Non-alcoholic steatohepatitis patients, health care providers and researchers must feel like they are navigating their way toward effective medications and better outcomes at a frustrating ratio of one step forward, two steps back. Every piece of good news seems to trigger an accompanying setback.
For instance, the current treatments for NASH are lifestyle changes and weight loss, which have proven effective. But they are also extremely difficult for patients to achieve and sustain.
Several companies are developing medications to treat NASH, though progress has been slow. Indeed, more than one promising therapy has been dropped after underwhelming research results.
And late last year, one drug trial produced a resounding success that may lead to an FDA approval soon. Although, insurance companies are already signaling reluctance to cover it. One red flag was the announcement by the Institute for Clinical and Economic Review that it would study NASH medications’ cost-effectiveness. It’s not the first time, or likely the last time, that the drug pricing watchdog has taken aim at a medication even before FDA approval.
Anticipating Insurance Barriers
Insurers and pharmacy benefit managers have used ICER’s reports as justification for limiting treatment access to only the sickest patients or not covering certain medications at all. There are already concerns that payers may restrict patients’ ability to get NASH drugs by requiring confirmatory diagnoses through invasive and expensive liver biopsies.
Or they may force patients and doctors to jump through various “fail first” hoops before “earning” the right to access the effective medicines they need.
About 22 million Americans suffer from non-alcoholic steatohepatitis. It’s a condition in which fat builds up in the liver, leading to inflammation and — in approximately one-third of current patients — significant fibrosis and liver damage. NASH’s prevalence and severity are projected to grow in the coming decade, alongside comorbidities like obesity and type 2 diabetes. Today, there are no treatments.
NASH is one of many conditions around which the research is moving fast, yet patient access may ultimately depend on policy decisions. Hopefully, by the time an effective treatment is approved, patients will not be forced to retreat from that big step forward with yet another step back.