ICER’s Final NASH Report Urges Step Therapy, Specialist Prescribing, Equitable Access

When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.

Cost control
ICER report recommends step therapy when NASH drugs reach market • Source: Shutterstock

The final assessment from the US Institute for Clinical and Economic Review (ICER) on the first drugs vying to open the market for non-alcoholic steatohepatitis (NASH), Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) and Madrigal Pharmaceuticals, Inc.’s resmetirom, concludes that payers should consider using step therapy for weight management before NASH drugs, that price-volume and outcomes-based agreements may be suitable for pricing the first NASH drugs to reach market, and that coverage criteria should foster equitable access to therapy.

The final report issued 25 May follows a draft report issued in February and a public hearing of ICER’s Midwest...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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

More from Drug Pricing

BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review Program

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By 

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By 

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Europe’s Drugmakers Lament EU Pharma Package

 
• By 

EFPIA says reforms make the continent less attractive for innovative firms.

More from Scrip

China Signals Restarting IPOs For Unprofitable Biotechs

 

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.