Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 36-year-old female with twin gestation.  She was noted to have cervical shortening (without dilation) and her provider has recommended 17 alpha-hydroxyprogesterone caproate (17P) injections to decrease the chance of a preterm delivery. The patients request for authorization was denied by the Health Plan based upon a determination that 17P therapy is experimental/investigational.The 2003 ACOG committee opinion cited above specifically recommends against the use of 17P in patients with multiple gestations and no history of prior preterm birth. Although there are currently placebo-controlled studies investigating the use of 17P with twin and triplet pregnancies, the results are not yet in. We do not have sufficient safety data to support the application of 17P therapy with twin gestation.  Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 36-year-old liparous female with a 30-week twin gestation and a reported history of preterm labor. On exam, her provider noted cervical shortening and an obstetrical ultrasound confirmed a shortened cervix, measuring 19mm (normal is greater than 24mm). The patients provider indicates she is at risk of preterm labor and delivery and recommends 17P injections to decrease her risk.  The providers request for authorization was denied by the Health Plan citing the experimental/investigational nature of the therapy.Approximately 12% of births in the United States are preterm. The women at greatest risk include those with prior preterm delivery, maternal weight less than 50kg, African American race, unexplained vaginal bleeding and multiple gestation. A recent large, randomized, placebo-controlled trial evaluated 17 alpha-hydroxyprogesterone caproate for prevention of preterm birth in a select high risk group of women (i.e. documented history of a previous spontaneous preterm birth at less than 37 weeks gestation). The study showed a significant protection against recurrent preterm birth in these women. However, the study is not applicable to this patient. She has a twin gestation which was an exclusion criterion for the above study, is iparous and therefore has no history of preterm birth, and is already in her 30th week where as the study started 17P injections between the 16th and 20th week.  Therefore there is no data to support treatment with 17P for this patient.Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:  The patient is a 36-year-old female whose pregnancy is complicated by twin gestation. She had an ultrasound at 29+ weeks which revealed a canal length of 19mm. A prior ultrasound had shown a cervical length of 26mm. Her provider has submitted a request for authorization of treatment with 17P injections to decrease the risk of preterm labor. The Health Plan considers this therapy experimental/investigational and has denied coverage.There is continued investigation of 17 alpha-hydroxyprogesterone to decrease the risk of preterm labor in patients with a history of preterm delivery. It appears to be beneficial in that patient population. Its usefulness in patients with no prior history of preterm labor or preterm delivery has not yet been studied. The therapy has not been studied in women with cervical shortening with no history of preterm delivery such as this patient.  As such, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.