4.1. Patient’s Journey
In both countries, the patient's journey begins when he or she seeks medical care after observing a chronic respiratory symptom.
In Brazil, the patient is admitted to the health system by a general practitioner from SUS or the supplementary health system. This patient may experience a long gap between the first appointment and the final diagnosis of an ILD, often established by a pulmonologist. In the Brazilian health system, according to local specialists, up to 40% of patients have private health insurance, which provides easier access to complementary exams and specialized care; the other 60% depend exclusively on SUS, where there are usually barriers to quick access to more complex tests, such as HRCT and biopsy, as well as appointments with specialized physicians.
The Brazilian public centers for interstitial lung diseases included in this study have different management and funding systems, which can influence the treatment dynamics for these patients. Santa Casa de Misericórdia is a non-profit organization that receives resources from the Ministry of Health and state government, and the Hospital Estadual Cleriston Andrade is linked to the State University of Feira De Santana, which receives resources from SUS and, as a teaching hospital, also receives funds from the Ministry of Education.
In Mexico, two different realities were presented with variable autonomy and speed of resolution according to the funding source. However, access to specific treatment was similar in both ways.
In a navy hospital serving Mexican armed forces workers, access to specialized care is usually shorter. When suspecting lung disease, the primary care physician requests a thoracic image test and forwards the patient to a pulmonologist.
In hospitals linked to the ISSSTE, the patient is initially evaluated by the primary care that, upon noticing an abnormality, requests a HRCT scan or chest x-ray. In case of radiological abnormalities, the physician presents the case to a specialist and if necessary, the patient is referred to a pulmonologist.
In Mexico, the distance between hospitals and a referral center seems to influence access to a specialist. According to Mexican specialists, patients at institutions closer to the referral hospital may experience faster access to specialized care. The average waiting time for an evaluation by a pulmonologist is more than 30 days, and most patients have already undergone an HRCT scan.
Patients from other cities or states may experience a longer journey due to the bureaucratic access barriers to specialized centers. However, according to experts, telemedicine has been an extremely useful tool in this process, allowing physicians from different provinces to consult an ILD specialist. A face-to-face consultation can be promptly scheduled if the diagnostic suspicion is confirmed.
Both countries face a very similar reality regarding the long delay between initial symptoms and the diagnosis of ILD. Generally, these patients are admitted to the ILD referral centers at an advanced stage of the disease due to diagnostic complexity. This trend may be partially explained by ILD symptoms that are also common to other respiratory diseases such as asthma or COPD.
The patient journey begins at the primary care level (
Figure 3), where a general practitioner usually conducts the patient’s initial investigation. In this scenario, interstitial pulmonary pathologies are often misdiagnosed as more prevalent illnesses such as COPD, asthma, or heart failure. This patient may receive inaccurate management until achieving a confident ILD diagnosis. Indeed, a crucial step in this patient's trajectory is HRCT scanning. Radiologists used to identify patterns of interstitial pulmonary involvement usually suggest the diagnosis of lung fibrotic disease, which speeds up the patient's referral to a specialist. According to experts, The elapsed time between the patient's first contact with a doctor and the definitive diagnosis of ILD can be long. In Brazil, the diagnostic process can take from 6 to 18 months. In the Mexican system, the time for the patient to reach the specialist can vary from 1 to 12 months.
In ILD referral centers, the patient undergoes a clinical investigation aimed at underlying pathology that usually includes pulmonary function testing with lung volumes and diffusion capacity, autoantibody testing, a 6-minute walk test, and, sometimes, a lung biopsy or a follow-up HRCT scan.
With the definitive diagnosis, the next step in this patient's journey is access to adequate treatment, which may be challenging (
Figure 3). At this specific point, there is a difference between Mexico and Brazil, as in the latter, antifibrotic drugs are not yet available by SUS. Elevated cost is a significant barrier to the direct purchase of antifibrotic drugs by most of the population. Most of the time, patients must resort to the judicial system to guarantee access to medication through SUS (
Figure 3).
The judicialization consists of the search for treatments (medicines, exams, surgeries) through lawsuits. This occurs when the patient cannot obtain these resources through the Unified Health System (SUS) or a private supplementary health system. The judicialization of health is characterized by the court's claim of medicines developed to treat rare or highly complex clinical conditions unavailable in the public network or the supplementary health system.
In Brazil, the lack of availability of these drugs in SUS leads specialists to offer only supportive care, such as oxygen supplementation, until the patient can obtain the medication through litigation; differently, in Mexico, antifibrotic drugs have been available in different health sectors since 2018, and it may take from 1 week to 1 month until treatment is initiated.
4.2. Antifibrotic Therapy for ILD
The Brazilian National Health Surveillance Agency (ANVISA) has already approved both antifibrotics, Nintedanibe esilate and Pirfenidone,[
27,
28] for use in Brazil. Still, the National Commission for the Incorporation of Technologies (CONITEC) has not yet incorporated these antifibrotics into the public health system.[
29]According to experts, Brazilian patients have access to antifibrotics through litigation, a process that can take up to 8 months to complete. In Mexico, antifibrotics were analyzed and incorporated in different sectors of public health, thus making it possible to offer a broader antifibrotic treatment to patients with idiopathic pulmonary fibrosis (IPF). [
30]
In 2018, the Mexican government, through the Comisión Permanente del H. Congreso de la Unión, classified Idiopathic Pulmonary Fibrosis (IPF) as a catastrophic disease, supporting actions and strategies to prevent, detect and, when appropriate, provide timely treatment for this condition.[
31]
The classification of IPF as a catastrophic disease is due to its high cost of treatment associated not only with the direct costs of antifibrotic therapies but also with other associated expenses, such as nutritional and psychological therapy, pulmonary rehabilitation, supplementary oxygen, hospitalization, and the increased risk of acute exacerbations.[
30]
The Mexican coordinators explained that antifibrotic drugs can only be prescribed by a specialist inside the registered reference centers, thus allowing for greater control over prescriptions.
Mexican specialists highlighted that the treatment of IPF, the integration of the centers of reference in a network, and the consequent reduction of the bureaucracy to prescribe antifibrotic drugs are key factors for the clinical care of IPF patients. Essential factors for proper patient care include staff familiarity with this disease and the necessary resources such as HRCT and pulmonary function tests. The Mexican specialists also emphasize that patients under antifibrotic treatment are monitored exclusively by pulmonologists, improving patient safety.
About the decision-making regarding the use of the antifibrotic medication, we notice certain autonomy that may vary depending on the health sector. The Naval hospital receives a portion of the funds allocated to the armed forces by the federal government, and validation by a pulmonologist is required to request the use of antifibrotic for a patient. For most patients, the decision takes place in a multidisciplinary discussion with a pulmonologist, a rheumatologist, a pathologist, a chest surgeon, and a radiologist. In hospitals linked to ISSSTE, which have a previously established budget, it is mandatory to rule out other alternative diagnoses, since IPF is an idiopathic disease, and to complete a checklist to allow the prescription of antifibrotics. A central committee must validate all data regarding the diagnostic criteria.
4.3. ILD Associated to COVID-19
According to the experts who participated in the panel, both countries experienced a significant burden of COVID-19 in the health systems.[
32] The prevalence of post-COVID-19 fibrosis will become apparent with time, but early analysis from patients with COVID-19 on hospital discharge suggests that more than a third of recovered patients develop fibrotic abnormalities.[
33] One study showed that 4% of patients with a disease duration of less than 1 week, 24% between weeks 1 and 3, and 61% of patients with a disease duration of greater than 3 weeks developed fibrosis.[
34]
In Brazil, COVID-19 profoundly impacted clinical follow-up and diagnostic procedures in ILD patients. With social isolation and lack of medical follow-up, the progression of the disease has been frequently described with a potentially higher risk of acute exacerbations, in addition to numerous cases of fibrosing disease secondary to COVID-19, including the need for specific outpatient clinics for the follow-up of these patients. There is particular concern that patients with COVID-19 remain symptomatic, a condition known as long-term COVID-19, and are at increased risk of bronchial remodeling and fibrosis.[
35] The pandemic overloaded the health system and limited access to pulmonary medical specialists, thoracic imaging, and pulmonary function tests. This complex scenario favored further diagnostic delays, including new cases of interstitial disease that were not adequately evaluated.
In Mexico, patients were instructed to maintain social isolation at home with their medications dispensed in the hospital to a proxy. Enough antifibrotic medication has been dispensed for several months of treatment, and some patients have remote medical follow-ups by telemedicine.
Additionally, imaging tests performed in patients with a suspected or confirmed diagnosis of COVID-19 have favored the identification of radiological findings compatible with ILD; as patients seek urgent medical care for suspected COVID-19, previous underlying interstitial disease could be early detected.