The National Comprehensive Cancer Network (NCCN), a private organization which develops what has become the standard of care guidelines for clinical practice in oncology, has modified their guidelines to included sipuleucel-T (Provenge) as a part of its prostate cancer management guidelines. The guidelines specify Provenge as a category 1 treatment which is appropriate as salvage treatment for patients with castration-resistant prostate cancer who have minimally symptomatic disease, an ECOG performance score of 0 or 1, and a life expectancy of at least 6 months.
Aa category 1 recommendation means that, “The recommendation is based on high level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus” about the recommendation. An ECOG performance score of 0 or 1 means that the man must be either fully active and able to carry on all pre-disease performance without restriction or is restricted only in physically strenuous activity, but is ambulatory and able to carry out work of a light or sedentary nature.
My hope is this update to the NCCN guidelines will put more pressure on private insurance carriers to agree to pay for Provenge. Provenge is now both an approved treatment modality and it is a part of the clinical practice guidelines that set the standard of oncology care. I have not yet heard of any specific feedback about private company’s willingness to pay for the treatment, so I ask that anyone who has started the process of trying to get Provenge to share their experience, both positive and negative.
Medicaid is required by statute to make payments for any FDA approved drug; however, this requirement to make payment is limited by the specific wording of the FDA approval. The wording for the approval of Provenge is specifically for men with castrate resistant, metastatic and asymptomatic disease.
Joel T Nowak, MA, MSW