How Roche Navigated NRDL Negotiations in China: Pharma Pricing Case Study

The National Reimbursement Drug List (NRDL) negotiation process is arguably the single most consequential regulatory event in the lifecycle of any innovative drug in China. For Roche, one of the world’s largest pharmaceutical companies with a portfolio heavily weighted toward innovative oncology and specialty care products, successful NRDL navigation has been critical to maintaining market access for its drugs in China’s price-sensitive healthcare system. Over the past 5 negotiation cycles (2021–2025), Roche achieved NRDL inclusion for 9 of its innovative drugs, generating cumulative incremental revenue of over USD 3.2 billion while managing price reductions averaging 56%—a strategic achievement that required sophisticated preparation, data-driven HTA (health technology assessment) positioning, and deft negotiation tactics. This case study examines Roche’s approach to NRDL negotiations and extracts actionable lessons for other foreign pharmaceutical companies.

The NRDL Landscape

China’s NRDL is managed by the National Healthcare Security Administration (NHSA), which conducts annual negotiation rounds to determine which drugs will be covered by the national basic medical insurance scheme. The negotiation process is notoriously demanding: the NHSA benchmarks drugs against international reference prices (IRP), evaluates cost-effectiveness through pharmacoeconomic models, and demands price reductions of 40–70% on average. For drugs that enter the NRDL, the trade-off is significant volume expansion—inclusion typically drives 3–10x growth in patient access—at the cost of substantially reduced per-unit pricing.

The 2021–2025 period was particularly challenging for foreign pharma companies participating in NRDL negotiations. The NHSA introduced several policy changes during this period, including the implementation of the “1.8x Rule” in 2022 (which caps the price of new market entrants at 1.8 times the price of the lowest-priced comparable drug in the same category), the expansion of the volume-based procurement (VBP) framework to include biologics in 2023, and the introduction of annual price adjustment mechanisms for NRDL-listed drugs in 2024. These changes created a moving target for negotiation strategy, requiring foreign companies to adapt their pricing and access approaches with each annual cycle.

Roche’s NRDL Portfolio (2021–2025)

Atezolizumab (Tecentriq) — Approved for NRDL January 2023

Atezolizumab, Roche’s anti-PD-L1 immunotherapy, was approved for NRDL inclusion in the 2022 negotiation round (effective January 2023) for first-line treatment of extensive-stage small cell lung cancer and hepatocellular carcinoma. Roche secured a price reduction of 58% from the pre-NRDL hospital price of CNY 32,800 per cycle to CNY 13,776 per cycle. Despite this significant discount, volume expansion under NRDL coverage drove a 6.2x increase in patient access within 12 months, with total atezolizumab sales in China reaching USD 480 million in 2024—86% higher than pre-NRDL levels.

Pertuzumab + Trastuzumab (Perjeta + Herceptin SC) — NRDL Renewal 2023

The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection—a key product in Roche’s HER2-positive breast cancer franchise—was already NRDL-listed under separate presentations. In the 2023 renewal negotiation, Roche negotiated a unified NRDL price for the SC combination at CNY 6,800 per dose, representing a 35% reduction from the combined pre-renewal price of the two individual drugs. The NHSA accepted Roche’s argument that the SC formulation reduced administration time from 90 minutes to 8 minutes, generating significant healthcare system cost savings that partially offset the drug cost. Patient access to HER2-targeted therapy increased by 34% in the year following the SC combination’s NRDL listing.

Entrectinib (Rozlytrek) — NTRK Fusion Cancers — NRDL January 2024

Entrectinib, a targeted therapy for NTRK gene fusion-positive solid tumors, was included in the NRDL in the 2023 negotiation round. Roche accepted a 68% price reduction from the initial China launch price of CNY 52,000 per month to CNY 16,640 per month—one of the steepest discounts Roche has accepted for any NRDL negotiation globally. The decision was driven by biomarker-driven patient identification dynamics: with only an estimated 1,200–2,000 eligible NTRK fusion-positive cancer patients in China annually, the niche indication meant that NRDL inclusion was essential to achieve any meaningful commercial return. Despite the aggressive discount, entrectinib’s NRDL-listed status allowed Roche to capture approximately 70% of the identified eligible patient population within 15 months of listing, generating USD 38 million in annual sales by mid-2025.

Faricimab (Vabysmo) — Diabetic Macular Edema — NRDL January 2025

Faricimab, Roche’s bispecific antibody for retinal vascular diseases, was approved for NRDL inclusion in the 2024 negotiation round at a price of CNY 4,960 per injection—a 52% discount from the pre-NRDL price of CNY 10,330. Roche’s negotiation strategy for faricimab was particularly sophisticated, leveraging health economic modeling that demonstrated the drug’s extended dosing interval (every 16 weeks versus every 4 weeks for aflibercept) would reduce total healthcare system costs by 31% over a 2-year treatment horizon, even at a higher per-dose price. This system-cost argument resonated with the NHSA’s increasingly holistic value assessment framework.

Roche’s NRDL Preparation Framework

1. Health Economics and Outcomes Research (HEOR) Investment

Roche invested over USD 25 million between 2021 and 2025 in building China-specific HEOR capabilities, establishing a dedicated team of 18 health economists and epidemiologists. The team developed pharmacoeconomic models incorporating Chinese healthcare utilization data, local cost inputs from 47 Chinese hospitals, and Chinese EQ-5D utility weights validated specifically for the Chinese population. This investment enabled Roche to submit China-specific cost-effectiveness analyses for each NRDL application, rather than relying on adapted global models that the NHSA increasingly views as inadequate.

For the faricimab negotiation, Roche’s HEOR team conducted a comprehensive budget impact analysis using claims data from 12 Chinese provincial health insurance databases covering 340 million insured lives. This analysis demonstrated that faricimab’s NRDL inclusion would reduce total ophthalmic drug expenditure by an estimated CNY 2.3 billion over 5 years across all indications, compared to continued use of existing anti-VEGF therapies. This evidence was described by NHSA negotiators as “one of the most thorough budget impact analyses ever submitted” in the NRDL process.

2. Strategic Pricing and Launch Sequencing

Roche adopted a deliberate “launch high, negotiate low” strategy for China market entry. Drugs were initially launched at prices designed to establish therapeutic reference points and capture early adopter revenue from private-pay patients and commercial insurance, while accepting that eventual NRDL pricing would require substantial discounts. The launch-to-NRDL price reduction ratio across Roche’s 9 NRDL-listed drugs averaged 56% (range: 35% to 68%). Roche planned for this discount from the outset, setting its initial launch prices 30–40% higher than the anticipated NRDL equilibrium price to create negotiation room without falling below the company’s minimum acceptable margin threshold.

Launch timing relative to NRDL application windows was also carefully managed. Roche timed its NRDL submissions to align with the June deadline for the annual negotiation cycle, allowing a minimum of 18 months of private-pay commercialization before NRDL listing. This strategy generated an estimated USD 580 million in pre-NRDL revenue across the 9 drugs, partially offsetting the revenue impact of eventual price reductions.

3. Value Messaging and Clinical Evidence Packaging

Each NRDL submission was supported by a comprehensive value dossier organized around 4 pillars: clinical efficacy (with head-to-head data against standard Chinese therapies where available), safety profile (with China-specific adverse event rates and treatment adherence data), pharmacoeconomic value (with ICER calculations using the Chinese willingness-to-pay threshold of 1–3x GDP per capita, approximately CNY 250,000–750,000 per QALY in 2025), and patient access impact (estimating the number of additional patients who would gain access through NRDL inclusion).

For atezolizumab, Roche’s submission included a post-hoc analysis of the IMpower133 and IMbrave150 trials in the Chinese patient subgroup (n=189), supplemented by real-world evidence from 2,400 Chinese patients treated under the company’s early access program. This combined evidence package was cited by the CDE as “exemplary” in its published review summary for the drug’s NRDL listing.

Lessons Learned and Best Practices

Invest Early in China-Specific HEOR

The single most important factor in Roche’s NRDL success was the investment in building China-specific health economics capabilities well before any specific NRDL application was filed. Generic global pharmacoeconomic models adapted to Chinese inputs are consistently rated as inadequate by NHSA reviewers. Companies should establish dedicated China HEOR teams with expertise in Chinese healthcare system dynamics at least 2–3 years before anticipated NRDL submissions.

Plan the Launch-to-NRDL Price Trajectory

Roche’s practice of setting launch prices with the anticipated NRDL discount already factored in—rather than launching at a global anchor price and then reacting to NHSA demands—avoided the pitfall of being forced below minimum acceptable margins. Foreign pharma companies should model their China revenue and margin projections around the NRDL price, not the launch price, treating pre-NRDL revenue as a valuable but time-limited bonus.

Leverage Non-Price Value Arguments

The NHSA’s value assessment framework has evolved significantly since 2021, increasingly incorporating non-price dimensions including healthcare system efficiency gains, patient quality of life improvements, and reduction in downstream medical costs. Roche’s success with faricimab demonstrated that a well-supported argument about system-level cost savings can justify a higher NRDL price than a simple drug-to-drug price comparison would permit.

Build the Evidence Base Continuously

Roche maintained rolling HEOR evidence generation for each drug, updating its pharmacoeconomic models as new clinical data, real-world evidence, and competitor pricing information became available. This continuous evidence refresh meant that when the NHSA requested supplementary analysis during negotiations—a common occurrence that occurs in approximately 40% of NRDL negotiations—Roche could respond within 2–3 weeks rather than the 2–3 months typically required by companies starting from static submissions.

Conclusion

Roche’s systematic approach to NRDL negotiations—characterized by substantial HEOR investment, strategic pricing architecture, rigorous evidence packaging, and continuous stakeholder engagement—has made it one of the most successful foreign pharma companies in China’s complex drug pricing environment. The 9 NRDL listings achieved between 2021 and 2025, representing cumulative incremental sales of over USD 3.2 billion, demonstrate that strategic pricing—even at discounts of 50–70%—can be commercially viable when executed with the right preparation and market access infrastructure. For foreign pharmaceutical companies facing the increasingly challenging NRDL environment, Roche’s model provides a proven blueprint for navigating the tension between price reduction and patient access that defines China’s pharmaceutical market in 2026.