Two drugs used to treat high blood pressure and depression are to be withdrawn from the Taiwanese market from late this year to early next year, but locally produced generics would fill the gap, the Food and Drug Administration (FDA) said on Monday.
The manufacturers notified the agency that they would stop providing Aprovel 150mg film-coated tablets, an antihypertensive, and Prozac Dispersible 20mg tablets, an antidepressant, after December and November respectively, FDA Deputy Director-General Wang Te-yuan (王德原) said.
The two companies informed the FDA on July 31 and June 24 respectively, he added.
Photo: Chiu Chih-jou, Taipei Times
However, the supply of the two drugs would not be affected, because they would be replaced by generic alternatives produced by local pharmaceutical companies, Wang said.
Generics have the same effects as brand-name drugs and are produced by other qualified pharmaceutical manufacturers using the same ingredients and procedures after the original patents expire, the Taiwan Generic Pharmaceutical Association said.
Aprovel 150mg film-coated tablets last year had a 67 percent share of the Taiwanese market, with 1.24 million tablets covered by National Health Insurance, said Tai Hsueh-yung (戴雪詠), an official from the National Health Insurance Administration’s (NHIA) Medical Review and Pharmaceutical Benefits Division.
The manufacturer of Aprovel 150mg tablets on April 1 proposed that the National Health Insurance Administration remove the drug from NHI coverage, and replace it with drugs that contain the same ingredients, Tai said.
Clinicians in Taiwan have supported that advice, saying that there are several generic drugs available, while the Pharmaceutical Benefit and Reimbursement Scheme Joint Committee approved the proposal during in June. The drug is to be removed from NHI coverage in January next year.
There are nine drugs covered by the NHI that contain the same active ingredients as Aprovel, Tai said.
Meanwhile, the NHI covers 11 alternatives to Prozac, which last year had a 15.3 percent market share with 2.92 million tablets covered by the NHI, Tai said.
Nearly 40 years have passed since Prozac first entered the market, and the market share of generic versions in Taiwan has reached 85 percent, Tai said.
In other news, the NHIA said that it would evaluate whether to include a one-time gene therapy to treat people with hemophilia B in the NHI drug reimbursement scheme, after it is approved in Taiwan.
The US Food and Drug Administration has approved the gene therapy fidanacogene elaparvovec (Beqvez), which has a hefty US$3.5 million price tag, for adults with hemophilia B, a rare bleeding disorder.
The therapy has only received conditional marketing authorization from the European Commission under the name Durveqtix because it was tested on a small number of people, Tai said.
The manufacturer of Beqvez is required to continue providing data on the treatment’s long-term efficacy, she said.
Applications for importing the one-time hemophilia B gene therapy product have been submitted to Taiwan’s Food and Drug Administration, Tai said.
If the suppliers submit reimbursement applications to the NHIA after an import permit is granted, the agency would begin evaluating the efficacy of the treatment, its cost-effectiveness and the extent to which it enhances a patient’s quality of life, Tai said.
Hemophilia B is a rare inherited disease caused by a deficiency or defect in blood clotting factor IX, meaning the blood cannot clot properly to control bleeding.
People with severe hemophilia B often receive regular infusions to prevent bleeding episodes. The disease affects 196 people in Taiwan, and the average annual cost of their treatments is about NT$5 million to NT$7 million (US$156,284 to US$218,798).
Although Beqvex costs about NT$100 million, the one-time gene therapy is intended to help people produce factor IX, rather than needing infusions multiple times a week.
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