CF Ibuprofen Lab: Physician Statement of Medical Necessity

The following is a letter of necessity, suggested by Dr. Michael Konstan, that covers both the need for pharmacokinetics and the use of Motrin^® and maybe used by the physician, if he/she deems appropriate, and provide it to the patient and/or insurance company for reimbursements purposes.

PHYSICIAN STATEMENT OF MEDICAL NECESSITY

Patient Name: __________________________________ Date of Birth: ____________

Street Address: ________________________________ Telephone: (____)__________

City, State, Zip: ______________________________

The above patient has the primary diagnosis of cystic fibrosis (CF); ICD-9-CM 277.0. Progressive lung disease accounts for most of the morbidity and nearly all the mortality in this disorder. Inflammation is a major component of the lung disease, and play a pivotal role in the progression of lung disease which ultimately leads to the patient's death. Since airway inflammation is contributing to lung destruction in the above patient, anti-inflammatory therapy is being to added to his/her therapeutic regimen. High-dose ibuprofen administered twice daily is the only long-term anti-inflammatory therapy for patients with CF which has been shown to be effective. In a 4-year clinical trial, Motrin^® brand of ibuprofen significantly delayed the progression of lung disease without significant adverse effects (NEW ENGLAND JOURNAL OF MEDICINE 1995; 332:848-54).

Peak plasma ibuprofen concentrations in a narrow therapeutic range (50-100 µg/ml) are required to achieve the desired effect described in the above study. Peak concentrations outside of this range may be harmful to the CF patient; low levels may increase inflammation, high levels may cause dangerous toxicity. Because of variable pharmacokinetics for ibuprofen in CF, doses need to be individualized for each patient (JOURNAL OF PEDIATRICS 1991; 118:956-64). This is accomplished by determining the correct dose through a 3 hour pharmacokinetic study. The Motrin^® brand of ibuprofen is the drug of choice because only this formulation has been studied in CF, and different brands of ibuprofen have different pharmacokinetic characteristics.

To achieve the beneficial effects (and to minimize the adverse effects) of long-term Motrin^® therapy, the correct dose has been determined in the above patient by a 3 hour pharmacokinetic study, and the patient will be closely monitored for adverse effects throughout the course of treatment. I believe the above patient would benefit from long-term anti-inflammatory therapy with Motrin^®. Establishment of the correct dose by the pharmacokinetic study and the use of Motrin^® brand of ibuprofen is a critical component of this patient's therapeutic regimen, and merits insurance coverage.

AUTHORIZING PHYSICIAN

Name: __________________________________________ Telephone: (____)_____________ 

Street Address: _______________________________________________________________ 

City, State, Zip: _______________________________________

The above patient has been prescribed Motrin^® _____ mg twice per day, everyday, for the remainder of his/her life. Generic or other brands of ibuprofen should not be substituted for Motrin^®. I certify that the use of the above therapy is medically indicated and necessary, and that I will be supervising the above patient's treatment.

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                    Physician Signature                Date

Updated August 22, 1997.