Generic versions of biologics?

While there are generic equivalents of many chemically based drugs that cost patients a fraction of the brand-name cost (thanks, I suppose, to the original drug patents expiring), this is not the case for the high-cost biologics -- like Enbrel, Humira and Remicade -- that many of us are turning to for relief. That high cost is raising the question of how long brand-name biologics can be exempt from market competition from "biosimilar" or "biogeneric" drugs -- especially in the U.S., where the high cost of drugs and cost containment are a crucial part of the health coverage debate. The Chicago Tribune has the story.

B.C. drug plan to cover TNF drugs for AS

The Vancouver Sun reports that British Columbia's provincial prescription drug plan will cover adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade) for patients with ankylosing spondylitis who meet the criteria of the plan's Special Authority program.

Update, March 8: Reaction from the Arthritis Society, which says that they and others have been lobbying the government for this decision for years.

Saskatchewan approves Enbrel, Humira for AS

Amazing what a change of government does. Saskatchewan's provincial drug plan now covers Enbrel and Humira for ankylosing spondylitis under Exception Drug Status coverage.

Update: CBC News coverage. Remicade wasn't approved because it costs more.

Previously: More about Saskatchewan's TNF coverage; Saskatchewan to AS patients: No biologics for you!

ACE demands biologics coverage for Aboriginal Canadians

Fresh from going after Saskatchewan for its refusal to cover biologics for AS, Arthritis Consumer Experts is now turning its attention to the drug coverage provided to Aboriginal Canadians by the Non-Insured Health Benefits program of Health Canada's First Nations and Inuit Health Branch. Noted without comment -- I'm presently working on contract at Health Canada.

More about Saskatchewan's TNF coverage

A follow-up article from the Regina Leader-Post on Saskatchewan's coverage of biologics -- they're covered for rheumatoid arthritis, two out of three are for psoriatic arthritis, but none for ankylosing spondylitis -- suggests, as an aside, that the newly elected Saskatchewan Party government may reverse the earlier decision not to approve coverage for AS. Indeed: why should our disease be treated, pun intended, differently?

Previously: Saskatchewan to AS patients: No biologics for you!

Nor New Zealand

Pharmac, New Zealand's state pharmaceutical plan, covers TNF inhibitors for rheumatoid arthritis, but not for ankylosing spondylitis or psoriatic arthritis. On its face, this looks less like pushback against the high cost of TNF blockers and more like taking a long time to approve it for diseases other than rheumatoid arthritis (which is usually the first disease these things get approved for).

Alberta won't cover biologics either

It's not just Saskatchewan: Alberta's public drug insurance plan refuses to cover biologics for the treatment of ankylosing spondylitis, the Calgary Herald reports. The issue forming up is the need to keep skyrocketing drug expenses under control versus the need to provide effective treatments for crippling, chronic illnesses. (It occurs to me that if a $15,000-a-year treatment is the difference between someone working and not working, it's money well spent.) In a letter to the editor, Ken Mulholland argues, "I realize that these drugs are very expensive, but how is it that provinces like Ontario and Quebec have approved their use while Alberta, with all of its wealth, can flatly deny sufferers within its borders?"

Saskatchewan to AS patients: No biologics for you!

Meanwhile, a Canadian arthritis lobby group is fulminating against the Saskatchewan government, which last month decided against listing three TNF blockers -- presumably the big three, Enbrel, Humira and Remicade -- for the treatment of ankylosing spondylitis. This isn't about prescription drug coverage, says the group; it's about access, pure and simple: "As a result, people living in Saskatchewan with this inflammatory disease have absolutely no access to biologic medications to manage their disease." That seems a bit much. No access at all?

Update, 11/15: CBC News has more, including the Saskatchewan Formulary Committee's rationale: their position is that "the clinical benefit does not justify the incremental cost of these drugs." As a result of last week's provincial election, there will shortly be a change of government in Saskatchewan, so this decision may well be reversed.

Update, 11/18: More coverage from the province's main newspapers.

NICE to AS patients: No Remicade for you!

Britain's National Institute for Health and Clinical Excellence (NICE) has made a decision that restricts access to anti-TNF therapy by patients with severe ankylosing spondylitis, and the National Ankylosing Spondylitis Society (NASS) isn't happy about it. Only two out of three biologics will be accepted for use against ankylosing spondylitis: etanercept (Enbrel) and adalimumab (Humira), but not infliximab (Remicade). And Enbrel and Humira cannot be used sequentially -- which is to say that if you try Enbrel and it doesn't work, you can't then try Humira. And if neither works, you're SOL for Remicade. Cost is being cited: Remicade is more expensive to administer (since it can't be self-injected). See coverage from Channel 4, the Daily Mail, and This Is London.

As anyone with chronic inflammatory arthritis will tell you, it's impossible to tell what treatment will work in advance: I'm on naproxen, but I know AS patients who can't tolerate it; I know people who use indomethacin, but couldn't handle it myself. To have only one shot at anti-TNF therapy may make sense from a cost perspective, but it's lousy from the perspective of the person actually suffering from the disease.

Pharmaceutical triage in the UK

We've heard before about the difficulties British ankylosing spondylitis patients have had trying to get coverage for the latest (and presumably greatest) treatments, the expensive TNF-alpha blockers. This BBC News article affords some insight into the process by which an individual patient can have such treatments approved -- or denied:

The first business is two requests from patients with a painful rheumatic disease, ankylosing spondylitis.

They want drugs which cost £11,000 a year, but haven't yet been given the seal of approval by the health watchdog, the National Institute for Health and Clinical Excellence (NICE).

Other local patients might be eligible -- so the question is: are these exceptional cases?

"For a PCT our size, I guess we're looking at anywhere between 250 and 500 cases who may potentially benefit from this drug," said the public health director.

Another panel member said: "The doctor who's presented this says the severity of this patient's symptoms is unusual -- but that's not the same as exceptional.

"I guess for me it's the uncertainty about how this drug will affect this patient. Funding it would be a speculative move -- given the evidence we've got here."

Both requests are turned down.

It's worth noting that biologics are usually indicated when more conventional treatments are ineffective. The whole lot of us aren't going on Remicade, and many of us, I suspect in my limited and unqualified way, won't ever need to.

Previously: Postcode lottery for TNF-alpha in the UK; AS and prescription drugs in Scotland.

PEI lags in drug approvals

The Arthritis Society is campaigning to raise the profile of arthritis patients during the upcoming provincial election in Prince Edward Island. Notably, they point to how long it takes the provincial drug plan to approve drugs: approvals for biologics lag behind other provinces, and even Celebrex isn't covered. Don't miss the boneheaded responses from the provincial parties that sidestep the question and talk about disease prevention and lifestyle choices: when you've got an inflammatory autoimmune disease, it's already too late for that, and you don't catch what we have from eating too many Ding-Dongs, you assclowns.

British Columbia and Remicade

British Columbia's provincial drug plan doesn't cover Remicade (infliximab) for ankylosing spondylitis, though it's been approved for rheumatoid arthritis and Crohn's disease, reports The Peace Arch News, leaving AS sufferers (or, presumably, their private plans) to pick up the full $24,000 tab if they want the newer treatment.

One interesting bit from the article encapsulates the problem with B.C.'s prescription drug coverage: "B.C. pays more for generic drugs than other provinces; and, B.C. is usually last to approve new medications. One drug, Enbrel, for the treatment of psoriatic arthritis, has been under study and review here for more than three years. Meanwhile, it’s approved for use in every other province except Prince Edward Island." Of course, Enbrel (etanercept) is of interest to AS sufferers too.