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BETTER ACCESS AUSTRALIA’S INPUT TO THE DRAFT HEALTH TECHNOLOGY ASSESSMENT (HTA) REVIEW TERMS OF REFERENCE

Friday 20 January 2023

With a 500-word limit, BAA made two submissions to this process, this was further informed by the release of the first communique’s from the Committee about the development process for these draft Terms of Reference the afternoon the input was due.

Like other organisations deemed ‘not relevant’ for consultation by the Reference Committee, BAA was given only two days to respond in this process.

BAA is seriously concerned about the lack of alignment to the National Medicines Policy, the selective consultation process adopted by the HTA Reference Committee, and the decided lack of focus on improving access for patients as a driving principle of this review when the average waiting time of 820 days or two and a half years dominates the PBS.

This is a public health program, and it must be treated as such with full and transparent consultation with everyone in the community, whether a clinical, industry or patient group or an individual.

BAA has supported the great work of other reviews within the federal health system, notably that of preventive health, obsesity, MBS taskforce, primary healthcare reviews and the newborn screening consultation to name but a few. The PBS and PBAC need to follow the leadership of these other stewards and custodians of public health programs.

We can do better and we must.

Our input is transparently provided in the attached document

A BUDGET THAT PRIORITISES EQUALITY AND AFFORDABILITY OF ACCESS TO OUR HEALTH SYSTEM CAN DELIVER BETTER ACCESS, AUSTRALIA

March 27, 2022

As the federal budget looms, the need for a focus on improving equality of access to health services in Australia remains critical. Individual treatment subsidies are always welcomed but the systemic shortcomings must be addressed now if we are to end the increasing tension of a system of those who have access and those who do not.

Budget 2022-23 is a chance to redefine and future-proof the system, not merely work around. Action is needed this Budget because right now:

  • PBS co-payments are tracking towards $50 per script outpacing the cost of living;

  • Australia’s babies are some of the least protected in the world for early screening and diagnosis of rare diseases;

  • Patients managing opioid addiction are being financially discriminated against by the government despite the protections of the law;

  • Average wait times for access to subsidised medicines are over 820 days and growing; and

  • Patients are being forced to accept huge out of pocket costs in their access to specialists for primary healthcare, none of which is covered by their private health insurance.

This week’s budget needs to:

  1. Introduce a mid-tier co-payment for the PBS based on Family Tax Benefit A, recognising the challenges for individuals, couples and families earning less than $136,000 and freezing indexation growth for 5 years

  2. Introduce an expanded and nationally consistent newborn bloodspot screening program following a once-off catch up review, with the new program rolled out by 1 July 2023 based on the funding model for the National Immunisation Program

  3. End the government’s requirement for pharmacies to charge out of pocket fees for access to medicines for managing opioid addiction and bring their distribution and subsidy into line with all other PBS medicines by 1 July 2022

  4. Establish a #100days from medicine and device registration to subsidy target in Australia to improve access to all therapeutics irrespective of indication or patient population with program administration and contracting based on this new standard

  5. Reduce out of pocket costs for patients obliged to see specialists on an annual basis to maintain access to ongoing PBS medicines used in the primary care setting

  6. Conduct a consumer-need analysis of private health in Australia recognising the interaction between the public and private health systems and the increasing use of private healthcare outside the hospital setting with no insurance coverage.

Full details in press release here.

HALTING REVIEW OF NATIONAL MEDICINES POLICY WON’T FIX INHERENT FLAWS
BAA CALLS FOR RESET FOR GENUINE REVIEW

March 24, 2022

The Government has decided to hold off the finalisation of the NMP Review until after the federal election.

BAA is sure that the 150 plus submission makers to the Review and in particular the individual patients and patient groups who have expressed so much concern about this process and the draft policy, will be greatly relieved that there is still a chance to comprehensively review the policy and not merely undertake a tick and flick ‘refresh’.

In welcoming this advice from the Minister to one stakeholder, we note this decision could have and should have been taken a lot earlier given the impost and stress it placed on many in the community trying to meet the response times over the past six months. The important thing is that the decision to stop the Review has been taken. The challenge now is where to from here? This cannot simply be a delay - it must mark change.

For Better Access Australia and the individuals and groups who published their submissions on our website, gave us input to the redrafting of the NMP, our work does not stop here.

We will be releasing our draft of the NMP for anyone to use as a new starting point as they see fit. It will be based on the input of patients, the community, clinicians and industry. We are committed to producing a document that reflects the community’s input.

BAA has written to the Prime Minister asking for this Review to be recommenced from a first principles basis after the election with an independent Chair, new terms of reference reflecting the community’s feedback, and a proper timetable for genuine policy development. Importantly, we will be asking for full transparency – no hidden sub-reports - just a community and patient led policy development process.

We are all acutely aware that the principles in the NMP will permeate and dictate not just medicines and vaccines access but as we increasingly see, access to diagnostics, therapeutics and devices. Maybe now we can give everyone involved in the process the opportunity to focus on that stewardship role.

Read our letter to the Prime Minister in full here.

THIS YEAR’S BUDGET NEEDS ACTION NOT WORDS AS POLLING SHOWS OVERWHELMING SUPPORT FOR EXPANSION OF NEWBORN SCREENING IN AUSTRALIA - WHATEVER IT COSTS

March 24, 2022

"I lost my son because newborn screening in Australia does not currently include Severe Combined Immunodeficiency (SCID), despite the rest of our industrialized neighbours having it. An updated newborn screening would have meant my son would be alive today. Because we knew about it in my second child we were able to save his life and he is a thriving toddler now" (Joh, mum of two).

As last year's Women's Budget Statement acknowledged, too many children are being lost to perinatal and congenital health conditions.

In this year's Budget Better Access Australia calls for action not words as national poll shows overwhelming support for newborn screening reform.

Many of these deaths could be avoided by bringing Australia's 1990s newborn screening program into the 21st century, including rare diseases that babies across Europe and the United States receive screening for every day.

The national polling shows the Australian community know that the current state of newborn screening in Australia for rare diseases is simply not good enough and it's time to fix this - whatever it costs.

84% of respondents agreed that Australia should screen newborn babies for more diseases than the current 25, with 68% saying whatever it costs to match California's standard of care at 80 diseases.

Families, patients, health professionals and the public agrees, it's time for updated and universal newborn screening now.

Please view the attached media release here.

Full details of the survey are available here.

ON WORLD RARE DISEASE DAY
PROOF THAT #100DAYS FROM DRUG REGISTRATION TO PBS SUBSIDY IS POSSIBLE

February 28, 2022

On Friday 25 February the PBAC released advice that it had found the drug molnupiravir used to treat COVID infection to be clinically effective and cost effective for listing on the PBS in the community setting.

In doing so they ensure pharmacists will be fairly remunerated for dispensing, and patients can purchase the product with the full protections of PBS co-payments and safety nets.

“This record assessment process for recommending and subsidising a medicine should be welcomed by everyone in Australia waiting for access to a medicine on the PBS” BAA Chair Felicity McNeill said.

“Today the PBAC and Department have shown that their HTA process can take a medicine provisionally listed on the Australian Registry of Therapeutic Goods (ARTG) on a limited dossier and assess it for cost-effectiveness under the National Health Act and find it suitable to list and deliver into a patient’s hands with a PBS co-payment in less than 40 days. It truly is a miracle.”

For patients – this is the window of opportunity we have all been waiting for. But only if industry and community hold the system to account for its decisions.

“When listings on the PBS are taking on average 820 days post ARTG registration, this is the innovation we have all been waiting for.

Better Access Australia first commenced advocating for a #100days from ARTG to subsidy process as part of its submission to the Zimmerman Inquiry, and again called for this reform as part of our 2022-23 pre-budget submission.

“28 February is World Rare Disease Day. We can only hope that the waiting times for breakthrough treatments for diseases such as cystic fibrosis, spinal muscular atrophy, Pompe, X-linked hypophosphataemia (XLH) and Leber congenital amaurosis might now be given this same expeditated process to make #100days a reality,” Ms McNeill said.

Read media release in full here.

IS THE GOVERNMENT ABOUT TO TAKE MEDICINES OFF THE PBS
BAA CALLS FOR A HALT TO THE NMP REVIEW AND DO THIS OURSELVES

February 17, 2022

Better Access Australia has written to the Prime Minister asking for urgent clarification on whether the Government is pursuing a policy of removing medicines from the PBS as part of its new National Medicines Policy (NMP) and to call a halt to the Review until after the election.

In an effort to rush this Review for completion patient and community input has been largely set aside.

More concerning is the inclusion of statements within the draft policy emphasising disinvestment in medicines, budget constraints and limiting patient access – a first for the national medicines policy, and at odds with every other health policy or strategy on the Department of Health’s website currently framing our leader’s priority of investment in health decisions.

Better Access Australia has commenced redrafting the NMP to reflect the feedback from the 120 publicly available submissions and is calling on others in the community to be part of the redrafting process.

Read the press release in full here.

Read BAA’s letter to the Prime Minister here.

BAA ASKS FOR EXTENSION ON RUSHED PERIOD OF STAKEHOLDER COMMENT ON NATIONAL MEDICINES POLICY DRAFT

February 03, 2022

Better Access Australia (BAA) encourages patient groups and individuals to ask for an extension on current NMP consultation process.

BAA has labelled the two-week consultation process on the draft National Medicines Policy document released today as farcical, and contemptuous of the effort over 150 stakeholders have already invested in the process.

BAA has requested the minister for health and the shadow minister for health support an extension to the two-week consultation period as a show of bipartisan support for the Australian community and this important public health policy.

This review had bipartisan support in the 2019 election period following election commitment requests by Medicines Australia for the review to be undertaken. We hope that continued joint commitment to medicines access in Australia can be put towards ending this unnecessary rush on a policy, inconsistent with the way the health system engages on any other public health consultation process.

We will also be drawing attention to the community that the period for reflection and comment is now open so that all who want to have their voice heard are made aware.

Full media release available here.

To read our letter to the Minister for Health in full, please click here (and for his response, please click here).

To read our letter to the Shadow Minister for Health in full, please click here.

BETTER ACCESS AUSTRALIA’S PRE-BUDGET SUBMISSION
CALLING FOR GOVERNMENT TO #MINDTHEGAP FOR AUSTRALIAN COMMUNITY

January 31, 2022

Calling for six areas to #MindTheGap, our submission to the government asks for:

1) A national Newborn Bloodspot Screening program to match international best practice of up to 80 diseases.

2) End the government-mandated discrimination by making all medicines that treat opioid dependence, a recognised disability, subject to the PBS co-payment and safety-net provisions as afforded to every other medicine on the PBS.

3) Daily medicine access to be made affordable for families once again by reducing the general PBS co-payment from $42.50 to $20 per script.

4) End the 820-day average wait by making a 100 day policy from TGA approval to subsidised access for medicines and medical devices.

5) End the costs to patients and costs to government of unnecessary annual referrals to specialists for long-term treatment of a chronic disease.

6) Change the emphasis of Private Health Reform to better capture the consumer interest in health coverage expectations rather than an exclusive debate between government and insurers on cost of devices and annual price increases.

These proposals are a combination of targeted reforms for some of the most vulnerable in our community as well as system-wide reforms to benefit the entire population.

Better Access Australia’s 2022-2023 Pre-Budget Submission is available to read here.

TOO LITTLE, TOO LATE
NMP REVIEW TEAM BACKFLIPS AND RELEASES SUBMISSIONS TO PUBLIC

January 24, 2022

Following close to three months of pressure to make them available to the public, 120 of the 156 submissions made to the National Medicines Policy (NMP) Review have finally been published online on the Department of Health’s website.

Better Access Australia (BAA) had previously launched a webpage, #voicesthatcannotbeheard, to host and link to submissions in one place whilst the public waited for the Department to make them available.

To read BAA’s full response, as published in PharmaInFocus please click here.

*Permission to publish this article was sought and received from PharmaInFocus prior to uploading article.

ACTIONS SPEAK LOUDER THAN WORDS
NATIONAL MEDICINES POLICY REVIEW CALLS FOR TRANSPARENCY BUT DOES NOT PROVIDE IT

November 3, 2021

Better Access Australia (BAA) has established a webpage with links to publicly available submissions made to the National Medicines Policy review.

The webpage is in response to confirmation the Department of Health will not make the submissions publicly available.

In a review process that asks the community to comment on whether accountability and transparency should be a pillar of any future medicines access policy, the Department of Health has determined that submissions will not be released.

Instead, a list of those who submitted will be included in the final report with interested readers free to search for contributions on individual organisations or patient websites.

Where is the transparency or best practice consultation in this approach?

To read the full media release, click here.

To read view some of the collated submissions please visit our #voicesthatcannotbeheard webpage.

We are calling for further submissions to be made available, to have yours published alongside others please email a PDF copy to tdavies@betteraccessaustralia.org.au under the subject ‘Our NMP Submission’.

“Patients as an afterthought must stop”

Better Access Australia’s submission to the National Medicines Policy Review

October 25, 2021

The original National Medicines Policy (NMP) was broader than just savings, but it has been weaponised such that its focus on affordability has become almost the sole focus of its influence. Better Access Australia is calling for an NMP that breaks down the silos and sees medicine policy as integrated into our national health system. A new contemporary NMP must recognise the interdependencies of the system and embrace it and be a leader in this long discussed but poorly executed area of health service.

The NMP must focus on patient health, patient outcomes, patient need as its primary objective. Patients as an afterthought must stop.

The NMP as currently drafted has allowed for a universal waiting system for medicines in Australia to reach unacceptable levels. Our medicines policy must increasingly grapple with the cost of delayed treatment due to delayed subsidy and delayed diagnosis. Better Access Australia is seeking an NMP that addresses these issues.

Better Access Australia wants to see ‘timely access’ as an equal and driving principle for a future NMP. An NMP that emphasises patient need and de-emphasises the over importance the system currently places on the cost to government.

To read the full submission BAA made, click here.

CONCERNS THAT CONSUMER VOICES CAN’T BE FULLY HEARD IN A REVIEW OF ESSENTIAL POLICY

7 October 2021

Better Access Australia has written to the Minister for Health requesting that consumers be given a greater chance to participate in the National Medicines Policy (NMP) Review.

It is essential to ensure that all Australians who want to participate in a meaningful way to this important review process are able to.

In order to future-proof the NMP for the next twenty years it is crucial that consumer voices are heard. Better Access Australia is concerned that the time frame has been too short to ensure quality submissions can be made.

Please read our letter here.

 

BILL ABOLISHING THE PROTECTIONS OF S135A OF THE NATIONAL HEALTH ACT SHOULD BE IMMEDIATELY WITHDRAWN

19 April 2021

Better Access Australia (BAA) is committed to advocating for improved access to health and continuity of care for all Australians. This is why BAA has written to health minister Greg Hunt calling for the withdrawal of a Bill that has raised serious concerns amongst stakeholders over the implications for access to medicines in Australia.

A copy of the Letter to the Minister for Health can be accessed here.

A copy of this media release can be accessed here.

 

UNINTENDED CONSEQUENCES OF GOOD INTENTIONS?

7 April 2021

The Senate is currently considering the National Health Amendment (Pharmaceutical Benefits Transparency and Cost Recovery) Bill 2021. Could this Bill have unintended consequences affecting Australian patients’ access to future medicines and technologies?

“Better Access Australia supports transparency in decision-making for the health and disabilities sector from all parties. Any move to improve consumer awareness of the system that determines their health and support services access is welcomed but that transparency must come from both sides – government and industry. And it must only be after full consultation to ensure there are no unintended consequences.

In particular, BAA recognises the health technology sectors’ increasing concerns about international reference pricing and the risks for timely access to new technologies and treatments in Australia.  Our lack of access to the COVID-19 vaccine demonstrates the risk of being last in line.

Australians currently wait an average 820 days for subsidised access to a new medicine following safety and efficacy approval by the TGA. This is too long and could be made worse by this measure. BAA wants no more than 100 days from TGA approval to government funded access to subsidised treatment. It is beholden on the Government in introducing these new measures to reassure patients this approach will improve access not jeopardise the already tardy access to treatments in Australia. 

We ask the Senate to refer this Bill to the Community Affairs Committee to ensure all implications of this Bill are understood and consulted upon. The Zimmerman inquiry is currently exploring all barriers to new technologies in Australia, we should not be adding risks to access without a clear and transparent consultation process.” 

A copy of this media release can be accessed here.

PUSHING POOR MEDICINE CHOICES TO SAVE MONEY WITH NO TRANSPARENCY

17 December 2020

NPS MedicineWise has combined with some patient and other groups to recommend 70yr old methotrexate instead of the appropriate use of biologicals. The only purpose is to achieve government savings of over $50M - this is a FACT.

Better Access Australia supports clinically appropriate prescribing of medicines. Yet these medicines are 50% cheaper than when 1st listed. Time for earlier intervention to stop burden of disease, not higher use of treatment that cause significant side effects in up to 65% of patients.

Media Release here

NEW DRUGS AND NOVEL MEDICAL TECHNOLOGIES INQUIRY

9 November 2020

Better Access Australia has provided a submission to the “Inquiry into the approval processes for new drugs and novel medical technologies in Australia, with a particular focus on those for the treatment of rare diseases and conditions where there is high unmet clinical need.

Better Access Australia argues:

“Rare disease or chronic disease, people are waiting too long - we need a system led apporach to reform, not a disease led approach to reform. All patients are equal in their need for access.”  

Read Better Access Australia’s submission here.