JimJimJimJim's Submission - Senate Enquiry on Cancer Drugs

[Paul Edwards]

The Committee is preparing a submission to the Senate Inquiry regarding Cancer Drugs.  We're still working on it but thought that you might be interested in the latest draft.

 

 

 

Australian Advanced Prostate Cancer Support Group

 

 

Submission to the Senate Inquiry

The availability of new, innovative and specialist cancer drugs in Australia.

 

Executive Summary

1. The timing of access for patients

• It takes longer for Australian patients to get access to the new cancer medicines than in comparable countries.  This is demonstrated by the delays in access for Australian men to the new anti‑androgen drugs for prostate cancer (such as Zytiga and Xtandi).

1. The affordability of access for patients

• Delivering safe, affordable and clinically effective medicines to all Australians should remain a key government objective, particularly as those with the highest medical need often have the least capacity to purchase medicines — particularly high cost medicines.
• In order to meet the challenge of cancer drug costs, we believe it is important for Australia’s cancer prevention spending to be increased. 
• As well as gains from prevention of cancer generally, there are gains to be had from the prevention of prostate cancer.
• The combination of PSA tests with recent developments in medical imaging technology means more accurate staging of individual cancers and better treatment.  More accurate staging and better treatment means less advanced prostate cancers which require long term treatment with expensive cancer drugs.
• To ensure enhanced accuracy in diagnosing and treating prostate cancer, we request that the cost of multiparametric magnetic resonance imaging (MRI) and Gallium(Ga⁶⁸) Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans be rebateable through the Medicare system.

1. the operation of the Pharmaceutical Benefits Advisory Committee and the Pharmaceutical Benefits Scheme in relation to such drugs, including the impact of delays in the approvals process for Australian patients; 

• Cancer patients are important stakeholders who should have a greater involvement in the operation of the Pharmaceutical Benefits Advisory Committee and the Pharmaceutical Benefits Scheme.
• The restrictions under the Pharmaceutical Benefits Scheme regarding the subsidisation of Zytiga and Xtandi should be removed so that men with advanced prostate cancer may have access to subsidised Zytiga or Xtandi, regardless of whether they have previously been treated with the other drug. 
• In order to overcome delays in the Australian approval process (a) the US Food and Drug Administration multi-tiered system of ‘fast-track’, ‘accelerated approval’, and ‘priority review’ should be adopted for cancer medicines; and (approvals made by overseas agencies, including the US Food and Drug Administration and the European Medicines Agency, should be recognised by the Pharmaceutical Benefits Advisory Committee.
• The economic cost/benefit ratios and quality of life instruments that are currently used to validate and compare drugs under the PBS should be re-assessed so to take into account factors such as disease free progression and quality of life.  These factors should be evaluated from the patient’s perspective (and their families); as well as a community perspective.
• The responsiveness of the TGA registration process needs to be improved to reflect changes in the clinical setting.
• The practice of setting reimbursed prices for new medicines with reference to older comparators may sometimes be an obstacle to patient access to innovative cancer medicines.

1. The impact of delays in the approvals process for Australian patients;

• It is heartbreaking for Australian patients and their families to be aware of, but not have access to, treatments that have been evaluated overseas and proven to be effective.

Submission

This submission is made on behalf of the Australian Advanced Prostate Cancer Support Group.  The members of our Group are men from all over Australia with advanced prostate cancer.  We have monthly meetings via teleconference: this is of particular benefit to patients in rural and remote areas who do not have ready access to other community support groups.  We also conduct an online discussion forum at www.JimJimJimJim.com.

Prostate cancer is the most common cancer in Australia (its incidence is higher than breast cancer) and in 2011 3924 men died from prostate cancer.[1]

As men with advanced prostate cancer, we appreciate the benefits of the Australian healthcare system which through the Pharmaceutical Benefits Scheme provides equitable and affordable access to necessary medicines.

 

1. The timing of access for patients

A number of recent reports[2] demonstrate beyond doubt that it takes longer for Australian patients to get access to the new cancer medicines than in comparable countries.

This is certainly the case with new medicines for prostate cancer where we as Australian patients are keenly awaiting the opportunity to access the new anti‑androgen drugs (such as Zytiga and Xtandi) that have been available for several years in other countries.  Current best practice in the United States is to use one or other of these drugs once a patient with prostate cancer becomes castration-resistant and prior to chemotherapy.  If one of these drugs is not, or ceases to be, effective then the other drug will be used.  Current clinical trials are even evaluating the role of Zytiga and Xtandi as the primary hormonal therapeutic approach.  These drugs delay the need for chemotherapy with its unpleasant side-effects and offer good quality of life.  These drugs can be self-administered at home, reducing the need for hospital-based care.

Details of the delay in access to these prostate cancer drugs to Australian patients are as follows:

• Zytiga (abiraterone acetate).  

In April 2011 the U.S. Food and Drug Administration approved Zytiga in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who had received prior docetaxel (chemotherapy).

In December 2012 the U.S. Food and Drug Administration approved Zytiga for use pre-chemotherapy.

In August 2014 Zytiga became available in Australia on the Pharmaceutical Benefits Scheme post-chemotherapy.  It is still not available in Australia on the Pharmaceutical Benefits Scheme pre-chemotherapy.

• Xtandi (enzalutamide)

In August 2012, the U.S. Food and Drug Administration approved Xtandi to treat patients with late-stage (metastatic) castration-resistant prostate cancer who had received prior docetaxel (chemotherapy).

In September 2014 the U.S. Food and Drug Administration approved Xtandi for use pre-chemotherapy.

In December 2014 Xtandi became available in Australia on the Pharmaceutical Benefits Scheme post-chemotherapy.  It is still not available in Australia on the Pharmaceutical Benefits Scheme pre-chemotherapy.

1. The affordability of access for patients

We agree with the National Commission of Audit that “Delivering safe, affordable and clinically effective medicines to all Australians should remain a key government objective”[3], particularly as “those with the highest medical need often have the least capacity to purchase medicines — particularly high cost medicines.”[4]

We understand the challenge to the health system of increasing medicine costs: with an ageing population, there is an increasing number of cancer patients who will require long term treatment with drugs which are very expensive.

However, we consider that it is a mistake to focus solely on cancer drugs and their cost.

In our view, it is essential to have increased cancer prevention measures in order that there will be less cancer patients who will require treatment with expensive drugs.

The Australian Institute of Health and Welfare believes that “Preventing or delaying chronic disease is one of the most important priorities for the Australian health care system today”[5].

As the Cancer Council of Australia pointed out:

“More than one third of current cancer cases and associated costs can be prevented through lifestyle changes, while a significant number (i.e. bowel, breast and cervical) can be prevented or treated at greatly reduced cost through improved screening.

Cancer has an inverse expenditure/disease burden ratio, accounting for 19% of all deaths and premature deaths (the highest of any disease group) and 7% of healthcare costs.

As 65% of those costs are for inpatient services, greater investment in cancer prevention and early detection....... would reduce hospital costs while addressing the increasingly disproportionate human cost of cancer;

Investment in cancer prevention will produce significant gains in the control of other major disease groups with common risk factors, such as cardiovascular disease, diabetes and stroke.”[6]

Australia spends less on prevention and public health services than most other Organisation for Economic Co-operation and Development (OECD) countries, ranking in the lowest third in 2010–11.[7]  In order to meet the challenge of cancer drug costs, we believe it is important for Australia’s cancer prevention spending to be increased.

As well as gains from prevention of cancer generally, there are gains to be had from the prevention of prostate cancer.

Prostate cancer that is detected early — when it is still confined to the prostate gland — has a better chance of successful treatment[8].  At present nearly 1 in 5 Australian men with prostate cancer has cancer which has already metastasised at the time of diagnosis.  These men whose cancer has not been detected early enough cannot be cured; instead they have to undergo long term treatment with expensive cancer drugs. 

Reducing the number of men who have metastatic prostate cancer when they are diagnosed will significantly reduce the expenditure on expensive prostate cancer drugs.

The issue of PSA testing to assess individual risk for prostate cancer is a matter of controversy.  “Although the PSA is not an ideal marker, it is still the best diagnostic bio-marker across the whole of oncology...........Since the PSA screening test was introduced, deaths from prostate cancer have fallen by 40 per cent. So the question isn't about whether PSA screening should be carried out or not. It's more about doing it cleverly."[9]  The combination of PSA tests with recent developments in medical imaging technology means more accurate staging of individual cancers and better treatment[10].  More accurate staging and better treatment means less advanced prostate cancers which require long term treatment with expensive cancer drugs.

To ensure this enhanced accuracy in diagnosing prostate cancer, we request that the cost of multiparametric magnetic resonance imaging (MRI) and Gallium(Ga⁶⁸) Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scan be rebateable through the Medicare system.

1. the operation of the Pharmaceutical Benefits Advisory Committee and the Pharmaceutical Benefits Scheme in relation to such drugs, including the impact of delays in the approvals process for Australian patients; 

A key issue for us is the limited involvement of cancer patients in the operation of the Pharmaceutical Benefits Advisory Committee and the Pharmaceutical Benefits Scheme.

Cancer patients are important stakeholders who should have a greater involvement.  While the Australian system provides for consumer representation on the PBAC, and allows for consumer input in relation to individual products, the opportunity for the consumer voice is limited.

We wish to raise an issue about the Pharmaceutical Benefits Scheme of specific concern to men with advanced prostate cancer – the need to make a choice between Zytiga and Xtandi.

 

At the present time the PBS listing for Zytiga provides that Zytiga is not available if the patient has received treatment with Xtandi and the PBS listing for Xtandi provides that Xtandi is not available if the patient has received treatment with Zytiga.  These restrictions do not accord with clinical practice in the US and Europe.  Some patients who do not respond to Zytiga respond to Xtandi and vice versa.  Australian patients and their oncologists should not have to play Russian Roulette - pick the wrong drug and you are dead.  It is clinical practice in the US and Europe, where either Zytiga or Xtandi ceases to have benefit, the other drug will be used to see whether it provides benefit.

We believe that, in order to overcome delays in the Australian approval process, the US Food and Drug Administration multi-tiered system of ‘fast-track’, ‘accelerated approval’, and ‘priority review’ should be adopted for cancer medicines.

We also support the recommendation of the National Commission of Audit that “recognising approvals made by overseas agencies, including the Food and Drug Administration (USA) and the European Medicines Agency (EU).....would provide better outcomes to consumers as the latest drugs could be brought to the market without being delayed by a lengthy approval process”[11].  The National Commission of Audit noted that recognising approvals made by overseas agencies would also reduce the estimated annual cost pharmaceutical companies incur by having to win separate approvals from the Therapeutic Goods Administration.

One issue with the approval of cancer medicines for funding through the PBS is the continued focus on overall survival rather than absence of disease activity, slowing disease progression or symptom control.

As men with advanced disease, an extended “time to progression” is a large benefit; yet, in isolation, this benefit would struggle to meet the “value” criteria currently set under the PBS.

The economic cost/benefit ratios and quality of life instruments that are currently used to validate and compare drugs under the PBS should be re-assessed so to take into account factors such as disease free progression and quality of life.  These factors should be evaluated from the patient’s perspective (and their families); as well as a community perspective.

We agree with Medical Oncology Group of Australia that the responsiveness of the TGA registration process needs to be improved to reflect changes in the clinical setting:

“Indications on the PBS do not reflect clinical practice, standard cancer care and treatment recommendations. PBS has inadequate coverage of indications that have a sound evidence base, but are outside of TGA-approved indications. TGA indications do not keep pace with evidence development. This is due to many factors including the complexity of the TGA approval process; only drug sponsors can lodge an application for a new indication; lack of commercial incentives; off-label prescribing is clinically acceptable if supported by evidence; and, new evidence can be developed without the involvement of the original sponsor.”[12]

As noted in the DeloitteAccess Economics report, the practice of setting reimbursed prices for new medicines with reference to older comparators may sometimes be an obstacle to patient access to innovative cancer medicines.

1. the impact of delays in the approvals process for Australian patients;

Cancer patients with advanced disease cannot afford to wait months or years.  The impact of delays in the approvals process means that patients and their families are aware of treatments that have been evaluated overseas and proven to be effective, treatments which could provide enhanced quality of life or extra time with their families.  It is tragic for them and their families to be aware that these benefits will not be available to them.

 

Very few of us have disposable income of $100,000 per annum.  Cost is a recognised barrier in timely and equitable access to these cancer treatments.  Patients and their families should never be placed in the position where they are faced with the decision of going into debt and selling their homes or foregoing treatment.  We are concerned with the increasingly common situation where patients are resorting to fundraising activities to afford treatments that are either not subsidised, or to pay for overseas travel and insurance costs to access medicines that are not yet available in Australia.  Access to potentially useful medicines should not be determined by a patient’s/caregiver’s ability to organise media campaigns.

 

[1] Australian Institute of Health and Welfare: Australia’s health 2014; Section 4.3 Cancer in Australia.

[2] See the Deloitte Access Economics Access to Cancer Medicines in Australia Report July 2013 and the Reimbursement success rates and timelines for new medicines for cancer; an international comparison (2014) prepared for the Medicines Australia Oncology Industry Task Force and the International Comparison of Medicines Usage: Quantitative Analysis prepared by the UK Office of Health Economics 2014

 

[3] Appendix to the Report of the National Commission of Audit 2014 – Volume 1  Section 9 - Managing expenditure growth 9.4 The Pharmaceutical Benefits Scheme.

[4] Appendix to the Report of the National Commission of Audit 2014 – Volume 1  Section 9 - Managing expenditure growth 9.4 The Pharmaceutical Benefits Scheme.

[5] Australian Institute of Health and Welfare: Australia’s health 2014; Section 8 Preventing and treating ill health.

[6] Cancer Council Australia: Cancer control priorities for the 2010-11 federal budget.

[7] Australian Institute of Health and Welfare: Australia’s health 2014; Section 8 Preventing and treating ill health.

[8] http://www.mayoclinic.org/diseases-conditions/prostate-cancer/basics/definition/con-20029597

[9] Professor Dr Shahrokh Shariat, Head of the University Department of Urology at the MedUni Vienna http://tinyurl.com/n3se3sj

[10] European Urology, Volume 66 Issue 1, July 2014, Pages 22-29; http://www.sciencedaily.com/releases/2015/02/150203094153.htm

[11] Appendix to the Report of the National Commission of Audit 2014 – Volume 1  Section 9 - Managing expenditure growth 9.4 The Pharmaceutical Benefits Scheme.

[12] Medical Oncology Group of Australia Submission to Medicines Oncology Industry Taskforce 2013