Tag: medical industry

Categories : Ethics and Law Medical IndustryTags :

Systematic Bias in Industry-sponsored Cost-effectiveness Studies

On By ModernMedia
Photo by Marek Studzinski on Unsplash

Industry-sponsored studies on a new drug or health technology are more likely to be found ‘cost-effective’ than independent studies, across a range of diseases, according to findings from a study published in The BMJ.

In a linked editorial, experts make a call for better reporting of results, more transparency, open-source cost-effectiveness models, and more independent studies, to reduce decision makers’ reliance on potentially biased cost-effectiveness analyses.

A cost-effectiveness analysis (CEA) provided the manufacturer is required by some countries to weigh up a product’s costs and effects.

This cost analysis evidence can be used to set the price for a drug or health technology or decide whether insurance policies will cover them. New drugs covered by insurance plans can be much more profitable than those not covered, which could lead to bias in CEAs funded by the drug and technology manufacturing industry.

While previous studies have consistently shown sponsorship bias in CEAs, most studies were limited to specific diseases, and are out of date. To fill in the gaps, Feng Xie and Ting Zhou from McMaster University, Canada, analysed data from all eligible CEAs published between 1976 and March 2021. 

They selected CEAs that reported an incremental cost-effectiveness ratio (ICER) using quality-adjusted life years or QALYs – a ‘value for money’ metric of years lived in good health.

The authors used data from the Tufts Cost-Effectiveness Analysis Registry. In total, 8192 CEAs were included in the study, of which nearly 30% were sponsored by industry. 

The study defined CEA industry sponsorship as an analysis funded by drug, medical device, or biotechnology companies, either wholly or in part. 

The results show that the industry-sponsored CEAs were significantly more likely to conclude that the new medicine or health technology was cost-effective than those not sponsored by industry.

For example, industry-sponsored studies were more likely to report the intervention being studied as cost-effective below the commonly used threshold of $50 000 per QALY gained than non-industry sponsored studies.

Among 5877 CEAs that reported the intervention was more effective but more expensive than the comparator, the ICERs from industry sponsored studies were one third (33%) lower than those from non-industry sponsored studies.

While only having the registry information to work with was a limitation, the authors said their analysis provides a basis for comparison with previous investigations.

As such, they suggested that “sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs.”

In lower and middle-income countries, industry bias can increase drug prices, where fewer resources mean decision-makers often need to rely on published, rather than independent CEAs. 

In a linked editorial, Adam Raymakers at Cancer Control Research, Canada, and Aaron Kesselheim at Brigham and Women’s Hospital, USA, argue that decision-makers “should exercise caution when using published cost-effectiveness analysis in coverage decisions.”

They say finding solutions to tackle bias is more important than ever, and make the case for open-source analysis models, increased transparency, and increased funding for independent analyses, to help minimise reliance on industry-sponsored cost analyses.

Source: The BMJ

Categories : HIV Medical IndustryTags :

Generic Options for HIV Prophylactic Cabotegravir Locked Out, MSF Warns

On By ModernMedia
Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

Médecins Sans Frontières (MSF) has warned that pharmaceutical company ViiV’s recent decision not to pursue voluntary licensing for the long-acting HIV prophylactic cabotegravir (CAB-LA) means that lower cost generic production in low- and middle-income countries (LMICs) is effectively locked out for countries like South Africa.

CAB-LA was approved for the prevention of HIV infection by the USFDA in December 2021, and ViiV currently charges $3700 (R55 000) per vial in the US ($22 200/R333 000 annually per person). The Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around $2.60 (R39) per vial (less than $20/R3000 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce what that price is.

According to MSF, generic manufacturer prices are often much lower than the patented drug – and they can even produce complicated formulations like CAB-LA.  The generic equivalent [PDF] of ViiV’s paediatric formulation of the HIV drug dolutegravir costs 22 times less.

Amanda Banda, Infectious Diseases Policy and Advocacy Advisor of the MSF Access Campaign, said: “What good is HIV prevention if the people who need it can’t afford it? This is the most effective form of HIV prevention for vulnerable and marginalised communities and yet ViiV is delaying the ability of generic manufacturers to supply the drug, meaning that many people across low- and middle-income countries who would benefit from the medicine to prevent HIV infection won’t be able to access it. CAB-LA will need to be available at a price that is comparable to currently available oral PrEP if country treatment programs and donors are expected to scale up its use to the levels needed – and it’s hard to imagine that ViiV will make CAB-LA available at less than $40 (R600) per year.  ViiV needs to immediately sign a licensing deal with the Medicines Patent Pool so that more affordable generics can be produced, and more lives can be saved.”

Dr Tom Ellman, Head of MSF’s South African Medical Unit said: “We want to urgently make this drug available for people at high risk of HIV infection in our programs in sub-Saharan Africa – we don’t want a donation with many strings attached from the corporation; it is not the role of ViiV to control the use of a drug that is approved by the USFDA. We want ViiV to sell us this drug at an affordable price.”

Source: MSF

Categories : Ethics and Law Medical IndustryTags :

‘Extensive Network’ of Opaque Medical Industry Ties

On By ModernMedia
Image: Pixabay CC0

A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!

Categories : Healthcare Politics and RegulationsTags :

A Trend of Amalgamations is Underway for Medical Schemes

On By ModernMedia
Image by Gustavo Fring on Pexels

A trend of amalgamations is underway in the South African private healthcare industry, in the face of growing challenges and the impending introduction of National Health Insurance (NHI).

Escalating healthcare inflation and costs, a declining and ageing membership, the impact of the COVID pandemic and a growing burden of disease are all impacting the not-for-profit Medical Scheme industry, which is highly regulated.

Medical scheme consolidation is one of the prominent trends, particularly given the prospect of NHI on the horizon, where smaller schemes will not compete, said Lee Callakoppen, principal officer of Bonitas Medical Fund.

The Council for Medical Schemes (CMS) advises that schemes that cannot compete sustainably on price should consider amalgamation partners, Callakoppen said.

“The trend towards amalgamations is not only for the sustainability of the medical scheme but for the benefit of members who ‘own’ the fund’.

“It is not only the call from CMS for schemes to join forces but also strict regulations around minimum solvency ratios and reserves which are more difficult for smaller schemes to maintain.”

It is a requirement of the Medical Schemes Act that medical schemes shall at all times maintain their business in a financially sound condition. They need to have sufficient assets for conducting business, providing for liabilities and having the prescribed solvency requirements of 25%, said Callakoppen.

“It’s a big ask for small schemes in this volatile and uncertain healthcare market,” he said.

A trend of amalgamation for small schemesThe CMS provides regulatory supervision of more than 80 medical schemes registered in the country and oversees amalgamation prospects.

One proviso for amalgamation is that schemes should complement each other and provide a more comprehensive offering to members.

“One clear indicator of risk is the size of the pool of lives being covered,” said Callakoppen. “Schemes with smaller risk pools are struggling to survive and experience more volatile claims”.

“Amalgamation into a bigger scheme means cross-subsidisation of costs. It is a trend I believe will continue, if not accelerate. In fact, in the past decade, we have seen 28 amalgamations approved by the CMS and the Competition Commission.”

The NHI has been criticised for potentially stifling innovation in healthcare, as well as not actually being able to fix the country’s flawed and unequal healthcare system.

Source: BusinessTech

Categories : Medical IndustryTags :

Financial Feasibility of NHI Challenged

On By ModernMedia
Photo by cottonbro from Pexels

Health groups are seeking detailed information on the workings of South Africa’s new National Health Insurance (NHI) scheme, particularly on its financial feasibility.

The Khayelitsha and Klipfonetin health forums said in a presentation to parliament that a proper analysis is necessary to see if South Africa can even afford to fund the NHI. This is a concern that has been echoed by experts. The analysis should also find out if the public trusts the government to be able to deliver an NHI that is fully inclusive of community participation, the forums said.

“There is a view that perhaps we need to be building our public healthcare system as a priority to ensure a successful transition to an NHI Fund,” it said.

The forums also raised concerns around what the NHI will mean for existing healthcare systems – including the future of the country’s medical aids.

“Clarity is needed with respect to how the NHI Bill will address the transition between private medical aids and a universal healthcare system for all.

“The gap between private and public healthcare needs to be bridged and how this is done is important.”

Other critics have also pointed out that the scheme does nothing to address the serious gaps and flaws in South Africa’s healthcare system.

The fate of medical aids

The NHI Bill currently states that when the system is “fully implemented”, services that are paid for by the NHI will not be covered by medical aids.

Discovery Health has said that while it is in general supportive of the structural changes being introduced through the NHI, medical aids should not be limited.

“Our strong view is that limiting the role of medical schemes would be counterproductive to the NHI because there are simply insufficient resources to meet the needs of all South Africans.

“Limiting people from purchasing the medical scheme coverage they seek will seriously curtail the healthcare they expect and demand. It poses the risks of eroding sentiment, and of denuding the country of critically needed skills, and is impacting negatively on local and international investor sentiment and business confidence.”

Crucially, by preventing those who can afford it from using their medical scheme cover, and forcing them into the NHI system, this approach will also have the effect of increasing the burden on the NHI and will drain the very resources that must be used for people in most need, the scheme said. Significantly, there is no indication by government as to how the NHI will be paid for, or whether it can even be afforded, with only mention made to payroll taxes and other revenue streams being tapped.

Source: BusinessTech

Categories : HospitalsTags :

SA Medical Insurance Schemes in the Crosshairs

On By ModernMedia

The Health Professions Council (HPCSA) said that South Africa’s new National Health Insurance (NHI) should be the sole funding mechanism for health in South Africa.

Addressing parliament on Tuesday, the president of HPCSA, Professor Simon Nemutandani, said that while the organisation accepts that the existence of private medical aid schemes in South Africa can continue, they should funded separately — over and above tax paid for the NHI.

The NHI itself should be funded through taxes paid by all employed South Africans, he said.

“For the NHI to succeed, health must be an exclusive national competence – and any sections of the Constitution that militate against this view must be amended,” the HPCSA stated.

“The Medical Schemes Act must also be amended to ensure alignment with the NHI. NHI should be about funding and contracting, while service provision is left to other entities — public and private.”

Prof Nemutandani said that the NHI Bill should repeal the Medical Schemes Act in its entirety, as the nationalised, centralised health funding system would have no place for it.

For those seeking additional insurance for health cover, they could apply for it under the Insurance Act. Medical schemes should also offer only complementary coverage for services that would not be covered by the NHI, he said.

Additionally, the current reserves of medical schemes — some R90 billion — and all other assets under their control should be transferred to the NHI, said Prof Nemutandani.

“It should be clear that the (NHI) replaces all funding mechanisms for health,” Prof Nemutandani said. “It must also be clear that the NHI is taking over from the medical schemes, and that all assets under the control of the medical schemes must be taken by over the NHI.”

Problematic aspects

The Board of Health Care Funders (BHF) said in its submission that current medical cover providers should be allowed to continue as insurance products. They also pointed out that a number of the Bill’s aspects are problematic, including a provision in the Bill transferring powers and duties of provinces to national government.

The BHF also expected there would be challenges from healthcare service providers and from members of the public over restrictions of their choices. Duplication of services and waste was another concern.

The NHI Bill was presented to and approved by cabinet in July 2019, and has been presented to parliament’s health portfolio committee.

Since then, it has been through an extensive public consultation process through committee roadshows and is scheduled for further parliamentary debates before being presented to the president for promulgation.

However, the Council for Medical Schemes has acknowledged that South Africa’s current financial situation and the impact of the COVID lockdown will make the rollout of the new NHI more difficult.

Source: BusinessTech

More information: Summary of all submissions (PDF)

Categories : COVID VaccinesTags :

New High-yield Vaccine Technology Recycles Cell Junk

On By ModernMedia

As the world struggles with COVID vaccine production bottlenecks and scaling issues, a team from Northwestern University synthetic biologists have developed a high-yield vaccine technology, increasing production of protein-based vaccines by a factor of five.

Scaling up COVID vaccine production has proved extremely challenging. Adenovirus vaccines such as AstraZeneca’s need to be cultured in 2000 litre tanks containing human cells and then extracted, while mRNA vaccines like that produced by Pfizer requires very careful mixing, as well as components and only a few companies have the skills to produce them. The promising protein subunit vaccines such as Novavax’s offering may be easier to scale up, but also require specific adjuvant, which uses saponin from the bark of a Chilean tree, Quillaja saponaria, which is also used in other vaccines.

Earlier this year, the researchers introduced a new biomanufacturing platform that can quickly make shelf-stable vaccines at the point of care, ensuring they will not go to waste due to transportation or storage problems. In this new study, the team found that enriching cell-free extracts with cellular membranes—the components needed to made conjugate vaccines—massively boosted yields of its freeze-dried platform.

The new technology can produce 40 000 doses per litre per day of antibiotics or vaccines, costing about $1 per dose. At that rate, the team could use a 1000 litre reactor to generate 40 million doses per day, reaching 1 billion doses in less than a month.

“Certainly, in the time of COVID-19, we have all realized how important it is to be able to make medicines when and where we need them,” said study leader Michael Jewett, a professor of chemical and biological engineering at Northwestern. “This work will transform how vaccines are made, including for bio-readiness and pandemic response.”

The new manufacturing platform—called in vitro conjugate vaccine expression (iVAX)—is made possible by cell-free synthetic biology, a process where a cell’s outer wall (or membrane) is removed, and its internal machinery repurposed. This repurposed machinery is then placed in a test tube and freeze-dry it. The cell-free system is activated by the addition of water, turning it into a catalyst for making usable medicine when and where it’s needed. With a shelf-life of over six months, the platform eliminates the need for complicated supply chains and extreme refrigeration, making it extremely valuable for remote or low-resource settings.

In a prior study, Jewett’s team used the iVAX platform to produce conjugate vaccines to protect against bacterial infections, repurposing molecular machinery from Escherichia coli to make a single dose of vaccine in an hour, at $5 per dose.

“It was still too expensive, and the yields were not high enough,” Prof Jewett said. “We set a goal to reach $1 per dose and reached that goal here. By increasing yields and lowering costs, we thought we might be able to facilitate greater access to lifesaving medicines.”

Prof Jewett and his team found that the cell’s membrane, which is typically discarded in cell-free synthetic biology, was key to solving this. When broken apart, membranes naturally reassemble into vesicles, spherical structures that still carry important molecular information. Studying these vesicles, the researchers discovered that increasing vesicle concentration could be useful in making components for protein therapeutics such as conjugate vaccines, which work by attaching a sugar unit—that is unique to a pathogen—to a carrier protein. 

Normally attaching the sugar unit to the protein is very complex, but the researchers found that the cell’s membrane contained machinery that enabled the sugar to more easily attach to the proteins. When they enriched vaccine extracts with this membrane-bound machinery, the researchers significantly boosted usable vaccine yields.

“For a variety of organisms, close to 30% of the genome is used to encode membrane proteins,” said study co-author Neha Kamat, who is an assistant professor of biomedical engineering at McCormick and an expert on cell membranes. “Membrane proteins are a really important part of life. By learning how to use membrane proteins effectively, we can really advance cell-free systems.”

Source: Phys.Org

Journal information: Improving cell-free glycoprotein synthesis by characterizing and enriching native membrane vesicles, Nature Communications (2021). DOI: 10.1038/s41467-021-22329-3

Categories : Mental Health New Compounds and TreatmentsTags :

Neurocrine’s Anticipated Schizophrenia Drug Flops in Clinical Trial

On By ModernMedia

Pharmaeceutical company Neurocrine’s anticipated schizophrenia drug, luvadaxistat, failed to have an impact on negative symptoms in a key clinical trial, but still showed promising cognitive benefits.

Neurocrine Biosciences had licensed seven of Takeda’s psychiatry drugs last year for over $2 billion. Luvadaxistat was the furthest along, having entered Phase 2 testing in 2017.

The experimental drug is supposed to help schizophrenia patients cope with “negative symptoms”—a range of difficult-to-treat conditions such as lack of motivation, trouble communicating and limited emotion. The drug is designed to block an enzyme that degrades a certain kind of amino acid important for brain function.

However, according to results from a mid-stage study, in comparison to placebo, patients treated with the drug didn’t perform significantly better, as measured by a scale that assesses the severity of negative symptoms.

While there was excitement around the science behind luvadaxistat, Wall Street analysts lost much of their optimism in the programme last month, after Concert Pharmaceuticals halted development of CTP-692, an experimental drug based on the same mechanism, after trials also saw disappointing results. 

Nevertheless, there remains a path ahead for luvadaxistat as Neurocrine is setting up to analyse the drug’s efficacy for cognitive benefits, as it appears that these results at least were in line with scientific predictions.

Source: BioPharma Dive

Categories : COVID Medical IndustryTags :

SA Medical Aid Schemes May Not Have to Pay for Public’s Vaccines

On By ModernMedia

Medical aid scheme executives have pointed out that the latest budget means that medical aid schemes may no longer need to contribute for the vaccination of the South African population without medical insurance. 

South Africa’s medical insurance schemes had been in discussions on funding at least part of the government’s vaccine rollout for uninsured members of the public.

The R9 billion allocated in the budget may be enough to cover the vaccine costs of the entire country, said executives from the two leading medical aid schemes.

About 7 million people are covered by medical aid schemes, about a quarter of the country’s population. Discovery Health, Medscheme and Momentum together administer some 80% of private sector medical aid plans.

“I think the government is looking at this and saying this is our role,” said Damian McHugh, executive head of sales and marketing at Momentum Health Solutions. He agreed with the idea that the budget figure implied that schemes may not have to help cover vaccinations for non-members, although it did not remove the discussion of subsidies.

McHugh went on to explain that the costs would depend on which vaccines were procured, and schemes would still have to contribute in case booster shots or new vaccination rounds became necessary.

However, given record additions to their reserves last year due to medical services not being taken or postponed, along with not having to contribute to the vaccination of non-members, medical aid schemes stand to reap even greater benefits.

Source: Reuters

Categories : COVID Medical IndustryTags :

Over Half of SA Has Had COVID, Says Discovery CEO

On By ModernMedia

From the number of excess deaths in South Africa, it appears that over half of South Africa has been infected with COVID at least once.

The CEO and founder of the Discovery Group, Adrian Gore, has said in an interview on 702’s The Money Show that he believes over half of the South African population has had COVID. He believes that there is “absolutely no ambiguity” that the “sky high” excess death rates recorded in SA are attributable to COVID. He said that the excess deaths point to over 50% of the SA population having been infected with COVID so far.

The latest data released by the South African Medical Research Council (SAMRC) puts the number of excess deaths in SA over the course of the pandemic at 137 731 – nearly triple the official death toll from COVID. Nearly 5000 Discovery members and 12 staff members have died. 
Last week, SA National Blood Service released a study showing that 32% of people in the Northern Cape up to 63% of people in the Eastern Cape had contracted COVID. Gore said that this high infection rate would hopefully reduce the impact of the third wave predicted to arrive in the colder winter months.

“We are hoping that a third wave may take longer and might be less because we think the infection rate has been high.” He said, adding that if the first and second phases of vaccination targetting healthcare workers and vulnerable individuals was completed by mid-year, a third wave might be completely avoided.

He said that young, healthy people who can afford a vaccine should not be able to get one before those who were older and more vulnerable. “Not following this process would mean low-risk people get vaccinated before the clinically vulnerable, resulting in unnecessary illness and death. This cannot and should not happen,” he said in a Linkedin post.

He also refuted the rumour that Discovery was not paying contributions towards non-members’ vaccinations. In fact, he said on The Money Show, that medical aid schemes have extra cash to pay for this since members had been going for fewer treatments during the pandemic. This amounts to some R24 billion in surplus, as revealed by regulatory filings, which would be right in the middle of cost estimates for SA’s entire vaccination programme as opposed to the 30% amount that medical aid companies were being expected to contribute.

Source: Business Insider