The Changing Management of Multiple Sclerosis-Dimethyl Fumarate (Tecfidera) for MS

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune demyelinating disease of the central nervous system that has recently received significant focus from health plans and those who manage drug benefits. MS affects nearly 400,000 individuals in the United States and the majority of those affected by the disease have relapsing-remitting MS (RRMS). RRMS is characterized by clearly defined attacks, or relapses, of worsening neurological function with periods of partial to complete recovery between attacks. This form of MS occurs more often in women than men, with disease onset typically occurring between the ages of 20 and 50 years. Ultimately, patients with RRMS experience an accumulation of central nervous system damage and associated cognitive and physical disability progression. With the widespread use of disease modifying therapies (DMTs), health plans have experienced improved clinical outcomes for MS together with increasing associated pharmacy-related expenses.¹

Prior to the 1993 launch of interferon beta-1b (IFNβ-1b), the first disease-modifying therapy for MS, there were only a few drugs available to treat MS exacerbations, and health plans were generally unconcerned with managing the cost of care associated with this illness. However, over the past 18 years, several additional DMTs have been developed to reduce relapse rates, improve short-term functionality, and modify the overall disease course. In 2010, prior to the launch of fingolimod (Gilenya), the first oral agent for the treatment of MS, there were 6 disease-modifying agents on the market: once-weekly intramuscular interferon beta-1a (IFNβ-1a), 3-times-weekly subcutaneous (SC) IFNβ-1a, 2 alternating daily SC IFNβ-1b products, once-daily SC glatiramer acetate (GA), and once-monthly intravenous natalizumab. Among these therapies, IFNβ formulations and GA have generally been regarded as the mainstays of first-line treatment.

The year 2012 saw the approval of the second oral agent for MS, teriflunomide (Aubagio). And this past month the US Food and Drug Administration approved dimethyl fumarate (Tecfidera) capsules for the treatment of adults with relapsing forms of MS. Like the other agents on the market, dimethyl fumarate has been shown to significantly reduce relapses and the development of brain lesions and slow disability progression over time.

Tecfidera, manufactured by Biogen Idec, is expected to be priced at a wholesale acquisition cost of $54,900 per patient per year. The price puts Tecfidera at a slight discount from the first multiple sclerosis oral agent, Gilenya, from Novartis, which has a list price of $60,000 per patient per year, but more than Aubagio from sanofi, which costs approximately $48,000 per year.²

Many experts expect Tecfidera to become one of the most commonly used MS drugs, taking share not only from newer pills like Gilenya and Aubagio, but also from older, commonly used injections such as Copaxone and Avonex. Although the medicines work in different ways, all of them basically aim to do the same thing: suppress the immune system, which appears in MS patients to attack the protective sheaths surrounding nerves.

Many doctors have been warehousing patients with early MS, waiting for this treatment to emerge. Because of this, financial analysts expect this drug to sell more than $1.77 billion in 2015 and $2.66 billion in 2017.²

The cost of treating MS has been escalating rapidly and for most payers it is the second-largest category of specialty drug spending, accounting for almost 30% of the specialty drug cost. With the introduction of the third oral agent to the market, it is likely that some of the traditional injectable therapies will be replaced by this oral agent at a higher cost. It is anticipated that payers will continue to manage the class with a comprehensive strategy of prior authorization (PA) of all of the MS agents, including the new oral products. Additionally, there are no data to support combination therapy of this agent with other products, so the PA processes at most plans will not support such combinations.

To date, no MS agent has truly emerged as a consensus “first-line” treatment, although this role is traditionally filled by glatiramer acetate and the interferons. However as the oral agents gain use and physicians gain experience with these agents, this may shift. Payers will need to be prepared to manage these changes of therapeutic direction as the care of this disease evolves.

REFERENCES

1. National MS Society. What we know about MS. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/who-gets-ms/epidemiology-of-ms/index.aspx. Accessed April 16, 2013.

2. Matthew Herper. Biogen prices new MS pill at $55K, prepares for marketing battle. Forbes website. http://www.forbes.com/sites/matthewherper/2013/03/29/biogen-reveals-pricing-for-new-ms-drug-tecfidera/. Published March 29, 2013. Accessed April 15, 2013.