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Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use

 
• By Sarah Karlin-Smith

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.

picture of a person's hand putting small amounts of coins into empty jar
Importing Drugs For Medicaid May Not Achieve Much (If Any) Savings For States. • Source: Shutterstock

The US Food and Drug Administration tends to get all the attention when it comes to barriers to Canadian drug importation, but now that Florida has become the first state to get FDA clearance for a Section 804 Importation Program more eyes could turn to the Centers for Medicare and Medicaid services regarding how such importation will impact reimbursement policies.

When FDA might actually allow drugs to be imported remains an open question (see sidebar) but CMS’s plan for handling drug importation thus far seems favorable to the

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More from Canada

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.

Health Canada Addresses Growing Diversity Of Co-Packaged Drugs

 
• By Vibha Sharma

The Canadian regulator says its current policy on identifying and labeling drug products in “kits” is insufficient to address the diverse types of co-packaged drug products that are entering the market.

Canada’s New Rare Disease Registry Guidance To Assist Regulatory And HTA Decision Making

 
• By Francesca Bruce

Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

More from North America

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.