New Delhi: The government on Monday released a draft policy, under which it proposed to fund one-time treatment cost to the tune of ₹15 lakh for certain treatable rare diseases, provided the patient was eligible under its flagship health insurance scheme, Ayushman Bharat’s Pradhan Mantri Jan Arogya Yojana.
Under the draft National Policy for Rare Diseases, the Ministry of Health and Family Welfare would provide financial support under its umbrella scheme Rashtriya Arogya Nidhi.
While Rashtriya Arogya Nidhi is aimed at providing financial assistance to patients living below the poverty line, under the rare disease policy, the financial benefits will also be extended to the broader class of Ayushman Bharat, which covers 40% of the population.
Under the policy, the government plans to notify certain medical institutes as Centers of Excellence for Rare Diseases. To begin with, these will include Delhi’s All India Institute of Medical Sciences and Maulana Azad Medical College, Chandigarh’s Post Graduate Institute of Medical Education and Research, Mumbai’s King Edward Medical Hospital, Lucknow’s Sanjay Gandhi Post Graduate Institute of Medical Sciences, and three others.
However, the scope of the draft policy proposed to limit financial support to patients suffering from only a few rare diseases categorised under Group 1, like osteopetrosis and certain immune deficiency disorders that can be cured with treatment, and certain diseases Tyrosinemia, Fabry’s disease and Maple Syrup Urine Disease, which require kidney or liver transplants.
The draft policy cited lack of adequate resources not provide financial assistance to rare diseases that require lifelong treatment.
These diseases include Gaucher’s Disease, Hurler Syndrome, Wolman Disease, among others. Treatment for some of these diseases may vary from ₹10 Lakhs to more than ₹1 crore per year, with drug dose and cost increasing with age.
For these diseases, the government has sought alternate funding mechanism like setting up a digital platform for voluntary and corporate donations.
“The financial capacity to support exorbitant cost of treatment, is an important consideration in public health policy development with reference to treatment for rare diseases. In resource-constrained settings, it is pertinent to balance competing interests of public health for achieving optimal outcome for the resources allocated," the draft policy said.
Some health activists have also criticised the limited scope of the proposed policy.
“It appears that entire policy is drafted to justify that govt cannot provide treatment due to high cost as it is resource constraint country… Some government hospitals are listed to be notified centre of excellence, but truly speaking, majority of severely compromised immunity patients cannot be taken to govt hospitals as they may acquire hospital contracted infections due to overcrowding and lack of hygiene and sanitation," Archana panda, director for patient advocacy at Cure SMA Foundation of India, said in a statement.
Cure SMA Foundation of India is a charitable trust for patients with spinal muscular atrophy, a rare genetic life threatening neuromuscular disease.
While the policy says that the government “shall promote R&D (research and development) for improving the availability of affordable therapies for rare diseases with adequate safeguards in place", it has also been criticised for not coming up with measures for it.
“The policy has adopted a very narrow scope limited to diseases listed in 3 categories, essentially purging diseases not listed such as for which no treatments currently exist. The policy ought to have addressed the need for R&D for these diseases," Malini Aisola, co-convenor of All India Drug Action Network, said.
The health ministry had formulated a national policy on treatment of rare diseases in 2017, which envisaged the setting up of a corpus fund with an initial amount of ₹100 crore towards funding treatment of rare genetic diseases, but this never picked up due to budget constraints.
In the US, the Orphan Drugs Act provides incentives to drug manufacturers to encourage them to manufacture drugs for rare diseases, and similar incentives are also provided in the UK and certain other developed countries.