Treatment Access

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Kiniksa OneConnect™ is a patient support program that provides personalized, one-on-one support at each step of the treatment journey: from exploring financial assistance options to starting treatment. Reach out to the Kiniksa OneConnect team today to learn more about our personalized treatment support for people suffering from recurrent pericarditis, Cryopyrin-Associated Periodic Syndromes (CAPS), and Deficiency of Interleukin-1 Receptor Antagonist (DIRA), and their families.

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Managed Access Programs

 

Kiniksa is focused on developing medicines for patients suffering from debilitating diseases with significant unmet medical need and is conducting clinical trials to support these efforts.
 
Clinical trials allow Kiniksa to evaluate investigational products to determine the efficacy of a product and obtain the safety information needed to potentially gain approval of those treatments and make them available to the appropriate patient population. Information regarding Kiniksa’s ongoing clinical trials can be found within the pipeline section of https://kiniksa.com or on https://clinicaltrials.gov.
 
 

WHAT IS MANAGED ACCESS?
 

Kiniksa understands that not all patients may be eligible for its clinical trials and may not have options for alternative therapies. Under these circumstances, and where patients have serious or life-threatening diseases or conditions with no satisfactory alternative treatment options, Kiniksa may provide a treating physician with an investigational or “un-licensed” (a product that has not received marketing authorization in a particular country) medicine. Such use of an investigational or “un-licensed” medicine outside a clinical trial setting is often referred to as “Managed Access”, which includes various types of programs including “Compassionate Use”, “Expanded Access”, and “Named Patient Program”.
 
 

WHO MAY BE ELIGIBLE FOR ACCESS THROUGH A MANAGED ACCESS PROGRAM?
 

Kiniksa uses the following criteria, in its sole judgment, to help evaluate Managed Access requests:
 
  • The patient has a serious or life-threatening illness or condition and is (a) no longer responsive to any available treatment option, (b) no longer able to tolerate any available treatment option, or (c) there is no comparable or satisfactory alternative therapy for the disease or condition.
  • A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational or “un-licensed” product available.
  • The product is in active clinical development or approved in another country in the disease state of interest with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition.
  • The product is in active clinical development or approved in another country in the disease state of interest with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition.
  • Making the investigational or “un-licensed” product available will not have a negative impact on or delay the conduct of clinical trials or regulatory review or approval of the investigational product for broader patient access.
  • There is a regulatory mechanism in the country or region to support a Managed Access Program.
  • A mechanism is in place for reporting of safety data during treatment.
  • Adequate supply of product is available to support providing it to the patient requesting access.
 
 

HOW DO I SUBMIT A MANAGED ACCESS REQUEST?

 

  • If you are a patient living in a country where a Kiniksa product is not commercially available and you are interested in seeking access through a Managed Access Program, please speak with your physician. Kiniksa can only respond to a physician’s request for access on behalf of a patient in their care.
     
  • If you are a physician wishing to enquire about access to an investigational or “un-licensed” Kiniksa product for one of your patients, please contact Kiniksa at managedaccess@kiniksa.com.
Kiniksa is committed to evaluating all requests for access to our products in a timely, fair, and unbiased manner. We will aim to acknowledge receipt of a request for product within 3 business days. Kiniksa will review all Managed Access requests in consideration of strict eligibility criteria and may require more detailed information to fully evaluate individual requests.
 
 

Additional Considerations:
 

Kiniksa evaluates the benefit-risk profile of its investigational, or “un-licensed” products based on emerging clinical data. Each of Kiniksa’s development programs is different. Making one product available for the treatment of a specific patient does not mean that it will be made available in response to other requests as individual patient circumstances and medical histories differ. As such, each request will be considered on a case-by-case basis. Kiniksa provides no guarantees that it will make the investigational or “un-licensed” product available for any Managed Access program.
 
Physicians who receive a Kiniksa investigational or “un-licensed” product through a Managed Access program will be required to comply with all applicable laws, regulations, and contractual conditions requested by Kiniksa, including, but not limited to, obtaining patient consent, patient monitoring and safety reporting, and obtaining appropriate regulatory and ethics committee approvals from their corresponding institution(s). Each request will be given careful consideration by a Kiniksa review team whose decisions are final.