Access challenges may undercut Novartis AG’s first-mover advantage as it seeks to establish itsnew plaque psoriasis treatment Cosentyx (secukinumab) in a tightly controlled reimbursement environment.

“The key going forward [for Cosentyx] is going to be gaining access, which we’re working through,” Novartis Pharmaceuticals Division Head David Epstein said during the company’s April 23 earnings call. “In the U.S. market, the first six months tends to be tough in this current environment.”

Because the market for psoriasis treatments has been expanding rapidly in recent years with new and more effective biologic treatments, payers are focused on ways to contain anticipated spending increases driven by patient demand for higher-priced drugs.

“Drugs used to treat individuals with psoriasis and psoriatic arthritis are some of the more highly managed medications,” National Psoriasis Foundation VP Government Relations and Advocacy Leah Howard said in an interview. “Many patients are required to go through step therapy, and … typically it’s the TNFs [tissue necrosis factor inhibitors] that you have to go through to get on some of the novel therapies.”

TNFs including Amgen Inc.’s Enbrel (etanercept), AbbVie Inc.’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab) have traditionally been the standard of care for psoriasis.

Cosentyx is the latest entry into the treatment category, launching in February 2015 as the first of a new class of interleukin inhibitors, known as IL-17 blockers, to treat moderate-to-severe plaque psoriasis. It has raised the bar on efficacy in the treatment of psoriasis and is supported by clinical data showing it performed better than Amgen’sentrenched treatment Enbrel and Johnson & Johnson’s IL-12/IL-23 inhibitor, Stelara (usetekinumab) ([A#00150330003]).

Analysts have predicted Cosentyx will be a major success in the coming years, with worldwide revenues of $700 million to $1 billion annually by 2020. Projections include assumptions that the drug will obtain a broader range of indications beyond psoriasis.

However, many payers have established prior authorization and step therapy requirements that delay coverage for Cosentyx until patients have tried more established treatments. Such policies may serve to limit access to the drug until new competitors begin to arrive in 2016, since that will put payers in a stronger position to demand lower pricing from Novartis.

Cosentyx also faces contracting challenges with payers because it is competing with TNF inhibitors that typically are covered by broad contracts that cover a range of indications.

“With more competition there is certainly that hope,” pharmacy benefit manager Magellan Health Services Inc. Chief Medical Officer for Rx Management Maria Lopes said in an interview. “As we have more treatments to consider, including biosimilars, I think that will tilt the dialogue to … looking at value overall,” she added.

The potential competitor that appears closest to market is Eli Lilly & Co’s. IL-17 blocker for psoriasis, ixekizumab, on track for approval in the first half of 2016. The company disclosed in April that it has submitted an application for the drug with FDA.

A biosimilar to Humira could launch in 2016 as well, following expiration of the drug’s patent. Amgen has said it plans a filing with FDA later in 2015 for its copy of adalimumab for plaque psoriasis and rheumatoid arthritis. Novartis’ Sandoz Inc. subsidiary is also developing a biosimilar of Humira for psoriasis, which is currently in Phase III trials.

Two IL-23 blocker drugs are in earlier stages of development but could enter the psoriasis market in the next few years: Johnson & Johnson’s guselkumab and Boehringer Ingelheim GMBH’s BI 655066 ([A#00150330005]).

After launching in 2009, Stelara appears to have made strong headway in the psoriasis market and gained preferred status on the formularies of major payers. U.S. sales for the drug reached $1.3 billion in 2014, up nearly 40% from the year before. Stelara added an indication for treatment of psoriatic arthritis in 2013.

Payer Coverage Policies

Aetna Inc.’s current clinical policy bulletin for psoriasis treatmentsstates that before the insurer will pay for Cosentyx, patients should try at least two of a group of designated “less costly” options, which include Stelara, Enbrel, Humira or Remicade.

Because Cosentyx is “more costly than these least-cost brands of targeted immune modulators and least-cost brands of targeted immune modulators are at least as likely to produce equivalent therapeutic results, no other brands of targeted immune modulator will be considered medically necessary unless the member has a contraindication, intolerance or incomplete response to at least two of the least-cost brands of targeted immune modulator,” the bulletin states.

Based on wholesale acquisition costs (WAC) for comparable doses of psoriasis treatments in the initial year of therapy, Cosentyx has a list price of $58,140 versus $51,200 for Enbrel, $49,139 for Stelara and $43,228 for Humira, according to an analysis by Alex Bastian, market access VP at the research and consulting firm GfK Bridgehead. WAC prices do not reflect rebates or discounts negotiated with payers.

Anthem Inc.has a prior authorization requirement that individuals in its commercial plans must have had an “inadequate response” to two preferred biologic therapies in the previous six months before coverage is approved for Cosentyx. Stelara, Enbrel, Humira and Remicade are the insurer’s current preferred biologics.

[UnitedHealthCare] commercial plans also have a step therapy program in place for Cosentyx, requiring that patients first try both Stelara and Humira before coverage is approved, according to an online description of the program.

The insurer says it will allow coverage for patients already started on Cosentyx, but not if the patient received a manufacturer-supplied sample at no cost in the prescriber’s office or a 30-day free trial from a pharmacy that was given “as a means to establish [the patient] as a current user of Cosentyx.”

Novartis is offering commercially insured patients who are awaiting a coverage determination for Cosentyx up to seven doses at no cost. Those whose insurance does not cover the drug have access to up to 13 doses free. In addition, commercially insured patients who have obtained insurance coverage for Cosentyx may obtain up to $16,000 worth of treatment with no cost sharing.

The copay assistance and free trial programs began in February 2015, when the drug was launched, and will expire at the end of 2015. The programs are not available to enrollees in Medicare or Medicaid, based on federal anti-kickback laws.

Cosentyx is not widely covered as yet in Medicare Part D plans. “The review cycle for products covered by Medicare Part D plans in 2015 occurred in 2014 (before Cosentyx was approved). So, we don’t have -- and didn’t anticipate -- broad-based Medicare Part D plan coverage for this year,” a Novartis spokesperson said. The spokesperson added the drug will be covered on Part D formularies offered by Express Scripts Holding Co., “thereby allowing appropriate patients on these plans access to the medication.”

Range Of Indications Gives TNF Drugs Advantage

In addition to coverage restrictions, Cosentyx faces contracting challenges because it is competing with TNF inhibitors that typically are covered by broad contracts covering a range of indications, giving them greater leverage with payers.

“Humira and Enbrel have contracted positions as first-line branded products for a variety of immunology conditions. As $10 to $14 billion dollar a year products, a contracted position for those products makes a lot of sense for a health plan,” GfK’s Bastian said in an email.

Adding an anti-IL agent as a preferred drug would likely conflict with current contracts, suggested Gary Owens, medical advisor for the Towers Watson Rx Collaborative, a purchasing consortium of 200 major employers.

The psoriasis market only drives about 20% of the TNF spend and payers are not willing to risk losing rebates from TNF manufacturers by adding a drug to the psoriasis class, he explained in an email. Renegotiating TNF contracts without psoriasis in the mix is time-consuming and expensive, Owens added.

Novartis and J&J are working on broadening the labels of Cosentyx and Stelara, which could give them more leverage against large TNF inhibitor contracts. Nevertheless, “I think it will take a good while to get more open access to the anti-IL agents. Stelara has made some progress, but slowly on this front,” Owens said.

New Concerns With Safety

Payers are concerned with the safety of new agents like Cosentyx and ixekizumab that don’t yet have a substantial track record in the real world. And they may be more wary now that an issue with suicide risk has arisen with another IL-17 inhibitor under development.

Amgen announced recently that it was withdrawing from a collaboration with AstraZeneca PLC to develop the IL-17 brodalumab because Phase III data suggested an increased risk of suicide among patients taking the drug for psoriasis ([A#14150522006]). AstraZeneca has not yet announced whether it will continue to develop brodalumab. The companies had previously planned to submit an application for the drug with FDA by the end of 2015.

Novartis and Lilly have maintained there is no evidence in studies on Cosentyx and ixekizumab that those agents pose a similar risk of suicide ([A#14150526002]).

Lilly Bio-Medicines President David Ricks suggested during the company’s April 23 earnings presentation that a difference in the mechanism of action between brodalumab and ixekizumab might account for variable safety results. Instead of blocking a particular ligand, brodalumab targets the IL-17 receptor, so it blocks action of multiple IL-17 cytokines, including IL-17A, IL-17C and IL-17F.

Observing that secukinumab and ixekizumab are both IL-17A antibodies to the protein, while brodalumab is a receptor antibody, Ricks said “it would be not unexpected to have slightly different types of clinical results and safety profiles as a result of those differences.”

Magellan’s Lopes maintained that “with any new mechanism of action, time will have to tell the story” on safety. She noted there have been cases in the past where serious problems surfaced years after a drug was launched, such as Genentech Inc.’s psoriasis treatment Raptiva (efalizumab). Raptiva was on the market for seven years before it was withdrawn in 2009 after cases of multifocal leukoencephalopathy were reported.

(Senior Writer Emily Hayes contributed to this story.)

Formulary Focus: Cosentyx Navigating Tightly Managed Psoriasis Market

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