02:24 , Mar 9, 2019 |  BioCentury  |  Politics, Policy & Law

Top-down solution to the U.K. Orkambi debacle

Cystic fibrosis patients hope that a meeting on Monday between Vertex and the U.K. Health Secretary will break the deadlock that has prevented reimbursement of Orkambi by NHS. If it works out, patients in England...
23:33 , Feb 13, 2019 |  BC Week In Review  |  Company News

NICE, CADTH partner to provide parallel scientific advice

NICE and the Canadian Agency for Drugs and Technology in Health (CADTH) partnered to offer parallel scientific advice to help pharmaceutical companies prepare for health technology assessments (HTA). The agencies have begun accepting applications. In...
23:08 , Jan 23, 2019 |  BC Extra  |  Politics & Policy

ICER aims to define HTA approach to gene therapies

The Institute for Clinical and Economic Review is taking the lead in defining the global health technology assessment (HTA) process for potentially curative treatments such as gene therapies, strengthening its position as the de facto...
22:58 , Sep 14, 2018 |  BioCentury  |  Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies. These tools allow...
18:49 , Aug 31, 2018 |  BC Week In Review  |  Company News

Gilead's Yescarta rebuffed by NICE, second orphan drug setback in August

One day after the European Commission approved CAR T therapy Yescarta axicabtagene ciloleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD), U.K.'s NICE published draft guidance recommending against the use of therapy....
21:39 , Aug 28, 2018 |  BC Extra  |  Company News

NICE rebuffs Gilead’s Yescarta, second setback for an orphan therapy this month

One day after the European Commission approved CAR T therapy Yescarta axicabtagene ciloleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD), U.K.'s NICE published draft guidance recommending against the use of therapy....
13:01 , May 25, 2018 |  BioCentury  |  Product Development

Patients at the core

With excitement mounting for the seven hemophilia gene therapies in the clinic, the National Hemophilia Foundation wanted to avoid a scenario in which patients, physicians and payers had no good way to compare them. The...
18:29 , May 3, 2018 |  BC Extra  |  Politics & Policy

Stakeholder group seeks to standardize trial outcomes

In a new white paper , the Green Park Collaborative of the Center for Medical Technology Policy (CMTP) outlined the challenges and solutions to the development of core outcomes sets for clinical trials, including the...
21:48 , Apr 27, 2018 |  BioCentury  |  Regulation

Independent opportunities

The scenario the U.K. is trying to avoid is a full disconnect from EMA when the Brexit curtain falls. But a clean break from the agency could create opportunities for the U.K.’s Medicines and Healthcare...
21:44 , Mar 23, 2018 |  BioCentury  |  Strategy

Arbiter of value

The Institute for Clinical and Economic Review is rapidly becoming the closest thing the U.S. has to an HTA agency. As an independent, non-governmental body, ICER does not have the authority over reimbursement decisions accorded...