Scottish RA patients to get RoActemra while English patients wait
This article was originally published in Scrip
The Scottish Medicines Consortium has accepted the use of Roche's RoActemra (tocilizumab) for some NHS Scotland patients with rheumatoid arthritis (RA). Meanwhile, patients in England and Wales are still waiting for a final decision from the National Institute of health and Clinical Excellence.
The SMC said yesterday that RoActemra could be used in combination with methotrexate for patients with moderate to severe active RA who have responded inadequately to or who are intolerant of previous therapy. This includes one or more disease-modifying anti-rheumatic or tumour necrosis factor antagonists. The SMC also says that RoActemra may be given as a monotherapy if treatment with methotrexate is inappropriate.
It concluded that adding RoActemra to disease-modifying anti-rheumatic drugs led to an increased response rate for reduction of disease activity. Roche estimated that the gross cost of the drug would total £1.2 million in the first year, rising to £7 million within five years as the percentage of patients with moderate to severe RA with a poor response to first-line treatment would rise from 5% in year one to 15% in year five.
Meanwhile, in England NICE is yet to make its final decision. In negative draft guidance the institute said that at £9,295 per patient per year (for a person weighing 70kg), the drug was not cost-effective. But in December, it gave Roche a reprieve and asked for more information before issuing its final guidance (scripnews.com, December 18th, 2009).
It asked Roche for a re-analysis of the cost-effectiveness of RoActemra as an addition to the treatment sequence for RA patients who have responded poorly to other TNF-alpha inhibitors. In addition it wanted a cost-effectiveness analysis of RoActemra as an addition to the treatment sequence for patients who have responded poorly to Roche's MabThera (rituximab). The institute also asked for an indirect comparison of the clinical and cost-effectiveness of RoActemra with MabThera in patients who have not responded well to other TNF-alpha inhibitors.
Roche says it has tried to give NICE as much information as possible ahead of tomorrow's response deadline. The company said that a closed appraisal meeting was likely to take place in February and that the final appraisal determination was likely to be released in March or April. A negative decision could be followed by an appeal, which would draw the process out even further.
NICE began its review of RoActemra when it was awarded its licence at the beginning of 2009, but this was put on hold until the drug's launch date was confirmed, a spokesperson explained. NICE released its first draft guidance, which was negative, in October when the drug was finally launched.
The SMC process was somewhat speedier. The firm submitted its dossier to the SMC in September 2009, and a positive decision came at the beginning of December. However, this was not made public until a month after it had been confirmed to the NHS in accordance with the organisation's new process, said the spokesperson.
The company said it gave both bodies the same information. "Why is it that England is behind Scotland and other countries?" asked the spokesperson.
But different healthcare systems fund drugs in different ways that reflect their own circumstances and priorities, said Sir Andrew Dillon, NICE's chief executive. "What is important is that the approach taken to establishing value is based on clear methods and processes, consistently applied and open to challenge," he told Scrip.
The institute says that its process is more thorough and more transparent than the Scottish one.
NICE generally undertakes a lengthier, more detailed review of the scientific evidence while the SMC arrives at its conclusions sooner, albeit after a less rigorous process.
And the NICE process does seem to be open to greater scrutiny. Each stage of its decision making is made public in appraisal consultation documents ahead of the final appraisal determination. However, the SMC only makes its final decision public.
The SMC told Scrip that the two bodies usually reached the same decision when assessing the same drugs. It declined to comment on the NICE process.