By: MPN Research Foundation Vice President Felisse Sigurdson

Like many MPN patients, I decided to try Pegasys when myelosuppressive therapy was recommended to control my PV. The good news is that a very low dose of the drug has been nothing short of remarkable in controlling and reversing the progression of the disease.

However, like many MPN patients, I had to appeal to my insurance company in order to receive coverage for the off-label use of the drug. Thankfully, the appeal was successful. I am sharing my story to offer some guidance and encouragement to patients who need to pursue an appeal.

Not all insurance companies deny Pegasys even though it is prescribed off-label for PV. For the first 18 months, my insurance company covered Pegasys without any additional information other than the doctor’s prescription. Then my insurance company
was acquired by another company, and when the Pegasys script needed to be renewed, I received a denial letter for coverage on the grounds that it was not FDA approved for PV.

The denial letter from the new insurance company stated they cover medications for ‘off-label’ indications when the drug is approved by the FDA and proven safe and effective for treatment of the specific medical condition as evidenced by supporting documentation in the standard compendia OR as evidenced by supporting documentation in the form of results of controlled clinical studies published in
at least two peer-reviewed English language, biomedical journals.

I called the medical director who sent me the letter and explained that while Pegasys is not listed in any of the compendia for polycythemia Vera, there are many published articles discussing the safety and effectiveness of Pegasys for PV. He told me that my case would be stronger to the extent I provided published research of clinical trials conducted with a good number of patients rather than small studies with less than 10 patients or secondary reports.

I sent the insurance company three things:

  1. A summary of my personal experience pre- and post- Pegasys, including the efficacy of Pegasys in terms of hematological and clinical response. I provided a chart that compared HCT, WBC, Platelets, CD34, LDH, Spleen Size and JAK2 % pre-Pegasys, 6 months later, 12 months, 20 and 27 months later. The chart showed all blood counts under control and signs of disease progression reversed.
  2. A letter from my hematologist.
  3. Seven published articles from peer reviewed scientific journals. The first three were the important clinical studies from France and MD Anderson. The other articles were published by leading researchers in the field discussing the safety and efficacy of Pegasys in treating PV patients. The MPNRF website contains the complete list of articles to consider using for a Pegasys appeal. This list is updated as new articles are published.

As a result of this initial submission, I received notification that my reconsideration was approved for 6 months. At the end of 6 months, the insurance company requested clinical data from my hematologist showing continued stability on the drug. They renewed the prescription for another year.

In addition to the process I just completed, I am currently in discussion with the insurance company to update its coverage policy for Pegasys for all MPN patients. I realize that the process is not the same for all insurance companies, but perhaps sharing my story can reduce the stress of the appeals process and improve the outcome for some patients.

Take the steps you need to help change your prognosis.