This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Part D reform has faded from the policy debate. This rerun explains why it is still needed. FYI, this is my favorite article from 2020 (so far).

Click here to see the original post and comments from January 2020.

---

Our high-list-price/high-rebate system remains a fundamental source of warped incentives and cascading problems within the Medicare Part D program.

For proof, check out the previously unpublished data below on market share for products that treat hepatitis C. Despite manufacturers offering products with lower list prices, Medicare Part D plans have rejected the therapeutically identical but lower-priced versions of these drugs.

List prices significantly affect seniors’ out of-pocket costs, so Part D plans are needlessly costing many of them thousands of dollars. The federal government's Medicare spending is also unnecessarily higher.

Anyone concerned about drug prices should pay close attention to this situation. Part D plans and seniors who don’t need specialty medications are benefiting, while seniors who need treatment with specialty medications are ripped off. Just another day inside the gross-to-net bubble!
Read more »

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

Click here to see the original post and comments from January 2020.

---

For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:

• The number of exclusions

• Management of specialty drugs

• Indication-based formularies

• The slow adoption of biosimilars

• The PBMs’ patient-unfriendly exclusions in the hepatitis C category

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
Read more »

An astrophysicist traces genealogy and art history to discover the origin of the famous motto

-- Read more on ScientificAmerican.com

Its sting is excruciating to people, but it is a bigger threat to honeybees vital for agriculture

-- Read more on ScientificAmerican.com

The agency fell well short of its goal of evaluating local flood control efforts every five years

-- Read more on ScientificAmerican.com

I’m an astrophysicist, but that doesn’t mean I have a motivation to debunk them

-- Read more on ScientificAmerican.com

To build trust with traditionally underserved groups, health officials need to craft their messaging in a much more culturally sensitive way

-- Read more on ScientificAmerican.com

With cars off the roads, scientists can study how smog and other types of pollution change  

-- Read more on ScientificAmerican.com

It’s essential if we’re going to protect our planet

-- Read more on ScientificAmerican.com

Higher temperatures and wetter weather may spur soil microbes to release more carbon into the atmosphere

-- Read more on ScientificAmerican.com

Pandemic news highlights of the week

-- Read more on ScientificAmerican.com

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....

2018 was a busy and productive year for ACRO’s European Scientific & Regulatory Committee, which meets quarterly in London. While the Committee focused largely on the continuing implementation of the EU Clinical Trial Regulation, there were also opportunities to engage with regulators on other topics ranging from European regulatory strategy to Advanced Therapies to the urgent challenges of Brexit.

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...

Additional donations of chloroquine sent to governments in numerous other countries / Various clinical and preclinical studies investigate the efficacy and adverse effects in COVID-19 infections / Bayer plans considerable expansion of production capacities in the event that the efficacy of chloroquine is proven for COVID-19

Two companies jointly have capacity to manufacture hundreds of millions of doses

• Coronavirus – latest updates
• See all our coronavirus coverage

Two of the world’s biggest vaccine companies have joined forces in an “unprecedented” collaboration to develop a Covid-19 vaccine.

GlaxoSmithKline and Sanofi, which combined have the largest vaccine manufacturing capability in the world, are working together on a hi-tech vaccine they say could be in human trials within months.

What is Covid-19?

Continue reading...

Pharmaceutical giants will bury treatments in a thicket of patents, making them unaffordable to the world’s poorest

• Coronavirus – latest updates
• See all our coronavirus coverage

How will the Covid-19 pandemic end? According to conventional wisdom, the crisis may ease in a few months, when some of the antiviral medicines on trial succeed. In a few years’ time, when a vaccine becomes available, we may eradicate the virus altogether.

Yet it’s unlikely that this is how the pandemic will actually play out. Although there is every indication that treatments for coronavirus may soon emerge, the mere fact of their existence is no guarantee that people will be able to access them. In fact, Covid-19 is more likely to end in the same way that every pandemic ends: treatments and vaccines will be buried in a thicket of patents – and pharmaceutical companies will ultimately make the decisions about who lives and who dies.

Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

Continue reading...

Stock index up more than 3% in early trading on the back of hopes for remdesivir treatment

Optimism about a potential treatment for Covid-19 gave a shot in the arm to stock markets around the world, amid claims that a drug called remdesivir has spurred rapid recovery in 113 patients.

A University of Chicago hospital participating in a study of the antiviral medication, made by US firm Gilead Sciences, found that nearly all patients suffering severe fever and respiratory symptoms were discharged within a week. A report of the study, issued by specialist healthcare publication Stat News shortly after Wall Street closed on Thursday night, spurred hopes among investors that lockdowns around the world could soon be eased.

Continue reading...

Pharmaceutical company says it can produce tests in the high tens of millions by June

• Coronavirus – latest updates
• See all our coronavirus coverage

The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.

Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.

Related: Antibody tests aren't perfect, but they may be Britain's way out of the lockdown | Eleanor Riley

Continue reading...

Government bodies, industry and charities to collaborate in research efforts

• Coronavirus – latest updates
• See all our coronavirus coverage
• Coronavirus vaccine – when will we have one?

The government has announced a new vaccines taskforce to help the development of a vaccine for Covid-19 and ensure its rapid production and rollout if one arrives.

The business secretary, Alok Sharma, also gave details of cash grants for work into both vaccines and potential treatments. Among the projects receiving cash is one led by Public Health England (PHE), which hopes to develop an antibody drug, something that has the potential to work as both a prophylactic and a treatment for those infected.

Related: The hunt for a coronavirus vaccine

Hydroxychloroquine, also known by its brand name, Plaquenil, is a drug used to treat malaria. It is a less toxic version of chloroquine, another malaria drug, which itself is related to quinine, an ingredient in tonic water.

Continue reading...

Patients were used as guinea pigs but denied access to resulting therapies. This time, Big Pharma must be held to account

• Coronavirus – latest updates
• See all our coronavirus coverage

The year I turned 11, my uncle Josiah Ssesanga was admitted to a hospital in Uganda with meningitis. It was 1994, and he was HIV positive. Between him and death stood a tattered post-civil war health system.

Treatments for HIV and Aids existed in other parts of the world, but in Uganda they were mostly limited to those used in clinical trials. For my uncle’s particular infection – cryptococcal meningitis – there was a drug called Fluconazole. But he didn’t know it existed; regardless, he wouldn’t have been able to afford it. and even among patients who took it, only 12% survived beyond six months.

Related: Macron calls for clinical trials of controversial coronavirus 'cure'

Related: Fear, bigotry and misinformation – this reminds me of the 1980s Aids pandemic | Edmund White

Continue reading...

Any vaccine has to work, but it also has to be safe. Making it happen is one of the government’s biggest priorities

• Patrick Vallance is the UK government chief scientific adviser

• Coronavirus – latest updates
• See all our coronavirus coverage

Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

The vaccines taskforce will be working in lockstep with the public and private sector

Related: New UK taskforce to help develop and roll out coronavirus vaccine

Continue reading...

The pressing need to find a solution to the pandemic means risks and shortcuts may have to be taken

• Coronavirus – latest updates
• See all our coronavirus coverage

The stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.

Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood.

Continue reading...

Video meeting seen as global endorsement of WHO and sign of Trump’s isolation on world stage

• Coronavirus – latest updates
• See all our coronavirus coverage

Global leaders have pledged to accelerate cooperation on a coronavirus vaccine and to share research, treatment and medicines across the globe. But the United States did not take part in the World Health Organization initiative, in a sign of Donald Trump’s increasing isolation on the global stage.

The cooperation pledge, made at a virtual meeting, was designed to show that wealthy countries will not keep the results of research from developing countries.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

Related: ‘Please don’t inject bleach’: Trump’s wild coronavirus claims prompt disbelief

Provide access to new treatments, technologies and vaccines across the world.

Commit to an unprecedented level of international partnership on research and coordinate efforts to tackle the pandemic and reduce infections.

Reach collective decisions on responding to the pandemic, recognising that the virus’s spread in one country can affect all countries.

Learn from experience and adapt the global response.

Be accountable, to the most vulnerable communities and the whole world.

Continue reading...

Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

• Coronavirus latest updates

• See all our coronavirus coverage

Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

Continue reading...

Investors shrug off US growth gloom after promising data from remdesivir drug trial

• Coronavirus – latest updates
• See all our coronavirus coverage

Shares have soared on the world’s stock markets after investors shrugged off a deep slump in the US economy and pinned their hopes on a possible breakthrough in treatment for Covid-19.

Despite news that the longest expansion in US history came to an abrupt end in the first three months of 2020, financial markets were buoyed by an update from the American biopharma company Gilead Sciences on its experimental drug remdesivir.

Continue reading...

Preliminary results of US government trial show patients who received drug recovered faster than others

Hopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.

Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11.

Related: World's stock markets soar on coronavirus treatment hopes

Continue reading...

Drugmaker will manufacture and distribute vaccine if human trials are successful

• Coronavirus – latest updates
• See all our coronavirus coverage

AstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.

News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

Continue reading...

Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

• Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?
• Sign up for Guardian Australia’s daily coronavirus email
• Download the free Guardian app to get the most important news notifications

The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

Continue reading...

The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks

• Coronavirus latest updates
• See all our coronavirus coverage

There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

Continue reading...

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.

Researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential treatment for COVID-19.

The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.

Almost half of Americans believe that the coronavirus was created in a lab, according to an April survey of 6,300 people.

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia becomes one of China’s most vocal critics of its response to the pandemic.

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms.

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

Nearly half of US states will have their ‘stay-at-home’ orders expire this week, paving the way for much of the US to relax its lockdowns.

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.