EuroPharma Today

Europe's Regulators Concede Dialog With HTAs Is Necessary

They may not like it, but Europe's top regulators are having to accommodate the growing influence of the continent's health technology assessment (HTA) bodies.

Eric Abadie, chairman of Europe's top scientific regulatory body, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP), initially appeared to reject the idea that the committee should become involved with HTA bodies.

Speaking at the Drug Information Association's 22nd annual EuroMeeting in Monaco on March 8, Abadie argued that CHMP was governed by regulations that explicitly say that marketing authorizations should be based on quality, safety and efficacy, to the exclusion of economic and other considerations. "We will not move from that," he declared.

German Health Minister Attacks Drug Prices With Forced Rebates

German health minister Philipp Roesler has opened fire against the branded drug industry with plans to break the sector's so-called "price monopoly" and force it to negotiate lower prices directly with the country's 200 or so health insurers.

If the industry doesn't, he says in a national press interview, it'll face fixed price ceilings.

NICE Rejects Vidaza, But Celgene Plans Comparator-Based Appeal

Celgene is preparing to appeal a decision by the UK's National Institute of Clinical Excellence that Vidaza (azacitidine) was too expensive for reimbursement by the UK National Health Service. The drug is approved and reimbursed for patients with a rare form of blood cancer known as higher-risk myelodysplastic syndrome (MDS) in over 30 countries.

EU Regulator Wants Closer Ties With Health Technology Assessors

LONDON - Among the proposals in the European Medicines Agency's five-year strategy document, the "Road Map to 2015", is a call for closer ties with health technology assessment (HTA) bodies like the UK National Institute for health and Clinical Excellence (NICE).

Ireland Cuts Drug Prices And May Also Introduce Reference Pricing

Ireland slashed the prices of 300 branded multisource medicines, including Zofran and Casodex , by around 40 percent at the start of the month, and there are strong indications that more cutbacks are to follow, with reference pricing and generic substitution as distinct possibilities.

U.K. NICE Snubs Novo's Victoza, But Drug Launches Fast In The U.S.

The U.K.'s cost-effectiveness watchdog, the National Institute of Clinical Excellence, issued draft guidance on Feb. 15 recommending only limited reimbursement for Novo Nordisk's newly-launched diabetes drug Victoza (liraglutide), despite the GLP-1 analog's proven efficacy not only in lowering blood sugar, but also in promoting weight loss.

On the bright side for Novo: a very rapid U.S. launch means the drug is now available in 90 percent of U.S. pharmacies, just three weeks after its delayed approval by FDA (¹ 'The Pink Sheet' DAILY, Jan 26, 2010).

UK's NICE Says No To Two CML Drugs; Invites Cost-Sharing Schemes

The UK cost-effectiveness watchdog NICE delivered a resounding "no" Feb. 9 to the use on the National Health Service of Bristol-Myers Squibb's Sprycel (dasatinib) and Novartis' Tasigna (nilotinib) in chronic myeloid leukemia patients who are intolerant to Glivec (imatinib, Gleevec in the U.S.).

Cimzia UK Access Scheme Reinforces Marketing Message

It seems that UK cost-sharing schemes - agreements whereby drug companies offer the National Health Service rebates or free doses of their medicines - aren't just about winning a favorable reimbursement policy. They can help further the product's marketing message too.

That, at least, is the idea behind UCB's scheme for its rheumatoid arthritis drug Cimzia (certolizumab), which was recommended for reimbursement by the UK's National Institute of Clinical Excellence in January 2010.

Report Highlights Issues Facing EU Device Sector

A ¹ report on the future of the medical device industry in the European Union highlights the need for more standardized technology assessment systems among member states, and for more robust mechanisms to support innovation.

Posted on the European Commission Web site Jan. 28, the report is intended to concisely explain to the new European commissioners the broad range of challenges facing the device industry.

UK Early Access Scheme Likely This Year, But Funding Is An Issue

UK patients may benefit later this year from a new scheme granting early access to certain new medicines prior to formal approval. But one stumbling block is that the government will not provide funding for drugs used under the program.