Radar on Drug Benefits

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.

Almost 12.8 million adults delayed or did not get prescription drugs in 2018-19 due to costs, including about 3.8 million privately insured nonelderly adults and 2.3 million elderly Medicare beneficiaries, according to a study by the Robert Wood Johnson Foundation and Urban Institute based on 2018–19 data from the Medical Expenditure Panel Survey. About 9.5% of adults who were uninsured all year reported unmet prescription drug needs, compared with 4.9% of Medicare beneficiaries and 5.6% of nonelderly Medicaid enrollees. More than one-quarter of adults with Medicare and 5.3% of privately insured people spent more than 1% of their family incomes on out-of-pocket prescription drug costs. In November, the House of Representatives passed the Build Back Better Act, which includes provisions seeking to bring down drug costs, but the bill’s fate in the Senate is in peril.

In a move that demonstrates just how quickly things can change in the prescription drug world, one of the five drugs featured in OptumRx’s latest quarterly Drug Pipeline Insights Report was rejected by the FDA not long after the report went live in late November. But an expert from the UnitedHealth Group-owned PBM says the other four drugs highlighted in the report remain worth watching — including one that just got the FDA’s blessing.

The rejected drug in question is plinabulin, which was being developed to prevent chemotherapy-induced neutropenia (CIN) — a condition in which patients have an abnormally low amount of a certain type of white blood cell. The FDA sent a response letter to plinabulin’s manufacturer, BeyondSpring Pharmaceuticals, on Dec. 1, stating that the results of a single registrational trial conducted by the company was not sufficiently robust to demonstrate the drug’s benefit and that a second, well-controlled trial “would be required to satisfy the substantial evidence requirement to support the CIN indication,” according to the drugmaker.

Regeneron Pharmaceuticals’ monoclonal antibody treatment for COVID-19 has “diminished potency” when used against the omicron variant, while AstraZeneca plc’s antibody product “retained neutralizing activity” against the new variant. The antibody treatments remain the standard of care for unvaccinated COVID-19 patients with severe disease. Regeneron emphasized that its treatment is effective against the delta variant. However, omicron has become the dominant variant in recent days: the Associated Press reported 73% of new infections last week were omicron.

The FDA’s accelerated approval pathway for experimental therapies has been criticized by practitioners and health insurers in recent months following the controversial approval of Alzheimer’s drug Aduhelm (aducanumab). Aduhelm is just the latest of many experimental therapies that has been approved with limited clinical evidence of efficacy — and payers and independent researchers say the FDA should revamp the process to contain costs.