Consensus lacking on ‘value’ for new anti-cancer drugs

8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...

Read more →

Accelerated approval - an unexpected pathway to value-based pricing?

18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...

Read more →

ICER opens nominations for new members of its voting panels

2 December 2020 - Independent panel members debate the evidence on the effectiveness and value of new drugs and other ...

Read more →

The real worth of cancer drugs

1 December 2020 - In November, 2020, we witnessed one of the most awaited elections in recent times—the USA elected Joe ...

Read more →

FDA announces all time low rates for FY2021 priority review vouchers

5 October 2020 - The US FDA has announced historic low rates for the fiscal year 2021 fees to use ...

Read more →

COVID-19 raises questions about the value of personalised medicine

8 May 2020 - A group of medical dissenters argues that tailoring treatment to the genetic profiles of individuals, a longstanding ...

Read more →

Inappropriate use of progression-free survival in cancer drug approvals

10 March 2020 - New drugs should be judged on overall survival or quality of life, preferably both. ...

Read more →

Complexity in assessing the benefit versus risk of vaccines: experience with rotavirus and dengue virus vaccines

17 October 2019 - The remarkable contribution of immunisation programs to public health is recognised by most people, including those who ...

Read more →

The $2.1 million question: what are the medical, ethical implications of the world's priciest drug?

10 June 2019 - With last month’s FDA approval, Zolgensma became the world’s most expensive medication.  ...

Read more →

The role of regulators in establishing added benefit of novel therapies

11 April 2019 - Regulators have a role to play in ensuring that there is a solid evidence base to support ...

Read more →

When biotechs get breakthrough therapy status, Mr. Market yawns

23 February 2019 - As a biotech consultant, I’ve heard many CEO’s tell me that a “drumbeat of news” is ...

Read more →

Comparative assessment of clinical benefit using the ESMO Magnitude of Clinical Benefit Scale version 1.1 and the ASCO Value Framework Net Health Benefit Score

19 December 2018 - To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) ...

Read more →

Novartis says SMA gene therapy is cost-effective at $4-5 million per patient

5 November 2018 - Novartis, which is shifting into rare diseases, said on Monday it believes its new gene therapy ...

Read more →

FDA allows off-label health care economic discussions. Is there more to come?

29 June 2018 - The Trump administration has issued final guidance that allows drug companies and device makers to provide ...

Read more →

AMCP applauds FDA for final guidance on payer and manufacturer communications to improve patient access to emerging therapies

13 June 2018 - The Academy of Managed Care Pharmacy commends the U.S. FDA for issuing final guidance that clarifies ...

Read more →