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4 more psoriasis drugs on the way

Psoriasis costs up 40% in 5 years. Will these drugs help?

Published: May 2022

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What do 4 new psoriasis drugs mean for specialty costs?

We know that the cost of specialty medicines continues to spiral upward. What may be less well-known is that the autoimmune category leads the way. By a lot.

In the last decade, spending on autoimmune treatments has increased 402%.1That’s 75% more than the overall specialty class.

And we can dig a layer deeper.

Among all autoimmune diseases, psoriasis ranks as one of the top three types.2Approximately 6 million Americans experience plaque psoriasis.3

With plenty of treatment options, market analysts expect psoriasis treatment sales to soar. Projections see a 40% increase in just four years. That’s over 5 billion dollars by 2026.4

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  • Expected 40% sales growth in psoriasis market, from $3.82 billion in 2021 to $5.33 billion in 2026.

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Source: Market Data Forecast. North America Psoriasis Drugs Market Research Report (2021 to 2026). Published January 2022. 

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New psoriasis treatments coming

Four new plaque psoriasis drugs could gain U.S. Food and Drug Administration (FDA) approval in 2022.5All of them are different in some way from existing drugs. The drug makers hope differentiation will mean more utilization. Let’s take a closer look at this important drug class.

Psoriasis basics

We don’t know exactly what causes psoriasis. Bur we do know that the immune system and genetics play major roles.6

Normal skin cells grow and shed in about a month. But with psoriasis, this happens in only three or four days. This causes dead skin cells to build up, creating itching, plaques and scales that can appear anywhere on the body.7

Current treatments

The first line of treatment for plaque psoriasis are topical agents (creams or ointments). Light therapy and systemic agents (drugs that involve the entire body), are prescribed when topical therapy is not effective.8

Systemic biologic drugs that target the immune system are increasingly popular.9 There are now at least a dozen biologic medicines approved to treat moderate to severe psoriasis. These include familiar names such as Humira® (adalimumab), Remicade® (infliximab) and Skyrizi® (risankizumab-rzaa).10

Pending new treatments

Here are four drugs that Optum Rx considers strong candidates for FDA approval in 2022. (New drug names are generic designations.)

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  • Table lists the four drugs discussed below, with manufacturer, types and projected approval dates.

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  • Tapinarof, from Dermavant Sciences, expects an FDA decision by May of this year.11

Tapinarof is a non-steroid topical treatment. In trials, it was more effective than placebo. Trials also showed it had limited side effects, which are commonly associated with the widely used steroids.12

  • Topical roflumilast is made by Arcutis Biotherapeutics. It expects an FDA decision in July.13

Roflumilast manages an enzyme called PDE4 that helps regulate inflammation in the body.14One other PDE4 inhibitor — the oral drug Otezla® (apremilast) — is already approved for plaque psoriasis.15In trials, roflumilast significantly reduced the severity of itch compared to placebo. Itch is the most frequently reported symptom with plaque psoriasis.16

  • Deucravacitinib, from Bristol Myers Squibb, expects an FDA decision by September.17

Deucravacitinib is an oral, biologic drug called a Janus kinase (JAK) inhibitor. In trials it was superior against both placebo and an existing drug (Otezla) over the course of one year.18

Analysts caution that the FDA has safety concerns for oral JAK inhibitors as a class.19However, deucravacitinib has not shown similar side effects as existing JAK inhibitors.20

  • Bimekizumab, from UCB, originally expected approval in October of 2021. But COVID-19-related travel restrictions prevented the FDA from inspecting the manufacturing facility as required. A new date has not been set.21

Bimekizumab is an injectable, biologic drug. It performed well against several standard biologic options for severe plaque psoriasis. Comparators included Humira® (adalimumab), Stelara® (ustekinumab) and Cosentyx® (secukinumab).22

Competitive environment

Something to watch is how the phase 3 trials for these drugs were designed. This could have an impact on how broadly or quickly they gain acceptance in the market.

Neither tapinarof or roflumilast were tested against existing drugs in their class. That doesn’t mean they won’t be effective. But they will be entering a topical marketplace that is dominated by existing corticosteroids and vitamin D analogs. Some of these are available as generics for as little as $1,000 per 30-day supply.23

In contrast, both deucravacitinib and bimekizumab were found superior against standard biologic treatments. The cost of these standard treatments is high. The wholesale acquisition cost for Otezla is approximately $4,000 per month.24The wholesale acquisition cost of Humira is approximately $5,000 per month.25

Speaking of prices …

No prices have been announced yet for any of these new drugs. However, we do have some data on how new drugs can impact prices in the psoriasis category.

A 2020 study tracked price increases for self-administered psoriasis therapies over a decade. While the net price of some therapies more than doubled in that period, the net price of other therapies decreased. The difference? Prices came down after FDA approval of a new branded drug that competed directly with an existing drug.26

This certainly suggests that competition can drive down net costs. But a lot will depend on exactly how directly each new drug lines up against an existing drug.

For example, does the new drug have the exact same indications? Is it just as safe? Can any patient use it? Every difference means the new drug is less of a direct competitor.

What happens next?

At the very least, it seems that physicians and patients will soon have new options to treat plaque psoriasis. There is some reason to hope that these new drugs will add new competitiveness to the class.

Still, there are many and varied existing treatments. These new therapies will need to be safer, more effective, or both, in order to justify any significant price premium.

For additional details concerning these new drugs, please consult the most recent issue of Drug Pipeline Insights Report.

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References

1.       U.S Food and Drug Administration. FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. Accessed April 27, 2022.

2.       U.S Food and Drug Administration. FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality. Accessed April 27, 2022.

3.       U.S Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. Accessed April 27, 2022.

4.        Gene Home. In vivo and Ex vivo Approaches to Gene Therapy. Accessed April 27, 2022.

5.       American Academy of Ophthalmology. Subretinal Injection of Luxturna. Accessed April 27, 2022.

6.       U.S Food and Drug Administration. What Is Gene Therapy? How Does It Work? Accessed April 27, 2022.

7.       U.S Food and Drug Administration. FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. Accessed April 27, 2022.

8.       Frontiers in Genetics. The Birth Prevalence of Spinal Muscular Atrophy: A Population Specific Approach in Estonia. Accessed April 27, 2022.

9.       BioPharma Dive. BioMarin plans return to FDA with updated data on hemophilia gene therapy. Accessed April 27, 2022.

10.   Centers for Disease Control and Prevention. A New Study of Hemophilia Occurrence Finds Many More Cases in the United States. Accessed April 27, 2022.

11.   Optum internal analysis, March 2022.

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STATEMENT REGARDING FINANCIAL INFLUENCE:
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author nor OptumRx has accepted any form of compensation for the preparation or distribution of this article.