What is Mavenclad and How Does It Work?

Mavenclad is the brand name for cladribine tablets, a prescription medication manufactured by EMD Serono (a division of Merck KGaA). It received FDA approval in 2019 for treating relapsing forms of multiple sclerosis, including relapsing-remitting MS and active secondary progressive MS.

As an immune reconstitution therapy, Mavenclad works by temporarily reducing specific types of white blood cells called B and T lymphocytes. These cells are part of the immune system that mistakenly attacks the protective covering of nerve fibers (myelin) in people with MS. By selectively targeting these cells, Mavenclad helps reduce inflammation and damage to the central nervous system without continuously suppressing the entire immune system.

The medication is taken orally as tablets for 4-5 days during two treatment weeks, separated by a month, for two consecutive years. After these two treatment courses, no additional Mavenclad treatment is required for years 3 and 4.

Treatment Schedule and Administration

Mavenclad follows a distinctive dosing schedule that sets it apart from many other MS treatments. The recommended cumulative dose is 3.5 mg/kg body weight over 2 years, administered as 1.75 mg/kg per treatment year.

Each treatment year consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month. Each treatment week consists of 4 or 5 days on which the patient receives 10 mg or 20 mg as a single daily dose, depending on body weight.

Following completion of the 2 treatment courses, no additional Mavenclad treatment is required in years 3 and 4. This unique approach means patients only need to take the medication for a maximum of 20 days over 2 years, rather than daily or weekly as with many other MS therapies.

Provider Comparison: Mavenclad vs. Other MS Treatments

When considering MS treatment options, it's important to understand how Mavenclad compares to alternatives:

TreatmentAdministrationTreatment ScheduleMonitoring Requirements
Mavenclad (cladribine)Oral tablets8-10 days per year for 2 yearsBlood tests before, during, and after treatment
Ocrevus (ocrelizumab)IV infusionEvery 6 monthsInfusion monitoring
Gilenya (fingolimod)Daily oral capsuleContinuous daily dosingFirst-dose monitoring, eye exams, blood tests
Tecfidera (dimethyl fumarate)Oral capsule twice dailyContinuous daily dosingBlood tests

Mavenclad offers distinct advantages in its limited treatment days compared to continuous therapies like Gilenya or Tecfidera. However, each medication has different safety profiles, side effects, and efficacy rates that must be considered when making treatment decisions.

Unlike infusion therapies such as Ocrevus that require facility visits for administration, Mavenclad can be taken at home. This convenience factor may be important for patients with mobility issues or those who live far from treatment centers.

Benefits and Drawbacks of Mavenclad

Benefits of Mavenclad include:

  • Limited treatment days (maximum 20 days over 2 years)
  • No need for daily medication adherence
  • Oral administration rather than injections or infusions
  • Sustained efficacy through the 4-year treatment period
  • Reduced risk of relapse and MRI activity

Potential drawbacks to consider:

  • Risk of lymphopenia (low white blood cell count)
  • Increased risk of infections, including herpes zoster (shingles)
  • Cannot be used by pregnant women or women planning pregnancy
  • Limited to 2 treatment courses over a lifetime due to potential long-term risks
  • Regular monitoring requirements including blood tests

According to clinical trials conducted by EMD Serono, Mavenclad reduced the annualized relapse rate by 58% compared to placebo. Additionally, 81% of patients remained relapse-free during the study period, demonstrating its effectiveness for appropriate candidates.

Pricing and Insurance Considerations

The cost of Mavenclad treatment can be substantial, with the list price before insurance typically exceeding $90,000 per treatment year. However, actual patient costs vary significantly based on insurance coverage, assistance programs, and individual circumstances.

Mavenclad offers patient support programs through MS LifeLines, which can help navigate insurance approvals, potential copay assistance, and other financial support options. Most commercial insurance plans cover Mavenclad for appropriate candidates, though prior authorization is typically required.

When considering this treatment, patients should work closely with their healthcare providers and insurance companies to understand coverage details. Many neurologists can connect patients with specialty pharmacies and MS nurse navigators who specialize in handling the administrative aspects of starting MS treatments.

The unique dosing schedule of Mavenclad means that while the upfront cost appears high, the total 4-year treatment cost may be comparable to or lower than continuous therapies when considering the medication is only taken for 2 of the 4 years.

Conclusion

Mavenclad represents an innovative approach to MS treatment with its unique dosing schedule and mechanism of action. For people with highly active relapsing MS, it offers the convenience of oral administration with limited treatment days while providing sustained efficacy. However, like all MS treatments, the decision to use Mavenclad should be made carefully after thorough discussion with healthcare providers about benefits, risks, monitoring requirements, and how it fits into individual treatment goals. The ideal candidate is someone seeking reduced treatment burden who understands and can comply with the safety monitoring requirements. With proper patient selection and monitoring, Mavenclad can be an effective option in the growing arsenal of MS therapies available today.

Citations

This content was written by AI and reviewed by a human for quality and compliance.