Key finding: Despite fibrosis stage being the strongest predictor of negative outcomes in NASH patients – only 17% of Pharmacy and Medical Directors (PD/MDs) surveyed by DRG suggested it would be the most important clinical factor when assessing cost-effectiveness of a novel therapy for NASH.

What’s more important to payers? The study showed that 47% of PD/MDs cited improvement or resolution of NASH as the most important clinical factor, and 20% say progression to cirrhosis.

 

The “so what” for decision makers: With no approved drug treatments for NASH, it is understandable that what is considered “effective” remains contentious.

Drug companies must carefully design their late-stage NASH trials in order to demonstrate improvements in NASH, fibrosis, and composite long-term outcomes in order to win support from both payers and prescribers. With payers holding control over physician prescribing, tailoring the trial to their preferred endpoints should facilitate improved access.

 

 

Learn what else matters for payer decisions around emerging NASH treatments and diagnostic tests:

 

Key questions answered in the analysis:

  • How do payers anticipate reimbursing emerging therapies for NASH, such as Intercept’s Ocaliva or Genfit’s elafibranor, post-approval? What restrictions will they impose?
  • What are physicians’ opinions on current late-phase emerging therapies (Intercept’s Ocaliva, Genfit’s elafibranor, Allergan’s cenicriviroc, and Gilead’s selonsertib)?
  • How do payers reimburse current diagnostic tests, such as liver biopsy, in 2018? What role will diagnostic tests play in the prescribing of emerging therapies?
  • What role do reimbursement, restriction, and patient cost play in physicians’ decisions to prescribe therapies for NASH?

 

Markets covered: United States.

Methodology: Survey of 27 hepatologists and 73 gastroenterologists in the United States in addition to 30 managed care organization (MCO) pharmacy and medical directors (PDs/MDs).

Indication coverage: non-alcoholic steatohepatitis (NASH).

Key drugs covered: Ocaliva (obeticholic acid), elafibranor, cenicriviroc, selonsertib, vitamin E, pioglitazone, ursodiol, statins, ezetimibe, metformin, SGLT-2 inhibitors, GLP-1 receptor agonists.

Key companies mentioned: Intercept Pharmaceuticals, Genfit, Allergan, Gilead Sciences

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