Will it be possible to expand the benefit of Prolia?

The government said, "We will collect the latest knowledge"

Attention is focusing on whether the criticism that biopharmaceuticals that treat osteoporosis by preventing bone absorption or activating bone formation are not fully enjoyed due to restrictions on Korea's benefit standards can be resolved.

 

This is directly related to Amgen's Prolia (Denosumab) and Evenity (Romosumab) access to patients, as experts argued the need every year and the National Assembly also agreed, the government said it would consider reflecting it after collecting opinions.

 

On the 7th, the MOHW promised to improve the benefit standards reflecting the latest treatment guidelines at the "policy discussion on improving the treatment environment for osteoporosis" hosted by Rep.

 

Lee Jong-sung of the People Power Party (YouTube).

 

Although the MOHW has made some prospective opinions on the benefit criteria for osteoporosis drugs, it remains to be seen whether it will actually lead to an improvement in the actual standards.

 

There are two reasons why critics say that domestic benefit standards are holding back biopharmaceuticals that treat osteoporosis.

 

First, if the osteoporosis drug benefit period exceeds the bone density level of T-Score -2.5, it is recognized only for one year.

 

The standard is applied to biopharmaceuticals, Prolia, including synthetic drugs such as bisphosphonate drugs, SERM drugs, and Zoledronic acid, and specialists are demanding improvement.

 

Another critical factor is that the "ultra-risk group for osteoporosis" drug benefit standard can only be used when fractures using bone absorption inhibitors occur for more than a year.

 

This is the standard applied to Evenity, a biopharmaceutical that promotes bone formation, and it is pointed out that evenness benefits are recognized only after bone absorption inhibitors are administered.

 

Specifically, Prolia obtained the first treatment benefit as of April 1, 2019.

 

If the bone density level (T-Score) is -2.5 or less, it will be applied twice a year, and if osteoporosis fractures are confirmed on radiography, it will be applied six times a year.

 

Despite the acquisition of primary benefits, experts are calling for an improvement in the benefit standard for osteoporosis treatments such as Prolia because of the current standard for suddenly converting the benefit drug to non-reimbursement a year later if the bone density level exceeds -2.5.

 

This is because patients' access to medicines is blocked by suspending their benefit if the drug is partially effective, even though fractures can be prevented by continuous administration of treatments.

 

Evenity is receiving the second treatment benefit as of December 1, 2020.

 

It is recognized only when additional conditions are satisfied based on the criteria that at least one of the existing bisphosphonate formulations is ineffective or unavailable.

 

An additional condition for Evenness Secondary benefit is ▲ postmenopausal women aged 65 or older,▲ Bone density test results measured by Dual-Energy X-ray Absorptiometry (DEXA) in the central bone (excluding lumbar spine and femur)] showed that the bone density test was less than T-score -2.5 SD, ▲When two or more osteoporosis fractures occur (data on osteoporosis fractures must be attached for fractures that have occurred in the past).

 

The administration period is recognized only up to 12 times every one month in a lifetime.

 

Professor Lee Yoo-mi of Endocrinology at Severance Hospital, who attended a policy debate hosted by Rep.

 

Lee Jong-sung, stressed that it should be improved and expanded to middle-aged people.

 

In fact, international guidelines recommend Evenity, a bone formation promoter, as the primary drug in the ultra-high risk group.

 

Ultra-high-risk groups, such as the elderly who have already experienced fractures, first use bone formation promoters to increase bone mass, and then prevent bone density and fracture by preventing absorption of increased bone mass with bone absorption inhibitors.

 

This means that Korea's benefit standards are the opposite of international guidelines.

 

At a policy debate hosted by Rep.

 

Lee Jong-sung, both irrationalities of the domestic osteoporosis benefit standard were a hot topic.

 

Experts pointed out all the problems of the innovation of bio-new drugs and domestic salary standards from disease risks and social costs caused by osteoporosis.

 

The MOHW, which attended the debate, plans to collect expert criticism and review international guidelines to improve and expand the standards.

 

Choi Kyung-ho, secretary of the insurance drug department, explained, "I agree with the pain of elderly patients due to osteoporosis and fractures and the burden of social and economic costs." He said, "We will try to improve access to new drugs so that the standards meet the latest medical guidelines, but we will also carefully review the soundness of sustainable health insurance finances."