The National Comprehensive Cancer Network has updated its prostate cancer management guidelines to give a category 1 recommendation for clinical use of sipuleucel-T (Provenge) in the treatment of selected patients. Specifically, the NCCN states that sipuleucel-T 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.
A 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 patient 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.
An article in The Pink Sheet this week provides a detailed report on the implications of this recommendation for coverage of sipuleucel-T by payers in the US.
There has been a good deal of discussion about the price of Provenge, and the article (which is available free to subscribers on the OncologySTAT web site) goes through the differing points of view about the pricing in detail. The bottom line for the time being is that insurance companies and Medicare will be paying for sipuleucel-T based on the combination of FDA approval and this strong recommendation from the NCCN.
Whether payers in other countries will be willing to accept the current pricing of sipuleucel-T as and when it is approved for use (for example) in Europe or Australia is a more difficult question to answer. In the UK, however, it seems highly unlikely that that the National Institute for Health and Clinical Excellence (NICE) would be willing to accept the pricing model used to justify the US price of sipuleucel-T, based on the way that NICE has been assessing the cost-effectiveness of other drugs for late-stage cancers.