MEDICAL POLICY HIGH-DOSE CHEMOTHERAPY WITH OR WITHOUT AUTOLOGOUS STEM CELL RESCUE FOR AUTOIMMUNE DISEASES, INCLUDING MULTIPLE SCLEROSIS MP-9.

Transcription

1 Original Issue Date (Created): August 23, 2002 Most Recent Review Date (Revised): Effective Date: June 17, 2008 July 1, RETIRED I. DESCRIPTION/BACKGROUND High dose chemotherapy (HDC) involves the administration of cytotoxic agents using doses several times greater than the standard therapeutic dose. The side effect of marrow ablation requires a reinfusion of stem cells to repopulate the bone marrow. There are two sources of autologous stem cells: Autologous bone marrow cells, including stem cells, can be harvested from the patient s own bone marrow prior to the cytotoxic therapy. Peripheral autologous stem cells circulate in the peripheral blood and can be harvested via a pheresis procedure. A prior course of chemotherapy or growth factors, or both, can increase the number of circulating stem cells. Peripheral stem cells are now the most common source of stem cells used. Autoimmune Diseases More than forty (40) disorders are recognized as having an autoimmune pathogenesis, ranging from some cases of insulin dependent diabetes mellitus to rheumatoid arthritis and other connective tissue diseases to multiple sclerosis. Immune suppression is a common treatment strategy for many of these diseases, particularly the rheumatic diseases (i.e., rheumatoid arthritis, systemic lupus erythematosus [SLE], and scleroderma). In a subset of patients who do not respond or cannot tolerate long-term immunosuppression, high-dose chemotherapy with autologous stem-cell support has been investigated as a curative technique. The rationale is based on the premise that autoimmune diseases are the manifestation of a clonal proliferation of pathogenic lymphocytes, which can be eliminated through marrow ablation. The autoimmune diseases that have been most commonly treated with high-dose chemotherapy and autologous stem-cell support include rheumatoid arthritis, scleroderma, SLE, and multiple sclerosis. Page 1

2 II. DEFINITIONS ALLOGENEIC refers to having a different genetic constitution but belonging to the same species, i.e., involves a donor and a recipient. AUTOLOGOUS refers to originating within an individual, i.e., self-donation. CYTOTOXIC AGENT is any pharmacologic compound that inhibits the proliferation of cells within the body. LYMPHOCYTE is a white blood cell responsible for much of the body's immune protection. PHERESIS refers to the removal of blood or other body fluids from a patient, separating certain elements (e.g., immunogloblulins, platelets, or red blood cells) and reinfusing the remaining elements into the patient. III. POLICY High-dose chemotherapy and autologous or allogeneic stem-cell support for treatment of autoimmune diseases is considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with treatment of autoimmune diseases, including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus (SLE), systemic sclerosis (i.e., scleroderma), and multiple sclerosis. IV. EXCLUSIONS N/A V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a Page 2

3 discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VII. REFERENCES BCBSA 2000 TEC Assessment: High dose Lymphoablative Therapy with or without Autologous Stem Cell Rescue for Treatment of Severe Autoimmune Diseases, Tab 1. BCBSA 2001 TEC Assessment: High Dose Lymphoablative Therapy with or without Stem Cell Rescue for Treatment of Severe Autoimmune Disease, Tab 14. Burt RK, Traynor A, Statkute L, et al. Nonmyeloablative hematopoietic stem cell transplantation for systemic lupus erythematosus. JAMA 2006; 295(5): Burt RK. BMT for severe autoimmune diseases: an idea whose time has come. Oncology (Williston Park) 1997; 11(7): Burt RK, Traynor AE, Pope R, et al. Treatment of autoimmune disease by intense immunosuppressive conditioning and autologous hematopoietic stem cell transplantation. Blood 1998; 92(10): Burt RK, Marmont A, Oyama Y, et al. Randomized controlled trials of autologous hematopoietic stem cell transplantation for autoimmune diseases: the evolution from myeloablative to lymphoablative transplant regimens. Arthritis Rheum 2006; 54(12): ECRI Custom Hotline Response. High-dose Chemotherapy (HDC) with Stem Cell Transplantation (SCT) for Multiple Sclerosis. 9/2005. ECRI Custom Hotline Response. High-Dose Chemotherapy and Stem Cell Transplantation for the Treatment of Systemic Lupus Erythematosus. 10/2005. Illei GG. Hematopoietic stem cell transplantation in autoimmune diseases: is the glass half full of half empty? Arthritis Rheum 2006; 54(12): Jantunen E, Luosujarvi R. Stem cell transplantation in autoimmune diseases: an update. Ann Med. 2005; 37(7): Machold KP, Smolen JS. Stem cell transplantation: limits and hopes. Ann Rheum Dis. 2001; 60(6): Marmont AM, Van Bekkum DW. Stem cell transplantation for severe autoimmune diseases: new proposals but still unanswered questions. Bone Marrow Transplant 1995; 16(4): Martin R. Is haematopoietic stem cell transplantation a treatment option for severe MS or not? Brain 2007; 130(pt 5): Mosby's Medical, Nursing, & Allied Health Dictionary, 6 th edition. Page 3

4 Petri M, Brodsky R. High-dose cyclophosphamide and stem cell transplantation for refractory systemiclupus erythematosus. JAMA 2006; 295(5): Scolding N. Stem cell therapy in patients with multiple sclerosis. Mult Scler 2006; 12(6): Snowden JA, Brooks PM, Biggs JC. Haemopoietic stem cell transplantation for autoimmune diseases. Br J Haematol 1997; 99(1): Taber's Cyclopedic Medical Dictionary, 19 th edition. Tisdale JF, Dunn DE, Geller N, Plante M, Nunez O, Dunbar CE, Barrett AJ, Walsh TJ, Rosenfeld SJ, Young NS. High-dose cyclophosphamide in severe aplastic anaemia: a randomised trial. Lancet 2000; 356(9241): Tyndall A, Daikeler T. Autologous hematopoietic stem cell transplantation for autoimmune diseases. Acta Haematol 2005; 114(4): Traynor AE, Schroeder J, Rosa RM, Cheng D, Stefka J, Mujais S, Baker S, Burt RK. Treatment of severe systemic lupus erythematosus with high-dose chemotherapy and haemopoietic stem-cell transplantation: a phase I study. Lancet. 2000; 356(9231): Tyndall A, Passweg J, Gratwohl A. Haemopoietic stem cell transplantation in the treatment of severe autoimmune diseases Ann Rheum Dis 2001; 60(7): Wicks I, Cooley H, Szer J. Autologous hemopoietic stem cell transplantation: a possible cure for rheumatoid arthritis? Arthritis Rheum 1997; 40(6): VIII. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] CHIP POS [N] PPO [N] HMO [N] CHIP HMO [Y] SeniorBlue* [Y] SeniorBlue PPO* [N] Indemnity [N] SpecialCare [N] POS [N] FEP HMO [N] FEP PPO * Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) , Stem Cell Transplantation. Page 4

5 IX. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement G0265 G0266 G0267 J9000 Q0083 Q0084 Q0085 S X. POLICY HISTORY MP CAC 6/29/04 CAC 7/26/05 CAC 6/27/06 CAC 6/26/07 CAC 5/27/08 Policy approved for retirement effective 7/1/2009. Information added into policy as of 7/1/2009. Effective 10/1/ was retired. Refer to new policy: Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company and Keystone Health Plan Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 5