SOUTH CAROLINA ONCOLOGY SOCIETY A Chapter Member of the Association of Community Cancer Centers and An Affiliate of the American Society of Clinical Oncology www.SCOSONLINE.com

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BOARD OF DIRECTORS Darren E. Mullins, MD President James D. Bearden, III, MD President-Elect G. Tripp Jones, MD Secretary/Treasurer Robert E. Smith, Jr., MD Immediate Past-President MEMBERS AT LARGE Elizabeth Christian, MD Rudolph Wise, MD MEDICARE CARRIER ADVISORY COMMITTEE REPRESENTATIVE Charles E. Bowers, MD

REIMBURSEMENT QUESTIONS Go to www.scosonline.com for answers to all your reimbursement and coding questions.

Please contact Shawna Belcher in the Executive Office at 614-8485404 if your company would like to support the work of the Society.

What Does That Acronym Mean? By Mary Lou Bowers, Senior Director, State Society Services Association of Community Cancer Centers With all the changes in drug payment, it is almost impossible to keep up. So I thought a few definitions from the ELM Services group might be helpful as you’re wading through ASP, WAC, MAC, The Big Four et al. 340B Price: The maximum price that manufacturers can charge covered entities participating in the Public Health Service’s 340B drug discount program. The 340B discount is calculated using the Medicaid rebate formula and is deducted from the manufacturer’s selling price rather than paid as a rebate. Compared to a drug’s AMP, covered entities receive a minimum discount of 15.1% for brand name drugs and 11% for generic and over-the-counter drugs and are entitled to an additional discount if the price of the drug has increased faster than the rate of inflation. Covered entities are free to negotiate discounts that are lower than the maximum allowable statutory price. Average Sales Price (ASP): A new system created by federal and state government prosecutors in settlements with pharmaceutical manufacturers TAP and Bayer to ensure more accurate price reporting. ASP is the weighted average of all non-federal sales to wholesalers and is net of charge backs, discounts, rebates, and other benefits tied to the purchase of the drug product, whether it is paid to the wholesaler or the retailer. Big 4: The four largest purchasers of pharmaceuticals within the federal government: Department of Veterans Affairs, Department of Defense, Public Health Service, and Coast Guard. These four federal agencies have the right to purchase their pharmaceuticals from the federal supply schedule like every other federal agency. However, the Big 4 often get pricing below FSS on brand name drugs because these drugs are subject to a maximum statutory price called the federal ceiling price. Average Manufacturer Price (AMP): The average price paid to a manufacturer by wholesalers for drugs distributed to retail pharmacies. AMP was a benchmark created by Congress in 1990 in calculating Medicaid rebates and is not publicly available. FSS and 340B prices, as well as prices associated with direct sales to HMOs and hospitals, are excluded from AMP under the rebate program. The Congressional Budget Office estimates AMP to be about 20 percent less than AWP for more than 200 drug products frequently purchased by Medicaid recipients. Federal Ceiling Price (FCP): The maximum price manufacturers can charge for FSS-listed brand name drugs to the Big 4 — VA, DOD, PHS, and the Coast Guard — even if the FSS price is higher. FCP must be at least 24 percent below the non-federal average manufacturer price. FCP prices are not publicly available. Federal Supply Schedule (FSS): The collection of multiple award contracts used by federal agencies, U.S. territories, Indian tribes and other specified entities to purchase supplies and services from outside vendors. FSS prices for the pharmaceutical schedule are negotiated by the VA and are based on the prices that manufacturers charge their “most-favored” non-federal customers under comparable terms and conditions. Because

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SCOS MEMBERSHIP There are 115 SCOS members.

2004 SPONSORS The society gratefully acknowledges the following companies who have contributed to the advancement of our society. We would like to recognize and thank them for their help and support.

CORPORATE SPONSORS Silver Bristol-Myers Squibb Corporate Members Amgen Aventis Biogen IDEC Genentech GlaxoSmithKline International Oncology Network (ION) Millennium Pharmaceuticals Novartis Ortho Biotech Pfizer Roche Laboratories Sanofi-Synthelabo MEETING SPONSORS Platinum Amgen Aventis Bristol-Myers Squibb Genentech Millennium Pharmaceuticals Gold MGI Pharma Oncology Supply Silver Biogen IDEC Novartis Roche Laboratories Celgene Bronze AstraZeneca Lilly Oncology

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terms and conditions can vary by drug and vendor, the most-favored customer price may not be the lowest price in the market. FSS prices are publicly available. Preferred Drug List: A list of drugs designated as “preferred” by private insurers, health plans or public programs if a manufacturer agrees to make the drug available at a lower price than other drugs that are considered therapeutic alternatives. Health plan enrollees may pay lower cost-sharing amounts for preferred drugs, pharmacists may be encouraged to dispense the preferred drug through higher reimbursement amounts and prescribers are required to receive prior authorization before prescribing a drug that is not on the preferred list. 340B Prime Vendor Program: The 340B law requires HHS to create a “prime vendor” program for the entities in the 340B drug discount program. The prime vendor is supposed to handle price negotiation and drug distribution responsibilities for those entities that choose to join the prime vendor. A covered entity does not have to join the prime vendor program in order to participate in the 340B program although the government encourages entities to join. The Office of Pharmacy Affairs has selected AmerisourceBergen to be the 340B prime vendor. OPA is hopeful that since the prime vendor has the potential to control a large volume of pharmaceuticals, it can negotiate favorable prices and develop a national distribution system that would not be possible for covered entities to obtain individually. VA National Contract Price: The price VA has obtained though competitive bids from manufacturers for select drugs in exchange for their inclusion on the VA formulary. Because the VA is entitled to FCP prices under federal statute, VA national contract prices are even lower than FCP prices and are often the lowest prices in the nation. These prices are publicly available. Wholesale Acquisition Cost (WAC): The price paid by a wholesaler for drugs purchased from the wholesaler’s supplier, typically the manufacturer of the drug. On financial statements, the total of these amounts equals the wholesaler’s cost of goods sold. Publicly disclosed or listed WAC amounts may not reflect all available discounts. Now you know why understanding drug pricing will make you crazy!!

Upcoming Events San Antonio Breast Cancer Review February 5, 2005 The Charleston Place Hotel, Charleston, SC 8:30 am – 2:30 pm 2005 Spring Membership Meeting held in conjunction the SCMA annual meeting April 22, 2005 Hilton Head Marriott Golf and Beach Resort, Hilton Head, SC 11:00 am – 4:45 pm Dinner Program – 6:00 pm – 8:00 pm Location - TBD

New J Codes CMS has published the HCPCS Update Code set for 2005 and has assigned J9055 as the new J code to Erbitux (cetuximab) for Injection. The billing unit will be 10 mg. This new J code is available for billing purposes January 3, 2005. As of January 1, 2005, the Avastin (bevacizumab) J code is J9035 per 10 mg. There will be no C Code overlap when J9035 becomes effective. C9214 and J9999 will not be accepted after December 31, 2004. Beginning January 1, 2005, Aloxi’s new J code is J2469 (25mcg).

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Legislative and Regulatory Round-up By Deborah Walter, Senior Director, Policy and Government Affairs Association of Community Cancer Centers 2005 OPPS Rule: What Your Hospital Should Know On November 2, 2004, the Centers for Medicare & Medicaid Services (CMS) released the 2005 hospital outpatient department prospective payment system (OPPS) final rule. The final rule provides for a 3.3 percent inflation update in payment rates for outpatient services. The inflation update—together with payment increases for certain “preventive services,” such as breast and colorectal exams, and revised payment for drugs and biologicals—will increase projected Medicare payments to hospitals for outpatient services to $24.6 billion compared to projected payments of $23.1 billion in 2004. With the final rule just released, ACCC is already thinking about 2006 when more changes to the hospital reimbursement system are due to take effect. CMS released its third-quarter average sales price (ASP) pricing data on December 17, 2004 and ACCC has asked hospitals to assess how the published prices compare with prices hospitals actually pay to acquire these drugs. We encourage hospitals to provide this information to ACCC [email protected] as expeditiously as possible to better access whether hospitals will be able to purchase the necessary treatments for their patients under ASP. Here are highlights of how the final OPPS rule will affect cancer care. Drugs, Biologicals, and Radiopharmaceuticals. In 2005 reimbursement for many of the anticancer drugs commonly used in the hospital outpatient setting declines 6 to 9 percent*. For the most part, this reduction was expected and can be attributed to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), which mandated that the payment floor for the average wholesale price (AWP) for single-source drugs drop from 88 percent of AWP in 2004 to 83 percent in 2005. *A table outlining this change can be found on the ACCC website www.accc-cancer.org in the OPPS Final Rule feature article. Except for radiopharmaceuticals, payment rates for existing drugs with continuing pass-through status in CY 2005 will be based on ASP +6 percent. Should these data not be available, CMS states it will use the product’s wholesale acquisition cost (WAC) or 95 percent of AWP (or first reported AWP to set the payment rate). In a change to existing policy, radiopharmaceuticals are to be considered “drugs” beginning in 2005. With this change, radiopharmaceuticals are subject to payment floors and ceilings, exclusion from outlier payments, and application of the $50 packaging threshold. If a new radiopharmaceutical that is assigned a payment code on or after Jan. 1, 2005, were approved for pass-through status, payment will be established at 83 percent of AWP. Regarding Zevalin® and Bexxar®, CMS determined these therapies are SCODs that are required to be paid 83% of their AWP. The agency notes that to the extent that if hospitals incur additional compounding costs for the radiolabeled monoclonal antibodies, these costs could be reported as a separate line item charge that could result in an outlier payment. In 2005 drugs, biologicals, and radiopharmaceuticals with median costs more than $50 per day will continue to receive separate payments. Payments for drugs, biologicals, and radiopharmaceuticals without pass-through status and whose median cost is less than the $50 threshold will continue to be bundled (or “packaged”) into the procedures with which they are billed—with one important exception. Injectable and oral forms of antiemetics that prevent nausea and vomiting will be paid separately in 2005, regardless of whether the drug exceeds the $50 threshold. Drug Administration Payments. Payments for drug administration will increase in 2005**. CMS is beginning a two-year data collection project to set drug administration payment rates for 2007 and beyond. Hospitals will continue to be paid according to existing APCs, but in 2005 CMS requires hospitals to report the associated current procedural terminology (CPT) codes for each procedure (see Table 2). For example, the first hour of chemotherapy would be billed using a CPT code (96410), and reimbursement will be the equivalent of the existing APC payment. If applicable, the hospital would then bill a second hour of chemotherapy (96412) for data collection purposes only. Hospitals will not be paid for this additional code. Still, hospitals must take care to code correctly for drug administration services they provide to ensure that CMS has accurate data when it calculates 2007 drug administration payments. **A table showing this increase can be found on the ACCC website www.accc-cancer.org in the OPPS Final Rule feature article. Preventive Services. The final rule implements provisions required by MMA for preventive services in hospital outpatient departments. These include the “Welcome to Medicare Physical” for new beneficiaries, which will provide baseline information to the physician on the patient’s health status, allow for early detection and treatment of diseases, and provide an opportunity to refer the patient to other Medicare-covered services. When this examination is provided in an outpatient department, Medicare will pay the hospital approximately

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$78 for the use of the facility. The fee does not include payment for the physician’s professional services, which will be separately paid under the Medicare Physician Fee Schedule (MPFS). Resulting from a provision of the MMA, diagnostic mammograms are removed from payment under the OPPS and paid, like screening mammograms, under the MPFS. As such, compared to 2004, in 2005 payments for traditional diagnostic mammograms will increase by nearly 19% for a unilateral exam and nearly 48% for a bilateral exam. Similarly, payments for digital diagnostic mammograms are expected to increase under the MPFS by about 60% for a unilateral exam and nearly 98 percent for a bilateral exam. Radiation Oncology in 2005 Reimbursement within radiation oncology will increase in a number of areas:

• • •

Most technical charges will increase between 5 to 9 percent. Overall reimbursement for intensity-modulated radiation therapy (IMRT) will increase by about 4 percent. Reimbursement for IMRT planning, however, decreases. Overall reimbursement for external beam radiation therapy will increase by about 6 percent. (CPT 77295, 3-D simulation, increases by 8 percent.) New linear source Palladium-103 is eligible for separate cost-based reimbursement as a Brach therapy source. The agency created two codes for high activity brachytherapy sources.

On the down side, reimbursement for brachytherapy isodose planning (CPT 77326) and radiation physics consultation (CPT 77370) are each reduced 51 percent from $200.60 in 2004 to $97.48 in 2005. In 2005 CMS intends to compensate providers for the “acquisition costs of seeds.” All brachytherapy sources will be paid based on the hospital’s charge for each device adjusted to cost. In other words, hospitals must use the contract price they pay for the seeds and then mark up the charge using the hospital’s departmental cost-to-charge (CCR) ratio. Remember to use the CCR from the department supplying the seeds and make sure it is taken from the latest settled cost report filed with Medicare. Do not use the most recent CCR or the hospital’s CCR because Medicare requires hospitals to use the relevant department’s CCR. 2005 OPPS at a Glance • “New” drugs (C9399) paid at 95 percent of AWP until a payment code is assigned • Sole-source drugs and radiopharmaceuticals paid at 83 percent of AWP • Innovator multiple-source drugs will be paid no more than 68 percent of AWP • Generic drugs paid at no more than 46 percent of AWP • Orphan drugs paid at 88 percent of AWP or 106 percent of ASP. Payment rates will be based on a quarterly comparison of the most recent available ASP and AWP • Drugs with continuing pass-through status will be paid at a rate equivalent to ASP +6 percent • Antiemetics that prevent nausea and vomiting are excluded from the $50 bundling threshold • Chemo administration (Q0081, Q0083, and Q0084) uses new crosswalks to CPT Codes

Welcome New Members William S. Buice, M.D. Piedmont Surgical Associates, P.A. Anderson

George P. Keogh, M.D. Medical Associates, P.S. Charleston

Bhanu Visvalingam, M.D. Coastal Cancer Center Myrtle Beach

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Office-based Oncology Reimbursement in 2005 By Marci Cali, Managing Director, State Society Services Association of Community Cancer Centers On November 1, 2004 CMS released the final physician fee schedule for 2005. We are continuing to assess the impact on the oncology community, which is proving significant for practices that administer chemotherapy in the office setting. Although practices differ in their financial structure and how they are reviewing the available data, it is possible that some practices could lose hundreds of thousands of dollars in revenue as a result of the Law’s proposed cuts; and because reimbursement cuts do not decrease any expenses, practices cannot operate when costs exceed revenue. Medical oncologists may have been spared a considerable loss of their revenue by last minute changes to coding and an unexpected demonstration project to address patient quality of care issues. On January 1, 2005, the Centers for Medicare and Medicaid Services (CMS) will implement coding changes and payment revisions to drug administration by refining some existing codes and adding several new drug administration codes. The purpose of these changes is to compensate more appropriately for the cost of services provided by physicians and their staff in conjunction with drug administration. And, we are optimistic that these new codes will give practices better opportunities to charge for services they are performing. Temporary G-codes will be in effect in 2005 until new CPT codes can be published in the 2006 code books. The codes reflect differences between initial and subsequent drug administration, and single and multiple administration during the same encounter. Overall, payments should increase for drug administration services; however the net effect will be lower than payments in 2004 because the transitional payment is reduced from 32% to 3%. The following chart shows Medicare’s new and revised G-codes with the description of the service in 2005, and compares the payment amounts of the national averages for services provided in the office setting in 2004 and 2005. 2005 Medicare Code/ 2004 Medicare Code G0345/90780 G0346/90781 G0347/90780 G0348/90781 G0349/90781 G0351/90782 N/A/90783 G0353/90784 G0354/N/A G0355/96400 G0356/96400 G0357/96408 G0358/96408 G0359/96410 G0360/96412 G0361/96414 G0362/96412 G0363/N/A 96520/96520 96530/96530

2005 Description

2005 Payment Rate

Initial hr. IV hydration $64.80 Hydration each additional hr. up to (8) hrs. $20.69 Initial hr. IV infusion for therapy/diagnosis $79.24 IV infusion for therapy/diagnosis each additional hr. $26.54 Additional, sequential infusion for therapy/diagnosis $43.72 Therapeutic or diagnostic injection $19.13 Injection, intra-arterial $19.52 IVP, single or initial substance or drug $58.95 Additional, sequential IVP $27.72 Chemotherapy, SC or IM, non-hormonal agent $53.09 Chemotherapy, SC or IM hormonal agent $36.69 Chemotherapy IVP, single or initial substance or drug $125.69 Chemotherapy IVP each additional substance or drug $73.00 Chemotherapy IV infusion initial hr., single or initial substance or drug $177.60 Chemotherapy infusion each additional hr. up to (8) hrs. $40.20 Initiation of prolonged chemotherapy infusion $190.88 Chemotherapy, each additional sequential infusion up to 1 hr. $86.65 Irrigation of implanted venous access device for drug delivery systems $28.88 Refilling and maintenance of portable pump $157.31 Refilling and maintenance of implantable pump $113.59

2004 Payment Rate $117.79 $33.02 $117.79 $33.02 N/A $24.64 $25.14 $49.78 N/A $64.07 $64.07 $154.76 $154.76 $217.35 $48.30 $269.59 N/A N/A $205.52 $152.29

The chart above can also be used to estimate the financial impact of the changes on each practice by replacing the 2005 national average dollar amounts column with the 2005 payment rates for a particular state or geographic location from Attachment B of the physician fee schedule, and entering the current 2004 payment rates for the practice in the 2004 payment rates column. Multiplying the payment rates times the volume of services performed by the practice will give an indication of the total revenue for these particular services. This process can be expanded to include other services that generate revenue in the office setting.

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Additionally, payment rates for 2006 can be found in Attachment E of the physician fee schedule and should help project the impact of the changes through another year. On Election Day in November, CMS announced a one-year demonstration project during 2005 that will pay physicians an additional $130 per patient per day in conjunction with billing for the patient’s chemotherapy encounter. The requirement for participating in the demonstration is that oncologists must provide G-codes that assess a chemotherapy patient’s status with respect to pain (G9025 – G9028), nausea and vomiting (G9021 – G9024), and fatigue (G9029 – G9032). By reporting data on the assessment levels for each of the patient status factors, the practitioner self-enrolls in the project. The assessment levels are based on the Rotterdam scale already in effect in cancer care. Note that physician’s whose patients receive infusion at hospitals will not be eligible to participate in the demonstration project. While physicians will notice an increase in payment for chemotherapy administration services, reimbursement for drugs will decrease. Contributing to the reimbursement landscape in 2005 is the new Average Sales Price (ASP)-based reimbursement system for determining Medicare payments for drugs. Drug reimbursement rates will be set at ASP plus 6 percent. CMS has reviewed first and second quarter ASP pricing data reported by pharmaceutical manufacturers. The agency will review third quarter ASP data and data submitted by the GAO in late October before they establish use of the ASP methodology for payment for drugs and biologicals. Third quarter ASP data were made available by CMS on December 17, 2004. At the time of press, no analysis was yet available on the potential impact on physician practices. Please see www.accc-cancer.org. Many oncologists are concerned about their ability to continue practicing. A chart outlining these changes can be found within the Summary of Key Issues in the 2005 Medicare Physician Fee Schedule Final Rule feature story. According to CMS, prices for chemotherapy and inhalation drugs remain within the price range identified by the General Accountability Office (GAO), and which GAO concluded would lead to sufficient provider reimbursement. Overall, the revenue impacts on particular types of providers are very similar to those reported in the Physician Payment Rule using second quarter data. For additional background on the recent Medicare Part B price changes, please see the GAO report “Medicare Chemotherapy Payments: New Drug and Administration Fees Are Closer to Providers’ Costs” available at www.gao.gov/docsearch/abstract.php?rptno=GAO-05-142R. See also www. accc-cancer.org for further information. As the physician rule begins to take shape, each practice should look at its office processes and possible ways to streamline the business in an effort to save costs. Practices will need to function at maximum efficiency if they are to remain viable. Without the margins that practices have become accustomed to, most will have to change their current collection policies; and it is likely that it will be financially necessary to hold each patient responsible for paying their 20 percent portion of the drug payment if there is no supplemental insurance to bill. Some practices have begun looking at adding non-clinical support services that work well in their communities with the intention of generating new revenue streams. Many practices are switching to less costly drugs and treatment protocols while others are modifying drug-purchasing practices. It will be necessary for practices to carefully track drug costs as well as costs for chemotherapy administration and ancillary services provided in the office setting. Above all, practices will need to capture every charge for which they can legitimately bill. Regularly, oncology practices should be reviewing payer contracts and focus on obtaining the most favorable drug prices possible going into a new contract year. Reimbursement rates will vary from payer to payer, but many mimic what Medicare does. It is important to review each contract carefully to determine if your practice is reasonably maximizing its revenue capture in relationship to what you are actually spending for drugs. The cancer community is now faced with many decision-making changes in adopting Medicare’s new codes, programs, and payment methodologies. It will be critical to collect data on a continual basis in order to fully analyze the impact of the new reimbursement models that are in place for 2005 and beyond.

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Drugs in the News •The FDA has granted accelerated approval for Alimta® (pemetrexed) (Eli Lilly, Indianapolis, Ind.) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in previously treated patients. In February 2004 Alimta was approved, in combination with cisplatin, for the treatment of malignant pleural mesothelioma, a cancer often associated with asbestos exposure. The FDA accelerated approval is based on Alimta’s activity and favorable safety profile as evidenced in one of the largest Phase III studies to date in the second-line setting that compared Alimta directly to Taxotere. In July, the study was the basis for a unanimous recommendation for accelerated approval by the FDA’s Oncologic Drugs Advisory Committee. •Wyeth Pharmaceuticals, a division of Wyeth (Madison, N.J.), has been granted FDA fast track designation for temsirolimus (CCI779), an investigational mTOR kinase inhibitor, in the first-line treatment of poor-prognosis patients with advanced renal cell carcinoma. •Roche (Nutley, N.J.) has submitted a supplemental New Drug Application (sNDA) with the FDA to market Xeloda® (capecitabine) for the treatment of colon cancer after surgery (adjuvant therapy). Xeloda is currently indicated as first-line treatment of patients with metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. •OSI Pharmaceuticals, Inc. and Genentech, Inc. have completed the submission of a New Drug Application (NDA) with the FDA for Tarceva™ (erlotinib HCI), as a monotherapy for the treatment of patients with advanced NSCLC for whom chemotherapy has failed. The NDA has been granted Pilot 1 status under the FDA’s Pilot 1 Program for Continuous Marketing Applications, a new program designed for investigational products that have been given fast track status and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition. The NDA filing is based on a pivotal Phase III doubleblind, placebo-controlled trial that included 732 patients and that compared Tarceva to placebo in the treatment of patients with relapsed NSCLC who had previously received chemotherapy. Tarceva demonstrated a 42 percent improvement in median survival and improved one-year survival by 45 percent. The study also demonstrated statistically significant improvement in all secondary endpoints of the trial including time to symptom deterioration, progression-free survival and rate response. The Food and Drug Administration (FDA) announced the approval of Tarceva (erlotinib) tablets as a single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Tarceva is being approved as a treatment for patients whose cancer has continued to progress despite other treatments, including at least one prior chemotherapy regimen. The drug will be manufactured by OSI Pharmaceuticals Inc., and distributed by Genentech Inc., of South San Francisco, Calif. •Provectus Pharmaceuticals, Inc. (Knoxville, Tenn.) has filed an Investigational New Drug (IND) application for Provecta™, an advanced drug therapy designed to treat breast, liver, prostate, and other potentially deadly cancers. If the FDA accepts the application, Provectus expects to begin enrolling patients in clinical trials beginning in early 2005. •Barr Pharmaceuticals, Inc. (Woodcliff Lake, N.J.) announced that Barr Laboratories, Inc. has received tentative FDA approval for its generic version of GlaxoSmithKline’s Zofran ODT® (ondansetron) Orally Disintegrating Tablets, 4mg and 8mg. The company anticipates receiving final approval and launching its generic product following the expiration of GlaxoSmithKline’s patent on June 24, 2006 or following any additional applicable exclusivity.

Approved Drugs •The Food and Drug Administration (FDA) has approved Taxotere® (docetaxel) injection concentrate (Aventis, Bridgewater, N.J.) in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable, node-positive breast cancer. The FDA based its decision on results from a second interim analysis from the pivotal Breast Cancer International Research Group 001/ TAX 316 study, which demonstrated that women with node-positive, early stage breast cancer who received Taxotere-based chemotherapy regimen after surgery experienced a significant 25.7 percent reduction in their risk of relapse as compared to women treated with another adjuvant combination regimen of 5-fluorouracil, doxorubicin, and cyclophosphamide. Notably, with nearly five years of follow-up, the significant reduction in the risk of relapse of this Taxotere-based regimen was observed regardless of a woman’s hormone receptor status. The FDA has also approved Taxotere® injection in combination with prednisone for the treatment of patients with advanced metastatic prostate cancer. The safety and effectiveness of Taxotere was established in a randomized, multi-center global clinical trial with over 1,000 patients comparing chemotherapy with Taxotere and prednisone to mitoxantrone and prednisone in men with metastatic, hormonerefractory prostate cancer. Taxotere, in combination with prednisone, given every three weeks showed a survival advantage of approximately 2.5 months over the control group in the trial. •The FDA has granted orphan drug status to AGRO100 (Aptamera, Inc., Louisville, Ky.) in the treatment of pancreatic cancer. AGRO100 is an anti-nucleolin aptamer. The FDA may award orphan drug designation to drugs that target conditions affecting 200,000 or fewer U.S. patients per year and provide a significant therapeutic advantage over existing treatments. •The FDA has awarded orphan drug status to Efaproxyn™ (efaproxiral) (Allos Therapeutics, Westminster, Colo.) for use as an adjunct to whole brain radiation therapy for the treatment of brain metastases in patients with breast cancer. Efaproxyn is currently being investigated in a Phase III clinical trial in this indication.

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•BioCryst Pharmaceuticals, Inc. (Birmingham, Ala.) has received FDA orphan drug designation for forodesine hydrocholoride [formerly known as BCX-1777 (forodesine)] in two additional cancer indications. Forodesine, a purine nucleoside phosphorylase inhibitor which functions by blocking the T-cell’s ability to synthesize DNA, was granted orphan status for treatment of T-cell non-Hodgkin’s lymphoma, including cutaneous T-cell lymphoma, in February 2004. The two additional indications are for treatment of chronic lymphocytic leukemia and related leukemias to include prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for treatment of acute lymphoblastic leukemia. The company is developing forodesine for treatment of T-cell mediated cancers, and a Phase II clinical trial in patients with T-cell leukemia is in progress. • HuMax-CD4 (Genmab A/S, Copenhagen, Denmark) has received FDA orphan drug designation for the treatment of mycosis fungoides, which constitutes 75 percent of all cutaneous T-cell lymphomas. •Seattle Genetics, Inc. (Bothell, Wash.) has been granted orphan drug status from the FDA for its product candidate SGN-40 for multiple myeloma. SGN-40 is a humanized monoclonal antibody that the company is currently evaluating in a Phase 1 clinical trial for the treatment of multiple myeloma. •The GLIADEL® Wafer (polifeprosan 20 carmustine implant) for brain cancer treatment, a product of Guilford Pharmaceuticals Inc. (Baltimore, Md.), has been assigned a new diagnosis related group (DRG) by the Centers for Medicare & Medicaid Services (CMS). DRG 543 Implantation of Chemotherapeutic Agents or Acute Complex Central Nervous System Principal Diagnosis took effect on October 1, 2004. The new DRG will increase payments to hospitals that provide the product to Medicare beneficiaries. GLIADEL ® Wafer is approved for use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation, and in patients with recurrent glioblastoma multiforme as an adjunct to surgery and radiation. In September 2004, GLIADEL® Wafer received orphan drug designation for the treatment of patients with malignant glioma undergoing primary surgical resection. Sanofi-Synthelabo, (Paris, France) a member of the sanofi-aventis Group announced November 5, 2004 that the US Food and Drug Administration (FDA) has approved ELOXATIN™, in combination with conventional chemotherapy (infusional 5- fluorouracil/leucovorin, known as 5-FU/LV), for the adjuvant (postsurgical) treatment of patients with stage III colon cancer who have undergone complete resection of the primary tumor.

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