At the end of April, we published a summary of the global response to COVID-19 as written by a selection of FingerPost's Global Associates who specialise in Market Access across different countries. The summary (available here) provided a brief overview of the statistics as they were at the end of April, measures implemented to reduce the outbreak and any other impact (political, economic or social) on each market as a result of the pandemic. This was a valuable snapshot ahead of the first steps taken to ease 'lockdown' measures across Europe and the US. However, this was far from the end of the pandemic and there was still a lot of uncertainty surrounding when and where 'second wave' outbreaks would occur.
Two months on, we have now published a follow up to the report to capture the continued impact of the pandemic. During this time, we have seen widespread outbreaks of COVID-19 shift from Europe and North America, through to Latin America, India and Pakistan. Brazil, in particular, is one of the worst hit with no sign that the pandemic has reached its peak. Meanwhile, widespread resurgences of the virus have also been documented in the US and Asia, as per the predictions for 'second wave' outbreaks. Local surges have also been documented in most of the countries 'recovering' from the initial outbreak but these are being managed via local restrictive measures, as well as nationalised tracing programs.
Various regulations have been relaxed to help ensure rapid access to medicines, devices, healthcare apps and personal protective equipment to help treat those with COVID-19, protect healthcare workers and prevent or identify further outbreaks. For example, in Spain protective masks that do not bear the appropriated CE mark (NIOSH or KN95) can now be commercialised. Many countries have also centralised pricing and supply/distribution systems to ensure an adequate supply of medicines.
Remdesivir has now received EMA and FDA marketing authorisation for COVID-19, and will be distributed by Gilead for patients on government-sponsored insurance in the US and other countries with national healthcare systems. In India and 126 other low- and middle-income countries, four Indian companies have been granted non-exclusive licences to produce remdesivir for distribution.
As the pandemic shows no sign of slowing on a global level, there are strong hopes for the 17 candidate vaccines in clinical evaluation and 132 in pre-clinical evaluation. AstraZeneca has already started to manufacture a vaccine that has been co-developed with scientists at Oxford University, which will be supplied to low- and middle-income countries via a licensing agreement with Serum Institute of India (SII). This is a big risk as they won't know until August whether the AZD1222 vaccine will be effective. Similarly, in the United Arab Emirates, the Abu-Dhabi-based Group 42 (G42) are partnering with the Chinese pharmaceutical giant Sinopharm China National Biotec Group (CNBG) to commercialise and develop a vaccine. And in Germany, €750 million has been allocated by the government to go towards vaccine development and to aid the international Coalition for Epidemic Preparedness Innovations.
Despite the COVID-19 pandemic, there is still a need to keep bringing other medicines to market. This is recognised by the majority of health technology assessment (HTA) agencies, who have continued to evaluate new treatments throughout the various 'lockdowns'. However, the Scottish Medicines Consortium (SMC) have experienced some delays and now expect to resume their meetings in August. Likewise, in Canada, the pan-Canadian Pharmaceutical Alliance (pCPA) have indicated that some negotiatons may be temporarily put on hold or delayed.
At FingerPost, we anticipate a more challenging Market Access environment over the next few years. Firstly, a number of 'non-urgent' medical appointments (e.g. cancer screening, minor surgeries, GP appointments) have been postponed throughout the pandemic. This is likely to have long-term consequences for the management of chronic conditions. Secondly, those who have 'recovered' after receiving intensive care for COVID-19 symptoms are likely to require long-term support to manage the damage left by the virus, the extent of which is largely unknown. And finally, financing COVID-19 is likely to take it's toll on global healthcare systems, exerting additional pressure on pricing and reimbursement negotiations to reduce the cost of medicines.
If you'd like to read more about the global impact of COVID-19 as of the 30th June 2020, you can download our latest 'Global snapshot of COVID-19' report below for free. The report contains summaries for 22 different global markets, with key insight from the FingerPost team and our Global Associates. I'd like to say a big thank you to all of the authors who contributed content to this report and hope you find the summaries as interesting as I did.
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:
[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:
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.
Two products in regenerative medicine (Zolgensma and Nepic) were also assessed separately from the drugs above:
Zolgensma (Novartis) was evaluated through Cost Comparison versus the daily treatment cost of Biogen’s Spinraza, for the same indication of SMA but diagnosed by genetic testing, and subject to strict conditions of use. Two premiums applied: 40% for Usefulness I, plus 10% for sakigake. Because of the comparison, the Innovation premium (70-120%) did not apply. The price per patient is 167 million yen, 30% below the US public price but, with a forecast of 25 patients, the implicit budget impact is limited to 4.2 billion Yen (about 350 million Euros). CEA (H3) will be required for Zolgensma.
The Cost Comparison approach was openly criticized by members of the reimbursement committee as “not transparent” (daily treatment cost derived from the estimated regimen of Spinraza, 11 vials, without clear evidence). The controversy included the sakigake premium (Novartis obtained the designation but did not follow the usual regulatory consultations), and how a premium could be awarded when the quality of the data submitted delayed the regulatory approval. To avoid an immediate correction, and loss of face, the price stands but will be reviewed in 2022, as well as the practice of giving an automatic sakigake premium to products with the sakigake designation.
In the same batch of regenerative products, while Zolgensma was considered a drug, for pricing purposes, Nepic, autologous cultured corneal epithelium (Japan Tissue Engineering, www.jpte.co.jp) was considered a new medical device. Nepic is a combination of two elements: the reimbursement price is close to 10 million yen, plus 548,000 yen for the procedure.
Cost effectiveness analysis
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:
Out of over 30 new products listed this year until May, four additional CEA dossiers were required.
Usually, four NHI price listings take place every year. Looking at the pipeline of new product approvals, 2020 will be another year busy with new launches. If you require any support understanding pricing, market access and reimbursement landscape in Japan, please get in touch.
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!
COVID-19 Update: United States of America