European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

Food and Drug Administration 74

Food and Drug Administration Medicine Safety Food 74

PM360

NOVEMBER 16, 2023

Moment to Life Coordinating multidisciplinary efforts can be a challenge for any agency.

Specialization 52

Specialization Media Leads Medical 52

Clarivate

MARCH 8, 2023

1] IPSOR, 2022-2023 Top 10 HEOR Trends, 2023 [2] FDA, Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices, August 2017. The post Reducing real world data lag time for improved patient outcomes appeared first on Clarivate.

Patients 59

Patients Biopharma Medical science Electronics 59

Clarivate

MAY 26, 2022

In one recent study [2] , nearly half of recent market launches observed missed their first-year forecasts due to market issues such as HEOR data that was too weak to substantiate pricing or higher than expected discounts and rebates.

Marketing 52

Marketing Patients Recruitment Management 52

Clarify Health

OCTOBER 24, 2021

The customer’s Patient/Health Impact Health Economics and Outcomes Research (HEOR) Vaccines team plans to share this information with the Advisory Committee on Immunization Practices (ACIP) of the CDC. What is the customer hoping to achieve with the insights emerging from the research?

Pharma 52

Pharma Education Medical Patients 52

PM360

JUNE 30, 2022

Inizio Advisory: This unit helps pharma, biotech, and life sciences companies to develop, execute, and operationalize their strategies across portfolio licensing and development, new product launches, established product and franchise strategy, HEOR, pricing, and market access.

Specialization 97

Specialization Consulting Healthcare Healthcare 97

pharmaphorum

DECEMBER 15, 2022

Thousands more UK patients with idiopathic pulmonary fibrosis (IPF) will now be eligible for treatment with Boehringer Ingelheim’s Ofev, following new guidance from health technology assessment agency NICE.

Pharmacology 101

Pharmacology Doctors Patients Medicine 101

pharmaphorum

SEPTEMBER 6, 2022

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker.

Manufacturing 108

Manufacturing Patients Marketing 108

pharmaphorum

SEPTEMBER 22, 2022

BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) has become the first drug in the class to be recommended for routine NHS use in England and Wales to treat Waldenström macroglobulinaemia (WM) – a rare form of non-Hodgkin lymphoma (NHL).

Medicine 96

Medicine Patients Marketing Healthcare 96

pharmaphorum

NOVEMBER 25, 2022

The European Commission has provided around €7 million ($7.2 million) in funding to a new project that aims to boost the ability of hospitals within the EU to collect real-world data (RWD) to gauge the effectiveness of novel cancer therapies.

Healthcare 89

Healthcare Healthcare Medicine Patients 89

pharmaphorum

NOVEMBER 16, 2022

NICE has recommended that three COVID-19 therapies can continue to be used to treat patients – Pfizer’s Paxlovid, Roche’s RoActemra and Eli Lilly’s Olumiant – but turned down another five in draft guidance published this week.

Patients 90

Patients Medicine Government Medical 90

pharmaphorum

JULY 15, 2022

Health technology assessment (HTA) agency NICE has finalised its guidance on Amarin’s Vazkepa, clearing the path for GPs to start prescribing the drug in up to 425,000 NHS patients at high cardiovascular risk because of raised triglyceride levels. mmol/litre or above) in their blood who are already taking statins.

Patients 97

Patients Competition Marketing Medicine 97

pharmaphorum

DECEMBER 22, 2022

One of the most highly-anticipated developments in pharma next year will be the FDA’s verdict on Eisai’s accelerated application for lecanemab in Alzheimer’s disease, due early in January.

FDA 76

FDA Patients Marketing Pharma 76

pharmaphorum

JULY 14, 2022

Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer – Gilead’s Trodelvy and Novartis’ Piqray – in England. .

Side effects 85

Side effects Medicine Patients Government 85

pharmaphorum

DECEMBER 21, 2022

AstraZeneca and Daiichi Sankyo’s Enhertu will become an option for hundreds more people with breast cancer in England and Wales, thanks to new guidance from NICE that will make it available via the Cancer Drugs Fund.

Patients 62

Patients Medicine Leads Pharmaceutical 62

PM360

JUNE 16, 2023

Acknowledgements: Special thanks to Sonalee Agarwal, VP, Alnylam Pharmaceuticals, and Crystal Watson, Head of HEOR, Atara Bio for their contributions to this article. “Implementing Outcomes-Based Managed Entry Agreements for Rare Disease Treatments: Nusinersen and Tisagenlecleucel.” Pharmacoeconomics. 2021 Sep;39(9):1021-1044.

Marketing 98

Marketing Management Insurance Specialization 98

pharmaphorum

NOVEMBER 7, 2022

Draft guidance in the UK has provisionally recommended that digital cognitive behavioural therapy (CBT) apps can be used within the NHS to treat children and young people with mild to moderate anxiety.

Government 62

Government Medical Patients Marketing 62

pharmaphorum

JANUARY 19, 2023

Alnylam’s gene-silencing drug Amvuttra has been recommended as a treatment for hereditary transthyretin-related (ATTR) amyloidosis by NICE, paving the way for the drug to be made available on the NHS in England and Wales.

Patients 52

Patients Medicine Medical Pharmaceutical 52

pharmaphorum

JANUARY 13, 2023

Cholesterol-lowering statin drugs could be available to millions more patients in the UK, if new recommendations from health technology assessment (HTA) organisation NICE are implemented.

Side effects 52

Side effects Patients Doctors Medical 52

pharmaphorum

NOVEMBER 24, 2022

Bristol-Myers Squibb’s Opdivo has been recommended as a treatment for around 3,000 people with rare forms of gastro-oesophageal cancer via the NHS in England and Wales.

Patients 52

Patients Medicine Marketing 52

pharmaphorum

OCTOBER 19, 2022

Patients across the UK with chronic immune thrombocytopenia (ITP) now have another treatment option, after NICE backed use of Spanish drugmaker Grifols’ Tavlesse for adults with the rare blood disorder.

Marketing 52

Marketing Patients Manufacturing Pharma 52

pharmaphorum

OCTOBER 11, 2022

Scotland has become the first country in the UK to back NHS funding for the use of Merck & Co/MSD’s Keytruda in combination with Eisai’s Lenvima as a treatment for advanced or recurrent endometrial cancer.

Medicine 52

Medicine Patients Leads Marketing 52

pharmaphorum

SEPTEMBER 23, 2022

Thousands of patients with a particular form of breast cancer in England and Wales can be confident they will continue to have access to Pfizer’s targeted therapy Ibrance, thanks to new guidance from NICE.

Medicine 52

Medicine Patients Marketing 52

pharmaphorum

AUGUST 18, 2022

UK cost-effectiveness organisation NICE has recommended routine NHS use of a recently-approved therapy for two forms of ANCA-associated vasculitis (AAV) – oral complement C5 inhibitor Tavneos – which will be launched in the next few weeks.

Medicine 52

Medicine Patients Marketing Pharma 52

pharmaphorum

JULY 11, 2022

NICE has updated its recommendations for NHS use of Johnson & Johnson’s IL-23 inhibitor Tremfya in the treatment of psoriatic arthritis (PsA), expanding the pool of patients eligible for treatment with the drug.

Patients 52

Patients Competition Marketing Sales 52

pharmaphorum

JULY 8, 2022

NICE has recommended routine use of Bristol-Myers Squibb’s Opdivo for the adjuvant treatment of some patients with urothelial carcinoma (UC), the most common form of bladder cancer.

Patients 52

Patients Marketing 52

Clarify Health

FEBRUARY 1, 2023

Senior leadership brought all the players together — market access, medicine, health economics and outcomes research (HEOR), epidemiology, and clinical development to collaborate on building a CoE that could centralize real-world data and real-world evidence for all the teams across the organization.

Physicians 52

Physicians Electronics Medicine Patients 52

Clarify Health

JUNE 8, 2021

It was attended by 35 commercial, HEOR, and RWE experts, from over 25 different top 50 pharma companies. On Tuesday, May 25, 2021 we hosted a workshop on “Using RWE to drive next-level commercial impact.”

Pharma 52

Pharma Patients Electronics Medical 52

pharmaphorum

FEBRUARY 11, 2016

The first in a trilogy of webinars focussed on the topic; Unlocking the value; the economic equation and part of the IMS Health Practical Insights series.

Medicine 52

Medicine Marketing Patients Healthcare 52

pharmaphorum

SEPTEMBER 14, 2022

After years of stagnation in the treatment of neurodegenerative disorder amyotrophic lateral sclerosis (ALS), patients in the US could soon have two new treatment options – but their pricing is already raising red flags.

Side effects 62

Side effects FDA Medical Patients 62

pharmaphorum

DECEMBER 8, 2022

The advent of biologic therapies in the 1970s along with the decoding of the human genome in 2003 heralded an explosion in pharmaceutical innovation.

Medicine 69

Medicine Marketing Patients Healthcare 69