The Union health ministry has asked eight designated hospitals that treat rare diseases to set up an expert committee each, which will decide on providing the cash aid of Rs 50 lakh within a month of receiving an application for financial assistance from a patient.
The eight Centres of Excellence (CoEs) will also be given one-time financial support up to Rs 5 crore for procurement of equipment for strengthening patients care services for screening, diagnosis and prevention (prenatal diagnosis) for rare diseases based on a gap analysis, according to the new guidelines issued by the health ministry.
Also, more CoEs will be added for regional outreach if they are found to be suitable in terms of infrastructure and human resources based on recommendations of the Technical Committee of the Ministry of Health and Family Welfare, the guidelines said.
The ministry on August 11 issued the guidelines and procedures for granting financial assistance to patients suffering from rare diseases as thalassemia, haemophilia, and sickle cell anaemia under the National Policy for Rare Diseases (NPRD), 2021.
The ministry on May 19 increased the financial support from Rs 20 lakh to Rs 50 lakh for patients belonging to all categories of rare diseases.
According to the guidelines, a ‘Rare Disease Committee’ is to be constituted in each CoE. The nodal officer for rare disease of the hospital will be the member secretary of the committee and the CoE may also opt for an outside expert on the panel, if required.
The applications received from the patients or guardians will first be scrutinized by the nodal officer, and thereafter placed before the committee for consideration and approval.
The committee will take decision for treatment and fund allocation within four weeks of receiving the application.
The employees of central/state government/PSUs/autonomous bodies/statutory bodies and their family, who are beneficiary under any Central government scheme, such as CGHS/EHS etc., state government health scheme and any other scheme of PSUs/autonomous bodies/statutory bodies, will not be eligible for getting financial assistance as per NPRD, 2021.
There will be no reimbursement of expenditure already incurred. Families covered under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojna (AB-PMJAY) will also be eligible for financial assistance as per NPRD, 2021, if the disease is not covered under AB-PMJAY packages.
The guidelines mentioned that a maximum financial assistance admissible under the scheme will be up to Rs 50 lakh per patient and the financial aid will be given to the concerned CoE, where the patient is getting treatment/admitted for treatment. The financial assistance shall not be given to the patient directly, the ministry said.
As envisaged in the policy, the state governments shall support patients of such rare diseases (listed in Group 2) that can be managed with special diets or hormonal supplements or other relatively low cost interventions.
The guidelines also mention about the crowdfunding portal, which was setup in August last year for receiving such fund for patients suffering from rare diseases.
Keeping in view the resource constraint and compelling health priorities, it will be difficult for the government to fully finance the treatment of high cost rare diseases. The gap will be filled up by providing financial assistance through crowdfunding, the guidelines said, adding a crowdfunding portal “http://rarediseases.nhp.gov.in/”http://rarediseases.nhp.gov.in has already been created for receiving such fund, the guidelines read.
The CoEs will share information relating to the patients, diseases from which they are suffering and estimated cost of treatment on the crowdfunding portal.
The CoEs have the option to explore the possibility of getting financial assistance from other agencies/drugs manufacturers/ corporate sector under CSR by signing of MoU.
The NPRD-2021 provides for a hospital-based National Registry for Rare Diseases at the ICMR. The registry is expected to yield information on hospital-based data and disease burden. To streamline the process of capturing data related to various rare diseases, CoEs have been asked to register itself on the ICMR registry immediately.
There are three groups in which patients diagnosed with rare diseases have been classified. The group 1 includes disorders amenable to one-time curative treatment while Group 2 includes diseases requiring long term lifelong treatment having relatively lower cost of treatment and benefit has been documented in literature and annual or more frequent surveillance is required.
Under group 3 falls those diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost and lifelong therapy.
The eight CoEs are AIIMS, New Delhi; Maulana Azad Medical College, New Delhi; Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow; Post Graduate Institute of Medical Education and Research, Chandigarh; Centre for DNA Fingerprinting and Diagnostics with Nizam’s Institute of Medical Sciences; King Edward Medical Hospital, Mumbai; Institute of Post Graduate Medical Education and Research, Kolkata; and Centre for Human Genetics with Indira Gandhi Hospital in Bengaluru.