SubHero Banner
Text

The multiple sclerosis (MS) Insight Report is part of an ongoing series presented by OptumRx that examines some of the most complex and expensive treatment classes today. In this article we review the key considerations for treating MS.

1. Options continue to increase

While there is still no cure for MS, existing treatments are divided into three categories: abortive therapies, symptomatic therapies and preventive therapies.1, 2

Abortive therapies are intended to shorten the duration and severity of an MS exacerbation (relapse, or flare-up). A steroid like methylprednisolone is sometimes prescribed to reduce inflammation and accelerate recovery.2

Symptomatic therapies are prescribed to maintain independent function and improve quality of life despite such classic MS symptoms as vision loss, pain, fatigue, and impaired coordination. Medications may be paired with physical therapy and occupational therapy designed to maintain normal function.2

Preventive therapies include the costly specialty medications that we most commonly associate with MS.2 They are described throughout the remainder of this article.

Until little more than 20 years ago, there were no truly effective treatments for MS. The 1990’s saw new medications called disease modifying therapies (DMTs), which work to limit the way the immune system attacks healthy nerve tissues.3

There are now 14 DMTs approved by the Food and Drug Administration (FDA). Most DMTs have an FDA indication for only the most common form of MS (relapsing remitting MS, or RRMS; ~90% of patients).4

Only one drug Ocrevus® (ocrelizumab), is FDA-approved to treat the second-most common form of MS (primary-progressive MS, PPMS).5 [Rituxan® (rituximab), is used off-label for both RRMS and PPMS.4]

DMTs are considered specialty drugs, due to their high cost and their complex administration.6

This graph shows some of the more commonly-prescribed DMTs and their estimated annual retail costs:

Text

Institute for Clinical and Economic Review. Final Evidence Report – DMTs for RRMS and PPMS. March 6, 2017. [PDF]

Text

2. Timing and adherence are critical

When to start DMT therapy is a key question. Damage to the central nervous system occurs early in MS – even before any obvious symptoms – and continues throughout a person’s lifetime. Therefore, early and ongoing treatment with disease-modifying therapies is important to lessen the damage from inflammation.6

It is tremendously important that MS patients continuously take their prescribed medications in order to prevent the disease from progressing. However, many people stop their medication after a period of weeks or months.7 For example, one study found that 43% of MS patients discontinue their DMT therapy within 14 months.8

Non-adherence can lead to relapses, which contribute to the high overall medical claims for MS patients. One research team found that the one-year cost of a low-to-moderate-intensity relapse cost $21,959 and a high-intensity one $33,961(in adjusted 2016 dollars).9

People give various reasons why they stop taking their DMT drugs: “I’m not feeling any better” or, “I had a flare-up anyway.” Unfortunately, these statements reflect the fact that DMTs aren’t really designed to treat symptoms, or make people feel better. Rather, their role is to help reduce underlying disease activity by working “behind the scenes” – that is, without any obvious signs.7

People with MS can face a disproportionate risk for additional medical conditions, including physical conditions like fibromyalgia, inflammatory bowel disease, and epilepsy plus psychiatric comorbidities like depression and bipolar disorder.10

These additional conditions require MS patients to juggle many medication regimens and additional therapies. Combined with the potential for misunderstanding how DMTs work, we can see how people could fall behind in their treatments, or even abandon them altogether. This highlights the importance of ongoing medication adherence support programs. (More on these below.)

3. The search for better treatments continues

Despite many recent improvements, DMT drugs remain less than ideal. As noted, there is no cure as yet. In addition, existing treatments can produce variable responses in patients, along with unwanted side-effects and potential safety concerns.11

The Institute for Clinical and Economic Review (ICER) has recently analyzed the relative safety and effectiveness of existing DMTs for relapsing-remitting MS (RRMS).4

Each drug or group of drugs is represented by an oval. The safest drugs are highest on the graph; the most effective are toward the right. Wider ovals reflect uncertainty about overall effectiveness, while taller ovals represent uncertainty about safety.5

The chart below summarizes the safety and efficacy of DMTs for RRMS:

Text

Institute for Clinical and Economic Review. Final Evidence Report – DMTs for RRMS and PPMS. March 6, 2017. [PDF]

Text

We can see that Lemtrada® (alemtuzumab), is located on the right side of the graph; it is considered the most effective drug, however it is also low on the safety scale. Conversely, the beta interferons, shown on the upper left, are among the safest DMTs, but also the least effective.

Critically, the ideal DMT, one that is both very safe and highly effective, would be to the upper right, in the space labeled “ideal for patients.” Unfortunately, based on the ICER evaluation, this space remains vacant.

There’s no question that DMTs must continue to play a key role in treating MS. The good news is that MS research continues to build momentum, and new discoveries and new potential treatments are always emerging. We continue to hope for new treatments that could be substantially safer and more effective.

An OptumRx analysis of the MS pipeline is tracking four agents with estimated approvals in the next two years:

  • cladribine (for relapsing forms of MS); Expected launch 2nd quarter 2019
  • siponimod (relapsing and secondary progressive forms of MS); Expected launch: 2nd quarter 2019
  • ALKS-8700 (for relapsing forms of MS); Expected launch: 4th quarter 2019
  • MD-1003 ( for primary progressive or secondary progressive MS and chronic vision loss); Expected launch: Late 2020

For more details on these developmental drugs, open the “Closer Look” file [PDF] below:

Text

Pharmacy insights closer look

Text

Conclusion

While the search for safer and more effective treatments for MS will continue, for now the best possible strategy for managing MS is to help patients stay adherent to their treatment plan. However, the relatively young age at which MS is commonly first diagnosed means taking DMT medications for prolonged periods, which can be challenging.7

That’s where proper support from available clinical UM programs from OptumRx can help. For example, the prior authorization, quantity limit and step therapy programs help promote the use of safe, effective and cost-effective medications, as supported by treatment guidelines and clinical evidence.

Optum Specialty Pharmacy's MS-specific therapy program provides a comprehensive approach to managing MS with a specialized and dedicated team of individuals, expertly trained to provide the best patient experience with each and every interaction.

Optum Specialty Pharmacy's therapy-specific programs use a coordinated smart-touch approach focused on staying connected to patients and building relationships with them in order to provide a high quality patient experience and improved clinical outcomes.

Check with your consultant or OptumRx representative for program details and availability. Look for the upcoming article on “management strategies” for more.

Text

References

  1. National MS Society. Medications. At: https://www.nationalmssociety.org/Treating-MS/Medications
  2. Johns Hopkins Health System. Treating Multiple Sclerosis (MS). Accessed at: https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/multiple_sclerosis/conditions/multiple_sclerosis_treatments.html on 06.01.2018.
  3. Medical News Today. Multiple sclerosis: Are we close to a cure? Aug. 21, 2017. At: https://www.medicalnewstoday.com/articles/319061.php
  4. Institute for Clinical and Economic Review. Final Evidence Report – DMTs for RRMS and PPMS. March 6, 2017. [PDF]
  5. Drug Topics. MS Group Praises New Drug Despite High Price Tag. April 04, 2017. At: http://drugtopics.modernmedicine.com/drug-topics/news/ms-group-praises-new-drug-despite-high-price-tag
  6. MS Coalition. Consensus on Disease-Modifying Therapies, Summary. March, 2017. [PDF]
  7. National MS Society. Adherence. At: https://www.nationalmssociety.org/Treating-MS/Medications/Adherence
  8. \Health Quality Life Outcomes. Glatiramer acetate treatment persistence - but not adherence - in multiple sclerosis patients is predicted by health-related quality of life and self-efficacy. Published online March 14, 2017. At: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5351176/
  9. Medscape Medical News. Multiple Sclerosis: Comorbidities Common at Diagnosis. March 24, 2016. At: https://www.medscape.com/viewarticle/860968
  10. Multiple Sclerosis News Today. Burden of Multiple Sclerosis Relapses Is Underappreciated, Study Says. May 5, 2017. At: https://multiplesclerosisnewstoday.com/2017/05/05/study-says-burden-of-multiple-sclerosis-relapses-is-underappreciated/
  11. Specialty Pharmacy Times. Late-Stage Pipeline Review for Multiple Sclerosis Treatments. Feb. 13, 2017. At: https://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2017/january-2017/late-stage-pipeline-review-for-multiple-sclerosis-treatments
  12. Medscape Medical News. Cladribine Back in the Running for Multiple Sclerosis. June 1, 2017. At: https://www.medscape.com/viewarticle/880990
  13. EndPoints News. Poised for an FDA pitch, Novartis lays out all its PhIII cards on MS drug siponimod. March 22, 2018. At: https://endpts.com/poised-for-an-fda-pitch-novartis-lays-out-all-its-phiii-cards-on-ms-drug-siponimod/
  14. Multiple Sclerosis News Today. #MSParis2017 – EVOLVE-MS-1 Interim Trial Data Shows Alkermes Therapy Safe for Treating Relapsing MS. Nov. 1, 2017.
  15. Multiple Sclerosis News Today. MedDay’s New Phase 3 Trial and Belief in Biotin’s Potential to Treat Progressive MS: An Interview with Dr. Frédéric Sedel. May 9, 2017. At: https://multiplesclerosisnewstoday.com/2017/05/09/medday-new-phase-3-trial-and-belief-in-biotin-potential-to-treat-progressive-ms-interview-with-frederic-sedel/
Horizontal Rule
Text

STATEMENT REGARDING FINANCIAL INFLUENCE:
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author nor OptumRx has accepted any form of compensation for the preparation or distribution of this article.

Horizontal Rule