Pharmacist Digest

STAT+: Medicare official says breakthrough device reimbursement rule coming in early summer

STAT

APRIL 19, 2024

WASHINGTON — A federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer, a Centers for Medicare and Medicaid Services official said on Thursday. The agency has faced intense pressure from device makers frustrated with the slow pace of Medicare reimbursement decisions.

Reimbursement Advancement of Clinical Pharmacy Services

Pharmacy Times

JULY 7, 2023

Clinical pharmacy services became eligible for reimbursement by all health insurance in Germany; however, challenges persist in upscaling and sustaining these services.

STAT+: Pharma loses a key battle over a state law concerning 340B pharmacies

STAT

MARCH 13, 2024

The closely watched decision comes amid a long-running battle over the program, which was designed three decades ago to help hospitals and clinics care for low-income and rural patients. There are roughly 12,400 hospitals and clinics that participate across the U.S. and their number has grown over the years.

Hospitals

Hospitals Pharmaceutical Companies Pharmaceutical Companies

STAT+: Hospital claims it was ‘drastically’ overcharged by pharma in a federal drug discount program

STAT

FEBRUARY 15, 2024

The federal government program requires drugmakers to offer discounts on all outpatient drugs used by hospitals and clinics that primarily serve lower-income patients. There are roughly 12,400 hospitals and clinics that participate across the U.S. and their number has grown over the years.

Hospitals

Hospitals Pharmaceutical Companies Pharmaceutical Companies Drug Pricing

‘It is sinking us even further’: STI clinics, already stretched thin, strain under weight of monkeypox response

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.

STAT+: Vertex may face another battle in the U.K. over the value of its cystic fibrosis medicines

STAT

NOVEMBER 6, 2023

In draft guidance published late last week, the National Institute for Health and Care Excellence stated that a groundbreaking treatment called Trikafta and two other cystic fibrosis medications sold by the company offer notable clinical benefits, but are not cost-effective.

STAT+: Beam Therapeutics to lay off 20% of its staff, reevaluate programs as it cuts costs

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.

Heart claims unlock Medicare coverage of obesity drugs

pharmaphorum

MARCH 22, 2024

Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.

Cap lifted on ARRS pharmacist recruitment under new GP contract

The Pharmacist

MARCH 6, 2024

Primary care networks (PCNs) in England will be able to recruit an unlimited number of pharmacists under the Additional Roles Reimbursement (ARRS) scheme, as part of the new GP contract arrangements.

STAT+: What to know about this summer’s landmark Wegovy heart health study

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…

Diabetes

Almost half of ARRS funding spent on pharmacists

The Pharmacist

OCTOBER 24, 2023

Nearly half (46%) of Additional Roles Reimbursement Scheme (ARRS) funding between 2019 and 2022 was spent on the recruitment of clinical pharmacists, health minister Neil O’Brien has revealed. In total, £839m was spent on ARRS roles between 2019 and 2022 – £387m of which was spent on clinical pharmacists.

STAT+: Pharmalittle: End of biotech’s stock market malaise may be near; cancer drug shortages hit rural clinics hard

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.

Drug Development

Understanding the value of credentialing and enrollment in provider networks

assurecare

MAY 18, 2023

As reimbursement for prescription medications continue, pharmacies have been forced to explore alternate sources of revenue beyond traditional prescription reimbursement. The current community pharmacy dispensing model has become increasingly difficult to sustain in recent years.

Medication Therapy Management (MTM)

Medication Therapy Management (MTM) Community Pharmacies Vaccines

FDA denial could delay launch of Minerva’s schizophrenia treatment roluperidone by at least two years: GlobalData

Express Pharma

FEBRUARY 28, 2024

To address the clinical deficiencies stated in the CRL, Minerva must provide additional safety and efficacy data for roluperidone including data to support concomitant antipsychotic usage. As such, pricing and reimbursement may limit the potential of products that only target negative symptoms to gain market share.”

STAT+: Pharmalittle: Some employers cut insurance coverage for weight loss drugs; U.S. urges ADHD pill makers to boost production

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.

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

Pharma in Brief

OCTOBER 24, 2023

Canada’s Drug and Health Technology Agency ( CADTH ) has published its procedures for a new time-limited reimbursement recommendation category. The pathway includes mechanisms to revisit the clinical and economic evidence for a drug once further trials are conducted. CADTH will then reach a final reimbursement recommendation.

Documentation

STAT+: Pharmalittle: Pfizer and Novo disclose upbeat data on oral weight loss drugs; PBM trade group blasts House committee over hearing

STAT

MAY 23, 2023

Meanwhile, an oral drug from Pfizer causes a similar amount of weight loss as Ozempic, according to results from a Phase 2 clinical trial, CNBC says. A lower-dose version of the drug is already approved as a treatment for type 2 diabetes under the brand name Rybelsus. Continue to STAT+ to read the full story…

Drug Pricing

Drug Pricing Dosage Diabetes

White paper reveals pathway for digital therapeutics use in Italy

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

Documentation Communication

UK approval for Pompe Disease therapy

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.

NICE recommends Eli Lilly ulcerative colitis biologic

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

Norstella, Citeline merge to create $5bn pharma tech firm

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.

Drug Development

Drug Development Communication

Biogen’s Aduhelm rollout goes from bad to worse

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.

Florida’s Prescription Drug Reform Act: What it Means for Florida Pharmacies

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.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Pharmacy Management

Job interview questions for Health Economics and Outcomes Research(HEOR)

LifeProNow

APRIL 6, 2023

RWE refers to data collected outside of clinical trials, such as electronic health records or claims data. HEOR plays a critical role in drug development and pricing by providing evidence of the value of healthcare interventions and helping to inform decisions regarding pricing and reimbursement.

Drug Development

From representation to empowerment: Putting patients at the centre of medicine reimbursement

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.

Integrated Approach for HEOR Learning in the Pharma Industry

PharmaState Academy

DECEMBER 1, 2023

Key Insights: Why Pharma Marketers Need to Learn Health Economics and Outcomes Research (HEOR): Informed Decision-Making: Understanding HEOR equips pharma marketers with the tools to analyze healthcare interventions’ economic and clinical outcomes. This integration enhances the overall efficiency of clinical development processes.

Communication

CDC Sees The Light! Pharmacist Reimbursement Is Necessary

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!

Evidence standard drawn up for digital therapeutics

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

Medicines priced under the early access programme in France see prices drop by 16%

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.

Drug Pricing

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies

How eligible patient numbers affect price of rare disease drugs in France

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.

Drug Pricing

Drug Pricing Drug Development

Lilly defers Alzheimer’s drug filing after CMS’ ‘disappointing’ decision

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 and Processing

Insurance Coverage and Processing Diabetes

Gene therapy specialist bluebird exits “untenable” European market

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

Digital interventions cut heart failure mortality, study shows

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

Orexo eyes opioid use disorder app launch before year-end

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.

Podcast – Simplifying The Medication Management Process with Varun Goyal – CapsuleRx Podcast

illuminate.health

AUGUST 15, 2022

I think in terms of the future of telehealth it is going to be the mix of a hybrid care model based on preferences on the provider and patient side, clinical protocols, insurance companies, and reimbursement of course […] The post Podcast – Simplifying The Medication Management Process with Varun Goyal – CapsuleRx Podcast appeared (..)

What’s All the Fuss About 340B?

Integra X Files

MARCH 20, 2023

When they dispense a drug under the 340B Program, they are reimbursed at market rates and can use the spread to support their mission, although they are not required to report how they use the windfall. The 340B Program was considered necessary due to an unintended consequence of the Medicaid Drug Rebate Program enacted by Congress in 1990.

Hospitals

Hospitals Pharmaceutical Companies Pharmaceutical Companies

Medicare limits Aduhelm coverage to clinical trial participants

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.

Podcast – Leading A Startup with Varun Goyal – The Business Of Pharmacy

illuminate.health

AUGUST 28, 2022

I think in terms of the future of telehealth it is going to be the mix of a hybrid care model based on preferences on the provider and patient side, clinical protocols, insurance companies, and reimbursement of course will have a role there.

Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

Pharma in Brief

JULY 19, 2023

CADTH Time-Limited Reimbursement Recommendations Starting in the fall of 2023, CADTH, which conducts health technology assessments ( HTAs ) to inform public insurers, will introduce time-limited reimbursement recommendations for certain drug products. Evidence-generation plans. Commitment. Evidentiary gaps.

Insurance Coverage and Processing

Insurance Coverage and Processing Drug Pricing

BioMarin gets first access deal in EU for gene therapy Roctavian

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.

EC approves treatment for rare haematological disorder

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

Vertex Pharma’s vision for reimbursement innovation

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.

Communication

Communication Pharmaceutical Companies Pharmaceutical Companies Hospitals

Leveraging Partnerships With Drug Manufacturers To Overcome 340B Restrictions On Specialty Drugs

Proxsys Rx

DECEMBER 11, 2023

Given that, why would a drug company want to reimburse the price of a 340B-covered specialty drug costing tens of thousands of dollars, if the provider isn’t dispensing it correctly and the patient doesn’t benefit? Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

Specialty Pharmacies

Specialty Pharmacies Hospitals Drug Pricing Compounding

Roche extends Kaiku digital monitoring partnership again

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

Chemotherapy Communication

STAT+: Medicare official says breakthrough device reimbursement rule coming in early summer

Reimbursement Advancement of Clinical Pharmacy Services

Trending Sources

STAT+: Pharma loses a key battle over a state law concerning 340B pharmacies

STAT+: Hospital claims it was ‘drastically’ overcharged by pharma in a federal drug discount program

‘It is sinking us even further’: STI clinics, already stretched thin, strain under weight of monkeypox response

STAT+: Vertex may face another battle in the U.K. over the value of its cystic fibrosis medicines

STAT+: Beam Therapeutics to lay off 20% of its staff, reevaluate programs as it cuts costs

Heart claims unlock Medicare coverage of obesity drugs

Cap lifted on ARRS pharmacist recruitment under new GP contract

STAT+: What to know about this summer’s landmark Wegovy heart health study

Almost half of ARRS funding spent on pharmacists

STAT+: Pharmalittle: End of biotech’s stock market malaise may be near; cancer drug shortages hit rural clinics hard

Understanding the value of credentialing and enrollment in provider networks

FDA denial could delay launch of Minerva’s schizophrenia treatment roluperidone by at least two years: GlobalData

STAT+: Pharmalittle: Some employers cut insurance coverage for weight loss drugs; U.S. urges ADHD pill makers to boost production

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

STAT+: Pharmalittle: Pfizer and Novo disclose upbeat data on oral weight loss drugs; PBM trade group blasts House committee over hearing

White paper reveals pathway for digital therapeutics use in Italy

UK approval for Pompe Disease therapy

NICE recommends Eli Lilly ulcerative colitis biologic

Norstella, Citeline merge to create $5bn pharma tech firm

Biogen’s Aduhelm rollout goes from bad to worse

Florida’s Prescription Drug Reform Act: What it Means for Florida Pharmacies

Job interview questions for Health Economics and Outcomes Research(HEOR)

From representation to empowerment: Putting patients at the centre of medicine reimbursement

Integrated Approach for HEOR Learning in the Pharma Industry

CDC Sees The Light! Pharmacist Reimbursement Is Necessary

Evidence standard drawn up for digital therapeutics

Medicines priced under the early access programme in France see prices drop by 16%

How eligible patient numbers affect price of rare disease drugs in France

Lilly defers Alzheimer’s drug filing after CMS’ ‘disappointing’ decision

Gene therapy specialist bluebird exits “untenable” European market

Digital interventions cut heart failure mortality, study shows

Orexo eyes opioid use disorder app launch before year-end

Podcast – Simplifying The Medication Management Process with Varun Goyal – CapsuleRx Podcast

What’s All the Fuss About 340B?

Medicare limits Aduhelm coverage to clinical trial participants

Podcast – Leading A Startup with Varun Goyal – The Business Of Pharmacy

Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

BioMarin gets first access deal in EU for gene therapy Roctavian

EC approves treatment for rare haematological disorder

Vertex Pharma’s vision for reimbursement innovation

Leveraging Partnerships With Drug Manufacturers To Overcome 340B Restrictions On Specialty Drugs

Roche extends Kaiku digital monitoring partnership again

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