"Expanded access to Pergoveris…for older infertile women"

The effect of FSH·LH combination therapy has been confirmed…emphasizing the importance of a personalized ovulation induction strategy

Merck strengthens CSR in response to low birth rates…'Fertility Counts' was established to support effective policy intervention

The paradigm of infertility treatment is shifting amid the increased age of mothers and the expansion of the patient population with poor ovarian response (POR).

 

Notably, the utilization of FSH (Follicle-Stimulating Hormone) and LH (Luteinizing Hormone) combination therapy has surged since the reimbursement criteria for 'Pergoveris inj (follitropin alfa, lutropin alfa)' were eased last year.

 

Consequently, a personalized ovulation induction strategy focused on older and low-responder patients is emerging as the core of domestic infertility treatment.

 

In response to this change, Merck Korea held a 'Fertility Academy' on November 13 at the Parnas Hotel in Gangnam-gu, Seoul, to share the clinical value of Pergoveris and emphasize the importance of personalized treatment strategies.

 

The event was held to commemorate Infertility Family Day (November 11), which was established to encourage infertile couples, raise social awareness, and share the clinical value and personalized treatment strategies associated with Pergoveris.

 

The expanded insurance reimbursement for Merck's ovulation induction injection last April provided new treatment opportunities for many infertility patients.

 

Professor Hee Jun Lee of CHA Gangnam Medical Center

Previously, Pergoveris was only reimbursed (up to 2 vials/day) for assisted reproductive technology in patients with severe endogenous Luteinizing Hormone (LH) deficiency (concentration below 1.2 IU/L).

 

However, the reimbursement criteria were expanded to cover 'cases where Pergoveris is administered (up to 2 vials/day) for ART in patients with LH deficiency.' Consequently, patients can now receive reimbursement benefits for Pergoveris without restriction based on LH levels.

 

Pergoveris is the only approved combination product in Korea that mixes recombinant rFSH and r-hLH.

 

It has shown significantly improved results across all indices, including pregnancy rate, cumulative pregnancy rate, and pregnancy rate per embryo transfer, compared to FSH monotherapy.

 

These data were consistent in the real world.

 

A large-scale analysis involving 10,000 poor ovarian response patients showed that Pergoveris resulted in a higher cumulative live birth rate compared to FSH monotherapy.

 

The effect of Pergoveris was particularly pronounced in cases of severe poor ovarian response.

 

Professor Hee Jun Lee of CHA Gangnam Medical Center's Department of Obstetrics and Gynecology assessed, "In older mothers and those with poor ovarian response, a treatment strategy that considers the balance of FSH and LH is paramount." He added, "It has been confirmed across multiple clinical trials and international expert consensus that co-administering recombinant LH from the beginning of ovulation induction improves both implantation and pregnancy success rates." Professor Lee added, "Given the high proportion of older mothers in Korea, the preference for combination therapy is increasing in actual clinical practice.

 

The FSH + LH combination, primarily with Pergoveris, is becoming a key treatment strategy.

 

The expanded reimbursement for Pergoveris has been a great help to patients.

 

However, support for oocyte cryopreservation is still lacking, and there is room for improvement." Professor Lee emphasized, "The importance of early treatment for infertility is continuously stressed.

 

As the efficacy and safety of these injectable agents have been confirmed, it is necessary to start treatment early." Merck's efforts to improve access for Korean infertility patients The infertility sector is particularly important due to the unique situation of low birth rates and aging demographics.

 

Korea's fertility rate was 0.75 last year, the lowest in the world, and the population is expected to halve by the end of this century.

 

The country remains at the lowest level among OECD nations.

 

Demand for infertility treatment is also rapidly increasing due to the rise in older mothers.

 

As of 2022, women aged 35 and over accounted for 70% of those receiving infertility procedures.

 

Female fertility rapidly declines after age 35, often leading to Low Ovarian Reserve (LOR).

 

When ovarian function is reduced, ovulation is less regular, and oocyte quality decreases, lowering fertilization and implantation rates.

 

Merck is involved in social activities to address the low birth rate, going beyond simply supplying treatments.

 

Kim Wook, Healthcare Fertility Unit Head at Merck Korea

Merck currently supplies the ovulation inducers 'Gonal-F' and 'Luveris,' in addition to Pergoveris, and has developed treatments for preventing premature ovulation.

 

Merck launched the 'Fertility Counts' initiative in 2023 to discuss and respond to the socioeconomic challenges arising from declining birth rates in the Asia-Pacific (APAC) region.

 

Fertility Counts was established to support effective policy intervention by authorities in building a family-friendly society through relevant research and resource provision, emphasizing the need for improved fertility-related policies to help those who wish to have children.

 

In particular, Merck plans to continue its environmental, social, and governance (ESG) activities in Korea through its Infertility Awareness Campaign.

 

Last year, Merck and the Korean Infertility Family Association signed an MOU to address the growing social problem of infertility rates.

 

Kim Wook, Healthcare Fertility Unit Head at Merck Korea, stated, "We are conducting various activities in collaboration with multiple stakeholders, including the Fertility Counts initiative, the Family-Friendly Future Forum, a network of companies, government, and academia, as well as collaboration with infertility patient groups," and added, "We will continue our efforts, focusing on Pergoveris, to contribute to healthy births for Korean mothers."