What is Cortisol Pumping?
The concept of Cortisol Pumping is the use of solu-cortef (inject-able version of cortisol when mixed with saline or bacteriostatic water) used in an insulin pump programmed to disperse cortisol according to the natural circadian rhythm by programming rates of delivery into the pump. This method bypasses the gastric passage and is able to deliver cortisol in a more natural way. With an infusion pump, an adrenal insufficient patient can receive a constant supply of cortisol and can lesson the instability experienced with oral steroid cortisol replacement. Side effects due to malabsorption can be decreased and patients have reported to have improved sleep, weight management and experience an overall improvement in their energy levels and sense of well-being. This method has also been shown to lessen the prevalence of adrenal crises and hospitalizations due to low cortisol.
Though this method is not a cure for adrenal disease, it is an option and a ray of hope for those who are struggling with quality of life.
According to a survey done by the Adrenal Alternatives Foundation concluded that 94.2% of the 52 anonymous cortisol pumping patients reported that the cortisol pump had improved their quality of life.
Is Cortisol Pumping FDA approved?
Adrenal Alternatives Foundation is actively working to gain FDA approval for the cortisol pumping method, but that involves years of clinical trials, patient studies and funding. We will achieve this one day, but until then, we are educating patients that FDA approval is not necessary to safely and legally begin cortisol pumping under the care of a licensed physician. Use of the infusion pump for adrenal insufficiency is considered “off label.”
Infusion pumps have long been approved for the administration of medications. According to the Department of Health and Human Services Centers for Medicare and Medicaid Services Medicare Coverage Issues Manual Section 60-14 A: “6. Other uses of external infusion pumps are covered if the contractor’s medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.”
In addition, according to the recently passed Right to Try Act, patients have legal rights to access to life-saving treatments which are not yet FDA approved. The act states the following:
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 360bbb–0) the following: ‘‘SEC. 561B. INVESTIGATION ‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS. ‘‘(a) DEFINITIONS.—For purposes of this section— ‘‘(1) the term ‘eligible patient’ means a patient— ‘‘(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); ‘‘(B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— ‘‘(i) is in good standing with the physician’s licensing organization or board; and ‘‘(ii) will not be compensated directly by the manufacturer for so certifying; and ‘‘(C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent.”
According to the above legislation, adrenal patients meet the criteria for legal use of an infusion pump to administer glucocorticoid medication.
How do I get a pump?
The first step to cortisol pumping is establishing a care plan with a licensed medical professional. This can be a difficult challenge when trying to find a physician to manage your care with the pumping method, as most have never heard of it. This is why Adrenal Alternative Foundation has volunteers on our clinical advisory team willing to communicate with your healthcare team to help you establish a plan regarding your care on the cortisol pumping method.
It may take you many tries to find a physician willing to manage your care with the cortisol pumping method. Send your research, your health information, everything you can to the endocrinologist before your appointment so they are aware of your intentions beforehand. It may benefit you to write a letter to the endocrinologist prior to your appointment that explains your diagnosis, failed treatments and desire to be on the pump. They may or may not be receptive to your request and alerting them of your intentions beforehand may save you time, money and effort.
Will insurance cover pumps and supplies?
What your insurance will cover is completely dependent on your specific coverage plan and insurance company. If you are denied, you can always file an appeal. Visit this link to download the example appeal letter you can fill out with your information to appeal your insurance company’s denial.
Adrenal Alternatives Foundation has also aligned with the organization CR3 to help adrenal patients acquire pumps in a safe and legal manner. Visit this link to apply for pump assistance.
It is also an option to cash purchase pumps and supplies specifically from companies such as Omnipod and Medtronic if you have a prescription from your overseeing physician.
Is cortisol pumping safe?
Adrenal insufficiency requires adequate cortisol replacement in the form of steroid medications. With the cortisol pumping method, patients can bypass the gastric pathway and absorb their life-sustaining medication better. This treatment is revolutionary for hypermetabolizers and for those with gastro-intestinal problems or malabsorption issues.
The pump truly puts adrenal patients in control of their cortisol distribution in a way that steroid pills cannot. In situations of physical or emotional stress where “updosing” is needed, the pump can immediately administer a bolus, which is extra cortisol administered through the pump canula at the amount you select. Instead of having to wait for pills to metabolize, the cortisol can be absorbed faster and can help prevent adrenal crisis.
Cortisol pumping is not a cure for adrenal insufficiency and is not a treatment that is right for everyone. If you are well managed on steroid replacement pills, being on the pump method may not be necessary to achieve quality of life.
Do I still need an emergency injection on the pumping method?
An adrenal crisis is defined as a life- threatening, medical emergency caused by insufficient levels of the hormone, cortisol. It will lead to death if left untreated and must be quickly addressed with the administration of an emergency cortisol injection. The pump is not a replacement for acute adrenal crisis care. Adrenal patients should always carry an emergency injection and administer it immediately in the event of an adrenal crisis.
More information on cortisol pumping can be found on the cortisol pump advocacy tab on our website and also in the book A patient’s guide to managing adrenal insufficiency.
 CORTISOL PUMPING SURVEY
In-text: (adrenalalternatives.com, 2020) adrenalalternatives.com. (2020). Cortisol Pumping Survey. [online] Available at: https://docs.google.com/forms/d/1eWYZjIFP9HRJDosvdimJnOr8p54Rmpx_2A4Xz40f77A/edit#responses
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