The average monthly cost of drugs to treat inflammatory conditions was more than $3,000 in 2015, according to Express Scripts’ 2015 Drug Trend Report, released in March 2016. Additionally, per member per year spend on drugs to treat autoimmune diseases was $89.10 in 2015, making inflammatory conditions the leading specialty therapy class as well as the leading class overall in the report.
“Spending on autoimmune drugs continues to increase and utilization is rising,” says April Kunze, PharmD, senior director, clinical formulary development and trend management strategy, Prime Therapeutics. “Autoimmune is the number one specialty drug spend category at Prime Therapeutics within our commercially insured business, comprising approximately one in 10 dollars spent on all drug expenditures through the medical and pharmacy benefits.”
According to Kunze, there are 15 autoimmune specialty drugs and more to be approved soon, making this class one of the fastest and most challenging to manage.
Specialty drugs available to treat inflammatory conditions include tumor necrosis factor (TNF) inhibitors, injectable biologics, and oral targeted synthetic DMARDs (disease-modifying antirheumatic drugs), says Aimee Tharaldson, PharmD, senior clinical consultant in the emerging therapeutics department at Express Scripts.
“The majority of the spend for autoimmune drugs is related to the biological products and especially the TNF inhibitors, says Kunze. “Humira and Enbrel are two of the top drugs by percent expenditure within Prime’s book of business (pharmacy benefit) and Remicade is the top drug on the medical benefit.”
The oral DMARDs include Xeljanz (tofacitinib, Pfizer) and Otezla (apremilast, Celgene).
Injectable biologics used to treat autoimmune conditions include Actemra (tocilizumab, Genentech), Stelara (ustekinumab, Janssen), Cosentyx (secukinumab, Novartis) and Taltz (ixekizumab, Eli Lilly and Company).
Several new options are in the pipeline for autoimmune conditions. Saracta (sarilumab, Sanofi) is a subcutaneous injection being studied for the treatment of rheumatoid arthritis (RA). Similarly, sirukumab, a human interleukin monoclonal antibody that targets interleukin-6, is being studied by GlaxoSmithKline in adults with moderately to severely active RA. Baricitinib, developed by Eli Lilly, is a once-daily oral option for RA with anticipated approval in early 2017.
There are also potential new options coming for the treatment of plaque psoriasis including Siliq (brodalumab, Valeant Pharmaceuticals), a monoclonal antibody that targets the IL-17 receptor. Additionally, Tharaldson explains that IL-23 inhibitors are another important therapy class to watch for in the psoriasis pipeline. These drugs include Janssen’s guselkumab and AbbVie’s risankizumab.
Will new autoimmune drugs address cost concerns?
For the first time in the autoimmune drug class, biosimilars are coming to the market. [A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company and can be manufactured when the original product's patent expires] A few examples include:
• Amjevita (adalimumab-atto, Amgen), Humira’s biosimilar;
• Erelzi (etanercept-szzs, Sandoz), Enbrel’s biosimilar; and
• Inflectra (infliximab-dyyb, Celltrion), Remicade’s biosimilar.
“Biosimilars for inflammatory conditions can help to mitigate spend in this therapy class.” says Tharaldson.
Kunze says competition from biosimilars will most likely not bring down the cost as much as traditional generic drugs. Current market examples indicate biosimilars may sell for 10% to 30% less than the original brand products.
Comprehensive management requires integrating medical and pharmacy benefits and data because, according to Kunze, more than 25% of the autoimmune drug class is processed and paid via the medical benefit and consequently, if the medical and pharmacy drug expenditures are not integrated, the autoimmune drug class cannot be optimally managed.
Kunze also says that savings within the autoimmune drug class are likely possible through an indication-based formulary followed by alignment of medical benefit policy approval criteria and pharmacy benefit utilization management criteria. An indication-based formulary will need to have integrated medical and pharmacy benefits and data to obtain optimal savings.