Christina Mattina

, the Supreme Court ruled Thursday that the Affordable Care Act (ACA) will stand, as plaintiffs seeking to declare the law unconstitutional did not have standing. The decision was delivered by Justice Stephen Breyer.

In the decision, the 3 justices appointed to the Supreme Court by then-President Donald Trump—Amy Coney Barrett, Neil Gorsuch, and Brett Kavanaugh—split their votes. Kavanaugh and Barrett joined the majority. Gorsuch was in dissent, signing on to an opinion from Justice Samuel Alito.

It is the third time the landmark law has survived a constitutional challenge since it was signed in 2010.

 was whether the ACA’s individual mandate remained constitutional after Congress set the penalty to $0 in the 2017 tax overhaul bill, and if not, whether the rest of the ACA’s provisions could be severed.

But there were also questions as to whether the plaintiffs had the standing to file the sui, which was brought by a coalition of Republican states and with the support of the Justice Department under the previous administration.

During the oral argument last fall, the justices appeared dubious that the court should strike down all or parts of the ACA, even if the mandate was found to be unconstitutional.

Breyer wrote in the decision that the states and people who filed a federal lawsuit “have failed to show that they have standing to attack as unconstitutional the Act’s minimum essential coverage provision.”

In dissent, Alito, who dissented in the earlier 2 cases, wrote, “Today’s decision is the third installment in our epic Affordable Care Act trilogy, and it follows the same pattern as installments one and two. In all three episodes, with the Affordable Care Act facing a serious threat, the Court has pulled off an improbable rescue.”

If the law had been struck down, numerous efforts and initiatives to improve access to health care, improve quality, and increase value-based care (VBC) would have lost their legal underpinning, including Medicaid expansion; protections for individuals with pre-existing health conditions; no-cost preventive services; a pathway for approval for 

 in the United States; and the Center for Medicare and Medicaid Innovation, which fosters alternative payment arrangements in Medicare and Medicaid to help drive VBC.

One of the most popular provisions of the ACA allows young adults to remain on their parents’ health plans until age 26.

Between 2010 and 2016, the number of nonelderly uninsured adults fell 41%, from 48.2 million to 28.2 million.

Earlier this month, the Biden administration announced that 31 million Americans have health coverage through the ACA, including 1.3 million who enrolled in marketplace plans after February and 14.8 million people enrolled in Medicaid as a result of expansion of the program in December 2020 as part of the American Rescue Plan.

“Today’s Supreme Court ruling once again underscored the incredible strength of the ACA. A record 31 million people have enrolled in health care through the law – 1.2 million more signed up using the special enrollment period, open through 8/15,” the White House tweeted Thursday.

In December 2018, a federal judge in Texas ruled that when the penalty for not having health insurance was removed, the individual mandate became unconstitutional, and without the individual mandate, the rest of the ACA is invalid because the mandate was “essential” to the health law.

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In a 7 to 2 decision, the Supreme Court ruled Thursday that the Affordable Care Act (ACA) will stand, as plaintiffs seeking to declare the law unconstitutional did not have standing.

Supreme Court Tosses Challenge to ACA for Lack of Standing

There are a number of new biologic options for treating psoriasis, but undertreatment is still a concern, and more long-term data are needed, according to Junko Takeshita, MD, PhD, MSCE, of Perelman School of Medicine at the University of Pennsylvania.

Takeshita, who is an assistant professor of dermatology and epidemiology, began her presentation at the National Association of Managed Care Physicians Virtual Spring Managed Care Forum with an overview of this chronic inflammatory skin disease. Plaque psoriasis is the most common type, affecting 80% of the 7.5 million patients with psoriasis in the United States. 

Although psoriasis appears to be more prevalent in White individuals, Black patients are more likely to have moderate to severe disease, and non-White patients are more likely to have undiagnosed psoriasis.

Treatment approaches are generally decided by disease severity, with mild psoriasis treated with topical therapies and moderate or severe disease treated with phototherapy and systemic therapies, which can be orals or biologics. An approach proposed by the International Psoriasis Council classifies patients as candidates for either topical or systemic therapy based on their level of body surface area involvement, psoriasis presence involving special body areas, and past failure of topical therapy.

Biologics have become the mainstay of therapy for moderate and severe disease, explained Takeshita, with therapeutic targets including tumor necrosis factor (TNF), interleukin (IL)-23, IL-12, IL-17A, and IL-17 receptors. The Psoriasis Area and Severity Index (PASI) end points are used to show levels of improvement, and these have been adapted as treatment options improve.

“PASI 75, which corresponds to at least 75% improvement in PASI score, has traditionally been the gold standard measure of drug efficacy, but with our increasingly efficacious treatments, PASI 90, or at least 90% improvement, rates are increasingly being reported and used as a primary measure of efficacy,” Takeshita explained.

She emphasized this point by showing slides with head-to-head trial results comparing the efficacy of various treatment options. For instance, the IL-17A inhibitor secukinumab was shown to have a statistically significantly higher proportion of patients achieving PASI 90 and even PASI 100 over 52 weeks compared with the IL-12 and IL-23 inhibitor ustekinumab. IL-23 inhibitors risankizumab and guselkumab have also shown superior efficacy to ustekinumab, and guselkumab appears to have superior long-term efficacy to secukinumab, which spurred a quicker response early in the trial before guselkumab caught up at around the 20-week mark.

The general takeaway from all these trials is that biologics are more efficacious than oral systemic drugs, and that newer treatments are generally more efficacious, although the incremental differences between them are relatively small, Takeshita said.

Real-world effectiveness for each of these options is generally lower than is reported in clinical trials, which may be due to differences in adherence or because patients seen in clinics may be sicker than the trial populations.

Recommendations for treatment selection can vary based on a patient’s comorbidities; for example, those with multiple sclerosis should not take TNF inhibitors, whereas those with Crohn disease should not take IL-17 inhibitors. Prescribers can also select a therapy based on its ease of administration, rapid onset of response, or flexible dosing options for patients who are obese.

Takeshita dedicated a part of her presentation to updating the audience on recommendations around psoriasis in the context of the COVID-19 pandemic. While psoriasis itself does not seem to be a risk factor for worse COVID-19 outcomes, those with severe psoriasis are more likely to have comorbidities that do increase that risk, such as obesity and hypertension. Fortunately, investigators have not seen strong signals of increased risk from immunomodulatory treatments of psoriasis, but the data have limitations and it’s still unknown whether certain mechanisms of action are more risky.

In the meantime, the National Psoriasis Foundation recommends that patients without COVID-19 should continue their psoriasis therapy as scheduled in most cases, and they should take the first vaccine made available to them.

Finally, Takeshita discussed the promise of a patient-centered treatment approach for psoriasis. “With all of the advancements in psoriasis treatment over the last decade or so, we really have a great opportunity to make a major impact in helping to improve the lives of our patients living with this chronic disease. In order to do this, we need to make sure to align our treatment goals with what matters to our patients,” she said.

Psoriasis is a highly stigmatizing disease with serious impacts on mental and physical functioning, and increasing PASI clearance scores are associated with increasing proportions of patients saying their psoriasis has no impact on their quality of life.

However, most patients with moderate and severe psoriasis are undertreated, with 55% and 52%, respectively, reporting that they use only topical therapy and 32% and 27% not taking any prescription treatment at all. Takeshita also cited her research showing that Black patients and individuals with higher out-of-pocket drug costs are less likely to receive biologic therapy.

Treat-to-target approaches can help focus clinical care on periodic assessment and adjustment until a goal is reached, and these targets can also be used in value-based care efforts. The Merit-based Incentive Payment system (MIPS) includes a measure with several psoriasis outcome targets, making it the first dermatology outcome measure in MIPS.

“It will be important for us to assess if a treat-to-target approach truly improves patient outcomes, and hopefully the collection of this data through MIPS and through other means will help us to identify this,” Takeshita concluded. “Specifically, we need to understand if this approach improves patient outcomes without significantly increasing potential side effects or other adverse outcomes that may be associated with treatment escalation.”

There are a number of new biologic options for treating psoriasis, but undertreatment is still a concern, and more long-term data are needed, according to Junko Takeshita, MD, PhD, MSCE, at the National Association of Managed Care Physicians Virtual Spring Managed Care Forum.

Despite Expanding Array of Psoriasis Treatments, Opportunities for Improvement Remain

Now that investigators have a better understanding of the biological mechanisms of migraine, new treatment and prevention options are making their way to patients and fueling an exciting time for the field, according to a presenter at the 

National Association of Managed Care Physicians Virtual Spring Managed Care Forum

Andrew Charles, MD, professor of neurology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and director of the UCLA Goldberg Migraine Program, kicked off his talk by outlining the burdens of migraine as a public health issue. It is the second leading cause of time spent disabled worldwide, according to the World Health Organization, and is often comorbid with other issues like depression, anxiety, and neck pain, placing migraine at the hub of the most disabling disorders on the planet.

Charles spoke of the traditional ideas about migraine that had to be dispelled to set the stage for new therapies. The vascular theory—that spasms and vasodilation of blood vessels cause migraine—has been around for decades, but recent research has shown that dilation is neither necessary nor sufficient to explain the condition, and investigators have begun to understand migraine as so much more than just about blood vessels. In addition to the debunking of the vascular theory, the multifaceted symptoms of migraine and the involvement of different brain structures throughout an attack have given rise to the idea of migraine as a “complex neurovascular event involving multiple brain regions and symptoms,” Charles said.

Diagnosis of migraine has also evolved in recent years, as more providers are moving away from using the complex 

International Classification of Headache Disorders

 criteria toward a simplified 3-question screener, ID Migraine, which asks patients simple questions about photophobia, impairment, and nausea. This screening has good specificity and sensitivity, as 93% of those who answer “yes” to at least 2 of the questions have migraine.

Once a diagnosis is in place, clinicians and patients work together to identify triggers, but Charles cautioned that some supposed triggers may actually be symptoms (eg, bright light may seem to be a trigger, but photophobia is an early symptom of a migraine attack). In terms of lifestyle changes, he emphasized that a focus on achieving consistency in one’s diet, sleep, caffeine intake, and exercise is more realistic and effective than radical changes.

The go-to acute therapy for migraines is the triptan class, but for patients whose migraines are interfering with their daily lives despite acute treatment, preventive therapies are available. Interestingly, there are no real biomarkers indicating which patients will respond to which therapy, so prescribers tend to choose based on patients’ other comorbidities. For instance, a patient who needs to lose weight may want to try the antiepileptic drug topiramate, whereas one with insomnia may see benefits from an antidepressant such as amitriptyline.

Recent advances have brought new migraine-specific therapies to the market. Lasmiditan is a selective 5HT1F agonist that can be used for acute treatment in place of a triptan, especially for those with cardiovascular disorder, in whom triptans are contraindicated.

Another major breakthrough was the realization of the role of calcitonin gene-related peptide (CGRP) in migraine. “There’s a very solid foundation of evidence supporting the use of therapies targeting CGRP,” Charles said, including that CGRP administration can trigger a migraine attack, showing that it is not just correlated but actually a causative event.

There are now 2 small-molecule CGRP receptor antagonists approved by the FDA for acute migraine treatment, ubrogepant and rimegepant, and these have the strengths of a longer half-life than most triptans and no vascular contraindications.

Additionally, there are now 4 large-molecule monoclonal antibodies (mAbs) in use: erenumab, galcanezumab, fremanezumab, and eptinezumab. They were approved by the FDA starting in May 2018. Unlike the small molecules, these agents have high target specificity, a longer half-life, and different methods of administration (subcutaneous or intravenous rather than oral).

Charles noted that the real-world experience with these drugs has shown that their impressive efficacy even exceeds that seen in clinical trials. “We’ve heard the words ‘my life has changed’ more over the last 3 years than over the last couple of decades within our practice,” Charles said.

Looking to the horizon, he noted that the “gepant” small-molecule CGRP drugs are currently in trials to test whether they are effective for migraine prevention. The major questions remaining in the field of migraine center around prioritizing treatments for migraine and predicting therapeutic response to the various options.

“These are very, very exciting times for those with migraine and those of us who take care of the millions of people in this country who suffer from this disabling disease,” he summarized.

Now that investigators have a better understanding of the biological mechanisms of migraine, new treatment and prevention options are making their way to patients and fueling an exciting time for the field, according to a presenter at the National Association of Managed Care Physicians Virtual Spring Managed Care Forum.

New Understanding of Migraine Biology Paves Way for Innovative Therapy Options

With the costs of biologic drugs increasing, biosimilars have emerged as an attractive option for containing costs and expanding access to treatment. However, some barriers to wider uptake still need to be addressed, according to a presentation at the National Association of Managed Care Physicians Virtual Spring Managed Care Forum.

Sanjiv S. Agarwala, MD, professor of medicine at Temple University, explained that biologics have revolutionized the treatment of serious conditions, including cancer, over the past few decades. However, costs are a pressing issue for all providers and biologics are a major culprit, accounting for half of Medicare’s drug spending in 2018.

As a melanoma specialist, Agarwala has used biologics for a long time, and they have “changed melanoma care completely and are curing people, but the cost is tremendous. Biologics are a major factor in both the success of cancer treatment and also the costs.”

Enter biosimilars—highly similar, though not identical, versions of biologics that are derived from living sources and have a complex manufacturing process. It’s important to note that biologics cannot have generics because they are too complicated, and in fact the biologics themselves undergo natural variability with time, making an identical copy of a biologic unnecessary because even the reference drug is not identical to itself over time.

That understanding has given rise to the current biosimilar approval pathway in which sponsors must only provide evidence that their drug candidate is not significantly different from the reference in terms of efficacy and safety. They are not required to repeat the clinical trials establishing the drug’s benefit or prove superiority over a placebo; instead, clinical studies are conducted with sensitive end points designed to detect any difference from the reference.

Agarwala outlined some unique issues relevant to biosimilars, including interchangeability, which would allow pharmacists to substitute a prescribed drug with a biosimilar but requires many different study designs; no biosimilars have received an interchangeable designation from the FDA yet. The naming of biosimilars also holds potential for confusion, which is why the FDA adopted rules using the core name and a unique suffix.

Aside from approval, there are also challenges to biosimilar uptake in the reimbursement landscape. Although the FDA has approved dozens of biosimilars, far fewer are actually available on the market due to ongoing litigation. Also, the “rebate trap” that occurs when manufacturers of higher-priced drugs offer rebates for preferred status can muddy the waters of cost savings by allowing health systems to actually pay less for expensive biologics than for biosimilars.

However, there is increasing recognition among architects of value-based care programs that biosimilars can improve affordability, access, and outcomes. The lower price point of biosimilars can enable additional doses of biosimilars to be given to more patients in need.

Education and familiarity are key in helping providers and patients become more comfortable with biosimilars, Agarwala said. In oncology, for instance, prescribers are more willing to accept biosimilars for palliative care rather than curative treatment because they may feel like they have only one shot at curing a patient’s cancer. Misperceptions around biosimilars can lead to uncomfortable conversations with patients who receive a biosimilar that does not improve their outcome and feel that the reference product would have worked better, when in fact the biosimilar and the reference have the same level of efficacy.

While reports have predicted large cost savings from biosimilar uptake, right now we have too little experience to assess their effect on lowering biologic spending. “This mixture of collecting data to show that costs are going down and more people are getting access to it, coupled with the fact that these are fair to use—you’re not using some snake oil here; these are actual drugs that the FDA regulates how they can be approved—will help us,” Agarwal said.

He also predicted that biosimilar access will expand in the near future more quickly than it has been so far, due to the fact that biologics are everywhere—no longer just for rare diseases, they’re now in the mainstream of care and on everyone’s radar.

“This problem is not going away. Biologics are going to be the ones that cure cancer for us one day, so we’d better be ready to make them more affordable for everybody,” Agarwal concluded.

Christina Mattina

Articles

Supreme Court Tosses Challenge to ACA for Lack of Standing

Despite Expanding Array of Psoriasis Treatments, Opportunities for Improvement Remain

New Understanding of Migraine Biology Paves Way for Innovative Therapy Options

Overcoming the Unique Hurdles to Biosimilar Uptake in Oncology