Patients with Hemophilia A could soon look forward to a bigger basket of treatment options, with third-generation products by multinational companies like Novo Nordisk and Baxalta entering the Indian market this year. At the same time, the products may not be cost-effective for the benefits offered, say experts.
While Novo Nordisk's 'NovoEight' was launched this week at half its international price, Baxalta will bring 'ADVATE' to the country in the second-half of 2016.
Third-generation hemophilia products (recombinant factor concentrates) don't use human or animal-derived protein in the growth medium as well as the final product. This reduces risk of transfusion-transmitted infections compared to other plasma-derived FVIII products, according to Novo Nordisk India Vice President & GM, Melvin D'Souza.
NovoEight, a recombinant Factor VIII (rFVIII) product, was introduced for Hemophilia A treatment in government and private hospitals here on April 26. Hemophilia A patients lack or have a defected Factor VIII (FVIII)—a clotting protein.
The product is "the only" rFVIII that can be stored at room temperature for up to nine months without cold chain and can therefore be dispensed as home therapy or emergency treatment, said D'Souza.
The government also recently approved Baxalta's ADVATE--an rFVIII product which has a proven safety and efficacy profile, according to Vineet Singhal, Country Head, Baxalta India. The product has otherwise been available in other markets like the US for over a decade.
"Local product registration timelines vary depending on local environment and regulatory approvals," he said.
Baxalta aims to work with the government, NGOs, payers and physicians to ensure that patients ultimately have access to adequate treatment, he added.
While a step ahead in safety, the two products are not any more efficacious than the blood-based products currently available here, according to Rupal Panchal, Founder, Hemophilia Society Mumbai Chapter.
The products would also be costlier at Rs30-40 a unit compared to the blood-derived products available for Rs15-20 a unit, he said. A hemophilia patient requires 30,000-50,000 units of the blood-derived products annually, according to him.
"There has been no viral transmission in any of the blood products in the last 10 years after the (various processes that these products were put through during formulation)," said Panchal.
Almost 50% of the world's hemophilia population lives in India and a majority of them are at risk because they either lack adequate knowledge or access to treatment, according to the World Federation of Hemophilia. Hemophilia A is the most common type of the disorder and occurs in about one in 5,000 births, according to the National Health Portal of India.
Source : economictimes.indiatimes.com