|
Rebif® (Interferon Beta-1a)
approved in Canada for relapsing-remitting multiple sclerosis
Medical Update Memo
February 18, 1998
Summary
Another form of beta interferon has been approved by the
federal Health Protection Branch for use in treating relapsing-remitting
multiple sclerosis. Rebif® (interferon beta-1a) was approved
on February 5 and launched by Serono Canada on February 18.
The drug is available in two dosages immediately.
The base cost of Rebif® is either $17,000 or $21,000 per
year, depending upon the dosage strength. Approval was based
on results from a large clinical trial that found the drug had
a positive impact on all major outcome measures: reducing the
number and frequency of MS relapses; slowing the progression
of disability; and reducing the number of brain lesions as measured
by MRI. The drug was self injected three times a week subcutaneously
(under the skin). Interferon beta-1a has been available in Canada
for the past four years under the federal Emergency Drug Release
Program.
"The MS Society welcomes the approval
of Rebif®. While not a cure for MS, it offers yet another
treatment choice for people with relapsing-remitting multiple
sclerosis," said Alistair M. Fraser, national president.
Background
Rebif® (interferon beta-1a) was approved February 5 by the
Federal Health Protection branch as a treatment for relapsing-remitting
MS. Approval was announced February 18 by Serono Canada. The
drug is available immediately. Rebif® is the second beta
interferon to be approved in Canada where it has been available
for the past four years under the federal Emergency Drug Release
Program. Rebif® is produced using recombinant DNA techniques.
It is based on a mammalian cell line compared to Betaseron®
(interferon beta-1b) which is derived from a bacterial source.
Rebif® will be available in two dosage
strengths based on the clinical trial results. The base cost
is $17,000 or $21,000 per year depending upon the dosage. The
cost charged at pharmacies will be higher than the base price
and may fluctuate from pharmacy to pharmacy.
Speaking on behalf of the Multiple Sclerosis
Society of Canada, Alistair M. Fraser, national president, said
that the MS Society welcomes the approval of Rebif® in Canada.
While not a cure for the disease, it offers yet another treatment
choice for people with relapsing-remitting MS. The Multiple
Sclerosis Society will be urging provincial governments across
Canada to provide drug cost reimbursement for this drug, as
a number of provinces have done with other approved MS treatments.
Clinical Trial Results
Results of a clinical trial of the use of interferon beta-1a
(Rebif®) in relapsing-remitting MS was presented at the
meeting of the American Neurological Association in San Diego
on September 30. Positive treatment results were reported for
each of the important outcome measures in both of the treated
groups compared with placebo.
The international, multi-centre trial, which
involved 560 people with relapsing-remitting MS, was the largest
MS clinical trial to date. Participants were enrolled at 22
MS clinics in Canada and eight other countries in Europe. Study
participants' disability levels ranged from 0 (no obvious disability)
to 5 (ambulatory without aid for approximately 200 metres) on
the Kurtzke Expanded Disability Status Scale (EDSS).
Participants were assigned randomly to three
groups: treatment with 12 MIU (million international units)
of interferon beta-1a, with 6 MIU or inactive placebo. They
self-injected the drug subcutaneously (under the skin) three
times a week for two years.
The primary endpoint of the study was the
number of relapses per study participant. There was a reduction
of 32.4% in the relapse rate in the 12 MIU group and 28.9% reduction
in the 6 MIU group.
There was an increase in the number of participants who had
no relapses during the study. For those with relapses, the time
to the first attack was significantly delayed and the number
of moderate and severe attacks was reduced.
Hospitalizations for those on 12 MIU were reduced by half and
the use of steroids to treat relapses was down by half in both
treatment groups.
The time to the progression of disability by an EDSS score of
1.0 was lengthened.
MRI-detected brain lesion burden and lesion activity was significantly
reduced.
Side Effects
The medication was reported to be well tolerated with some participants
reporting temporary flu-like symptoms and some injection site
reaction. Neutralizing antibodies to interferon treatment, which
can develop over time, were seen in about 23% of participants
in the 6 MIU group but in just 14% of those who received 12
MIU for reasons that are not yet understood.
This is the third clinical trial of a beta
interferon to be reported. Because of differences in clinical
study design, it is not possible to make direct comparisons
between Rebif® (interferon beta-1a), Avonex (interferon
beta-1a) and Betaseron® (interferon beta-1b).
The results of a clinical trial of interferon
beta-1a (Rebif®) on secondary progressive MS will be analyzed
in the coming months. Interferon beta-1b (Betaseron®) is
also being studied as a treatment for secondary progressive
MS. That study began in early 1996 and after interim analysis
of the European portion of the study, an independent review
panel recommended that because of the positive outcome, the
study be stopped and all participants be switched to active
treatment.
For more information about Rebif® , please
call Serono Canada at 1-888-677-3243. For more information about
Betaseron®, please call Berlex Canada at 1-800-977-2770,
ext. 5000 for general information and ext. 4000 for drug-related
information.
Additional Information
-
The outcome of the Rebif® clinical
trial found: reduction in the number and severity of MS
relapses; delay in progression to disability; and reduction
in MS activity as measured by MRI brain scans.
-
Rebif® is the first of the MS treatments
now approved to be available in ready-to-use, pre-filled
syringes. This eliminates the need for individuals to reconstitute
(mix) the product before self-injecting it.
-
Rebif® is available in two dosage
options 12 MIU/44 mcg and 6 MIU/22 mcg. This is the first
time there has been a dosage choice in an MS treatment.
-
The DIN numbers (Drug Identification
Numbers) for Rebif® are:
Pre-filled syringe, 22 mcg (6 MIU) -- DIN # 02237319
Pre-filled syringe, 44 mcg (12 MIU) -- DIN # 02237320
Vials/lyophilate*, 11 mcg -- DIN # 02237317
Vials/lyophilate*, 44 mcg -- DIN # 02237318
(* Vials with freeze-dried powder. It is unlikely these would
be used frequently.)
-
Rebif® is self-injected three times
a week subcutaneously (under the skin).
-
Prescribing criteria as listed in the
product monograph are: having relapsing- remitting MS with
an EDSS between 0 (no disability) and 5.0 (able to walk without
assistance or rest 200 metres). The recommended dosage for
most is 22 mcg/6 MIU. People with a higher degree of disability
(an EDSS of 4.0 or higher) may benefit from the higher dosage
of 44 mcg/12 MIU.
-
The base cost of the product is approximately
$17,000 per year for the lower dosage (22 mcg/6 MIU) and $21,000
for the higher dosage (44 mcg/12 MIU). The cost charged at
pharmacies will be higher than the base price because of the
retail mark up and may fluctuate from pharmacy to pharmacy.
-
All or much of the cost of the product
should be reimbursed by private or group insurance plans if
individuals have such coverage and if they meet the prescribing
criteria. Individuals should read their policies carefully
to determine what is covered since drug plans can vary.
-
Individuals who do not have coverage
and who meet the prescribing criteria, should be able to
access the drug through provincial or territorial drug
reimbursement plans once provincial/territorial governments
agree to add Rebif® to their programs. Serono Canada, the company responsible
for marketing Rebif®, is submitting information to
all of the provincial and territorial drug benefits programs.
This is the first step in obtaining provincial and territorial
drug cost reimbursement. Updates will be forwarded as soon
as they are available.
- Individuals wanting specific information
about Rebif® can call Serono Canada's toll free number
at 1-888-677-3243 -- (new information number).
Disclaimer
The Multiple Sclerosis Society of Canada is an independent,
voluntary health agency and does not approve, endorse or recommend
any specific product or therapy but provides information to
assist individuals in making their own decisions. |
