Cancer burden on rise in China
With rise in cancer burden in China since 2000, to ease the financial burden of patients with cancer and reduce the price of costly cancer drugs, the Chinese government has vowed to take immediate steps to exempt tariffs on imported cancer drugs, initiate centralised government negotiations and procurement of cancer drugs, and incorporate more cancer drugs into the catalogue of medical insurance reimbursement. China has also reached an agreement with India on reduction of tariffs on the import of Indian medicines, particularly cancer drugs.
Cancer is a major public health concern in China. According to the National Central Cancer Registry of China, there were around 4•3 million new cancer cases and 2•8 million cancer deaths in China in 2015. In 2014, there were about 3.8 million new cancer cases and 2.3 million cancer deaths in China. The age-standardized cancer incidence and mortality rates were 190.63/100,000 and 106.98/100,000, respectively. The overall cancer burden in China has been increasing since 2000.
“Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country,” says Professor Yi-Long Wu, a tenured director of Guangdong General Hospital and the chair of the Chinese Thoracic Oncology Group.
There are approximately 781,000 new cases of lung cancer diagnosed in China each year, equalling approximately 15 new cases every 10 minutes. This number continues to rise, with more than 800,000 new cases and 700,000 new deaths projected by 2020. Survival rates vary depending on the stage and type of the cancer when diagnosed, with the five-year survival rate lower than 5 per cent. For patients with advanced squamous cell lung cancer and non-squamous non-small cell lung cancer (NSCLC) without any known driver genetic mutation, treatment measures are quite limited. Therefore, long-term survival is the most urgent need of those patients.
Chinese government has taken up many steps to support the patient population.
Some of the initiatives include formation of a comprehensive network on cancer prevention and control; building up a nationwide population-based
cancer surveillance; expanding the population coverage of cancer surveillance, and improving the data quality. With an increase in aging population and persistence of unhealthy life styles among Chinese, there will be an unavoidable cancer burden in China.
To meet the requirements of cancer patients, the China Food and Drug Administration on June 15, has given approval to Bristol Myers Squibb’s Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations.
This is China’s first and only PD-1 inhibitor and is the only Immuno-Oncology (I-O) agent to demonstrate a survival benefit compared with chemotherapy, based on data from the pivotal Phase 3 CheckMate -078 trial, in which 90 per cent of the patients enrolled were Chinese.
The company noted that the approval is based on results from the Phase 3 CheckMate -078 trial of Opdivo versus chemotherapy among patients with previously treated NSCLC, findings from which were presented at the American Association for Cancer Research Annual Meeting in April 2018. In November 2017, the trial was stopped early because the independent Data Monitoring Committee concluded that Opdivo demonstrated superior overall survival compared with chemotherapy. The application later received priority review by the Centre for Drug Evaluation in China.
Bristol Myers Squibb further pointed out in a release that in CheckMate -078, Opdivo reduced the risk of death by 32 per cent versus chemotherapy, the primary endpoint (HR 0.68; 97.7% CI: 0.52 to 0.90; p=0.0006), in patients with previously treated NSCLC. Both efficacy and safety of Opdivo in this patient population were consistent with the results of the landmark global CheckMate -017 and -057 studies. In CheckMate -078, Grade 3-4 treatment-related adverse events (TRAEs) occurred less frequently with Opdivo versus docetaxel (10% vs. 48%). Discontinuations due to Grade 3-4 TRAEs were also less frequent with Opdivo (3%) than with docetaxel (5%).
Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb, shared, “With approvals in more than 60 countries, Opdivo is a global standard of care for previously treated
NSCLC, and we are proud to bring this foundational I-O treatment option to patients and physicians in China. We look forward to continuing to work together with the CNDA to usher in additional healthcare innovations in China, with our shared commitment to moving quickly to help patients.”
Professor Yi-Long Wu, a tenured director of Guangdong General Hospital and the chair of the Chinese Thoracic Oncology Group said, “With most lung cancer patients already at an advanced stage when diagnosed, prolonging survival is an important goal. The approval of Opdivo as the first I-O agent in China is a significant therapeutic advance and is great news for patients and clinicians alike, offering for the first time an I-O treatment option that is proven to extend survival in predominantly Chinese patients with previously treated NSCLC.”
“We are thrilled to be able to bring this proven treatment, Opdivo, which has demonstrated superior overall survival versus chemotherapy in previously treated NSCLC patients in China, and are committed to working with stakeholders to ensure patients can quickly access Opdivo,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “With more than 7,500 cancer deaths per day estimated in China, we will continue to work with urgency to integrate the unmet treatment needs of Chinese patients in our ongoing I-O global development program, with the goal of bringing them innovative therapies as quickly as possible.”
Improving accessibility and availability
According to The Lancet report published on May 12, 2018 titled ‘Cancer drugs in China: affordability and creativity’, “Improving the accessibility and availability of effective treatments is key to tackling the huge burden of cancer in China. However, in terms of local affordability of cancer drugs, China emerges as one of the countries with the least affordable prices in the world.”
The report notes that to ease the financial burden of patients with cancer and reduce the price of costly cancer drugs, the Chinese government has vowed to take immediate steps to exempt tariffs on imported cancer drugs as of May 1, initiate centralised government negotiations and procurement of cancer drugs, and incorporate more cancer drugs into the catalogue of medical insurance reimbursement. Furthermore, as the vice director of the National Health Commission Zeng Yixin pointed
out, a long-term strategy of controlling cancer drug pricing further will be built up through four major areas: encouraging new cancer drug discovery and development, accelerating the review and approval procedures for new medicines, reducing circulation costs, and improving cancer diagnosis and rational drug use in China.
Cancer care remains a massive burden on China's health system. The sales of anticancer medicines in China exceed 120 billion yuan ($19•12 billion) per year, half of which are generated by imported medicines that China heavily relies on.
The Lancet continues to add that understandably, there is concern that the tariff cut could put some pressure on domestic pharmaceutical companies due to more tense competition. However, it will be crucial to seize the great opportunity of China's longterm plan of greater investment in drug discovery, to strengthen China's own vibrant and innovative pharmaceutical industry, in collaboration with different stakeholders, particularly academia, and to develop affordable and effective medicines for patients in China. Even without tariffs, the price of imported drugs is still likely to be unsustainable (as elsewhere in the world) without local Chinese solutions.