Determination:

Molina Healthcare of New Mexico consider Modulen investigational and not a covered benefit unless it meets requirements for benefit exception.

When to consider for benefit exception:

• Exception is requested by pediatric GI physician, or by PCP supported by documented specialist opinion.
• Child has evidence of moderate to severe Crohn's Disease
• "Flare" is evident by increase in symptoms and by weight loss.
• Standard intensive treatment of flare has been instituted and is not working
• Hospitalization or initiation of TPN is imminent.

Approve as 12 cans per month for 3 months. This is usual course; renewals usually not necessary.

Background:

Modulen T is an oral polymeric diet which is rich in transforming growth factor beta2. It is a sole source of nutrition during the active phase of Crohn's disease and nutritional support during the remission phase for malnourished patients with Crohn's disease.

Contraindications and Cautions:

None noted.

References:

Jones, H. Shannon, E. Srivastava & N Haboubi. A Novel Approach to a Patient with Chron's Disease and a High Stoma Output: A missed Opportunity Scand J Gastroenteral 2004; 39: 398-400S.

JME Fell, A Hollis, P Kitching, M Paintain, F Arnaud - Battandier, TT macDonald, JA Walker Smith Mucosal Healing and a fall in mucosal pro-inflammatory cytokine mRNA induced by a specific oral polymeric diet in Paediatric Crohn's Disease Aliment Pharmacol Ther 2000 14 281-289.

A Donnet-Hughes, N Duc, P Seaant, VK Vidal, EJ Schiffrin Bioactive molecules in milk and their role in health and disease: The role of transforming growth factor b Immunology and Cell Biology 2000 74-70

RM Beattie, C Camacho-Hubner, S Wacharasindhu, AM Cotterill, JA Walker Smith, MO Savage. Responsiveness of IGF-1 and IGFBP-3 to therapeutic intervention in children and adolescents with Crohn's disease Clinical Endocrinology 1998 49 483-48

RM Beattie, EJ Schiffrin, A Donnet Hughes, AC Huggett, P Domizio, TT Macdonald, JA Walker Smith Polymeric nutrition as the primary therapy in children with small bowel Crohn's Disease Aliment Pharmacol Ther 1994 8 609-615

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Determination:

Molina Healthcare of New Mexico considers implantation of the Essure Micro-Insert medically necessary for women who desire permanent birth control by bilateral occlusion of the fallopian tubes.

Contraindications to use of the Essure Micro-Insert are presented as an appendix to the background section.

Background:

The Essure Micro-Insert System is the first FDA-approved hysteroscopic approach to tubal sterilization. The primary advantages of the Essure System over other techniques of female sterilization are that the Essure System is non-incisional and sterilization can be performed without general anesthesia.

Using a hysteroscopic approach, one Essure micro-insert is placed in the proximal section of each fallopian tube lumen. The micro-insert expands upon release, acutely anchoring itself in the fallopian tube. The micro-insert subsequently elicits a benign tissue response. Tissue in-growth into the micro-insert anchors the device and occludes the fallopian tube, resulting in sterilization.

FDA approval of the Essure System was based on the results of a Phase III clinical trial involving 518 sexually active reproductive-age women who underwent a placement procedure. The Essure System was reported to be 98 percent effective in preventing pregnancy after two years follow up.

The primary endpoints of the Phase III study of Essure were pregnancy prevention, safety of the placement procedure, and safety of long-term use. Secondary endpoints included patient satisfaction and bilateral placement rate. Bilateral placement rate was 86% on 1st attempt and 90% on 2nd attempt. Average hysteroscopy time was 13 minutes, and average procedure time was 35 minutes.

Appendix:

According to the FDA-approved labeling, the Essure System is contraindicated in any woman who:

• Is uncertain about her desire to end fertility; or
• Can have only 1 micro-insert placed (including members with apparent contralateral proximal tubal occlusion and members with a suspected unicornuate uterus); or
• Has previously undergone a tubal ligation.

The Essure System is also contraindicated for women with any of the following conditions:

• Pregnancy or suspected pregnancy; or
• Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement; or
• Active or recent upper or lower pelvic infection; or
• Known allergy to contrast media or known hypersensitivity to nickel confirmed by skin test.

References:

Conceptus, Inc. Essure Microinsert System. Prescribing information. Document No. CC-0366. San Carlos, CA: Conceptus; July 16, 2004. Available at: http://www.essure.com. Accessed 2005.

Kerin JF, Carignan CS< Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: Results of the first Essure pbc clinical study. Aust N Z J Obstet Gynaecol. 2001;41(4):364-370.

Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Selective tubal occlusion procedure. Ottawa, ON: CCOHTA; 2001.

National Horizon Scanning Centre (NHSC). Selective tubal occlusion (Essure) for female sterilization - horizon scanning review. Birmingham, UK: NHSC; 2002.

National Institute for Clinical Excellence (NICE). Hysteroscopic sterilization by tubal cannulation and placement of intrafallopian implant. Interventional Procedure Guidance 44. Londaon, UK:NICE; February 2004. Available at: http://www.nice.org.uk/page.aspx?o=104525. Accessed 2005.

Ubeda A, Labastida R, Dexeus S. Essure: A new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril. 2004;82(1):196-199.

Medical Services Advisory Committee (MSAC). Hysteroscopic sterilization by tubal cannulation and placement of intrafallopian implant. Assessment Report. MSAC application 1055. Canberra. Austrialia: MSAC; November 2003. Available at: http://www.msac.gov. Accessed 2005.

McSwain H, Shaw C, Hall LD. Placement of the Essure permanent birth control device with fluoroscopic guidance: A novel method for tubal sterilization. J Vasc Interv Radiol. 2005;16(7):1007-1012.

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Determination:

Molina Healthcare of New Mexico considers Fabrazyme (agalsidase beta) medically necessary for treatment of members in specific diagnostic categories who meet criteria as outlined.

Background:

Fabrazyme (agalsidase beta)

Biotechnology engineered recombinant form of human alpha galactosidase A. Dosage is 1.0 mg/kg every 2 weeks as an IV infusion, treatment must continue indefinitely. Used to treat Fabry disease an X linked recessive disease with an estimated frequency of 1 in 50,000 male births. Disease may have incomplete penetrance. Classic form of Fabry disease is an enzyme deficiency resulting in progressive accumulation of glycosphingolipids, (primarily GL-3) in cellular lysosomes found in blood vessels, kidneys and heart. Classic disease results in symptoms starting in childhood, of intermittent severe pain in the extremities, vascular skin lesions, decreased ability to sweat, temperature intolerance, proteinuria and gastrointestinal problems. Lifelong accumulation of GL-3 results in severe renal, cardiac and cerebrovascular disease leading to premature death at 30-50 years of age. Female carriers may be asymptomatic but can have manifestations ranging from mild cardiomyopathy to full-blown disease. Males with some residual enzyme activity may have late onset of mild, atypical renal and cardiac disease but usually do not have the classic episodes of pain or skin problems. Diagnosis is made in males with markedly decreased or absent alpha-galactosidase A activity in plasma or peripheral leukocytes. Molecular studies can confirm the diagnosis.

Indications / Required Criteria:

Fabrazyme will be covered for patients meeting the following criteria:

• Patient has been diagnosed with classic Fabry disease with typical clinical manifestations OR has been diagnosed as a carrier with significant clinical manifestations.
• Diagnosis has been made or confirmed by a specialist familiar with the diagnosis of this uncommon disease (ie geneticist). Diagnosis is to be made utilizing alpha galactosidase assays and confirmed by molecular studies. A second opinion is required to establish that patients diagnosed with Fabry disease have sufficient clinical manifestations to justify treatment.
• IV administration to be provided by a Molina Healthcare of New Mexico participating infusion center or home health provider.

No known contraindications.

References:

• Agalsidase Beta (fabrazyme) for Fabry Disease. The Medical Letter, volume 45, September 15, 2003.
• Schiffman, R. et al. Enzyme Replacement Therapy in Fabry Disease: a randomized controlled trial. JAMA 2001, June 6:285 (21):2743-9.
• Hereditary peripheral neuropathies associated with other defects, Fabry Disease. Up To Date online, version 11.3.

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Determination:

Molina Healthcare of New Mexico considers growth hormone (GH) medically necessary for treatment of members in specific diagnostic categories who meet criteria as outlined. Tev-Tropin is the preferred formulation.

Indications / Required Criteria:

Treatment with Growth Hormone (GH) will be approved when any of the following indications exist:

A. Turner's Syndrome (TS)

• Chart notes/written medical summary documenting diagnosis of Turner's Syndrome.
• Request is initiated by an endocrinologist
• GH product requested is FDA-approved for treatment of TS.

Authorization will be given for 1 year, after which documentation will be required to support improvement in growth.

B. Chronic Renal Insufficiency (CRI)

• Chart notes/written medical summary documenting growth retardation with height less than the 3rd percentile for age (greater than two standard deviations below the mean), AND
• Growth velocity less than the 3rd percentile for bone age (greater than two standard deviations below the mean), AND
• Bone age at least two standard deviations below the mean for age and gender, AND
• Pretreatment bone age less than 13 years for females and less than 15 years for males, AND
• No obvious clinical evidence for another unrelated etiology for growth retardation. AND
• Request is initiated by an endocrinologist/nephrologists
• GH product requested is FDA-approved for treatment of CRI.

Authorization will be given for 1 year, after which documentation will be required to support improvement in growth.

C. Growth Failure Cause by GH Deficiency

• Chart notes/written medical summary documenting hypoglycemia in newborn accompanied by a diagnosis of hypopituitarism/panhypopituitarism, OR
• Positive provocative GH testing (usually 2 are done) - GH level below 10ng/ml in response to either insulin, arginine, L-Dopa, or clonidine, AND
• Documentation of clinical features of GH deficiency (at least two):
  Growth velocity less than the 3rd percentile for bone age (greater than two standard deviations below the mean)
  Height below 5th percentile for age
  Delayed bone age
• Request is initiated by an endocrinologist
• GH product requested is FDA-approved for treatment of growth failure caused by lack of endogenous GH secretion.

Authorization will be given for 1 year, after which documentation will be required to support improvement in growth.

D. Prader-Willi syndrome (PWS)

• Chart notes/written medical summary documenting growth failure caused by PWS, AND
• Confirmed diagnosis via genetic testing AND
• Request is initiated by an endocrinologist AND
• GH product requested is FDA-approved for treatment of growth failure caused by PWS.

Authorization will be given for 1 year, after which documentation will be required to support improvement in growth.

E. AIDS Wasting of Cachexia

• Chart notes/written medical summary documenting AIDS wasting or cachexia, unresponsive to other therapies.
• Request must be initiated by infectious disease specialist following member for AIDS.

F. Adult Growth Hormone Deficiency (GHD)

• Chart notes/written medical summary documenting surgery or other insult resulting in pituitary disease; AND
• Evidence of and treatment for other hormonal deficiencies (e.g. steroid replacement therapy, thyroid replacement therapy), AND
• Provocative testing indicating absolute deficiency of growth hormone (<3ng/ml); AND
• Presence of clinical features associated with GHD (e.g, increased fat mass with abdominal preponderance, decreased lean body mass, decreased muscle mass and strength, decreased exercise capacity, impaired sense of well-being). AND
• Request is initiated by an endocrinologist AND
• GH product requested is FDA-approved for treatment of Adult GHD.
• Authorization will be given for 1 year, after which documentation will be required to support therapy benefit.

G. Short Bowel Syndrome (SBS)3

• Chart notes/written medical summary documenting diagnosis of SBS, AND
• Medication will be used to reduce patient dependence on total parenteral nutrition, AND
• Request is initiated by gastroenterologist or surgeon.

Growth Hormone (GH) treatment Will Not be approved for any of the following indications. Additionally, if member's benefit does not cover cosmetic conditions, requests for cosmetic use (e.g., idiopathic short stature) will not be approved:

• Idiopathic short stature (non-growth hormone deficient). Studies used for FDA-approval were very small, and not published in peer-reviewed journals. Most literature suggests that total height gain would be 4-6 cm at best. Larger studies would be required in order to assess true efficacy and utility for this indication. 2-3
• Intrauterine growth retardation (IUGR)/Small for Gestational Age (SGA). -not FDA-approved. For the limited studies available, there is limited data documenting final adult height of GH-treated children compared to controls. Well-designed trails are necessary in order to establish benefits derived from GH therapy in this population. 4-5
• Cystic fibrosis---not FDA-approved
• Down syndrome---not FDA-approved
• Fibromyalgia---not FDA-approved
• Adjuvant treatment to ovulation induction for treatment of infertility---not FDA-approved

**Coverage Note:

Coverage may be subject to 1) contract terms with certain providers/medical groups and 2) coverage by other State-run programs for Medicaid recipients.

If approved, medication will be dispensed by specialty injectable vendor of Molina Healthcare of New Mexico's choosing.

Contraindications and Cautions:

• Subjects with closed epiphyses. The effectiveness, benefits, and risks of continuing GH in patients with GHD deficiency who have attained closed growth plates has not been established.
• Evidence of tumor activity or active neoplasia (intracranial lesions must be inactive and antitumor therapy completed prior to instituting therapy).

References:

• Drug Facts and Comparisons, St. Louis, Wolters Kluwer Company, November 2003
• BS Finkelstein et al, Arch Pediatr Adolesc Med 2002; 156:230.
• The Medical Letter on Drugs and Therapeutics, New Rochelle, NY, Medical Letter, Inc. Vol 45, issue 1169. 11/10/2003.
• Wilton P et al. Growth hormone treatment induces a dose-dependent catch-up growth in short children born small for gestational age: A summary of four clinical trials. Horm Res 1997; 48 (suppl 1):67-71.
• Ranke MB, Lindberg A. Growth hormone treatment of short children born small for gestational age or with Silver-Russell syndrome: results from KIGS (Kabi International Growth Study), including the first report on final height. Acta Paediatr 1996;47(suppl):18-26.
• Nutropin Depot Product Information, Genentech, Inc. , San Francisco, December 1999.
• Nutropin AQ Product Information, Genentech, Inc., San Francisco, April 2000.
• Genotropin Product Information, Pharmacia corporation, Kalamazoo, July 2001.

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