ICER’s Final Report on Disease-Modifying Therapies for Multiple Sclerosis Finds Most Drugs are Over-Priced in Relation to Benefits for Patients; Highlights Need for Stakeholder Collaboration to Address System Issues

–Key policy recommendations call on manufacturers to cease price increases and payers to ease coverage restrictions and lower out-of-pocket costs if drug prices align with benefits–

Boston, Mass., March 6, 2017– The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report and Meeting Summary on the comparative clinical effectiveness and value of disease-modifying therapies (DMTs) for treatment of relapsing-remitting and primary progressive multiple sclerosis (RRMS and PPMS).

“Evidence on DMTs for MS shows that they offer important clinical benefits for patients in terms of reduced relapse rates and delayed disability progression,” stated ICER’s President Steven D. Pearson, MD, MSc. ICER’s analysis found, however, that prices of the drugs do not align with the benefits they provide to patients, contributing to pervasive access problems and large financial burdens for patients with a lifelong disease. “We agree with the view expressed by many patients and patient groups: despite important treatment advances, the health care system is broken for MS patients. High prices and regular price increases contribute significantly to restrictions on coverage and access that make it difficult for patients to get the medications they need. It will take concerted effort on the part of all stakeholders to bring prices into alignment with each drug’s clinical benefit, ease coverage restrictions once prices have come down, and move towards a system that better meets the needs of the diverse population of individuals living with MS.”

The report reviews the evidence on the comparative clinical effectiveness of DMTs and includes economic analyses to determine the value of the drugs in the short- and long-term. Economic analyses in this report rely on pricing information from SSR Health LLC, which uses publicly disclosed data on net dollar sales and volume information to estimate average prices after typical discounts and rebates. The report incorporates a summary of votes taken during a public meeting of the California Technology Assessment Forum (CTAF), as well as key policy implications stemming from discussion with a panel that included a patient, a patient advocate, clinical experts, two major insurers, and a drug manufacturer representative. The report is accompanied by a Report-at-a-Glance document, which summarizes key points of the evidence review and economic model, value-based price benchmarks for each drug, voting results, and policy implications. Highlights of the meeting, as summarized in the Final Evidence Report, include:

Comparative Clinical Effectiveness and Value

The panel deliberated on several questions related to the effectiveness and value of DMTs for RRMS and PPMS. Although several drugs were more effective than comparators at reducing relapse rates, this advantage was not enough to outweigh substantial uncertainty around the drugs’ effects on disability progression, an outcome of high importance to patients. In addition, many of the comparisons included drugs with distinct but overall largely comparable safety profiles. As such, many votes did not hinge on considerations around risk.

RRMS

A majority of the Panel voted that there is inadequate evidence to show that dimethyl fumarate (Tecfidera®, Biogen) offers a greater net health benefit than teriflunomide (Aubagio®, Sanofi Genzyme), while the Panel was evenly divided in a vote on whether fingolimod offers added net health benefit over teriflunomide. Panel members also voted that the net health benefit of dimethyl fumarate and fingolimod (Gilenya®, Novartis) could not be distinguished.

Voting on daclizumab (Zinbryta®, Biogen and AbbVie), the Panel voted that evidence was not adequate to show a net health benefit of daclizumab over dimethyl fumarate and fingolimod. The Panel was split on whether evidence was adequate to show a greater net health benefit of daclizumab as compared to generic glatiramer acetate 20 mg. Those voting in favor of a greater net health benefit cited reduced rates of relapse for patients, while those voting against pointed to safety risks and inconvenient monitoring requirements as important factors in the overall benefit. In considering the value of daclizumab, the Panel voted that the drug represents low long-term value for money compared to glatiramer acetate 20 mg because while the drug is more effective at reducing relapse rates, this improvement was not substantial enough to outweigh the drug’s risker safety profile and increased cost.

A majority of the panel voted that ocrelizumab offers a greater net health benefit compared to generic glatiramer acetate 20mg, due largely to the superiority of ocrelizumab (Ocrevus®, Genentech) in reducing relapse rates.

PPMS

A majority of the Panel voted that evidence is adequate to show the net health benefit of treatment with ocrelizumab is greater than that of supportive care.

A more detailed review of the votes can be found in the full report.

Policy Implications

During the meeting, the Panel discussed policy implications of their evidence votes with a panel of subject-matter experts, including a patient and patient advocate, clinical experts, a drug manufacturer representative, and two payer representatives. Key policy themes highlighted the need for collaboration among all stakeholders to improve access and affordability of available treatments for MS. Among the key implications are the following:

  • Manufacturers should link launch prices of new DMTs to the added value they bring to patients compared to existing clinical options. In addition, they should cease annual price increases that exceed medical inflation without new evidence of improved outcomes.
  • Payers should work to develop policies that allow patients to continue using a treatment that is working for them, regardless of changes to coverage or formulary structure. In addition, payers should increase access to therapies for which the cost aligns with the value brought to patients. Any pricing concessions should be shared with patients, who often face high out-of-pocket costs for treatment.
  • Patient advocates should work with clinicians and researchers to ensure that consistent patient-centered outcomes are integrated into all clinical trials.
  • Clinicians and specialty societies should work to develop more conclusive guidelines around treatment sequencing and develop clearly defined criteria for patients who should be started on more effective but higher risk treatments.

A full list of recommendations along with a more detailed discussion of each can be found in the full report. The final report and the Report-at-a-Glance can be found on the ICER website.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.