Immunotherapy concept illustrating Keytruda’s mechanism in combination chemoradiation for advanced cervical cancer. (Editorial illustration.)
Sweden’s health agency finds survival benefit from Merck’s Keytruda in chemoradiation, but long-term value remains uncertain
Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has released its long-awaited health economic assessment of Keytruda for use alongside radiotherapy and chemotherapy in women with locally advanced cervical cancer, confirming significant survival advantages but cautioning that the therapy’s long-term value remains uncertain.
The review, finalized on November 6, 2025, evaluates Keytruda’s cost-effectiveness for patients in FIGO stages III–IVA who have not previously received definitive treatment. TLV’s analysis draws on results from the phase III KEYNOTE-A18 study, which demonstrated that adding Keytruda to concurrent chemoradiation significantly improved both progression-free and overall survival compared with chemoradiation alone.
According to TLV’s summary, Keytruda-treated patients lived longer and remained progression-free for extended periods, with the benefit deemed clinically relevant. The agency notes that median overall survival had not yet been reached in either study arm at the January 2024 data cut, reflecting strong early efficacy but limited long-term data.
What You Need To Know
- Sweden’s TLV finds Keytruda plus chemoradiation offers a clinically meaningful survival benefit for patients with locally advanced cervical cancer, based on KEYNOTE-A18 trial data.
- The cost per QALY is estimated at SEK 1.25 million, though TLV notes real-world cost-effectiveness is likely more favourable after confidential price discounts.
- TLV highlights long-term efficacy uncertainty, as median overall survival hasn’t been reached and control-arm under-treatment may overstate benefit.
- The assessment, submitted to Sweden’s Council for New Therapies (NT Council), will guide national reimbursement decisions for Keytruda’s curative use in high-risk cervical cancer.
“Patients treated with Keytruda lived longer and also lived longer without the disease getting worse compared to radiotherapy and chemotherapy alone,” TLV wrote. “The greatest uncertainty in the analysis is linked to the long-term effect of the treatment.”
Modeling and Cost-Effectiveness Findings
TLV’s economic evaluation used a Markov model incorporating four health states: progression-free on first treatment, progression on first treatment, progression on subsequent treatment, and death. Based on this framework, the agency estimated a cost per quality-adjusted life year (QALY) of approximately SEK 1.25 million.
However, this figure was based on public list prices, not the confidential discounted price under Sweden’s national procurement agreement with Merck. The agency emphasized that actual cost-effectiveness is likely more favourable once the negotiated price is applied.
The analysis accounted for treatment costs of roughly SEK 97,000 per month, with pembrolizumab representing the dominant cost driver. TLV noted that chemotherapy (cisplatin) and radiotherapy costs were minimal in comparison.
Clinical Evidence and Safety
The KEYNOTE-A18 trial enrolled 1,060 patients with locally advanced cervical cancer, including 601 in FIGO stage III–IVA. Patients receiving pembrolizumab plus chemoradiation showed a 43% reduction in risk of progression or death (HR 0.57) and a similar reduction in mortality risk (HR 0.57) versus placebo plus chemoradiation.
Safety outcomes were consistent with established profiles of both pembrolizumab and cisplatin-based chemoradiation, with no new safety signals reported. Common adverse events included hypothyroidism and mild immune-related reactions, most of which were manageable.
Importantly, TLV found that patient-reported quality of life remained stable throughout treatment, with no clinically meaningful differences between arms an important consideration in value-based assessments.
Despite the positive efficacy data, TLV emphasized high uncertainty regarding long-term outcomes and real-world cost-effectiveness. The model assumed sustained benefit over time, even though Keytruda treatment duration is capped at two years.
The agency also noted discrepancies between the trial and clinical practice far fewer patients in the control arm received Keytruda as second-line therapy in the study compared to what Swedish clinicians would typically prescribe. As a result, the comparator group may have been under-treated, potentially inflating Keytruda’s incremental survival advantage.
TLV’s health economists concluded that, under realistic pricing and treatment scenarios, the therapy is likely to be cost-effective, particularly given the severity of advanced cervical cancer and the lack of curative alternatives. The final assessment was submitted to Sweden’s Council for New Therapies (NT Council) to guide reimbursement recommendations across the country’s 21 healthcare regions.
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Cervical cancer remains one of the most common cancers globally, though incidence in Sweden has halved in recent decades thanks to HPV screening. Still, about 550 women are diagnosed annually, with survival rates dropping steeply for advanced stages.
Merck’s Keytruda, approved by the European Commission in October 2024 for this indication, is the first immunotherapy authorized as part of curative-intent chemoradiation for high-risk locally advanced disease.
With TLV’s positive yet measured stance, Sweden joins a growing number of EU member states assessing immunotherapy integration into standard curative cancer regimens. The final NT Council recommendation, expected in early 2026, will determine whether Keytruda will be publicly reimbursed for this indication.