The FDA finally approved the use of Cinacalcet for primary hyperparathyroidism. This is a relatively common condition in which one (or more) of the parathyroids become overactive and thus raising calcium levels. While most patients are asymptomatic, in severe cases, left untreated this may lead to premature osteoporosis, symptomatic hypercalcemia (the medstudents amongst you would know the phrase I'd bet: Bones, Stones ....) and kidney stones.
While the only curative treatment is surgery, most patients are mild enough that this can be safely monitored conservatively.
The problem is when patients clearly have indications for surgery, but yet they are poor surgical candidates. Minimally invasive parathyroidectomy is not a big deal, generally. Generally. But when you have an 80-year old who's had a 3 vessel bypass and still angina symptoms, then the rules change.
The many I struggle with are elderly patients with severe hypercalcemia and osteoporosis, but yet, because of underlying vascular or lung disease and their advanced age, places them at higher risk for surgery itself. And being a firm believer of Primum Non Nocere (First Do No Harm) I'm not too sure the treatment is worth the risk.
Fortunately, this is where Cinacalcet comes it. It's a calcimimetic which lowers PTH and hence calcium levels; it treats the problem pretty well.
Unfortunately, for the longest time this wasn't FDA approved (it's not an experimental drug- it's been used a long time by the nephrologists for secondary hyperparathyroidism here. Also been used for primary HPT in Europe for awhile). So until it received this indication for use, the insurance companies consider its use in my patients to be 'off label' and hence won't pay for the drug. When clearly, it's a drug that works, and is safer than surgery for some patients. They'd rather my 86 year old female patient undergo general anesthesia and surgery. I've had that argument with numerous 'medical directors' of the insurance companies before, and the answer is always the same: We won't pay for it.
You wonder if their primary interest is the patient's wellbeing.
Anyway, with this welcome indication for Cinacalcet, it should be a thing of the past. It's good to have an alternative to surgery when you have a high-risk patient.