Asia-Pacific Roundup: Australia seeks input on health technology assessment policy

The Australian government has started a series of consultations into whether its health technology assessment (HTA) policy and methods are working effectively.

Australian officials agreed to review the HTA policy as part of the strategic agreement they reached with the medicines industry in 2021. At that time, the government committed to reform its process to ensure that Australians can access breakthrough new medicines as early as possible and to support the robust and uninterrupted supply of treatments for use every day.

Officials have already gathered information via multiple forums, including an inquiry by the Standing Committee on Health, Aged Care and Sport; a consultation on the National Medicines Policy; work by the Conversations for Change initiative; and a discussion of the terms of the HTA review with stakeholders representing patients, consumers, industry, advisory bodies and the government.

Now, the government is casting the net wider by holding “Consultation 1,” and aim to “gather evidence or examples in relation to the objectives of the HTA Review, not previously considered through other recent” discussions. The new information will help the reference committee that will prepare the final report and recommendations, according to the Department of Health and Aged Care.

Through the consultation, the government wants to identify features of HTA policy and methods that: are working effectively; may act as current or future barriers to earliest possible access; may act as current or future barriers to equitable access; detract from person-centeredness; and may be creating perverse incentives.

As part of the effort, the government has launched an online survey that asks respondents to provide information on Australian HTA elements and features that are working effectively and should not change, including details of actual positive outcomes if possible. Officials also want specific examples of aspects of the HTA policy and methods that are impeding or may impede, early, equitable access. The survey gives the respondents a chance to share “feasible options or suggestions” for how to address barriers to access.

Officials have made similar requests for information about policies that detract from person-centeredness and may be creating perverse incentives, as well as asking for suggestions of possible fixes for the issues.

The final two questions expand the scope of the consultation beyond the five topics identified by the Australian government as the focal point of the discussion. One of the questions lays the groundwork for “Consultation 2,” which will seek feedback on the initial findings of an analysis of the methodologies and purchasing practices used by comparable international jurisdictions. To inform the analysis, officials have asked for details of practices that Australia should consider adopting. Consultation 2 will run this year.

In the final question, the government gives respondents the chance to push for the expansion of the review. The government wants to know if any information relevant to the review is missing. Officials are accepting feedback until 6 June.

Consultation Page, Survey Questions

Malaysia’s NPRA releases guideline on electronic labeling of pharmaceutical products

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has set out its general guidance and conditions for electronic labeling (e-labeling).

NPRA defines e-labeling as “the dissemination of approved product information for medicinal products in a dynamic digital format allowing for the development of personalized product information based on the needs of the patients and healthcare professionals.” The medicine industry proposed using e-labels in Malaysia in 2019 to bring the country in line with international digitization initiatives.

Malaysia adopted e-labeling for COVID-19 therapies and vaccines, enabling manufacturers to use global packs in the country and thereby clearing a barrier to distribution. Now, NPRA has outlined guidelines for the voluntary use of e-labels on new drug products, biologics and generic products containing scheduled poisons for human use.

Manufacturers can present e-labels as QR codes on the outer carton or, if there is no outer carton, the inner label of the product. The QR code should link to a NPRA QUEST3+ page that displays the product information in a PDF format. Video format is not allowed. QR codes can be stick-on labels, provided they are not easily removed and do not cover any information.

The addition of stick-on labels to packaging must take place at a licensed secondary repacker facility that complies with good manufacturing and distribution practice requirements. Product registration holders are responsible for ensuring the information on QUEST3+ is aligned with the latest approved product information. E-labels should be updated as soon as label updates are approved.

NPRA Guideline

India’s NPPA responds to feedback on online data portal, confirms system is operational

India’s National Pharmaceutical Pricing Authority (NPPA) has responded to the feedback and requests it has received in relation to version 2.0 of its Integrated Public Database Management System (IPDMS).

In a notice, NPPA lists the issues raised by the Federation of Indian Chambers of Commerce and Industry alongside its responses to the feedback. NPPA pushed back against some of the requests, responding to feedback that formulations and therapeutic categories are missing from the options by stating that “it is not possible to determine the ‘New Drugs’ that may be approved in the future” and that “there are no missing therapeutic categories.”

NPPA also rejected a request to make the provision of batch numbers optional but was more amenable to other feedback. The price watchdog responded to feedback that “capturing data at plant name wise will be a challenge and this exercise involve updating data product wise” by stating that “along with separate plants, the download of data of all plants shall also be given.”

Users again commented on problems with bulk uploading, stating that the option “has to be restored at the earliest keeping in view of the challenges faced by the user on IPDMS 2.0 Portal.” NPPA said the bulk option is active and working but users need to avoid using the “%” character when adding information via the Excel option.

NPPA Memo

Singapore’s HSA prepares for consultation on eCTD

The Health Sciences Authority (HSA) has alerted the biopharma industry to an upcoming consultation on the introduction of the electronic common technical document (eCTD) to enable full e-submissions in Singapore.

HSA plans to switch to e-submissions to minimize the need for applicants to submit documents using media such as CD/DVD ROMs. The regulator also expects the move away from physical filings to support better product life cycle management for both companies and HSA.

Initially, HSA plans to use the system for new drug applications, generic drug applications and corresponding drug master file submissions. Use of eCTD for dossier submissions will be voluntary.

HSA will accept feedback on its plan from 2 May to 12 June and will hold a webinar on 9 May to brief the industry about its plans.

HSA Notice

Asia-Pacific Roundup: Australia seeks input on health technology assessment policy

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