The makers of a drug that helps people with multiple sclerosis to walk are to make a fresh application to have it covered by the Health Service Executive-funded drug schemes. People with MS, who say Fampridine (known commercially as Fampyra) has greatly increased their mobility, have criticised the HSE for not reimbursing the cost of the drug on the long-term illness scheme.
In 2012, regulatory authorities concluded that Fampyra was not demonstrably cost-effective for the treatment of MS. The HSE said the manufacturers, Biogen Idec, had failed to demonstrate or provide any formal justification of the prices proposed, but did not rule out a revised application.
The National Centre for Pharmaco-economics (NCPE), which rules on the cost-effectiveness of new drugs, said Fampyra would cost nearly €7,000 a patient each year. It said the €20 million annual cost to the State over five years would take money from other areas. Biogen later made the drug available free of charge to some patients as part of a late-stage clinical trial.
Since Fampyra was licensed for sale and became commercially available here this year, Biogen started charging for the product, leaving patients facing a €500 monthly bill to continue treatment.
One of these is Rosaleen Rafter, from Ballina, Co Mayo, whose daughter Caitríona Redmond says it will be impossible for her mother to afford the drug on her pension. Ms Redmond has been running a campaign through Facebook to highlight her mother’s battle to continue getting “the only treatment that has improved and stabilised her symptoms of MS”. “My mum retired early because of the illness and her loss of mobility and loss of power in her arms and hands. She uses a rollator to walk and has a hand-controlled adapted car as her legs have severely reduced power. She has foot drop and has had two falls, one of which took me and my brother ages to get her off the ground and resulted in a fractured shoulder.
“Watching the effects that her condition has on her has been awful and, without her medication, things will progress sooner.”
Last week, Minister of State for Primary Care Alex White told the Dáil he understood Biogen had told the HSE it intended to submit a revised application to the NCPE. The HSE would then reconsider the application “in line with the agreed procedures and timescales for the assessment of new medicines”.
Mr White said he was aware that studies were ongoing to assess the wider impact of the drug on both walking and quality of life for people with MS.
Their results would contribute to the evidence base demonstrating the clinical effectiveness of the product, which could be used to support future applications for inclusion on HSE drugs schemes.
Biogen said it was working with the authorities to make Fampyra available to all patients. It said it provided the drug free for 2½ years to qualifying patients and continued to provide the first four weeks of treatment free, so that patients who responded to it could be identified.
Source: The Irish Times © 2014 THE IRISH TIMES (17/06/14)
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)
People with multiple sclerosis will have to pay up to €500 a month for a new drug that could help them walk, after the HSE confirmed Fampyra is not covered under any of its community drugs schemes.
Famprya or fampridine has been licensed in Ireland and became commercially available though pharmacies for the first time this year.
A number of MS patients in Ireland have been using it as part of a late stage clinical trial.
The drug works by helping damaged nerve fibres to conduct messages better by blocking tiny pores on the fibres.
The HSE said its manufacturer, Biogen Idec, does not currently have an arrangement in place for its funding under the community drugs schemes in accordance with the provision of the Health (Pricing and Supply of Medical Goods) Act 2013.
It also said Biogen Idec had failed to demonstrate or provide any formal justification of the prices proposed.
But the executive said it is open to Biogen submitting a new revised application, and would consider any such application in line with the processes formally agreed with the pharmaceutical industry.
HSE clinical lead for the Medicines Management Programme Professor Michael Barry said he will consider including Fampyra under the HSE community drug scheme if there is new evidence to suggest that the drug has a beneficial effect for patients or if Biogen lowers the price.
Speaking on RTÉ's Morning Ireland, Prof Barry said that when the decision was made not to include the MS drug under the scheme in 2012, there was not sufficient evidence to suggest it was successful.
However, he said new evidence may change this decision.
He also said that the drug would cost nearly €7,000 per patient per year which would potentially cost the state €20m over five years.
He suggested that this could take money from other healthcare, such as cancer therapy.
Biogen said it is committed to advancing and supporting MS care in Ireland and "strives to make our therapies available to all patients who need them"
It said it is "committed to working with authorities to ensure people living with MS who qualify for our treatments have access to them."
The company added that it remains committed to understanding the full benefit of Fampyra through continued investment in a clinical trial programme.
Source: RTÉ © RTÉ 2014-RTÉ Commercial Enterprises Ltd (27/05/14)
Biogen Idec today announced that Fampyra® (prolonged-release fampridine tablets) has been made available in Ireland for the symptomatic treatment of walking impairment in adults with Multiple Sclerosis (MS). Fampyra is a prescription drug and is licensed for use in all types of the disease, including the progressive forms. FAMPYRA is available by way of retail pharmacy on a private payment basis. Fampyra is not currently available for reimbursement through any of the Health Service Executive’s (HSE’s) payment schemes.
“We are very pleased that Fampyra is now available for use in Ireland”, said Terry O’Regan, Vice President & Managing Director of Biogen Idec Ltd. “As a leading company in MS, we feel a strong sense of obligation to the MS community to bring new and innovative therapies to the people that need them, and we’re absolutely delighted to be able to offer this new treatment option for MS patients with walking disability.”
“Walking and mobility are the number one concerns for people with MS, so a therapy that potentially offers an improvement is a valued and welcomed addition to the treatment options available”, said Doctor Christopher McGuigan, Consultant Neurologist, St. Vincent's Hospital, Dublin. Dr. McGuigan is one of a number of healthcare professionals in Ireland who has previous experience with Fampyra as a participant in clinical trials, and via the Named Patient Supply programme. In clinical trials, Fampyra demonstrated efficacy in improving walking speed. In the pivotal MS-F203 phase III study by Goodman et al, around 35% of patients taking FAMPYRA responded to treatment compared with 8% of patients taking placebo. In the second study, the results were similar with 43% of patients in the Fampyra group responding to treatment compared with 9% in the placebo group.
Fampyra is not reimbursed by the Health Service Executive (HSE), however, Biogen Idec is providing up to four weeks’ treatment of Fampyra at no cost, enabling clinicians and patients to trial the product and assess its effectiveness before committing to pay for treatment. Treatment effect is usually evident between two to four weeks.
Fampyra is currently available throughout most of Europe.
Source: MarketWatch Copyright © 2014 MarketWatch (15/01/14)