Understanding the financial impact of covering new screening technologies. The case of automated Pap smears.

OBJECTIVE: To develop a decision tool facilitating understanding of the potential financial impact on managed care plans associated with automated primary screening for Pap smears. STUDY DESIGN: A baseline decision analytic model was developed with claims data from two managed care plans to replicate the treatment costs patients accrue subsequent to receiving a routine Pap smear with initial human review. Probabilities that a patient was at a particular decision point, as well as payments associated with that patient, were also determined empirically from the claims data. Clinical trial results for the AutoPap System (TriPath Imaging, Inc., Burlington, North Carolina) were incorporated into the model to develop an alternate scenario with 15% fewer false positives and 32% fewer false negatives. Sensitivity analyses were performed to model likely "real world" variation in laboratory results and treatment costs. Marginal costs associated with automated screening were calculated. Financial impacts were calculated in per member per month (PMPM) terms and included an incremental $20 payment for automated primary screening. Given that total PMPMs associated with health care delivery vary widely across the U.S., incremental impacts were also calculated from baseline PMPMs ranging from $80 to $160. RESULTS: PMPMs increased 5-10 cents, depending on baseline PMPM, test performance and treatment costs. CONCLUSION: Although costs rose with automated Pap smears, the costs shifted to the diagnosis and treatment of true positives.

Desirable and undesirable cutaneous effects of oral contraceptives.

PIP: A review of cutaneous reactions associated with oral contraceptives intended to help the practitioner is presented. The skin responses to gestagens depend upon the sensitivity of the patient, the nature of the gestagen, and the ratio of progestogen to estrogen. Reactions are classified according to their physiologic mechanisms: hormonal effects, immune response, altered porphyrin metabolism, and miscellaneous skin problems. Some of the reactions associated with pseudopregnancy include herpes gestationis, melasma, vaginal candidiasis, cholestatic jaundice, alopecia, and possibly hypertophic gingivitis, neurofibromatosis, and telangiectasia. Hormonal effects include acneform eruptions, diffuse hair loss, and decrease of sebum production. Adverse effects exerted via the immune system include: candidiasis, decreased delayed skin-test reactivity, increased viral infections, flare of lupus erthematosus, erythema nodosum, erythema multiforme, photodermatitis, and herpes gestationis. Altered porphyrin metabolism effects include induction of porphyria and of variegate porphyria. Beneficial effects of oral contraceptives include improvement of acne, lessening of premenstrual flaring of aphthous ulcers, and improvement of Fox-Fordyce disease with estrogenic preparations. There is an unclear association between seborrhea, epithelial inclusion cysts, and hidradenitis supporativa and contraceptive therapy.^ieng

Evaluation of d-norgestrel 1.0 mg in cyclic regimen.

PIP: 111 women took a total of 584 cycles of 1.0 mg norgestrel for 21 days out of a 28 day cycle, in a trial of a low-dose progestin-only oral contraceptive, intended to avoid the side effects of estrogen and the menstrual irregularity of mini-pills. This study followed an 18 month blind trial of norgestrel, .5, 1.0 and 1.5 mg in 100 patients, which found the 1.0 mg dose most suitable. 33.6% of these subjects had used pills within the last 90 days, and all were private patients of the Western Gynecological and Obstetrical Clinic, Inc. 97.7% of menstrual cycles before, and 81% during the trial were 21-35 days in length; the mean cycle length was 28.8 days before, and 29.0 days during treatment. Menses lasted a mean of 4.8 days before and 5.6 days during norgestrel. Menstrual flow became lighter in most, but breakthrough bleeding increased from 1.8% to 10%, spotting from 6.3% to 30.7%, and amenorrhea from 4.5% to 11.1%. Dropouts included 10 for bleeding, 5 for weight gain, 3 for acne, and 1 each for edema, generalized somatic complaints, irritability, depression and decreased libido. One pregnancy resulted from patient failure. The authors concluded that, except for the "fastidious," most women should not object to this degree of irregular bleeding, once it becomes "individualized."^ieng