Biogen, maker of the spinal muscular atrophy (SMA) drug Spinraza (nusinersen), and Roche, maker of Evrysdi (risdiplam), recently reached a dramatic agreement with the government by even extending drug price negotiations.

Now, the patients are also shifting their attention to dosing standards

According to industry insiders, the National Health Insurance Service (NHIS) and the two companies reached an 11th-hour agreement on Sept. 11, the deadline for the extended drug price negotiation.

As a result, Spinraza's reimbursement expansion and Evrysdi's new reimbursement have only a process at the Health Insurance Review and Assessment Service (HIRA) left. If the HIRA review ends this month, these benefits could go into effect as early as next month.

Evrysdi previously applied for new reimbursement in July 2021, and Spinraza applied for expanding coverage in late 2021.

Upon the negotiation’s settlement news, patients and their families are focusing on the new dosing standards.

The government has been discussing dosing standards for SMA treatments with medical experts for more than one-and-a-half after delaying the benefit review, as Spinraza treatment costs nearly 300 million won ($227,300) per patient yearly, and it is necessary to develop a follow-up plan to ensure the financial stability of the insurance system.

The newly announced Spinraza reimbursement guidelines should include information on treatment recipients, evaluation methods, discontinuation criteria, and replacement dosing. This will likely be applied in part to Evrysdi.

According to sources, the eligibility will be expanded to include type 3 patients not on a permanent ventilator. However, when applying for prior authorization, patients will have to meet the conditions for starting treatment based on the results of age-specific (24 months-under 18 and over 18) motor function assessments.

The government has reportedly accepted medical experts' opinions, diversified the types of motor function assessment tools to consider the various clinical symptoms of patients, and presented the definition of "improvement," a key factor in the discontinuation criteria, for each assessment tool.