (AMD) and several other eye diseases, such as diabetic macular edema (DME), treatment of visual impairment due to choroidal neovascularisation (CNV) and proliferative diabetic retinopathy. The UK is the first nation in Europe to grant a license for Teva’s ophthalmology biosimilar Ongavia.
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