Parties declare war over drugs

Access to medicines has become an election battleground, with the Coalition warning a Labor pledge to keep the cost of prescription drugs down will push many lifesaving treatments out of reach.

In his second major health announcement of the campaign, Opposition leader Bill Shorten announced a Labor Government would scrap Coalition plans to increase the patient co-payment for Pharmaceutical Benefit Scheme medicines and lift safety net thresholds.

The measure, which Labor estimates will cost $971 billion over four years and $3.6 billion over a decade, seeks to undo changes unveiled by Joe Hockey in the 2014 Budget to add $5 to the $38.30 PBS co-payment for general patients and 80 cents to the $6.20 co-payment for concession card patient.

In addition, Labor has promised not to increase safety net thresholds (currently at $1475.70 for general patients and ($372 for concessional patients) faster than inflation – as opposed to Coalition plans for an annual 10 per cent increase.

Legislation to implement the 2014 Budget changes has been stalled in the Senate but was included in the most recent Budget, indicating that the Government remains committed to its implementation, and creating an opening for Labor.

“Malcolm Turnbull confirmed his commitment to these cuts by building them into his first Budget earlier this month,” Mr Shorten said. “Labor will not stand by and let Malcolm Turnbull and the Liberals dismantle universal health care. Labor believes every Australia deserves access to affordable medicine.”

Mr Shorten said Labor’s promise would be funded from the proceeds of ditching the Coalition’s planned $50 billion company tax cut.

But the Prime Minister hit back by calling into question whether a future Labor Government would be able to afford to subsidise access to new but often hugely expensive treatments for cancer, hepatitis and other serious illnesses.

Mr Turnbull said that by managing “the health budget well, we have been able to bring onto the PBS $3 billion worth of new medicines”.

The Government claims that since coming to office it has funded the addition of almost 1000 medicines worth about $4.4 billion to the PBS, including treatments for hepatitis C, melanoma, breast cancer and diabetes.

Health Minster Sussan Ley accused Labor of having “no plan for listing medicines at all. I see increased spending, poorly targeted. I do not see any of the reforms necessary to do what the Coalition has been able to do in the medicines listing space”.

Among its election promises, the Coalition has announced it will invest $7 million to make Australia an easier place to conduct clinical trials – potentially giving Australians early access to access to breakthrough treatments.

The Minister said the Coalition had a much stronger record than Labor of listing new drugs – “We are talking about breakthrough cures here. There is no time to wait. We know we will list it and the Labor Party will not”.

But Shadow Health Minster Catherine King said Labor would maintain the arrangement under which new drugs were assessed for listing on the PBS by the Pharmaceutical Benefits Advisory Committee, including the threshold set by the Coalition over which approval must be considered by Cabinet.

AMA President Professor Brian Owler welcomed Labor’s pledge to dump the planned PBS patient co-payments and changes to safety net threshold indexation.

Professor Owler said the Coalition had sought to impose new and higher costs of patients “at all levels” of the health system, including GPs, pathology, diagnostic imaging and prescriptions.

“This is deterring those that can least afford it from going and filling their prescription,” he told Sky News. “So Labor’s pledge is very welcome, and I think patients should be very pleased about that. Particularly those with complex and chronic illnesses.”

Professor Owler said it was wrong for the Minister to claim Labor would not list new drugs.

“The recommendations [to list drugs] come through an independent committee through the PBAC process, and that’s a very robust assessment process, and then the recommendations are made,” he said. “Now, there have been some very good things that have been done, particularly around the hep-C medicines that have been funded, and that’s been very good for those patients, but that doesn’t preclude that happening under Labor’s plans.”

Adrian Rollins

Pathology deal a fresh assault on medical practices

The Federal Government has intensified its assault on medical practice incomes, promising to clamp down on rents charged for pathology collection centres in exchange for an end to the pathology sector’s damaging campaign over cuts to bulk billing incentives.

Just two weeks after it announced a two-year extension of the Medicare rebate freeze to 2020, ripping $925 million out of primary and specialist care, the Government has sliced further into practice earnings by stitching up a peace deal with Pathology Australia that analysts predict will force collection centre rents down by 30 per cent and leave major players like Sonic Healthcare and Primary Healthcare up to $100 million a year better off.

Prime Minister Malcom Turnbull announced the agreement during his first televised debate with Opposition leader Bill Shorten, declaring that it meant that “the concern that has been expressed about patients who go to have their blood tests done and so forth being charged extra, not being bulk billed, is… that concern is gone; the pathologists have agreed to continue bulk billing”.

But the Prime Minister’s boast could be premature.

Primary Healthcare, which holds 34 per cent of the market and is not a member of Pathology Australia, has written to doctors to distance itself from the deal, and smaller pathology providers complain it does little for them and they will have to begin charging patients a co-payment of up to $50.

AMA President Professor Brian Owler said the deal “doesn’t guarantee anything”.

“The cut to bulk billing incentives for pathology has merely been deferred. The cuts are still there, they’re still taking $650 million out of health over the next four years,” Professor Owler said.

Professor Owler said he had been in contact with Pathology Australia about the deal, and they had admitted there was no guarantee the pathologists would continue to bulk bill.

“They don’t have the ability to make that guarantee, and it will be up to the individual pathology companies to actually make that decision over time,” he said.

Under the deal, the Government has committed that, if it is re-elected, it will delay bulk billing incentive cuts by around three months while it introduces provisions to the Health Insurance Act to clarify what is meant by ‘market value’ and link it with local commercial market rents.

This will be backed by “appropriate compliance mechanisms”, and those seeking to register collection centres will need to provide more information.

Pathology Australia said the reduced rents would enable its members to absorb the bulk billing incentive cuts and sustain current rates of bulk billing. As a result, the organisation has agreed to drop its national “Don’t Kill Bulk Bill” campaign.

The announcement amounts to a backflip by Health Minister Sussan Ley.

In a review of Approved Pathology Collection centre arrangements last year, Ms Ley rejected pathology sector calls for a change in the definition of ‘market value’ and determined that existing regulations regarding prohibited practices and market rent were appropriate.

Macquarie Securities analyst Craig Collie told Guardian Australia that Sonic Healthcare could be up to $70 million a year better off under the Government deal.

Mr Collie estimated the company would save about $116 million a year on rent at its 2000 collection centres, which more than offset the $50 million cost of losing the bulk billing incentive.

Guardian Australia reported that both Sonic and Pathology Australia have been major Coalition donors in recent years.

There are around 4000 collection centres across the country, and medical practitioners have warned the Government will need to consult closely with general practice to ensure that the new regulations are not simply a form of price control that puts many existing leases into jeopardy.

The Government has declared there will be a moratorium on any new collection centre approvals until the new regulations are in place, and “the measure to remove bulk billing incentives will commence at the date that the changes to the regulatory framework take effect”.

But Professor Owler said that, even with the deal, there was no getting away from the fact that the Government was ripping hundreds of millions of dollars out of pathology services.

“To suggest that somehow the concern is now gone I think overstates the results of the agreement that was reached between the Government and Pathology Australia,” he said. “There will be some easing of costs pressures through this change to rents, but at the end of the day they are still experiencing a very significant cut.”

St Vincent’s Health Australia Chief Executive Toby Hall told the Adelaide Advertiser the axing of the bulk billing incentive would rip $3 million from his organisation’s bottom line, forcing them to consider “some form of patient co-payment. I think we’d have to look at between $20 and $50”.

And the deal has done nothing to address the cut to bulk billing incentives for diagnostic imaging services.

The Australian Diagnostic Imaging Association warned patients still faced cuts to their rebates for x-rays, CT scans, MRIs and ultrasounds, and smaller pathology companies cautioned they would be forced to charge out-of-pocket expenses despite the Government’s deal.

Adrian Rollins

Labor’s antifreeze policy puts heat on Coalition

Main points

Labor promises to resume Medicare rebate indexation
Policy to cost $12.2 billion over 10 years
Welcomed by AMA as a win for patients

Labor has pledged to resume indexation of the Medicare patient rebate from 1 January next year if it wins the Federal Election, in a $12 billion commitment hailed as a big win for patients.

Seeking to outflank the Coalition on health, Opposition leader Bill Shorten has announced that a Labor Government would lift the Medicare rebate freeze and reinstate indexation, at a cost of $2.4 billion over four years and $12.2 billion over a decade.

The announcement came just days after the AMA launched a national campaign against the freeze, warning it would force many GPs to abandon bulk billing and begin charging patients up to $20 or more per visit.

“Nobody wants to head down the same path as America when it comes to our health system,” Mr Shorten said. “We will reverse Mr Turnbull’s cuts, which will reduce bulk billing and hit Australian families every time they visit the doctor.”

AMA President Professor Brian Owler said Labor’s announcement established a “real difference” between the major parties on health policy.

“Labor’s promise to lift the Medicare rebate freeze will be welcomed by doctors – GPs and other specialists – and patients across the country,” Professor Owler said. “Patients are the big winners from this announcement, especially working families with a few kids, the elderly, the chronically ill, and the most vulnerable in the community.”

In its Budget unveiled earlier this month, the Government announced that it would save $925 million by extending the Medicare rebate freeze, already in place from 2014 to 2018, through to 2020.

Medicare rebates were first frozen by Labor in November 2013 for eight months, but they have since been extended twice by the Coalition Government after failing in its attempts to introduce a patient co-payment.

Professor Owler said the freeze amounted to a “co-payment by stealth” by forcing medical practices to dump bulk billing and begin charging patients if they were to remain financially viable.

He said that for years GPs have done their best to shelter patients from the impact of the freeze, but the decision to extend it to 2020 would push many medical practices over the edge.

“Many GPs are now at a tipping point. With the freeze stretching out for seven years, they have no choice but to pass on the increased costs of running their practices to patients,” the AMA President said. “The Medicare rebate freeze is bad policy, and it should be scrapped.”

Bulk billing climbs

Last week, Health Minister Sussan Ley trumpeted official figures showing the GP bulk billing rate climbed to 84.8 per cent between July last year and March this year to argue that the Government was investing heavily in Medicare.

But Professor Owler said that the Government’s Budget decision to hold Medicare rebates down for a further two years was causing medical practices across the country to reconsider their finances and billing arrangements.

“The extension of the freeze for another two years under the last Budget has prompted many doctors now to contact the AMA requesting our help to transition them from bulk billing practices to ones that charge a fee,” he told Sky News. “Unless the freeze is lifted, I think we are going to see more costs being passed on to patients and so that’s why Labour’s announcement today is indeed very welcome by GPs but I think also by patients around the country.”

Labor’s promise has been costed by the Parliamentary Budget Office, and Opposition said it would be paid for by scrapping the $1000 bonus for single-income families with a child younger than one year, (saving $1.4 billion over 10 years), capping vocational education loans at $8000 ($6 billion over 10 years) and axing business tax cuts, saving more than $4.7 billion over four years (Labor would retain some relief for businesses with a turnover of less than $2 million).

The funding arrangement means Labor will be able to campaign on the claim that it is putting access to primary health care before tax cuts for business.

“This is about choices,” Shaodw Helath Minster Catherine King said on ABC Radio. “People get sick. We want people to go to what is in fact, the cheapest and most efficient part of our system, your GP, to stay well, to manage your chronic conditions, manage episodic illness, because if we don’t do that, people end up in the more expensive part of the system, the acute system where we are again, facing increasing demand.”

Ms King said that by reducing the barriers to people seeing their GP, the policy would help contain the growth in health costs.

“What we want to be able to do is actually have as many people going to your general practitioner because it is our cheapest part of the system, frankly. It’s the most efficient part of the system,” she said. “We want people to go for prevention. We want people to go and get advice about how do you manage obesity, if you find that you’ve got heart disease in the family, we want them to go and use the Medicare system to stay well and that is how you contain costs in the more expensive part of the system, our hospital system, by actually keeping people well.”

But Labor has so far resisted calls to reinstate bulk billing incentives for pathology and diagnostic imaging services.

Adrian Rollins

Pathologists happy with new deal but it’s ‘another blow for GPs’

GPs have expressed concerns over the Coalition’s announcement that it will cap rent on pathology collection centres.

The deal would take place under a returned Turnbull Coalition Government and will help reduce regulatory cost pressures on pathology providers to help them provide affordable services and maintain current bulk billing rates.

It’s a move that is supported by the Royal College of Pathologists of Australasia:

“The Coalition’s new proposed plans will see a delay in the changes to the bulk billing incentive, as well as a solution to the high cost of rents being paid for pathology collection centres. In addition there will be a moratorium for the next 3 years on any further changes to Pathology Services Table without agreement from the profession. The RCPA believes this will result in the profession maintaining the current billing practices and high quality services and efficiencies offered,” Dr Michael Harrison, President of the RCPA said.

However the Royal Australian College of General Practitioners says the changes are another blow to GPs, on top of the ongoing Medical Benefits Freeze.

“The RACGP has always supported universal access to healthcare services and therefore welcomes the announcement of continued bulk-billing arrangements for pathology services,” RACGP President Dr Frank Jones said.

“However, the proposed changes effectively create an anti-competitive environment, where multi-national corporations who make hundreds of millions of profit each year are propped up, while GPs running small businesses lose funding.”

AMA President Professor Brian Owler said the deal “doesn’t guarantee anything”.

He also said there is no guarantee that the pathologists will not abandon bulk billing.

When he spoke to Pathology Australia, they admitted they don’t have the ability to make that guarantee.

“It will be up to the individual pathology companies to actually make that decision over time,” he said.

Latest news:

Freeze a white-hot election issue

The Medicare rebate freeze is set to become a top issue in the Federal Election following the launch of a nationwide AMA campaign targeting Coalition MPs and candidates over the issue.

In a blow for Malcolm Turnbull as he seeks to win his first election as Prime Minister, the nation’s peak medical organisation is mobilising doctors and patients, accusing the Government of cutting Medicare and trying to sneak through a tax that would hit every Australian household.

AMA President Professor Brian Owler said that ever since Budget night the AMA has been flooded with complaints from medical practitioners and members of the public outraged by the Government’s decision.

“The Medicare freeze is not just a co-payment by stealth – it is a sneaky tax that punishes every Australian family,” Professor Owler said. “It will hit working families with kids really hard. It will hit people with chronic illness, and it will hit the elderly.”

The Budget decision to extend the Medicare rebate freeze through to 2020, at a saving of almost $1 billion over four years, has undermined Government attempts to neutralise health as an issue in the Federal Election.

Prime Minister Malcolm Turnbull acted to get public hospital funding out of the headlines by giving the states and territories an extra $2.9 billion at a Council of Australian Governments meeting last month, and Health Minister Sussan Ley has been accused of trying to deflect public attention by mounting attacks on the professionalism and integrity of doctors and other health workers.

But the Government, which has previously been forced to back down on plans to introduce patient co-payments in the face of widespread doctor and patient fury, faces a similar outcry over the extended Medicare freeze.

Professor Owler said the decision placed GPs and other specialists under enormous financial strain and left them no choice but pass their increased costs onto their patients.

“The costs of running a medical practice – rents, staff, technology and equipment, indemnity insurance, accreditation – continue to rise year-on-year,” the AMA President said. “Many doctors have absorbed the impact of the freeze until now, but the two-year extension has pushed them over the edge. Their businesses are now struggling to remain viable.”

Professor Owler has warned that for practices that have traditionally bulk billed their patients, moving to a model in which they begin to charge some will be expensive.

To recoup the outlay and cover associated costs, patients faced being charged up to $30 or more a visit, he said.

Combined with the Government’s decision to axe bulk billing incentives for pathology and diagnostic imaging services, it meant that patients would “face higher costs for their health every step of their health care journey – every GP visit, every specialist visit, every blood test, every x-ray”.

Posters supporting the #nomedicarefreeze campaign are being distributed to 30,000 GPs and other medical specialists around the country, and doctors and patients are being provided with the contact details of MPs and candidates in every electorate.

Professor Owler said the medical profession was united in its efforts to put an end to the Medicare freeze, and the AMA campaign would complement those of other medical organisations.

For information and to download campaign materials, visit: ama.com.au/nomedicarefreeze

Adrian Rollins

Latest news:

Vote #1 Health

The AMA has called on whoever wins the Federal Election to bring an immediate end to the Medicare rebate freeze, boost public hospital funding and retain bulk billing incentives for pathology and diagnostic imaging services.

Launching the AMA’s policy manifesto for the election at Parliament House today, AMA President Professor Brian Owler said health will be at the core of the contest between the major parties, and whoever forms government “must significantly invest in the health of the Australian people”.

“Elections are about choices. The type of health system we want is one of those crucial decisions,” Professor Owler said.

The Turnbull Government is facing a backlash from patients and the medical profession over a series of controversial funding cuts, including the Budget move to extend the Medicare rebate freeze to 2020, to slash billions from the future funding of public hospitals, and to axe bulk billing incentives for pathology services.

The Medicare rebate freeze, initially introduced by Labor in 2013 and extended twice by the Coalition since, has been condemned as a policy to introduce a patient co-payment “by stealth”, with warnings it threatens the financial viability of many practices and will force many GPs to abandon bulk billing and begin to charge their patients.

“The freeze on MBS indexation will create a two-tier health system, where those who can afford to pay for their medical treatment receive the best care and those who cannot are forced to delay their treatment or avoid it altogether,” the AMA’s Key Health Issues for the 2016 Federal Election document said.

Professor Owler said the freeze will mean “patients pay more for their health care. It also affects the viability of medical practices.”

The AMA President has also warned that massive cuts to public hospital funding were likely to stymie improvements in their performance and increase the delays patients face.

In 2014, the Coalition Government announced it would scale back growth in hospital funding, savings $57 billion over 10 years, provoking a storm of protest from State and Territory governments. To try to placate them ahead of the Federal Election, Prime Minister Malcolm Turnbull thrashed out a deal to provide an extra $2.9 billion over the three years to 2020.

But Professor Owler said the funds were an inadequate short-term fix that fell “well short of what is needed for the long term”.

The AMA has called on the major parties to commit to adequate long-term public hospital funding, including an annual rate indexation that provides for population growth and demographic change.

The Government is also under pressure over its decision to save $650 million over four years by scrapping bulk billing incentives for pathology services and reducing them for diagnostic imaging services, with loud warnings it will deter many patients, particularly the sickest and most vulnerable, from undertaking the tests they need to manage their health and stay out of hospital.

The AMA said the move was a “short-sighted policy that will ultimately cost future government and the Australian community much more in having to treat more complicated disease – disease that could have been identified or avoided through good access to pathology and diagnostic imaging services”.

It said the major parties should commit to maintaining the current subsidies.

In addition, the AMA is calling for all those contesting the Federal Election to commit to:

advancing the care of patients with chronic illnesses by providing adequate funding of the Government’s Health Care Homes trial;
ensuring the medical workforce meets future community need by boosting GP and specialist training programs and completing workforce modelling by the end of 2018;
increasing funding for Indigenous health services and strengthen programs to address preventable health problems;
improving the GP infrastructure grants program;
increasing investment in preventive health initiatives;
cracking down on the marketing and promotion of e-cigarettes, including banning their sale to children; and
adopting a National Physical Activity Strategy to improve health and reduce the incidence of obesity, heart disease, diabetes, stroke and other illnesses.

“The next Government must significantly invest in the health of the Australian people,” Professor Owler said. “Investment in health is the best investment that governments can make.”

The AMA’s Key Health Issues for the 2016 Federal Election document is available at article/key-health-issues-federal-election-2016

Adrian Rollins

Don’t shoot the messenger

The Turnbull Government, led by Health Minister Sussan Ley, has recently made a habit of launching attacks on health professionals to justify its health policy decisions, especially the cuts to funding and services and the cost shifting.

It has not just been doctors in the firing line, although the Government has made a habit of demonising GPs, surgeons, radiologists, pathologists, and anaesthetists on a regular basis.

If not through direct attack, it has been via friendly journalists on the drip, or under cover of disenchanted private health insurers desperate to avoid the spotlight as their own sector is under forensic review.

Dentists have been copping it lately, joining the growing queue of health professionals being blamed for the Government’s health policy mistakes and misadventures. Pharmacists and nurses have also come under attack, and they are not amused, and do not take these attacks lightly.

None of the health professions appreciate being criticised publicly in the media, especially when these attacks do not reflect what is discussed in private meetings.

The public – voters – do not like it, either.

Every poll of the professions in living memory has doctors, nurses, and pharmacists rated as the most trusted professions in the community. People trust their doctors and other health professionals. They do not like the ugly spectacle of politicians and some in the media attacking the integrity of health professionals. Needless to say, politicians rate very low on the trusted profession scale.

So, what is behind the misguided strategy of demonising doctors and other health professionals so close to an election? There can’t be any votes in it.

You would think that an incumbent Government would want to win the hearts and minds of health sector leaders in the months ahead of a Federal Election, and on the eve of the Federal Budget, which will shape the direction of the Coalition’s election health policies.

But this is not the case.

Doctors, pharmacists, nurses, Aboriginal health services, and even medical receptionists, have in the past week been blamed for rorts and waste in the system, with incorrect and inaccurate statistics being used to push these mischievous claims.

This is all subterfuge to keep the public focus off the main game – the fact that the Government’s health policies, in the main, are all about making savings to the Budget, not improving access to quality affordable health care for all Australians.

The Government’s ongoing justification for its extreme health savings measures, including cuts to public hospital funding, has been that Australia’s health spending is unsustainable. This is simply not true.

The most recent comparative figures reported by the OECD show Australia’s health expenditure as a proportion of GDP was below the OECD average and lower than 18 other OECD countries.

Australia’s health costs (8.8 per cent), as assessed by the OECD, were just over half the corresponding proportion for the USA (16.4 per cent). Australia achieves better health outcomes for its significantly lower proportional spend than the USA and many other countries, with the second highest life expectancy in the world, with the exception of Indigenous Australians.

Moreover, the Commonwealth Government’s total health expenditure is reducing as a percentage of the total Commonwealth Budget. In the 2014-15 Commonwealth Budget, health was 16.13 per cent of the total, down from 18.09 per cent in 2006-07. It reduced further in the 2015-16 Budget, representing only 15.97 per cent of the total Commonwealth Budget.

Clearly, total health spending is not out of control. Nor is spending on medical services.

The reality is that today we are not spending any more on medical services as a proportion of total health spending than we were a decade ago.

The proportion today is 18.2 per cent, compared with 18.5 per cent a decade ago. While we are spending more on health in total, we are spending less on medical services.

Today, 86 per cent of privately insured medical services are charged at no gap by the doctor – which means that the doctor accepts the fee level set by the patient’s private health insurer.

A further 6.4 per cent are charged under ‘known’ gap arrangements. This means that less than 8 per cent of privately insured patients may be charged fees exceeding private health insurance levels, including known gap amounts.

The number of doctors charging ‘excessive’ fees is in the absolute minority, and the AMA continues to work with the relevant specialist colleges, associations and societies to address this.

Nor are doctors’ fees contributing to Budget woes, with specialist fees in many cases not being indexed for up to a decade.

Contrary to the line being pushed by the Government and the private health insurers, medical services are not an issue for the insurers or for patients.

Some insurers have been only too eager to vilify doctors even though the publicly listed PHIs have posted record profits, their executives are paid multimillion dollar salaries, and when doctors charge above the PHI schedule, i.e. a gap, the PHI contribution falls to 25 per cent of the scheduled fee.

During the December 2015 quarter, insurers paid $3,542 million in hospital treatment benefits. This was broken down into 70 per cent on hospital services such as accommodation and nursing, approximately 15 per cent on medical services, and 14 per cent on prostheses.

General practice, too, has demonstrated a real willingness to work with the Government to deliver high quality reforms, particularly in relation to the treatment of patients with complex and chronic disease.

The 2016 Budget provided the Government with a real opportunity to steer a new course and a new strategy of health policy and health sector engagement, but they passed on this opportunity. We can only hope the Government is saving some health largesse to be announced ahead of the election.

Doctors and the other health professions are restless and demanding better health policy, better consultation, and greater respect in public conversations and pronouncements. We need a mature and honest exchanges of views, not sneaky media leaks and cheap attacks on our integrity and professionalism.

Doctors see millions of Australians face-to-face every day. Multiply that number when you count radiology and pathology centres, pharmacies, and other health professionals.

Some groups have already commenced campaigns against Government health policies. More will join them if there is not a change in policy direction and a change in the Government’s public relationship with the health sector.

* An edited version of this column first appeared in the Australian Financial Review on 4 May 2016.

Hep C drug mystery

The Federal Government has not disclosed how much it intends to spend on its goal of virtually eradicating hepatitis C from the country within a generation.

In one of the Government’s most ambitious public health measures, all adults with chronic hepatitis C have been provided subsidised access to hugely expensive frontline drugs that have a high rate of success in eliminating the disease within months.

More than 230,000 are estimated to be currently living with hepatitis C, which kills around 700 a year, but for most the drugs that could cure their ailment – Sofosbuvir, Daclatasvir and Ribavirin – were prohibitively expensive, costing as much as up to $100,000 for a course of treatment.

But hepatitis C have, since 1 March, had subsidised access to the drugs through the Pharmaceutical Benefits Scheme – an arrangement confirmed in the Budget.

Announcing the measure at the time, Health Minister Sussan Ley said it provided “great hope we can not only halt the spread of this deadly infectious virus, but eliminate it altogether in time”.

The Minister has explicitly linked the decision with the highly controversial move to axe bulk billing incentives for pathology services and cut them for diagnostic imaging – a measure expected to save $650 million over four years.

But in the Budget the Health Department said the cost of the measure was “not for publication”.

By contrast, it has announced that $57.6 million has been set aside to fund new and amended listings of drugs on the PBS and the Life Saving Drugs Program.

The Department said the PBS would cost $10.1 billion overall in 2016-17.

In addition, the Government has revealed it will spend $20.4 million to improve speed and efficiency of the system to regulate therapeutic goods, with the aim of bringing new drugs to market more quickly – in some cases up to two years sooner.

Under the plan, the number of committees advising the TGA will be cut from 11 to seven, costs and administrative burden for industry will be reduced, and the time taken to assess products will be reduced by up to three months by drawing on the work of comparable regulators overseas, such as the US Food and Drug Administration.

In addition, commercial organisations approved by the TGA will be allowed to undertake assessments of medical devices, and there will be new approval pathways for sponsors to add medicines and devices.

Adrian Rollins

[Series] Mitral valve disease—current management and future challenges

The field of mitral valve disease diagnosis and management is rapidly changing. New understanding of disease pathology and progression, with improvements in and increased use of sophisticated imaging modalities, have led to early diagnosis and complex treatment. In primary mitral regurgitation, surgical repair is the standard of care. Treatment of asymptomatic patients with severe mitral regurgitation in valve reference centres, in which successful repair is more than 95% and surgical mortality is less than 1%, should be the expectation for the next 5 years.

Self-sampling HPV testing versus mainstream cervical screening and HPV testing

A comprehensive review of Australia’s National Cervical Screening Program (NCSP), the Renewal, has been undertaken over the past few years.1 This review recommended a number of changes, including that human papillomavirus (HPV) testing replace conventional cytology (ie, Pap tests) as the primary screening test, with 5-yearly screening commencing at age 25. The proposals have been endorsed by the Medical Services Advisory Committee (MSAC).2

The Renewal deliberations also considered the question of the recruitment of women who had never been screened or who were underscreened, a significant concern because it has been estimated that 80% of cervical cancers are diagnosed in these women.1 One proposed solution is to offer a separate self-sampling HPV testing pathway, as studies, both in Australia 3 and internationally,4 have shown self-sampling to increase recruitment and to be advantageous in underscreened women. The Renewal proposal is that the self-sampling option be organised by a clinician who also offers routine screening. It would be offered to women who have not been screened during the previous 6 years, or who have never been screened and have declined to participate in the mainstream screening pathway. The sample would be taken by the patient, possibly in the clinic, and sent to the laboratory for testing. If the sample is positive for HPV, the patient would be asked to return to give a cytology sample.

This edition of the MJA includes the report on a study by Smith and colleagues that compared the benefits of self-sampling HPV testing with the mainstream screening program.5 One consideration for the NCSP was that offering two different screening options might cause confusion. Some women who normally undergo screening may even prefer the self-sampling option. Smith and colleagues, using a dynamic modelling approach, clearly established that self-sampling is associated with a lower risk of a cervical cancer diagnosis than not being screened. However, it also found that HPV testing as part of the recommended mainstream screening program has clear advantages over the self-sampling pathway, and that women should avail themselves of this option.

The importance of education and communication is well illustrated by the self-sampling question. Self-sampling has already received quite significant publicity in mainstream media; however, there appear to be many misconceptions. Many of the reports, for example, imply that self-sampling was the only significant change recommended and that it is significantly beneficial. Headlines such as “Australian women will be able to do their own Pap smear”6 and “You could soon be doing your own Pap smear”7 have appeared online. Such comments are confusing and misleading for both the general public and the medical profession. The study by Smith and colleagues is therefore important, as it clearly establishes that there are two different testing pathways to be preferred under different circumstances.

This difference in the two pathways also highlights how the test result can be affected by the nature of the sample and the type of HPV testing. At the last count, more than 500 different types of HPV testing are available worldwide. The technology of HPV testing is complex and variable, and, until the commencement of the new program, will have predominantly been used as a diagnostic rather than a screening test. Validated assays that assure high quality screening must be used. A recent article suggested that only HPV tests that have been subjected to large randomised trials with a long cohort follow-up be used.8 The Netherlands has recently introduced HPV self-sampling as the primary screening test, but, unlike Australia, has designated one specific type of high risk HPV assay for use.9

The Australian Renewal recommends that any type of HPV test can be used, but that the test must meet certain quality criteria. The study by Smith and colleagues points out that, although self-sampling has been shown to be beneficial, it is dependent on the nature of the HPV assay. Specific quality standards for self-sampling HPV testing will need to be set. The National Pathology Accreditation Advisory Council (NPAAC) is in the process of setting quality parameters for HPV testing and will consider the criteria for the two pathways.10 Laboratories will be left to choose which type of HPV test they perform, but the testing will have to fulfil the quality standards mandated by NPAAC.

The proposed changes to cervical screening are major and will need accurate and concise information to be distributed to both sample takers and women. The message from Smith and her colleagues is quite clear: self-sampling offers an alternative pathway for women who will not participate in routine screening, but it is significantly less beneficial than mainstream cervical screening. For both screening pathways, the quality of the HPV assay will be crucial to the success of the program and the safety of women.