Last Week in Review: 2/8/2021 – 2/12/2021

COVID-19

The World Health Organization (WHO) has recommended wide use of the AstraZeneca (AZ) and Oxford University COVID-19 vaccine in adults over 18, regardless of the variant situation. The decision, which was made by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) panel, comes just after South Africa suspended the use of AstraZeneca’s COVID-19 vaccine following data that shows it offers limited protection against a new strain of the virus.

The European Commission has finalized an agreement for 300 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, dubbed “Comirnaty”. An initial supply agreement was reached in November 2020 but has now been finalized by the Commission and Pfizer. It brings the Commission’s overall order to 600 million doses.

The U.S. Food and Drug Administration has granted emergency use authorization (EUA) to Eli Lilly’s COVID-19 combination antibody therapy (bamlanivimab/etesevimab).

POLICY

The Pharmaceutical Research and Manufacturers of America (PhRMA) has published a new report that “sheds light” on the distribution and pricing of medicines administered in the hospital outpatient setting, an area in which “little information is available,” said the bloc.

The UK government has announced an overhaul of the country’s NHS, revealing plans to publish a white paper containing proposals that it hopes will “bring health and care services closer together.”

France’s National Cancer Institute has unveiled a new 10-year cancer control strategy, with hopes to significantly reduce the burden of cancer on patients in France. Notably, the plan allocates an additional 20% funding, meaning that the total is now EUR 1.74 billion, including additional funding of EUR 284 million for the next five years.

DRUG APPROVAL

The Spanish Agency for Medicines and Health Products (AEMPS) has approved Hospital Clinic’s homegrown CAR-T ARI-0001 as an advanced therapy drug of non-industrial manufacture for the treatment of patients aged 25 years and up with acute lymphoblastic leukemia (ALL) resistant to conventional treatments.

HTA

In an appraisal consultation document, the National Institute for Health and Care Excellence (NICE) has recommended against the use of Bluebird Bio’s Zynteglo (betibeglogene autotemcel) for the treatment of patients with transfusion-dependent beta-thalassaemia (TDT). The one-time gene therapy was rejected on the grounds that clinical trial data is small and insufficient to justify reimbursement, according to NICE, which means that the organization has uncertainties about the cost-effectiveness. Further, the cost estimate for Zynteglo is “considerably” higher than what NICE normally considers an acceptable use of NHS resources at £1,450,000 per patient.

NICE also recommended against Lupin’s Namuscla (mexiletine) for treating the symptoms of myotonia in adults with non-dystrophic myotonic disorders, and launched a public consultation on its processes of technology evaluation.

PRICING & REIMBURSEMENT

Germany’s Federal Joint Committee (G-BA) has asked Novartis to collect data on Zolgensma (onasemnogene abeparvovec) when used in routine clinical practice, in order to evaluate it for an additional benefit assessment. This is because there is no direct comparison available for Zolgensma in the treatment of spinal muscular atrophy (SMA), due to the nature and the novelty of the treatment, and as such the G-BA says that its comparison to treatment alternatives cannot yet be conclusively assessed.

The Irish Government has released the first EUR 30 million of its promised EUR 50 million to help clear a list of “backlogged” medicines, which will help give patients access to treatments for a range of diseases, including lung cancer, renal cell carcinoma, urethral carcinoma, leukemia, Parkinson’s disease and chronic migraine.

Following an investigation that began in May 2017 into Aspen’s pricing practices regarding six critical off-patent cancer meds, the European Commission has made Aspen’s resulting commitments legally binding under EU antitrust rules. The commitments mean that Aspen must reduce its prices in Europe for the six critical cancer medicines in question by 73% on average, as well as ensuring the supply of the treatments for a “significant” period.