Ferring’s Rekovelle (follitropin delta), a treatment to promote egg production in ovaries, became reimbursable when used in combination with human menopausal gonadotropin (hMG) in women receiving in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Ferring Korea said Rekovelle got health insurance benefits in combo with hMG starting from May 1, citing a Health Insurance Review and Assessment Service (HIRA) notice.
The broader health insurance coverage for Rekovelle was based on the MARCS trial, which evaluated the efficacy and safety of Rekovelle plus hMG in 110 patients who received IVF or ICSI.
The study results showed that Rekovelle plus hMG increased the possibility of collecting high-quality blastocysts (grade 3BB or higher according to the Gardener classification).
The number of quality blastocysts usable on days 5 and 6, set as the primary endpoint, was 4.9 on average, significantly higher than two in the ESTHER-1 trial of Rekovelle monotherapy.
The number of mature oocytes retrieved, set as the secondary endpoint, was 11.3 on average, much higher than 7.4 in the ESTHER-1 study.
Even when MARCS participants were stratified by age, those who received Rekovelle and hMG had a statistically significantly higher mean in the number of good-quality blastocysts compared with the ESTHER-1 trial.
The ratio of optimal oocyte collection (8-14 oocytes) was higher in patients aged 35 or more than those under 35, proving that the combination therapy was more effective than Rekovelle alone in older patients with low pregnancy rates.
Lee Won-don, director of Maria Fertility Hospital, said older infertile women preferred the combo therapy using Rekovelle with hMG because the therapeutic effect could be maximized.
However, Rekovelle had been reimbursable only when used as monotherapy, which made it difficult for older women to use combo therapy.
“Fortunately, the latest expansion of reimbursement for Rekovelle and hMG combo relieved financial burdens for patients who needed more effective treatment. I hope this will lead to higher fertility rates,” Lee said.