EARLY ACCESS PROGRAMS FOR TREATMENTS AND SOLUTIONS
Early Access Programs (EAPs), also known as compassionate use programs or expanded access programs, are initiatives that allow patients with serious or life-threatening conditions, such as kidney disease, to gain access to either investigational treatments or solutions before they are fully approved, subsidised and available on the market. These programs are designed to provide potential benefits to patients who have exhausted all other readily available treatment options and have no satisfactory alternative treatments available.
Here are some key aspects of Early Access Programs for treatments and solutions in kidney care:
ACCESS TO INVESTIGATIONAL TREATMENTS
EAPs provide a pathway for patients to access promising investigational treatments that are still undergoing clinical trials or awaiting regulatory approval. These treatments may include new medications, medical devices, procedures, or therapies that have shown potential benefits in earlier stages of research. By participating in an EAP, patients can receive access to these innovative treatments that may not be available through standard care options.
ACCESS TO NON-SUBSIDISED TREATMENTS
EAPs enable fully approved and registered therapeutics to be made available to the patients, while the local data is being generated for authorities to add them to the list of subsidised treatment options. This provides a crucial route of making beneficial treatments available to patients, who otherwise would not be able to afford it.
ELIGIBILITY CRITERIA
Each Early Access Program has specific eligibility criteria that determine who can participate. Typically, patients need to meet certain medical criteria, have a confirmed diagnosis of a serious or life-threatening kidney condition, and have exhausted all other available treatment options. The decision to grant access to an investigational treatment ultimately rests with the healthcare provider overseeing the program, with the help of the pharmaceutical or medical device company providing the treatment.
BALANCING RISKS AND BENEFITS
EAPs carefully consider the potential risks and benefits of the investigational treatment. Although the treatment may offer a potential benefit, it is important to recognise that these treatments are still in the experimental stage and their safety and efficacy may not be fully established. The healthcare provider and the patient must engage in informed discussions regarding the potential risks, benefits, and uncertainties associated with the treatment before deciding to participate. For treatments that are proven and fully registered, but not yet subsidised, the EAP must carefully balance the cost-effectiveness of providing such expensive treatments to patients, by carefully studying the available literature by a panel of Kidney Care specialists.
REGULATORY OVERSIGHT
Early Access Programs are subject to regulatory oversight to ensure patient safety and ethical considerations. Regulatory agencies provide guidance and oversight for these programs. Physicians in-charge of the care must register such therapeutics usage with the relevant authorities and fulfil all criteria before proceeding. The authorities evaluate the available data on the investigational treatment, assess the potential risks, and review the program's protocols and procedures to protect patient welfare. There are also feedback and monitoring mechanisms in place for safety and quality control of using such special protocols for early access.
INFORMED CONSENT
Participation in an Early Access Program involving investigational treatments, requires the patient's informed consent. Patients must be provided with comprehensive information about the treatment, including its potential risks, benefits, uncertainties, and alternatives. The patient has the right to make an informed decision regarding their participation and can withdraw from the program at any time. For therapeutics involving expensive medications, appropriate counselling is provided to the patient regarding sustainability of the program and funding available.
It's important to note that Early Access Programs are not available for all investigational treatments, and their availability may vary according to the regulations and data available. The decision to provide early access is ultimately based on a case-by-case evaluation by healthcare providers and kidney specialists.
If you are interested in exploring Early Access Programs for kidney care treatments or solutions, please contact RHS and we will help facilitate a consultation with a Kidney Specialist and a team of healthcare experts. They can provide guidance and information on any available programs that may be suitable for your specific situation, with practical tools on how to avail such solutions.
