ASCO Study: Mandatory Drug Licensing Can Bridge Care Divide

Expanding the market for biosimilars and generic medications, by circumventing patents in some cases, is necessary to help ensure affordability and access for patients with lymphoma and chronic lymphocytic leukemia (CLL) in India and across the globe, according to a new study.

“The advent of biosimilars has reduced the cost of and made treatment of CLL and lymphoma similar in the United States and India in terms of survival and patient quality of life,” but many powerful new drugs still have patent protection and are costly, placing them beyond the reach of patients, the authors said.

They recommend implementing the Doha Declaration, which would allow governments to use compulsory licensing of patented drugs and price caps according to extreme need. They also recommend price caps and expansion of insurance coverage, which is rare in India compared with the United States.

“A systematic effort from the government agencies and use of a hub-and-spoke model for rural outreach may be required to improve access in remote areas of India. In the United States, by allowing Medicare and the FDA to have a say in drug prices, laws that enable importing drugs and negotiating drug prices can help reduce drug costs,” the authors wrote.

Barriers to Cancer Care Accessibility

Both the United States and India have patients who face difficulties in accessing cancer care. In the United States, many novel cancer medications are priced at more than $100,000 per year, making them affordable only via insurance, which can be costly for the covered patient and nearly impossible for the 10% of Americans the authors estimated don’t have health insurance.

The availability of biosimilars and the rise of India’s pharmaceutical industry have vastly improved access to drug products, both generics and biosimilars, the authors note. In addition, purchasing power is stronger in India given the relative costs of drugs. For example, 1000 mg of rituximab in the United States costs $9467 versus $1100 in India.

But new blockbuster medications could substantially improve treatment outcomes for patients were access more affordable, the authors said. One of those is pembrolizumab, which in KEYNOTE-170 led to an overall response rate of 45% in patients with relapsed/refractory classic Hodgkin lymphoma. In India, pembrolizumab is available at the cost of $6010 per 200 mg dose. There are no biosimilars for pembrolizumab.

Pharmaceutical companies keep drug prices higher through lobbying, which can delay the entry of biosimilars and generics into the market, according to the investigators. They recommend an effort to expand markets for generics and biosimilars.

In India, access to oncologists is scarce, with the ratio for oncologists to patients being 1 in 2000. In addition, a substantial portion of the population lives in rural areas with little or no awareness of what health care options and treatment facilities are around them. Many citizens pay out of pocket for health care and only a minority have health insurance.

“Individuals with lymphoma who live in rural areas and those who are uninsured have inferior outcomes probably because they have less access to cancer care,” the investigators wrote.

Additionally, the United States spends 17.8% of its gross domestic product (GDP) on health care and is often a trailblazer at adopting new therapies. By contrast, India spends just 3.89% of its GDP on health care.

Proven Results of Biosimilars and Generics

According to the investigators, the overall outcome of cancer care and quality of life have improved for patients in both countries who have access to care.

For the treatment of lymphoma and CLL, agents such as rituximab and pegfilgrastim have biosimilar versions that have increased the access and affordability of biologics in India. India’s thriving pharmaceutical industry has led to more affordable drug prices in the region.

For more about proposed and actual changes to improve drug access in India, click here.

Investigators mentioned how the market introduction of Reditux, a rituximab biosimilar developed by Dr. Reddy’s Laboratories, in 2007 forced a decrease in pricing for originator rituximab (Rituxan, Genentech) and made the drug available across India.

“The advent of biosimilars has reduced the cost of and made treatment of CLL and lymphoma similar in the United States and India in terms of survival and patient quality of life. Innovative strategies would help expand access to other novel agents to patients in India as well,” the authors wrote.

Reference

Sathyanarayanan V, Flowers CR, Iyer SP. Comparison of access to novel drugs for lymphoma and chronic lymphocytic leukemia between India and the United States. JCO Glob Oncol. 2020;6:1124-1133. doi:10.1200/GO.20.00012