As of January 1, 2015 there will be some significant changes in the billing and reimbursement schedule for men receiving Bayer healthcare’s radium Ra223 dichloride (Xofigo). Xofigo is FDA approved for the treatment of men with castration-resistant metastatic prostate cancer (mCRPC) who have symptomatic bone metastases and no known visceral metastatic disease. These changes result from the following determinations from the Centers for Medicare & Medicaid Services (CMS).
• CMS has assigned a new permanent Healthcare Common Procedure Coding System (HCPCS) code to Xofigo. This code, A9606 (Radium ra-233 dichloride, therapeutic, per microcurie) will become effective this January 1, 2015. The code is mandated by CMS and is specifically designed to facilitate automated billing and reimbursement by the doctors and hospitals.
• Prior to the assignment of this code Xofigo was purchased and reimbursed at a flat patient ready dose (PRD), which meant that all patients paid the same no matter how much drug they received (Xofigo doses are calculated based upon a patients weight with heavier patients requiring more drug). Under the new CMS-mandated microcurie A-code, A9606, providers will have to purchase Xofigo and bill payers (insurance companies and patients without insurance) based on the number of microcuries administered (the amount of drug) to each patient, rather than per patient ready dose.
Bayer has indicated that for the average man the cost will not change. For men who are smaller their actual cost will decline and for heavier men their cost will increase.
Bayer has assured Malecare that it is committed to supporting patient access to Xofigo through its support programs for eligible uninsured and underinsured men. It also will continue its program to assist qualified men in meeting their co-insurance obligations.
If you need financial assistance in paying for Xofigo now or after January 1, 2015 you should contact Xofigo Access Services at 1-855-696-3446.
Joel T. Nowak, M.A., M.S.W.
Doctors are not trained to communicate with patients. Now, with the onset of electronic medical records this problem has become worse. Many of them hardly even look their patient in the eyes; instead their faces are often buried in the computer screen and not on us.
Since they don’t really know us, they stumble around, often awkwardly, unable to give us the difficult information we need to know and then run out of the examining room. Not knowing who we are means that they can not help us make decisions, they can not support us in our tough often life and death decisions about what drugs, treatments and settings we want to use in our fight. To often they don’t know what we want and what is important to us, especially as we approach the end of our life.
Many doctors struggle to tell us we have some serious disease, like advanced prostate cancer. They are also uncomfortable and simply terrible at talking to us about our death, which simply is the ultimate result of life.
A good doctor gets to know and understand the thoughts, desires and life concerns of their patients. As hard as this might be there are some simple ways that would help a doctor overcome their barriers, their fears and let them get to know their patients.
Good doctor to patient communication can be very successful with a doctor asking four simple questions and then allowing the conversation to go as it develops:
1- What is your understanding of your health or condition?
2- What would be your goals if your health worsens?
3- What are your fears?
4- What are the trade-offs you would be willing to make and not willing to make?
Repeating these questions, actually conversations, again and again will, over time allow your or doctors to really get to know our wishes and desires. Each interview will yield different answers because the answers to these questions will change for us as our needs change, our concerns change and our disease progresses. These conversations will allow a doctor to get to know how you think and what is important to you. Knowledge like this will allow a doctor to respect and support you and your priorities.
Joel T. Nowak, M.A., M.S.W.
On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated.
Europe now joins the United States in allowing Xtandi to be given to men who have not yet had chemotherapy.
The rationales for this amendment are derived from the pivotal phase III PREVAIL study that demonstrated that Xtandi improved outcomes for men with advanced prostate cancer who have not received chemotherapy. These findings were:
• significantly reduced the risk of radiographic progression or death by 81% compared with placebo.
• Enzalutamide demonstrated a significant impact on overall survival compared to placebo.
• Men treated with enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared to placebo.
“Enzalutamide provides a viable treatment option for a broad population of men with mCRPC, regardless of age, or their readiness for chemotherapy, which provides a meaningful period of time during which men have their disease controlled without the need for chemotherapy”, said Professor Bertrand Tombal, MD, PhD, Chairman of the Division of Urology and Professor of Physiology, Université Catholique de Louvain (UCL) and European Principal Investigator for PREVAIL. “The decision from the European Commission to approve enzalutamide, an effective and well tolerated alternative to chemotherapy, is a very important milestone for men with prostate cancer that has advanced.”
Astellas has indicated that they intend to launch Xtandi in the chemotherapy-naïve setting in the first European countries, including the UK beginning December 2014.
Joel T. Nowak, M.A., M.S.W.