Access to Sativex
Access to Sativex
About Sativex
Sativex is a cannabis-based medicine that is administered in the form of a mouth spray.* The drug has recently been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of moderate to severe spasticity in people with MS in the UK. The drug is only licensed for people who have not responded adequately to other anti-spasticity medication and who demonstrate a clinically significant improvement in an initial trial of therapy.
Just under 50 per cent of people with MS who have not responded to other treatments can be expected to show a clinically significant response to Sativex after four weeks treatment, according to the most recent clinical trials.
Sativex has not been assessed by the National Institute for Health and Clinical Excellence (NICE). This means that decisions on whether to prescribe Sativex will be made at the local level.
Who can prescribe Sativex?
Sativex should only be prescribed under the supervision of a doctor experienced in the management of MS spasticity. In most cases this will be an MS specialist neurologist but may also include rehabilitation specialists or pain specialists who regularly treat MS spasticity. Sativex may also be prescribed by GPs on the instruction of the specialist.
Your rights
The MS Society believes that people with MS should have access to proven treatments for their condition no matter where they live in the UK.* However, not everyone with MS gets access to the right treatment at the right time, and in some cases people with MS are denied access altogether.
There are some MS drugs, like Sativex, that have been licensed and approved for use on the NHS but have not been approved by NICE.* Without NICE approval, local health authorities have no legal obligation to provide you with access to the drug. Whilst there are fewer policies supporting your entitlement to MS drugs not approved by NICE, you can still (and should) make a case for access to these treatments.
Under the NHS Constitution, patients have the right to expect that local funding decisions of drugs and treatments not approved by NICE will be made rationally following a proper consideration of the evidence.* If the local NHS decides not to fund a drug or treatment that you and your doctor feel would be right for you, the local NHS is obliged to explain that decision to you.*
Making an individual request for Sativex
It may be the case that a local health authority (a primary care trust, for example) will take the decision not to prescribe Sativex on a routine basis.* You should be able to find out what the local policy is on Sativex by completing the template letter (downloadable from this webpage) and sending it to your local health authority.* If it is the case that the authority has decided not to prescribe Sativex routinely, an individual request for the drug will have to be made on your behalf if you want to access the treatment.*
Individual requests for Sativex should be made by your specialist. The request should be accompanied by as much information as possible about why you and your healthcare professional think the treatment will be beneficial for you.* It should be possible to assess whether Sativex is effective after a four week period of treatment.* The health authority may therefore decide to provide Sativex for a preliminary four week period before making a decision about whether to fund the medicine long term.
Exceptional circumstances
Sometimes a request will only be considered for “exceptional circumstances” so you will be required to demonstrate “exceptionality” in your individual case.* In these circumstances, it needs to be demonstrated that you are significantly different from the general population of patients with MS and that you are likely to gain significantly more benefit from the intervention than might normally be expected for patients with MS.
It will be very important to demonstrate that you have tried other spasticity medications that have not provided adequate symptom relief and/or have caused intolerable side effects. Highlighting the alternative treatment options available to you will also be necessary – if Sativex is not provided, intrathecal baclofen or botulinum toxin may be considered as options for treatment-resistant MS spasticity but are invasive and are associated with considerable costs to the NHS.
Lifestyle factors are also important here – for example, taking Sativex may allow you to be more independent, and lessen the need for a high level of care provision for certain daily tasks.* If this is likely to be the case for you, this should be highlighted in your request for Sativex.* This is just one example; many other factors could be taken into account.* Sativex is not effective for everyone; this is why it is so important to show in your request why you and your healthcare professional think Sativex will be effective for you and how it will improve your quality of life to a greater extent than for the general population of people with MS.**
How much does Sativex cost?
The cost to the NHS is £125 per 10ml vial.* This works out on average at £11 per person per day, based on 8 sprays per day.*
Who considers your request for Sativex?*
Your request for Sativex will usually be considered by a panel, the name of which will depend on the internal structures that are in place in that particular health authority.* Once the panel has considered the request, a letter will usually be sent to you and your doctor communicating the panel’s decision and their reasons for making this decision.*
What should I do if my health authority refuses to provide Sativex?
Your health authority may refuse your request for Sativex.* There are additional steps you can take at this stage to try to make the health authority review its decision.* The paragraphs below explain what you can do in this situation.
How does the appeals system work?
If your request for Sativex is refused, you may wish to appeal the decision.* It is a good idea to discuss this with your consultant or MS nurse before going ahead with the appeal.* If you decide to make an appeal, you should take note of the following points:
Make sure you know how your health authority’s appeals process works.* This will vary depending on where you live.* Details of the process should be available on request from the health authority – the person who sent you the refusal letter should be able to help with this.* The process might also be available from the health authority’s website.
Make sure that you appeal the decision within the specified number of days after receipt of the refusal letter otherwise the health authority has the right not to consider your appeal.* The time limit should be stated clearly in the refusal letter.* If no time limit is specified, it is advisable to check this with your health authority.*
When you are invited by the appeal panel to submit written evidence in support of your case, your treating clinician will usually provide most of the evidence.* However, there should be an opportunity for you to add to this with other information which you feel might be relevant to your case.* Make sure you include as much information as possible about why you think Sativex will be beneficial for you.*
If you are invited to make an oral representation to the panel to supplement a written statement, you should take up the opportunity if you feel it would strengthen your appeal.* Equally though, you should not feel under any pressure to appear before the panel if you think this might cause you additional stress or anxiety.* The panel may allow someone else to make the presentation on your behalf.
Health authorities vary in how often their appeals panels meet.* For example, some meet once a month while others meet once a quarter.* The panel will usually be a group of people who had no involvement in your original request for the drug.*
The panel’s decision should be communicated to you in a letter shortly after the meeting to discuss your case.* The panel is obliged to give you a clear explanation of how it reached its decision.*
When going through the appeals process, remember to stay positive and to keep persevering.* Good luck and don’t give up!
How to get loud
If your appeal for Sativex is refused, there are still ways in which you can challenge your health authority’s decision:
1. Involving the Policy and Campaigns team
If accessing Sativex is proving to be a problem in your area, we want to know about it, so please do get in touch.* There may be grounds to start a local campaign in your area and we can help with putting the wheels in motion for this.*
The MS Society has five area teams in England and relies on the regional service development officers (SDOs) within these teams to influence local services for people with MS. The Society also has national offices in Scotland, Wales and Northern Ireland. We can put you in touch with your local SDO or national office so that you have access to local support and expertise to help with your campaign.
You can also get in touch with us if you have any general enquiries relating to the information in this document. *If you have reached the end of the appeals process and have been unsuccessful, we can advise you about the next steps to take.* Please call 020 8438 0700 and ask for the Policy and Campaigns team or email us at [email protected]
2. Involving the local press
If you want to share your story with the press, you should first consider the following:
In conversation with the Policy and Campaigns team, work out if you have a story the press will want to tell – and whether telling the press is really the best option.* We can advise you on the best course of action, which may not always be to involve the media, and we will discuss your case with our Press Office.
If you are comfortable with the idea and your story does merit media attention, the MS Society Press Office will guide you through the process of contacting the local media, or can do this on your behalf.*
You will have to give out personal details like your name and where you live. You should also be prepared to be photographed.* If you are not comfortable with this, then sharing your story is not appropriate.
By telling your story in the local media, you will be helping to shine the light on a situation that may well be affecting many other people and you will hopefully help change things for the better.
3. Involving your local MP
Your local MP might be able to help with influencing your health authority to review its position on Sativex. *You can find out who your local MP is by entering your postcode on the parliament website here - http://findyourmp.parliament.uk/ - or by calling the House of Commons Information Office on 020 7219 4272. *You can use the template letter on page 7 to write to them about your case. *Remember to keep your letter concise and to the point.
Step-by-step guide
This simple guide summarises the steps you can take to try to access Sativex.
Step 1 – Ask your neurologist or MS nurse about whether they think Sativex might be beneficial for you.
Step 2 – Ask your neurologist or MS nurse about the process for accessing Sativex. This will vary depending on where you live.
Step 3 – If your neurologist or MS nurse is unable to help you to access Sativex due to restrictions put in place by the health authority but they think the treatment will be beneficial for you, complete the template letter on page 6 and send it to your PCT/NHS Board/Health Board.
Step 4 – Once you have established what the local NHS policy is on Sativex provision, you may have to consider making an individual funding request for Sativex.
Step 5 – If your individual request for funding is refused, you may wish to appeal the decision. Details of this process are above.
more sativex info/fact sheet HERE
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Originally Posted by Poet
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