Disease Management Consensus Statement - Treatment Recommendations for Physicians

Disease Management Consensus Statement - Treatment Recommendations for Physicians

Published: US Neurology Review 2005
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While recognizing that factors entering into a decision to treat are complex and are best analyzed by the individual patient’s neurologist, the Executive Committee of the Medical Advisory Board of the National Multiple Sclerosis Society (NMSS) has adopted the following recommendations regarding use of the current multiple sclerosis (MS) disease-modifying agents (DMAs).

Immunomodulators

  • interferon-beta (IFNß) 1a-intramuscular (Avonex®);
  • IFNß 1a-subcutaneous (Rebif®);
  • IFNß 1b (Betaseron®); and
  • glatiramer acetate (Copaxone®).


Immunosuppressant
Mitoxantrone (Novantrone®)

  • Initiation of therapy with an immunomodulator should be considered as soon as possible following a definite diagnosis of MS with active disease, and may also be considered for selected patients with a first attack who are at high risk of MS.
  • Patients’ access to medication should not be limited by frequency of relapses, age, or level of disability.
  • Treatment is not to be stopped while insurers evaluate for continuing coverage of treatment.
  • Therapy is to be continued indefinitely, except if there is clear lack of benefit, there are intolerable side effects, or better therapy becomes available.
  • All of these US Food and Drug Administration (FDA)-approved agents should be included in formularies and covered by third-party payers so that physicians and patients can determine the most appropriate agent on an individual basis – failure to do so is unethical and discriminatory.
  • Movement from one immunomodulatory drug to another should occur only for medically appropriate reasons.
  • Immunosuppressant therapy with Novantrone® (mitoxantrone) may be considered for selected relapsing patients with worsening disease or patients with secondary-progressive MS.
  • Most concurrent medical conditions do not contraindicate use of the immunomodulatory drugs.
  • None of the therapies have been approved for use by women who are trying to become pregnant, are pregnant, or are nursing mothers.


Introduction
MS has been substantially advanced by the availability of the DMAs IFNß 1a and 1b and glatiramer acetate, and the immunosuppressant agent, mitoxantrone.A number of positive outcomes have been demonstrated in people with relapsing disease – reduction in the frequency and severity of relapses 1  (Betaseron,2–5 Avonex,6–9 Copaxone,10–11 Rebif,2–14 and Novantrone 15), reduction of brain lesion development, as evidenced by magnetic resonance imaging (MRI) (Betaseron,2,16–17 Avonex,6–9 Copaxone,18–20 Rebif,12–14,21–22 and Novantrone 23), and the possibility of reduction of future disability 24 (Betaseron,2,16–17 Avonex,6–9 Copaxone,10–11 Rebif,12–14 and Novantrone 15,23).

Based on several years of experience with IFNßs and glatiramer acetate, it is the consensus of researchers and clinicians with expertise in MS that these agents can reduce future disease activity and improve quality of life (QOL) for many individuals with relapsing forms of MS, including those with secondary progressive disease who continue to have relapses. For those who are appropriate candidates for one of these drugs, treatment must be sustained for years. Cessation of treatment may result in a resumption of pre-treatment disease activity.25

Clinical trials are designed to evaluate the smallest number of people over the shortest period of time at the lowest cost. In order to accomplish this, inclusion criteria are necessarily narrow.

These restricted parameters of clinical trials are not intended to regulate subsequent clinical use of the agent.With demonstrated benefit to people with MS from continued use of Betaseron, Avonex, Rebif, or Copaxone, it is critical that these therapies be made available early in the disease process to appropriate candidates as indicated in the labeling of each of these medications, and that Novantrone be available for judicious use in aggressive relapsing disease and for those not responding to immunomodulators.

Background
In August 1994, the Quality Standards Subcommittee of the American Academy of Neurology (AAN) published an advisory statement on the selection of patients with multiple sclerosis for treatment with Betaseron (IFNß 1b). Since then, four additional agents that modify the underlying disease process have been approved by the FDA – Avonex (IFNß 1a), Copaxone (glatiramer acetate), Novantrone (mitoxantrone), and Rebif (IFNß 1a). The benefits of these agents include direct evidence of disease modification,1–23 with inferred advantage to function and quality of life.The NMSS has maintained the timeliness of its consensus statement as additional agents have been studied and approved, and new clinical trial data have become available. The current revision references all of the currently approved drugs.

Significant obstacles to obtaining these agents exist for appropriate candidates with MS.

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