The Institute of Clinical and Economic Review (ICER) released the early draft of a paper intended to inform a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called a draft scoping document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and Value, Draft Background and Scope,” and open to the public for comment through mid-July.

According to an ICER press release, the document has been developed with input from stakeholders, including relevant multiple sclerosis (MS) organizations, clinical experts, and pharmaceutical manufacturers of the disease-modifying drugs included in the study. Comments from the public can be submitted to [email protected], and must be received by Friday, July 15th, at 5 p.m. Pacific Time.

Currently, there are more than 10 disease-modifying therapies for RRMS. Each aims to decrease the frequency of relapses and prevent the disability that comes with disease progression. But most of these drugs can cause severe side effects, such as liver and cardiac toxicity, cancer, central nervous system infections, and autoimmune diseases. The relative efficacy of one drug compared to the others is also still a matter of debate and inquiry, and scientific comparisons are difficult due to the heterogeneous nature of RRMS.

The drugs to be reviewed in the report include:

Platform agents: interferon beta-1a, peginterferon beta-1a, interferon beta-1b, and glatiramer acetate; particular focus should be given to the comparison of two competing formulations of interferon beta-1a (Rebif and Avonex)

Oral agents: fingolimod (Gilenya), teriflunomide (Aubagio), and dimethyl fumarate (Tecfidera)

Other injectable or infused agents: natalizumab (Tysabri), alemtuzumab (Lemtrada), rituximab (Rituxan), daclizumab (Zinbryta), and ocrelizumab (Ocrevus).

No definitive clinical guideline exists to help doctors decide on an initial therapy, or on subsequent therapies after treatment failure, and patient preference plays an important role in such decisions. In the initial discussions conducted by stakeholders for the draft scoping document, important considerations on patient’s preference were identified, including the general preference for oral medications over injectable ones.

The ICER report includes an analysis of each drug regarding their comparative effectiveness, and their cost-effectiveness and budget impact on patients and the healthcare system. The report, according to the release, supports “the goal of getting excellent drugs to market quickly and at a price that is affordable to patients and the health system, without hindering the development of new and effective drugs.”

Following the public comment period, a revised scoping document will be posted on July 22, which will guide the development of a Draft Evidence Report, expected to be released in late November. This report will also be open for public comment for three weeks, and its key questions addressed and decided at a February 2017 public meeting of the California Technology Assessment Forum (CTAF). At this meeting, a policy roundtable of patient, clinical, and other experts in the MS field will also discuss recommendations for how best to apply the evidence gathered to policy and practice.