UPDATE : Wednesday, August 21, 2019
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Reimbursement for orphan drug Spinraza imminent
  • By Kim Yun-mi
  • Published 2019.03.18 12:02
  • Updated 2019.04.19 15:08
  • comments 0

Biogen’s Spinraza (ingredient: nusinersen), a treatment for spinal muscular atrophy (SMA), is likely to obtain reimbursement as early as next month.

The pharmaceutical company and the National Health Insurance Service (NHIS) on Friday reached an agreement on pricing for the treatment of the rare neuromuscular disease. The negotiation talks for Spinraza pricing has been stuck until Thursday.

The Ministry of Health and Welfare’s health insurance policy review committee is to make the final decision on reimbursement for the drug. The pharmaceutical industry expects the committee may discuss it at the upcoming meeting in late March. If the scenario unfolds as predicted, Spinraza may get insurance benefit from April at the earliest.

Spinraza was the first SMA treatment to win the U.S. approval in December 2016. A year later, the drug gained the license in Korea in December 2017.

SMA is a rare neuromuscular disorder in which muscles are gradually contracted due to damage in motor neurons in the spinal cord and brain stem. Cognitive function stays normal, but all muscles grow weak, making it difficult to perform basic tasks for life such as breathing or eating. If left untreated, a patient with SMA is highly likely to die.

The health authorities quickly approved Spinraza due to SMA’s seriousness and the drug’s innovative efficacy.

However, procedures for reimbursement for the drug have not been smooth.

The biggest hurdle was Spinraza’s astronomical list price, which was known to cost over 92.3 million won ($81,000) a vial.

Biogen had applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) in April last year, but the pharmaceutical reimbursement assessment committee has repeatedly refused to discuss the issue. In November, the committee ruled that Spinraza needed an assessment again.

In December, Spinraza passed the committee’s approval for reimbursement. Biogen was able to start price negotiations with the HIRA on Jan. 29.

The two sides failed to reach an agreement in three rounds of talks but finally set the reimbursement price in the additional and final negotiations on Friday.

Patients suffering from SMA also helped Spinraza pass the reimbursement approval after over a year since obtaining the local license.

SMA patients and families sent a letter to demand 22 members of the National Assembly’s Health and Welfare Committee persuade the government to make Spinraza reimbursable in March. They sent similar letters to Health and Welfare Minister Park Neung-hoo in April, and to President Moon Jae-in in August.

In December, a group of SMA patients staged an online campaign to push for reimbursement for Spinraza and garnered more than 1,700 postings and participation of celebrities.

kym@docdocdoc.co.kr

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