STAT

SEPTEMBER 27, 2022

At the Los Angeles LGBT Center’s sexual health clinic, patients are normally seen within 24 hours. At Open Door Health, an LGBTQ+ community clinic in Providence, R.I., Insurance reimbursement doesn’t cover all that added time. Recently, amid the monkeypox outbreak , it’s been a five-day wait.

Insurance 110

Insurance 110

STAT

OCTOBER 19, 2023

The biotech hired rapidly, announced its intention to treat a broad range of diseases, and received clearance to start clinical trials in cancer and sickle cell. Meanwhile, the biotech stock market has stayed cold , including for gene-editing companies, whose technologies raise new regulatory, safety , and reimbursement questions.

115

115

Fierce Healthcare

OCTOBER 25, 2023

As health systems continue to navigate several interrelated challenges — from rising costs to shifting reimbursement models — many are leveraging innovative strategies that positively impact clinic | A data-driven approach to managing care variation allows for targeted improvement efforts that yield significant cost savings without compromising the (..)

52

52

European Pharmaceutical Review

AUGUST 16, 2023

The National Institute for Health and Care Excellence (NICE) has also issued guidance recommending reimbursement of Pombiliti + Opfolda for use within the National Health Service (NHS) in England and Wales. Both the MHRA and NICE decisions were based on clinical data from the Phase III PROPEL study.

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88

pharmaphorum

FEBRUARY 4, 2021

CEO and founder Roberto Ascione noted that Italy could follow the example of Germany, which has taken steps to reimburse DTx at a national level. Several vertical projects should address specific issues, such as the creation of a national observatory of digital medicine and decentralised clinical trials.

Documentation 139

Documentation Communication 139

PQA

DECEMBER 15, 2023

We also highlight our members' perspectives on hypertension management and approaches to pharmacy reimbursement. Considering Differential Pharmacy Reimbursement Troy Trygstad, executive director of CPESN USA, shared insights on differential reimbursement in a new opinion article. Learn more about the comment period below.

Community Pharmacies 59

Community Pharmacies Patient Care 59

European Pharmaceutical Review

SEPTEMBER 22, 2023

Eli Lily’s ulcerative colitis biologic This recommendation makes “Great Britain one of the first countries in the world to provide nationally reimbursed access; and national access should now be implemented within 30 days,” shared Laura Steele, President & General Manager, Northern Europe, Eli Lilly and Company. There were 24.2

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101

pharmaphorum

NOVEMBER 2, 2022

Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year.

Communication 101

Communication 101

Digital Pharmacist

OCTOBER 6, 2023

Below is more insight into these requirements: Reimbursement Information: PBMs must provide pharmacies with reimbursement details at the time of adjudication or reimbursement. This information must include applicable network reimbursement IDs.

Insurance 105

Insurance 105

pharmaphorum

OCTOBER 21, 2021

The company’s chief executive Michel Vounatsos said he was “obviously disappointed” with the result, which he maintained resulted mainly from a lack of clarity on reimbursement which has delayed patient access. Analysts meanwhile have suggested that Aduhelm may start to pick up momentum if that review is positive.

Insurance 121

Insurance FDA 121

STAT

JULY 6, 2023

Those drugs have demonstrated an ability to help people lose dramatic amounts of weight in clinical trials, but payers, including Medicare, have been slow to reimburse for them without definitive data on their long-term health benefits. Continue to STAT+ to read the full story…

Insurance Coverage 98

Insurance Coverage Insurance 98

Omnicell

JANUARY 10, 2023

In addition to the recent reimbursement cuts, a host of harmful actions by pharmaceutical manufacturers are causing issues. Hospitals and clinics are eligible based on defined criteria. There are now 20 states that have enacted or are considering state laws to limit discriminatory reimbursement. So, how does 340B ESP work?

Omnicell 52

Omnicell Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

MAY 17, 2021

Experts from Vynamic discuss their vision for a future where patients are at the heart of medicine reimbursement in Europe – and provide actionable steps for achieving this. Read below for a sneak-peak: The reimbursement landscape in Europe is complex. This article appears in full in our digital magazine Deep Dive: Market Access 2021.

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93

pharmaphorum

DECEMBER 7, 2022

The HTA body, the CT ( Commission de la Transparence – Transparency Commission), is charged with providing guidance to inform pricing negotiations in two main forms: a comparative clinical benefit rating, the ASMR ( Amélioration du Service Médical Rendu ), and a target patient population. Rare diseases: a flawed system.

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104

Med Ed 101

MARCH 20, 2022

Pharmacist reimbursement has been a frustrating battle for us pharmacists. provider status) and reimbursement of clinical services. Pharmacist Reimbursement Is Necessary appeared first on Med Ed 101. We don’t get enough respect when it comes to legislation (i.e. The post CDC Sees The Light!

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40

pharmaphorum

DECEMBER 6, 2022

A model framework for generating the evidence to demonstrate the efficacy of digital therapeutics so they can secure regulatory approval and reimbursement has been published by a trade organisation representing digital health companies. The post Evidence standard drawn up for digital therapeutics appeared first on.

Documentation 105

Documentation 105

Pharmaceutical Technology

DECEMBER 15, 2022

Post-early access/ATU, a negotiated price and reimbursement level is determined according to the clinical value rating (Service Médical Rend, SMR) and Amélioration du Service Médical Rendu (ASMR) rating, evaluated by the Transparency Commission (TC) of HAS. 53% of medicines under ATU/early access treat oncology indications.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

AUGUST 10, 2021

Europe market has proved so hostile to gene therapies when it comes to pricing and reimbursement for gene therapies that bluebird bio has decided to quit the market altogether, according to Andrew Obenshain, president of its severe genetic diseases unit. FDA places clinical hold on CALD studies. bluebird had set an initial price of $1.8

FDA 135

FDA 135

pharmaphorum

FEBRUARY 4, 2022

Eli Lilly has backed away from plans to file Alzheimer’s drug donanemab in the first quarter of this year, saying the proposal to limit reimbursement of Biogen’s first-to-market Aduhelm has made going down the accelerated approval route all-but pointless.

Insurance Coverage 98

Insurance Coverage Insurance FDA 98

STAT

SEPTEMBER 25, 2023

Eisai, a Japanese pharma firm, spearheaded work on the drug, which clinical trials found modestly slowed the progression of Alzheimer’s. Eisai must now win reimbursement approval from the country’s national health system, after which the company has said it will begin marketing the drug in Japan within two months.

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94

pharmaphorum

APRIL 25, 2022

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. Patients in the digital arms also lost fewer days due to hospitalisation for heart failure – 1.77 days compared to 3.06

Hospitals 139

Hospitals 139

pharmaphorum

OCTOBER 2, 2020

Like its earlier digital therapies for alcohol misuse and depression , Modia’s earlier-than-expected rollout stems from legislation that has made it possible to secure reimbursement for certain digital products for psychiatric disorders during the COVID-19 pandemic.

Insurance 98

Insurance FDA 98

Omnicell

JANUARY 10, 2023

James Stevenson Chief Clinical Officer, Omnicell Since the beginning of COVID-19, healthcare employment has fallen by 524,000 jobs , resulting in a nationwide shortage of nurses, technicians, and more. This bill would allow pharmacists to be reimbursed as healthcare providers for treating Medicare beneficiaries in underserved areas.

Omnicell 52

Omnicell Community Pharmacies Immunization Insurance 52

pharmaphorum

JANUARY 12, 2022

Biogen’s difficult launch of controversial Alzheimer’s therapy Aduhelm has been made even harder by a proposal by Medicare to cover the drug only for certain patients enrolled in clinical trials. The post Medicare limits Aduhelm coverage to clinical trial participants appeared first on.

Insurance 52

Insurance FDA 52

European Pharmaceutical Review

DECEMBER 13, 2023

EC’s approval of the treatment was based on data from a Phase II double-blind, placebo-controlled clinical trial, PIONEER. Additional markets will follow dependent on local healthcare technology assessment and reimbursement process timelines. It was also well-tolerated with a favourable safety profile.

Hospitals 64

Hospitals 64

pharmaphorum

JANUARY 11, 2023

BioMarin’s has signed the first contract with an insurer in Germany for Roctavian, its recently approved gene therapy for haemophilia A, as it tests out its outcomes-based agreement (OBA) reimbursement model in the EU.

Insurance 52

Insurance 52

pharmaphorum

NOVEMBER 17, 2020

He tells pharmaphorum about embracing digital change and the need for innovative reimbursement solutions. There was already a direction of the clinical community to be having these interactions or helping patients manage their disease virtually. COVID-19 sped up all of that.”. The challenge we face is universal to any biotech company.

Pharmaceutical Companies 116

Pharmaceutical Companies Pharmaceutical Companies Communication Hospitals 116

Omnicell

JANUARY 10, 2023

James Stevenson PharmD, FASHP, Chief Clinical Officer, Omnicell The United States faces a shortage of physicians – expected to reach approximately 139,000 by 2030. Pharmacist provider status would align reimbursement with pharmacists' services and give underserved patients more access to crucial care.

Patient Care 52

Patient Care Independent Pharmacies Omnicell Hospitals 52

pharmaphorum

MAY 10, 2022

In the same year, the partnership was expanded to include the co-development of three patient monitoring modules designed for use alongside Roche medicines with the aim of improving quality of life for patients, optimising the use of healthcare resources, improving clinical workflows, and gathering real-world data.

Chemotherapy 137

Chemotherapy Communication 137

Pharmaceutical Technology

FEBRUARY 10, 2023

Partly in response to such drugs, risk-sharing agreements (RSAs) have increased in popularity and aim to mitigate the risks of including high-cost drugs on reimbursement lists and healthcare plans. This is not the first treatment to come with a high price tag. Further breakdowns on RSAs are available within GlobalData’s Risk sharing database.

FDA 105

FDA 105

pharmaphorum

AUGUST 6, 2021

There’s been an increase in the use of sensors and digital biomarkers in clinical trials of pharmaceuticals and medical devices that has allowed more studies to be carried out in a virtual or decentralised way. The trends identified by IQVIA tie in with rising levels of investment in the digital health sector, with a record $14.7

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145

pharmaphorum

APRIL 20, 2022

Gilead has won a crucial court order in a wide-ranging lawsuit against a network of clinics, prescribers, medical labs and pharmacies in Florida that it claims have been making fraudulent reimbursement claims for HIV medicines.

Insurance 68

Insurance 68

Hospital Pharmacy Europe

DECEMBER 14, 2023

With an additional focus on delivering the Network Contract Directed Enhanced Service (DES), the guidance stresses that where PCNs are reimbursed via the Additional Roles Reimbursement Scheme (ARRS), ’they must ensure recruitment of clinical pharmacists is in accordance with the Network Contract DES’.

Community Pharmacies 52

Community Pharmacies Hospitals Patient Care 52

Hospital Pharmacy Europe

AUGUST 17, 2023

The approval comes as the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Pombiliti + Opfolda for use within the NHS in England and Wales. This rare, inherited lysosomal disorder is caused by deficiency of the enzyme acid alpha-glucosidase (GAA).

Hospitals 98

Hospitals 98

pharmaphorum

DECEMBER 1, 2022

Myeloma Patients Europe (MPE) has identified significant inequalities among patients’ access to myeloma clinical trials in Central and Eastern Europe (CEE) in a first-of-its-kind advocacy report. Of the CEE countries that ran at least one myeloma clinical trial, 11 were EU members.

71

71

Pharmaceutical Technology

JUNE 2, 2023

EDDING is now working towards securing National Reimbursement Drug Listing (NRDL) for Vascepa in China, with plans to launch it commercially by the end of this year. Vascepa has been approved as an adjunct to diet to cut the levels of triglyceride in adult patients suffering from severe hypertriglyceridemia (≥500mg/dL).

52

52

STAT

AUGUST 2, 2023

 The reimbursement cuts, along with restrictions that other employers are implementing, mark the financial downside of the drugs’ medical triumph. The outlays are straining the finances of some plans, including those funded by employers. The Besides the $26,500 annual price tag, treatment could cost U.S.

Insurance Coverage 90

Insurance Coverage Insurance 90