A drug derived from cannabis, which many people with multiple sclerosis say helps ease their symptoms, has been ruled too expensive to be used by the NHS in England even though it is approved for Wales.
In new guidelines for the diagnosis and treatment of people with the disabling disease, the National Institute for Health and Care Excellence (Nice) says the price set by the manufacturer of Sativex (nabiximols) is too high for the benefit it gives patients. But the decision opens up the sort of “postcode lottery” that Nice was set up to end, with MS patients in Wales able to use the drug on the NHS while those in England either have to buy it themselves or go without. Some will use the illegal drug instead.
A second drug, Fampyra (fampridine), designed to improve people’s ability to walk, has been rejected by both England and Wales. Neither drug is routinely available in Scotland.
“The substantial cost of Sativex and fampridine compared to the modest benefit does not justify their use; there are better ways to improve care for people with MS,” said Dr Paul Cooper, a consultant neurologist who chaired the guideline development group.
In a Guardian podcast, he suggested Wales had been “a little naive” in their assessment of Sativex: “They have taken information from the drug company at face value without seeing the original data and they’ve used dosages and potential benefits that we would not agree with.”
But the MS Society’s chief executive, Michelle Mitchell, said the rejection of the two drugs by Nice was disappointing. “Surely we should be striving for the most innovative treatment and care to be made available to people with MS, not limiting options even further,” she said.
The charity published a survey of nearly 4,000 people with MS that found 82% of those taking Sativex considered it essential or a high priority. The main reasons people gave for not taking Sativex were that it was not available where they lived – prior to Nice’s decisions, the NHS makes local decisions about funding the drug – or that they would have to pay privately.
“I experience very painful spasms around my ribs, the MS hug, and tightness in my arms and legs. I’ve been told that Sativex could give me some relief but it seems so out of reach,” said Shona Garrett, 38, from Lowestoft, who was diagnosed two years ago and is on a waiting list for the drug in her area. “I also experience nerve pain like constant pins and needles in my feet, and I’ve heard Sativex could help with this too. No one has offered me any other options.”
She and her husband had discussed paying for the drug privately, but they had been told it would cost £500 a month, which is more than they can afford.
About 100,000 people in the UK have MS. It tends to hit younger people and can lead to serious long-term disability.
The guideline says people with suspected disease should be referred promptly to a consultant neurologist for diagnosis. Among other recommendations are that they should have a single expert to speak to about their care, concerns and treatment options so they are not shuttled about between different doctors and nurses. They should also be encouraged and helped to exercise.
The MS Trust said although it welcomed its publication, “regrettably, we believe that the guideline falls short. Though it contains a number of welcome recommendations, it also contains some significant gaps and omissions. Overall we believe it demonstrates a lack of ambition to provide what people with MS need, that is, a genuinely comprehensive description of best practice in MS care.”
Source: The Guardian © 2014 Guardian News and Media Limited (08/10/14)
A multiple sclerosis patient has complained of a "postcode lottery" in the funding of a drug to help with his symptoms.
Sativex is not considered cost-effective and is not routinely funded by health bodies in England.
Philip Grace, 58, from Great Tey in Essex, has been paying privately to get the drug, which cannot be prescribed by his GP.
He was told it might be funded on the NHS if he lived elsewhere.
"My doctor used the term 'postcode lottery' to describe my situation. I know other people in Essex who take it under NHS prescription," he said.
Diagnosed with MS 13 years ago, Mr Grace said the condition has had a huge impact on his movement.
He said: "Before I started taking Sativex, walking felt like trying to walk through water. It was like my body was fighting itself.
"I would also have really bad spasms during the night, which would mean I couldn't sleep. Nowadays, I still don't have much control over my legs, but my strength is coming back.
Sativex helps with muscle spasms and is used by patients when other treatments are ineffective. It was the first cannabis-based medicine to be licensed in the UK.
In August, the NHS in Wales announced it would fund the medicine, following an appraisal by the All Wales Medicines Strategy Group.
But in draft guidance published by Nice (National Institute for Health and Care Excellence), the drug was not considered to "represent cost-effectiveness".
The Mid Essex Clinical Commissioning Group, which funds health services in Mr Grace's area, said it did not routinely fund Sativex, but patients could be referred for "exceptional funding" by their GPs.
Mr Grace said his referral was made in July, but he is yet to receive a reply.
Source: BBC News © British Broadcasting Corporation 2014 (09/09/14)
Sativex, a cannabis-derived drug for treating muscle spasms in multiple sclerosis, could be available in Wales but blocked in England.
GW Pharmaceuticals, the British company that develops cannabis-based medicines, is facing the prospect of having its multiple sclerosis treatment blocked in England but available in Wales.
The Welsh medicines board has recommended the use of Sativex to treat medium to severe muscle spasms in multiple sclerosis and is awaiting final approval from the devolved Government, The Sunday Telegraph has learnt.
Sativex could, however, be blocked from routine use in England. Draft guidelines from the National Institute of Health and Care Excellence (Nice), issued in April, recommended against the use of Sativex in multiple sclerosis. If this remains unchanged in the final guidelines, expected in October, Sativex will not be available on the NHS in England.
Justin Gover, chief executive of GW Pharmaceuticals, said it was a “travesty” that different parts of the UK could have different guidelines on Sativex, a mouth spray made from compounds derived from the cannabis plant.
“We very much hope that it [Nice] will indeed endorse use of the medicine – it would make little sense if you could drive to Wales and get the drug but not in England,” he added.
The draft guidelines have also attracted criticism from neurologists and patient groups, who say Sativex and Famprya, another drug which could be blocked, can stop patients “screaming out” in pain.
Experts have questioned Nice’s cost-benefit methodology, saying it had vastly overestimated the doses needed for the effective management of symptoms.
Sativex has been licensed for use in the UK since 2010, but did not undergo a clinical assessment until this year, with Nice due to update its multiple sclerosis guidelines for the first time in a decade.
About 100,000 people in the UK currently have MS.
Source: The Daily Telegraph © Copyright of Telegraph Media Group Limited 2014 (11/08/14)
People with multiple sclerosis are on the verge of being denied two drugs that help alleviate pain as a result of new NHS recommendations.
Fampyra and Sativex have been licenced in recent years to help people who experience mobility problems and muscle spasms.
However, the National Institute of Health and Care Excellence (NICE) is due to reject the drugs as treatments for MS, with experts saying they are not cost-effective.
In a letter to the Daily Telegraph, a group of experts including the head of the MS Society and seven neurologists say NICE has not taken full account of the "life-changing" differences the two drugs make to sufferers' lives.
"NICE is proposing to block access to two potentially life-changing MS treatments which are licensed and proven to be effective at helping people walk more easily and control painful muscle spasms," they wrote.
"If this guideline remains unchanged, people will be forced to pay privately, or face the agonising daily frustration of living with painful and debilitating symptoms, knowing there are drugs that may help them, but that they can't get access to."
Fampyra helps treat mobility problems, while sativex can be used to treat muscle spasms. On a private prescription, they would cost an MS surferer between £200 and £350.
The experts said NICE has over-estimated how much medication people would need for the drugs to be effective.
It is estimated that of the 100,000 people in the UK with MS, 40,000 would benefit from Fampyra and Sativex.
Michelle Mitchell, chief executive of the MS Society, told the Telegraph: "We understand that NICE has to make difficult decisions which balance cost to the NHS with the efficacy of a given treatment. But we don't understand why NICE deliberately excluded organisations that represent people with MS from a process which resulted in a proposal that two relatively affordable drugs with proven efficacy should be not be used in the NHS."
Willy Notcutt, Consultant in Pain Management at James Paget University Hospital, Norfolk, added: "Many people, including doctors, don't really understand how unpleasant symptoms such as spasms are - for example someone screaming in pain whenever someone tries to wash them.
"For many of them these treatments are invaluable and make life worth living again."
NICE said organisations will have their chance to comment and that the guidelines will be revised if new evidence emerges in support of Fampyra and Sativex.
Source: International Business Times © Copyright 2014 IBTimes Co., Ltd (10/06/14)
GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has received regulatory approval for its prescription medicine Sativex(R) in Switzerland. A full marketing authorization has been granted by the Swissmedic authorities in the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. Launch timing is dependent on completion of pricing and reimbursement procedures. Sativex will be commercialized in Switzerland by GW's European partner, Almirall S.A.
"This approval in Switzerland marks yet another regulatory success for Sativex, which is now approved in a total of 23 countries," stated Justin Gover, Chief Executive Officer of GW. "We now look forward to working with our partners, Almirall, towards this launch so as to enable MS patients in Switzerland to benefit from this important new treatment."
Sativex is approved for use in the treatment of MS spasticity in 23 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait.
Source: GW Pharmaceuticals plc (27/11/13)
GW Pharmaceuticals plc, today announced the successful closing of the European Mutual Recognition Procedure (MRP) in France for Sativex(R) oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS) and a resulting recommendation for approval by the French authorities.
The next step in the regulatory process is to work with the French National Agency of Medicine and Health Products Safety (ANSM) to finalize any country-specific requirements. Following completion of this next step, it is then expected that France will issue a national marketing authorisation. Launch timing in France is dependent on completion of subsequent national pricing and reimbursement procedures. Sativex will be commercialized in France by GW's European partner, Almirall S.A.
"The successful completion of this regulatory process for Sativex in France maintains our positive regulatory track record for Sativex, which is already approved in 22 countries, and provides further endorsement of the important role Sativex can play in meeting a substantial unmet need of people with Multiple Sclerosis," stated Justin Gover, Chief Executive Officer of GW Pharmaceuticals. "We look forward to working with our partners, Almirall, towards the launch of Sativex in this important European country." Sativex is approved as a treatment for MS spasticity in 22 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait.
In the United States, GW announced in August 2013 that it had opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex(R) for the treatment of MS spasticity. GW expects the U.S. Phase 3 trial to commence in 2014.
Sativex is also currently in Phase 3 clinical trials as a treatment for cancer pain. This represents the lead target indication for the product in the United States.
Source: GW Pharmaceuticals plc (21/10/13)
GW Pharmaceuticals PLC said new test data had reinforced the efficacy and safety profile of its Sativex drug for treatment of Multiple Sclerosis spasticity.
It said the latest results from several studies show that the drug's effectiveness is maintained long term with no additional safety concerns identified in clinical practice.
It will present the data Wednesday at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Copenhagen.
Sudies in specialist MS centres across the EU showed improvements in spasticity were confirmed by more than 70% of patients, but also by physicians and carers, with Sativex was generally well tolerated, GW Pharma said in a statement.
Another study conducted in three German centres showed the drug had no adverse effects on driving ability, the MS spasticity and spasms count improved and the treatment was again well tolerated.
Sativex is a cannaboid which is administered in spray form. It has been launched in 11 countries including the UK, Spain, Italy and Germany, and has approvals for a further 11 countries.
GW Pharma shares were up 2.4% at 86.78 pence Wednesday morning.
By Steve McGrath; email@example.com; @SteveMcGrath1
Source: Copyright 2013 Alliance News Limited. All Rights Reserved. (02/10/13)