Prime Therapeutics has found that specialty drug spend for autoimmune drugs doubled between 2012 and 2015, accounting for 10% of drug expenses for 4.4 million commercially insured members.
Biopharmaceutical companies have 311 medicines and vaccines for autoimmune diseases in clinical trials or awaiting review by the FDA according to the Lupus Foundation of America’s “Medicines in Development 2016 Report.” They target conditions, such as Crohn’s disease, psoriasis and rheumatoid arthritis.
Rivera says autoimmune diseases were a concern in 2016 and are expected to continue to be on payers’ radar—especially with the introduction of biosimilars treating conditions in this category.
The FDA approved Inflectra (infliximab), which is a biosimilar to Remicade for Crohn’s disease, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis April 2016; it is expected to be on the market in November. The biosimilar should sell for 15% less than the originator drug—$946 vs. $1,113 a vial, respectively—according to Truven Health Analytics.
Biosimilar alternatives to Humira (adalimumab) and Enbrel (etanercept), two anti-inflammatory drugs for rheumatoid arthritis, are headed to the market, but the originator manufacturers—AbbVie and Amgen, respectively—are trying to push new patents to prevent them from coming on board. The FDA approved Sandoz’s new product for Enbrel, called Erelzi (etanercept-szzs), in August 2016 and the one for Amgen’s Humira—Amjevita (adalimumab-atto)—in September 2016.
Rivera is concerned that a lack of familiarity with and information about biosimilars might deter physician prescribing. “Many physicians are brand loyal and might not be comfortable with interchangeability,” she says, “driving up costs.”
Rivera anticipates that biosimilars could bring additional competition that might bring the cost down by as much as 30%. “We will be able to deploy care management principles, such as formulary—what’s covered, what’s excluded—to drive manufacturer rebates,” she says.
Rubin says executives should keep an eye on new drugs coming to market, evaluating their formularies to keep costs down and hopefully keep patients more compliant and in remission for longer in 2017.
Robert Goldberg, vice president, Center for Medicine in the Public Interest, agrees that 2017 will yield more drugs regulating rare autoimmune disorders such as Lupuzor, the first specific and non-immunosuppressant therapy for lupus; however, it has not yet been approved.
The FDA also has approved seletalisib, a potent and selective small molecule inhibitor of PI3K delta for the treatment of immunodeficiency disorders.
“These drugs are examples of first-in-class medicines for orphan diseases that also have fewer side effects,” Goldberg says. “Payers that limit or delay access to such medicines may find themselves facing lawsuits from patient groups.”
Payers have to move away from formularies based on how much rebate revenue they can get and focus on finding out what works for each patient, he says. “Similarly, payers will have to shift away from step therapy in which patients are required to start on one drug and see if they respond. The fact is, step therapy actually risks patient well-being. Requiring a treatment because it's cheapest or generates the most rebate often leads to inappropriate treatment and in turn, organ damage or more severe illness.”
In addition, Goldberg says, “The most effective drug is the one that works and that patients continue to take. So again, payers should focus on adherence rather than the drug itself.”
Treatments for rheumatoid arthritis and multiple sclerosis have generally been effective at reducing disease fueling inflammation, but have been limited to treating the symptoms of the disease, allowing for a steady, rapid progression from disease onset to disability, Goldberg says. Biologic disease-modifying drugs target the underlying sources of inflammation and re-establish balance in a cell's immune system. So these drugs improve physical well-being and promote repair of joint and organ damage and remission.
That means new medicines are not interchangeable with older drugs, nor are they interchangeable with each other; however, often they can be used in combination to target various drivers of illness, Goldberg says.
Another new area of interest is NASH (nonalcoholic steatohepatitis), or fatty liver disease. In May 2016, the FDA approved Ocaliva (obeticholic acid) in combination with ursodeoxycholic acid. Its cost is expected to be about $69,350 per year, according to Intercept.
Lassen says despite its price tag, the new drug could be a gamechanger.
Finally, two new drugs for atopic dermatitis are expected at the end of March 2017; the unnamed drugs are both forms of dupilumab. They are biologic injections with no other competition.
At press time, Ocrevus (ocrelizumab) for multiple sclerosis was expected to appear on the market by late December 2016, along with other competitors in 2018, Rivera says.
And finally, Taltz (ixekizumab) was approved in March 2016 for psoriasis.