The FDA recently approved the first long-acting regimen for the treatment of HIV in adults. The dosing schedule could help with adherence in a condition where that is particularly crucial. However, some potential challenges exist with the medication, including whether health plans actually will cover it.

On Jan. 21, the FDA approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine) for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in people who are virologically suppressed on it with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.

More than one in three nonelderly adults reported delaying or forgoing at least one type of health care service because of concerns about being exposed to the coronavirus or because a provider limited services during the pandemic, according to an Urban Institute study. Rates of delayed or forgone care were particularly high among adults with mental health conditions. Dental care was the most common type of health care adults chose to postpone or skip. The study also suggested that almost 33% of the adults who delayed or went without care reported a negative effect on their health, ability to work or ability to perform other daily activities.

Thanks to recent regulatory moves as well as the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector. However, it’s still unclear how the Biden administration will approach the issue, industry experts say, so stakeholders on both sides of the debate should prepare for more uncertainty.

Ohio recently cleared a key hurdle in its plan to revamp how Medicaid enrollees’ pharmacy benefits are managed, choosing Gainwell Technologies as the single PBM that will replace big-name firms including Cigna Corp.’s Express Scripts, CVS Heath Corp.’s Caremark, UnitedHealth Group’s OptumRx and Centene Corp.’s Envolve Pharmacy Solutions.

Ohio’s 2.4 million Medicaid drug lives are currently managed by five PBMs, which contract with both the state and its managed care plans. Gainwell Technologies will take over as the state’s single PBM in 2022, the beginning of a 7.5-year contract. Ohio is also rebidding its Medicaid managed care contracts for 2022, but it’s unclear when awards will be unveiled.

Understanding a therapeutic area can be challenging, and more so because the health care ecosystem is constantly evolving. Payers are continually seeking innovative ways to contain costs on drug spend, regulators are implementing strategies to better control the pharma industry, and prescribers are facing administrative burdens associated with getting a patient on therapy — all while new and innovative treatments are coming to market.

At least two-thirds of health insurance plans offered in the Affordable Care Act marketplaces in 32 states include a copay accumulator adjustment policy (CAAP), which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits, according to a recent study by The AIDS Institute. Meanwhile, the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey showed that large companies are increasingly adopting copay accumulator programs to reduce prescription drug costs, as 49% of employers said they either had such a program in place in 2020 or were adding one in 2021, and another 14% planned one for 2022-2023.

UnitedHealthcare (UHC), the health insurance unit of UnitedHealth Group, Inc., is the largest health insurer in the U.S., offering products across all sectors. Nationally, UHC is the top insurer in the group risk, administrative services only (ASO) and Medicare Advantage (MA) markets. As of March 2021, United controls a whopping 26.7% of the national MA market, and has expanded its presence significantly year over year since 2018.

The FDA is conducting an industrywide evaluation of drugs with indications given accelerated approval in an effort to determine whether confirmatory clinical trials verified the therapies’ clinical benefits. Manufacturers already have withdrawn indications approved in the U.S. for four drugs, and an upcoming meeting will scrutinize six additional indications. It’s important that the agency speed approvals of cancer drug indications if they look promising, contend experts, but it’s equally important that the FDA confirms their efficacy.

One year into the COVID-19 pandemic, the U.S. has three effective vaccines with Emergency Use Authorizations (EUAs), and manufacturers are considering post-pandemic plans for when these vaccines transition into the commercial market, according to experts at consulting firm Avalere Health.

To date in the U.S., the federal government has purchased vaccine doses for distribution to the states. But that’s likely to change in the next year or two, said Avalere’s Loren Becker, associate principal of vaccine policy and market access.