Access to Our Therapies
Above all, our goal is to ensure that patients have the opportunity to achieve the best possible therapeutic outcomes. We invest in broadening access to our therapies to meet the needs of patients, in addition to offering personalized and comprehensive support services – at no cost.
We work closely with the patient community to ensure that all who are medically eligible for our therapies have affordable access to Thiola®(tiopronin) tablets, Cholbam® (cholic acid) capsules, and Chenodal® (Chenodiol Tablets 250 mg).
Our Total Care HUB® is a free support program for people who have been prescribed Retrophin therapies. This program eases access to therapy, while providing live, on-demand support from dedicated pharmacists and HUB counselors to answer product questions, and assist with insurance verification, reimbursement options, and financial support.
We offer co-pay assistance and provide free medication to those who qualify, as part of our patient assistance program. We also sponsor free cholestatic genetic testing for patients who qualify to help diagnose a variety of disorders.
Below, you can learn more about our Total Care HUB® services exclusively for patients prescribed a Retrophin therapy:
Compassionate Use/Expanded Access
Retrophin is committed to developing investigational therapies for people living with life-threatening conditions. We believe that participating in a clinical trial is the best way for patients to access our investigational therapies, however, we recognize that there are situations in which patients may not be able to access our investigational products through our clinical trials.
For example, some individuals may not satisfy all the eligibility conditions required to enter our clinical trial, some may have a critical need for immediate care, and some may live in a location that is not accessible a participating clinical trial site. For patients in any of these situations, we will consider requests for special access to our investigational therapies, which is often referred to as compassionate use or expanded access.
Each request will be carefully considered for many factors, including the circumstances and medical history of the patient, the local and national laws and regulations, the potential risks and benefits for each patient, and the best interests of the entire patient community. It is important to remember that the regulatory agencies (such as the US FDA or European Medicines Agency) have discretion to grant or deny access to investigational medications through the compassionate use program.
If you feel you may be eligible for compassionate use of one of our investigational therapies, your physician must submit a request on your behalf. Treating physicians who would like to request access to one of our investigational therapies are encouraged to contact us at firstname.lastname@example.org or +1 877-659-5518. Retrophin expects to acknowledge receipt of requests to the requesting physician within seven business days.
Submissions will be reviewed by an internal committee, who will carefully consider each request based in part on the following:
- Is the patient ineligible to participate in a clinical trial?
- Is there is sufficient evidence to expect that the investigational therapy will have an acceptable safety profile for the intended patient?
- Is there enough of the investigational therapy to support the compassionate use request without jeopardizing other needs, such as ongoing clinical trials?
- Does the patient have a serious or imminently life-threatening disease or condition?
- Are there other comparable or suitable alternative treatments available?
- Can the requesting physician meet the explicitly set criteria for treating the intended patient with the investigational therapy?
It’s also important to know that the compassionate use of an investigational therapy may be discontinued at any time at the discretion of the treating physician, the patient or their caregiver, the local regulatory agency, such as the FDA, or Retrophin.
To learn more about our expanded access program and process, please contact email@example.com or +1 877-659-5518.