Solesta (Dextranomer and Sodium Hyaluronate Gel for Submucosal Injection)
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
Fecal incontinence (FI) is the involuntary loss of bowel control which may be caused by nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence.
The Cleveland Clinic Florida Incontinence Score (CCFIS) is a scale from 0 (continent) to 20 (complete incontinence). It is a composite score based on a patient’s recall using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage, and lifestyle alterations during the past 3 months. A CCFIS of 10 or higher has been shown to correlate to a significant poorer quality of life compared to healthy individuals.
Solesta (dextranomer and sodium hyaluronate gel for submucosal injection) was approved in May 2011 for the treatment of fecal incontinence in patients 18 years of age and older who have failed conservative therapy.
Solesta is supplied in a carton of four 1 mL syringes per treatment session, and is injected by the physician under direct visualization into the submucosal of the layer in the proximal part of the high pressure zone of the anal canal about 5 mm above the dentate line. Solesta injections may help build tissue in that area which narrows the opening of the anus so that the patient may be able to better control those muscles.
1. Solesta should only be administered by physicians experienced in performing anorectal procedures.
[INFORMATIONAL NOTE: Solesta is administered as an outpatient procedure without anesthesia and requires direct visualization using an anoscope. As per the FDA labeling, physicians should have successfully completed a comprehensive training and certification program in the Solesta injection procedure. Prior to treatment, the rectum should be evacuated with an enema. The enema should be given immediately prior to the procedure to ensure evacuation of the anorectum. Additional cleansing of the injection area with an antiseptic may be performed prior to injection. Use of prophylactic antibiotics is recommended. Intravascular injection of Solesta should be avoided as this may cause vascular occlusion. Injection in the midline of the anterior wall of the rectum should be avoided in men with enlarged prostate.
Protect from sunlight and freezing. Solesta may be stored at room temperature up to 25°C (77°F).]
2. Solesta is considered medically necessary for the FDA-approved indication of fecal incontinence, when the following criteria are met:
- Patient is 18 years or older; AND
- History of fecal incontinence for at least 12 months; AND
- Patient has tried and failed conservative therapy (e.g., diet, fiber, anti-motility medications); AND
- ≥4 fecal incontinence episodes over a 14 day period; AND
- Patient does NOT have any of the following conditions:
- Active inflammatory bowel disease;
- Immunodeficiency disorders or ongoing immunosuppressive therapy;
- Previous radiation treatment to the pelvic area;
- Significant mucosal or full thickness rectal prolapse;
- Active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections;
- Anorectal atresia, tumors, stenosis or malformation;
- Rectal varices;
- Presence of existing implant (other than Solesta) in anorectal region; OR
- Allergy to hyaluronic acid based products (e.g. Synvisc, Synvisc-One, Hyalgan, Supartz, Euflexxa, Orthovisc, etc.)
- Grade IV hemorrhoids
- History of anorectal surgery within 12 months
[INFORMATIONAL NOTE: Safety and effectiveness of Solesta have not been evaluated in patients younger than 18 years old or in pregnant or breastfeeding women). Clinical trials included patients with a history of fecal incontinence for at least 12 months, a CCFIS at baseline of ≥10, and ≥4 fecal incontinence episodes over a 14 day period. Patients with grade IV hemorrhoids or those with a history of anorectal surgery within 12 months prior to study were excluded from the study. The other excluded conditions listed above are contraindications listed in the FDA approved labeling.]
3. When Solesta is considered medically necessary, initial therapy will be approved for a period of 4 weeks at the FDA recommended dose of four submucosal injections (4 - 1 mL syringes) each treatment session.
4. Repeat therapy will be approved for one box of four syringes (4 - 1 mL syringes) no less than 4 weeks after the initial dose.
[INFORMATIONAL NOTE: The safety and effectiveness of Solesta have been studied in patients who received one or two treatments. No patients received more than two treatments in clinical trials. In the pivotal study, the majority of patients received two treatments, four weeks apart. A repeated Solesta injection procedure may be required to achieve a satisfactory level of improvement in incontinence. In clinical trials, patients were required to have a CCFIS of ≥10 to be eligible for re-treatment. Patients across two clinical trials were followed for 12 months, and no patients received more than 2 treatments with Solesta.]
5. Other uses of Solesta are considered investigational including, but not limited to, incontinence to flatus only.
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
Solesta (Dextranomer and Sodium Hyaluronate Gel for Submucosal Injection)
1. Solesta (dextranomer and sodium hyaluronate). Oceana Therapeutics, Inc. Edison, NJ. Jan 2014.
2. U.S. Food and Drug Administration: FDA News. FDA approves injectable gel to treat fecal incontinence. May 2011. [Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257112.html]
3. Danielson J, Karlbom U, Sonesson A, et al. Submucosal injection of stabilized nonanimal hyaluronic acid with desxtranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009;52:1101-6.
4. Graf W, Mellgren A, Matzel KE, et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011;377:997-1003.
5. Dodi G, Jongen J, de la Portilla F, et al. An open-label, noncomparative, multicenter study to evaluate efficacy and safety of NASHA/Dx gel as a bulking agent for the treatment of fecal incontinence. Gastroenterol Res Pract. 2010;2010:467136. Epub 2010 Dec 27.
6. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations. Dextranomer and Sodium Hyaluronate Gel. Available at: http://www.thomsonhc.com. Accessed April 21, 2014.
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