Plan B National Pharmacy Access, OTC Availability Weighed By Barr

Pharmacy access to the Plan B emergency contraceptive could be key to realizing the product's potential in the U.S., Barr Labs CEO Bruce Downey commented during a Nov. 6 earnings call.

Noting that Washington state and California have programs that allow emergency contraceptives to be dispensed by pharmacists in a "behind the counter" setting, Downey said: "I think that approach would provide most of the access that would be necessary to fully develop the product."

Extrapolating use rates in Washington on a national basis, Downey suggested "you get a product that's in the $30 mil.-plus range." He estimated sales in the emergency contraceptive category in the U.S. currently are $13 mil. to $15 mil., divided between the private sector and clinical practice.

He added that "OTC status, which is currently pending...would increase that potential sum. But not a lot. I don't think anybody has a definitive answer about what the potential is."

Barr has said it will continue to pursue an Rx-to-OTC switch for Plan B following its planned purchase of the product from Women's Capital Corp. (¹ (Also see "Barr Plans Move To OTC Market With Plan B Emergency Contraceptive" - Pink Sheet, 6 Oct, 2003.), p. 3). FDA's Nonprescription Drugs Advisory Committee is scheduled to review WCC's switch application for Plan B at a Dec. 16 meeting.

OTC availability of Plan B was highlighted as an optimal means of preventing unwanted pregnancies in a cost analysis report released by New York State Comptroller Alan Hevesi Nov. 6.

A recommendation in favor of the Plan B switch accompanies a study showing expanded access to emergency contraception could save the state $452 mil. annually in health care spending.

"This move, perhaps more than any other, would help women in preventing unintended pregnancies," the report states.

The New York report estimates that 122,000 fewer pregnancies and 82,000 fewer abortions would occur each year if emergency contraceptives were readily available. Resulting savings in state Medicaid costs are estimated at $254 mil. and savings to private insurers would total $200 mil., according to the report.

"The problem is too many women still don't know about emergency contraception and the treatment is still not easy enough to find in many areas of the state," Hevesi said in a same-day release.

To determine potential financial benefits of expanded access to ECs, the Office of the State Comptroller extrapolated 2000 pregnancy and spending figures and projected that expenditures on unintended pregnancies would total roughly $913 mil. in 2003.

The study is based on Medicaid and private health insurance data showing that in the year 2000, there were 224,321 unintended pregnancies in New York.

In addition to urging FDA approval of OTC status for Plan B, the report recommends state policymakers support legislation funding public health education programs that would inform women how to access the regimen.

The "Emergency Contraception Act," introduced in the House and Senate in March 2002, would allocate $10 mil. over a five year-period to establish such programs.

The report also recommends that EC access be provided through advance prescriptions, allowing physicians and nurse practitioners to provide women with prescriptions for ECs to keep on hand.

Access to ECs through telephone prescription is also recommended, "since a physical exam and pregnancy test are not necessary prior to using" the drugs, the report states.

Non-patient specific prescriptions are supported in the report. Such a measure may allow pharmacists and nurses to directly dispense ECs more quickly.

The report also notes that non-patient specific prescriptions have been used successfully in other states, and would "serve as a meaningful measure while awaiting FDA approval of over-the-counter status for [ECs] and, even if one dedicated product attains over-the-counter status, continue to offer women a choice of product."

Plan B requires a woman to take two .75 mg levonorgestrel tablets 12 hours apart and no later than 72 hours after unprotected sex.