Experts from IQVIA’s Pharma Pricing & Reimbursement and Market Prognosis teams provide an update on the outlook for “off-year” price revisions in Japan.
Original (December 2020) Article:
WADING INTO THE ONGOING DEBATE OVER PLANS TO CARRY OUT AN ‘OFF-YEAR’ REVISION IN 2021 OF NATIONAL HEALTH INSURANCE (NHI) REIMBURSEMENT PRICES FOR PRESCRIPTION MEDICINES, NEW PRIME MINISTER (PM) YOSHIHIDE SUGA IS REPORTED TO HAVE STRONGLY BACKED THE PROPOSALS, DESPITE ONGOING RESISTANCE FROM THE MEDICINES INDUSTRY. AND WHILE THE MINISTRY OF HEALTH, LABOUR AND WELFARE (KOROSHO) HAS YET TO MAKE A FINAL DECISION ON THE MATTER, WITH OTHER STAKEHOLDERS – INCLUDING THE MINISTRY OF FINANCE (MOF) – URGING AN EVEN TOUGHER STANCE ON DRUG PRICES, FEW WOULD BET AGAINST THE PRICE ADJUSTMENTS GOING AHEAD NEXT YEAR.
The debate over ‘off-year’ price revisions has its roots in proposals set out by the government in late 2016 and formalised by Korosho in late 2017. Under the proposals, the Ministry plans to complement the existing biennial price revision process (under which prices for all reimbursed medicines are adjusted every two years – most recently in April 2020) with a separate process that would review the NHI reimbursement prices of certain medicines in the ‘off-year’ between each biennial revision.
It was agreed some time ago that the new process would be rolled out to enable ‘off-year’ reviews to take place for the first time in 2021. But the question of which products should become subject to such a review has, to date, remained open. Furthermore, the impact of the coronavirus/COVID-19 crisis has entrenched divisions between manufacturers (and certain elements within the government), who favour a postponement or delay of the planned 2021 implementation date, and the health and finance ministries, which are mindful of the potential savings to be gained from implementing the new system sooner rather than later.
The appointment of Prime Minister Suga in mid-September 2020, replacing his predecessor Shinzo Abe following the latter’s resignation on health grounds, has added further political impetus to the debate over whether, and how, to proceed. According to Pharma Japan, in his first policy speech to the Japanese Diet (parliament) on 26 October 2020, Suga emphasised that his government will seek to “rectify inefficiency and unfairness” and that in this context it will “work to realise annual NHI price revisions”.
但是作为回应,日本制造商协会(FPMAJ)和日本制药商协会(JPMA)的联合会重申了他们要求政府采用“谨慎的方法”的呼吁。该协会认为,大流行的影响使科罗索更难在计划的2021年价格修订之前进行准确的市场价格调查,因为许多批发商和医疗保健提供者之间的价格谈判尚未得出结论,使其更难得出结论,使其更加困难必威手机APP衡量市场上产品的实际价格。他们认为,在医疗保健提供者和药品制造商寻求更紧密地合作以确保可以维持稳定的药品供应时,计划的价格修订将是不必要的干扰。必威手机APP
Wholesalers, for their part, are worried that medical institutions that have been impacted by the COVID-19 pandemic might be seeking deeper discounts on drug purchases than usual (hospitals were reported to be requesting excessive discounts in some cases, as earnings deteriorated during the pandemic). Moreover, due to COVID-related restrictions, negotiations by sales reps have also been hit. As a result, the findings of the market price survey at this critical period may lead to much deeper price cuts next year, wholesalers warn.,
Korosho, however, faces opposing pressure from other quarters. The MOF in early October 2020 advised that the proposed scope of products to be subject to an ‘off-year’ review should be broadened, suggesting that the health ministry should look at the overall (actual monetary value) difference between a product’s NHI reimbursement price and its actual market price, rather than just the percentage difference (yakkasa), when deciding whether a drug’s price should be adjusted. The MOF reportedly argues that focusing only on the yakkasa would mean that the vast majority of products subject to an ‘off-year’ revision would be generic drugs, rather than more expensive innovative medicines.
Notably, IQVIA’s Market Prognosis, which provides five-year forecasts of pharmaceutical sales in Japan, assumes that the off-year price revisions will indeed go ahead from April 2021 onwards, but that the impact on the total market value will be less significant than the full biennial revisions. Estimated price impacts are as follows:- Biennial price revisions (even years 2022 and 2024): -5.3 to -6.3%
- ‘Off-year’ price revisions (odd years 2021 and 2023): -4.0 to -5.0%
Korosho曾表示,仅在完成市场价格调查后才继续进行“关闭年”修订,这将做出决定。据报道,该调查正在进行中(截至2020年11月),这意味着可能是2020年末或2021年初在该部进行最后的电话,并且对如何将Covid-19的效果付诸实践尚不清楚帐户。如果要在2021年4月1日实施修订的价格,这可能会使制造商仅几周的时间准备。尽管据报道(回应制药商的关注)Korosho担心调查的可靠性,但总理的支持最终可能证明是决定性的。
January 2021 Update from PPR and Market Prognosis Teams:
Since IQVIA published the above analysis in December 2020, the Japanese authorities have continued to work toward implementation of the first ever ‘off-year’ NHI price revision in April 2021.
There have been a number of key milestones in this regard:- In early December 2020,Koroshoannounced the result of the market price survey that commenced in September 2020 (see above). According to press reports, the survey found that the averageyakkasa(即NHI报销价格与实际市场价格之间的差异)所有药物的差异约为8.0%。这比预期的要低一些。利益相关者已经预测yakkasacould be above 9.0% as a result of increased discount pressure from pharmacies and wholesalers experiencing turnover problems due to the economic impact of the ongoing pandemic.
- 在发布调查结果之后,Korosho2020年12月中旬宣布,计划的产品范围将由2021年的“低年度”价格调整涵盖。范围是基于yakkasa,价格调整将于2021年4月适用于所有发现的产品yakkasaof more than 5.0%. Initial calculations by the Ministry suggest that this means that around 70% of all products included on the NHI reimbursement list as at September 2020 will be subject to NHI price adjustments in 2021.
- Korosho随后,提供了有关如何计算单个产品价格调整的进一步详细信息。值得注意的是,这在某些关键方面将与每两年一次的NHI价格调整的方法有所不同。根据实际市场价格实施价格调整时,Koroshonormally allows a variation of up to 2.0% (known as the price adjustment range). Applying this to the 8.0% figure would mean that, if implemented, the average NHI price reduction in April 2021 would be around 6.0%. Instead, however, in April 2021 the price adjustment range is to be set at 2.8% -这意味着该机制下的平均价格降低约为5.2%(尽管每种产品的最终价格调整也将取决于其他因素,例如实施新药的价格溢价,以及某些“必需”药物可能允许的价格上涨)。
宣布其财政年度(FY)2021(即2021年4月1日至2022年3月31日)预算于2020年12月21日预算,据报道,政府指出,它预计实施“下年”价格修订将产生日元431的节省2021财年的卫生系统为.5亿。必威手机APP这与最新的市场预后预测一致,该预测预测2021年价格调整对总市场价值的影响将为-4.0%至-5.0%。
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