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Health Net considers Alprostadil Intravenous (IV) medically necessary for use in ischemic conditions such as Raynaud's disease, with or without scleroderma, or peripheral vascular disease.
Health Net considers Alprostadil Intravenous (IV) medically necessary for use in ischemic conditions such as Raynaud's disease, with or without scleroderma, or peripheral vascular disease.
Health Net considers Alprostadil Intravenous (IV) medically necessary for use in ischemic conditions such as Raynaud's disease, with or without scleroderma, or peripheral vascular disease.
Subject: Alprostadil Intravenous for Raynauds Syndrome
Policy Number: NMP112
Effective Date*: March 2004
Updated: February 2006, February 2008, February 2010
This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document
Current Policy Statement (Update February 2010 - A Medline search failed to reveal any studies that would cause Health Net, Inc. to change its current position)
Health Net, Inc. considers alprostadil intravenous (IV) medically necessary for use in ischemic conditions such as Raynaud's disease, with or without scleroderma, or peripheral vascular disease to dilate small vessels during acute exacerbations of finger, toe or limb vasospasm, sepsis and/or necrosis when other treatment modalities have failed.
Note: Under the FDA Orphan Drug designation, Alprostadil was approved in 1993 for treatment of severe peripheral arterial occlusive disease (critical limb ischemia) in patients where other procedures, grafts or angioplasty, are not indicated.
IV Alprostadil is medically necessary in any of the following:
1. A limb(s), finger(s), or toe(s) is severely ischemic, gangrenous or loss of a limb or digit is possible, or 2. As treatment of severe peripheral arterial occlusive disease (critical limb ischemia) in patients where other procedures, such as grafts or angioplasty, are not indicated, or 3. Patients with non healing digital ulcers related to Raynaud's disease or severe peripheral arterial occlusive disease, where amputation would otherwise be unavoidable.
Codes Related To This Policy ICD-9 Codes 440.23 Atherosclerosis of the extremities with ulceration 440.24 Atherosclerosis of the extremities with gangrene Alprostadil Intravenous for Raynauds Syndrome Feb 10 1 1 Posted: February 17, 2010 443 Other peripheral vascular disease 443.0 Raynauds syndrome 443.1 Thromboangiitis obliterans (Buergers disease) 443.9 Peripheral vascular disease, unspecified 707 Chronic ulcer of skin, non-healing ulcer 707.1 Ulcer of lower limbs, except decubitus 707.10 Ulcer of lower limb, unspecified 707.15 Ulcer of other part of foot; toes 785.4 Gangrene
CPT Codes 37202 Transcatheter therapy, infusion other than for thrombolysis, any type (e.g. spasmolytic, vasoconstrictive) 90783 Therapeutic, prophylactic or diagnostic injection, intra-arterial (deleted 12/31/05) 90784 Therapeutic, prophylactic or diagnostic injection, intravenous (deleted 12/31/05) 96373 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intra-arterial 96374 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug
2006 CPT Codes 90773 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intra-arterial (deleted 12/31/2008) 90774 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug) (deleted 12/31/2008)
HCPCS Codes J0270 Injection alprostadil, 1.25 mcg (code may be used for Medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered
Scientific Rationale - Update February 2006 A Medline search of the published peer review literature revealed no new information to support any revisions to this current policy. Most patients with intermittent claudication are treated initially with medical therapy, risk factor modification, exercise, pharmacology or with percutaneous intervention or surgery. Alprostadil intravenous (IV) is considered medically necessary if these measures fail to reverse the ischemia, or if the clinical presentation is severe as noted in the above criteria. Alprostadil intravenous (IV) is not recommended for the routine treatment of intermittent claudication.
Scientific Rationale - Initial In Raynaud's phenomenon, exposure to the cold, or strong emotions, trigger blood vessel spasms that result in interruption of blood flow to the fingers and toes. Occasionally, an episode affects just one or two fingers or toes, and episodes don't necessarily always affect the same digits. Although Raynaud's most commonly affects the fingers and toes, the condition can also affect other areas of the body including the nose, cheeks, ears and tongue. An attack may last less than a minute to several hours. Over time, attacks may grow more severe. If the condition Alprostadil Intravenous for Raynauds Syndrome Feb 10 2 2 Posted: February 17, 2010 progresses, blood flow to the affected area(s) could become permanently decreased causing the fingers to become thin and tapered, with smooth, shiny skin and slow growing nails. If an artery becomes blocked completely, gangrene or ulcerations of the skin can occur.
Raynauds phenomenon consists of three phases of color change: pallor, cyanosis, and erythema, which represent phases of vasoconstriction, decreased blood flow, and reperfusion, respectively. At first during an attack of Raynaud's, affected areas of the skin turn pale or white. Color changes extend proximally from the tips of digits to various levels, with a well-demarcated border. During this period of vasospasm, endothelial injury is believed to result in intimal hyperplasia and fibrosis, causing concentric narrowing of digital arteries by as much as 75-80% and occlusion by intravascular thrombi. Affected areas often turn blue, feel cold and numb, and sensory perception is dulled. The affected skin may look slightly swollen. As circulation improves, the affected areas may turn red, throb, tingle or swell. Signs and symptoms of Raynaud's depend on the frequency, duration and severity of the blood vessel spasms that underlie the disorder.
Raynaud's occurs in two main types: Primary Raynaud's. This is Raynaud's without an underlying disease or associated medical problem that could provoke vasospasm. Also called Raynaud's disease, it's the most common form of the disorder. Primary Raynaud's typically affects both hands and both feet.
Secondary Raynaud's. This is Raynaud's caused by an underlying problem, such as scleroderma, atherosclerosis, rheumatoid arthritis, Buergers disease or systemic lupus erythematosus. Also called Raynaud's phenomenon, secondary Raynaud's usually affects either both hands or both feet. Although secondary Raynaud's is less common than the primary form, it's often a more complex and serious disorder.
Raynaud's phenomenon has been documented in association with repetitive trauma (i.e. carpal tunnel syndrome), chemical exposure (specifically, exposure to vinyl chloride) and certain medications that promote vasocontriction (e.g. beta blockers, - ergot alkaloids, oral contraceptives/estrogen replacement therapy, and certain chemotherapy agents). Other risk factors include smoking, history of frostbite, and history of injury to the hands and/or feet.
Medical management of Raynaud's phenomenon is aimed at preventing vasospasm, reducing the number and severity of attacks and preventing tissue damage. The most basic therapy is protection against vasoconstrictive stimuli such as cold, fright or frustration. Other management options include teaching hand and body warming techniques and smoking cessation. Improvement of resting digital skin temperature has been noted after biofeedback training, however long-term maintenance of this response is variable.
Medications are also a mainstay of Raynauds treatment and include calcium channel blockers, alpha blockers, vasodilators, and topical nitropaste. In patients with persistent symptoms, pentoxifylline (Trental) is used to improve circulation by making red blood cells more flexible as they pass through narrowed blood vessels. In severe cases, Alprostadil is used for nonhealing ulcers or severe ischemia. Alprostadil Intravenous for Raynauds Syndrome Feb 10 3 3 Posted: February 17, 2010
When medical management is insufficient, other treatment options to be considered are cervical or digital sympathectomy, chemical injections into the affected area(s) and/or amputation. Unfortunately, amputation is sometimes unavoidable in the event of nonhealing digital ulcers.
Alprostadil (Prostaglandin E1, PGE1) is a hormone like substance known as a potent arterial vasodilator and platelet-aggregation inhibitor. Prostaglandin infusions are used in ischemic conditions such as Raynaud's disease and peripheral vascular disease to dilate small vessels during acute exacerbations of finger sepsis and necrosis.
The beneficial effects of prostaglandins on the peripheral microcirculation have been documented in the published literature in numerous studies. Improved cold tolerance was noted, and attacks of Raynaud's phenomenon were noted to be less frequent, less severe, and shorter in duration following PGE1 infusions. Hemodynamic assessments included measurements of skin temperature and finger systolic pressure response to localized digital cooling. Non-healing wound improvements have been measured by documentation of decreased ulcer size and improved granulation following prostaglandin infusions. Many ischemic ulcers healed between 2-6 weeks following treatment and the beneficial effects persisted for between 1-18 months. Administration of a three day course of IV Alprostadil has been documented to statistically improve outcome measures and effects have been noted to last for at least three to four weeks. Unlike sympathectomy, it is a minor procedure without prolonged side effects and is repeatable.
A study published by Bartolone et al in 1999 examined the effects of PGE1 (Alprostadil) in patients with scleroderma and severe Raynaud's disease. Twelve females were included in the study. Six women received a 3-hour infusion of alprostadil at the standard dosage of 60 micrograms in 250 cc of physiological infusion for six consecutive days. The remaining six receiving placebo (250 cc of physiological infusion administered in the same manner). After infusion, blood flow, digitally measured by telethermography was increased only in patients treated with alprostadil. The number, frequency and severity of attacks recorded were reduced only in patients treated with alprostadil. The authors concluded, alprostadil is effective in the management of Raynaud's phenomenon.
In a retrospective case study by Langevitz et al, twenty Prostaglandin E1 (PGE1) infusions were administered to 12 patients with severe Raynaud's phenomenon, associated with refractory ischemic skin ulcers. There was symptomatic improvement following 17 of the 20 infusions, while 35 of the 65 ischemic ulcers healed between 2-6 weeks following treatment. The beneficial effects persisted for between 1-18 months.
Gardinali et al evaluated the efficacy and safety of prostaglandin (PG) E1alpha- cyclodextrin for Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). Thirty-six women were given three 60 microg intravenous PGE1alpha-cyclodextrin infusions on 5 consecutive days at 6 week intervals. RP symptoms and healing of digital lesions were evaluated. Twenty age matched healthy women were the controls. RP symptoms were improved 87% of the patients. The benefit of each 5 day cycle lasted 4 or more weeks in 75%. PGE1alpha-cyclodextrin reduced the daily frequency of RP symptoms by 20% (p < 0.05), 41% (p < 0.005), and 53% (p < 0.0005) from baseline after the 1st, 2nd, and 3rd infusions, respectively. The Alprostadil Intravenous for Raynauds Syndrome Feb 10 4 4 Posted: February 17, 2010 severity of the attacks was reduced to a limited degree. In 12 of the 14 patients with digital lesions, these healed completely. Ten patients had mild side effects during treatment (headache, increased intestinal motility, flushing). The authors concluded, PGE1alpha-cyclodextrin reduces RP symptoms and plasma levels of the markers of endothelial injury in SSc, suggesting that an improvement of endothelial dysfunction contributes to its prolonged therapeutic effect.
In 1981, Martin et al. tested twelve patients with systemic sclerosis (SS) and severe Raynaud's phenomenon; each received infusions of prostaglandin E1 (PGE1) with either saline or 5% dextrose, for 72 hours in a single-blind cross-over study. Following the PGE1 infusion cold tolerance improved and attacks of Raynaud's phenomenon were less frequent, less severe, and shorter in duration. This subjective improvement was maintained for several weeks in most patients, and 2 noted healing of ischaemic ulcers. There was no significant change in objective measurements of hand function after either infusion. However, pain measured on a 10 cm visual analogue scale improved 2.19 cm with PGE1 and only 0.91 cm with normal saline (P less than 0.05). Temperature of the fingers and hands recorded by thermography did not change significantly with saline infusions, but did rise during PGE1 infusions (mean rise 2.0 degrees C at 48 hours, p less than 0.001), and was maintained when measured again 2 weeks later (mean rise 1.56 degrees C, p less 0.001).
Contraindications for use of IV Alprostadil include documented hypersensitivity, and coadministration with anticoagulants may increase bleeding risk because of shared effects on platelet aggregation. Precautions are warranted upon initiation of alprostadil because infusions require experienced personnel and physiologic monitoring. Side effects such as bradycardia, hypotension, and/or postural hypotension, fever, headache, and flushing can occur.
Review History March 16, 2004 Medical Advisory Council, initial approval February 2006 Update no revisions February 2008 Update no revisions. Updated HCPCS code. February 2010 Update no revisions. Code updates
Patient Education Websites English 1. National Institiute of Arthritis and Musculoskeletal and Skin Disease. Questions and Answers about Raynaud's Phenomenon. Available at: http://www.niams.nih.gov/hi/topics/raynaud/ar125fs.htm
Spanish 1. Arthritis Foundation. Fenmeno de Raynaud. Acesso en: http://www.arthritis.org/Espanol/enfermedades/tipos_de_artritis/raynaud.asp
This policy is based on the following evidence-based guidelines: 1. National Guideline Clearinghouse. Guideline for management of wounds in patients with lower-extremity arterial disease. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=12613&nbr=006521 &string=lower-extremity+AND+arterial+AND+disease 2. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, Alprostadil Intravenous for Raynauds Syndrome Feb 10 5 5 Posted: February 17, 2010 mesenteric, and abdominal aortic): a collaborative report [trunc]. Bethesda (MD): American College of Cardiology Foundation; 2005. Available at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=8503&nbr=0 04740&string=lower-extremity+AND+arterial+AND+disease
References Update February 2010 1. Clinical trials.gov. Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL) Available at: http://clinicaltrials.gov/ct2/show/NCT00596752 2. Di Stefano R, Barsotti MC, Melillo E, et al. The prostacyclin analogue iloprost increases circulating endothelial progenitor cells in patients with critical limb ischemia. Thromb Haemost. 2008 Nov;100(5):871-7. 3. Ikushima I, Hirai T, Ishii A, Yamashita Y. Combined stent placement and high dose PGE1 drip infusion for chronic occlusion of the superficial femoral artery as a modality to salvage chronic critical limb ischemia. Eur J Radiol. 2008 Apr;66(1):95-9. 4. Milio G, Novo G, Genova C, et al. Pharmacological treatment of patients with chronic critical limb ischemia: L-propionyl-carnitine enhances the short-term effects of PGE-1. Cardiovasc Drugs Ther. 2009 Aug;23(4):301-6. 5. Minar E. Critical limb ischaemia. Hamostaseologie. 2009 Jan;29(1):102-9. 6. U.S. Food and Drug Administration. List of Orphan Products Designations and Approvals. Available at: http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/lst0094.pdf
References Update February 2008 1. Henness SA, Wigley FM. Current drug therapy for scleroderma and secondary Raynaud's phenomenon: evidence-based review. Current Opinion in Rheumatology. 19(6):611-618, November 2007.
References - Update February 2006 1. Marasini B, Massarotti M, Bottasso B, et al. Comparison between iloprost and alprostadil in the treatment of Raynaud's phenomenon. Scand J Rheumatol. 2004;33(4):253-6. 2. Pokrovskii AV, Dan VN, Chupin AV, Kalinin AA. Alprostan for management of critical lower limb ischemia. Angiol Sosud Khir. 2005;11(1):7-10. 3. Heidrich H, Schmidt T, Fahrig C. Are there predictors for the outcome of a PGE1 treatment in peripheral arterial disease with critical limb ischaemia? Vasa. 2005 May;34(2):101-7. 4. Mlekusch W, Schillinger M, Sabeti S, et al. Effects of intravenous prostaglandin E1 on arterial compliance: a randomized controlled trial. Vasa. 2004 Aug;33(3):131-6. 5. Schellong S, Altmann E, von Bilderling P, et al. Microcirculation and tolerability following i.v. infusion of PGE1 and iloprost: a randomized cross-over study in patients with critical limb ischemia. Prostaglandins Leukot Essent Fatty Acids. 2004 Jun;70(6):503-9. 6. Marchesi S, Pasqualini L, Lombardini R, et al. Prostaglandin E1 improves endothelial function in critical limb ischemia. J Cardiovasc Pharmacol. 2003 Feb;41(2):249-53. 7. Bandiera G, Forletta M, Di Paola FM, Cirielli C. PGE(1) short term therapy in critical lower limb ischemia. Int Angiol. 2003 Mar;22(1):58-63. 8. Grader-Beck T, Wigley FM. Raynaud's phenomenon in mixed connective tissue disease. Rheum Dis Clin North Am. 2005, Aug ; 31(3): 465-81, vi Alprostadil Intravenous for Raynauds Syndrome Feb 10 6 6 Posted: February 17, 2010 9. Hiatt WR. Treatment of disability in peripheral arterial disease: new drugs. Curr Drug Targets Cardiovasc Haematol Disord. 2004 Sep;4(3):227-31 10. Zeni S, Ingegnoli F. Raynaud's phenomenon. Reumatismo. 2004 Apr- Jun;56(2):77- 11. Reiter, M, Bucek, R, Stumpflen, A, Minar, E. Prostanoids for intermittent claudication. Cochrane Database Syst Rev 2004; 1:CD000986. 12. Amendt K. PGE1 and other prostaglandins in the treatment of intermittent claudication: a meta-analysis. Angiology. 2005 Jul-Aug;56(4):409-15. 13. Hashiguchi M, Ohno K, Saito R. Studies on the effectiveness and safety of cilostazol, beraprost sodium, prostaglandin E1 for the treatment of intermittent claudication.Yakugaku Zasshi. 2004 Jun;124(6):321-32.
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