Canada

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

The rolling reimbursement reviews that Canada’s Drug Agency introduced as a pilot scheme to speed up patient access to COVID-19 products can now be used for any drug application. The move to open up the mechanism follows prompts by industry.

England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.

The European Commission’s new research and innovation funding scheme should have a higher budget and be more “flexible and fit-for-purpose” than the existing “one-size-fits-all approach,” pharma industry federation EFPIA says.

A new requirement for drug companies on how much safety stock to maintain and a mechanism for extending the expiration date of a lot or batch of a drug if there is a shortage that could cause harm are among the measures Health Canada is proposing to adopt.

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification.

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Health technology assessment bodies must strike a fine balance between standardizing their real-world evidence frameworks with those of other countries and tailoring them to meet population-specific needs, an expert tells England’s NICE.

Decentralized clinical trials are subject to the same regulatory requirements as traditional site-based trials, but are of special interest to regulators because they represent a new way of working.

Among the provisions in a newly tabled bill seeking to introduce a national pharmacare system in Canada is a bulk purchasing strategy for prescription drugs that could help lower costs.

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

Regulatory tools designed to prevent medicines intended for Canada being diverted elsewhere will be “crucial” for preventing shortages in the country, say Canadian authorities and industry representatives.

International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”

CMS guidance on the Medicaid Drug Rebate Program, best price and drug importation from 2020 should make it less attractive for states to implement importation programs and help pharma.

The US FDA's authorization of the first ever Section 804 importation program is a notable political move, but hurdles remain before the state can import drugs and savings are expected to be minimal.

The newly created agency will build on the mandate and functions of the health technology assessment body, CADTH.