Welcome to the FINGERPOST Global Payer Round Up for March 2020.  As a team we were all extremely busy at the beginning of 2020 so our Global Payer Round Up had to be postponed. To make up for it, this month we include a summary of all of the technology appraisals published between December 2019 and March 2020 in the UK, France, Germany and Canada.  These can be found in the slideshow below.

This months blog also features commentary pieces from two of our Global Associates:

• Sharon Leadbitter summarises the current Cancer Screening Programs in Australia
• Wilson Follador provides an insight into the current Covid-19 status in his home country - Brazil.
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Finally, and in response to the rapidly changing working environment for many companies as the Coronavirus continues to spread, FINGERPOST have collated some hints and tips for successful home working - both from our past 5 years of experience and also from colleagues and peers who are well versed in using their home as a professional workspace!

The Australia Government currently funds three national cancer screening programs that aim to reduce morbidity and mortality through a systematic approach to early detection. All three programs experience lower-than-desired participation rates, especially in communities that are hard to reach. As with any population screening, the programs also face challenges in balancing benefits, harms and cost-effectiveness. This includes potential for over-diagnosis and over-treatment of cancers that were unlikely to cause harm if undetected.

​From December 2017, the 2-yearly Pap test that looked for changes in cervical cells for women aged 18 to 69 was replaced by a 5-yearly human papillomavirus (HPV) test for women aged 25 to 74 years. As approximately 90% of cervical cancers are caused by HPV, this change to cervical screening is expected to save up to 30% more lives.
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The National Immunisation Program (NIP) funds HPV vaccination of all 12-13-year-old children. The vaccine protects against 9 types of HPV that are the most common cause of cervical cancers and genital warts in Australia. As it does not protect against all types of HPV, regular cervical screening is recommended irrespective of whether they are received the vaccine. In men, vaccination helps protect against genital warts and some anal, penile and throat cancers.

​A review of the benefits, costs and harms of Australia’s screening program for bowel cancer showed the program costs as little as AU$3,380 for each year of life saved - well below what the paper describes as the “indicative willingness-to-pay threshold” – $30,000 to $50,000 per life-year saved – used by Australian governments to tell which health programs represent a good use of finite health dollars. (Lew J-B, Feletto E, Wade S et al. Benefits, harms and cost-effectiveness of cancer screening in Australia: an overview of modelling estimates. Public Health Research & Practice 2019;29(2):e2921913.)

The program began in 2006 with all people aged 50 to 74 who have a Medicare or Department of Veterans Affairs card are sent a free bowel cancer screening kit in the mail every two years.

Despite being quick and simple to do in your own home, the 2017–2018, participation rate was 42.4% of the over 5 million people invited. The re-participation rate for people who had taken part in their previous invitation round and were receiving a subsequent screening invitation was 78%.

A new early-detection national targeted lung cancer screening program is currently the subject of an enquiry to explore the benefits and harms of screening, cost effectiveness, initial scoping of the target population and understanding the screening and assessment pathway. The enquiry is scheduled to wrap up in October 2020.

Lung cancer is the leading cause of cancer death and kills more Australians than breast and bowel cancer combined. The five-year survival rate of lung cancer is approximately 17%, compared with a 5-year survival rate of 69% for all cancers (Cancer Australia 2019).
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Early diagnosis of lung cancer is critical to improve outcomes, with more than 50% of lung cancer cases being diagnosed at an advanced stage.

,I wrote a report about the status of COVID-19 in Brazil 10 days ago (see next article). Now it is time to update information.

The last report from the Brazilian government about COVID-19, published yesterday at 5:30PM, shows that the number of cases has risen up to 28,320 confirmed cases (6 times higher than on April 6th) and 1,736 deaths (about 10 times more), distributed across the Brazillian territory (figure 1) but with higher prevalence in the South-East and North-East of the country.  85% of deaths were registered in people over 60 years old.  The global mortality rate was estimated at 6.1% for infected patients. The daily number of cases in Brazil is still growing, despite irregular behavior (figure 2)

​Fortunately, it seems that the capacity of our healthcare services has not been overloaded, but as the number of cases is still growing, this is not a comfortable situation.
 
However, there is not only bad news. A series of good initiatives are bringing the perception that people are aware of the situation of those who are most vulnerable to the social and economic problems associated with the disease. These initiatives come from both simple groups that are organizing themselves to provide food and essential goods to the needy and workers in essential services, to larger corporations that are donating billions of reais for support activities. This always existed, but now the number and importance of these groups is higher than ever.
 
The Brazilian Minister of Science and Technology, Marcos Pontes, was interviewed yesterday and said that two in-market medicines (which seem to be neither chloroquine/hidroxichloroquine or azithromycin) had reported an efficacy of 94% for treating COVID-19 – but he refused to mention their names, ‘to avoid a run to the pharmacies’.
 
Today, we are imminently expecting the Brazilian Minister of Health, Luiz Henrique Mandetta, to be fired by the President Jair Bolsonaro, due to disagreements between them regarding social isolation. To be monitored…

​At first, some epidemiologic data: today is March 31st and 36 days after the first case reported, Brazil currently has 4,685 COVID-19 patients (22 cases per million inhabitants) and 168 deaths (0.8 deaths/million), but – unfortunately – still in an ascendant curve of incidence (during the time I was writing this paper, the incidence raised to 4,715 patients). The mortality tax is 3.2% in the infected patients. The cases distribution around the country is very heterogeneous; along the 27 Brazilian states, Sao Paulo state (44 million citizens, 21% of Brazilian population) concentrates 1,517 (32.4%) cases and 159 deaths, and Rio de Janeiro is in the 2nd position (600 cases). It happens because Sao Paulo presents the biggest cities, economic dynamics and demographic density.
 
Data models has estimated that 460,000 people will be infected only in Sao Paulo during the epidemic’s course.
 
The disease numbers in Brazil are not absolutely reliable, because there is a lack of confirmatory tests for COVID-19. Many cases are being diagnosed in a base of clinic signs and symptoms, and sometimes the results of lab tests come later (or never). But they are good enough to know that Brazilian, as all the citizens worldwide, are into a war – a war against suffering and death.
 
Like many other parts of the world, the largest Brazilian cities have adopted the social isolation strategy to reduce the virus dissemination – not an imposed lockdown, but a voluntary isolation, which is being accomplished by most of population. Despite the lack of data on how many people have adopted the social isolation, is clearly visible that most Brazilians are at home, with exception of those working in essential services. It seems that Brazil has started to quarantine in an opportune term, something that maybe can be succeed on flattening the disease incidence curves and consequently provide some alleviation to our healthcare system. Anyway, health authorities have already started building field hospitals to attend COVID-19 cases and are reinforcing the flu vaccination, considering that Brazilian climate is going to autumn and winter, a risk factor for spreading infectious pulmonary diseases.
 
The Brazilian public healthcare system, called SUS – Unique Health System – was created under some basic principles: universality, equity and integrality. Under these principles, SUS must provide health care for everyone (210 million citizens) along its all 8.2 million square meters land area, from Amazonas to Sao Paulo and from the poorest to the richest people, and from the primary care to organ transplantations. To this challenge, the total funding that came from the three governmental entities (federal, states and municipalities) sums about R$ 1,400 per citizen per year (~£260 by today’s exchange rate). Now, under the explosive demand of COVID-19 epidemic, there is a risk that the resources driven to the healthcare funding will be scarce, despite the Minister of Economy has done important additions to the health system budget.
 
About the private healthcare system in Brazil, is possible to say that it has better financial condition compared to the public system. The annual billing of the Brazilian private healthcare system is about R$ 231 billion (~£35 billion), but the population covered is 25% of the Brazilian population and so the average amount available per beneficiary is higher, of R$4,812 per year (~£745). However, even the private system is very concerned about the capacity to meet the demand that may emerge if the number of cases of COVID-19 rises in a massive way, as is happening in several cities around the world. The quality of care to be offered is not only a matter of financial capacity, but also about infrastructure, which cannot be built in a very short term.
 
Until this moment, the healthcare resources are being enough to give access for the current demand. This not means that we are having the desired success on having the full control of disease or avoid mortality, but at least no one is failing to receive the necessary care.
 
The only part that has been systematically disagreeing with this set of preventive measures is the Brazilian President, Jair Bolsonaro, who is always refusing to acknowledge the seriousness of health and insists on the need to maintain productive activities in Brazil to avoid an economic crisis, so breaking the quarantine. But at least he is allowing the Health Minister to manage the sanitary crisis, which is a healthy positioning of him.

Many of us who aren’t in vital key worker roles during this global Coronavirus pandemic have slowly but surely moved our working day to the comfort of our own homes over the last few weeks.  For Cath, myself and our Global Associates, this hasn’t really made much of a significant difference as we all operate remotely as normal practice (in fact, prior to the current situation, we were investigating a WeWork space in order to have somewhere convenient to meet when we do need to get together!).

However, speaking to clients, colleagues in other businesses, and friends, this change of working model has caused varying degrees of operational issues, a slow down in efficiency and also personal struggles for those who thrive on the routine of ‘going to work’ and being flanked physically by their team.  Many are also not in a practical position to work from home and have had to create a makeshift office space. And that’s not to mention the all too familiar daily struggle of keeping children, spouse or pets at bay whilst essential work calls take place – we all had a giggle at Professor Robert Kelly in March 2017 when his child interrupted a BBC interview, but three years on this is turning into an acceptable ‘normal’.

So how can we help ourselves to make working from home a bit easier both professionally and personally?  We asked our colleagues and LinkedIn audience for their top tips…here are a selection to give you some ideas….

• If this is all new to you, get up, shower, get dressed, style your hair, have breakfast, do some exercise, make your lunch, walk the dog and conduct your working day routine as close to normal as you can.  Keep your head in work mode.  This will also work really well to ensure there is some differentiation come the weekend.
• Implement boundaries - define your working space and make housemates/partners/older children aware that this is now a ‘professional’ zone. Make a sign to indicate when you can’t be interrupted. If you have small children, a colour coded system might work better than a written note.
• Reimagine your workload – complete ‘urgent’ tasks as normal but split the rest of your list into those items that require concentration and those which can be completed as second nature.  Set aside and communicate ‘concentration time’ so these tasks can be completed with no interruption – it’s far less frustrating and stressful being disturbed doing the non-concentration tasks.
• If your company isn’t used to a working from home structure and are tentative about how document sharing will work, then packages like Microsoft Sharepoint and Teams are great for collating everything that everybody needs centrally.  You can also virtually communicate through calls and instant messenger options.  Sharepoint also has the convenient facility of allowing multiple (authorised) users to edit the same document at the same time so it offers good working efficiency and saves multiple email trails back and forth (and don’t worry, you can scroll through the version history if something gets lost!!)
• Breaks – make sure you factor them in – have a cup of tea, watch some telly, do something non-work related. Even if you have to push back your break due to a last-minute work commitment, make sure you re-schedule the time.
• Evaluate the working week – in communication and agreement with your employer, take a look at what your working week looks like.  For example, if you and your partner have children and are both still contracted to full working weeks, then it is wise to take a 7 day view with a flexible approach.  It can take a bit of organisation but absolutely worth it when you are struggling to manage multiple expectations during the course of the normal working day.
• Keep remembering that we are all in the same boat but at the same time feeling the changes differently – be kind to yourself, to colleagues, to suppliers and clients.  This should be normal practice regardless but is more acutely appreciated and positively reciprocated at present.
• Prioritise virtual team meetings several times a week that get as many staff members involved as possible. Keeping staff engaged and feeling together will be vital throughout this time.  Most web meeting functions have a record option, so record any meetings and forward on to absent team members and remember to acknowledge their absence/include their role and responsibilities in the call – not only will they benefit from experiencing the same meeting as everyone else but it personally keeps people feeling involved.
• Most web communication platforms have an option to blur the background or change your background to something more tropical/mundane/unusual – explore your system and feel a bit more comfortable on video calls!
• If you have children and a full-time job then remember that you are not a teacher and the children won’t fall behind if you don’t do 5/6 hours of school related activity with them every day.  This situation is strange for children as well – more so when many children really thrive on routine - they will always remember this time, so it shouldn’t be stressful for either party.
• Have a virtual team lunch!  Pencil a web call in over lunch and all sit down to chat about non work things over a sandwich and cuppa (or Burgers and a Beer as one of the teams did on Friday!!)
  
  

FINGERPOST have long been champions of working from home, working flexibly and viewing work as a part of your life rather than life fitting around work.  To make it work; communication, commitment to workload and acceptance of responsibility and transparency are key.  This could be a great opportunity for businesses who have previously not entertained flexible working to realise that it can work well whilst also having a positive impact on staff wellbeing, productivity and recruitment retention.
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If you need any advice on homeworking or are struggling to think outside the box as to how challenges can be overcome, then feel free to drop us a note.

See the slideshow below for the HTA summary tables.  Get in touch if you have any questions or would like to see HTA outcomes for other countries in future Round-ups.

This month, as well as the summary of NICE’s Scientific Advice service we also include an insightful overview from our Consultant for Australia and New Zealand, Sharon Leadbitter. Sharon has given a great round-up of policy changes in the access/reimbursement space over the past year.  

As per last month, we have also included a quick round-up of technology appraisals published during November in UK, France, Germany and Italy. In 2020, we plan to expand this list to decisions made by other global HTA agencies.

PLEASE NOTE: All information reported in the blog represents the views of FINGERPOST and/or the individuals credited and does not reflect the views or opinions of other organisations that may be mentioned in context
ere to edit.

Last month, I was told that NICE were offering a ‘Scientific Advice Masterclass for Consultancies’. My limited understanding of the Scientific Advice service and Office for Market Access led me to believe these were competing services to what many Market Access Consultancies already offer. As such, my initial scepticism was that the Masterclass was a clever tactic to encourage Consultancies to bring in more business for NICE, but curiosity got the better of me and I signed up. I’m pleased to say that I’m now feeling better informed!

So, what is the Scientific Advice service?
The Scientific Advice team at NICE provide an early check and answer any questions regarding evidence generation plans for products that are expected to go through NICE appraisal. That covers clinical trials, economic models, network meta-analyses… and so on. To help answer Industry’s questions, as well as the experts on the Scientific Advice team, an expert panel consisting of Clinicians, Health Economists and Patients is compiled. However, it is worth pointing out that they do not provide any commercial advice (that’s the remit of the Office of Market Access) and can not answer any questions that might indicate the likely outcome from Committee review. Instead, the advice is targeted towards whether or not the evidence meets the requirements for HTA submission.

Ultimately, this service was set up to help Industry prepare earlier for the submission process and ensure changes can be implemented before it’s too late. It’s not very helpful to find out at the first Committee meeting (or, as per recent changes to the technology appraisal process, at the slightly earlier Technical Engagement meeting) that the ‘wrong’ endpoints have been used in clinical trials, or the wrong assumptions have been applied to the economic model. These issues may still come up post-ERG review, of course, but hopefully to a lesser degree if the early advice has been followed.
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Another beneficial service offered by the Scientific Advice team is parallel advice with other regulatory (EMA, MHRA) and HTA (EUnetHTA, CADTH) groups. There are also plans for similar arrangements with Blue Cross Blue Shield, FDA and FINOSE (Finland, Norway and Sweden), and informal arrangements with ICER (the US HTA agency, not the Incremental Cost-effectiveness Ratio!). This is a key point from my perspective as evidence generation needs to consider the needs of multiple markets, not just the UK.

Interesting points raised during the Masterclass

• There has been a lower uptake of the recently introduced ‘Fast Track Appraisal’ process than anticipated.
• One of the key changes taking place from April 2020 is the fact that NICE will be reviewing all new active substances and indications. This means there will be more certainty regarding whether or not a product will undergo NICE review, but it wasn’t clear how this will impact the remit of the AWMSG who currently review the products that NICE don’t review.
• Also, in April 2020, the review process for non-cancer medicines will be sped up to match the process for cancer medicines.
• It is important to engage the services of the Scientific Advice team and/or the Office for Market Access before evidence generation plans are finalised, and with sufficient time to incorporate any advice received. If the submission is due in 3 months or less then it’s too late and presents as a conflict of interest for NICE.
• When preparing a Briefing Book, it is important to focus on providing specific, detailed questions for which you want NICE’s advice and avoid holding back any relevant information (confidentiality is maintained, of course). As with any HTA document, there is a need to avoid any element of spin/product promotion; sticking to the facts and highlighting any issues is more likely to result in better advice. Also, it is a wasted effort asking how expected outcomes will influence the final outcome!
• To maximise this service, there is a need to plan ahead and allow sufficient time for evidence review, developing the briefing book and for the Scientific Advice review itself. Although it typically takes 18 weeks to turn around the full Scientific Advice service, NICE do also offer a quicker, 12 week turnaround at a premium price.

 
Conclusions
The Scientific Advice service is no doubt useful in helping Industry to be more prepared and efficient with respect to evidence generation budgets. But there is a need to engage very early on in the process to ensure evidence generation plans can be adjusted, and with a turnaround of up to 18 weeks, it sounds challenging to schedule in. Even before that, time must be allocated to review the available evidence, develop evidence generation plans and prepare a briefing book, which may or may not involve the support of Consultancies. And this takes me to another point… the cost. Is the service sufficiently beneficial to offset NICE’s fee and Consultancy fees? Or is it just adding more cost and slowing down a process that is still highly uncertain until the Phase III results are available?

From my side of the fence, I can see the benefits of such a service. I have always thought that Industry is put in an impossible situation when it comes to technology appraisals. The length of time it takes to generate the required evidence for a new product is far slower than the rate of change in the HTA process. By the time a product gets to market, they are being compared to products that may not have been available when the clinical trials were designed. The available evidence is often limited due to factors beyond Industry’s control, for example, Patient Reported Outcome measures not having the required completion rate to be considered. The ‘reference case’ provided by NICE is limited for non-standard indications (e.g. paediatric populations, ultra-rare conditions) and there is little advice regarding what is deemed acceptable in these situations. I could go on…. So, I appreciate the efforts by NICE to help find a solution…even if it does increase the cost of an already expensive process.

Aside from the Scientific Advice service, I still have a number of questions that all relate to how the remit of the various services provided by NICE will change post-election, post-Brexit and post-Sir Andrew Dillon. Understandably, the individuals presenting at the Masterclass were very clear that they have to remain impartial whenever the conversation was derailed in this direction, so I held back on my questions this time around. For now, I will just have to wait and see. 2020 is certainly going to be an interesting year for NICE so I will be keeping my eyes and ears open!

Written by Catherine Bacon. Catherine has been a Market Access Consultant for 12 years and now heads up the FINGERPOST team. More information available here: https://www.fingerpostconsulting.com/catherinebacon.html and via Linked In: https://www.linkedin.com/in/catherine-bacon-fpc/
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PLEASE NOTE: The summary of the Scientific Advice Masterclass represents the views of FINGERPOST and does not reflect the views or opinions of NICE or any other organisations that may be mentioned in context.

Professor Andrew Wilson, Chair of the PBAC, speaking at the annual industry function at Parliament House, Canberra.​

Australia
Since the unexpected return of the incumbent Conservatives (Liberal National Party coalition) to power in the May 2019 Federal Election, it has been business as usual with the Minister of Health, Greg Hunt, retaining the portfolio he has led since early 2017.

August saw the roll out of ‘Australia’s Long Term National Health Plan - to build the world’s best health system’, which is the rhetoric being played to the public. It is only once engaged with the system as a patient, that the reality of overstretched services and uncapped out-of-pocket payments become apparent.

At admission, public hospitals ‘strongly encourage’ privately insured patients to use their coverage. In some states, the level reaches over 20% of inpatients, which cost-shifts to insurance companies, and opens the door for providers to charge above scheduled rebate fees leading to out-of-pockets for the patient. This is on top of Medicare levy as part of taxation and private health insurance premiums.

In terms of prescription medicines, the Government delivers equitable and timely access via the national Pharmaceutical Benefits Scheme (PBS). Despite increases in service numbers associated with an ageing demographic, and upward of 50% of the population managing a chronic condition, the PBS has effectively flat-lined at AU $11 Billion (US $7.45 B) per year for the past decade. This is due to losses of patent exclusivity, highly effective pricing policies and approximately 30% of prescriptions being self-funded as the cost is below the indexed co-payment threshold.

Further policy initiatives are expected to make up the short fall in savings to Government committed by Medicines Australia in the 2017-2022 Strategic Agreement (SA). Savings of AU $1.8 Billion (US $1.22 B) are to be delivered for reinvestment into listing of new medicines, however the delay in entry of Humira biosimilar competition has left a significant gap to date. 
Electronic and active ingredient prescribing will be introduced in 2020 forcing clinicians to take extra steps to prescribe a specific brand. Biosimilar uptake initiatives are also being developed with the intent to require a telephone approval to access an originator biologic.
The first phase of movement towards full cost recovery fees commenced in July 2019, with the final phase in July 2020. Once complete, the process of PBS listing of an innovative medicine will cost approximately half a million AU dollars (US 340K).

The ongoing Aged Care Royal Commission Interim Report triggered the announcement of ‘Medicines Safety’ as the 10th National Health Priority, a spot long coveted by many therapeutic areas. This has especially been welcomed by the Pharmacy Guild, who represents the owners of Australia’s 5,700 community pharmacies, and the Pharmaceutical Society of Australia (PSA) representing the pharmacy profession. Both are currently in negotiations with the Government on terms of a new agreement which is meant to take effect from June 2020.
A review of the 20-year old National Medicines Policy will begin in March 2020 stimulated by the lack of a clear access and reimbursement pathway for cell and gene therapies. Novartis’s Kymriah currently has 2-year approval for use in children and adolescents with ALL.

As elsewhere in the world, consumer and patient input to all steps in the research and access journey are being recognised and formalised into processes. The PBAC now has the opportunity to meet with select members of patient organisations prior consideration of a relevant medicine at one of their three meetings per year.
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As most new products are reimbursed under confidential Special Pricing Arrangements, multi-national companies are closely watching the global happenings with regard to price transparency. Due to parallel processing, where regulatory and reimbursement dossiers are evaluated simultaneously, Australia is often in price negotiations early. Any risk that effective (actual) vs list prices are made public will drop Australia way down the list of countries where new drugs can be accessed.

New Zealand
The absolute capped budget for medicine funding in New Zealand, managed by PHARMAC has come under sustained pressure in 2019. Lauded for their approach over the years (see BMJ 2010;340:c2441), the New Zealand public has had enough of needing to travel to Australia, where reciprocity applies, to access the latest treatments.

For those unable to afford the travel and accommodation costs, this has meant treatment with interferon instead of pegylated versions, and years waiting for access to the direct-antiviral agents that effectively offer a cure for Hepatitis C, as just one example. Even when available, choice will be limited and patients may be forced to switch brands as tender providers change.

Most recently, over 11,000 patients were impacted by a forced change to a single brand of the anti-epilepsy drug, lamotrigine in return for annual savings of NZ$ 6 million (USD 3.8 m). Numerous patients have experienced adverse events and four reported deaths are considered to be associated with the policy. Further investigations have revealed that the NZ regulator, MEDSAFE advised against the switch.

This is on the background of an approximate NZ $1 billion (USD 64 m) PHARMAC annual budget for a population approaching 5 million in 2020. That is, USD 130 per person. The equivalent for Australia is USD 298 (AU $11 Billion, population 25 million) and USD 1,045 in the USA (US $350 Billion, 335m population).

A recent IQVIA report showed that of 304 new medicines funded internationally between 2011-17, only 17 were funded in New Zealand. As of June 2019, 138 medicines with a positive recommendation remained on the waiting list for PHARMAC funding.

In the past year, 20 petitions for medicine funding from different patient groups have been presented to the NZ Government, along with consistent media headlines, such as ‘Patients with rare disorders encouraged to leave NZ to live’. Advocacy has aligned behind the Patient Voice Aotearoa (PVA) with an overall objective of a healthcare system where everyone has access to treatment.
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The NZ Government has responded with injections of funding for cancer treatments, but continues to not offer any commitment to long term reform.

Written by Sharon Leadbitter.  Sharon has over 15 years pharmaceutical company and consulting experience working in market access including health economics, pricing and evidence generation. Sharon is also an experienced health care professional with a background in clinical research. You can learn more about or connect with Sharon on Linkedin: https://www.linkedin.com/in/s-leadbitter/

​See the slideshow below for the HTA summary tables. Get in touch if you have any questions or would like to see HTA outcomes for other markets in future Global Round-ups.

This month we include insight from Sheri Sellmeyer about the US bill aiming to lower drug prices and we’ve summarised the drug reviews that have been conducted in the UK, France and Germany over the past month. If you have any questions regarding the information below please contact Cath at cbacon@fingerpostconsulting.com.

PLEASE NOTE: All information reported in the blog represents the views of FINGERPOST and/or the individuals credited and do not reflect the views or opinions of other organisations that may be mentioned in context.

USA: U.S. bill that would lower drug prices heads to House vote
The current impeachment inquiry into President Donald Trump has overshadowed a huge event in the world of drug pricing and reimbursement – a proposed bill to lower drug costs in the United States.

The bill would allow the government to negotiate lower prices for at least 35 high-cost drugs each year, provided the drugs do not have at least two generic competitors. The prices would apply to both Medicare (covering seniors) and those who are privately insured – more than 280 million people.

This would be a sea change for the United States. Unlike other countries, the U.S. does not regulate the prices of new prescription drugs, and it allows every drug proven safe to come into the market, regardless of whether the benefit is determined to justify the cost.

The bill is considered likely to be passed by the Democratic-majority House, but faces stiff opposition in the Republican-controlled Senate. The drug industry argues that lowering drug prices would lower profits, which would make the industry less attractive to investors and result in less research for new cures. A recent blog post on PhRMA, the leading biopharmaceutical trade group, argues that the drug pricing plan would hurt the development of treatments for Alzheimer’s, which affects 5.4 million Americans, predicted to grow to 14 million by 2050.

Lowering the cost of prescription drugs was a major tenet of President Trump’s campaign platform, but he has yet to gain any traction on his own proposals. A plan to require drug companies to disclose their prices in television ads was struck down by a federal judge. His blueprint for lowering drug costs published in spring 2018 lists a number of proposals, including “take steps to end the gaming of regulatory and patent processes by drug makers to unfairly protect monopolies.” He has frequently complained that other countries use socialized healthcare to command unfairly low prices from U.S. drug makers, putting the burden of financing drug development on Americans.

The Congressional Budget Office estimated the bill would save Medicare $345 billion over seven years. About a fourth of Americans say they have difficulty paying for their drugs – a percentage that goes to 33% for those with low incomes, 38% for those taking four or more prescription drugs, and 43% for those in fair or poor health, according to the Kaiser Family Foundation, a nonprofit, nonpartisan organization that focuses on healthcare issues.

Prescription drugs in the U.S. cost on average more than 50% than in other developed markets, according to analysis by information and analytics company IHS Markit. Prices for cardiovascular, musculoskeletal and nervous system drugs average about 80% lower in other developed countries. For example, according to the Kaiser Family Foundation, the average price of the blood-thinner drug Xarelto is more than double that in the United Kingdom.
 
The House bill could reach the floor for debate next week. In the meantime, House Democrats are debating the bill among themselves, with some arguing the proposed law doesn’t go far enough to negotiate prices and others concerned about crafting a bill that’s palatable to the Senate.

Thanks to Sheri Sellmeyer for submitting this article. To find out more about Sheri, you can access her Linked In profile via our Global Associates tab.
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Health technology appraisal published during October: UK,  France, Germany
See the slideshow below for the HTA summary tables. Get in touch if you have any questions or would like to see HTA outcomes for other markets in future Global Round-ups.

At Fingerpost we support and deliver projects via a specialized network of freelancers operating within market access and related fields. We assess the needs for each project and compile a team of independent specialists to deliver that project to its highest potential.  We understand the value that  flexibility brings, and find that this allows us all to work smartly and effectively when it counts. Of course, this way of working leads to some very busy weeks but it also means that we absolutely, without quibble take that time back in lieu: have some extra hours with the children or squeeze in an extra yoga session on a quieter week.

As Fingerpost grows and we continue to evaluate and refine our offering, we have been engaging with more and more freelancers across the globe. However, the increased volume of freelancers on our database has also highlighted a number of inconsistencies and differences between individuals in market access and related fields.  Some of these differences can be attributed to cultural practice (how individuals like to work, communication styles etc), whereas others relate to the practical elements of billing for work (rates, how many hours count as ‘a day’ etc). After noticing some of the differences, Cath and I both agreed it would be useful to conduct a survey that would help us identify some of the trends amongst freelancers in market access (and related fields e.g. HEOR, pricing, medical communications). The insight from the survey will hopefully help us to understand best we can support our freelance team and represent them fairly with the clients we work with.

So, in May, we developed an anonymous, 10-question survey to capture data that would address the following research questions:

•       What are the minimum requirements to become a freelancer?
•       What fees are people charging and what influences this?
•       How are freelancers contracting within market access and related fields?
•       Why do people leave permanent roles to take up a freelance position within Market          Access and related fields?
•       What aspect of freelancing could be improved?

A small (n=39) but representative sample completed our survey over the 7 weeks we ran it for. Participation was completely voluntary and anonymous, which relieved any burden associated with processing personal data.

We have now analysed the data and summarized the outcomes into a concise presentation report. Although the outcomes are primarily targeted at informing ourselves and other freelancers within the sector, we’re also aware that the findings may appeal to those currently, or considering, working with freelancers. Here’s a quick taster of some of the key findings from the survey:

·       There are no obvious minimum requirements/expectations with respect to level of degree or number of years in a permanent role, prior to becoming a freelancer.
·       The average hourly rate was slightly higher for those with a PhD (vs MSc, BSc and job experience), but there was no trend to suggest that a higher level of degree qualifies a freelancer to charge more. However, those with a BSc were less inclined to contract with Academia or Medical Communications agencies than those with a MSc or PhD.
·       Higher hourly rates were associated with more years of work experience, as well as pricing, outcomes research and strategic market access/HEOR services.
·       Industry and public sector appear to accept higher hourly rates than consultancies and agencies.
·       More freelancers actively pursue business with new clients than those who do not, but the frequency of contact is most likely down to personal preference.
·       Flexibility and quality of life were the main reasons people choose to move into a freelance position, and flexibility and variation of roles are deemed to be the most enjoyable aspects of freelancing. However, uncertainty (financial/workstream) and lack of interaction were reportedly the least enjoyable aspects.

The survey also allowed us to analyse the average hourly fee charged based on years of experience, type of contracting organization and area of expertise. There were some very interesting findings from this perspective but you’ll have to read the report to find out more!
If you would like a copy of the report, please drop me (cbacon@fingerpostconsulting.com) or Victoria (vwooldridge@fingerpostconsulting.com) an email. Anyone is welcome to peruse the findings; just state why you are interested in the email and we’ll pop a copy over to you.
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From our perspective the results have been very interesting and, although some of the findings only confirmed what we already suspected, there have also been some other key findings that we weren’t expecting. Overall, the survey has prompted us to change some of the ways we engage with freelancers. Ultimately, we hope this will make our project operation experience better for both the client and the freelancer, resulting in greater transparency and efficiency.