Can novel bone-builder Evenity win reimbursement this year?

Pricing negotiation with NHIS started after DREC passing the drug in September

Coverage is crucial for Evenity with double indication to form bone and reduce bone resorption

Apparently, a novel bone-builder Evenity is making its last push to nab the National Health Insurance (NHI) benefit by the end of the year.

 

The South Korean pharmaceutical industry sources reported, Amgen Korea and National Health Insurance Service (NHIS) have recently initiated a pricing negotiation on an osteoporosis drug Evenity (romososumab) indicated to promote bone formation and inhibit bone resorption.

 

As the 60-day negotiation is due next month, the drug could be listed for reimbursement within this year if the administrative procedure rushes on.

 

After receiving an approval for the South Korean market in May last year, the drug applied for reimbursement listing after a year.

 

The Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) green lit the listing after confirming the feasibility.

 

The drug is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, and for bone formation in men with osteoporosis at high risk for fracture.

 

The specialists have been anticipating for the novel drug as it is the only bone-builder to have proven the effect of lessening hip fracture.

 

As any of novel osteoporosis drugs had struggled through most of their reimbursement listing process in South Korea, Evenity would have to see if it could successfully get listed.

 

For about a decade, 70 percent to 80 percent of osteoporosis patients in South Korea have been using bisphosphonate, which was tackled on its strict limitation for drug administration and efficacy lacking sufficient data.

 

In fact, a bone formation medicine Forsteo (teriparatide) has taken a decade from item approval to reimbursement listing.

 

Amgen’s Prolia was also approved for the South Korean market in 2014 and launched as a non-reimbursed treatment in November 2016, but finally got to list its name in October 2017.

 

President of Korean Society for Bone and Mineral Research (KSBMR) Chung Ho-yeon noted, “Osteoporosis treatment prioritizes prevention of bone fracture.

 

So a treatment option preventing bone loss while forming new bone would induce prompt treatment benefit.” The efficacy of Evenity has been confirmed during Phase III FRAME and ARCH studies, as well as in Phase III 3 BRDIGE study for the indication treating male patients.

 

In the Phase III placebo-controlled FRAME study, Evenity has demonstrated effect of reducing the risk of new vertebral fracture in postmenopausal women with osteoporosis at risk for fracture resulting in bone mineral density (BMD) T-score of -2.5 to -3.5 at the total hip or femoral neck.

 

Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture.

 

The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia.

 

And in Phase III alendronate-controlled study ARCH, Evenity confirmed preventive effect of reducing risk of vertebral fracture and clinical fracture superior than alendronate.

 

Compared to the patient group treated only with alendronate, the patient group switched to alendronate after being treated with Evenity for 12 months had 50 percent lower risk of new vertebral fracture at 24 months.