Japan has become the first country worldwide to both approve and grant reimbursement to PD-1 checkpoint inhibitor Opdivo (nivolumab, recombinant), a novel treatment targeting non-resectable malignant melanoma. The country has also granted a significant 60% premium on Opdivo and reimbursed 21 other active pharmaceutical ingredients, a record number.
IHS Life Sciences perspective | |
Significance | Unusually, Japan has become the first country worldwide to grant reimbursement for PD-1 checkpoint inhibitor Opdivo (nivolumab, recombinant), and it also first to grant marketing approval to the drug in July. According to Pharma Japan, the 22 APIs include six that were developed under a designated development scheme started in 2010 to target unmet needs and reduce the drug lag. |
Implications | By reimbursing the first PD-1 checkpoint inhibitor on the market globally, Japan is validating a completely new mechanism of action in oncology treatment and the 60% premium it has granted on Opdivo is aimed at rewarding innovation. Japan's attempts to speed up the development of unapproved drugs targeting unmet needs also appears to be paying off, since six out of the 22 approved APIs joining the national health insurance (NHI) price list is a higher proportion than two out of 14 APIs at the previous listing in May, according to a Pharma Japan report. |
Outlook | Japan's more innovation-friendly stance is likely to encourage pharmaceutical companies to prioritise the Japan market when applying for marketing approval. Furthermore, Japan's efforts to encourage designated development of unapproved drugs for unmet needs are expected to go some way towards reducing the drug lag in the country. |
Japan is the first country to grant reimbursement for a PD-1 checkpoint inhibitor, Opdivo (nivolumab, recombinant), a novel treatment targeting non-resectable malignant melanoma, after becoming the first worldwide to grant marketing approval to the treatment in July.
Opdivo is one of a record 22 active pharmaceutical ingredients (APIs) approved for reimbursement by Japan's Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Ministry of Health, Labour and Welfare (MHLW). The full list of the MHLW's latest listing is available here, in Japanese. The APIs were listed on Japan's national health insurance (NHI) price list on 2September. According to Pharma Japan, the 22 APIs include six that were developed under a designated development scheme started in 2010 to target unmet needs and reduce the drug lag.
Japan has also granted a 60% premium on Ono Pharmaceutical's cancer treatment drug Opdivo (nivolumab, recombinant), as well as a 40% premium on Otsuka Pharmaceutical's Deltyba (delamanid) and Bristol-Myers KK's (subsidiary of US major Bristol-Myers Squibb) Daklinza (daclatasvir), according to Pharma Japan.
In April, Japan revised its NHI drug pricing system and raised the ceiling for premiums on innovative drugs, in the absence of similar treatments, to 100% from 50%. The 60% premium on operating profit is the first time Japan has applied new guidelines, according to the source.
The highest premium prior to this was a 40% premium granted to Eisai's oncology treatment Halaven IV (eribulin mesylate), which was listed in July 2011. Opdivo received the 60% premium in recognition of its superior efficacy and other advantages compared with existing drugs, Pharma Japan reports. Besides Opdivo, Otsuka Pharmaceutical's multidrug-resistant tuberculosis (MDR-TB) treatment Deltyba (delamanid) and Bristol-Myers KK's hepatitis C treatment Daklinza (daclatasvir) were granted a 40% premium.
Outlook and implications
Japan's positive reimbursement decision is significant, as it clears Opdivo to enter the global market for the first time and is the first full approval of a PD-1 immune checkpoint inhibitor, a highly competitive and promising research area. The regulatory approval therefore validates Opdivo's safety and efficacy.
Furthermore, Japan's reimbursement premium underscores its willingness to reward innovation over existing therapies in an area of continued high unmet clinical need. It also highlights that Japan is one of the few countries in the world where the government is seeking to improve the potential for price premiums for innovative products.
The approvals come in the wake of the NHI pricing reforms in April, and indicate that despite the pressure on the Japanese government to control prices and encourage the introduction of authorised generics as the population ages, it is nevertheless willing to grant higher premiums on innovative treatments.
Other APIs receiving a premium include Besides Opdivo, Otsuka Pharmaceutical's MDR-TB treatment Deltyba (delamanid), the first new TB treatment in Japan in over 40 years, with a 40% premium, and Bristol-Myers KK's hepatitis C treatment Daklinza (daclatasvir), which received a 40% premium for usefulness.
Opdivo was approved in Japan in July as a treatment for unresectable melanoma, thereby becoming the first PD-1 checkpoint inhibitor to be approved anywhere in the world (see Japan: 8 July 2014: Oncology drugs alectinib and nivolumab among new approvals in Japan). The drug is also being developed for the treatment of several other tumour types across more than 35 trials – as a monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.
At the same time, the fact that six of the 22 APIs were developed under a designated development scheme underscores Japan's eagerness to reduce the drug lag. The scale of the drug lag has been such that drugs and indications approved for marketing in other developed markets remained unapproved in Japan for years. In May 2010, Japan's MHLW attempted to address access delays to drugs by issuing requests to pharmaceutical companies for the development of 108 unapproved drugs or indications with unmet medical needs. According to Pharma Japan, the provisional premium pricing on innovative drugs was having the desired effect of speeding up the development of novel drugs targeting unmet needs.