Last Week in Review: 5/10/2021 – 5/14/2021

DRUG LAUNCH

Sinopharm executives have announced plans for the company to expand its production capacity to five billion doses of COVID-19 vaccine per year.

HTA

During a debate organized by Spanish pharmaceutical industry magazine Diariofarma and the Spanish Chapter of ISPOR, experts, including payers and drug assessors, from Spain’s national health system (SNS) discussed the newly introduced REvalMed system with economic evaluations as a part of Therapeutic Positioning Reports (TPRs).

The All Wales Medicines Strategy Group (AWMSG) has announced that Sunovion’s Latuda (lurasidone) for the treatment of schizophrenia in adolescents aged 13 to 17 years was the first medicine to pass through the agency’s new process for appraising medicines that have had their license extended to include use in children and young people under 18 years.

POLICY

The Rare Disease Company Coalition in the U.S. has launched with the aim of informing and educating policymakers on the rare disease company business model, specifically the unique circumstances facing life science companies when developing and bringing to market therapies intended for extremely small and differentiated patient populations.

In the recent parliamentary election, the Scottish National Party (SNP) won 64 seats in the Scottish Parliament, thus paving the way for increased funding for the NHS and the establishment of the National Pharmacy Agency (NPA), as was promised in the SNP Manifesto.

DRUG APPROVAL

The United States Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s COVID-19 Comirnaty to include individuals aged 12 to 15 years.

According to unnamed sources closely linked to Novavax’s plans, the company will not file its COVID-19 vaccine for approval until July at the earliest, due to manufacturing issues that could delay showing regulators that its vaccine manufacturing process is consistent across different sites.

Pfizer is seeking approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for use of COVID-19 vaccine Comirnaty in 12-to-15-year-olds.

PRICING & REIMBURSEMENT

At the Handelsblatt Annual Conference Pharma 2021, representatives from the Federal Joint Committee (G-BA) and Germany’s statutory health insurers urged for modifications to the pricing procedure for orphan and oncology drugs, specifically combination therapies and new active pharmaceutical ingredients (APIs).

The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report assessing the comparative clinical effectiveness and value of three new treatments targeting the B-cell maturation antigen (BCMA) for heavily pre-treated patients with triple class refractory multiple myeloma (TCRMM) who have cycled through numerous previous lines of therapy.

Through “Guidance Opinions for Establishing and Improving the ‘Dual-Channel’ Management Mechanism of Negotiated NRDL Drug Products,” Chinese authorities are allowing a second channel, retail pharmacies, to supply National Reimbursement Drug List (NRDL) drugs, expanding the previous scope of suppliers of these drugs from just hospitals.

China’s National Healthcare Security Administration (NHSA) has announced that 19 drugs newly included in the 2020 National Reimbursement Drug List (NRDL) are now available in 3,324 designated medical institutions, with 15 of these drugs available in 20 provinces.

The Zorginstituut has advised the Netherlands’ Minister for Medical Care to only reimburse Novartis’ Zolgensma (onasemnogene abeparvovec) as part of the country’s basic package after a substantial price reduction and a potential performance-related payment plan.

REGULATION

Moderna has announced a new supply agreement with the government of Australia for 10 million doses of its COVID-19 vaccine against the ancestral strain (mRNA-1273) to be delivered in 2021 and 15 million doses of its updated variant booster vaccine candidate to be delivered in 2022.

As generic drugs have been crucial to Spain’s efforts to fight COVID-19, AESEG’s Coordinator of Regulatory Affairs Maria Alvarez Fernandez at the 40th symposium of the Spanish Association of Industry Pharmacists (AEFI) shared the challenges Spain’s generic industry has faced during the pandemic to set a clear path forward for the future.

The European Commission is holding a consultation  on its revisions to the regulations for medicines for children and rare diseases (orphan drugs) until July 30, 2021.

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a confidentiality arrangement with the Brazilian Health Regulatory Agency (ANVISA).

The World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) have jointly called on the pharmaceutical industry to provide “wide access” to clinical data for new medicines and vaccines, regardless of approval status, and for clinical trial reports to be published without redaction of confidential information.

TENDER

The Joint Procurement Office (JPO) has released a notice that it is currently collecting relevant drug information, including on companies and their certifications, for China’s fifth round of volume-based procurement, which according to the announcement will cover 60 drugs for 202 product specifications.

OTHER

The Bolivian Government has signed a deal with Johnson & Johnson for 15 million doses of the company’s COVID-19 vaccine but wants Canada-based Biolyse Pharma to manufacture the doses and the World Trade Organization (WTO) to waive the vaccine’s patent.

Gavi, the Vaccine Alliance has announced it signed an Advanced Purchase Agreement with Novavax for up to 350 million doses of the company’s COVID-19 vaccine candidate, NVX-CoV2373 for self-funding high- and upper-middle-income and 92 lower-income economics through the COVAX Facility.