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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. England & Wales: NICE’s Scientific Advice service – friend or foe?  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. 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
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/ 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. A summary of key issues from the year for Australia & New Zealand. 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. 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. 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/ Health technology appraisal published during November: UK, France, Germany and Italy.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.
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