More immunotherapy trials need to come to India: IQVIA

PT Jyothi Datta Mumbai | Updated on October 20, 2020

Cancer patients in India can get better access to immuno-oncology therapies, if more global trials on these drugs are undertaken in India, according to a white paper from IQVIA, a human data science company.

India has all that is needed in terms of the skills, research centres, regulatory framework and patient population, and more global companies need to recognise this and bring their trials to the country, said Anju Gopan, primary author of the paper and IQVIA Medical Director-Oncology, Medical Science and Strategy Asia.

“Over the last decade, clinical data generated by Indian clinical sites have been used successfully to support drug approvals in the United States, European Union and elsewhere. India remains on track to become a major center for clinical trials and should be routinely considered by international sponsors for global IO trials,” the IQVIA paper noted. IQVIA is the joint entity of contract research organisation Quintiles and data-cruncher IMS Health.

Immuno-oncology (IO) therapeutics are driving change in cancer treatment by mobilising the patient’s immune system against their cancer. Substantial benefits have been observed with these therapies for solid tumors — especially in advanced and metastatic cancers with limited treatment options — and these are increasingly being included in global cancer treatment guidelines as the standard of care, the paper said.

Recently, monoclonal antibodies (a type of immuno-therapy) have been in the spotlight after an experimental drug was given to US President Donald Trump to treat Covid-19. The IQVIA white paper, however, limited its view to cancer drugs.

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Cost factor

The constraint with these drugs is that they are difficult to produce and are expensive, say healthcare experts. “Indian patients also often lack low-cost access to IO therapies that are approved in US and European markets. Currently, while IO therapies are available in India — either on demand or on compassionate use grounds — cost and affordability remain a concern even for higher income groups . IO therapy in India is only reimbursed by medical insurance for patients who have been approved, and when used in combination with chemotherapy,” the paper noted, reflecting the concerns of experts that participated in a meeting on the issue earlier this year.

“In future, it would be helpful if the reimbursement decisions of insurance companies could take account of multiple factors, including overall survival benefit, efficiency, value, drug approval status, magnitude of clinical benefit and improved quality of life,” it added.

Gopan point out that health insurance companies had been directed by the regulator to recognise monoclonal antibodies and immunotherapies. Details are now awaited from the companies, she added.

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Advantage India

Outlining advantages the country holds out, the paper said, India has an improved regulatory environment that is now streamlined, simple and structured. There are numerous government-funded and private cancer hospitals, besides research institutes that can support multi-center clinical trials. There are experienced and highly-trained oncologists, English-speaking investigators and clinical trial staff, among other things, the IQVIA paper said.

India is estimated to have 1.16 million new cases of cancer annually, the paper said, citing a World Health Organization report. The common types include breast, oral, cervical, lung, stomach, and colorectal cancers. By 2030, India may see a 50 per cent rise in cancer incidence, compared to 2012.

Published on October 20, 2020

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