Archived Policies - Prescription Drugs


Lupron, Lupron Depot Leuprolide Acetate

Number:RX501.041

Effective Date:09-01-1996

End Date:09-30-2004

Coverage:

Coverage is allowed for the use of Lupron in the following conditions:

  • Advanced Prostatic Cancer
  • Documented SEVERE Endometriosis, verified by operative and/or tissue report, in a patient who is not being treated for infertility and is not responsive to conservative medical treatment with oral contraceptives, progestins, or Danazol; and, the patient opts for medical treatment rather than surgical intervention, such as a hysterectomy
  • Documented Endometriosis, verified by operative and/or tissue report, in a patient who desires to maintain fertility, having failed conservative medical treatment (including laparoscopic fulguration or laser treatment) and where surgical intervention is not an option,
  • Documented SEVERE endometriosis, verified by operative and/or tissue report, in a patient who desires to maintain fertility and where surgical intervention is not an option
  • Preoperative treatment of uterine leiomyoma, 14 weeks or greater in size,
  • Precocious puberty, early appearance of secondary sexual characteristics before the age of 8 in girls and the age of 9 in boys
  • Preparation of endometrium for ablation

Coverage is considered investigational and experimental and not allowed for the use of Lupron in the treatment of:

  • Anovulation accompanying polycystic ovarian disease
  • Menstrual cycle regulation in in-vitro fertilization
  • Advanced metastatic ovarian malignancy or endometrial cancer
  • Non-specific chronic intestinal diseases, e.g., pseudo obstruction, functional disease, or hollow visceral neuropathy
  • Breast cancer
  • Prostatic hypertrophy
  • Liver Cancer

Description:

Lupron, also known as Leuprolide Acetate, is a synthetic gonadotropin-releasing hormone (GnRH) analogue of naturally occurring GnRH with greater potency than the natural hormone.  Lupron suppresses functions of the ovaries and testes, via the pituitary gland in the brain.  Repeated monthly injections of Lupron cause those gonadal hormone dependent tissues/organs to reduce or cease activity, such as the normal prostrate gland that is dependent on testosterone for the growth and function.  This effect is reversible on discontinuation of the drug therapy. Lupron is not active when given orally.

Rationale:

None

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

None

References:

Facts and Comparisons on Drugs, Fax-Stat, Vol. II, No. 17, April 30, 1993.

American Journal of Diseases of Children (1993 June) 147(6): pages 653 - 657.

Digestive Diseases & Sciences (1994 June) 39(6): pages 1155-62 and 1163-70.

Carrier Advisory Committee, June 22, 1994.

Journal of Reproductive Medicine (1994 September) 39(9): pages 663 - 666.

Gynecologic and Obstetric Investigation (1995) 39(2): pages 115 - 119.

Fertility and Sterility (1995 March) 63(3): pages 487 - 490.

The Journal of the American Medical Association, June 7, 1995. 273(21): pages 1700 -1701.

Drug Evaluation Monographs, (on-line copy Micro Medex Inc., 1974 - 1996) Volume 87, 2/29/96

Drugs, Facts and Comparison, April 1996, page 669c - 670c.

PDR 1995 (on-line), search done on August 9, 1996

Policy History:

Archived Document(s):

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