Radar on Drug Benefits

So Far, New Therapies Have Limited Impact on ADHD Management

April 26, 2021

In recent months, some innovative treatments have emerged for attention deficit hyperactivity disorder (ADHD), which affects millions of children and is one of the most common neurodevelopmental disorders in childhood. But because those therapies are so new — and in one case, very unconventional — payers appear reticent to change their coverage tactics to accommodate them.

On April 2, the FDA approved Supernus Pharmaceuticals, Inc.’s Qelbree (viloxazine extended-release capsules) for treating ADHD in patients ages 6 to 17 — a therapy that “represents the first novel non-stimulant treatment for ADHD in a decade,” according to the manufacturer.

NOTE: The abstract below is a shortened version of the RADAR on Drug Benefits article “New ADHD Therapies Make Splash, Meet Payer Skepticism.”

By Leslie Small

In recent months, some innovative treatments have emerged for attention deficit hyperactivity disorder (ADHD), which affects millions of children and is one of the most common neurodevelopmental disorders in childhood. But because those therapies are so new — and in one case, very unconventional — payers appear reticent to change their coverage tactics to accommodate them.

On April 2, the FDA approved Supernus Pharmaceuticals, Inc.’s Qelbree (viloxazine extended-release capsules) for treating ADHD in patients ages 6 to 17 — a therapy that “represents the first novel non-stimulant treatment for ADHD in a decade,” according to the manufacturer.

“Qelbree may bring competition to the non-stimulant ADHD market if it continues to show promising data of earlier onset of action compared to Strattera,” says Mesfin Tegenu, R.Ph., CEO of RxParadigm. Both Qelbree and Eli Lilly and Co.’s Strattera (atomoxetine), which are non-stimulants, have the advantage of avoiding the abuse and addiction risks posed by other ADHD therapies like Ritalin (methylphenidate) and Adderall (amphetamine/dextroamphetamine).

“Based on current Phase III studies, Qelbree began to show improvement after the first week of therapy through the end of the study at week 7, while Strattera requires 4 to 8 weeks to begin working,” Tegenu points out. Ultimately, he adds, “more information will be needed before we see a shift in payers’ attitude towards Qelbree.”

Qelbree is not the only new ADHD treatment to make headlines in the last year. In June 2020, the FDA approved the “first game-based digital therapeutic device to improve attention function in children with ADHD.” The EndeavorRx device, manufactured by Boston-based Akili Interactive, is available only by prescription and is designed for patients between 8 and 12 years old who are primarily inattentive or combined-type ADHD with a demonstrated attention issue. The device currently is not covered by health insurance, according to the EndeavorRx website, although the manufacturer said it is trying to change that.

Even with these new treatments coming to market, Tegenu points out that behavioral therapy is generally recommended as the first-line treatment for preschool-age children who have been diagnosed with ADHD. That may be “followed by the addition of methylphenidate based on tolerability profile, if warranted,” he says.

Similar to their younger counterparts, children and adolescents who are in elementary school and older “may receive behavioral therapy and stimulant medication to help achieve target goals and improve symptoms,” Tegenu adds.

Uber Partnership With ScriptDrop Heats Up Rx Delivery Space

April 19, 2021

Uber, seeking to expand its prescription delivery business nationwide, has inked a deal with pharmacy home delivery start-up ScriptDrop that makes Uber the default delivery app for a network of grocery store and independent pharmacies that spans 37 states.

The partnership, which is just one of many corporate moves in the pharmacy delivery space, positions Uber to take advantage of the vastly increased consumer demand for home delivery services sparked by the pandemic.

NOTE: The abstract below is a shortened version of the RADAR on Drug Benefits article “Uber-ScriptDrop Deal Stirs Up Already Active Rx Delivery Space.”

By Jane Anderson

Uber, seeking to expand its prescription delivery business nationwide, has inked a deal with pharmacy home delivery start-up ScriptDrop that makes Uber the default delivery app for a network of grocery store and independent pharmacies that spans 37 states.

The partnership, which is just one of many corporate moves in the pharmacy delivery space, positions Uber to take advantage of the vastly increased consumer demand for home delivery services sparked by the pandemic.

It also puts PBMs in the position of playing some catch-up on developing and promoting home delivery services beyond traditional mail order, says Ashraf Shehata, partner and advisory industry leader for health plans at consulting firm KPMG.

The immediate question, he says, is “as we start to see these home delivery options, are we really starting to see the digital world competing against the bricks-and-mortar world, plus delivery? That’s really the dynamic tension here. And I think that there are a lot more chapters to be written in that story.”

But Uber is far from the only company investing in this space, and opportunities for partnerships and acquisitions are plentiful. Meanwhile, PBMs do not appear to be reacting much to the changes in prescription delivery and purchasing patterns, says David Dross, national practice leader for managed care pharmacy consulting at Mercer. “It feels like, at this juncture, PBMs are honestly not seeing enough threat to do something different,” he says.

Competition from Amazon and its subsidiary PillPack hasn’t turned out to be as big of a threat as some in the industry had feared, at least so far, Dross notes. Shehata also doesn’t see Uber and Amazon as immediate threats to PBMs and mail-order pharmacy.

However, Peter Manoogian, principal at the consulting firm ZS Associates, notes that that there are multiple deals that touch on prescription delivery, and PBMs definitely are watching. “I think my clients — PBMs and mail order pharmacies — they are thinking about the threat that an Amazon could bring in the Rx delivery space, because the Amazon delivery model is so intertwined into so many people’s lives,” he says.

Many prescription benefit plans already offer same-day or next-day delivery for pharmaceuticals, Manoogian says. However, they haven’t always promoted that capability well enough that members know to use it, he says: “PBMs do need to ensure they get out the right communication to members.”

Evernorth Drug Trend Report Highlights Pandemic’s Impact on Utilization

April 12, 2021

In the 2020 Drug Trend Report recently released by Evernorth, the Cigna Corp. division added yet another chapter to the growing volume of data detailing the profound effects that the COVID-19 pandemic has had on health care.

On the one hand, the massive amount of deferred routine and elective health care utilization had a dampening effect on the number of new medication users that Evernorth — which houses the PBM Express Scripts — recorded in 2020. New users of asthma/COPD medications dropped the most, by 7.1% year over year, likely reflecting the avoidance of clinical settings among a group that is at particular risk of contracting severe COVID-19.

NOTE: The abstract below is a shortened version of the RADAR on Drug Benefits article “Evernorth Drug Trend Report Shows Varied Pandemic Impacts.”

By Leslie Small

In the 2020 Drug Trend Report recently released by Evernorth, the Cigna Corp. division added yet another chapter to the growing volume of data detailing the profound effects that the COVID-19 pandemic has had on health care.

On the one hand, the massive amount of deferred routine and elective health care utilization had a dampening effect on the number of new medication users that Evernorth — which houses the PBM Express Scripts — recorded in 2020. New users of asthma/COPD medications dropped the most, by 7.1% year over year, likely reflecting the avoidance of clinical settings among a group that is at particular risk of contracting severe COVID-19.

Yet for commercial plans managed by Evernorth, the overall drug utilization trend increased by 3.1%, compared with just 1.4% in 2019.

“We saw higher utilization of prescription drugs to treat mental health issues associated with the pandemic — anxiety, insomnia, and depression,” says Evernorth Chief Innovation Officer Glen Stettin, M.D. “Among people with previously diagnosed and common chronic conditions, such as diabetes, high blood pressure and heart disease, many of which are risk factors for hospitalization and death from COVID-19, we also saw an increase in utilization. This utilization was driven by higher medication adherence, itself a result of more people choosing to fill their medication for 90 day vs. 30 day supplies, and the convenience and safety of having their medication delivered to their homes.”

The overall use of diabetes drugs, for example, increased by 7.4%, while utilization of asthma/COPD medications and anticoagulants each ticked up by 6.6%. To respond to the rising demand, Evernorth said it ordered significantly more albuterol.

Similarly, “when we saw spikes in prescriptions for treating COVID-19 inappropriately with hydroxychloroquine, we worked to protect the supply for people who truly needed it to treat rheumatoid arthritis and lupus,” the report said.

Evernorth’s report also included statistics that are typical of drug trend reports in more normal years. The Cigna division reported 4% total trend across its commercial plans, 3% trend in Medicare, 1.4% in Medicaid and 5.5% in health insurance exchange plans.

“Adverse selection likely played a small part in driving higher trend for health exchange plans,” the report suggested. “Of the top five classes, four are driven primarily by specialty medications, and the difference in prevalence rates among these classes compared to commercial plans is very small.”

PBM Regulation, Rebate Rule Are High on Legislative Agenda

March 31, 2021

As a new bill introduced by Sen. Bernie Sanders (I-VT) indicates, Congress is once again looking seriously at tackling drug pricing reform. D.C. insiders say that Democrats could pursue big changes to PBM regulation and Medicare’s ability to negotiate drug prices.

Also, Congress could repeal the Trump administration’s so-called “rebate rule,” which would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs and Medicare Part D plans.

NOTE: The abstract below is a shortened version of the RADAR on Drug Benefits article “PBM and Part D Reform Could Be on Legislative Agenda.”

By Peter Johnson

As a new bill introduced by Sen. Bernie Sanders (I-VT) indicates, Congress is once again looking seriously at tackling drug pricing reform. D.C. insiders say that Democrats could pursue big changes to PBM regulation and Medicare’s ability to negotiate drug prices.

Also, Congress could repeal the Trump administration’s so-called “rebate rule,” which would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs and Medicare Part D plans.

Each of H.R. 3 , the new bill from Sanders, and a Senate bill sponsored by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) would implement out-of-pocket spending caps for Part D beneficiaries and considerably change how costs are divided up in the catastrophic phase of coverage. In each bill, Medicare would pay less, enrollees would pay nothing, and manufacturers and plan sponsors would pay more in the catastrophic coverage phase. H.R. 3 also would mandate more drug price transparency from manufacturers, allow HHS to negotiate prices for covered drugs, and set the maximum price for a drug at 120% of the average of prices in Australia, Canada, France, Germany, Japan and the United Kingdom.

Dan Mendelson, founder of Avalere Health, says that lowering drug prices is a popular policy.

“They need to pass something if they do it at all, because next year it’s going to be the run-up to the [2022 midterm] election,” Mendelson observes. “What sits on the other side of that is that these laws are exceedingly difficult to pass. I think there’s…an intensified support for the pharmaceutical industry given their incredible performance in getting these COVID vaccines to market so quickly. And they are a force of nature when it comes to lobbying, so…it’s likely that this stuff will get tempered a lot.”

Further complicating matters is Democrats’ narrow majority in the Senate. A standalone drug reform bill is unlikely to garner support from enough members of the upper chamber.

As the American Rescue Plan was passed through the budget reconciliation process, eliminating the rebate rule is likely to be part of the next package. The rebate rule would be costly but hasn’t actually been implemented, so eliminating it would create a massive savings on paper without the political cost that would come from cutting a real program of similar scale.

New Administration’s Stance on Copay Accumulators Remains Unclear

March 29, 2021

Thanks to recent regulatory moves and the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector.

Copay accumulators work by preventing any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Their close cousin, copay maximizers, take the total amount of a manufacturer’s copay offset program and divide it by 12, and that amount becomes the new monthly copayment for all patients on any given drug over the course of a year.

NOTE: The abstract below is a shortened version of the RADAR on Drug Benefits article “How Will Biden Administration Handle Copay Accumulators?

By Leslie Small

Thanks to recent regulatory moves and the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector.

Copay accumulators work by preventing any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Their close cousin, copay maximizers, take the total amount of a manufacturer’s copay offset program and divide it by 12, and that amount becomes the new monthly copayment for all patients on any given drug over the course of a year.

From insurers’ perspective, the goal of copay accumulators/maximizers is to help steer patients toward lower-cost drugs. However, copay accumulator programs have been fiercely criticized by the pharmaceutical industry and patient advocates, who argue that they lead to higher costs for consumers and thus limit access to life-saving medications.

Data collected by AIS Health’s parent company, MMIT, show that copay accumulators and maximizers are gaining steam across the commercial insurance space. Of insurers covering a collective 127.5 million lives, 41% had implemented a copay accumulator program and 32% had implemented a copay maximizer program prior to 2020, and another 26% and 24%, respectively, implemented such programs in 2020.

Recent revisions to federal regulations may be contributing to the increasing prevalence of copay accumulators. In its Notice of Benefit and Payment Parameters (NBPP) for 2021, CMS allowed non-grandfathered group and individual market plans to use copay accumulator policies even when a generic equivalent to a drug isn’t available.

A Feb. 23 analysis from Avalere Health also pointed to a December 2020 rule aimed at facilitating value-based contracts for prescription drugs in Medicaid managed care, which “created new risks for manufacturers when copay accumulator or maximizers are applied to their products.”

“They’ve definitely introduced new uncertainties and complexities into the market,” Mark Gooding, a principal at Avalere and co-author of the report, says of the regulatory developments related to copay accumulators.

Both regulations were finalized under the Trump administration, and therefore could be revised by the Biden administration. According to Gooding, it’s not yet obvious what stance the administration will take. “It’ll be interesting to see; we are still getting a sense of how new leadership at HHS and CMS view the role of accumulators and the risk that they pose to patient access and affordability,” he says.