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.

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.

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.

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.

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.

The Biden administration’s first Medicare Advantage and Part D regulation is pending review at the Office of Management and Budget. The CMS final rule, titled “Policy and Technical Changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; MOOP and Cost Sharing Limits (CMS-4190),” was received on Nov. 10. It is not economically significant, according to the posting at RegInfo.gov.