Last Week in Review: 3/29/2021 – 4/2/2021

REGULATION 

In a pivotal Phase 3 trial in 2,260 adolescents aged 12 to 15 years with or without prior evidence of SARS-CoV-2 infection, Pfizer and BioNTech’s COVID-19 vaccine Comirnaty (previously BNT162b2) demonstrated 100% efficacy and robust antibody responses and was well tolerated, announced both companies.

Janssen Pharmaceutica NV has entered into a deal with the African Vaccine Acquisition Trust (AVAT) to deliver 220 million doses of its COVID-19 vaccine, with the option for an additional 180 million doses, starting from the third quarter (Q3) of this year

The Collegiate Board of the National Health Surveillance Agency (ANVISA) in Brazil has granted temporary authorization for emergency use to Johnson & Johnson’s COVID-19 vaccine.

The Ministry of Health, Labor, and Welfare (MHLW) of Japan has approved Bristol-Myer Squibb’s (BMS) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma.

The Russian Ministry of Health’s draft law amending Article 37 of “On the Basics of Protecting the Health of Citizens in Russia” would allow off-label drugs to be included in the standard of medical care for children.

POLICY

The Federal Joint Committee (G-BA) in Germany has tasked the Institute for Quality and Efficiency in Health Care (IQWiG) to come up with new ways to collect application-related data for new drugs, specifically CAR-T cell therapies, and its first concept should be ready in six months.

The National Organization for Rare Disorders (NORD) has issued “Orphan Drugs in the United States: An Examination of Patents and Orphan Drug Exclusivity,” a report detailing the number of available orphan products, generics, and biosimilars for the treatment of rare diseases in the United States, which have increased significantly with the enactment of the Orphan Drug Act in 1983.

The Market Access Committee of the Biosimilar Medicines Group (under the ambit of Medicines for Europe) has published its 2020 Market Review of the European biosimilar market, including related policy measures.

The Association of the British Pharmaceutical Industry (ABPI) has published its cross-sector insights report on cancer care in the United Kingdom along with suggestions to improve outcomes for patients, considering the impact of the ongoing COVID-19 Pandemic. ABPI reached out to experts across the UK cancer ecosystem, including representatives from the National Institute for Health and Care Excellence (NICE) and the National Health Service (NHS) regarding their experience with the pandemic to find ways to both reverse its impact on cancer services and improve cancer outcomes in the long term.

The Portuguese presidency of the Council of the European Union (EU) has obtained a mandate from the bloc’s member states to start negotiations with the European Parliament for a legislative proposal on a joint UE Health Technology Assessment (HTA).

DRUG APPROVAL

The United States Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) B-cell maturation antigen (BCMA)-directed CAR-T cell therapy Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) after four or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

HTA

The Finnish Medicines Agency (FIMEA) has published its evaluation report on Gilead/Kite’s CAR-T therapy Tecartus (brexucabtagene autoleucel) for the treatment of patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of prior systemic therapy, including treatment with a Bruton’s tyrosine kinase (BTK) inhibitor—in the case of this assessment, Janssen’s Imbruvica (ibrutinib).

PRICING & REIMBURSEMENT

At the recent National Health, Medical Care, and Medical Insurance meeting, Ukraine Minister of Health Maksym Stepanov announced that Ukraine is initiating the adoption of the National Strategy for Prevention, Diagnosis, and Treatment of Rare (Orphan) Diseases.

Through 2023, Poland aims to implement 40 steps under the Rare Disease Plan to improve the situation for rare disease patients in Poland, which will cost an estimated PLN 90 million to implement, and PLN 750 million per year will be allocated from the Medical Fund and another PLN 30-50 million will come from the National Health Fund (NFZ) to finance new genetic diagnosis methods.

The Italian Medicines Agency (AIFA) has published on its website the new simplified procedure for negotiating the price and reimbursement of parallel imported medicines, which pursues cost savings in Italy for these medicines.

United States Senators Tammy Baldwin (D-WI), Mike Braun (R-IN), Tina Smith (D-MN), and Lisa Murkowski (R-AK) have reintroduced the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act, bipartisan legislation that would require increased transparency from pharmaceutical companies that plan on increasing the prices of their drugs.

The Valencia Autonomous Consell has approved its first framework agreement for the supply of biosimilar medicines to Ministry of Health-associated centers, with a maximum budget of 80,045,624.57 euros for two years and the potential for more funding. The supply agreement reportedly includes 20 lots (although the terms of the agreement have yet to be fully disclosed), and it is possible for contracts to be modified by up to 20% of the bid amount in order to meet actual need if initial estimates are off.