IMF Revlimid Update: Where do we stand?

Revlimid Update: Where Do We Stand?
By Brian G.M. Durie, MD
2.21.06

Revlimid® (Lenalidomide) is an important new agent for the treatment of myeloma. It has shown great promise as both a single agent and in combination with dexamethasone and other drugs. With use of Revlimid there is much less risk of nerve toxicity than with thalidomide, which is one of the reasons patients have been eagerly awaiting access to it.

Celgene has opened the unique expanded access protocol (EAP) at over 80 centers across the United States. Through this program, patients with relapsing myeloma can have access to free Revlimid in a protocol that consists of Revlimid plus dexamethasone. To find out if there is an open trial site close to you, call the IMF at 800-452-CURE (2873) or Celgene at 888-423-5436 or www.revlimid.com.

For patients with newly diagnosed myeloma, Revlimid is available through two national trials involving ECOG (Eastern Cooperative Oncology Group) and SWOG (Southwest Oncology Group). A number of other trials are being planned and will be available in the coming months in various disease settings. Check the Myeloma Matrix and the Myeloma Minute for announcements as these trials open, or call the IMF hotline at the above number.

At the present time, access to commercially available Revlimid by prescription is more limited. The FDA has approved Revlimid for MDS, (Myelo Dysplastic Syndrome), a type of pre-leukemia. This means that use for myeloma patients is "off-label." For myeloma patients whose oncologists have recommended therapy with Revlimid, this presents problems. First, since Revlimid will probably not be approved specifically for myeloma until later in the year, it will not, generally speaking, be covered by insurance for myeloma patients. Second, and perhaps more importantly, the commercial Revlimid pricing is currently set for the much lower dose schedule used for MDS (5-10mg daily versus 25mg daily for myeloma), thus making the cost disproportionately and prohibitively high for myeloma patients at this time. With specific FDA approval for myeloma, there are indications that the pricing will be geared to the recommended myeloma dosing and schedule. This is a delicate point in that although myeloma patients need and want Revlimid right now, FDA approval is absolutely required to promote use for myeloma. The 25mg capsule that is provided free through EAP is not an appropriate dose for MDS. Thus the 25mg capsule is not currently available commercially! This complex scenario will be worked out in the coming months.

Many drug formularies of insurance companies offering Medicare Part D drug coverage currently do include Revlimid for MDS. Thus if you have not done so already, it is recommended that myeloma patients do some research and sign up for an insurance plan under Medicare Part D prior to the May 15^th 2006 deadline in anticipation of reimbursement for Revlimid through this mechanism. Many pharmacies, including Walgreens, will help you determine which insurers in your region include the drugs you need in their coverage formularies.

Stay tuned for future updates.

Source: http://myeloma.org/main.jsp?source=link&source_link_id=2081&type=article&tab_id=1&menu_id=0&id=1724