Evrysdi also subject to prior authorization for reimb

Jin-Su Lee, Chair of the Healthcare Review and Assessment Committee, “Will analyze other prior authorization items as well”

Will set standards through active use of RWD...expects Spinraza to help prevent unnecessary fiscal spending

Pic of SMA treatments (from the left) Spinraza, Evrysdi, Zolgensma

The Health Insurance Review and Assessment Service is expected to require the oral SMA (spinal muscular atrophy) treatment ‘Evrysdi Dry Syrup (risdiplam, Roche)’ to receive prior authorization for reimbursement.

 

Also, HIRA is planning to reflect the prior authorization experience it has accumulated from Spinraza for Evrysdi.

 

HIRA’s Healthcare Review and Assessment Committee announced so at a special press corps meeting with industry reporters on the 18th.

 

Jin-Su Lee, Chair of the Healthcare Review and Assessment Committee, said, ”After literature review and reflection of overseas cases, we have prepared an announcement on the revised measures for prior authorization drugs based on the RWD (Real World Data) data we obtained from the prior authorization for Spinraza.

 

The revised standards will be applied to the prior authorization review of the oral SMA treatment Evrysdi that was recently granted reimbursement.

 

Jin-Su Lee, Chair of HIRA’s Healthcare Review and Assessment Committee is answering questions at a special press corp meeting on the 18th

Currently, Roche is having pricing negotiations with the National Health Insurance Service for Evrysdi, after which reimbursement listing is expected.

 

Also, the company for Spinraza Inj, a drug already listed for reimbursement, is negotiating to expand the use age for the drug with NHIS.

 

The reimbursement standards for the two drugs are prepared after completing pricing negotiations, and the measure HIRA presented on the 18th will be reflected then.

 

Lee said, “We expect the new measure to contribute to saving finances unnecessarily spent on SMA patients who are judged to have no effect with Spinraza Inj.” Based on the comment, it is likely that the Healthcare Review and Assessment Committee will be disapproving reimbursement of the drug to patients who are judged to have no effect.

 

Spinraza is a high-priced drug that costs KRW 554 million per patient in the first year, then KRW 277 million every year thereafter.

 

A HIRA official explained, "We cannot conclusively say that Evrysdi will be subject to prior authorizations as its reimbursement standards have not been announced yet.

 

However, as the other existing SMA treatments are also required to receive prior authorizations, it is true that the drug’s chances of being subject to the same conditions are high.” Currently, the SMA treatments Spinraza and Zolgensma are subject to prior authorizations for reimbursement.

 

Lee also added that just as in Spinraza's reimbursement standards, the committee will be reflecting the experience accumulated from other prior authorizations in the reimbursement review process as well.

 

Lee stressed, “We will continue to sequentially analyze the data of other prior authorization drugs in addition to Spinraza inj.

 

Although the purpose and content analyzed may differ by item, we will be assessing the possibility and need for the subject drugs to switch to general review drugs and identify whether there is a need to improve the reimbursement standards for others.” He added, "If the committee judges that it is necessary to improve the reimbursement standard based on data analysis, and there is valid evidence to support the change, we will closely work with relevant departments to make the necessary improvements." SMA is a rare condition in which the SMN1 gene is innately deficient or mutated to result in progressive muscle atrophy.

 

In the case of SMA Type 1, the most common and severe form of SMA, if left untreated, over 95% of the motor neurons are damaged within 6 months, and 90% die before the age of 2 or require permanent respiratory support devices.

 

Also, 30% of SMA Type 2 patients can die before the age of 25 and requires lifelong treatment.

 

The reimbursement decision for the SMA treatment Spinraza has been subject to prior authorization ever since it was listed for reimbursement in April 2019.

 

Also, ‘Zolgensma Inj,’ better known as the one-shot treatment for SMA, has been added as a prior authorization drug.