The Lai administration has bold ambitions for supporting cancer patients, but many details about the plan still remain uncertain.

President Lai Ching-te gained widespread public interest during his election campaign last year by announcing his “Healthy Taiwan” policy focusing on disease prevention and health maintenance.

The cornerstone of the plan is the establishment of a Taiwan Multi-Support Cancer Drugs Fund (CDF). Lai has dedicated NT$10 billion (around US$330 million) to the fund, which is designed to support Taiwan’s cancer patients and their families in accessing necessary treatment, who often can’t sustain the high out-of-pocket costs of innovative treatments not covered by National Health Insurance (NHI).

According to the CDF’s website, the plan is to establish a CDF expert committee that will determine the priority of support items based on the fund’s size and the urgency of the disease. The committee would be composed of government agents, clinical specialists, pharmacists, legal experts, and representatives of cancer patient groups. The government would prepare an annual budget, for which funding would come from the government, pharmaceutical companies, donations, and other sources, and plan incentives and supporting programs to encourage companies to participate.

With the theme “Blueprint for a Comprehensive Cancer Drugs Fund,” AmCham Taiwan’s 2024 Cancer Summit, held July 15 at the Regent Taipei, examined the opportunities and challenges presented by the plan. In his keynote address, Shan Yan-shen, dean of the Institute of Clinical Medicine at National Cheng Kung University (NCKU), told the attendees that the CDF has the potential to cut the cancer mortality rate in Taiwan by a third by 2030. The Ministry of Health and Welfare in 2023 reported that the cancer mortality rate had risen by 2.2% year-on-year to reach 227.6 per 100,000 people.

Although there is broad agreement that the fund holds the potential for being a significant boost to public health and social welfare, many aspects of the program are still unknown, including the exact source of the funding, the scope and timing of the implementation, and the execution guidelines.

“The government needs to find the funding, and we as legislators will do our best,” said Liu Chien-kuo, legislator and chair of the Cancer Drugs Accessibility Committee at the Health and Welfare Association (HWE) during the Summit. He added that it should be possible to get some funding approved by next year rather than looking at a three- or five-year timeframe as is often the case with new public investments to ensure project viability.

Besides direct government appropriations, funding for the program from other sources is also expected to be necessary, possibly including public-private partnerships and the reallocation of items already budgeted for other purposes.

At the summit, Han Hsing-wen, a professor of accounting at Tamkang University, advocated the idea of imposing sugar and alcohol surcharges as an additional funding mechanism, though she noted that the National Health Insurance Administration (NHIA) has said it has no plan for that to be done. Han suggested that such surcharges should not be dismissed as a potentially viable source of funding. She went on to further recommend that the NHIA reform its own funding structure to expose surpluses that could go toward the CDF, though this is highly unlikely, she added.

Although meeting the expectations of patients and patient groups is a constant priority, even when the required NT$10 billion is raised, the full sum will not be immediately available for treatment coverage, Legislator Liu noted. Before money can be allocated to various targets, a substantial portion – NT$5 billion is the amount usually mentioned – will be needed to establish the fund and its related administrative framework.

“Is five billion enough?” asked Tamkang University’s Han rhetorically. “I have no idea.” She said the appropriate level will depend on how the CDF is officially designed and what objectives are set. In addition, a key issue is political – whether a steady stream of resources can be assured to permit the program to continue running smoothly over time.

Jane Tsai, deputy head of the non-profit Formosa Cancer Foundation, notes that budgets never catch up with the speed at which new drugs are rolled out. Given the limited government financial resources, diverse and sustainable sources of funding will be needed to secure the longevity and scope of the program.

Once the CDF is created, the next challenge will be to “solve the timing of the introduction of new drugs,” Liu said. In Chinese, the name of the fund translates as the “New Cancer Drugs Fund” (新藥基金, xīnyào jījīn), with the word “new” referring to new drugs rather than it being a new fund. Opinions vary sharply about which drugs should be considered “new” and at what point in the clinical trial process the determination should be made to include them under the fund.

It is believed that the CDF will focus on innovative oncology drugs currently undergoing phase 2 trials. Cancer drugs in phase 3 trials are likely to be excluded on the assumption that cancer patients have more accessibility to those treatments and therefore have less need for financial support through the fund. Not everyone agrees with that prioritization, and Summit speakers stressed the need for a concerted effort to address patient expectations and mitigate confusion during the startup period when many details of the program remain to be clarified.

Improving policy

The connection between the CDF’s immediate financial needs and the broader scope of public health spending is readily apparent. The NHIA has sought to protect the solvency of the national health insurance program by excluding high-priced cancer drugs from the reimbursement scheme to health providers, leaving those medications in the self-pay category. In the United States, much of that burden would be taken up by commercial insurers, but such insurance coverage is less common in Taiwan.

Dr. Lee Po-chang, then-director general of the NHIA, said in 2022 that the growth rate of NHI spending on cancer drugs was the highest of all drug categories, costing the NHI over NT$40 billion in 2021. He noted that while over 70% of Taiwanese have private insurance policies, most policy-holders are unclear about the terms and conditions of their insurance plan, often leading to claims disputes. Lee recommends that people purchase a “pay-as-you-go” hospitalization insurance plan, plus a cancer treatment plan.

But even if private insurance and the NHI were working efficiently and in tandem, they still wouldn’t provide enough patient protection. Specialized procedures, long-term care, and preventive or wellness services often fall outside of what traditional insurance models provide.

Next-generation cancer drugs, including immunotherapies and personalized medicine tailored to the genetic profile of individual tumors, often come with prohibitive costs that put them out of reach for many patients. For instance, the annual cost of treatment with certain targeted cancer therapies can exceed NT$2 million. The aim of the CDF is to subsidize these costs, ensuring that financial barriers do not impede access to lifesaving medications.

The introduction of the CDF will require strong inter-agency cooperation in Taiwan’s public health policy, and the NHIA will play a vital role in integrating the CDF with existing health services. By leveraging its extensive database and administrative capabilities, the NHIA will be responsible for ensuring that fund allocations are efficiently managed and that patients receive timely access to the supported treatments.

Financial barriers are just one of the challenges. Current practices regarding clinical trials in Taiwan that impede a patient’s ability to receive new cancer drugs are another. “We need alignment with international standards so that patients can join international clinical trials,” says Tsai of the Formosa Cancer Foundation.

Unlike the streamlined regulatory processes observed in other countries like the United States, where the FDA’s approval timeline for an initial Investigational New Drug is approximately 30 days, Taiwan’s approach includes an additional layer of scrutiny. This involves the Ethics Committee or Institutional Review Board (IRB), an independent body dedicated to safeguarding the rights and safety of human subjects. The inclusion of this step, though crucial for ethical oversight, extends the review process for clinical trial applications to about 60 to 90 days or more, making it considerably more time-consuming.

Japanese multinational pharmaceutical company Takeda has demonstrated its expertise in providing advanced treatments for hematological cancers and solid tumors associated with lung, prostate, colorectal, ovarian, and other types of cancer. When addressing the challenges in delivering treatment to cancer patients in Taiwan, Takeda highlights limited local clinical experience and the financial uncertainties surrounding rare cancers as primary obstacles.

“Often, only a fraction of rare cancer patients receive proper diagnosis and treatment,” explains Takeda General Manager Alexis Lin. Therefore, expediting approval processes to facilitate early patient access is crucial for gathering local evidence to alleviate concerns regarding clinical and financial uncertainties among Taiwan’s health authorities.

NCKU’s Shan notes that the CDF may help ease the strict conditions for qualifying for treatments. Since “cancer drugs already have clear efficacies,” CDF support could mitigate perceived financial risks and thus encourage the health authorities to recognize treatments with successful case studies more efficiently.

In this decade, the stage 4 five-year cancer survival rate in Taiwan has remained at a low 13%, compared to around 20% globally, depending on the type of cancer and region. Shan notes that the introduction of lifesaving, innovative treatments are often delayed due to additional regulatory requirements and administrative procedures. In some cases, Taiwan requires additional local clinical trials or studies to address specific regulatory or population-related concerns, even if trials have been conducted abroad.

For late-stage cancer patients, any delays in treatment can be devastating.

Lin stresses the importance of government investment in research and development (R&D) to propel advancements in cancer treatment. She underscores that R&D entails significant financial commitments for companies, particularly in the development of treatments for rare cancers and cutting-edge technologies.

The CDF may be able to expedite the introduction of new drugs by making treatments immediately available to patients. Expedited listings could lead to earlier rewards from innovative technologies that can be re-injected into R&D. Despite these potential savings, budgeting can be further impacted by uncertain rebate rates that have yet to be articulated.

“Once the clinical efficacy of a treatment is established, the reimbursement process – whether through the NHI or the CDF – introduces unpredictable barriers,” notes Lin.

The potential for redundant review processes delaying new drug access and the prioritization of innovations based on cost constraints within the CDF pose challenges for companies. These hurdles impeded the assurance of patients’ rights and the continuity of their treatments without interruptions.

“We advocate for government decisions grounded in patient-centric principles rather than budgetary considerations,” says Lin. Emphasizing meaningful patient engagement as the cornerstone, the government should foster an environment that promotes the discovery of crucial new medications for patients with unmet medical needs, Lin adds.

The CDF is not just about cancer treatments – it’s a comprehensive movement to improve health and recognize the value of life, former health minister and now Minister Without Portfolio Chen Shih-chung said at the Summit. He noted that although early detection, screenings, and new drugs will introduce higher costs through increased diagnoses, expenditures can be stabilized in the next five years thanks to early and effective treatment, reduced advanced-stage costs, and cost-reduced chronic disease management.

“We have to spend now to save money and lives in the future,” says Chen.