Interventional Therapy

With the growing use of Intrathecal (IT) therapy in treating severe chronic pain patients, issues associated with reimbursement arise. This article illustrates an excellent reimbursement model utilizing Ziconotide, a powerful non-opioid analgesic for chronic pain that is administered in combination IT therapy.

—Lynn Webster, MD, FACPM, FASAM
Interventional Therapy Department Head

William Stuart, RPh,(left) and Keri L. Fakata, PharmD (right)

Intrathecal (IT) therapy for the treatment of chronic severe pain is growing in terms of the number of medications that are being utilized and currently under research. Ziconotide (Prialt)—a synthetic conopeptide drug isolated from a marine cone snail—is a non-opioid IT therapy that received FDA approval for the treatment of chronic severe pain at the end of 2005 (see subsequent section for indications). Ziconotide has been a catalyst in IT therapy. The Polyanalgesic Consensus Panel 2007 just recently met and produced a new algorithm that will be published later this year.¹ This new algorithm recommends ziconotide monotherapy as a first-line therapy. Opioids such as hydromorphone and morphine are also first-line therapy recommendations. The panel also made recommendations for ziconotide use in combination therapy for second- and third-line therapies. Although this is an area of great growth and promise in the treatment of chronic severe pain, reimbursement remains a challenge and concern for many physicians. This article discusses some issues surrounding reimbursement related to IT pump medications and will suggest ways to maximize reimbursement when utilizing ziconotide in combination therapy.

Reimbursement Scenarios
Reimbursement for IT drugs administered through implantable pumps varies depending on insurance providers. Federal and private healthcare insurance providers cover IT therapy for the management of pain and spasticity. Per the Medicare Modernization Act of 2003, the Department of Health & Human Services’ Centers for Medicare & Medicaid Services (CMS) should reimburse drugs administered via implanted durable medical equipment at 95% of the drugs’ average wholesale price (AWP) listed on Oct. 1, 2003, or the first published AWP price for those drugs approved after Oct. 1, 2003. However, some Medicare Part B carriers have chosen to reimburse these drugs at average sales price (ASP) + 6%. Since the Medicare Modernization Act in October 2003, most injectable drugs are now reimbursed using the ASP + 6 % method. The ASP price is determined by the manufacturer and is reported to the CMS. Private and industrial insurance healthcare providers usually reimburse for services based on CMS guidelines or previously established coverage policies.

The exact determination of AWP by CMS standards is not very clear; current policy bases AWP on prices published in the 2003 Redbook