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MS Legislative Action
Feb 19 2002 Apr 11 2001 Jan 15 2001 Mar 1 2000 Jan 11 2000 Dec 27 1999 Dec 26 1999 Letter from Pharmac announcing the lifting of the funding cap on beta interferon and review of qualifying criteria7 March 2002 Kathy Forbes Dear Kathy, Glen and Nadine Removal of expenditure cap for beta-interferon Further to our consultation letter of 7 February 2002, I am pleased to announce that the PHARMAC Board has agreed to remove the expenditure cap that has limited the number of patients meeting the current criteria for subsidies for beta-interferon who are able to obtain funding to date. Around 50 patients who are currently on the waiting list will be able to commence funded treatment with beta-interferon as soon as their current base EDSS and relapse rate has been established. For patients who have only recently been approved subject to funding, this means that funded treatment can coincide with the next scheduled monthly delivery of whichever brand of beta-interferon is chosen. Patients who have been on the waiting list for some time will require reassessment by a neurologist before treatment commences. This is to ensure that they are not disadvantaged when their response to treatment is reviewed in 12 months. All patients who meet the entry criteria from now on will be able to commence treatment without delay. Many of you, in your submissions, expressed the view that the entry criteria for access to subsidies for beta-interferon should be widened to enable patients to qualify for treatment earlier in the course of the disease. Late last month, the Pharmacology and Therapeutics Advisory Committee (PTAC) considered the recommendation of the Multiple Sclerosis Treatments Advisory Committee (MSTAC) to grant subsidies for patients with an EDSS of between 2.0 and 6.5 who have had 3.0 or more relapses in a 12 month period (in addition to those patients who would qualify under the current criteria). Unfortunately, the minutes of PTAC's discussion have not yet been finalised and PHARMAC is unable to comment on this issue until they are. However, it is expected that MSTAC and PTAC will meet in May to discuss this issue further. Some of you also mentioned the fact that there are two other treatments for MS registered in New Zealand, which are not currently funded. While the suppliers of the other agents have not indicated an interest in pursuing a listing on the Pharmaceutical Schedule to date, consultation on this issue has also re-opened dialogue between PHARMAC and suppliers of treatments for multiple sclerosis. We will keep interested parties advised of progress on these issues, primarily via MS Societies. Yours sincerely Cristine Della Barca Submission to Pharmac from the Multiple Sclerosis Society of Auckland regarding Beta InterferonFeb 19, 2002 We strongly support the cap being removed for the number of people with Multiple Sclerosis who can be funded for treatment with Beta Interferon. Trials have ascertained that Beta Interferon slows the progression of MS thus allowing people affected to remain in the workforce for much longer. This decreases the number of people who require government assistance, either through invalid benefits or through rest home subsidies. Use of already over-extended health services such as Home Help, Wheelchair Services and Occupational Therapists is also minimized or avoided. Evidence of this statement can be confirmed in the:
With access to Beta Interferon, people who otherwise would be disabled and dependent upon family or community care can remain functioning and contributing members of society, paying taxes instead of being supported by them. We are also concerned about some of our younger members whose attacks are frequent but whose symptoms are not yet so severe. Theoretical links between early-stage inflammation and later degradation are compelling to us, and have been discussed by our patron, Dr Ernie Willoughby. Currently these people do not meet the Pharmac criteria, but the cost-benefit analyses of their situation may make them the most compelling subjects for Beta Interferon. This submission is made on behalf of our 533 members and their families. The benefit to both people with MS and the wider community will be considerable if the cap is removed and the criteria widened for people with MS to be treated with Beta Interferon. Yours sincerely Kathy Forbes, Dip.Social Work Pharmac reports beta-interferon subsidiesThe following is the unedited text of a letter from Pharmac general manager Wayne McNee to the MS Society Pharmaceutical Management Agency 11 April 2001 Peter Old Dear Peter, Beta-interferon subsidy applications We write to update you on the number and status of applications for subsidised access to beta-interferon. As at 31 January 2001, 180 applications for subsidised access to beta-interferon had been approved - the maximum number able to be funded within the assigned budget for beta-interferon. As at 5 April 2001, there are 15 patients who have been assessed as having met the entry criteria but who are awaiting the availability of places within the 180 limit or additional funding in order to commence treatment. 250 of the 252 applications MSTAC have received have been decided so far (the decline rate to date is 16%). There are 8 applications for which further information is required before a decision will be made. The rate of declined applications is 16%. MSTAC is meeting this month to assess the first of the reapplications for patients who commenced funded treatment on 1 June 2001. We will update you again when we next update the PHARMAC Board on this issue in two months time. Yours sincerely Wayne McNee Pharmac defends beta-interferon funding limitThe following is the unedited text of a letter from Pharmac general manager Wayne McNee to the MS Society 15 January 2001 Peter Old Dear Peter Various issues in respect of beta-interferon for multiple sclerosis (MS) I am writing to you regarding two issues - in respect of funding for subsidised beta-interferon for MS patients and on the matter of certain letters that have been sent to PHARMAC by MS patients. Funding arrangements for beta-interferon for multiple sclerosis (MS) Firstly, I wish to formally advise you of the current situation regarding subsidised funding for beta-interferon. When the Minister of Health made the decision to fund beta-interferon in December 1999 a cap was placed on the number of subsidised places that were to be made available. The cap, which was for 180 fully funded applicants, has now been met as of December 2000. Therefore, patients whose applications were/are first submitted to MSTAC after the cut-off date for December meeting and who meet the criteria cannot be commenced on funded beta-interferon therapy until a place becomes available. Fortunately, we have been able to accommodate all those eligible patients whose applications were reviewed by MSTAC at the December meeting. There is also sufficient provision within the budget to approve all those patients whose applications have been assessed by MSTAC to date, where the decision whether or not to approve funding has been deferred. Applications for subsidies for beta-interferon can still be submitted to MSTAC (the Multiple Sclerosis Treatment Assessment Committee) and those applicants that meet the entry criteria will be approved subject to funding being available for them to commence treatment. A funded place could arise if: 1. a patient currently on subsidised treatment decides to withdraw from treatment; 2. a patient currently on subsidised treatment meets the criteria for stopping treatment and has the subsidy withdrawn (reassessments begin April 2001); or 3. PHARMAC allocates extra funding for treatment of patients above the 180 limit. MSTAC meets approximately every month to review applications for subsidised treatment. Each month, before assessing any new applications, the committee will review the number of approved patients still receiving a subsidy for beta-interferon. If the number has fallen below the limit, patients who have been approved subject to funding will be allocated a subsidy. If there are more patients who have been waiting to commence treatment than there are places available, then patients who have been waiting longest will be granted a place first. This advice was communicated verbally to your staff on Friday 12 January and there has already been media interest. We realize that the situation will cause disappointment and frustration for some MS patients and invite you to meet with us if you wish to discuss your concerns or any questions you have with us further. As usual, if you wish to meet with us, please contact Christine Della Barca to arrange a time and place. Correspondence from MS patients On a separate matter, we are in receipt of a number of form letters from MS patients concerned about PHARMAC'S recent decision to widen access to pharmaceutical treatments for HIV/AIDS. We would very much like to have responded to these letters individually but, unfortunately, most of the authors did not supply their addresses. We are hoping that perhaps you know the origins of the letter (copies of which are attached), and might forward our response to the appropriate people. The gist of the letter is that PHARMAC is unfairly discriminating against MS patients by funding treatments for patients with HIV/AIDS while only funding beta-interferon for a limited number of MS patients and under strict criteria. This opinion has been raised many times - in consultation, and more recently in statements that we understand have been made by MS Society representatives to the media. We wish to point out that PHARMAC's decisions are based entirely on our decision criteria, which take into consideration the health needs of all patients in New Zealand. Indeed it is our role to balance scarce health resources across those needs. We regard all patients with health needs as equal regardless of the nature and/or origin of their diseases. Your members seem to be suggesting that PHARMAC should not fund treatments for diseases caused by illicit, morally corrupt or irresponsible lifestyles. Would they also suggest that doctors should not treat patients injured whilst driving drunk? Are they suggesting that the New Zealand Government should not allocate resources to address the high rates of teenage pregnancies and chlamydia in New Zealand? These conditions all have known causes. Your members are misinformed if they believe that HIV/AIDS sufferers have the level of access to treatments they consider to be ideal. While HIV/AIDS sufferers lobbied hard (and for even longer than MS patients) for access to treatments, they still do not have access to what they consider to be optimal treatment. Like MS patients, they have to meet strict clinical criteria before they qualify for subsidised treatment. Like MS patients, their disease is unpleasant and the treatments available are far from a cure. Unlike MS patients, they face the problem of the treatments that are effective and available to them becoming ineffective because of viral resistance. This is one of the reasons provision was recently made by PHARMAC to allow access to dual PI therapy. Other reasons include the fact that because of agreements that PHARMAC was able to achieve with suppliers the therapies were cost neutral, or close to it. Yes, there is a limit on the amount of funding PHARMAC will allocate to MS treatments and no such limit on HIV/AIDS treatments. However, that fact reflects the cost-effectiveness of HIV/AIDS treatments (and poor cost-effectiveness of beta-interferon) and scarce resources. Not, as you members suggest, discrimination against MS patients. New research into beta-interferon will be taken into account when the criteria are reviewed. If it is concluded that there is evidence of benefit in patients with different characteristics than those in the current criteria, then it is possible that the criteria will be amended. However, the PHARMAC Board's approval of such amendments would still be contingent on justification under our Decision Criteria and the availability of any additional funding required. If the benefits of beta-interferon in such other patients are not greater than in those currently being treated, or the new evidence does not demonstrate improved cost-effectiveness in those patients or, even if it does, if beta-interferon is still not the best use of the available funds under our decision criteria, then it is possible that the criteria would not be widened immediately. We realize that opinions on the allocation of health funding are strong and can often run high, but we also hope that with your assistance some of the erroneous statements that are currently being voiced by some MS patients can be answered appropriately. If you have any queries regarding this matter please do not hesitate to contact me. Yours sincerely, Wayne McNee Beta-interferon: entry criteria* Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis should as a rule include MRI confirmation. For patients diagnosed before MRI was widely utilised in NZ, confirmation of diagnosis via clinical assessment and laboratory/ancillary data must be provided by a neurologist and * Patients must have active relapsing MS (confirmed by MRI scan where necessary) with or without underlying progression and * Patients must have experienced at least 2 significant relapses of MS in the previous 12 months. Each relapse must
* Patients must have an EDSS score of between 3.0 and 6.5 inclusive, and * Patients must have no previous history of lack of response to beta-interferon (see criteria for stopping beta-interferon). * Applications must be submitted to the Multiple Sclerosis Treatment Panel (MSTAP) by the patient's neurologist, and * Applications must be accompanied with a completed MSQOL-54 survey, to supplement clinical information submitted by the referring neurologist, and * Patients must agree (via informed consent) to co-operate if as a result of their meeting the stopping criteria, funding is withdrawn and to the collection of clinical data relating to their MS and use of those data by PHARMAC, and * Patients must agree to allow clinical data to be collected and reviewed by the MSTAP annually for each year in which they receive funding for beta-interferon * Funding is subject to a budgetary cap. Approval of funding for patients who meet the above criteria may be contingent upon funding availability. Stopping Criteria * Confirmed progression of disability that is sustained for 3 months after a minimum of 1 year of treatment. Progression of disability is defined as either a loss of EDSS point on the Kurtzke scale or an increase in EDSS score to 7.0 or more, or * Stable or increasing (relative to 12 months preceding commencement of treatment) relapse rate over 12 months of treatment, or * Pregnancy and/or lactation, or * Intolerance to both interferon beta 1a and interferon beta 1b, or * Non-compliance with treatment, including refusal to undergo annual assessment and/or for the results of the assessment to be submitted to MSTAP, or * Patients may, subject to conclusions drawn from published evidence available at the time be excluded if they develop a high titre of neutralising anti-bodies to beta-interferon. Beta-interferon funding by May 200011 January 2000 The government's drug-funding agency, Pharmac, says funding of Beta-Interferon for people with MS may not be in place until May 2000. In a letter to the MS Society dated 11 January 2000, Pharmac general manager Wayne McNee pointed out that beta-interferon would be subsidised "according to targeting criteria." McNee said Pharmac was putting in place a "subsidy management mechanism," consisting of a committee of neurologists that would be responsible for:
"The Minister indicated approximately 130 patients will be eligible for a subsidy for beta-interferon under those conditions. However, there is still some uncertainty around this estimate," McNee said. He said Pharmac also needed to obtain agreement from one or both suppliers of beta-interferon on commercial terms for provision of the drug. McNee said he hoped Pharmac would be able to start reviewing applications around March or April of this year. "Once that process is complete or, at least, well underway, we expect to have a clearer idea of how many patients will be eligible for subsidy and (assuming commercial negotiations have been successful) the required budget," McNee said. The Pharmac board would then have to approve a budget for beta-interferon, and any commercial agreements with one or both of the current suppliers. As a result, McNee said it could be as late as May 2000 before Pharmac is able to begin funding beta-interferon for people with MS. Government to fund beta-interferon26 December 1999 News release issued by the Minister of Health Health Minister Annette King has directed the Health Funding Authority to instruct the board of Pharmac to fund the beta-interferon drugs for the treatment of multiple sclerosis. Her decision brings to a successful end a long campaign by sufferers of the disease and the Multiple Sclerosis Society. Mrs King said today: "We made this pledge during the election campaign, and it was a decision supported by the health select committee which heard compelling evidence that the previous government took little notice of. "Multiple sclerosis is a disease with little or no treatment possible, and the Government wants to do what it can to help sufferers who can benefit from this drug treatment. "Until this decision, New Zealand was one of only two countries in the world mean enough not to fund these drugs." Mrs King said criteria for eligibility for beta-interferon has (sic) been developed in direct consultation with leading New Zealand neurologists who specialise in the management of multiple sclerosis. Multiple sclerosis (MS) is a chronic disease of the nervous system that impairs the flow of messages from the brain and spinal cord to other parts of the body. The disease goes through bouts of becoming worse or better, and while there is no cure, clinical trials have shown beta interferon drugs can help reduce the number of relapses in some patients by about 30 per cent a year, and the rate of severe attacks by about 50 per cent. For patients whose disease has caused ongoing progression of disability (the secondary progressive form of MS), beta-interferon delays progression by about 50 per cent, meaning the drugs may prolong the time between when a person is diagnosed with MS and becomes quite disabled. Mrs King said perhaps up to 130 New Zealanders could be helped by the new subsidy. Some New Zealanders already paid for the drugs themselves, but their eligibility for access to the subsidy would be no higher or lower than any other patient, Mrs King said.
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