Radar on Drug Benefits

Although the approval of Kisunla (donanemab) earlier this month was celebrated by the Alzheimer’s Association as “real progress,” the challenge of getting commercial insurers to cover the drug will likely end up tempering that excitement.

Eli Lilly’s Kisunla, which received full FDA approval on July 2, is a once-monthly, IV-infused treatment for people with early symptoms of Alzheimer’s disease, including mild cognitive impairment and mild dementia. Like the drug Leqembi (lecanemab), which received full approval last July, Kisunla aims to slow the progression of Alzheimer’s by removing amyloid plaques from the brain. (The naturally occurring protein amyloid can create plaques when clumped together, and if those plaques build up excessively in the brain, it may lead to memory and cognitive issues associated with Alzheimer's disease.)

The FDA’s approval last month of Verona Pharma plc’s Ohtuvayre (ensifentrine) provides another treatment option for patients with chronic obstructive pulmonary disease (COPD). While Verona touts Ohtuvayre’s novel mechanism of action and broad indication, and Wall Street analysts expect it to have a major market impact, its price is well above the cost-effectiveness threshold estimated by the Institute for Clinical and Economic Review (ICER), potentially leading to payers balking at covering the product.

Chris Martin, Verona’s chief commercial officer, said on a June 26 conference call that Ohtuvayre’s wholesale acquisition cost (WAC) of $2,950 per month or $35,400 annually “reflects the overall benefit and value to the health care system.” He added that the total annual medical costs associated with COPD are about $50 billion per year in the U.S., while the costs associated with a severe COPD exacerbation are about $26,000.

GoodRx, Inc. has dipped its toes into the booming Humira (adalimumab) biosimilar market with the help of Boehringer Ingelheim (BI), which will offer patients its Cyltezo (adalimumab-adbm) interchangeable adalimumab biosimilar direct to patients through GoodRx. Experts say that while GoodRx is another welcome entrant to the Humira biosimilar fray, the deal is unlikely to capture GoodRx or BI a great deal of market share.

According to a July 18 press release, BI and GoodRx now offer both high- and low-concentration Cyltezo to "anyone with a valid prescription, regardless of insurance status...at over 70,000 retail pharmacies nationwide," at an "exclusive cost" of $550 per two-pack of auto injectors or pre-filled syringes. The companies say that this price "represents a 92% discount from the Humira list price."

Beginning on July 18, Boehringer Ingelheim will offer its citrate-free Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab), at a low cash price available exclusively on the GoodRx website, according to a press release. Both high- and low- concentration versions of the biosimilar, administered in either auto-injectors or pre-filled syringes, will be available at a price of $550 per two pack, a 92% discount from the Humira list price.

Following the launch of Amgen Inc.’s Amjevita (adalimumab-atto), another nine FDA-approved Humira biosimilars entered the U.S. market. Most recently, Teva Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd., and Alvotech launched Simlandi (adalimumab-ryvk) in May. The FDA approved the interchangeable, high-concentration, citrate-free drug in February for nine of its reference drug’s indications.

CVS Health Corp.'s Caremark will pay at least $45 million to the state of Illinois to settle accusations from the state's attorney general, Democrat Kwame Raoul, that the PBM didn’t pass through rebates to the state's health plans. According to a June settlement document obtained by STAT, Raoul accused CVS of "unlawfully depriv[ing] the state" of owed rebates negotiated with manufacturers for prescription drugs. CVS denied mishandling the rebates but still agreed to settle the case.

Vermont Attorney General Charity Clark, a Democrat has filed a lawsuit against The Cigna Group’s Evernorth and Caremark. A July 17 press release alleges that the two PBMs “grant placement on their standard formularies to the prescription drugs with the largest payments from manufacturers and the highest list prices, while excluding lower-cost prescription drugs.” Clark is just the latest state attorney general to target PBMs. Among others, Arkansas Republican Attorney general Tim Griffin recently sued UnitedHealth Group’s Optum Rx and Evernorth over their alleged roles in the opioid epidemic. And in 2023, Ohio Attorney General Dave Yost filed a lawsuit accusing Express Scripts, Prime Therapeutics, Humana Pharmacy Solutions and Ascent Health Services of colluding to drive up drug prices.