Questions Remain about Nonprescription Opill

In July 2023, the FDA approved Opill (norgestrel), the first over-the-counter (OTC) daily oral contraceptive. Perrigo, the company marketing Opill, has indicated that it will be available in 2024. Because it will be sold without a prescription, Opill is widely viewed as holding the promise of increasing access to contraception. Standing in the way, though, may its price and convoluted uncertainties about health insurance coverage because it is an OTC product. There may also be practical problems with how claims will be filed and processed.

Related: FDA Approves First Nonprescription Oral Contraceptive

KFF, the new official name of the Kaiser Family Foundation, issued a report about Opill, OTC contraception and related health insurance and access issues in on Sept. 14. Christopher Robertson, J.D., Ph.D., an associate professor at the Boston University School of Law, and Anna Braman, a student there, published a perspective piece in the New England Journal of Medicine about Opill and financial access issues earlier this month. Here are seven takeaways from those articles.

Medicaid coverage for OTC contraception is spotty

Federal law requires Medicaid programs to cover family planning services without cost sharing but that requirement does not include OTC products or OTC contraception. Seven states — California (starting next year), Illinois, Maryland Michigan, New Jersey, New York and Washington — cover nonprescribed OTC contraception for people covered by Medicaid with state funds. But currently that coverage is specific to emergency contraception — levonorgestrel (sold under the name Plan B One-Step) — or condoms, so it is not clear whether Opill will be covered by Medicaid programs even in those states. California is an exception; the Medicaid coverage it is starting next year is not limited to emergency contraception.

ACA coverage mandate may extend to Opill

The Affordable Care Act requires most private insurers to cover preventive services without cost sharing. That provision of the law is under legal challenge but that initial ruling on that lawsuit did not extend to services recommended by the Health Resources and Services Administration (HRSA), which is part of the Department of Health and Human Services, and HRSA is in charge of services that pertain to women’s health. The HRSA’s recommendation had included the proviso that services were covered “as prescribed” but the “as prescribed” language has been dropped. Although there is still some uncertainty, the ACA coverage should apply to Opill.

Some states require insurers to cover OTC contraceptive

Some states have imposed their own requirements for coverage of OTC contraceptive. Robertson and Braman say 12, plus Washington, D.C., have done so. KFF say it is six. The reason for the discrepancy is not clear. Regardless, these state requirements apply only to state-regulated health insurers and therefore not to the health plans of employers that self-insure. About two-thirds of workers in the country work for employers who self-insure.

Pharmacist prescribing may help broaden access to Opill

According to KFF, 27 states and Washington, D.C., have passed laws that allow pharmacists to prescribe certain methods of contraception, including OTC contraception. The KFF report says pharmacist prescribing could be a way to broaden access to Opill in states where coverage is not required or billing requirements are unclear. But the KFF report also notes that pharmacist prescribing, in general, has gotten off to a slow start for a number of reasons, including the additional training requirements for pharmacists and lack of insurance reimbursement to pharmacists for the time it takes to counsel and evaluate patients.

Claim processing looms as an obstacle

The KFF report says that one national pharmacy benefit manager (PBM) said a prescription is required for a claim for OTC drugs to be adjudicated through its claims system. If Opill is dispensed without a prescription that requirement could bog down billing and reduce access, There some workarounds that pharmacists could use — such workarounds were used by pharmacists who dispensed at-home COVID-19 tests — but pharmacists expressed concern that doing so would trigger PBM audits and perhaps open them up to legal liability, according to the KFF report.

Opill will likely present some adherence challenges

Because it is a progestin-only pills must be taken at the same time every day. If it is taken three hours late, then a backup method of contraception must be used for two days, according to Robertson and Braman. A company called Cadene is developing an OTC progestin-estrogen pill that would not have this requirement.

The price hasn’t been set

Contraception pills cost between $10 and $50 per month. Whether Perrigo will price Opill in this range is not clear, and it might be more expensive.

This story originally appeared on Managed Healthcare Executive.