Radar on Drug Benefits

A new biologic for severe asthma, a drug for anemia related to chronic kidney disease (CKD) and a long acting pre-exposure prophylaxis (PrEP) for HIV-1 are among the first-in-class therapies featured in OptumRx’s Q1 2022 Drug Pipeline Insights Report. In addition to these new drugs, the PBM also calls attention to the likelihood of more COVID-19 vaccines and treatments receiving full approval and additional uses in 2022.

Tezepelumab (brand name Tezspire) was approved by the FDA for maintenance treatment of severe asthma in December 2021. Many biologics for severe asthma are already on the market, but these drugs target asthma subtypes determined by baseline blood eosinophil counts, according to the OptumRx report. On the other hand, tezepelumab, developed by AstraZeneca and AmGen Inc., has been developed with a broader indication.

New drugs are becoming less expensive to bring to market and more profitable at launch, according to a new Deloitte Ltd. white paper. “Cost to bring an asset to market has declined over the past three years, as peak sales forecasts increase,” the report says. “The combined cohort’s average cost to develop an asset was $2,006 million, a decrease of $370 million from 2020....This decrease in 2021 compared to 2020 is due mainly to the overall increase in the number of assets in the late-stage pipeline.” However, the report also notes that this figure is “an increase of $710 million from 2013.” In addition, the cycle time for drug development has increased, especially since the start of the pandemic.

New Hampshire is the latest state to settle its suit against Centene Corp, accepting $21 million from the Medicaid-focused carrier. More than a dozen states have sued the health insurer, accusing Centene of mismanaging their Medicaid programs’ pharmacy benefits. As with the other settlements, in the New Hampshire agreement Centene denied it was liable for any wrongdoing or violations of federal or state statute. The insurer has paid out more than $241 million in settlements with Arkansas, Illinois, Kansas, Mississippi and Ohio out of the $1.25 billion it set aside earlier this year to settle such suits.

Drug pricing reform hit another major roadblock on Dec. 19, as Sen. Joe Manchin (D-W.Va.) said he would not support the Build Back Better Act (BBBA) in its current form. While drug pricing reforms are more likely than many of the dozens of policies included in the bill to pass Congress, D.C. health care insiders tell AIS Health that there still are barriers that could prevent such provisions from ever making it through the Senate.

The BBBA is a massive package that includes most of President Joe Biden’s domestic policy agenda. In its latest form, the bill would cost in the neighborhood of $2 trillion. Manchin, a centrist, has objected to the large price tag. The Senate has an even partisan split, meaning no member of the Democrats’ caucus can vote against the BBBA, as all the chamber’s Republican members have come out against it — giving Manchin (and each other member of the Democratic caucus) an effective veto over the bill.

Earlier this month, as the debate over legal abortion in the U.S. intensified, the FDA removed a requirement that the pregnancy-ending drug mifepristone be dispensed only in clinics, medical offices and hospitals. That move will effectively open the door for “certified prescribers or pharmacies” in states that haven’t already banned the practice to dispense mifepristone by mail.

Experts tell AIS Health, however, that there are more questions than answers about how those loosened regulations will ultimately affect patient access to the controversial drug, as well as how industry players such as health plans and PBMs will be affected.

Since the FDA greenlit the Alzheimer’s drug Aduhelm (aducanumab) in July under the accelerated approval program, concerns over the drug’s hefty price tag and overall effectiveness have been mounting. Now, the drug’s manufacturer, Biogen Inc., has cut the price approximately in half. One expert tells AIS Health that the move may cause private insurers to view the drug slightly more favorably, but they’re still likely to impose coverage restrictions on it. And a health plan trade group signaled that it isn’t impressed by the price cut.

After all, the furor surrounding Aduhelm is not all about price. “The clinical evidence that the FDA relied upon when approving the drug had various limitations, and the findings of the two clinical studies were conflicting,” James Chambers, Ph.D., MPharm., an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, tells AIS Health via email.