Nirsevimab for RSV Prevention in India: Economic Viability and Implementation Pathways for National Introduction: A Review

India-specific cost-effectiveness modeling

A cohort-based decision-analytic model was constructed for India’s annual birth cohort to compare outcomes with and without Nirsevimab prophylaxis. The model incorporated probabilities of RSV infection, hospitalization, mortality, and long-term respiratory sequelae.

Key epidemiologic assumptions and uncertainty ranges used in modeling is summarized in Table 1, and cost-effectiveness outcomes across alternative burden and pricing scenarios are presented in Table 2.

The decision-analytic framework used in this analysis is illustrated in Figure 2. A static cohort model was constructed comparing a hypothetical Indian annual birth cohort of 25 million infants receiving universal Nirsevimab prophylaxis at 80% coverage against a no-prophylaxis comparator, over a 12-month (single RSV season) time horizon from a healthcare payer perspective. Given the short time horizon, costs and outcomes were not discounted. Model structure and parameter assumptions were derived from published RSV burden estimates [Table 1], Nirsevimab clinical efficacy data,^[18-22] and WHO-recommended economic evaluation methodology.^[23] Disability-adjusted life years (DALYs) were calculated as the sum of years of life lost (YLL), based on standard life-expectancy tables, and years lived with disability (YLD), with DALY estimation following WHO-CHOICE guidance using standard disability weights for acute lower respiratory infection. Cost-effectiveness thresholds were defined relative to India’s per-capita gross domestic product (GDP), consistent with WHO-recommended benchmarks.^[23] Deterministic sensitivity analysis was undertaken by varying hospitalization rates, mortality estimates, and dose price across plausible ranges [Table 2], and probabilistic sensitivity analysis was performed using Monte Carlo simulation with 10,000 iterations, assigning beta distributions to probability parameters (hospitalization and mortality rates) and gamma distributions to cost parameters, to evaluate robustness across epidemiologic and pricing uncertainty ranges. Model outputs were compared against published nirsevimab cost-effectiveness analyses from Spain and the Netherlands for face validity.^[24,25]

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Figure 2: Decision-analytic model structure for Nirsevimab introduction in India. Cohort model comparing outcomes with and without prophylaxis, incorporating hospitalization, mortality, and DALYs. DALY: Disability-adjusted life years

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At 80% coverage, Nirsevimab introduction at negotiated pricing could prevent approximately 640,000 hospitalizations and 6,800 deaths annually, corresponding to an estimated 256,600 DALYs averted. Using WHO-recommended thresholds for cost-effectiveness, the maximum economically justifiable price for India is estimated at approximately ₹6,300 per dose.

Sensitivity analyses demonstrate economically justifiable pricing ranges across plausible hospitalization and mortality scenarios, with lower thresholds in conservative burden scenarios and higher thresholds where mortality estimates are greater [Table 2].

Probabilistic sensitivity analysis

Probabilistic sensitivity analysis using Monte Carlo simulation was conducted to evaluate parameter uncertainty across disease burden, effectiveness, and cost inputs. Results are illustrated in Figure 3, which demonstrates clustering of simulations within accepted cost-effectiveness thresholds at negotiated pricing levels.

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Figure 3: Probabilistic sensitivity analysis cost-effectiveness plane. Scatter plot of simulations showing incremental cost versus DALYs averted with base-case and threshold indication. DALY: Disability-adjusted life years

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At current market prices (₹40,000–₹80,000 per dose), national introduction would be economically unsustainable. However, at negotiated pricing within the range of ₹4,000–₹6,000 per dose, Nirsevimab remains consistently cost-effective across a wide range of assumptions.

One-way sensitivity and cost-effective acceptability analyses are provided in Supplementary Figures 1 and 2, demonstrating that dose price and RSV mortality assumptions are the principal drivers of economic outcomes, while overall conclusions remain robust.

Phased introduction strategy

Given current economic constraints, a phased implementation strategy is proposed [Figure 4].

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Figure 4: Proposed phased implementation pathway for national introduction. Illustrates pilot, risk-targeted expansion, and universal integration phases.

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Phase 1 (Years 1–2): Pilot implementation in high-burden states

An initial rollout in selected high-burden states targeting infants entering their first RSV season would reduce initial fiscal exposure while covering a substantial share of the disease burden. Pilot implementation will generate real-world effectiveness, safety, and operational data to guide national scale-up.

Phase 2 (Years 3–5): Risk-targeted expansion

Expansion to include pre-term infants, infants with congenital heart disease, chronic lung disease, and high-transmission regions. Depending on pricing negotiations and supply availability, risk-targeted expansion may be initiated in parallel with pilot evaluation to shorten the timeline to broader coverage.

Phase 3 (Years 6+): Universal integration

National introduction through birth facilities and primary-care platforms once pricing stability, supply predictability, and surveillance capacity are established.

Integration with the universal immunization programmer

Successful integration into India’s immunization framework will require structured program readiness planning:

• Cold-chain compatibility: Nirsevimab requires storage at 2–8°C and is compatible with the existing Universal Immunization Program (UIP) cold-chain infrastructure.

• Co-administration: As a passive monoclonal antibody rather than an active vaccine, Nirsevimab does not interfere with immune responses to routine childhood immunizations. Current guidance permits co-administration with routine vaccines, including the hepatitis B birth dose. Post-introduction pharmacovigilance and effectiveness monitoring should accompany rollout.

• Catch-up dosing: Administration at birth or during early infancy alongside routine immunization visits (e.g., 6-week visit) is operationally feasible and programmatically convenient.

• Operational preparedness: Introduction will require development of operational guidelines, healthcare worker training, updating immunization cards and electronic registries, and strengthening adverse event surveillance systems.

• Delivery model: Early phases may employ a mixed delivery strategy involving selected public-sector birth facilities and participating private hospitals in high-burden states to enable rapid early coverage while generating implementation data.

Supply and procurement considerations

Sustainable national introduction will depend on predictable supply through advanced procurement planning, multi-year volume commitments, and potential regional or domestic manufacturing partnerships. Early policy dialogue with manufacturers and procurement agencies will be essential to ensure uninterrupted availability during phased scale-up.

Implications for policy and practice

RSV is a major yet under-recognized cause of infant hospitalization and mortality in India. Nirsevimab offers a single-dose, season-long prevention strategy suitable for LMIC settings. At current prices, national implementation is economically unfeasible; however, negotiated pricing of ₹4,000– ₹6,000 per dose makes the intervention highly cost-effective. Phased introduction targeting high-burden states and highrisk infants provides a pragmatic pathway for integration into India’s Universal Immunization Program. The analysis supports early national policy dialogue on RSV prevention financing, procurement strategy, and surveillance strengthening.