<Date>

<Payer Name>

ATTN: Medical Director

<Payer Address>

<Payer City, State, Zip>

Re: Letter of Medical Necessity for RELiZORB®(iMMOBILIZED LIPASE) CARTRIDGE

Patient: <Patient’s First and Last Name>

Subscriber ID#: <Insurance ID Number>

Subscriber Group#: <Insurance Group Number>

Dates of Service: <Dates>

Dear Medical Director:

I am writing on behalf of my patient, Patient Name>, to <request prior authorization or document medical necessity> for treatment with RELiZORB® (iMMOBILIZED LIPASE) CARTRIDGE.This letter provides information about my patient’s medical history, diagnoses, and a statement summarizing my treatment plan.On behalf of my patient, I am requesting approval for use and subsequent payment for treatment.

Patient’s Clinical History

Patient Name is a <age>-year-old <male/female> who has cystic fibrosisand exocrine pancreatic insufficiency (EPI). Because of <his/her> EPI, Patient Namemust take oral pancreatic enzyme replacement therapy (PERT) with all of <his/her> oral meals to break down the nutrients, including fatty acids, present in <his/her> food.

Despite the use of PERT with oral meals, Patient Namefailed to maintain <his/her> body weight and BMI, resulting in the need for supplemental enteral nutrition.Patient Name> has been receiving enteral nutrition with PERT for <insert time on enteral therapy> but has not achieved <his/her> target BMI and/or weight. Failure to achieve target BMI and/or weight will negatively impactPatient Name’s lung function and overall health.

Patient Nameis failing supplemental enteral nutrition therapy because of <his/her> EPI. PERT capsules are formulated for an oral route of administration and are not approved for use with enteral nutrition. The common practice of crushing enzymes and adding them to formula is against manufacturer’s labeling and Instructions for Use. The inability to have enzymes present during the entire 6-8 enteral feedings is causing significant symptoms of fat malabsorption, including abdominal pain, bloating, nausea and vomiting, decreased appetite, and diarrhea for Patient Name.Of more concern, Patient Nameis not absorbing the essential long-chain fatty acids present in the enteral formula that are needed to both gain weight and improve nutritional status.

Treatment Plan

RELiZORB is an FDA-cleared device designed for use with enteral feeding only and is indicated for usein pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB connects to the patient’s enteral feeding set, allowing the enteral formula to flow through the cartridge prior to entering the patient’s gastric tube. As the formula flows through the RELiZORB cartridge, the fats in the formula are broken down by the enzyme lipase and enter Patient Name’s body in a form readily absorbable for <him/her>.

RELiZORB allows lipase to be present duringthe entire enteral feeding process.In a recently published study, use of RELiZORBhas been demonstrated to significantly reduce the frequency of some of the GI eventsassociated with the inability to absorb unhydrolyzed fats. Additionally, RELiZORB is the only digestive enzyme intervention that is FDA-approved for use in enteral nutrition.

As stated previously, use of oral enzymes with enteral nutrition is off label:

  • The practice of crushing enzymes for use in formula is against manufacturer’s recommendations and was noted in the most recent Cystic Fibrosis Foundation’s guidelines on enteral nutrition published in 2016
  • There is a lackof sufficient clinical evidence to support the use of PERTs during enteral feeding
  • Patient Name is failing enteral nutrition therapy because of ongoing issues with fat malabsorption due to the ineffectiveness of oral enzyme use with enteral nutrition

Patient Namewill use RELiZORB with <his/her> overnight enteral feedings only. During the day, <he/she> will continue to use oral PERT as prescribed.

Summary

In summary, please consider coverage for RELiZORB on Patient Name’s behalf and approve use and subsequent payment for RELiZORB as planned. Please refer to the enclosed Prescribing Information for RELiZORB, and if you have any additional questions regarding this matter, please do not hesitate to contact me at <insert phone number.

Thank you for your prompt attention to this matter.

Sincerely,

Physician Name, Title

Enclosures:

  • RELiZORB Instructions for Use