Bluebird Bio Inc. disclosed during its second-quarter earnings release on Aug. 14 that it has had only four patients start treatment with Lyfgenia (lovotibeglogene autotemcel), a gene therapy for sickle cell disease (SCD) that the FDA approved in December. While company executives claimed there was still strong patient demand and payer interest for the treatment, Wall Street analysts noted the launch was slower than expected and called into question the ability of the medication to make an impact in the market.

Bluebird executives also said they’re encouraged with the strides they’re making in discussions with payers, but admitted it was “too early to tell” if the drug will run into any coverage issues.

Integrated delivery networks (IDNs) are becoming an increasingly larger stakeholder within the U.S. health care system. As of January 2024, almost 80% of physicians were employees of hospitals/health systems and other corporate entities such as private-equity firms, according to an April report prepared by Avalere Health and commissioned by the Physicians Advocacy Institute. Pharma manufacturers can take steps to enhance their partnerships with these entities, said industry experts at a recent webinar.

With policymakers and industry stakeholders increasingly focused on the cost savings opportunities tied to biosimilars, a new Health Affairs study sheds light on some of the factors that influence uptake of these near-copies of pricey biologic medications.

Among almost 200,000 commercial and Medicare Advantage enrollees who newly initiated one of seven biologic drugs with available biosimilar versions — filgrastim, bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab and rituximab — the share of people initiating a biosimilar increased from 1% in 2013 to 34% in 2022. Patients who were younger than 18 years were less likely to initiate a biosimilar than other age groups. Meanwhile, enrollees in commercial high-deductible health plans were more likely to use a biosimilar, compared with those in MA plans.

A newly approved immune globulin for primary immunodeficiency will bring another option to a class of products that often is plagued by shortages. It is also a crowded space, and payers have several considerations when deciding on the coverage of these agents, say industry experts.

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.

With policymakers and industry stakeholders increasingly focused on the cost savings opportunities tied to biosimilars, a new Health Affairs study sheds light on some of the factors that influence uptake of these near-copies of pricey biologic medications.

Among almost 200,000 commercial and Medicare Advantage enrollees who newly initiated one of seven biologic drugs with available biosimilar versions — filgrastim, bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab and rituximab — the share of people initiating a biosimilar increased from 1% in 2013 to 34% in 2022. Patients who were younger than 18 years were less likely to initiate a biosimilar than other age groups. Meanwhile, enrollees in commercial high-deductible health plans were more likely to use a biosimilar, compared with those in MA plans.

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.)

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.

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.)

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."

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.