As biosimilars continue to arrive on the psoriasis scene, wider measures to influence drug access and emerging treatment choices in the US healthcare system are causing a treatment paradigm shift.

The US Food and Drug Administration (FDA) approved the first biosimilar of Johnson and Johnson Innovation Medicine’s (J&J) blockbuster autoimmune disease drug Stelara (ustekinumab), Amgen’s Wezlana, in October 2023. Since then, the agency has approved several other cheaper versions of the biologic including Formycon and Fresenius Kabi’s Otulfi and Alvotech and Allentown, Pennsylvania-based Genus Pharmaceuticals’ Selarsdi.

“When generics and biosimilars join the market, drug prices plummet,” says Dr. Robert Popovian, founder of the New York-based strategic consulting firm Conquest Advisors. However, concurrent with the entry of Stelara biosimilars, factors like the Inflation Reduction Act (IRA) are influencing drug pricing and patient access.

The US government chose Stelara and Pfizer’s psoriatic arthritis therapy Enbrel (etanercept) to be among the batch of drugs in the first round of drug price negotiations under the IRA. If the next US administration continues the path set by the Biden administration, regulators will cut Stelara’s price by 66% and Enbrel’s price will drop by 67%, as per a 15 August government press release.

However, a drug’s list price is only one of the factors at play here. “In the US, access to branded psoriasis therapies is highly variable based on the type of insurance the patient has [if they have insurance], and also varies substantially by geographical region,” says Dr. Joel Gelfand, the director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania Perelman School of Medicine in Pennsylvania, in an email to Pharmaceutical Technology.

Next, psoriasis treatments, in particular, form a distinct case study because of how different options have emerged in recent years. “There is a lot of competition in the marketplace for the psoriasis therapies, considering their unique mechanism of action and being considered as biologic agents, I think they are priced significantly. To this point access will likely remain an issue for psoriasis patients,” says Kwaku Marfo PharmD, a global brand medical director at Novartis.

As more biosimilar psoriasis drugs arrive and drug pricing is in flux, we may see a shift in physician’s choices for psoriasis treatment, says Marfo.

Changing treatment paradigms

The FDA first approved Stelara for the treatment of psoriasis in September 2009, and soon followed this with six more approvals of the drug for the treatment of different autoimmune conditions. It proved to be a blockbuster for J&J, earning $6.96bn in global sales in 2023, as per the company’s annual financial report. “Stelara really anchored us into the era of psoriasis treatments that are really low in side effects and so high in efficacy,” says Dr. Steven Feldman, a professor of dermatology at the Wake Forest University School of Medicine in North Carolina.

However, the psoriasis space has evolved, with newer drugs like J&J’s Tremfya (guselkumab) and AbbVie’s Skyrizi (risankizumab) taking a major part of Stelara’s market share; as Feldman says, they are “just as safe but more effective.”

The FDA approved Tremfya for the treatment of moderate to severe plaque psoriasis in 2017, following this with an approval for Skyrizi for the same condition in 2019. The two therapies belong to a class of autoimmune drugs called IL-23 inhibitors, which have been shown to be more effective than IL-17 inhibitors like Stelara for the treatment of psoriasis in recent clinical studies. “The drawback you see with some of these IL-17 drugs is the potential to exacerbate inflammatory disease, which you do not see with the IL-23 inhibitors,” says Marfo.

Feldman explains that the current standard of care involves therapies that target IL-23 like Skyrizi, Tremfya, and Sun Pharmaceuticals’ Ilumya (tildrakizumab). Patients also have the option of using faster-acting IL-17 blockers like Eli Lilly’s Taltz (ixekizumab) and Novartis’s Cosentyx (secukinumab), he adds. There is a belief that IL-17 blockers are better at treating psoriatic arthritis, so some doctors will prescribe those for patients with that condition, says Feldman.

In recent years, biosimilars have emerged as another alternative. “It is possible that increasingly patients will need to use biosimilar versions of adalimumab or ustekinumab before they can access more effective biologics which target IL-17 or IL-23,” says Gelfand. This may be a larger issue for patients with histories of inflammatory bowel disease, adds Marfo. Adalimumab is the scientific name for AbbVie’s blockbuster drug Humira, for which there are several marketed biosimilars.

Drug pricing and access

To justify the higher prices of some of these psoriasis therapies, it is strategically advantageous to seek approval for the therapy for the treatment of several autoimmune conditions, as is seen for several marketed competitors, says Marfo, referring to his previous work as the medical director of dermatology at Novartis.

In 2022, the IRA was introduced to allow Medicare to negotiate prices and rebates for different therapies with drug manufacturers. The proposed legislation has elicited split opinions within the industry, with some pharmaceutical companies striking back with legal action.

Feldman is unsure about the IRA’s impact on improving psoriasis drug access. “These drugs are very expensive. If they negotiate price down some, they are still going to be very, very expensive.”

Feldman adds that patient assistance programs are already fairly accessible for psoriasis patients. Companies often cover the drug copay and if an insurance plan refuses to cover a particular drug, the company “pretty much gives it to the patient”, he says. For example, J&J offers a patient assistance program called Janssen Cares, while AbbVie has its Simplefill program for prescription assistance with Skyrizi and the Skyrizi Complete App, where patients can find savings resources, among other assistance.

“I would fear that price controls in these negotiations might discourage the companies from giving the drug away free to uninsured patients,” says Feldman. Popovian agrees, saying that pharmaceutical companies were already giving rebates to insurers and pharmacy benefit managers (PBMs) based on list prices in most cases, and now with the IRA, the companies will have to drop the drug prices that they offer to the government to match what was seen with the previous rebates.

However, several critics, including US Congress representatives, have noted that such rebates create an incentive for PBMs to prioritise drugs with high list prices. Last month, Novo Nordisk’s CEO, when grilled about the company’s role in high drug prices, also highlighted that lowering drug prices can limit the extent of insurance coverage for a particular drug.

Nonetheless, Popovian says that negotiations for drugs such as Stelara will likely result in savings for the government, but psoriasis patients may not benefit, and those who rely on Medicare may even be affected in a negative manner. Given the increased premiums for Medicare Part D patients in the last two years since the IRA was passed, the US government has had to allocate an extra $5 billion to backfill some of the increases on premiums, says Popovian.

“This is hurting patients. It is hurting taxpayers. But again, the administration is going to claim that they're saving a lot of money,” says Popovian. The Centers for Medicare and Medicaid Services (CMS) needs to monitor and look at what actually happens once the policy change goes into effect to evaluate all of the micro-effects the IRA could have, he adds.