The highlight of the first quarter of 2020 was the bi-annual revision of National Health Insurance (NHI) prices and of medical fees, announced in March and coming into effect on April 1. Key changes included:

• The impact of the revised prices was an average reduction of 4.38% of the price paid by the NHI, with large differences by product.
• The repricing of 17 products, mostly due to sales having exceeded the initial estimates which the manufacturers presented at the time of the first pricing decision. Among them, Faslodex (-25%), Dupixent (-20.2%), Keytruda (-20.9%), Lixiana (-25%).
• A new re-pricing rule was created to hit Xolair (-37.3%) after its approval for allergic rhinitis, a much larger indication than the earlier indication for asthma, resulted in reimbursement at a lower NHI price than asthma, and – going forward –  further tweaking of the repricing of products having already been re-priced, to cut deeper.
• On a positive note, three drugs could mitigate re-pricing with a post-launch premium for “true clinical effectiveness”: dapagliflozin (Forxiga), canagliflozin (Canaglu) and alirocumab (Praluent). Six others gained a premium for an additional pediatric indication.
• Minor adjustments were also made to the standard values and rates (eg profit ratio) used in the cost calculation method.

[To read more about the methods used to determine reimbursement price, please click 'read more' below.]

Besides price revisions and special re-pricing, the Central Social Insurance Council, known as Chuikyo, approved the reimbursement of over 30 new products from January to the end of May.  These decisions are summarized below:

• January: two anti-virals for HIV were approved, Dovato (dolutegravir/lamivudine) and Pifeltro (doravirine). Anti-viral drugs are usually reimbursed the moment they are approved, bypassing the quarterly listing and qualifying for the so-called Price Maintenance Premium. Both were priced by Cost Comparison Method I (standard) and Method II (no innovation).
• End of April: Nine new products, in 14 product presentations, joined the NHI price list. The Cost Comparison Method was used to evaluate five products, and the Cost Calculation Method for the other four. Only two obtained a premium, at the lowest possible rate of 5%. Of these nine new products, Noxafil (MSD) will have to submit a CEA dossier (estimated peak sales are 10% above the threshold).
• May 8: Remdesivir was approved to treat severely ill COVID-19 patients under an expedited review process but Gilead have not yet applied for reimbursement. Avigan (the 'national champion') was also anticipated to obtain PMDA approval for COVID-19 as an additional indication, but this wasn't the case as further trials were deemed necessary. 
• End of May:  A larger group of 18 new products (28 product presentations) was listed. The methods used to evaluate the products for reimbursement included the Cost Comparison for nine of them, Cost Calculation for another five, Combination price for three and New Formulation for one. A premium was awarded to eight of them, including three sakigake (pioneer) premiums of 10% to Nippon Shinyaku’s DMD treatment vitolarsen, Merck Biopharma c-MET inhibitor tepotinib and Stella Pharma’s borofalan (Steboronine). Steboronine is a nuclear medicine boron compound for head & neck cancer, used in conjunction with Boron Neutron irradiation (called BNCT), a new procedure recently approved in Japan. It obtained a price of 444,215 yen per unit, a premium of 35% for Usefulness I, to which 10% for sakigake was added. Combined, the treatment with Steboronine (3 units) and the BNCT procedure will cost about 3.7 million yen but they were not retained for CEA. Cabometyx and Enhertu have to submit a CEA dossier (see further below).

Not all approved products obtained reimbursement. Eli Lilly’s glucagon nasal powder Baqsimi, approved in March 2020 and, again, Zeria’s Ferinject, an injectable iron preparation used in dialysis and approved in March 2019, was still unable to obtain reimbursement.

In 2019, 51 new pharmaceutical products were listed on the NHI reimbursement list. Including Kymriah, classified as a regenerative medicine product, six of them have to submit a Cost-Effectiveness Analysis (CEA) dossier:

1. The triple combination, Trelegy (Chronic Obstructive Pulmonary Disorder, COPD)
2. Tisagenlecleucel (Kymriah, Acute Lymphoblastic Leukemia)
3. Ravulizumab (Utomiris, Paroxysmal Nocturnal Hemoglobinuria)
4. Another triple combination for COPD, Breztri Aerosphere. NB: no formal analysis required as it was priced in comparison to Trelegy
5. Vortioxetine (Trintellix, depression)
6. Ivabradine (Coralan, Coronary Heart Failure)

 
Out of over 30 new products listed this year until May, four additional CEA dossiers were required.

1. Posaconazole (Noxafil tablets, aspergillus and candida. NB: the injection is not subject to CEA)
2. Cabozantinib (Cabometyx, Renal Cell Carcinoma)
3. Trastuzumab deruxtecan (Enhertu, Breast Cancer),
4. Onamasemnogen abeparvovec (Zolgensma, Spinal Muscular Atrophy )

​In FINGERPOST’s March newsletter, Wilson our associate in Brazil, provided a Covid-19 update from his home country.  The article received  positive feedback as an interesting insight into a country that readers, in the UK especially, haven’t heard too much about in the news and media.  This response prompted us to change tact slightly for our April blog/newsletter and instead of publishing a global round-up of HTA decisions as usual, we decided a Covid-19 round up from a cross-section of countries globally would be more apt this month.  

Summarised by a selection of FINGERPOST's Global Affiliates who are either based in, and/or are market experts on the country they write about, we present a brief overview of the current statistics, measures implemented to reduce the outbreak and any other impact (political, economic or social) on the market as a result of the pandemic.

This blog provides an abridged version of the pieces our colleagues submitted, however, we have collated their full contributions (including links, images and references) into a report which can be downloaded from the link below. 

It has been a really interesting and collaborative exercise to collate the insights from 15 countries across the world. Whilst lockdown and social distancing are common practice with recurrent themes across all the cited countries, the leniency of these measures vary greatly, as do the statistics associated with the disease, the general management of the situation and population response. We'd like to say a big thank you to all of the authors who contributed content to this blog (see below) and hope you find the summary as interesting as we do!

The number of COVID-19 cases passed the one million mark in the United States on April 28th. More than 55,000 U.S. residents have died from complications resulting from COVID-19.

Most of the country remains under stay-at-home measures, with only essential businesses open. Without consistent and widespread diagnostic testing, state governors are uncertain when it will be safe to lift restrictions. The U.S. conducted 1.6 million tests last week but needs to be doing at least twice as many, according to the Covid Tracking Project. 

While most states are being cautious, a dozen are beginning to ease social distancing measures. Texas, the country’s second-largest state by population (29 million), has announced that stores, movie theaters, restaurants and malls will be allowed to reopen on a limited basis on Friday, May 1st. 

Besides issues with diagnostic testing, the United States is struggling to provide sufficient antibody testing to determine how far the virus has spread. The FDA is allowing private companies to conduct their own validation, but that has resulted in a lack of consistently reliable tests. Part of the problem is the United States’ fragmented healthcare system that hampers its ability to systematically conduct tests, assure adequate supplies, and share information across hospital systems and clinics.  

​Source: https://covidtracking.com/data

Since my last bulletin for the FINGERPOST newsletter, certain things have changed in Brazil. Namely, the Brazilian President has changed the Minister of Health, who is now an experienced oncologist, Nelson Teich.
 
The COVID-19 epidemic is still showing growing numbers in Brazil. The last bulletin from the Brazilian government, issued yesterday (28th April 2020), shows 71,886 confirmed cases  and 5,017 deaths, with a general mortality rate of 7%.
 
As predicted, the disease initially affected people who had better purchasing power, possibly because this group were exposed to the virus earlier (e.g., due to the frequency of international travel). However, the incidence is now much more intense in low-income populations, mainly because this group is less able to maintain social isolation practices for a long time. The number increase in this low-income demographic is also evident in mortality rates, as this population is totally dependent on the public health system, which is becoming dangerously overburdened.
 
A major problem in Brazil has been the identification of COVID-19 cases. The overload of the health system, coupled with the low availability of laboratory tests for the disease, has led to the perception that under reporting is very high.

Source: https://covid.saude.gov.br/

On March 19th, the Argentinean President passed a decree (Nr. 297/2020) on Preventive and Compulsory Social Isolation (lockdown), although some activities are being progressively released. The decree mandated that all people who live in the country or are in it temporarily must remain in their usual homes or where they were at 00:00 on March 20, 2020. 

Until May 10th inclusive (last update), people must refrain from attending their workplaces and may not circulate on routes, roads and public spaces. Only minimum and essential trips to stock up on cleaning supplies, medicines and food are allowed. During the term of the isolation, educational, cultural, recreational, sports, religious or any other type of events that involve the attendance of people may not be held. 

As of 29th April, the total number of confirmed cases in Argentina is 4,127 (50.2% women, 49.8% men), of which 207 have died. Regarding the confirmed cases, 909 (22%) are imported, 1,766 (42.8%) are close contacts of confirmed cases, 984 (23.8%) are cases of community circulation and the rest are under epidemiological investigation. To date, the total number of discharges is 1,192 patients. 

On the 28th April, 2,458 new samples were tested and since the beginning of the outbreak 56,058 diagnostic tests have been carried out for the disease overall, which is equivalent to 1,235.4 samples per million inhabitants. ​

Sources:
www.argentina.gob.ar
www.indec.gob.ar

The first confirmed cases of COVID-19 were identified in the UK on 29th January 2020, initially associated with individuals returning from overseas.  A month later, on 28th February, the UK’s first confirmed case in a British national who had not travelled outside of the UK was confirmed.  On the same day, the first Covid-19 death in the UK occurred in a British Citizen who had contracted the virus aboard a cruise ship.  The UK Government gradually began to encourage social distancing measures, however as the confirmed cases and fatalities grew, schools were closed on Friday 20th March and the country went into formal lockdown from Monday 23rd March 2020. 

The lockdown here has seen more leniency by comparison to some of our European neighbours.  

There is information this week to suggest that the UK has ‘passed its peak’ but these assertions are still to be monitored and still very much rely on the population continuing to comply with lockdown and social distancing rules.  Our current lockdown phase is due to end on 5th May, but it is widely regarded this will be extended further, especially as at the time of writing we have once again seen a significant rise in daily figures published (although this is attributed to the figures coming from Care Homes being included in the totals for the first time). 

The current figures as of Thursday 30th April 2020 in the UK are: 687,369 tested, 171,253 confirmed cases, 26,771 confirmed deaths.*
​
*Source: Public Health England: https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public#number-of-cases-and-deaths

As of 29th April 2020, France has over 130,442 confirmed cases of COVID-19, with 24,087 deaths. The strict confinement measures implemented in mid-March appear to be working, as the number of new cases and deaths each day are declining. 

On 12th March 2020, the government began implementing a lock-down where nearly all public establishments were closed with only "essential services (food shops, pharmacies, banks, newsagents, petrol/service stations…) and essential public services" being authorized to remain open.  On 23rd March, a further measure was implemented whereby all people were required to complete and carry an attestation form when leaving their homes.  Essential journeys include shopping for food, travelling to work (if unable to work from home), accessing healthcare, and exercising within 1 km from home for up to 1 hour. 

Presently, testing is only conducted on an order from a GP for patients with breathing difficulties, chronic illnesses, symptomatic elderly people, symptomatic health professionals, organ, cell, tissue donors and pregnant women.  The government's objective is to be able to carry out 700,000 tests per week at the time of deconfinement, in order to test all people with symptoms and those who have been in contact with a COVID-19 patients. 
​
On 28th April 2020, after being under strict confinement for 6 weeks, the details of a plan for a phased deconfinement were communicated.  Deconfinement will being on May 11th, the extent of which will vary by department.  In general, young children will return to school and stores and public services will reopen.  In early June additional measures (e.g. opening restaurants, high schools, etc.) may be relaxed if all goes well during the first phase with regards to the control of the disease.  ​

Source: Source: https://www.gouvernement.fr/info-coronavirus/carte-et-donnees

The first cases of COVID-19 in Germany were recorded in January 2020. As of April 29, 2020, 157,641 cases of the disease had been confirmed by laboratory test, of which 6,115 had died.
The states with the highest incidence of the disease, expressed as cases per 100,000 inhabitants, were Bavaria (320), Baden-Württemberg (283), Saarland (254) and Hamburg (246)—among the most-affluent areas of the country. Incidence was much lower in the states in the east of the country (the former German Democratic Republic)—just 43 cases per 100,000 inhabitants were recorded in Mecklenburg-Vorpommern, for example.

Two-thirds of COVID-19 patients were aged 15-59. Nineteen per cent of patients were aged 70 or older, but 87% of deaths were in this age cohort. 

An estimated 120,400 patients had recovered from the illness. 

Self-isolation has been generally well supported across Germany and the country has not had to adopt measures as extreme as those of some of its neighbours in Europe.
State administrations have considerable autonomy in determining policy, but the federal government was able to command a broad consensus throughout the early stages of the pandemic.

On 20th April, however, Angela Merkel, the Chancellor, warned against what she called Öffnungsdiskussionsorgien (orgies of discussion about reopening).
​
At a stormy meeting on 6th May, the federal government agreed to allow states to begin reopening shops, restaurants and hotels, and to resume professional football (behind closed doors). Social distancing requirements will remain in place and an "emergency brake" will allow for the reimposition of stricter controls if necessary.

Source: 
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Situationsberichte/2020-04-29-de.pdf

Spain has been one of the countries worst affected by the COVID-19 outbreak. The first case was confirmed on the 31st January and the first death was reported on the 4th of March. Since then there have been 236,899 confirmed cases and 24,275 confirmed deaths, i.e. 515 deaths per million population (data from 29th of April 2020).   

To combat the spread of the virus, Spain implemented one of the toughest lockdowns on 14th of March, however, this Tuesday (28th April) Prime Minister Pedro Sánchez announced plans to begin relaxing the lockdown over the next two months and bringing in a shift towards a “new normality”. This shift is anticipated to take place over four stages, which will vary by province: 

• Phase 0 (start 4th May) - restaurants able to open for takeaway service 

• Phase 1 (start 11th May in mainland Spain) - restaurants allowed to open outside terraces, hotels and places of worship allowed to open, all restricted to a maximum of 30% occupancy 
• Phase 2 - restaurants able to open indoor dining areas, cinemas, theatres and exhibitions able to resume business all restricted to a maximum of 1/3 of their capacity 
• Phase 3 – occupancy/capacity criteria would be relaxed, but continued social distancing of about two metres required 

Schools will generally not return until September. 
​
Progress will be determined by epidemiological, transport and socio-economic data, and the capacity of the Spanish healthcare system, in terms of primary care and intensive care beds. 

Sources: 
​https://coronavirus.jhu.edu/map.html 
 ​​https://www.ine.es/
 https://elpais.com/sociedad/2020/04/09/actualidad/1586437657_937910.html
https://www.eldiario.es/politica/Pedro-Sanchez-anuncia-desescalada_0_1021548525.html
 https://www.ft.com/content/c03f61a9-2d16-47cc-8289-0c732a782dda

April 29th, 2020: The country has been under lockdown measures since early March to tackle the spread of the virus; nearly eight weeks later, Italy has reported 27,359 fatalities.

The third-largest economy in the eurozone is suffering the highest recorded death toll in Europe and its economy is about to collapse.

The government together with several committees are now planning and co-ordinating the next phase of the lockdown relaxation. COVID-phase 2 is expected to start on 4th May. Phase 2 will gradually lift some lock-down measures; certain activities, shops, businesses and factories will be allowed to re-open under strict safety measures. With less than one week to go, phase 2 is still unclear and contradictory and it is causing further distress and uncertainty about the future.  

Based on the current understanding of the COVID-19 virus, the Italian Government is trying to assess, manage and balance the risk related to a potential second wave. This could once more hit the ageing Italian population, (23.1%* are over 65 years) and the already exhausted medical staff, hospitals, and ICUs.
​
Sources:
http://opendatadpc.maps.arcgis.com/apps/opsdashboard/index.html#/b0c68bce2cce478eaac82fe38d4138b1
https://www.statista.com/statistics/785104/elderly-population-in-italy/

'Same but different' is a relevant phrase to describe life in Sweden. Restaurants are open, public transport is running, and the majority of children are at school. Yet, there is a feeling of uneasiness as the nation keeps updated on the latest numbers.  

At the time of writing (29th April) there have been  2,462 confirmed deaths linked to corona virus which ranks  Sweden as 11th highest deaths per million of population (225), significantly higher than neighbouring Denmark at only 76.  While testing hasn't been widespread, the trend regarding daily deaths suggests that Sweden has at least reached the peak.  Health resources have been put under pressure but have not yet reached capacity. In fact, the additional 'field hospital' that has been built outside of Stockholm has yet to receive a patient. Therefore, it could be concluded that the voluntary measures to flatten the curve have worked sufficiently for Sweden's infrastructure to cope. 
​
While media outlets have suggested the Swedish approach is a gamble and irresponsible vs the lockdown measures in other nations, the majority of Swedes support the government's decision  to stand behind the  data driven recommendations of the Swedish Public Health Agency, headed by Anders Tegnell.  More importantly, the data suggest that the Swedish people are adhering to the guidance by working from home, travelling less and social distancing. While much has been made of the open bars and restaurants, measures have been taken to mitigate risk. Hand sanitizer is everywhere, capacity has been halved and it’s table service only. ​

​Source: https://www.folkhalsomyndigheten.se

Even though around 22% of Portugal’s 10.3 million people are 65 or older, making them particularly vulnerable to coronavirus, there have so far been fewer infections and deaths than in neighbouring countries. On the 29th of April 2020 there had been 24,505 confirmed cases and 973 confirmed deaths (94.5 deaths per million population).  

The main reasons for the lower infection and death rates are believed to be: 

• Time to prepare - being behind other countries in the spread of the virus allowed the country and hospitals to get ready and increase capacity in ICUs, and learn from other countries’ experience 
• Acting early - Portugal introduced lockdown measures e.g. school and universities closures on the 12th of March before any fatalities had occurred, and declared a state of emergency shutting most non-essential services and travel six days later (only two days after the first COVID-19 death) 

• Centralised healthcare system - allowed quick implementation of measures compared to more regionalised systems 

Portugal also has one of the highest testing rates worldwide, with >37,000 tests per million population carried out by 29th of April. 

This Tuesday (28th April), President Marcelo Rebelo de Sousa announced that the state of emergency would end at midnight on the 2nd of May. He warned that this will not be a return to normality and that activities will be resumed slowly and gradually while monitoring a range of indicators. Nurseries will open on the 18th of May and pre-schools will open on the 1st of June; further details are anticipated on the 30th of April. ​

Sources:
https://www.ine.pt/xportal/xmain?xpgid=ine_main&xpid=INE&xlang=p ​https://coronavirus.jhu.edu/map.html
https://www.theguardian.com/world/2020/apr/19/swift-action-kept-portugals-coronavirus-crisis-in-check-says-minister
https://www.ine.pt/xportal/xmain?xpid=INE&xpgid=ine_destaques&DESTAQUESdest_boui=354227526&DESTAQUESmodo=2&xlang=pt
https://www.statista.com/statistics/1104645/covid19-testing-rate-select-countries-worldwide/
https://pt.euronews.com/2020/04/28/fim-do-estado-de-emergencia-em-portugal-no-dia-2
https://www.publico.pt/2020/04/29/sociedade/noticia/creches-abrem-ja-18-maio-preescolar-1-junho-1914472

As of 27th April 2020, the Netherlands has 38,424 confirmed cases of COVID-19 with 4,677 deaths. Measures to limit personal contact implemented in mid-March appear to be working, as the number of new cases and deaths each day are declining. 

The first patient in the Netherlands was diagnosed with COVID-19 on 27th February 2020, having contracted the disease during a trip to Italy. Seeing the spread of the virus in its southern European neighbours, and also within the country itself, on 12th March the Dutch government began imposing measures to limit personal contact.  It was explicitly stated that the government chose not to resort to confinement measures, reasoning that the virus is here to stay, so that the preferred approach was to tackle the epidemic by building population immunity.  With that said, social distancing (1.5m) was enforced with fines, schools were closed, along with cafés, restaurants, sports clubs, saunas, sex clubs, and coffee shops.  While stores were never forced to close, many chose to do so as they could not guarantee the safety of their staff. The same was true for some public services like libraries.  Masks were never mandatory, as the Dutch feel that they cannot be effectively used by the public, only by medical personnel. 

Testing is only for vulnerable groups (e.g.: elderly, patients with comorbidities) and healthcare workers. The testing capacity in the Netherlands is currently around 17,500 tests per day, which can be increased to around 29,000 if necessary, especially following the return of children to school and opening testing up to teachers. 

The government announced on April 15th that all current measures will remain in place although beginning on 28th April, children may return to participating in outdoor sports, though no parents may be present, and 12-18 y/o children must maintain the 1.5m distancing.  On 11th May elementary schools will re-open and on 2nd June middle and high schools are scheduled to open.  Following this announcement, many stores that had voluntarily closed in March, made the decision to re-open on 30th April.  ​

Source:  https://www.rivm.nl/coronavirus-covid-19/grafieken

New cases in the UAE started to plateau on the 23rd April, with newly diagnosed patients ranging between 518 and 549 per day. In total, there have been 105 deaths, and 2,429 recovered patients. 

Restrictions in the UAE started differently to Europe, with initial restrictions only in the form of a curfew between 8PM and 6AM. These restrictions were called out as a ‘disinfection program’. This was further extended to a 24 hour stay indoors order, whereby permits were required to leave the house for essential services or medical emergencies.
 
Since the start of Ramadan on 24th April, restrictions were loosened once more to a curfew between 10PM – 6AM. Restaurants and businesses are able to operate at 30% capacity, whereas social distancing measures are still recommended and masks are required to be worn at all times.
 
Whilst the UAE authorities have mentioned that all citizens and residents will be tested, the plans on execution are not yet clear, although there are some drive through facilities in Abu Dhabi where citizens are able to get free tests (ex-pats are able to get tested for $100 if they do not have symptoms). 

Source:
​https://www.mohap.gov.ae/en/AwarenessCenter/Pages/COVID19-Information-Center.aspx

​Population 25 million
Total cases 6,746 (19 new in past day) with 89 deaths.
Total tests conducted 544, 410.
(As at 28th April 2020)
 
More than 600 cases and at least 21 deaths have been linked to the cruise ship, Ruby Princess. All 2,700 passengers were controversially allowed to disembark without health checks when it docked in Sydney a month ago. It the single biggest source of COVID-19 infections in Australia.
 
Despite lockdown laws requiring people to stay at home except for essential tasks and exercise, keeping Australians off the beach has been difficult. This photo is from last weekend when beaches were re-opened. Restrictions were re-introduced soon after influx and lack of social distancing! 

A COVID Safe app has been released with approximately 10% of the population downloading it in the first day. The Government says that to be beneficial in controlling outbreaks, at least 40% coverage is required.
 
People are also being encouraged to have the flu vaccination as winter approaches. The aim is to avoid simultaneous COVID-19 and influenza spikes. Despite this lockdown restrictions are starting to be loosened as the crisis seems to have passed but ‘normal service’ with shops, restaurants, gyms and public places re-opening is a long way off. 
​
Source:
​https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/coronavirus-covid-19-current-situation-and-case-numbers

Population 5 million
Total cases 1,474 (2 new in past day) with 19 deaths.
Total tests conducted 128,703
(As at 28th April 2020)

New Zealand’s decisive action on March 25th to move directly to the strictest “Level 4” (eliminate) lockdown restrictions has been hailed as a standout in leadership by Prime Minister, Jacinda Arden.

Even as cases declined in early April, border restrictions were tightened so that all citizens and permanent residents arriving in New Zealand were required to spend two weeks quarantined in an approved facility rather than at home.

The New Zealand Government announced earlier this week that it had effectively “eliminated” the coronavirus and moved to ease restrictions to “Level 3” (restrict). Some non-essential business, healthcare and education activity will be able to resume, but most people will still be required to remain at home at all times and avoid all social interactions.
 
Modelling has indicated that New Zealand could have had more than 1,000 cases a day if it had not brought in the lockdown so early. Reports are that Queen Elizabeth called Jacinda Arden to congratulate her and have a chat!

Source: 
​https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-current-situation/covid-19-current-cases

To view current updates on global statistical information relating to COVID-19, please visit: https://coronavirus.jhu.edu/map.html and ​https://www.ft.com/coronavirus-latest. If you would like to read more about the COVID-19 impact in each market, please email cbacon@fingerpostconsulting.com for a copy of the full report.

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.
  ​
  

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.
​
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).
​
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.