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9 Countries Form Transcontinental Market Access…

A group of international organizations has created a new working group to discuss potential solutions to ensure sustainable and equitable access to effective medicines, particularly in smaller marketsThe nine organizations consist of Amgros I/S (Denmark), Sykehusinnkjøp (Norway), Swedish Association of Local Authorities and Regions (Sweden), Landspítali (Iceland), National Center for Pharmacoeconomics and the Corporate Pharmaceutical Unit of the Health Service Executive (Ireland), Ministerie van Volksgezondheid, Welzijn en Sport (The Netherlands), RIZIV-INAMI (Belgium), Infarmed (Portugal), and the Pan-Canadian Pharmaceutical Alliance and Patented Medicine Prices Review Board (Canada)The organizations have agreed that, going forward, they will focus on ways to manage insufficient data on the effect of new, expensive medicines, to help secure stable and effective access to new medicines

Spain Set to Update its Internal Reference Prices for…

Spain is set to change the prices of 17,097 presentations of drugs from January 1, 2023, following an update to the internal reference prices (OPR), which could lead to a saving of around EUR 271 million for the National Health System (SNS)The government stated in a release that the change is an “essential tool for controlling pharmaceutical spending, necessary for the sustainability of the public health system”However, the Spanish Association of Biosimilar Medicines (Biosim) considers that the new OPR "has not taken advantage of the opportunity to approach" the sector and places biosimilar companies at a “clear disadvantage”

AIFA to Create Unified “Scientific and Economic…

Following months of whispers around a major AIFA reform, it is finally in writing that the Technical Commission (CTS) and Pricing and Reimbursement Committee (CPR) will become a new AIFA “unified commission”, dubbed “Scientific and Economic Commission” (CSE)The merged unit will oversee the current tasks and responsibilities of both the CTS and CPR, however the CSE is set to halve its current number of members. In place of the DG, two new roles will be established, the Scientific Director and the Administrative Director. The final unit will be composed of ten members yet to be appointed, and methods set out in a decree to be adopted within 60 days of the approval of the lawThe 2022 PNRR first confirmed that the government was renewing the membership of the CTS and CPR until at least the end of February 2022. The move extended the previous membership of the two bodies for at least another four months, strongly indicating that AIFA would undergo a reshuffle. Under the temporary renewal of their memberships, P&R activity was able to continue uninterrupted whilst the government planned an official reorganization of the system

France Rejects Early Access for Tecentriq as NSCLC…

Roche’s Tecentriq (atezolizumab) has been denied a post-marketing authorization (MA) early access scheme by France’s High Authority for Health (HAS) for the adjuvant treatment of patients with non-small cell lung cancer (NSCLC) with a high risk of recurrence, whose tumors show PD-L1 expression ≥50% on tumor cells (TC) and who do not show NSCLC with mutated EGFR or ALK gene rearrangement (ALK-positive)According to the TC, the efficacy results available on the Marketing Authorization population come from post-hoc analyses, not adjusted for multiplicity, without any interaction having been studied or demonstrated. The effect size estimate for disease-free survival is “likely overestimated” in the MA population, it notes, based on an investigator assessment in an open-label studyGiven all the above methodological limitations, “no formal conclusion can be drawn from these results and it is not possible to conclude that this new treatment modality is likely to bring a substantial change to patients in an adjuvant setting.” The TC also stated that the drug does not fill a currently unmet medical need, as such the implementation of the therapy is deferred. Finally, the development plan is not considered suitable. As such Tecentriq does not meet the innovation criteria in this setting

South Korea’s IRP A7 to Expand From 7 to 9 Countries…

South Korea’s international reference pricing (IRP) system is set to expand from seven to nine countries with the addition of Australia and Canada in January 2023, following the Health Insurance Review and Assessment Service’s (HIRA) amendments to the Regulations on Evaluation Criteria and Procedures for Eligibility for Medical Care BenefitsAdditionally, the method for calculating the foreign average medicine price will also be revised, taking into account ex-manufacturer prices, exchange rates, value-added tax (VAT), and distribution channels in each comparator countryHIRA commented that the reason for the revision is that the method for calculating the foreign average medicine prices in the current A7 “is outdated and the basis is insufficient”

Major Global Companies Lowering Investment Priority in…

The Office of Pharmaceutical Industry Research (OPIR) has released a report in which it finds 27% of JPMA/PhRMA/EFPIA companies see Japan as a “lower priority” market, particularly since 2016 - According to the findings, “Low economic rationality, especially low drug prices and assumed drug prices” are the key factors deterring companies from seeing Japan as a priority marketOf the 10 companies who professed to a low investment priority, nine answered that the economic rationality, business feasibility or profitability of their Japanese business was low - None believed that there was no medical needAccording to OPIR, it “became clear that about 40% of major global companies are declining their investment priority in the Japanese business.” The group also suggested that the growth potential of the Japanese pharmaceutical market influences the decision-making of corporate investment priorities in major global pharmaceutical companies

Japan’s MoF Looks to U.S.’ IRA as Justification of…

Japan’s Ministry of Finance (MoF) has reiterated its call for a full drug price revision in FY2023, requesting that re-pricing be conducted for all listed medicines by applying “all relevant rules”It wants full product coverage and the application of all relevant price rules including those not directly linked to market price-based price revisions that were not applied in the FY2021 off-year revisionIn the same session, held on November 7, the MoF highlighted the U.S.’ use of the inflation Reduction Act (IRA), suggesting that a similar policy would apply well to Japan, while acknowledging the differences between the two systemS

WODC: EMA Official Worries DARWIN EU “Not Fit for…

Speaking at the World Orphan Drug Congress (WODC) in Sitges, Spain, Kristina Larsson, Head of Orphan Medicines, Division for Human Medicines Evidence Generation at the European Medicines Agency (EMA) suggested that DARWIN EU may “not be completely fit for rare diseases,” despite previous claims that the RWE from DARWIN EU will “provide data from multiple European countries to support the orphan designation”The concern was voiced as part of a wider discussion regarding the changing EU Orphan Drug Legislation. Orphan Regulations in the EU are currently under revision, providing opportunities to amend and “hopefully improve” existing aspects of the legislationYann Le Cam, EURORDIS Co-founder, expressed a want to “fix” the legislation, primarily because of the impact of high-priced drugs. He added, “If we change it, it has to be better, not downsized or compromised. That’s the purpose of the group, to set the right goals and ambitions”

WODC: German MoH Official Sees Potential Friction…

Speaking at the World Orphan Drug Congress (WODC) in Sitges, Spain, a Policy Advisor at Germany’s Ministry of Health suggested the need for internal discussions to align on the European Union’s (EU) joint HTA initiative when assessing orphan drugs, as Germany’s procedure does not require the use of a comparator for orphan drugs that have not passed the EUR 30 million thresholdIn Germany the additional medical benefit is already proven through the approval. Under this clause, as long as a drug’s turnover within one calendar year is under EUR 50 million, no evidence of its medical benefit and medical additional benefit compared to a comparator need to be submittedIn contrast, the joint EU HTA contains a stipulation that a national body must contribute what they have determined to be the appropriate comparator. To mitigate this difference, Hannah points out the need to hold internal discussions, as currently the process is “all up in the air”

Pharmaceutical Company Q3 Earnings Reports Reflect…

Q3 financial filings indicate that pharmaceutical companies are already feeling the impact of the Inflation Reduction Act, which was passed in the U.S. in August 2022Although most provisions have not yet gone into effect, pharmaceutical companies anticipate the law to impact both finances and business strategiesSome companies, including Eli Lilly, have already made changes to research & development activities based on the projected outcome of the Inflation Reduction Act

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