For the millions of patients looking for affordable treatments options for autoimmune forms of arthritis (such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis), generic versions of biologic medications represent the holy grail. Unfortunately, it could be a few years before these lower-cost, disease-modifying drugs reach the market.
A wave of so-called “biosimilars” had been anticipated over the next few years as the first biologics to start to lose their patent protection. However, difficulties in reproducing biologics in general, as well as a new patent for etanercept (Enbrel) specifically – which could make it off-limits to generic makers for another 17 years – will mean longer-than-expected waits.
Unlike other types of medications, which are relatively easy for drug manufacturers to copy, the size and complexity of the molecules in biologics and the slight differences in manufacturing processes makes them virtually impossible to duplicate exactly. As a result, biosimilars will have to go through a special evaluation process before the Food and Drug Administration (FDA) approves them, adding time and cost for their development.
To help lay out this process, the Biosimilar User Fee Act of 2012 (BsUFA) authorizes the FDA to assess and collect fees from manufacturers between October 2012 through September 2017. This will allow the agency to hire new staff in order to establish and move forward with review and approval procedures for biosimilars.
Other Promising Options
The FDA approved in November 2012 a new drug called tofacitinib for rheumatoid arthritis (RA). It is the first in a new class of drug called JAK inhibitors, which work by blocking Janus kinase (JAK) pathways. These pathways play a role in inflammation.
In clinical trials, tofacitinib, brand name Xeljanz (ZEL'jans), generally performed similarly to biologics against RA – and with a similar safety profile.
Unlike biologics, which must be injected or infused, tofacitinib is a small molecule, which means it (and others in its class) can be taken orally. And because these small molecule drugs are not as complicated to manufacture as biologics, the hope is that they will cost less than biologics.
Other similar drugs are in the pipeline, including two additional kinase inhibitors, VX-509 (another JAK inhibitor) and fostamatinib (a so-called SYK inhibitor, which targets another part of the inflammatory process known as the spleen tyrosine kinase pathway).
There is also apremilast, a small molecule in phase III trials for psoriatic arthritis and psoriasis that that inhibits the production of a number of inflammatory molecules, or cytokines.
Managing the High Cost of Biologics
Despite the promise of biosimilars and the approval of tofacitinib, the need for current biologic agents will be a reality for many people for a long time to come. But their effectiveness comes at a price – a price too high for most people to afford without insurance – and too high a price for some even with insurance.
While many insurers have fixed co-pays for less costly medications, some are moving biologics into “specialty tiers” that require the patient to pay a percentage of the cost of medication – often 25 to 33 percent. For a medication that costs between $1,000 and $ 2,000 a month – or more – the cost could easily run well into hundreds of dollars monthly, even with insurance.
Fortunately, there are things you can do to reduce your out-of-pocket costs for biologics. Visit the Paying for Healthcare for information on assistance plans that can help cover the cost of biologic therapy.