Decisions relating to multiple sclerosis treatments
PHARMAC is pleased to announce the approval of proposals to fund two new treatments for Multiple Sclerosis (MS) – dimethyl fumarate and teriflunomide – and to make amendments to the Special Authority criteria relating to MRI requirements for all MS treatments. This decision was the subject of a consultation letter dated 16 October 2015.
In summary, the effect of the decision is that from 1 February 2016:
- two new treatments:
- dimethyl fumarate (Tecfidera), supplied by Biogen NZ Biopharma Limited (Biogen), and
- teriflunomide (Aubagio), supplied by Sanofi-Aventis New Zealand Limited (Sanofi)
- there will be changes to the Special Authority criteria for all MS treatments relating to MRI requirements.
In addition, following consideration of feedback to consultation, the wastage rule will apply to dispensings of dimethyl fumarate and teriflunomide, so pharmacies will be able to claim for any unused stock from partly dispensed packs.
Dimethyl fumarate
- Dimethyl fumarate (Tecfidera) will be listed in Section B and in Part II of Section H (the Hospital Medicines List, or HML) of the Pharmaceutical Schedule, as a result of a provisional agreement with Biogen, at the following price and subsidy from 1 February 2016 (ex-manufacturer, excluding GST):
Chemical Presentation Brand Pack size Price and subsidy Dimethyl fumarate Cap 120 mg Tecfidera 14 $520.00 Dimethyl fumarate Cap 240 mg Tecfidera 56 $2,000.00 - A confidential rebate will apply to Tecfidera, reducing its net price.
- The wastage rule will apply to dispensings of dimethyl fumarate, so pharmacies will be able to claim for any unused stock from partly dispensed packs.
Dimethyl fumarate will be subject to the following Special Authority criteria in Section B of the Pharmaceutical Schedule from 1 February 2016; please note that these criteria are the same as those for natalizumab, fingolimod and teriflunomide.
Special Authority for subsidy
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Entry Criteria
- Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
- patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
- patients must have:
a. EDSS score 0 – 4.0 and:
- Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
- Evidence of new inflammatory activity on an MR scan within the past 24 months, any of the following:
i. a gadolinium enhancing lesion; or
ii. a Diffusion Weighted Imaging positive lesion; or
iii. a T2 lesion with associated local swelling;
iv. a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
v. new T2 lesions compared with a previous MR scan; and
4. A significant relapse must:
a. be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
b. be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
c. last at least one week;
d. start at least one month after the onset of a previous relapse;
e. be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
f. be distinguishable from the effects of general fatigue; and
g. not be associated with a fever (T>37.5°C); and
5. applications must be made by the patient’s neurologist or general physician; and
6. patients must have no previous history of lack of response to dimethyl fumarate; and
7. patients must have not previously had intolerance to dimethyl fumarate; and
8. patients must not be co-prescribed beta interferon or glatiramer acetate.
Stopping Criteria
Any of the following:
1. Confirmed progression of disability that is sustained for six months. Progression of disability is defined as progress by any of the following EDSS points:
a. from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
b. 1.0 to 3.0, or
c. 1.5 to 3.5; or
d. 2.0 to 4.0; or
e. 2.5 to 4.5; or
f. 3.0 to 4.5; or
g. 3.5 to 4.5; or
h. 4.0 to 4.5.
2. increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment) (see note); or
3. intolerance to dimethyl fumarate; or
4. non-compliance with treatment, including refusal to undergo annual assessment.
Note:
Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate.
Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
- Dimethyl fumarate will be subject to the following access criteria in Part II of Section H of the Pharmaceutical Schedule from 1 February 2016:
Restricted
Only for use in patients with approval by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (set out in Section B of the Pharmaceutical Schedule).
Teriflunomide
- Teriflunomide (Aubagio) will be listed in Section B and in Part II of Section H (the Hospital Medicines List, or HML) of the Pharmaceutical Schedule, as a result of a provisional agreement with Sanofi, at the following price and subsidy from 1 February 2016 (ex-manufacturer, excluding GST):
| Chemical | Presentation | Brand | Pack size | Price and subsidy |
|---|---|---|---|---|
| Teriflunomide | Tab 14 mg | Aubagio | 28 | $1,582.62 |
- A confidential rebate will apply to Aubagio, reducing its net price.
- Aubagio will have subsidy and delisting protection until 31 October 2017.
- The wastage rule will apply to dispensings of teriflunomide, so pharmacies will be able to claim for any unused stock from partly dispensed packs.
- Teriflunomide will be subject to the following Special Authority criteria in Section B of the Pharmaceutical Schedule from 1 February 2016; please note that these criteria are the same as those for natalizumab, fingolimod and dimethyl fumarate:
Special Authority for subsidy
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Entry Criteria
1) Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
2) patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
3) patients must have:
a) EDSS score 0 – 4.0 and:
- Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
- Evidence of new inflammatory activity on anMR scan within the past 24 months, any of the following:
i. a gadolinium enhancing lesion; or
ii. a Diffusion Weighted Imaging positive lesion; or
iii. a T2 lesion with associated local swelling; or
iv. a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
v. new T2 lesions compared with a previous MR scan; and
4) A significant relapse must:
a) be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
b) be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
c) last at least one week;
d) start at least one month after the onset of a previous relapse;
e) be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
f) be distinguishable from the effects of general fatigue; and
g) not be associated with a fever (T>37.5°C); and
5) applications must be made by the patient’s neurologist or general physician; and
6) patients must have no previous history of lack of response to teriflunomide; and
7) patients must have not previously had intolerance to teriflunomide; and
8) patients must not be co-prescribed beta interferon or glatiramer acetate.
Stopping Criteria
Any of the following:
1) Confirmed progression of disability that is sustained for six months. Progression of disability is defined as progress by any of the following EDSS points:
a) from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
b) 1.0 to 3.0; or
c) 1.5 to 3.5; or
d) 2.0 to 4.0; or
e) 2.5 to 4.5; or
f) 3.0 to 4.5; or
g) 3.5 to 4.5; or
h) 4.0 to 4.5.
2) increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment)(see note);
3) intolerance to teriflunomide; or
4) non-compliance with treatment, including refusal to undergo annual assessment.
Note:
Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate.
Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
- Teriflunomide will be subject to the following access criteria in Part II of Section H of the Pharmaceutical Schedule from 1 February 2016:
Restricted
Only for use in patients with approval by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (set out in Section B of the Pharmaceutical Schedule).
Changes to multiple sclerosis treatments Special Authority criteria
- From 1 February 2016 the note in the Special Authority criteria for the multiple sclerosis treatments natalizumab, and fingolimod in Section B of the Pharmaceutical Schedule will be replaced with the following:
Note:
Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate.
Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
- From 1 February 2016 criterion 3 (a) of the Special Authority criteria for Multiple Sclerosis treatments, natalizumab and fingolimod, in Section B of the Pharmaceutical Schedule will be replaced with the following:
3) patients must have:
1. EDSS score 0 – 4.0 and:
- Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
- Evidence of new inflammatory activity on an MR scan within the past 24 months, either:
i. a gadolinium enhancing lesion; or
ii. a Diffusion Weighted Imaging positive lesion; or
iii. a T2 lesion with associated local swelling; or
iv. a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
v. new T2 lesions compared with a previous MR scan; and
Changes to Other Multiple Sclerosis treatments Special Authority Criteria:
- From 1 February 2016 criterion 3 (a) of the Special Authority criteria for Other Multiple Sclerosis treatments, interferon beta-1a, interferon beta-1-b and glatiramer acetate, in Section B of the Pharmaceutical Schedule will be replaced with the following:
3) patients must have:
- EDSS score 0 – 4.0 and:
- Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
- Evidence of new inflammatory activity on an MR scan within the past 24 months, either:
i. a gadolinium enhancing lesion; or
ii. a Diffusion Weighted Imaging positive lesion; or
iii. a T2 lesion with associated local swelling; or
iv. a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
v. new T2 lesions compared with a previous MR scan; and
Funding for the beta-interferons (interferon beta-1a (Avonex), interferon beta-1beta (Betaferon)) and glatiramer acetate (Copaxone):
- The beta-inferferons and glatiramer acetate remain as funded treatment options for those patients who cannot take fingolimod and natalizumab for clinical reasons. Patients are not required to be contraindicated or unable to tolerate dimethyl fumarate and teriflunomide to access funding for the beta-interferons or glatiramer acetate treatments.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 6 November 2015 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:
| Theme | Comment |
|---|---|
|
Welcome the option of two additional oral treatments for patients to choose from. Provides an alternative treatment to fingolimod for those unable to tolerate the interferons / glatiramer acetate and for whom natalizumab is not an option. |
Noted. |
|
The use of these oral preparations, rather than IV natalizumab, will be accompanied by other cost savings. |
Noted. Cost-offsets were included in our analysis. |
|
Confusion was expressed with the number of funded treatments available, which treatment would be best and whether they would have to change from their current treatment to one of the new funded treatments. |
Patients do not have to change from their current treatment, and can stay on their existing treatment provided the stopping criteria (for which they were approved for) are not met. Patients should discuss with their doctor which treatment option would be best for them. They may change to dimethyl fumarate or teriflunomide if they meet the criteria. The MS treatments Questions and Answers section on the PHARMAC website will be updated to address any questions that people raise about the funding and access criteria for the treatments. |
|
Off-label leflunomide may be substantially cheaper than teriflunomide and may offer comparable benefit. |
Leflunomide (Arava) is fully funded, without restrictions, on the Pharmaceutical Schedule. Leflunomide’s registration does not include the indication of relapsing remitting MS. |
|
Both dimethyl fumarate and teriflunomide are modestly effective and have similar efficacy to the interferons/glatiramer. |
Noted. |
|
Expressed concern that PTAC’s recommendation to only fund dimethyl fumarate provided it was no more expensive than the interferons/glatiramer, may prevent the listing of dimethyl fumarate. Enclosed a review article (Broadley et al J Clin Neurosci 2014) that was not considered by PTAC, showing comparisons of efficacy for all MS treatments. At present it is not possible to assess in an evidence-based manner whether one drug is superior, due to no head to head trials. |
Noted. In providing its advice, PTAC considered PHARMAC’s nine decision criteria, in particular (i) The health needs of all eligible people within New Zealand; (iii) The availability and suitability of existing medicines, therapeutic medical devices and related products and related things; (iv) The clinical benefits and risks of pharmaceuticals; and (vi) The budgetary impact (in terms of the pharmaceutical budget and the Government’s overall health budget) of any changes to the Pharmaceutical Schedule. |
|
There are accumulating reports of opportunistic infections with dimethyl fumarate and that there have been three cases of progressive multifocal leukoencephalopathy (PML) with dimethyl fumarate. Teriflunomide is generally well tolerated; however, there are risks of hepatic toxicity, opportunistic infections and the potential for teratogenesis. Although the risks of infection and PML associated with dimethyl fumarate are low, and are much lower than natalizumab, that due to the modest efficacy of dimethyl fumarate the safety bar should be a lot higher. Considers that, based on safety concerns they would not recommend that patients use these treatments first line and that all patients prescribed dimethyl fumarate should have JC virus testing performed and if positive should have more frequent MRI scans, making the cost of treatment much higher. In addition close monitoring of lymphocyte should be mandated for patients prescribed dimethyl fumarate. |
Noted. Dimethyl fumarate and teriflunomide have been approved by Medsafe for registration in New Zealand. PHARMAC staff note that there is no requirement for either dimethyl fumarate or teriflunomide to be used as first line treatments and that, with regards to monitoring, DHBs are able to put in place guidelines, including any Medsafe recommendations for monitoring, if deemed clinically appropriate. |
|
Concerned that having to apply for funding through a panel makes the process unnecessarily lengthy and complicated. The panel should be reserved for applications where the neurologist is uncertain about the eligibility or where the patient does not meet the criteria but there are valid clinical circumstances. |
The Multiple Sclerosis Treatment Assessment Committee (MSTAC)’s role is to assess whether a patient meets the Special Authority criteria determined by PHARMAC and is therefore eligible for funding. Due to the complexities of the disease and the disease metrics, MSTAC ensures quality and nationally consistent equity of access so this arrangement will remain in place at this time. Clinicians should continue to apply under the NPPA process for any patients who do not meet the Special Authority criteria and who have unusual clinical circumstances. |
|
MSTAC should be given discretion around cases that don’t quite fit the criteria but meet the intent of the criteria. |
MSTAC is able to make a recommendation for consideration by PHARMAC for a Special Authority Waiver when it considers that an application should be approved due to meeting the intent of the criteria. |
|
There needs to be a mechanism for consideration of patients who would see benefit from treatment who do not quite fit the criteria, due to rarity of presenting symptoms. |
Clinicians can continue to apply under the NPPA process for any patients who have exceptional circumstances. |
|
There is a group of patients who often present with a significant and debilitating first demyelinating episode and who would fulfil the McDonald 2010 diagnostic criteria for MS. These patients are a group in whom early treatment would seem highly appropriate, however are not eligible under the current criteria until they have a further ‘clinical attack’. |
We note that PTAC has previously recommended funding be declined for patients with clinically isolated syndrome (CIS) fulfilling the McDonald 2010 criteria. Funding for subgroups of patients would require specific consideration of relative benefits, risks, cost-effectiveness and budget impacts. We would welcome a funding application at any time for MS treatments for this specific sub-group of patients, should the respondent consider it to be a different group to that previously considered by PTAC, or if new evidence has become available. |
|
The following is permitted under the SA criteria: ‘If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to the stopping criteria, a period of six months is allowed from the start of the relapse in order for recovery to occur.’ Considers that patients be required to switch treatments and then be reviewed again at the next annual review, then if at the next annual review their EDSS is unchanged or improved and there have been no relapses and no progression on MRI they should remain on treatment. |
Extensions of funding for EDSS states would require specific consideration of relative benefits, risks, cost-effectiveness and budget impacts. We would welcome a funding application at any time for wider access. |
|
The entry and exit criteria are too restrictive. |
Treating additional EDSS and relapse states would require specific consideration of relative benefits, risks, cost-effectiveness and budget impacts. We would welcome a funding application at any time for wider access. |
|
Supports the MRI amendments and notes the criteria are substantially improved, however considers the requirements for MRI appear to be based on inclusion criteria in studies rather than based on good evidence. |
The clinical advice we have received is that the purpose of requiring MRI activity on a scan is to ensure that patients who present with symptoms that may not be due to active MS are not treated inappropriately, and that treatment is targeted to patients with clinically definite relapsing/remitting MS with active inflammatory disease. There are no other objective measures of disease activity, at this time, that could be used instead of MRI and MR scans are a necessary part of the diagnosis and ongoing management of MS. |
|
Supportive of changes to MRI criteria; significantly improve the clarity. The new criteria may slightly reduce the number of scans that are required to confirm eligibility and the amount of patients required gadolinium enhanced MRI scans. |
Noted. |
More information
If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz.
Questions and answers
What is happening?
Two new treatments will be funded from 1 February 2016 for relapsing-remitting multiple sclerosis (RRMS) – dimethyl fumarate (Tecfidera) and teriflunomide (Aubagio).
Do I have to change treatment?
No – you can continue to receive the funded treatment you are on until you meet the stopping criteria. Whether to change is a decision for you to make in consultation with your health professionals and your family.
How do I get funding for these treatments?
To get funded access to these treatments, applications are made by your neurologist or general physician to the Multiple Sclerosis Treatment Assessment Committee (MSTAC). The access criteria for these treatments are the same as for fingolimod and natalizumab.
What happens if I try dimethyl fumarate or teriflunomide and it does not suit me but I am still within the criteria for funding?
- If you are currently on an interferon or glatiramer and you switch to dimethyl fumarate or teriflunomide, you will only be able to switch back to your beta interferon or glatiramer if you are unable to take fingolimod or natalizumab for clinical reasons and you continue to meet the access criteria for treatment. The beta-interferons and glatiramer acetate are only funded for those unable to take fingolimod or natalizumab for clinical reasons and for those patients who were started on treatment before 1 November 2014.
- If you are currently on fingolimod or natalizumab and you switch to dimethyl fumarate or teriflunomide and they do not suit you, you may be able to switch back to fingolimod or natalizumab, so long as you continue to meet the access criteria for treatment.
We encourage you to talk to your neurologist or MS nurse about your options.
If I get funded access to dimethyl fumarate or teriflunomide, how would I receive these medicines?
- Dimethyl fumarate and teriflunomide are both capsules that you swallow. They are available for dispensing via community pharmacy.
Distribution methods for the other funded treatments are:
- Beta interferons and glatiramer will continue to be directly distributed
- Fingolimod is available from community pharmacy
- Natalizumab is available via an infusion every 4 weeks in a hospital setting.
What is changing?
- From 1 February 2016, two new treatments will be funded – dimethyl fumarate (Tecfidera) and teriflunomide (Aubagio). Dimethyl fumarate and teriflunomide have the same access criteria as fingolimod and natalizumab.
- From 1 February 2016, a small amendment to the Special Authority criteria around the necessity for MRI scans will mean that some patients who would have needed to have further MRI studies to demonstrate new inflammatory MRI activity may not need additional MRI studies.
My patient currently has MSTAC approval for an interferon or glatiramer acetate. Can they switch to dimethyl fumarate or teriflunomide?
Patients can switch to dimethyl fumarate or teriflunomide if they meet the entry criteria, which are the same as for natalizumab and fingolimod. Once they change, they can only change back to an interferon or glatiramer acetate if they are unable to take fingolimod or natalizumab for clinical reasons and continue to meet the access criteria for treatment.
My patient currently has MSTAC approval for fingolimod or natalizumab. Can they switch to dimethyl fumarate or teriflunomide?
Yes – if they meet the funding criteria for these treatments, they can change to dimethyl fumarate or teriflunomide.
Patients must have an EDSS of 0 – 4.0 as per the entry criteria to be eligible to switch.
What happens if my patient tried dimethyl fumarate or teriflunomide and it does not suit them but they are still within the criteria for funding?
- If your patient is currently on an interferon or glatiramer and they switch to dimethyl fumarate or teriflunomide, they will only be able to switch back to beta interferon or glatiramer if they are unable to take fingolimod or natalizumab for clinical reasons and they continue to meet the access criteria for treatment.
- If your patient is currently on fingolimod or natalizumab and they switch to dimethyl fumarate or teriflunomide and they do not suit your patient, they may be able to switch back to fingolimod or natalizumab, so long as they continue to meet the access criteria for treatment.
Can I make an application for my patient for funding for dimethyl fumarate or teriflunomide prior to 1 February 2016?
You will be able to make an application for your patient for dimethyl fumarate or teriflunomide prior to 1 February 2016. However no approval numbers for these treatments will be valid teriflunomide prior to 1 February 2016.
The MSTAC application forms will be updated by mid-January 2016 to include dimethyl fumarate and teriflunomide
How will patients receive their funded MS treatments?
Once a medicine’s funding has been approved for your patient, you will be informed as to how they will be able to access their funded treatment:
- Beta interferons and glatiramer will continue to be directly distributed to patients
- Fingolimod is available to patients via community pharmacy (but first dose should be monitored in a clinical setting)
- Dimethyl fumarate and teriflunomide are available to patients via community pharmacy and are able to be taken by patients without clinical supervision
- Natalizumab is available to patients in a clinical setting via an infusion every 4 weeks.
What does the change to the MRI criteria mean?
The changes to the MRI criteria, relating to MRI evidence of active inflammatory disease, are to ensure clarity and better reflect the intent of the criteria. The changes may mean that some patients, who would otherwise have needed to undergo further MRI studies to demonstrate new inflammatory MRI activity, will now not need additional MRI studies.
Will community pharmacy be able to dispense the new treatments?
Yes. Both dimethyl fumarate and teriflunomide will be dispensed through community pharmacy. Fingolimod will continue to be dispensed via community pharmacy. Patients will need to have an active Special Authority number in order to access these funded treatments.
The beta interferons and glatiramer will continue to be delivered directly to patients.
Natalizumab continues to be dispensed by pharmacists registered with the TAPP programme operated by the supplier, Biogen, and administered in a hospital setting.
Will the wastage rule apply to the new treatments?
Yes. The wastage rule will apply to dimethyl fumarate and teriflunomide (as well as continuing for fingolimod).