The latest shot in the battle against drug costs comes from the Centers for Medicaid and Medicare Services, which is reported to be denying coverage for off-label use of drugs such as Actiq and Fentora.
Whenever CMS moves, the healthcare world shakes, and this is no exception. There are a host of possible ‘downstream implications’ in areas as diverse as workers comp, formulary management, and hospice.
According to the Archives of Internal Medicine, up to one-fifth of scripts are for off-label use of particular drugs – that is, a use for which the drug has not been approved by the FDA.
I’vce noted in the past the high level of off-label usage of Actiq in workers comp. The highly potent narcotic comes in lollypop form, and accounts for over $60 million in drug spend for workers comp. And Actiq is only FDA-approved for breakthru cancer pain. Nonetheless, it is often seen prescribed for treatment of chronic pain.
Studies indicate as much as 80% of Actiq usavge is off-label.
CMS’ policy has been in place for several months, but has likely not yet had any ‘trickle-down’ effect.
The impact of CMS decisions on the overall health insurance and reimbursement arena is pervasive. DRGs, coverage of experimental treatment, reimbursement for ASCs, and many other coverage decisions and determinations are often based in large part on CMS’ lead.
Whether the workers comp and group health worlds will follow CMS’ lead is, as yet, unclear. But at the least, it gives political cover for any decisions to deny off-label reimbursement.
Could you please give me any guidance with this one? My mother has terminal lung cancer and her insurance company, after having approved and paid for the actiq transmucousal pop for over a year has now began to deny her claim and prescription for it. She has stage 4 small-cell lung cancer, and uses it only for breakthrough pain(as manufactured and prescribed) and they are denying her and making her go through the appeals process when she barely has the energy to fight for comfort. Any suggestions? Have you ever heard of the insurance companies attempting to deny this medication to cancer patients? Thanks for your help on this.
I have been taking the generic Actiq (fentanyl citrate) for 18 months. My Medicare provider for Part D has just indicated that they will no longer cover this under my plan. They claim the issue is off-label use – it’s FDA approved for pain from cancer. I suffer from severe chronic pain but do not have cancer. The REAL issue is the cost – $3500/monthly for the GENERIC version of Actiq. Without this med, my blood pressure sky rockets & I’ve tried the other major pain meds on the market. We cannot allow these insurance companies to control our lives like this. Whomever decided to give the insurance company final word should also have to be subjected to their decisions. Our health care is now determined by not our health needs but by cost to a insurance company!!!