Appeal Letter – Betaseron Following 1st Demyelinating Event

Today’s date

Pharmacy/Medical Director Name
Health Plan/Entity Name
Plan Address

To whom it may concern:

This is a (request for pre-authorization, continued authorization or appeal of your denial) for Betaseron (interferon beta-1b) for my patient ______who experienced a documented episode of (optic neuritis, paralysis, numbness, other—describe with detail) suggestive of multiple sclerosis.

An event of this type, known as clinically isolated syndrome (CIS), is indicative of a demyelinating process and is often a precursor to multiple sclerosis. The goal of Interferon Beta 1b at this stage is the delay of a second event and diagnosis of clinically definite multiple sclerosis.

A multicenter, double-blind, placebo-controlled trial of 468 patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions randomized patients to either 250 mg IFNB-1b subcutaneously, or placebo until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months1. The treatment group showed delayed conversion to clinically definite multiple sclerosis.

A follow-up study of the same patients after three years showed 99 patients (37%) in the early treatment group developed CDMS compared with 85 patients (51%) in the delayed treatment group. Early treatment reduced the risk of CDMS by 41%2.

I have enclosed for your information the treatment recommendations of the National Multiple Sclerosis Society’s “Disease Management Consensus Statement”. This consensus statement by national leaders in the diagnosis and management of multiple sclerosis supports the use of immunomodulating therapy for select patients with a first attack who are at high risk of MS.

Sincerely,
John Smith, MD
CC: (patient’s name)

1Kappos L, Polman CH, Freedman MS, Et. al., Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006 Oct 10;67(7):1242–9. Epub 2006 Aug 16.

2Kappos L, Freedman MS, Polman CH, et.al., Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007 Aug 4;370(9585):389–97

Betaseron Following 1st Demyelinating Event – Abstract 1 of 2

CITATION: Neurology. 2006 Oct 10;67(7):1242–9. Epub 2006 Aug 16.

TITLE: Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.

AUTHORS: Kappos L, Polman CH, Freedman MS, Et. al.

OBJECTIVE:To assess efficacy, safety, and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis (MS) (clinically isolated syndrome).

METHODS:We conducted a multicenter, randomized, double-blind, placebo-controlled trial. Patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions were randomized to interferon beta-1b (IFNB-1b) 250 mug subcutaneously (SC) every other day (EOD) (n = 292) or placebo (n = 176), until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months.

RESULTS:After 2 years, 45% of placebo patients had converted to CDMS (Kaplan-Meier estimate; primary outcome measure) and 85% fulfilled the McDonald criteria (co-primary outcome measure). Overall interferon beta-1b delayed the time to diagnosis of CDMS (p < 0.0001) and McDonald MS (p < 0.00001). Hazard ratios (95% CI) were 0.50 (0.36 to 0.70) for CDMS and 0.54 (0.43 to 0.67) for McDonald MS favoring treatment with IFNB-1b. Treatment was well tolerated, as indicated by the low rate of patients dropping out of the study before CDMS was reached (6.6% overall, 7.2% in the IFNB-1b group).

CONCLUSIONS:Interferon beta-1b 250 mug subcutaneously every other day delayed conversion to clinically definite multiple sclerosis and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis.

Betaseron Following 1st Demyelinating Event – Abstract 2 of 2

CITATION: Lancet. 2007 Aug 4;370(9585):363-4.

TITLE: Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study.

AUTHORS: Kappos L, Freedman MS, Polman CH, et. al.

BACKGROUND:Several controlled studies provide evidence that treatment with interferon beta in patients with a first event suggestive of multiple sclerosis (MS) delays conversion to clinically definite MS (CDMS). Our aim was to determine whether early initiation of treatment with interferon beta prevents development of confirmed disability in MS.

METHODS:In the initial placebo-controlled phase of the double-blinded BENEFIT study, patients with a first event suggestive of MS and a minimum of two clinically silent lesions in MRI were randomized to receive either interferon beta-1b 250 microg (n=292) or placebo (n=176) subcutaneously every other day for 2 years, or until diagnosis of CDMS. Patients were then eligible to enter the follow-up phase with open-label interferon beta-1b. In the current prospectively planned analysis 3 years after randomization, the effects of early interferon beta-1b treatment were compared with those of delayed treatment initiated after diagnosis of CDMS or after 2 years on the study. The primary outcomes of this ITT analysis were time to diagnosis of CDMS, time to confirmed expanded disability status scale (EDSS) progression, and score on a patient-reported functional assessment scale (FAMS-TOI). This trial is registered with ClinicalTrials.gov, number NCT00185211.

FINDINGS:Of the 468 patients originally randomized, 418 (89%) entered the follow-up phase; 392 (84%) completed 3 years' post-randomization follow-up. After 3 years, 99 (37%) patients in the early group developed CDMS compared with 85 (51%) patients in the delayed treatment group. Early treatment reduced the risk of CDMS by 41% (hazard ratio 0.59, 95% CI 0.44-0.80; p=0.0011; absolute risk reduction 14%) compared with delayed treatment. Over 3 years, 42 (16%) patients in the early group and 40 (24%) in the delayed group had confirmed EDSS progression; early treatment reduced the risk for progression of disability by 40% compared with delayed treatment (0.60, 0.39-0.92; p=0.022; absolute risk reduction 8%). The FAMS-TOI score was high and stable in both groups over the 3-year period (p=0.31).

INTERPRETATION:Our data suggest that early initiation of treatment with interferon beta-1b prevents the development of confirmed disability, supporting its use after the first manifestation of relapsing-remitting MS.

To be reviewed by clinical staff:

Oct 2012 - Penner I-K, Stemper B, Calabrese P, et al. Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis.Multiple Sclerosis (Houndmills, Basingstoke, England). 2012;18(10):1466-1471. doi:10.1177/1352458512442438.

5/8/2018