United Kingdom

NHS widens access, relaxes drug fees

Christe Bruderlin-Nelson — Wed, 05 Nov 2008 09:40:09 -0500

The UK's National Health Service will now allow patients to receive NHS care even if they privately pay for drugs, and will implement measures to increase access to NHS-covered treatments.

Alan Johnson, the UK's health secretary, overturned a rule that had previously banned patients from receiving services if they paid for their own medications. At the same time, Michael Richards, the National Cancer Director, published a report that showed government plans to work on new pricing arrangements for new drugs as well as speed up the appraisal and approval process for new medications.

As a result, the public will have greater access to drugs for cancer and other terminal conditions. The move ends what some have called a "cruel practice" that prevented individuals from purchasing certain medications by removing other NHS benefits.

- see the full story at the Financial Times

UK patients lobby Celgene for discounts

Tracy Staton — Tue, 28 Oct 2008 11:24:43 -0400

When Johnson & Johnson made a pay-for-performance deal covering Velcade sales to the U.K.'s National Health Service, industry observers figured it was just a matter of time before other companies did the same. And sure enough, Novartis recently forged a cost-sharing deal to get its macular degeneration drug Lucentis onto the NHS formulary. Now, patient groups are lobbying Celgene to negotiate its own price-cutting scheme on the myeloma drug Revlimid.

The background: The National Institute of Health and Clinical Excellence deemed Revlimid unacceptable for NHS reimbursement, saying the drug isn't cost-effective. At $56,400 per year and an estimated three extra years of life, the cost blows past NICE's cost-effectiveness threshold. But patient advocates say Revlimid is a breakthrough that could help make myeloma into a manageable disease.

That's the same conclusion NICE reached on Velcade, before J&J pitched its pay-for-performance deal, under which the drugmaker refunds the cost on patients who don't respond. Whether Celgene plans to negotiate isn't yet clear, but you can count on more calls for discount deals as NICE continues its hard-line stand.

- read the BBC story
- check out Pharmalot's post

Roche cuts Tarceva price for U.K.

Tracy Staton — Mon, 06 Oct 2008 10:19:16 -0400

Need more evidence that the U.K. is playing hardball on drug prices? Here it is: The National Institute for Health and Clinical Excellence agreed to pay for Roche's lung cancer med Tarceva--if and only if the drugmaker matched the price of an older, less costly remedy.

NICE had calculated that Tarceva was $3,700 more expensive than the Sanofi-Aventis treatment Taxotere. Roche proposed the discount, and NICE accepted; now, the drug-price watchdog will recommend Tarceva as an alternative to Taxotere in patients whose chemo has failed. Patients and their doctors will decide which drug to use.

Expensive cancer meds have become an explosive issue in the U.K. As NICE has taken a hard line on cost-benefit analysis, patients and advocacy groups have been demanding greater access to new, potentially life-saving or life-extending treatments. For example, NICE recently nixed four kidney cancer drugs--Roche's Avastin, Bayer's Nexavar, Pfizer's Sutent, and Wyeth's Torisel--saying they're not effective enough to warrant the big price tag. Patient groups were outraged. Then, last week, the government suggested that drugmakers should discount their prices if they want these costly meds to be adopted.

Apparently Roche took that advice. Will other drugmakers follow suit?

- read the story in the Wall Street Journal
- check out the WSJ Health Blog post

ED drug scrips go online in U.K.

Tracy Staton — Mon, 29 Sep 2008 10:45:13 -0400

U.K. men afraid to discuss a small, er, problem with their doctors will now be able to get their prescription online. That's right, two British pharmacies will begin prescribing ED meds via their websites. Lloyds pharmacy says the service will appeal to men too embarrassed--or perfectly brave but much too busy--to ask their GPs.

Here's how it will work. Patients fill out an online questionnaire that asks for height, weight, blood pressure, other scrips, and info on libido. GPs from the health website DrThom will evaluate the answers to see whether each patient is suitable for one of three popular ED drugs: Viagra, Levitra, and Cialis. At first, men will get an intro pack of eight pills. Then they can order 16 at a time.

The pharmacies are pitching this as an alternative to buying ED drugs online from potentially risky sources. Indeed, Viagra remains one of the most highly counterfeited pills. We'll have to wait and see whether the pharmacies see a deluge of orders--and whether men in the U.S. might ever have this alternative.

- see the story in The Guardian

NICE urges docs to curtail ADHD meds

Tracy Staton — Thu, 25 Sep 2008 10:59:00 -0400

Can parents treat ADHD? The U.K.'s National Institute for Health and Clinical Excellence says the first line of treatment for attention deficit hyperactivity disorder should be parental management. Moms and Dads--and other caregivers--should receive training in caring for and managing ADHD kids. Next comes counselling, for older kids. Drugs, NICE says, should be reserved for kids with severe ADHD or used as a last resort for other children. And they should never be given to kids under 5 years.

NICE's new treatment guidelines come at a time of intense debate over the prevalence of ADHD drug use among youngsters. Prescriptions in the UK, for instance, doubled between 1998 and 2004. But many parents and teachers hail the drugs for their ability to help difficult children learn and behave in the classroom and at home.

NICE also says that, when drugs are prescribed, they should be part of a treatment plan that includes "psychological and behavioral interventions."

Experts figure that actual drug use won't change much initially. But it seems that growth in ADHD drugs could be curtailed over time. And because NICE's decisions are closely watched in Europe and elsewhere, the policy could spread.

- read the BBC story
- check out The Guardian's coverage
- see the article at CTV

Moody's downgrades Euro-Pharma

Tracy Staton — Thu, 11 Sep 2008 11:30:05 -0400

European pharma companies aren't looking too rosy, either--at least according to Moody's. The ratings agency says the drugmakers--including heavyweights Roche, GlaxoSmithKline, Sanofi-Aventis, AstraZeneca and Novartis--won't be as credit-worthy in the coming 18 months. The problems Moody's cites are familiar: pipelines, patent expirations and a tough U.S. regulatory environment.

And then there's pharma's penchant for biotech companies, because those deals don't tend to send much to the bottom line at first. Plus, Moody's doesn't like the fact that drugmakers have been buying back their own stock to prop up the share price.

But Moody's isn't completely dejected about pharma's prospects. The industry is still profitable, after all.

- read the Wall Street Journal Health Blog item

Does NICE want pricing power?

Tracy Staton — Tue, 26 Aug 2008 11:37:45 -0400

Last week, the chief of the U.K.'s National Institute for Health and Clinical Excellence accused drug companies of overpricing their products. Now, sources are telling PharmaTimes that the attack signals that NICE wants a "central role in price negotiation" as the government is overhauling its Pharmaceutical Price Regulation Scheme.

There's an interim pricing deal now, details of which were released two weeks ago. But experts are saying that the new deal, scheduled to start in January, will be a more radical departure from the past arrangement with industry, which guaranteed drugmakers profits on their products. And NICE may be partly responsible for that. "There will be regulation on prices; NICE will be involved in it and prices will go down," pledged Joe Collier, a medicines policy expert.

- read the PharmaTimes article
- see the post at Pharmalot

NICE wants to limit anti-TNF use

Tracy Staton — Mon, 21 Jul 2008 10:42:48 -0400

Hear those cries of protest? They're coming from the U.K., whose National Institute for Health and Clinical Excellence (NICE) issued guidelines today that would limit patients' access to high-tech arthritis meds. Under the guidelines, each patient could use only one of the anti-TNF drugs--Centocor's Remicade (infliximab), Abbott Laboratories' Humira (adalimumab), and Amgen's Enbrel (etanercept)--and couldn't try another if the first stopped working or didn't help in the first place.

NICE said that giving patients more than one of these meds is not cost-effective, and that if one of them doesn't work, then docs should use Roche's Rituxan--known as Mab Thera in the U.K. and Rituxan in the U.S. Rheumatoid arthritis activists rose to the anti-TNF drugs' defense, saying that a limit of one would amount to "one roll of the dice" and "rationing without rationality."

The guidelines aren't in force yet; a final version is due in September. Activists are hoping that the outcry convinces NICE to change its mind. It worked before; NICE proposed anti-TNF limits in 2006, but recanted after protest.

- see the BBC story
- check out the coverage in the Telegraph

More NICE debate over cancer meds

Tracy Staton — Fri, 27 Jun 2008 09:16:33 -0400

It's not just Roche that refused to fork over cost-effectiveness info on its cancer med to the U.K.'s National Institution for Clinical Health and Excellence. So, too, has Merck Serono. Yesterday, you'll recall, NICE said it was rejecting Roche's Avastin for National Health Service use because it lacked that data. Merck Serono's Erbitux is in the same boat. And given the fact that NICE is increasingly skeptical of high-priced cancer meds, there's likely to be more wrangling among the regulators and pharma.

Merck Serono's U.K. oncology chief Denise Richard maintains that NICE needs to change its criteria and procedures--and needs to speed up its reviews, too. For instance, NICE doesn't allow drugmakers to update their applications even during long appeals, she told the Financial Times, even though efficacy data often changes quickly.

Richard also thinks NICE should change its requirements for cost-effectiveness for patients with late-stage cancer. One of the regulators' gripes is that some of these expensive meds only extend life by months rather than years; Richard says late-stage patients rarely live more than a few months. So that extra time can be precious.

Interestingly, the FT posits that the best value might lie in using these high-tech meds earlier in the cancer-fighting game--but at lower prices, so that drugmakers would make up the price difference by selling a higher volume.

- see the FT article