Mannstadt Lab

September 11, 2019

Here is a letter I sent to insurance companies (your doctor should edit it to reflect your situation):

To Whom It May Concern:

xxxx has chronic hypoparathyroidism, a disease of low parathyroid hormone (PTH) that leads to low calcium (hypocalcemia) and other abnormalities.  Hypocalcemia can lead to mild symptoms or to severe symptoms requiring hospitalization and i.v. calcium. 

Xxxx;s hypoparathyroidism was not well controlled on oral calcium and calcitriol.  She was, therefore, started on PTH replacement therapy with Natpara several years ago.  Treatment with Natpara (PTH[1-84]) has been very successful, and the patient has had significantly fewer episodes of hypocalcemia.  She is on 50 mcg Natpara daily.

Takeda, the sole producer of Natpara, (temporarily) recalled Natpara from the US market on September 6th, 2019, and xxxx will run out of Natpara soon.

This leaves xxxx in a potentially dangerous situation: when Natpara is suddenly discontinued, some patients might develop a transient increase in pre-Natpara calcium and calcitriol requirements.  That might lead to profound hypocalcemia with tetany requiring Emergency Room treatment.

But, there is an alternative. Forteo (teriparatide) is also an injectable form of PTH, PTH(1-34), and has been successfully used in clinical trials at the NIH for hypoparathyroidism.  Forteo is approved for osteoporosis, but for not hypoparathyroidism in the US.

To avoid the complication of hypocalcemia, I want to start xxxx on Forteo 20 mcg daily sc as soon as possible so that she does not have a gap in her PTH treatment.

Please approve Forteo on a compassionate use basis for this patient.

Let me know if you have any questions.


zzzz, MD