The Trump administration has finalized a partnership with EMD Serono to reduce drug costs, an initiative aimed at enhancing coverage and affordability for fertility services, announced officials at the White House on Thursday.
This initiative features multiple components, including commitments from the drug company to reduce medication prices, new regulations intended to encourage employers to provide in vitro fertilization coverage beyond standard health insurance, and a priority review voucher from the Food and Drug Administration for a fertility medication not yet available in the U.S.
EMD Serono is the latest pharmaceutical firm to make an agreement with the administration, following similar announcements from Pfizer and AstraZeneca in recent weeks. The firm has committed to offering direct-to-consumer sales of its IVF medications and engaging in the TrumpRx purchasing platform by 2026.
As a U.S. subsidiary of the German giant Merck, EMD Serono produces widely-used IVF drugs, including Gonal-f for stimulating egg production, Ovidrel for egg release, and Cetrotide to prevent premature ovulation.
The new arrangement will provide EMD Serono’s medications at an 84% discount off established list prices, according to Libby Horne, the senior vice president for U.S. fertility & endocrinology. Administration representatives asserted that the deal will effectively halve the costs associated with IVF treatments.
Like the agreements reached with other pharmaceutical companies, EMD Serono will be exempt from national security tariffs currently affecting the industry if it commits to investing in U.S. manufacturing, although no new commitment has yet been made.
This agreement represents the latest effort from the administration to address rising drug prices through an extensive pressure campaign spanning months. However, both the administration and the companies involved have been reticent to disclose the specifics of their agreements, leading experts to question whether prior deals would significantly lower costs for the average American.
A senior administration official labeled this arrangement a “special deal” before the announcement, highlighting its focus on expanding access and reducing costs for sought-after treatments. The deal holds particular significance as Trump has advocated for increased access to IVF, calling for universal coverage of the treatment, even as some states governed by Republicans pursued measures that may restrict IVF access by defining life as beginning with conception.
Additional pharmaceutical companies, seeking favorable agreements with the administration, might interpret the announcement as an innovative strategy focused on popular medications.
According to The World Health Organization, one in six individuals experiences infertility on a global scale. In vitro fertilization has emerged as the standard method for addressing infertility, entailing a meticulous procedure to stimulate egg production, extract eggs, and combine them with sperm in a laboratory setting to create viable embryos. This is a complex process that often necessitates multiple medication cycles.
The deal also encompasses pharmacy benefit managers, according to administration officials. CVS Specialty’s fertility pharmacy and Express Scripts Freedom Fertility Pharmacy have pledged to significantly lower their costs associated with fertility treatments, with officials clarifying that no commitments have been made to the PBMs in return.
Although IVF has gained mainstream acceptance, it remains financially unattainable for many families. A single treatment cycle can cost between $15,000 and $30,000, as per HHS estimates, and insurance companies have frequently regarded the procedure as “medically unnecessary.” Medication costs can add an additional $2,000 to $7,000, as indicated by GoodRx. Further expenses arise from genetic testing and utilization of donor eggs.
Employers are progressively offering fertility treatment coverage, with 21 states mandating private insurance coverage for these services. However, this mandate does not apply to self-insured plans, affecting about 61% of workers. Moreover, there is no mandate for IVF coverage in 29 states, and most state Medicaid programs do not include this treatment in their coverage.
Administration officials stated that there are no ongoing discussions regarding subsidizing IVF coverage through employer-sponsored insurance. Instead, they believe that lower drug prices and separating fertility treatments from standard health insurance may encourage employers to consider adding such coverage. The proposed changes in coverage rules from the Departments of Labor, Treasury, and Health and Human Services are expected to provide employees with additional opportunities to minimize out-of-pocket expenses, as per the officials.
In recognition of its role in reducing prices, EMD Serono will receive a priority voucher from the FDA to expedite the review of its drug, Pergoveris. This drug, similar to Gonal-f, aids in developing egg-producing structures in the ovaries, requiring fewer injections and potentially improving patient experience and affordability, according to a statement from EMD Serono. The medication is approved in 74 countries.
The FDA introduced the Commissioner’s National Priority Voucher program in June, committing to accelerate drug reviews for companies that align with the health priorities set forth by the Trump administration. The goal is to provide companies with feedback on their drug submissions within one to two months. EMD Serono is the first to benefit from this initiative.
Trump encouraged employers to offer insurance policies for IVF, although there is no formal requirement established.
During the announcement, CMS Administrator Mehmet Oz predicted that these new policies would result in more births in the future — referring to them as “Trump babies.”