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
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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.

​In post as Director of Operations and External Resource at Fingerpost my role is quite self-explanatory; I manage our internal operations and I resource all the projects that we win with clients.  In this month’s blog it’s the external resource part that I’m keen to talk more about.

I’d been in recruitment for nearly 12 years prior to joining Cath at Fingerpost – the first 6 years solely within temporary market, where hourly/daily rates and large networks of ‘freelance’ candidates were my norm and the latter 6 years predominantly centric to permanent recruitment.  I loved the temporary side of recruitment but the markets I worked in didn’t win my interest - this was truly piqued when I went into Market Access and permanent resourcing.   The opportunity to join Cath and take responsibility for pulling together and managing project teams for her outsourced offering presented me with a chance to take two areas of interest (and a wealth of opportunity to learn new things) and blend them into what has been a wonderful role so far!

I’m a MASSIVE advocate of freelancers.  If, as a business, you are under resourced or under skilled and there is time pressure on you to deliver then why would you not invest in someone experienced who is willing to come into an unknown culture and team and leave again once the job is done? (They may even provide you with some great insights on methodology or practise whilst they’re at it!)  I’m pretty sure all the hiring managers/team leads reading this now are thinking ‘cost’ as one of the barriers, but I have experienced many a situation where the simple “pay as you go” cost of the freelancer is far less than the cost of not getting the job done on time or having to pull people off other projects to deliver yours.

Asides ‘cost’ another area for concern could be 'risk’.  Of course, the great thing about a freelancer is that there is no employment risk to your business but granted, this ‘risk’ element manifests itself in skill and ability to do the job well – and I will give you this one!  It’s always nerve-wracking as a recruiter, indeed as a manager, when you place a contractor who may not turn out to be as good as you thought; even with marvellous references, things can go wrong.  This is where the Fingerpost model works incredibly well.  We build a freelance project team where we are involved and can guarantee the outcome.  More often than not Cath works on content, provides quality control or strategic advice. Occasionally when we face extreme time pressures and see there may be a burden on one freelancer, we manage multiple freelancers working in unison to get the work completed quickly.  We have worked with many of our freelancers before and continue to build the network on positive recommendations.

Not only am I a massive advocate of freelancers but it seems so is the general workforce.  According to a 2018 report from the Office of National Statistics (UK) “The number of self-employed increased from 3.3 million people (12.0% of the labour force) in 2001 to 4.8 million (15.1% of the labour force) in 2017”.  As we frequently get enquiries about “becoming a freelancer” in the Market Access space, we have decided to conduct a short survey on freelancer experience to understand more about the role of a freelancer; measuring how freelancers are currently operating within market access and related fields e.g. medical communications, brand strategy, healthcare market research, HEOR, etc’ (you can participate here: https://www.surveymonkey.com/r/XK8BVXJ).  These results will be analysed in June and communicated in our July newsletter, although to give you a little snippet thus far, the overriding reasons for individuals taking the leap into the world of freelance are: lack of flexibility in permanent roles and negative company culture/politics in previous work places.
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Freelancing isn’t for everyone (and we have asked about the negatives in our survey too!), nor is it necessary or practical for businesses to engage with freelancers continuously. However, given the limited pool of candidates within Market Access/HEOR, we hope our survey results will prove valuable to both freelancers and employers alike – indeed, freelancers may even help us all to understand the best approach for attracting and retaining high-calibre individuals within the industry.

Victoria Wooldridge