Lauren Clason | (TNS) CQ-Roll Call
A recent adjustment to a Medicaid calculation may be causing the changes in inhaler products, impacting patients with asthma and COPD in both positive and negative ways.
Three out of four major inhaler manufacturers have decided to limit patient copays for all their inhalers to $35 per month and have also lowered the list prices of some of these products. However, one company has removed two popular children's inhalers from the market, and the alternative is in short supply.
Boehringer Ingelheim, AstraZeneca PLC, and GlaxoSmithKline (GSK PLC) have all introduced a $35 monthly copay limit, which could significantly expand the reach of their ongoing patient assistance programs. The companies have at the same time reduced the list prices for some, but not all, of their inhalers.
The pharmaceutical companies claim that they have made these changes to support patients. Some Democrats in Congress speculate that this was a response to public pressure. However, some experts in drug pricing attribute these changes to a recent adjustment in the Medicaid mandatory drug rebate program. This is the same factor that experts pointed to when insulin manufacturers lowered their list prices, although those reductions were more widespread.
The rebate change may compel drug manufacturers to pay Medicaid in certain cases if list prices on older products exceed inflation. The impact is less significant on asthma products compared to insulin, due to a 2009 prohibition on chlorofluorocarbons in old inhalers, leading to a new wave of inhalers with new patents.
Since the alteration to the Medicaid rebate formula penalizes older drugs with higher prices the most, the newer inhalers are less affected than older insulin products.
“They’re still playing the same game,” said Anna Kaltenboeck, a former Senate Finance Committee staffer under Oregon Democrat Ron Wyden who now leads ATI Advisory’s Prescription Drug Reimbursement Practice. “It just brought the ceiling on the game down a little bit. And they’re sort of diffusing it vis-a-vis the patients by giving them these copay coupons.”
The rebate change is connected to the adjustment in list prices, not copays. Copay limits are crucial as they reduce what patients, including uninsured patients in this case, have to pay. Lowering list prices helps reduce hidden costs borne by the healthcare system.
The rebate modification came into effect in January. In January, GlaxoSmithKline reduced the list price for its Advair Diskus and Advair HFA inhalers, while AstraZeneca also cut the list price of Symbicort. Boehringer Ingelheim is also planning to reduce the list prices for Spiriva HandiHaler and Atrovent HFA.
Other factors such as Medicare's new penalty for raising prices faster than inflation could also be steering these changes.
“Inhalers are prime examples, like insulin, of products where manufacturers have raised list prices over very long periods of time,” said Will Feldman, a pulmonary doctor with Brigham and Women’s Hospital and an instructor at Harvard Medical School.
He said that Boehringer Ingelheim chose to lower prices on an older inhaler, Spiriva HandiHaler, rather than their newer product, Spiriva Respimat, which faces competition from generic versions.
He stated that the Medicaid rebate cap policy change is less likely to affect the newer product, as compared to Spiriva HandiHaler.
Both Boehringer Ingelheim and AstraZeneca denied that the decision to reduce list prices was influenced by the Medicaid rebate.
An AstraZeneca spokesperson stated that they continuously assess market conditions to improve access to and affordability of their respiratory disease medicines for patients' well-being.
In January, GlaxoSmithKline discontinued two inhalers for children, Flovent HFA and Flovent Diskus. Coverage for the authorized generics may vary, and the alternative, Organon’s Asmanex, is currently in short supply due to increased demand.
Feldman referred to the negative impact on patients, stating, “This situation exemplifies the flaws in our pharmaceutical system, resulting in some patients suffering and not receiving the necessary products.”
GlaxoSmithKline did not confirm whether the rebate influenced its pricing changes or the decision to discontinue the two inhalers, mentioning that the branded products had been planned for discontinuation.
A company spokesperson emphasized the company's efforts to increase access and enhance affordability of their medicines through responsible pricing and ongoing commitments.
Implementing copay caps could significantly enhance consumer access, despite the existing patient assistance programs offered by drugmakers. Kaltenboeck highlighted the ongoing access challenges for insulin, despite the manufacturers’ assistance programs.
She noted that people were dying due to lack of insulin, suggesting that copay coupons and patient assistance programs were not reaching enough people.
Public pressure
In January, Senate Health, Education, Labor and Pensions Chairman Bernie Sanders, I-Vermont, singled out the four major manufacturers for investigation into inhaler prices. Following the drugmakers’ announcements to cap copays, Sanders expressed satisfaction, stating that the companies are beginning to realize that Americans are exasperated with exorbitant prescription drug prices.
He acknowledged that the companies are only lowering list prices on some products, but emphasized the significance of copay caps to patients. He also attributed the drug companies’ announcements to the committee’s investigation and public backlash, rather than Medicaid’s rebate program.
“In this instance, we think it’s public pressure,” he said.
In addition, Sanders urged Teva Pharmaceutical Industries Ltd., the remaining major manufacturer yet to cap copays, to do so. He noted that although Teva is smaller and more focused on generics, he hoped the executives would come around.
“He said they are thinking about it.”
Teva did not reply to requests for comment.
In November, the Federal Trade Commission cautioned several drugmakers, including Teva and the other main inhaler producers, that they had incorrectly listed patents in the Food and Drug Administration’s registry called the Orange Book, which can hinder competition from generic competitors.
Teva was among several companies that declined to withdraw any of the patents the FTC contested. On Friday, the FTC took another action against the manufacturer by filing an amicus brief in a patent infringement lawsuit Teva brought against Amneal Pharmaceuticals Inc. for trying to introduce a generic version of its ProAir HFA to market. The FTC argues that the patents Teva is asserting are listed incorrectly.
The issues highlight the larger challenges that lawmakers and regulators still confront in simplifying the complex drug pricing system. The copay caps benefit patients, according to Feldman, but are not nearly sufficient.
“It’s a temporary solution for a problematic drug pricing system in our country,” he said.
The post Experts say that changes in Medicaid rebates are the reason behind the price reductions for inhalers. appeared first on Roll Call.
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