After 9 years, greenlight for 'Ilaris' reimbursement likely

Novartis’ 'continued efforts' have been shown

Novartis has accepted the decision of the DREC reivew, which was under a conditional pass

What remains is the negotiations for drug pricing with the National Health Insurance Service (NHIS)…aims to be listed in August

Novartis

In about nine years since its approval in South Korea, the orphan drug 'Ilaris' is heading toward reimbursement listing.

 

Novartis’ continued effort has shined.

 

In February, Ilaris (canakinumab), a drug used to treat periodic fever syndromes (PFS), received a conditional pass decision from the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA).

 

Subsequently, it was redeliberated to the DREC review on April 4th, but it has received the same result.

 

Contrary to the last review, reducing the scope of the government’s requirement for post-marketing evidence submission was the main discussion.

 

In February, Novartis did not accept the condition proposed by the DREC.

 

However, during this round of review, the DREC has likely made a conditional reimbursement pass again, requiring the same scope of the post-marketing evidence submission.

 

This time, Novartis has agreed to accept the DREC’s conditional pass and deliberation result.

 

They have also responded quickly to the decision.

 

Although the required evidence scope has been reduced, it may not have been an easy for a pharmaceutical company.

 

To deliver Ilrais to patients, Novartis has made significant efforts.

 

It is also encouraging that the government responded promptly to the initial objection application and reduced the scope of the required evidence.

 

However, what remains is the drug pricing negotiations with the National Health Insurance Service (NHIS).

 

During the talks with the NHIS, the specifics of the conditional reimbursement will be discussed.

 

The company will negotiate with NHIS for two months following the negotiations order by the Ministry of Health and Welfare (MOHW).

 

Once the negotiations are completed, the item will be passed along to the Health Insurance Policy Review Committee, and Ilrais can be expected to be reimbursed starting in August.

 

“We expect that the negotiating process with the NHIS will likely be equally challenging, but we will put our best efforts into negotiating for patients who have waited for the approval for a long time,” a Novartis representative stated.

 

In South Korea, Ilrais can be prescribed for the following diseases: ▲Periodic fever syndromes (PFS), cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial mediterranean fever (FMF) ▲Active systemic juvenile idiopathic arthritis (Systemic JIA).

 

For CAPS, it is further categorized into the following symptoms: ▲Familial cold autoinflammatory syndrome (FCAS)/ familial cold urticaria (FCU) ▲Muckle-Wells syndrome (MWS) ▲Neonatal onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous and articular syndrome (CINCA).

 

Discussions for reimbursement of Ilaris are challenging due to its limited patient targets and complicated indications.

 

Only a few patients meet the Ilaris’ number of indications.

 

Furthermore, some Ilaris’ indications are missing disease codes and were recently registered.