Drugs in development for non-alcoholic steatohepatitis (NASH) threaten the same kind of cost burden to payers as have the newer hepatitis C drugs, according to OptumRx Inc. Pipeline and Drug Surveillance Manager Farrah Wong.

“I’m often asked what I think is going to be the next hepatitis C class” in terms of cost. “It’s going to be another liver-type disease state called NASH,” Wong told the Pharmaceutical Care Management Association national policy forum April 11. OptumRx is UnitedHealth Group Co.’s in-house pharmacy benefit manager, covering over 60 million lives. The PBM manages pharmacy benefits for UnitedHealth plans and some outside clients.

OptumRx believes the size of the NASH population is about 16 million individuals in the US, or about 5% of Americans. Analysts project the worldwide market for the class could reach $35bn to $40bn, Wong noted. The drugs in development so far are not expected to offer a cure for the disease, so treatment would presumably be for life, which factors into cost considerations.

More than 20 companies are working on drugs in this class and the list of firms getting into the field continues to grow ([A#00160418001]).

“Everybody is trying to get NASH [approval] first, but a lot of them are still in Phase II, with one or two in Phase III,” Wong pointed out. “We are starting to see a lot these manufacturers trying to look for that next hepatitis C situation – which involves limited-to-no [treatment] options and a huge population. That’s what we’re seeing with NASH.”

NASH is a form of non-alcoholic fatty liver disease that can progress to cirrhosis, liver failure and cancer. There is currently no treatment for NASH; the standard of care is lifestyle modifications, control of metabolic disease (which is often seen in patients with NASH), and vitamin E. Because NASH is a slow progressive disease, its treatment is expected to be covered primarily by Medicare and Medicaid, Wong said.

It’s not clear which drug will get to market first with a NASH approval and when that might happen. Two drugs are currently in Phase III study for the indication – Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) and Genfit SA’s elfibranor.

Ocaliva received a breakthrough designation for treatment of NASH with concomitant liver fibrosis in January 2015 but interim results from the Phase III trial on the drug, called REGENERATE, are not expected to be available until March 2017.

Concerns With Off-Label Use

However, Ocaliva may reach the market in June with an expected approval for a separate orphan indication in primary biliary cholangitis (PBC) ([A#14160407004]). The goal date for an FDA decision on the PBC application is May 29.

Because there is a strong unmet need for NASH, payers are worried that prescribers will try to use Ocaliva off label in the condition. To avoid that, many are likely to develop coverage restrictions that limit use to PBC. That is what Harvard Pilgrim Health Care is considering, Chief Medical Officer Michael Sherman said in an interview. Harvard Pilgrim has already begun to work on its coverage policy for Ocaliva, he said.

Ever since Gilead Sciences Inc.’s hepatitis C drug Solvadi (sofosbuvir) shocked payers with its high price when it launched in late 2013, Harvard Pilgrim has made an effort to look ahead and identify drugs that threaten to account for 0.5%-1% of its total medical costs, he noted. The hepatitis C drugs cost in the 1% range, Sherman added.

Payer policies may be informed by a technology assessment on Ocaliva that is being developed by the Institute for Clinical and Economic Review. A draft report on the evaluation is scheduled to be released May 25.

OptumRx’s Wong suggested one concern with off-label use of Ocaliva that could be used to justify use restrictions. She noted the studies on the drug showed a dose-related itching side effect and “because the NASH dose is going to be a little bit higher [than PBC] we might see more itching involved” with NASH. In addition, she noted there has been an association between Ocaliva and a reduction in the HDL (good) cholesterol, “so we are monitoring the cardiovascular outcomes of this drug very closely.”

NASH Drug Cost Concerns On Level With HCV Treatments For Payers

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