1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>Canada

Pricing Reforms Prompt Canadian Business Rethink

Roche Has Withdrawn Tecentriq From HTA Processes

 
• By Francesca Bruce

The R&D based pharmaceutical industry would welcome changes to guidelines that will operationalize controversial new pricing regulations in Canada but industry experts say more is needed.

Canadian_Dollars
It's a question of cost • Source: Shutterstock

Pharmaceutical companies in Canada have responded to controversial new pricing regulations by cutting staff and withdrawing products from health technology appraisal processes. Potential changes to draft guidelines that set out how the regulations will work in practice will be well received but should go further, says Arvind Mani, founder of Morse, a Canada-based consultancy firm.

The Patented Medicines Prices Review Board (PMPRB), which sets ceiling prices in Canada, told the Pink Sheet that it was...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Canada

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

‘Hope And Scientific Spillover’ – Cross-Atlantic HTA Alliance To Focus On Novel Benefits

 
• By Francesca Bruce

An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.

More from North America

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.