Market access

Access to the abortion pill mifepristone is in limbo following two contradictory court rulings. On April 7, U.S. District Judge Matthew Kacsmaryk ordered the FDA to suspend its approval of mifepristone, which the agency first issued in 2000. The judge gave the Biden administration seven days to appeal.

On April 10, the Dept. of Justice asked the 5th U.S. Circuit Court of Appeals to block the ruling and keep the drug on the market as litigation plays out. On April 12, the court ruled that mifepristone will remain available for now but with new restrictions, including a requirement for in-person doctor visits to obtain the drug. The Biden administration then responded that it would immediately seek emergency relief from the Supreme Court to restore full access to mifepristone.

Meanwhile, states including New York, Massachusetts, California and Washington are rushing to stockpile abortion pills.

The FDA will withdraw Makena (hydroxyprogesterone caproate) from the U.S. market, the agency said April 6. The move follows manufacturer Covis Pharma Group saying on March 7 that it had requested an “orderly wind-down” of the drug from the market. However, “effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” said the agency in its statement. “Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved.”

The decision brings to a close a long-running saga that started more than a decade ago, as well as shines a spotlight on the FDA’s often-criticized accelerated approval pathway.

A review of market access for treatments of adults with chronic obstructive pulmonary disease (COPD) shows that under the pharmacy benefit, about 13% of the lives under commercial formularies are covered with utilization management restrictions. Around 26% of the lives under Medicare formularies are not covered for at least one of the drugs.

While drugs are increasingly hitting the market that address unmet needs and even offer cures for some rare diseases, private insurers are highly concerned about such therapies’ eye-popping price tags, a recent survey indicated. But one prominent payer executive who spoke during AHIP’s Medicare, Medicaid, Duals & Commercial Markets Forum suggested that insurers are better off working collaboratively with drugmakers to ensure prices are tied to value — rather than engaging in an inter-industry war of words.

“More and more we’re seeing drugs come through with limited evidence through accelerated approval processes, which generally is a marker for an unmet need, which is a good thing. But the evidence can be thin,” said Michael Sherman, M.D., executive vice president and chief medical officer of Point32Health. During a March 14 panel at the AHIP forum, Sherman pointed to the example of Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births but failed to prove clinical effectiveness in trials conducted after it received accelerated approval. With the FDA poised to make a final decision on the drug’s status, Clovis Pharma Group recently announced it would voluntarily pull Makena off the market.

Most new drugs covered under Medicare Part D are subject to prior authorization (PA) requirements, largely due to their high launch prices. A recent study published in JAMA Health Forum observed that these policies are frequently inconsistent across payers and may prove too burdensome for patients and providers.

Researchers identified drugs approved between 2013 and 2017 and reviewed the 2020 formularies of the eight largest Part D payers, which cover about 90% of all Part D beneficiaries. They compared PA policies to each drug’s FDA-approved indications and noted if payers mirrored the approved labeling or were more restrictive than the drug’s label. Researchers observed substantial variation in the frequency and type of PA across payers, and they found that about 40% of the new drugs had PA criteria that went beyond the drug’s labeling.

A review of market access for treatments of adults with heterozygous familial hypercholesterolemia (HeFH) shows that under the pharmacy benefit, about 63% of the lives under commercial formularies are covered with utilization management restrictions. Around 47% of the lives under Medicare formularies are not covered for at least one of the drugs.

A review of market access for treatments of primary humoral immunodeficiency (PID) disease shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. Around 43% of the lives under Medicare formularies are not covered for at least one of the drugs.

While drugs are increasingly hitting the market that address unmet needs and even offer cures for some rare diseases, private insurers are highly concerned about such therapies’ eye-popping price tags, a recent survey indicated. But one prominent payer executive who spoke during AHIP’s Medicare, Medicaid, Duals & Commercial Markets Forum suggested that insurers are better off working collaboratively with drugmakers to ensure prices are tied to value — rather than engaging in an inter-industry war of words.

“More and more we’re seeing drugs come through with limited evidence through accelerated approval processes, which generally is a marker for an unmet need, which is a good thing. But the evidence can be thin,” said Michael Sherman, M.D., executive vice president and chief medical officer of Point32Health. During a March 14 panel at the AHIP forum, Sherman pointed to the example of Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births but failed to prove clinical effectiveness in trials conducted after it received accelerated approval. With the FDA poised to make a final decision on the drug’s status, Clovis Pharma Group recently announced it would voluntarily pull Makena off the market.

The FDA is expected to approve several biosimilar medications in the next few years, potentially leading to billions of dollars in savings for payers and patients, according to a recent report from Cardinal Health. However, Bruce Feinberg, D.O., Cardinal Health’s chief medical officer, tells AIS Health that the promise of biosimilars to decrease medication and overall health care costs remains uncertain. He adds that the price differential between biologic drugs and their biosimilars has not reached anywhere near the levels seen between small-molecule medications and their generics.

Feinberg says that “in most of the biosimilars to date, none of the manufacturers have been quite willing to initiate that race to the bottom on price,” in large part due the high costs of producing biosimilars and funding research and development of them. Whereas the introduction of a generic can reduce prices by 90%, Feinberg says “we’re not seeing those kinds of changes [with biosimilars],” claiming the range is usually from 10% to 30% with an average of 15%.

Amid a trend of steep insulin price cuts by Eli Lilly & Co., Novo Nordisk A/S and Sanofi S.A., the state of California said it would develop its own line of affordable insulins with Civica Rx, the nonprofit drug manufacturer that launched in 2020. Experts say that patients will finally see relief from sky-high insulin prices and drug manufacturers will maintain a healthy margin — but they add that PBMs and some payers may actually see the costs of their insulin purchasing increase as rebate revenue decreases.

California and Civica's new insulin line will, according to a Civica press release, be called CalRx and will be sold at "no more than $30 per 10 mL vial and no more than $55 for a box of five 3 mL pre-filled pens." Allan Coukell, Civica's senior vice president of public policy, tells AIS Health, a division of MMIT, that the company expects to start selling the insulin after submitting biosimilars for FDA approval starting in 2024. According to the press release, the Civica insulin line will include biosimilars glargine (which references Sanofi's Lantus), lispro (Lilly's Humalog) and aspart (Novo's Novolog).