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.

As the U.S. continues to grapple with drugs in short supply, a variety of strategies from onshoring production of agents to stockpiling have been proposed. A recent event by The Hill brought together a mix of stakeholders to take a closer look at the situation. Multiple factors are contributing to it, and, thus, one single solution is not going to address the situation, but numerous steps could help alleviate the current, as well as future, shortages, industry experts claimed.

Sponsored by the Healthcare Distribution Alliance, the event, titled “Keeping Pharmacy Shelves Filled: Solutions to Address Drug Shortages,” was held June 25 in Washington, D.C.

The FDA recently approved a new agent for the treatment of primary immunodeficiency. Payers expect it will have a moderate impact on their coverage of other agents in the class, while immunologists also anticipate its availability will affect their prescribing of competing drugs, according to a survey conducted late last year.

On June 13, the FDA approved Grifols Group company Biotest AG’s Yimmugo (immune globulin intravenous, human-dira) for the treatment of primary humoral immunodeficiency in people at least 2 years old. Dosing via intravenous infusion is every three to four weeks, with the first infusion started at 0.5 mg/kg per minute and increasing up to 3.0 mg/kg per minute; afterwards, the maintenance infusion rate is 13 mg/kg per minute. The dosage can be adjusted over time to achieve the desired trough levels and clinical response.

June 7: The FDA expanded the treatment area of Almirall, LLC’s Klisyri (tirbanibulin) from up to 25 cm2 of the face or scalp to up to 100 cm2 for the treatment of adults with actinic keratosis. The agency first approved the microtubule inhibitor on Dec. 14, 2020. Dosing is one unit-dose packet on the face or scalp once daily for five consecutive days. Drugs.com lists the price of five packets of the ointment as more than $1,179.

June 10: The FDA gave another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Kevzara (sarilumab) for the treatment of people weighing at least 63 kg with active polyarticular juvenile idiopathic arthritis. The agency initially approved the interleukin-6 (IL-6) receptor antagonist on May 22, 2017. The recommended dose is 200 mg via subcutaneous injection every two weeks. Drugs.com lists the price of both the 150 mg/1.14 mL and 200 mg/1.14 mL as more than $4,582.

In May, the FDA approved three interchangeable biosimilars that were the first for their reference drugs. With an additional three approvals in June, that brings the total number of biosimilars to 57 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With the three agents approved in May also gaining interchangeability status, that brings the count of interchangeable biosimilars to 15. While the market is certainly heating up, it still is grappling with issues such as expected rebates, maintains one industry expert.

On May 20, the FDA approved the first biosimilars of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept): Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf) and Samsung Bioepis Co., Ltd. and Biogen Inc.’s Opuviz (aflibercept-yszy). On June 28, the FDA approved a third Eylea biosimilar, Formycon AG and Klinge Biopharma GmbH’s Ahzantive (aflibercept-mrbb) for the same indications as the first two agents, but it does not have interchangeable status.

When the biosimilar pathway was first established, it created a two-tier system of biosimilars and interchangeable biosimilars, but multiple attempts have been made recently to level the playing field. In the latest move, the FDA proposed doing away with switching studies for interchangeables. But while the move could bring biosimilars onto the U.S. market faster and result in more competition, industry efforts are divided about whether it could prompt broader payer uptake.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

Safety and efficacy data of generic versions of several drugs, including Pfizer Inc.’s Viagra (sildenafil) and Eli Lilly & Co.’s Cialis (tadalafil), may have been falsified, according to Bloomberg. Bloomberg on July 9 reported that the FDA in June notified drug manufacturers that data from Synapse Labs Pvt. Ltd., an Indian drug researcher, may have been used in hundreds of drugs currently on sale. The FDA was tipped off by European regulators about the problematic data. In an interview with Bloomberg, former FDA inspector Massoud Motamed expressed concerns that the affected drugs may have too much or too little of their active ingredient. However, the FDA has not revealed specifics about which drugmakers used Synapse’s data, citing confidentiality reasons, and has not suspended sales of any drugs — unlike EU regulators, who recommended that member states stop sales of certain drugs. Cherie Duvall-Jones, a spokesperson for the agency, told Bloomberg that "the FDA remains vigilant and will act should we identify safety issues."

The FDA recently took another step toward levelling the playing field between biosimilars and interchangeable biosimilars when it proposed doing away with switching studies for interchangeable products. While the draft guidance may receive some resistance, ultimately it should help provide clarity that all biosimilars are similar in their safety and efficacy, bringing these agents onto the U.S. market faster and prompting more competition among the agents, industry experts maintain.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

Arkansas Attorney General Tim Griffin, a Republican, sued UnitedHealth Group’s Optum Rx and The Cigna Group’s Express Scripts over their alleged roles in the opioid epidemic. In the suit, Griffin accuses the PBMs of profiting from inappropriate opioid prescribing. According to a statement from Griffin’s office, between 2006 and 2014, 1.5 billion “units of addictive opioids” were dispensed in Arkansas, amounting to a rate of 114.6 opioid fills per every 100 Arkansans. The suit alleges that PBMs “increas[ed] opioid utilization by placing opioids on lower tiers of their formularies” and operated online pharmacies that dispensed opioids “while failing to follow state and federal laws on controlled substances.”