This is the text extract for SA0855 – Multiple Sclerosis treatments, Initial Application for beta-interferon or glatiramer acetate, browse documents here.

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MSTAC INITIAL APPLICATION FOR FUNDING OF BETA-INTERFERON OR GLATIRAMER ACETATE

Please send applications to:

The Co-ordinator MSTAC PHARMAC P O Box 10-254 WELLINGTON

Phone: 04 460 4990 Facsimile: 04 916 7571 Email: mstaccoordinator@pharmac.govt.nz

Applications must be complete and accompanied by all supporting data. Have you attached:

q q q q q

MR scan reports? Other laboratory reports? Signed patient’s consent form? Relapse history form? EDSS summary?

Patient Details Title: Surname: First Name/s: Address: Mr/Mrs/Miss/Ms/Dr

Gender: D.O.B: NHI No: Phone No: Fax No: Email Address: Cell phone No:

Male/Female

Applying Practitioner Speciality (circle): Surname: First Name: NZMC Registration Number: Address:

Neurologist or Physician

Phone No: Fax No: Email Address: Cell phone No: Patient’s General Practitioner Surname: First Name: Address:

Phone No: Fax No: 1

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Patient Details Surname: First Name/s: NHI No: Details of Diagnosis Diagnosis of Multiple Sclerosis made: MR Scan: Other Supporting Reports: Underlying Progression Present? Year: YES/NO YES/NO YES/NO (Please attach report(s) if available) (Please attach report(s) if available .e.g. CT Scan, EP’s, CSF) (In addition to relapses)

Previous Treatment with Disease Modifying Therapy (DMT) q q q

Beta-interferon Copaxone Other DMT Note:

· · ·

Relapses in year before starting treatment EDSS at time of starting treatment Relapses occurring during treatment

Details of Treatment:

Notes:

Neurologist’s Declaration I confirm that the above and attached details are correct and that in signing this form I understand that I may be audited. Signature: ______________________________ Date: __________________________________

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EDSS

Patient Details Surname: First Name/s: NHI No: DATE EDSS ASSESSED: ASSESSOR:

Functional System Pyramidal Cerebellar Brainstem Sensory Bowel and Bladder Visual (or Optic Nerve) Cerebral (or Mental) Other Measured Walking Distance without aid or rest. If Aids Used to Walk – type of aid used and distance walked without rest, using the aid EDSS SCORE

Score

Please Describe Main Signs

VAR =

VAL =

3

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EXPANDED DISABILITY STATUS SCALE (EDSS)

0

1.0 1.5 2.0 2.5 3.0 3.5 4.0

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Normal neurologic exam (all grade 0 in Functional Systems [FS]; Cerebral grade 1 acceptable). No disability, minimal signs. (one or two FS grade 1 excluding Cerebral grade 1). No disability, minimal signs in three or more FS (three or more FS grade 1 excluding Cerebral grade 1). Mild disability in one FS (one FS grade 2, others 0 or 1). Mild disability in two FS (two FS grade 2, others 0 or 1). Moderate disability in one FS (one FS grade 3, others 0 or 1) or mild disability in three or four FS (three/four FS grade 2, others 0 or 1) though fully ambulatory. Fully ambulatory but with moderate disability exceeding 3.0 (one FS and one or two or more grade 2; or two FS grade 3; or five FS grade 2 (with other FS 0 or 1). Fully ambulatory without aid or rest for 500 metres or more. One FS grade 4 (others 0 or 1) or combinations of lesser grades exceeding limits of previous steps. Able to walk without aid or rest some 500 metres. Fully ambulatory without aid or rest for about 300 metres. One FS grade 4 (others 0 or 1) or combinations of lesser grades exceeding limits of previous steps. Ambulatory without aid or rest for about 200 metres (Usual FS equivalents are one grade 5 alone, others 0 or 1; or combinations of lesser grades exceeding specifications for step 4.5). Ambulatory without aid or rest for about 100 metres. (Usual FS equivalents are one grade 5 alone, others 0 or 1; or combinations of lesser grades exceeding those for step 5.0). Intermittent or unilateral constant assistance (cane, crutch or brace) required to walk about 100 metres with or without resting. (Usual FS equivalents are combinations with more than two FS grade 3+). Constant bilateral assistance (canes, crutches, or braces) required to walk about 20 metres without resting. (Usual FS equivalents are combinations with more than two FS grade 3+). Unable to walk beyond about 5 metres even with aid, essentially restricted to wheelchair, wheels self in standard wheelchair and transfers alone. (Usual FS equivalents are combinations with more than one FS grade 4+, very rarely pyramidal grade 5 alone). Unable to take more than a few steps, restricted to wheelchair, may need aid in transfer, wheels self but cannot carry on in standard wheelchair a full day, may require motorised wheelchair. (Usual FS equivalents are combinations more than one FS grade 4+). Essentially restricted to bed or chair or perambulated in wheelchair but retains many self-care functions and generally has effective use of arms. (Usual FS equivalents are combinations with grade 4+ in more than one FS). Essentially restricted to bed much of the day, has some effective use of arm(s), retains some self-care functions. (Usual FS equivalents are combinations, generally 4+ in several systems). Helpless bed patient, can communicate and eat. (Usual FS equivalents are combinations, mostly grade 4+). Totally helpless bed patient, unable to communicate effectively or eat/swallow. (Usual FS equivalents are combinations, almost all grade 4+). Death due to MS.

4.5 5.0 5.5 6.0 6.5 7.0

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7.5

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8.0

-

8.5 9.0 9.5 10

-

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Relapse Summary (Initial Application)

Patient Details Surname: First Name/s: NHI No: Date Assessed: For an initial application for a patient who has never been treated with DMTs, please record details for all relapses that have occurred in the last 2 years. For an initial application for a patient currently being treated with DMTs funded elsewhere, please record details for pre-treatment relapses in the 1-2 years before treatment and all relapses since treatment was started. Onset of relapse (month & year) Duration of relapse (weeks) New or recurrent symptom(s) of relapse. (Sufficient to change EDSS or a FS by 1 point) Period of any Treatment hospitalisation during relapse (days) o o Steroids Other Relapse Monitored/confirmed by:

o o

Steroids Other

o o

Steroids Other

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CONSENT FORM FOR BETA INTERFERON SUBSIDY OR GLATIRAMER ACETATE APPLICATION To be provided with initial application for subsidy for beta-interferon. Patient Surname: First Name/s: NHI No:

I consent to:

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Allow the specialist making an application for subsidy on my behalf to collect all the information required by the Multiple Sclerosis Treatment Assessment Committee (MSTAC) and/or PHARMAC via the initial application form for funding of beta-interferon or glatiramer acetate and the application form for renewal of approval (and relevant attachments). The secure distribution of all information contained in and relating to the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments) to members of MSTAC and, where necessary, an appeal committee and PHARMAC staff. The release of all information contained in and relating to the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments) on request to my specialist(s) and my General Practitioner (as identified on the forms). The use of all information contained in and relating to the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments) by members of MSTAC and, if necessary, an appeal committee and PHARMAC staff, for the purposes of assessing, and reviewing my eligibility for a subsidy for beta-interferon and/or for the purposes of audit. The distribution of information contained in the non-compulsory selfassessment form and MSQoL–54 form relating to my age, gender, medical condition and care (but excluding my name, address and/or NHI number) to PHARMAC (including person(s) contracted to PHARMAC) and use of that information by PHARMAC (including person(s) contracted to PHARMAC) for the purposes of research and/or analysis related to assessing the cost6

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effectiveness of treatments for MS and making decisions regarding future funding of those treatments. I understand that:

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The information contained in and relating to the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments) and any self assessment questionnaires I complete and return to the MSTAC co-ordinator will be held securely by the co-ordinator at PHARMAC’s usual place of business or usual place of record storage, or at other premises where the coordinator may, in future, be based. I have the rights to access and correct any information contained in and relating to the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments), and any self-assessment questionnaires I complete and return to the MSTAC co-ordinator on request to the MSTAC coordinator. I may not be eligible for a subsidy for beta-interferon or glatiramer acetate. Although I am not required to by law, if I do not consent to the collection and use of the information in the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments), my application for betainterferon will not be considered. If my application is approved and I later prevent access to the information (as outlined above), my subsidy may be withdrawn. I will not be disqualified from eligibility for funding for beta-interferon or glatiramer acetate if I do not complete PHARMAC’s non-compulsory selfassessment form and MSQoL–54 questionnaires. If my application is approved and I subsequently become ineligible under the stopping criteria, my subsidy may be stopped. PHARMAC may, from time to time, review funding of beta-interferon and glatiramer acetate.

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PATIENT DECLARATION

I declare that: No information has been withheld and that this consent form may be relied upon by the specialist completing the application for subsidy of beta interferon or glatiramer acetate on my behalf. I understand that the application forms for funding of beta-interferon or glatiramer acetate (and relevant attachments) collect personal information about me and that the information is used to assess my eligibility for subsidy for beta-interferon or glatiramer acetate and/or for the purposes of audit. I understand that completion of PHARMAC’s self-assessment and MSQoL-54 questionnaires is not compulsory.

I agree to: Inform my neurologist if I become pregnant and/or breastfeed a child. If required at a future date, undergo an annual blood test for neutralising antibodies and/or biologic responsiveness to beta-interferon or glatiramer acetate and understand that if the results indicate a lack of biologic responsiveness to betainterferon or glatiramer acetate, my subsidy may be stopped. Notify my neurologist and the co-ordinator of MSTAC if I stop treatment. Signature:………………………………………………………… Date:………………………………………

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