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”.

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.

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 has said that it will make a decision on whether to go ahead with the ‘off-year’ revision only once the market price survey has been completed. With the survey now reported to be under way (as at November 2020), this means it will likely be late 2020 or early 2021 before the Ministry makes a final call, and there remains little clarity on how COVID-19 effects will be taken into account. This potentially gives manufacturers just weeks to prepare if the revised prices are to be implemented on 1 April 2021 as expected. And although (echoing drug makers’ concerns) Korosho is reportedly worried about the reliability of the survey, the Prime Minister’s backing could ultimately prove decisive.

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, Korosho announced the result of the market price survey that commenced in September 2020 (see above). According to press reports, the survey found that the average yakkasa (ie the difference between the NHI reimbursement price and the actual market price) across all drugs was around 8.0%. This was somewhat lower than expected; stakeholders had predicted that the yakkasa could 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.
• Following publication of the survey results, Korosho announced 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 the yakkasa, with price adjustments to be applied in April 2021 to all products found to have a yakkasa of 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 subsequently 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 normally 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% - 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.

IQVIA Pharma Pricing & Reimbursement (PPR) draws on decades of experience in the market access space to bring you the latest global developments in pricing and reimbursement. With access to IQVIA’s network of local offices, and extensive contacts within government and industry, the PPR service offers timely news and articles alongside comprehensive guides to P&R regulations around the world.

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