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日本: New PM Backs “Off-Year” Price Revisions
IQVIA Pharma定价和报销经理Eoin Jennings Eoin Jennings
IQVIA市场预后经理Khyati Arora
2021年1月28日

IQVIA的药品定价和报销和市场预后团队的专家提供了有关日本“下年”价格修订前景的最新信息。

原始(2020年12月)文章:

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.

在2020年9月中旬任命Suga总理,在以健康理由辞职后,取代了他的前任Shinzo Abe,这进一步增加了有关是否以及如何进行的辩论。必威手机APP根据日本制药公司的说法,苏加在他对日本饮食(议会)的第一次政策演讲中强调,他的政府将寻求“纠正效率低下和不公平”,在这种情况下,它将“努力实现年度NHI价格修订”。

But in response, the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) and the Japan Pharmaceutical Manufacturers Association (JPMA) have reiterated their call for the government to adopt a “cautious approach”. The associations argue that the impact of the pandemic has made it more difficult for Korosho to conduct an accurate market price survey ahead of the planned 2021 price revision, since price negotiations between many wholesalers and healthcare providers have yet to conclude, making it more difficult to gauge the actual prices of products in the market. Furthermore, they argue, the planned price revisions would serve as an unnecessary distraction at a time when healthcare providers and drug manufacturers are seeking to work more closely together to ensure that the stable supply of medicines can be maintained.

就批发商而言,批发商担心受到COVID-19的大流行影响的医疗机构可​​能会比往常寻求更深层次的毒品购买折扣(据报道,医院在某些情况下要求过度折扣,因为在大流行期间的收入恶化,)。此外,由于与共同相关的限制,销售代表的谈判也受到了打击。结果,在这个关键时期,市场价格调查的发现可能会导致明年更深的降价,批发商警告说。

Korosho但是,面临其他方面的反对压力。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:
  • 两年一度的价格修订(甚至2022年和2024年):-5.3至-6.3%
  • “下年”价格修订(奇数2021和2023):-4.0至-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。

2021年1月,PPR和市场预后团队的更新:

自iqvia于2020年12月发布上述分析以来,日本当局继续致力于实施2021年4月的首次“低年度” NHI价格修订。

在这方面有许多关键里程碑:
  • 在2020年12月上旬Korosho宣布了2020年9月开始的市场价格调查的结果(见上文)。根据新闻报道,调查发现平均Yakkasa(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Yakkasa由于正在进行的大流行的经济影响,药房和批发商的折扣压力增加,可能高于9.0%。
  • Following publication of the survey results,Koroshoannounced in mid-December 2020 the planned scope of products to be covered by the 2021 ‘off-year’ price adjustment. The scope is to be based on theYakkasa, with price adjustments to be applied in April 2021 to all products found to have aYakkasa超过5.0%。该部的初步计算表明,这意味着截至2020年9月,NHI报销清单中包含的所有产品中约有70%将在2021年接受NHI价格调整。
  • Koroshosubsequently provided further detail on how price adjustments for individual products will be calculated. Notably, this will differ in some key respects from the methodology used for biennial (‘on-year’) NHI price adjustments. When implementing price adjustments based on actual market prices,Korosho通常允许多达2.0%的变化(称为价格调整范围)。将其应用于8.0%的数字将意味着,如果实施,2021年4月的NHI平均价格降低约为6.0%。但是,相反,在2021年4月,价格调整范围将设定为2.8% -meaning that the average price reduction under this mechanism will be around 5.2%(although the final price adjustment for each individual product will also depend on other factors, such as the implementation of the price premium for the development of new drugs, and price increases that may be permitted for certain “essential” drugs).

Announcing its fiscal year (FY) 2021 (ie 1 April 2021 to 31 March 2022) budget on 21 December 2020, the government is reported to have stated that it expects the implementation of the “off-year” price revisions to generate savings of Yen431.5 billion for the health system in FY2021. This aligns with the latest Market Prognosis forecast that predicts a -4.0% to -5.0% impact of 2021 price adjustments on total market value.

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