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Terminally-ill patients protest HIRA’s latest ban on off-label prescriptions on immune checkpoint inhibitors
  • By Yang Geum-deok
  • Published 2017.08.30 14:07
  • Updated 2017.08.30 14:58
  • comments 0

“Withdraw your decision to ban off-label prescriptions on immune checkpoint inhibitors, our last hope!”

About 30 people including cancer patients and their families Tuesday waged a protest in front of the Health Insurance Review & Assessment Service (HIRA).

The government decided to allow medical insurance coverage for immuno-oncology therapy Opdivo (compound: nivolumab) and Keytruda(compound: pembrolizumab) as of Aug. 21 for non-small cell lung cancer patients who showed a certain level of PD-L1 incidence. The announcement included a criteria that only large medical institutions capable of managing side effects through multidisciplinary efforts can prescribe such drugs.

The government’s approval includes patients who receive off-label prescriptions. But to minimize the treatment suspension, the government set the grace period for hospital transfer until the end of this year. Therefore, patients can get the immuno-oncology therapy in previous hospitals until they move to another medical institution that treats them with the drugs.

However, the protesters, who are also members of immuno-oncology online community on Naver, said HIRA has put pressure on hospitals to prevent off-label prescriptions of immuno-oncology therapies.

“One-third of 600 patients across the nation have already missed the treatment time and more patients will have to stop treatment,” said a member of the community.

They argued hospitals have suspended the off-label prescriptions because they were worried that the HIRA might cut their insurance coverage for prescribing such drugs in off-label ways.

“Hospitals have cancelled the treatments or sent out refund notices, although the HIRA said they could continue to offer treatment to the existing patients. I heard a hospital official saying they did so after getting a phone call from the HIRA, which pressured them,” said a man identified only by his surname Kim, who was the representative of the patient group.

“It’s hard for patients to look for hospitals individually. The HIRA has to help us find hospitals that provide immuno-oncology therapies or give us the list of the available hospitals.”

Kim said the HIRA has limited the off-label prescriptions due to concerns for side effects.

“It doesn’t make sense they can’t use drugs because of side effects. Who thinks we can overuse a drug that costs 3 million won ($ 2,669) per one shot?” he said.

They spent more than one hour for the rally and visited HIRA’s drug management office to request follow-up measures to resolve the issue of treatment suspension, full medical coverage when patients take standard cancer and immuno-oncology therapies together, and a quicker assessment.

About 30 protesters who are members of immuno-oncology online community on Naver Tuesday waged a protest about off-label prescriptions in front of HIRA.

‘HIRA can’t identify hospitals that are uncovered for insurance in using immune checkpoint inhibitors’

HIRA, however, said the reality was different from what patients argued and promised it would ask medical institutions not to suspend prescriptions.

“It is impossible to put pressure on hospitals because HIRA doesn’t know which hospitals provide prescriptions,” said Lee Byung-il이병일, director at HIRA’s drug management office in a meeting with reporters.

Lee said HIRA would take strong measures to punish those who put pressure on hospitals by threatening that the agency would cut the insurance coverage, if there is any case.

Lee said if patients can give out details which hospital and which doctors refused to provide treatment, he will check and take appropriate measures.

Lee said because the measure to cover medical insurance for immuno-oncology therapy is based on the notice from the Ministry of Health and Welfare (MOHW), HIRA could not take arbitrary measures. And he said he would raise the issue in a meeting of an advisory committee consisting of cancer experts on Aug. 30.

“We sent an official letter to medical institutions that have the multi-disciplinary committee to prevent the suspension of off-label prescriptions last Friday and Monday. Afterwards, we will separately guide hospitals that have trouble in prescriptions,” Lee said.

“Because other cancer patients also get treatment with insured drugs through the multi-disciplinary committee, we have to consider fairness. Most of all, HIRA can’t exercise its influence on doctors’ treatments,” Lee added.


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