Appendix 4 - Health Sciences Centre, St. John’s, Newfoundland

Multiple Sclerosis Clinic

Criteria and Methodologies

for the Use of New Therapies in Multiple Sclerosis (MS)

Subject to Revision

Last updated November 4, 1999

The following recommendations synthesize the MS Society, and the Canadian Neurological Society. The criteria for the use of Betaseron, the first drug released, were based on the results of specific trial criteria, aimed particularly at relapsing-remitting and later relapsing-progressive MS.

Available guidelines for the selection of patients include the "Practice Advisory on Selection of Patients with Multiple Sclerosis for Treatment with Betaseron" from the Quality Standards Subcommittee of the American Academy of Neurology (Neurology 1994: 44:1537-1540)(Appendix 1), and similar criteria published by the Canadian Neurological Society. Although these criteria are helpful and have stood the test of time in most aspects, they were developed when the first of the four drugs was released for use in MS, and the experience since then has required the two groups to begin a reassessment of the documents. New versions are expected in the coming year.

The following are criteria established for patients being provided with these agents by the Newfoundland and Labrador Prescription Drug Program.

Selection Criteria

Patients are candidates for coverage of new therapies if they are covered under the Newfoundland and Labrador Prescription Drug Program (ie. Income Support Drug Program or the Senior Citizens Drug Subsidy Plan) and meet the following criteria:

1. Subjects over 18 years.

2. Confident diagnosis of relapsing-remitting , relapsing-progressive, or secondary progressive MS

3. Two relapses in the previous 24 months (Relapse defined as the appearance of symptoms and signs compatable with MS, lasting greater than 24 hours and not due to a rise in temperature.)

4. Kurtzke EDSS score of 6.5 or less (assistance needed to walk about 20m without resting).

1. Non-compliance

2. A side-effect profile that is not tolerable

3. Persistent severe reduction in WBC counts or evidence of liver toxicity, etc.

4. Deterioration of one or more EDSS points over a year, maintained for over 3/12 (change to progressive state).

5. Two or more courses of steroid therapy required in last year.

6. Severe depression on therapy

7. Planned or actual pregnancy

Note that discontinuation of one new therapy should not jeopardize a subject’s right to try another, subject to meeting criteria.

Drugs

This programme and these criteria refer to the use of Avonex, Betaseron, Copaxone, and Rebif.

As indicated by the current June 9, 1998 draft of the Disease Management Advisory Statement of the National MS Society, and that Society’s Consensus statement of September 1998, criteria do change with the passing of time, with more research information and with experience. As such, these criteria will be re-evaluated by the provincial expert committee as new information becomes available.

Because the therapies are very expensive, ranging in cost from $12,300 to $21,000 (not including markup or dispensing fees) per year per patient, and because only a small percentage of patients are expected to receive substantial benefit from these drugs, a clear method of assessment and monitoring is required.

A method of assessment is in place at the Health Sciences Centre MS Clinic for patients wishing to learn more about the indications for the new therapies, their expectations and limitations, their side effects and risks, and the documentation and follow-up required for anyone beginning such therapy.

1. Educational materials for patients, families, public, and health professionals.

2. Criteria for eligibility outline.

3. Referral by physician to Health Sciences Centre

4. Central assessment and education program.

5. Following decision to treat, management can be by the patient’s usual physician.

6. Scheduled follow-up assessments by staff of MS Clinic (phone/mail/visit).

7. Documentation of outcomes of individual patients and overall program.

Any registered physician or specialist may refer a patient to the Health Sciences Centre of assessment for the new therapies, and must sent relevant documentation on the patient at the time of referral. When contacted the clinic will present or mail information on the therapies to the patient, and an appointment will be made for formal assessment.

At the time of referral by the physician, all relevant documentation on the patient must be sent to the clinic, including medical history, investigations including MRI, consultations, and information about other health problems and any medications. At this time, a computerized profile on the patient will document relevant medical and neurological information.

• At the initial visit the following items will be documented:

• General Physical Examination findings

• Neurological Examination findings

• MS Classification

• MS Type

• Functional Disability Scale, and Expanded Disability Status Scale score (EDSS)

The patient will have the opportunity to receive information on all the therapies, including other options and treatments, and to ask any questions she/he may have.

Screening will be directed towards the determination of the patient’s current status and his/her eligibility to receive one of the new agents in accordance with the established selection criteria.

Recommendations about the choice of agent will be made at this session.

Training for injection of the selected drug will be carried out by the Health Sciences Centre MS Unit Staff (or by the VON at the request of and on referral from MS Clinic). In some cases, such as with hospitalized patients, local nursing staff may instruct the patient on injection methods, side effects, care and storage of medication, and will be responsible for follow-up in the first weeks to determine acceptability, unwanted effects, and response and to ensure that blood tests are made, as indicated.

Well-developed information packages are available for the patient and the nurse on the method of injection and the proper use of the drug.

Education of the patient and the family is essential before therapy is agreed or initiated. Education sessions will be organized for individuals or groups through the HSC MS Clinic.

The RN Coordinator of the MS Clinic will provide education for individual patients and for large groups, classes, MS Chapters and professional groups as required to assure that patients and their care givers are fully informed and that only those that would substantially benefit will embark on this complex and expensive therapy. The aim will be to ensure that subjects have an awareness of the nature and natural history of MS, the risks and benefits of the new therapies, the methods of administration, the side effects of such treatments and criteria for discontinuation.

Drugs will be provided for patients covered under the NLPDP and meeting the established criteria following special authorization obtained through Pharmaceutical Services of the Department of Health and Community Services. This authorization will be provided through the pharmacy of the patients choosing.

The Health Sciences Centre MS Clinic shall be the assessment unit. This Clinic has been carrying out assessments by recognized criteria and classification on all patients evaluated in the Unit for six years as part of research protocols, collaborative research with international groups, and as a method of documentation of the course of all patients. These are normally carried out by physicians or neurologists in the normal care process.

Patients may be followed by their family physicians and neurologists, or by the MS Clinic, as determined by the wishes of the patient or the family physician. Initial and annual assessments will be carried out by the MS Clinic to determine the appropriateness of the therapy and to measure outcomes.

A research protocol will be developed so that all patients will be documented whether they enter the treatment program or not, and continuing evaluation will record factors that allow us to be more specific about who would benefit, what patients need additional support and what factors may predict better outcomes.

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