The UK's cost containment agency, the National Institute for health and Clinical Excellence (NICE), has issued draft guidance saying that while Roche's blockbuster cancer drug Avastin (bevacizumab) delays the spread of ovarian cancer when used in combination with paclitaxel and carboplatin, it is not recommend as a cost-effective treatment. NICE's Appraisal Committee concluded that Avastin in combination with the other two cancer drugs showed a difference in median pr...

The functions of determining regulatory approval and reimbursement for a product traditionally have been at opposite ends of the development process. Historically, any product that received regulatory approval was reimbursed by payers. This is no longer the case in today's global market. While regulatory approval by a single body is still the basic requirement for commercializing a product, obtaining optimal reimbursement requires interaction with many diverse public an...

The UK's National Institute for Health and Clinical Excellence (NICE) has confirmed David Haslam, a distinguished advisor to several governmental organizations, as the new chairman of the agency, replacing the outgoing and longtime chair Sir Michael Rawlins. Rawlins has been chairman of NICE since the agency's founding in 1999, and the transition to Haslam comes as NICE has been under increasing fire from industry over its health economic assessments of regulated produ...

Integrating Health Outcome Parameters with Clinical Development For drug developers, getting a treatment to market with regulatory approval is proving to be only half the battle. Once in Phase 4, applying for reimbursement approval prompts an entirely new process, which can differ considerably from regulatory approval in terms of the health outcomes and evidence parameters that are evaluated. Regulatory approval, once considered the gold standard, is no longer good eno...

The European Commission has launched a consultation on the "situations" in which post-authorization studies would be imposed, something required by the 2010 legislation that revamped the EU pharmacovigilance system. The Commission's reflection paper notes in the section on "Efficacy Versus Effectiveness" that the criteria used by the European Medicines Agency (EMA) for a marketing approval recommendation have been the subject of some debate in recent years.  The...

A new first-of-its-kind database, the European Evidence Database on New Technologies ( EVIDENT ), is now accessible for all government-appointed Health Technology Assessment (HTA) agencies in Europe, related regional agencies and not-for-profit organizations. The database permits HTA agencies to register Additional Data Collection (ADC) studies they have undertaken to fill gaps in HTA-related information as well as search for studies being registered by other HTA agencie...

The EU health technology assessment network (EUnetHTA) has released for public comment five draft European methodology guidelines for relative effectiveness assessment of pharmaceuticals: Guideline on direct and indirect comparisons   Guideline on clinical endpoints Guideline on Health related quality of life (HRQoL) Guideline on safety Guideline on internal validity The primary objective of these guidelines is to assist national HTA assessors in E...

The UK's National Institute for Health and Clinical Excellence (NICE) has opened a consultation on its  draft medical technology guidance  on the use of a device to heal fractured bones. The draft guidance recommends use by the National Health System (NHS) of Smith & Nephew's EXOGEN ultrasound bone healing system in treating long bone fractures that have failed to heal after 9 months. Long bone fractures are suitable for treatment if the fracture is stab...

General Electric (GE) Healthcare's diagnostic test (SeHCAT) for bile acid malabsorption in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and Crohn's disease without ileal resection has been restricted for research use by the National Health Service (NHS) according to  draft guidance  issued yesterday by the National Institute for Health and Clinical Excellence (NICE).  The draft recommends restricting SeHCAT to research settings in or...

The UK's national health technology assessment (HTA) body, the National Institutes for Health and Clinical Excellence (NICE), is set to start assessing what it refers to as the "very high cost [of] drugs for people who suffer with rare conditions" under the new Health and Social Care Act of 2012. Under the plan, the agency-which assesses a product's value relative to its cost, societal impact and benefit to patients-would assume the responsibilities of conducting similar...

Two federal agencies charged with controlling costs by conducting non-binding comparative effectiveness research stand to be eliminated under the latest draft of an appropriations bill in the House of Representatives. AHRQ to be 'Terminated' The Agency for Healthcare Research and Quality (AHRQ) is, like the US Food and Drug Administration (FDA), contained under the umbrella of the US Department of Health and Human Services, and is run by longtime-Director Carolyn Clan...

In a statement on 5 June 2012, the German health technology assessment body Institute for Quality and Efficiency in Health Care (IQWiG) said it would reverse its  April 2012 decision not to recommend Eviplera (rilpivirine) for HIV in fixed combination.  The agency said in a statement its change in determination was due to the manufacturer having submitted additional information supporting this dosage form. The company used an alternative so-called vi...