Submission to the Ontario
Drug Strategy Review
May 14, 2003
INTRODUCTION
The Multiple Sclerosis Society of
Canada is actively involved with Canada’s
federal and provincial governments across a wide range of concerns affecting
people with multiple sclerosis and their families and caregivers. These
concerns include the adequacy and fair administration of income security
programs, taxation policies affecting people with disabilities, access
to community-based services such as home and community care and accessible
housing, prompt access to diagnostic services and access to approved
drug therapies and medical devices.
The Ontario Division of the MS Society
of Canada is pleased to participate in the Government of Ontario’s
drug strategy review. There are a number of areas where we feel improvements
can be made easily that
will save money, improve efficiency and improve the timely access to
drug therapies for people with MS. These are outlined below.
MULTIPLE SCLEROSIS: A PROGRESSIVE, SEVERE AND CHRONIC DISEASE
MS is a chronic disease of the central nervous system that unfortunately
often leads to severe disability. MS attacks the protective myelin covering
of the nerves, causing inflammation and often the destruction of the
myelin in patches. This interrupts the normal flow of nerve impulses.
The results often include vision problems, numbness, loss of balance,
extreme fatigue and even paralysis.
MS is one of many chronic conditions
affecting Canadians. According to the National Population Health Survey,
in 1998-99, more than half
of all Canadians reported having a chronic condition. As the leading
cause of disability, loss of productivity, and deterioration in the quality
of life, chronic non-communicable diseases are the major health burden
today in developed countries1. Although the cause and the cure are so
far unknown, four drugs are now in use for the treatment of MS and can
reduce the frequency and severity of attacks and slow the progression
of disability. Other medications and therapy can help many MS symptoms.
Epidemiological studies indicate that Canada has one of the highest
rates of MS in the world. An estimated 50,000 Canadians have this all
too frequently disabling disease. Usually diagnosed between the ages
of 20 and 40, MS is the most common disease of the central nervous system
affecting young adults in Canada. Women are affected almost twice as
often as men. Periods of spontaneous recovery are interrupted by unpredictable
attacks that over time result in most people with MS becoming disabled.
The result: young Canadians face a progressive and unpredictable disease
that cannot be prevented, and that they must live with for 40 or more
years.
Most people with MS are eventually unable to work full-time and many
experience total disability. In 1991, 44% of adults with disabilities
(aged 15-44) were not part of the labour force. With MS, however, this
is significantly higher. Seventy per cent of people with MS are not working
5-10 years after they are diagnosed.
RESPONSE TO STEERING COMMITTEE ISSUES FOR DISCUSSION
1. ACHIEVING MORE PATIENT-CENTRED
PHARMACEUTICAL CARE
Reducing bureaucracy in the Section 8 mechanism
There is agreement among clinicians that people with MS benefit from
early treatment with drugs that can reduce the frequency and severity
of attacks and slow the progression of disability. In Ontario, the four
drugs most commonly used are not on the Drug Benefit Plan Formulary.
Rather, they are available under the Section 8 mechanism.
Our understanding of the Section 8 mechanism is that it was designed
to accommodate drug therapies that are effective for some patients but
which either involve side-effects that warrant close control of their
prescribing or are very expensive and, therefore, should be used only
if less expensive alternatives are not effective. These circumstances
seem reasonable.
However, in recent years, our interpretation
is that Section 8 has become used increasingly as a cost-constraint
mechanism — in other words,
putting products in this category limits their use because each prescription
requires case-by case scrutiny and delays before the patient can receive
the drug prescribed by the physician.
More than 96,000 Section 8 requests
were processed in 2002, an average of almost 400 per working day. Roughly
three-quarters were considered
to be urgent. Right now, it takes approximately 10 weeks to process a “non-urgent” request.
According to ODB figures, the volume of Section 8 requests more than
tripled between 1997/98 and 2000/01, yet the overall approval rate of
requests remained steady at more than two-thirds.
Many of the drugs approved under Section 8 achieve very high rates of
approval. Indeed, the 10 most frequently requested drugs under Section
8 are approved at rates that vary from 81-97%. The most frequently requested
drug, Plavix (indicated for the secondary prevention of heart attack
or stroke in patients with underlying atherosclerosis) accounted for
fully 38% of the total volume of requests in 2001 and yet 97% of the
requests for Plavix were approved. Among MS-specific therapies in 2000
(the last year in which statistics were available) two of these therapies,
Copaxone (glatiramer acetate) and Rebif (interferon beta-1a) were approved
in 84% of requests.
It does not make sense to us that drugs that are approved more than
80% of the time despite individual assessment of the prescriptions should
be subject to a bureaucratic mechanism designed to limit such prescriptions
to appropriate cases. Surely, the evidence lies in the results. The disease
modifying therapies are being appropriately prescribed.
One of the consequences of using the Section 8 mechanism is that prescriptions
are delayed. According to the ODB Plan, 88% of prescription requests
are assessed within three weeks. However, for patients in the 12% minority,
delays can be quite substantial.
Most people with MS have difficulty
finding family physicians with the specialized knowledge necessary
to treat
a complex disease like MS. They
receive much better and more expert treatment from neurologists – especially
those working in MS Clinics. Given the delays in filling a Section 8
prescription, people with MS often find it hard to accommodate the cycle
of neurological consultation/prescription/evaluation of effects/follow-up
examination by the neurologist in a timely way. In far too many cases,
by the time the effect of a drug therapy can be assessed, it is already
past time to see the neurologist again, given the time it takes to get
an appointment and then have the prescription renewal processed.
This can be harmful to people with MS as prompt treatment can mitigate
the severity of symptoms. Moreover, given that fatigue and limited mobility
are among the most common symptoms, the difficulties of getting to the
doctor for a renewal and delays in getting a prescription renewed can
result in cumulative problems.
As one MS Clinic coordinator notes,
“The current requirement is
that the patient secures an appointment for neurological consultation
and examination
within 1-3 months of the
expiry date of the previous funding approval date. This is a challenge
in a busy clinic where every effort is made to accommodate patients with
MS, but it is not always possible to arrange for a timely consultation. …
“There are often lapses of funding between approval periods, when
Section 8 letters are submitted less than two months in advance. There
have also been instances when request letters have been submitted and
approval granted several weeks after a previous prescription’s
expiry date, leaving patients vulnerable.”
MS Clinic coordinators report that it takes far too long to receive
a response on requests for new drugs used for MS symptom relief. As one
coordinator reports,
“It takes 8 – 10 weeks to receive a response on requests
for Section 8 approval for Alertec (for fatigue); Neurontin (for severe
pain) and Zanaflex (for spasticity). In addition, often the approval
for these drugs is only for three months which means you have to start
the reapplication process right away because it takes 8 – 10 weeks
(for the Section 8 to be processed) before you have had a chance to assess
how the patient is doing on the drug.”
A nurse in Ottawa who handles Section 8 requests also notes problems
with approval times for MS-related drugs such as Neurontin, Alertec and
Zanaflex:
“It takes eight weeks for
approval of requests for these drugs, but in Quebec requests can be
processed
within 48 hours to a week. In
Quebec, they have hired pharmacists to review the requests and not external
consultants.”
Some of this backlog and delay could be eliminated by transferring drugs
that over time are approved in the overwhelming majority of cases either
to Limited Use listing (eliminating the need for case-by-case assessment
of prescriptions) or to unrestricted listing on the formulary. The rationale
for Section 8 listing in these cases seems to us to be rebutted by prescribing
experience and, by removing these drugs from the Section 8 process, resources
would be freed up that might well allow the roughly 6,000 cases per year
that experience multi-week processing to be dealt with more efficiently.
Patients, ODB Program administration and taxpayers would benefit.
The MS Society is also concerned that the increased use of the Section
8 process undercuts the clinical expertise of the physician who is treating
the patient, knows that individual best and what treatment is most likely
to work for him or her. A patient-centred approach would respect the
physician-patient relationship and also allow for the patient to be more
actively involved in the process, leading to better understanding and
compliance.
Harmonizing Criteria for most commonly prescribed drugs for people with
MS
It would be more beneficial to people with MS if the same prescribing
and reimbursement criteria were used for all four disease modifying therapies
for MS (Avonex, Betaseron, Copaxone and Rebif) where Health Canada approved
indications allow. This would make it easier to switch people from one
therapy to another, which is sometimes necessary because of how individuals
respond to particular drugs or if they have problems with side-effects.
Recommendations
- Transfer drugs with very high rates
of request approvals from Section 8 to either Limited Use or unrestricted
formulary listing.
- If
MS drugs remain available through the Section 8 mechanism or if they
are moved to Limited Use listing, the criteria for the four current
disease-modifying therapies for people with MS should be harmonized where
appropriate.
- If separate
criteria for the four current disease-modifying therapies are maintained,
the criteria should be easily available to prescribers
and the public on the Ministry of Health web site and prescribers should
have easy access to MS drug templates which include the current criteria.
2. IMPROVING ODB PROCESSES
MS Clinic coordinators and people with MS report that a lack of administrative
transparency leads to problems. According to one clinic coordinator,
“One patient was turned down after a wait of 10 weeks because
the rules had been changed and we weren’t notified of that change.
We re-applied supplying more information and still had to wait another
10 weeks for a response. It is vital that the Ontario Drug Programs Branch
communicate clearly to physicians about the criteria for both Limited
Use and Section 8. If this information could be posted on the Drug Programs
Branch web site, it would be helpful to health care professionals.
“Physicians who don’t
treat a lot of MS (unlike those at the MS clinics) often have Section
8 applications
rejected because they
are not familiar with the required EDSS scores and other information.
For these physicians, they find it far too complicated and many of their
applications on behalf of patients are turned down.”
Personal Story: Barbara
Barbara was diagnosed with MS in 1982. She recovered well from her first
attacks and had no major MS attacks until 1998. At that time she had
a major attack which affected her physically as well as her memory and
cognitive processes. Her doctor prescribed the high dose of Rebif (interferon
beta-1a).
Her doctor did the paperwork for the Section 8 but unfortunately because
of a misunderstanding it was approved for the low dose (22 mL). This
did not match the paperwork done for the Trillium Drug Program and the
reimbursement was refused. She was desperate to start treatment so she
started to pay for the drug herself even though she had virtually no
money.
She found the entire process very confusing especially at a time when
MS was affecting her ability to think and her memory. She found the lack
of cooperation between the Section 8 process and the Trillium Drug Program
difficult and did not feel that she received clear information from staff
responsible for either program.
Personal Story: Lisa
Lisa has been on Betaseron (interferon beta-1b) for almost six years.
She credits the treatment for slowing the worsening of her disability.
She can still walk although for long distances she uses a scooter.
Because she is considered on “the edge” of the eligibility
criteria for the drug, her doctor’s Section 8 requests for her
to continue on treatment have been turned down several times. On appeal,
she has been able to have them approved. This has caused her much stress
and on occasion she has been very close to running out of medication.
“This is not a fluid way to help people with MS who don’t
need extra stresses in their lives,” she explains. “I’m
grateful that I qualify for financial assistance (she now receives benefits
from the Ontario Disability Support Program) because otherwise I couldn’t
afford this treatment which is keeping me from becoming more disabled.”
Recommendations
- Improve the transparency of the
process to both prescribers and the public.
- Although
we feel the best solution is to transfer the MS disease-modifying
therapies and other frequently used and approved therapies from Section
8 to either Limited Use or unrestricted formulary listings, in all cases
communication with prescribers about Section 8 and Limited Use criteria
should be improved. Information on program criteria and administrative
requirements should be posted on the Ministry of Health web site, including
recent changes, so that prescribers can ensure that they are responding
to current requirements.
- The
amount of time given for a Section 8 approval should be increased to
six months at a minimum.
- Section
8 requests for people with severe, chronic diseases should be fast-tracked
(e.g., processed within two to seven days as is the case
in Quebec).
3. TRILLIUM DRUG PLAN
The MS Society of Canada, Ontario Division, has received many complaints
from people attempting to gain reimbursement through the Trillium Drug
Plan.
For example, an MS Clinic director in eastern Ontario reports as follows:
“I hear mostly complaints
from patients about the cumbersome deductible provisions, especially
the quarterly
application. More patients have
gone to their MPP over this than any other issue I can recall. I would
suggest that the interface to the patients undergo a full examination
with a view to improving the patient friendliness of the program.
“Some patients have just given
up trying to get reimbursement from Trillium even though they are entitled
to
it. If this were solved,
I would tolerate all the Section 8 problems!”
An MS Clinic coordinator in southern Ontario reports issues regarding
response times:
“It takes far too long to
receive a response from the Trillium Drug Program and it is not well
coordinated
with the Section 8 process.
We warn patients not to fill their prescriptions until they get the notice
from Trillium that they are approved otherwise they would have to pay
the whole cost of these expensive drugs. This is very frustrating for
patients and for us as health care professionals since we know that it
is best to start the disease modifying therapies as early as possible.
It should be a goal for the Trillium Drug Program to have a maximum turn
around time of 4 weeks.
“The deductible for Trillium
is still too high for many patients. Even if they have high family
incomes,
paying $4,000 out of pocket can
be very difficult.”
Personal Story: Lynette
Lynette has had MS for five years. Shortly after she was diagnosed,
her doctor prescribed Rebif (interferon beta-1a) and she has responded
well to treatment. The Section 8 process has worked well for the most
part and approvals for renewal usually come through in two to three weeks.
Her Section 8 applications are handled through the local MS Clinic which
is very experienced and knowledgeable about the procedures to be followed.
However, her experience with the Trillium Drug Program has not been
as smooth, and she has been off medication for the past six weeks because
she has not been able to afford it. She is beginning to experience MS
symptoms that have not presented for some time.
There has been ongoing difficulty
in coordinating the Trillium Plan with the private insurance she has
through her husband’s
employer. Trillium is consistently 8-12 weeks behind in the money owed
to the family
which several times has caused them considerable financial hardship.
At one point her husband took a second job to help pay for the medication
but then learned this put the family in a higher category for the deductible
under the Trillium Drug Program.
She and her husband are extremely
frustrated with the lack of information from staff at the Trillium
Drug Program.
They say that no one ever returns
their calls, they are never able to talk to the same person more than
once and at times, staff members’ command of English is not good.
Lynette’s husband points out
that this is doubly frustrating because their private insurance saves
the Government
of Ontario 80% of the cost
of the medication.
Recommendations
- Improve communications about the
Trillium Drug Program and how people can apply. This could be done
in part by better use of the expertise
of pharmacists in letting people know about the program and how to apply
to it.
- Ensure that Trillium
Drug Program staff are well trained in working with the public and
that their communication
skills are of a high quality.
- Ensure
that the interface between the Trillium Drug Program and private insurers
is seamless.
- Ensure that
people receive reimbursement payments from the Trillium Drug Program
in a timely manner – eight
to 12 weeks is far too long for most people.
- Investigate
the use of a simple electronic card that Trillium Drug Program recipients
can use at pharmacies that would allow them to know
how much they need to pay and what the TDP will be paying.
4. DECREASED ACCESS TO APPROVED THERAPIES IN ONTARIO
The MS Society of Canada, Ontario Division, is concerned that recent
trends in formulary approvals indicate trends toward decreased access
to approved drug therapies. According to ODB figures, in recent years,
- Ontario has approved fewer single-source
drug products for formulary listing than Quebec, Alberta and British
Columbia
- Ontario
has by far the lowest number of full listings and
the highest number of partial listings among these four
provinces
- Ontario takes longer to list drugs than
Alberta, Quebec or British Columbia
Recommendation
- Ontario should strive to improve
its listing time for adding new drugs to the formulary and increase
the number of drugs receiving full listing
to match those of the three leading provinces. This will greatly improve
access to people who must rely on drug therapies.
5. COMMON DRUG REVIEW
The MS Society is also concerned that recent steps toward participation
in the Common Drug Review (CDR) initiative could add to current delays
and add additional layers of decision-making and potential bottlenecks
in getting timely listing of new therapies to the Ontario Drug Benefit
formulary.
Recommendation
- We urge that the Government of Ontario
ensure that its participation in the Common Drug Review does not lead
to longer approval times or add
to current delays, and that it uses its influence with the other CDR
partners to ensure that this principle is accepted across Canada.
CONCLUSION
Our discussions with staff, volunteers, physicians and other health
care workers and many, many people with MS indicate that Ontarians with
MS are appreciative of the Section 8 process and the Trillium Drug Program.
Their experience leads them to hope that the Government of Ontario will
make the needed changes in its drug programs to improve transparency,
communication with prescribers and potential beneficiaries, speed of
response and as uncomplicated a system as possible.
We hope our suggestions are helpful. We think the current consultative
process is useful and urge the government to continue to solicit input
from consumers or consumer groups on a regular basis to ensure that its
drug programs meet the needs of people in Ontario. We would support and
be pleased to participate in a consumer advisory group that could work
with and perhaps report to the Drug Quality and Therapeutics Committee.
1 Dr. David MacLean,
Addressing the Burden of Chronic Disease in Canada, Brief to the Senate
Committee on Social Affairs, Science and Technology,
3 April 2001, p.1.
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