NAVLIN Brief
- Japan’s Central Social Insurance Medical Council (Chuikyo) has revealed preliminary plans for the 2023 round of off-year repricing. At a meeting on July 20, the group announced that the 2023 price cuts will be undertaken with a smaller survey than in regular – or “on-year” repricing efforts.
- The German cabinet has passed the long-discussed “Financial Stabilisation of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill, first proposed by the country’s Health Minister Professor Karl Lauterbach in March this year. The final draft includes a number of “significant” measures, including a reform of the AMNOG process, amended AMNOG negotiating powers, and a change in the orphan medicine threshold for benefits assessment. The bill also delays the introduction of the biosimilar substitution initiative by a year.
- The Federal Joint Committee of Germany (G-BA) has released its 2021 annual report, announcing that the organization carried out a “record” 146 early benefit assessments of medicinal products in 2021. This brings the total number of decisions made by the G-BA to more than 5,000 since its inception in 2014, as the 5,000 mark was reached on September 2, 2021. In the upcoming joint European HTA, the joint clinical analysis of the EU level “will not replace the national benefit assessments,” according to the G-BA but will precede them.
Details
COVID -19
Moderna is set to provide the U.S. with 66 million doses of mRNA-1273.222, its bivalent COVID-19 vaccine booster candidate, and the U.S. has the option to order 234 million additional doses. Last month, HHS secured 105 million bivalent vaccine boosters from Pfizer, meaning the U.S. has lined up a total of 600 million? booster doses for the fall.
The NMPA granted conditional approval for Genuine’s azvudine to treat COVID-19. Initially, the antiviral was approved last July to treat HIV. Azvudine will compete against Pfizer’s oral antiviral Paxlovid in China.
Biological E (BE) has submitted Corbevax to WHO for emergency use listing (EUL), and a “detailed review” of the application is underway. If Corbevax gets WHO approval, it will be the third vaccine in India to get approval.
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has begun a review of sabizabulin for the treatment of COVID-19. To complete the review, the EMA will look at all available data, including data from a study involving hospitalized patients with moderate-to-severe COVID-19 who are at high risk of acute respiratory distress syndrome and death.
The High Health Authority (HAS) of France has recommended AstraZeneca’s pre-exposure prophylaxis (prevention) of COVID-19 treatment, Evusheld (tixagevimab and cilgavimab) for certain adults and adolescents aged 12 years and older weighing at least 40 kg.
On behalf of Novavax, Biocelect has secured TGA provisional approval for Nuvaxovid to prevent COVID-19 in 12–17-year-olds. As part of the approval, the company must continue to submit efficacy and safety data while TGA inspects each batch of vaccines.
Policy
The German cabinet has passed the long-discussed “Financial Stabilisation of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill, first proposed by the country’s Health Minister Professor Karl Lauterbach in March this year. The final draft includes a number of “significant” measures, including a reform of the AMNOG process, amended AMNOG negotiating powers, and a change in the orphan medicine threshold for benefits assessment. The bill also delays the introduction of the biosimilar substitution initiative by a year.
The National Pharmaceutical Pricing Authority (NPPA) of India has so far fixed ceiling prices of 890 scheduled formulations and retail prices of around 2,023 new drugs, among others, Union Minister of State for Chemicals and Fertilizers Bhagwanth Khuba told Pharmabiz. The maximum retail price (MRP) of 106 non-scheduled drug formulations was capped, including those for 22 diabetic and 84 cardiovascular drugs.
Several foreign pharmaceutical multinational corporations (MNCs) are planning to move out of Pakistan. The taxes imposed by the government led to a 45% increase in production costs. As a result, around 60 essential medicines, including suicide-prevention drugs, have vanished from the market, as Asian News International (ANI) reported.
Malaysia’s health minister, Jamaluddin, informed parliament he would submit a proposal for drug price disclosure. Companies would be required to provide a breakdown – including development costs – of the price they charge for their drugs, such as those for cancer.
Senate Democrats came to a consensus on the Inflation Reduction Act of 2022 as part of the FY2022 Budget Reconciliation Bill. The Act would allow Medicare to begin negotiating prices for 10 drugs in 2023, which is forecasted to save CMS $288 billion. In addition, American Rescue Plan subsidies to lower insurance premium costs would be extended another three years through 2025, since they were set to expire at the end of 2022.
The Technical Table for Medicines recommended adding five more polyclinics to the MedicSol program and purchasing 22 medicines abroad to curb shortages and boost affordability. MedicSol is a temporary program allowing beneficiaries to still purchase drugs outside the scope of the CSS free of charge. Panama is also looking into asking COMISCA, PAHO, and UNOPS to facilitate additional drug purchases.
HTA
The Federal joint Committee of Germany (G-BA) has released its 2021 annual report, announcing that the organization carried out a “record” 146 early benefit assessments of medicinal products in 2021. This brings the total number of decisions made by the G-BA to more than 5,000 since its inception in 2014, as the 5,000 mark was reached on September 2, 2021. In the upcoming European HTA, the joint clinical analysis of the EU level “will not replace the national benefit assessments,” according to the G-BA but will precede them.
The Federal Joint committee of Germany (G-BA) has said that the added benefit of Crysvita (burosumab) is “not proven” for the treatment of X-linked hypophosphataemia (XLH) in adults, following the drug’s passing of the EUR 50 million thresholds. Crysvita was supported by data from two single-arm Phase II studies, UX023-CL201 and UX023-CL205, along with data from the randomized, controlled, open-label Phase III study UX023-CL301.
The REvalMed SNS Coordinating Group (CG) has agreed to start working on Therapeutic Positioning Reports (TPRs) for six drugs that recently gained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). At a meeting held on June 30, via teleconference, the CG decided to begin working on TPRs of the six drugs, Pepaxti (melphalan flufenamide), Rayvow (lasmiditan), (Scemblix (asciminib), Sunlenca (lenacapavir), Vyvgart (efgartigimod alfa), as well as a number of indication extensions.
Germany’s Federal Joint Committee (G-BA) has found the added benefit of Secura’s Copiktra (duvelisib) is “not proven” for two separate indications, chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). G-BA cited that data submitted by the company was “insufficient” to assess the added benefit of the drug.
Pricing & Reimbursement
Japan’s Central Social Insurance Medical Council (Chuikyo) has revealed preliminary plans for the 2023 round of off-year repricing. At a meeting on July 20, the group announced that the 2023 price cuts would be undertaken with a smaller survey than in regular – or “on-year” repricing efforts.
An extensive list of celebrities, activists, and industry personnel have co-penned a letter to ViiV’s CEO, Deborah Waterhouse, urging the company to “urgently ensure equitable and affordable access” to cabotegravir and other new HIV medicines. Specifically, the letter asks ViiV to lower the price for cabotegravir to a “public and transparent” price as close as possible to that of other HIV prevention medicines.
The NMPA approved Alunbrig for ALK+ NSCLC in March, although Takeda’s TKI was available in the Boao Lecheng pilot zone since last August. Takeda plans to launch Alunbrig in 20 provinces across China within the next week. While ALK+ NSCLC is low in China, more than half of these lung cancer patients will develop brain metastases.
The Italian Medicines Agency (AIFA) has updated the monitoring register for Vyndaqel (tafamidis) to allow a one-time prescription for three months. Vyndaqel is used to delay nerve damage caused by transthyretin amyloidosis, a hereditary disease in which fibers called amyloid build up in tissues around the body, including around the nerves. Vyndaqel is used in adult patients with the early stage of nerve disease.
Amidst the crowds of the COVID-19 pandemic, ABRADIMEX acquired 351 million units of specialty medicines, such as those for highly complex and rare diseases.
According to the Social Insurance Institution of Finland (Kela), in April, the price of lenalidomide fell by up to 98% following the loss of Bristol Myers Squibb’s (BMS) patent for Revlimid, which opened the floodgates for other companies to launch their generic versions of lenalidomide.
The deal with Europe’s pandemic authority has GSK reserving future production space for 85 million doses of its pandemic influenza vaccine, Adjupanrix.
Drug Approval
The FDA awarded Fast Track designation to ERC’s Gliovac (sitoiganap; ERC1671) for the most aggressive form of brain cancer. Gliovac is intended for those with glioma– glioblastoma or gliosarcoma – when other traditional treatments have failed.
The FDA will decide on Biogen’s tofersen, the first treatment targeting superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), in January 2023.
Kira’s KP104 received orphan drug status from the U.S. FDA as a treatment for the rare, life-threatening blood disease, PNH.
Today’s nod from the FDA means Benlysta can be used for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who receive standard therapy.
AbbVie has bagged the sixth approval for its selective and reversible JAK inhibitor, Rinvoq (upadacitinib), by the European Commission (EC) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
Other
As the World Health Organization (WHO) has escalated the monkeypox outbreak to a Public Health Emergency of International Concern (PHEIC), the European Medicines Agency (EMA) announced it has initiated a series of actions in response to the PHEIC.
The Uzbek Ministry of Health wants to go fully digital by 2026. First, all health entities will be integrated via an online platform, and then Uzbekistan will launch registries and issue e-prescriptions. The government will also roll out an electronic system for the country’s health insurance fund in preparation for state medical insurance.
NHS England accelerates monkeypox vaccination rollout in London as the UK Health Security Agency (UKHSA) secures more vaccines.
Prestige Biopharma and Intas Pharma have entered into a binding agreement under which Intas will supply and commercialize Prestige’s bevacizumab biosimilar in the U.S., Europe, Canada, and MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and Tajikistan.
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