The High Price Tag of Vumerity for Multiple Sclerosis Treatment
For those living with multiple sclerosis (MS), managing the costs of treatment can be incredibly challenging. One of the newest drugs approved for treating relapsing forms of MS is vumerity. This oral medication received FDA approval in 2019 as a viable alternative to other disease-modifying therapies. However, with an average retail price of over $88,000 per year, vumerity's price tag is raising serious affordability concerns for the MS community.
What Is Vumerity and How Does It Work?
Vumerity is the brand name for diroximel fumarate, a prodrug of the fumaric acid ester monomethyl fumarate (MMF). As an oral capsule taken twice daily, vumerity aims to alter immune system responses that damage the central nervous system in MS. It activates a pathway known as Nrf2, with antioxidant and anti-inflammatory effects to help protect nerve cells from injury. Unlike many injectable MS drugs, vumerity offers convenience as a pill. It's indicated for relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
In clinical trials, vumerity demonstrated efficacy in reducing annual MS relapses, disability progression, brain lesions, and brain shrinkage. The most common side effects are flushing and gastrointestinal issues. It carries a warning for the rare but serious brain condition PML. Overall, its safety profile is similar to its predecessor drug Tecfidera.
The Steep Price of This Novel MS Therapy
When vumerity hit the market in 2019, its maker Biogen set the initial list price at $88,000 for a year's supply. Taking the recommended dose of 231 mg twice daily equals about $240 per day. For MS patients needing lifelong treatment, these costs really add up.
At nearly $90,000 per year, vumerity is priced higher than many existing oral and injectable MS therapies. Copaxone, a common injectable drug, costs around $70,000 annually. Extavia and Plegridy, two interferon-based injectables, ring in between $60,000-$70,000. Gilenya, an oral sphingosine 1-phosphate receptor modulator, is priced at about $100,000 per year. The most expensive option is Tysabri, a monthly intravenous infusion with a yearly cost of $130,000.
In comparison to these other branded MS medications, vumerity sits at the higher end of the pricing spectrum. Yet as a newer agent in the oral MS drug market, theres concern its high costs will set a precedent. This could drive prices even higher for future oral MS therapies currently in development.
Why the High Cost for This Multiple Sclerosis Treatment?
With a rising number of disease-modifying therapies for MS now available, why does vumerity come with such a steep price tag? Several key factors play a role here:
- Patent protections - As a newly approved medication, vumerity currently faces no generic competition, giving Biogen exclusivity in setting its cost. Strong patents secure market share for an extended period.
- R&D investments - Developing and testing a novel MS therapy requires massive investments over a decade or more. Biogen cites the need to recoup expenses from its robust drug development program.
- Advanced mechanism - Vumerity taps into the Nrf2 pathway not leveraged by older platforms, which Biogen suggests creates added value for patients.
- Orphan drug status - Because MS is a rare disease, vumerity qualified for certain benefits during FDA review, including enhanced market exclusivity.
- Unmet need - Few oral options exist to treat MS, so tapping into this underserved niche allows a higher price point.
Essentially, as a unique oral product for treating MS, vumerity fills an important gap. But its novel mechanism and lack of generic competitors enables Biogen to command a premium price while sales remain protected.
Payer Coverage and Patient Assistance Options
Given the high costs, obtaining insurance coverage for vumerity can be difficult. Many plans manage specialty medications like vumerity through prior authorization, higher tiers with increased co-insurance, or exclusion from formularies altogether.
Those with private insurance may encounter deductibles of $1,000 or more before coverage kicks in. Even after meeting a deductible, co-pays for vumerity typically remain 20-50% of the drug's total cost. Medicare Part D beneficiaries also get hit with the donut hole coverage gap, where they must pay 25% coinsurance for brand-name drugs.
For uninsured or underinsured patients, paying such high out-of-pocket costs for vumerity becomes unmanageable. In these cases, patient assistance can help bridge the affordability gap. Some options include:
- Copay programs - These sponsored programs cover copays for eligible, privately insured patients. However, many have annual limits as low as $12,000, still leaving a large burden.
- Patient assistance programs - Provided by drug makers, these programs offer free medication to qualifying patients based on financial need and insurance status.
- Non-profit support - Organizations like the HealthWell Foundation and Patient Advocate Foundation help subsidize costs through grant funds or copay relief.
- High-deductible plans - Enrolling in a lower-premium, higher deductible plan keeps monthly costs in check while accumulating funds in a tax-advantaged account.
Seeking financial assistance takes added effort but can be essential for gaining access to medications like vumerity. Talking with your provider to explore appropriate programs or adjustments to your treatment plan is advised.
The Ongoing Debate Over Soaring MS Drug Prices
The introduction of vumerity at nearly $90,000 per patient annually reignited concerns over skyrocketing costs for MS care. On average, disease-modifying therapies for MS have increased in price by over 750% since the mid-1990s. The annual mean expense for MS drugs is estimated at $84,537 per person.
In a landscape where new therapies for treating MS frequently debut at six-figure price tags, concerns over cost barriers rightfully remain. Advocacy groups argue the high costs hinder access, exposure patients to financial hardship, and strain the healthcare system. With specialty drug spending rising faster than other costs, the trend is likely unsustainable.
On the other hand, pharmaceutical developers justify the investment required to bring a novel MS therapy to market. Lengthy R&D timelines, stringent regulations, patient support programs, and limited competition all influence pricing decisions. Still, calls for greater transparency around true R&D spending continue.
For real change to occur, stakeholders across the board must collaboratively tackle the multifaceted factors enabling escalating costs for MS treatment. This conversation remains ever important to ensure access and affordability in MS care.
Weighing Treatment Options Versus Costs
Living with MS means making difficult choices balancing efficacy, safety, and cost when selecting therapy. Vumerity provides a compelling new oral option that may work for some patients. Yet its high price tag presents a barrier to access.
When exploring your treatment options, have candid conversations with your provider about costs alongside benefits. Don't be afraid to speak up and advocate for yourself when it comes to affordability. Financial resources exist to provide assistance in accessing medications like vumerity. With open communication and a thoughtful approach, finding optimal therapy that fits your clinical needs and budgetary constraints is possible.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.
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