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.
Further information about the methods of evaluation for reimbursement prices in Japan: Cost Comparison Method: Reimbursement prices (“NHI prices”) are determined by applying, on the basis of daily treatment costs, the price of the closest reference product most recently listed on NHI. The “closest” is defined, in the following order, by indication, mode of action, chemical structure and route of administration (hence “Comparison”). This is the preferred method.
Cost Calculation Method: When there is no such comparator for pricing purposes, the costs of manufacturer, development, distribution and a standard rate of profit are added (hence “Cost Calculation”).
A schedule of premiums can apply (as shown in the tables above) to reward innovation or utility, and encourage the development of small indications (“Marketability”).
Finally, Foreign Price Adjustment takes into account the public prices in four countries of reference: the USA, UK, France and Germany.