Single Product, Single Price: Medicare Will Include All Versions Of Active Ingredient For Negotiation

The US Medicare agency intends to treat all dosage forms of the same active ingredient as a single drug for purposes of its new price negotiation authority. The approach will have implications for product branding and line extension strategies.

wide net
CMS is casting a wide net on dosage forms, branding and indications as it prepares for Rx price negotiations. • Source: Shutterstock

The US Medicare agency is casting a very broad net to ensure that all versions of the same active ingredient are included in the price negotiation process, regardless of differences in dosage form, branding, indications, or regulatory pathway.

More from Market Access

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

PBMs Must Prepare For Revival Of Drug Price Transparency Requirements

 

Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.

Is Optum Rx Payment Remodel To Favor Generics A Peace Offering For US FTC?

 

Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.

England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

More from Pink Sheet

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By 

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.