Boehringer Ingelheim

Executive Summary

Socio-economic development, the aging population, and the impact of the COVID-19 pandemic have compounded the increasing prevalence of respiratory diseases. As a major set of respiratory conditions, pulmonary fibrosis (PF) has caused significant disease and economic burdens on Chinese patients, families and society, and its prognosis is poor. Although PF is defined as a rare disease, the number of patients worldwide with idiopathic pulmonary fibrosis (IPF) alone has reached 3 million. According to the latest data from the 2024 Survey Report on the Diagnosis, Treatment, and Quality of Life of Chinese Patients with IPF and  Progressive Pulmonary Fibrosis (PPF) published by the Chinese Organization for Rare Disorders (CORD), there may be up to 126,000 new PF cases each year in China if calculated at an annual incidence rate of 9.7 per 100,000. The number is expected to further increase as the population ages and the incidence rate rises. Economically, the average annual direct expenditure of Chinese PF patients and their families accounts for 70.2% of household income, far exceeding the 40% threshold set by the World Health Organization as catastrophic health expenditure. Moreover, 32.4% of patient families became indebted due to the disease, further exacerbating their already fragile financial status. Moreover, there is no cure available for PF, and its prognosis compared with other rare diseases is very poor. For example, for IPF patients, the median survival is only 2-3 years from diagnosis, and the five-year survival rate is lower than 30%.

In recent years, China has attached great importance to the diagnosis, treatment, and healthcare security of PF. However, there remains challenges in the following three aspects:

1. Low awareness of PF, low attention paid to the diseases, late diagnosis and treatment, and poor disease management.

2. Immature PF diagnosis and treatment system, unnecessary patient referrals, long diagnosis time, and high misdiagnosis rate.

3. Limited treatment options for PF, high unmet clinical needs, and poor patient survival status.

The grim situation requires coordinated efforts of multiple parties across the entire industry chain, including medical institutions, government authorities, industry, universities, research institutes, and patients. The aims are to jointly improve patients’ sense of gain, disease diagnosis and treatment level, and industrial innovation capability. To do this, we propose the following recommendations:

1. Strengthen awareness campaigns and patient education to enhance public awareness of PF, and promote early diagnosis and treatment. Rely on medical experts and primary medical institutions to improve public education. Conduct education activities through various channels (such as online platforms, community lectures, etc.) to cover the general public and high-risk groups. Encourage people with suspected symptoms to seek professional medical assistance as early as possible. Strengthen patient and family education together with medical experts and patient support organizations to introduce basic disease knowledge, the importance of long-term treatment plans, self-care techniques, and emergency response measures. Establish a continuous follow-up care mechanism.

2. Optimize IPF diagnosis and treatment network, strengthen the basic diagnosis and treatment capabilities of PPF, and improve the quality of diagnosis and treatment and patients’ sense of gain. Optimize the network by promoting the building and certification of national interstitial lung disease diagnosis and treatment centers, enhancing the IPF diagnosis and treatment capabilities of local core hospitals, and publishing a diagnosis and treatment map to optimize patient care pathways. Strengthen training in lower-tier cities and primary hospitals, improve the disease awareness and early identification capabilities of primary doctors, and establish a two-way referral system to ensure timely and effective management and treatment for patients. Strengthen the groundwork to improve PPF diagnosis and treatment capabilities, including organizing experts to compile clinical guidelines for the diagnosis and treatment of PPF, standardizing diagnosis and treatment processes, and improving the level of care. Enhance the screening and early diagnosis capabilities of rheumatologists for PPF patients, especially high-risk patients. Adopt a multidisciplinary team model to develop personalized treatment plans for PPF patients, and ensure timely initiation of anti-fibrosis treatment and long-term management of the primary disease.

3. Accelerate the market access of innovative therapies for PF, improve medical insurance policies, and enhance the accessibility and affordability of drugs. Promote the approval and launch of innovative PF drugs as soon as possible, include PF drugs approved overseas into China’s list of drugs with urgent clinical needs, and grant priority review and approval to PF drugs to shorten the approval time. Optimize the NRDL negotiation and adjustment mechanism, prioritize the inclusion of innovative PF drugs into the NRDL, optimize the comparator selection mechanism (not selecting volume-based procurement drugs as comparators), and evaluate the value of PF drugs in comprehensive ways to fully reflect their innovative and clinical value. Improve the existing medical insurance policies for PF, continue the current policies for specialty drugs such as dual channels and separate payment, improve the reimbursement level of outpatient chronic and special diseases, and improve the medical insurance payment policies for hospitalized patients.

4. Promote the development of patient organizations and strengthen the role of patients and patient organizations in decision-makings across the PF industry chain. Continuously promote the development of PF patient organizations, support their growth with policies, funding and capacity building, enhance their capabilities in public education, information sharing, community support and resource assistance, and provide better services for PF patients. Give patients and patient organizations more voice in medical decision-making, actively and increasingly involve them in decision-making processes such as review and approval, NRDL inclusion and clinical use of PF drugs, and understand patient needs and fully incorporate them into the medical decision-making process to achieve “patient centricity”.

Download the full report：Improving Diagnosis, Treatment and Healthcare Security for Pulmonary Fibrosis to Advance Healthy China 2030